Category Archives: Genetic Therapy

Minneapolis May 1, 2020 (Thomson StreetEvents) -- Edited Transcript of Bio-Techne Corp earnings conference call or presentation Thursday, April 30, 2020 at 1:00:00pm GMT

* Charles R. Kummeth

* James T. Hippel

Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst

Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst

* Jacob K. Johnson

Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst

SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst

Good morning, and welcome to the Bio-Techne earnings conference call for the third quarter of fiscal year 2020. (Operator Instructions) I would now like to turn the call over to David Clair, Bio-Techne's Senior Director, Investor Relations and Corporate Development.

David Clair, Bio-Techne Corporation - Senior Director of Corporate Development [2]

Good morning, and thank you for joining us. On the call with me this morning are Chuck Kummeth, Chief Executive Officer; and Jim Hippel, Chief Financial Officer of Bio-Techne. Before we begin, let me briefly cover our safe harbor statement. Some of the comments made during this conference call may be considered forward-looking statements, including beliefs and expectations about the company's future results as well as the potential impact of the COVID-19 pandemic on our operations and financial results. The company's 10-K for fiscal year 2019 identifies certain factors that could cause the company's actual results to differ materially from those projected in the forward-looking statements made during this call. The company does not undertake to update any forward-looking statements as a result of any new information or future events or developments. The 10-K as well as the company's other SEC filings are available on the company's website within its Investor Relations section. During the call, non-GAAP financial measures may be used to provide information pertinent to ongoing business performance. Tables reconciling these measures to most comparable GAAP measures are available in the company's press release issued earlier this morning on the Bio-Techne Corporation website at http://www.bio-techne.com. I'll now turn the call over to Chuck.

Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [3]

Thanks, Dave, and good morning, everyone. Thank you for joining us for our third quarter conference call. This has been an extraordinary quarter. First, I want to thank all the employees, suppliers and partners of Bio-Techne for their exemplary service as we have worked through the COVID-19 pandemic. We are happy to report that we have no coronavirus cases in any of our global sites and implemented proactive safety measures very early in the crisis in February to protect our employees. Our balance sheet is sound with a very strong cash position and low leverage. We have not conducted any restructuring or furloughs to date, easing the minds of our employees and enabling them to focus on serving our life science research customers and clinical diagnostics partners.

While COVID-19 negatively impacted our business this quarter, primarily due to the temporary shutdown of academic labs, we are playing a critical role in the global fight to develop tests and cures for the virus. Overall, we were having a very strong Q3 until the virus pandemic had a pronounced impact on our business in mid-March. But even so, we ended the quarter with 6% organic growth. Adjusting for the impact of coronavirus in the quarter, we estimate our organic growth would have been closer to 9%.

Our team also delivered incredibly strong operational results in Q3, with adjusted operating margins expanding year-over-year by 130 basis points to 36.5%, ahead of schedule and with strong cash flow.

Now I'll get into some details of the quarter. Starting with our performance by geography, the North American market was very strong with low double-digit growth organically in the quarter. Biopharma growth in the region was over 20% while academia increased mid-single digit. In general, both end markets were impacted by COVID-19-related shutdowns starting in mid-March, although our academic market experienced a disproportionate negative impact from the virus. The good news is that these are academic labs, not large industrial manufacturing lines. As researchers return to the lab and get back to work, we anticipate utilization of our consumables will snap back very quickly.

Overall, biopharma research activity has been less impacted by the virus, with many labs continuing to operate at varying capacities. I don't believe we are alone in our belief that once this pandemic is under control, life sciences research will likely increase significantly. It appears everyone in society from governments through the private sector now knows what an antibody is, this can only be good for our industry. With current stay-at-home policies, many of our customers are spending much more time -- of their time online. Therefore, we continue to focus on our digital marketing efforts that have driven significant increases in website traffic across our brands over the past couple of years. Search engine optimization, continual refinement of our website and digital advertising will remain a growth lever for the company going forward and will be even more important as a differentiator in the current pandemic environment. We have never done more webinars and digital projects to reach out to our customers. For example, we recently held an Exosome Diagnostics webinar for urologists, many of whom are working from home now and had over 100 participants.

Moving on to Europe, which was positioned for a sequential recovery until the virus hit, finished the quarter with revenue down from last year by 7%. Here, we had a very strong quarter in Biologics as well as with our Simple Plex platform, which is seeing strong growth in COVID-19-related patient care decisions by monitoring cytokine storm onset and progression. However, this strength was not enough to offset the March shutdowns in academia, which especially impacted our Simple Western, Genomics, assay and reagent businesses in the quarter. It is still uncertain when European labs will begin to open back up, but we're expecting this to be country-by-country process.

So far, in April, our German business is showing signs of an initial recovery, with Italy potentially not far behind. Our largest business is in the U.K., which is likely to be a month or so behind Germany in the recovery process.

Finally, we had a surprisingly strong Q3 in Asia. Given the complete shutdown in China in late February, we were prepared for a quarter of negative organic growth in this country, but finished with positive organic growth in the mid-single digits. This fantastic finish reflects the outstanding work done there by the local team. Our employees in China are back to work serving -- servicing a research market that has largely turned back on and expecting to revert to their long-term trend of double-digit growth in Q4. The rest of Asia also performed extraordinary well in Q3 with growth in the mid-teens. However, many of these countries, including Japan, Korea and India are currently in varying states of lockdown and expected to remain so for most of Q4. Accordingly, we are expecting double-digit negative growth outside of China in Q4.

Before I turn the call over to Jim for the financial review, I would like to provide some more detail on the initiatives that our company is working on to help our customers develop tests and find remedies for COVID-19. I will also provide an update on some of the strategic growth initiatives that will have the largest impact to our company for years to come.

Starting with our COVID-19 initiatives, we are experiencing significant demand in ramping production of our proteins and antibodies used in coronavirus research, including reagents that are components in serological assays. Also, we are working with several health care providers in perfecting antibody assays using the traditional ELISA platform that can detect an individual exposure profile to COVID-19, something that many health experts believe will require mass testing before world economies can resume any sort of pre-COVID-19 normalcy. Also, as I mentioned in my commentary regarding Europe, we've experienced significant global interest in demand to leverage Ella as an automation tool for the detection and monitoring of COVID-19 patients that are potentially experiencing cytokine release syndrome. This dangerous condition represents a critical and potentially fatal point in disease management.

In our Genomics division, we are supplying COVID-19 RNAscope Pro for virus detection in tissue, allowing researchers to confirm the organs that are impacted by this virus. And in Exosome Diagnostics, we have validated and preparing to perform COVID-19 real-time qPCR testing at our labs in both Munich, Germany and Waltham, Massachusetts. Following the implementation of processes and instruments to automate the test, we'll be capable of processing over 200 samples a day, and we can ramp further after that. This lab-developed test will provide rapid and reliable detection of patients with active COVID-19 infections.

These are just a few examples of how practically every division of our company has pivoted resources to find innovative solutions for COVID-19 and participate on a global level to help eradicate this horrible virus. We are uniquely positioned to provide reagents and assays for all aspects of COVID-19 research and diagnostics, and our mission thrives in helping solve these types of problems.

Next, I will provide an update on 2 of our important strategic growth platforms, cell and gene therapy as well as Exosome Diagnostics. Starting with cell and gene therapy, we continue to make progress on the construction of our new dedicated GMP protein factory. Construction of the facility remains on track to provide GMP proteins in large-scale to our cell and gene therapy customers by the second half of fiscal 2021. We are very encouraged by initial interest in demand from biopharma customers as we actively market our coming GMP protein production capabilities and capacities. In fact, during the quarter, we executed our first large-scale GMP protein supply agreement. This customer is still making its way through the regulatory approval process for its therapy, making the GMP protein with a revenue likely in fiscal '21.

Many other customers have been engaging us with interest in long-term supply agreements to ensure continuity of supply for their present clinical studies and to meet their future commercial needs. In the meantime, our GMP portfolio has been growing at a rapid pace with a number of immune cytokines being used to grow cells in clinical trials.

Also within our cell and gene therapy business, we have begun operationalizing the joint venture with Wilson Wolf and Fresenius Kabi that we announced last quarter. As a reminder, this commercial consortium offers a complete and simplified cell and gene therapy workflow solution using products from all 3 parties. During Q3, we focused on establishing a unified sales structure, a customer-facing website and point-of-sale and creating impactful marketing collateral, featuring all 3 parents offerings. In addition, the emerging interest in natural killer cell therapies for oncology has been demonstrating some great clinical potential. And the JV is well positioned for the renewed natural killer interest, leveraging our GMP proteins, cloud, media and PC buster platforms for cell genetic engineering of difficult to grow natural killer cells.

Now an update on Exosome Diagnostics and the ExoDx prostate test. There were several positive developments in Q3, and there is still much to do to make sure this noninvasive prostate cancer test becomes available to all patients with heightened PSA levels who are contemplating a more expensive, more risky and painful tissue biopsy. Following the final local coverage decision, or LCD, from our medical -- Medicare Administrative Contractor or MAC, National Government Services, NGS, we have been billing Medicare for applicable patient tests and are receiving steady reimbursement for tests submitted to this important payer. Recall that our -- we are currently preparing for the reconsideration process with our MAC, NGS to get the LCD more accurately mirroring the more inclusive NCCN Guidelines, which will expand the potential market size of the test. Based on our prior experience, we anticipate a public comment period to take place in the summer, followed by a final LCD in the fall.

Continuing on the reimbursement front, we announced the receipt of an unlimited 10-year reimbursement contract with General Services Administration, or GSA, making the ExoDx prostate test available to more than 140 government entities, including the Veterans Administration health care system. Our conversations with private payer community continue to progress, but many payers want to see a clinical utility study published prior to issuing favorable coverage decisions. We expect such publication in a leading peer-reviewed urology journal within the next couple of months. The clinical utility study shows improved patient compliance to either defer prostate biopsy or proceed with biopsy compared to the control arm when implementing the ExoDx prostate test in clinical practice. Due to this increased compliance to proceed with biopsy, physicians detected 30% more cases of clinically significant or high-grade prostate cancer compared to the standard of care control alarm. Implementing EPI not only saves the health care system money by avoiding unnecessary biopsies but also increases compliance among patients that need biopsies, leading to higher cancer detection rates. We anticipate the clinical utility and economic value shown in this study will resonate with the private payer community, increasing the frequency of our conversations and strengthening the argument for favorable coverage decisions.

Currently, the coronavirus pandemic has had an impact on a number of individual-seeking wellness business which in turn has had an impact on the number of PSA tests and ultimately the number of ExoDx prostate tests conducted. We saw this play out during the month of March, and the decline in test has continued into April. We responded by recently launching an at home collection kit for our ExoDx prostate test, enabling men who are sheltering in place and thus unable to see a health care professional to know if a biopsy should be prioritized. The solution was launched with a patient-targeted marketing strategy, including Search Engine Optimization, a Facebook campaign and webinars to drive awareness that patients do not need to go into the urologist's office to have access to this valuable test. We believe the flexibility of providing a urine sample at the convenience of the patient will be yet another key differentiator of the ExoDx prostate test from the competition.

With a pipeline of additional tests, companion diagnostic applications and partnership opportunities, there are multiple avenues to create value with Exosome Diagnostics. We have a few partnerships in place and are in active discussions with several diagnostics and biopharmaceutical companies for potential applications of Exosome Diagnostics technology. In summary, I'm very proud of the way our team executed in our fiscal third quarter, especially considering the global challenges created by COVID-19. The pandemic creates some near-term challenges, but also some near-term opportunities as we deploy reagents to enable vaccine and therapeutic discoveries and diagnostic solutions. Stepping back from the current environment, our pillars for growth are fully in place. We remain in the very early innings of realizing a tremendous liquid biopsy and cell and gene therapy potential opportunities. And our proteomic and genomic and analytical tools remain extremely well positioned in very underpenetrated markets. I firmly believe that the environment for life science research and diagnostics will be even stronger as we emerge from this pandemic, and we have the financial strength and product portfolio to capitalize on these opportunities. With that, I'll turn the call over to Jim.

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James T. Hippel, Bio-Techne Corporation - Senior VP of Finance & CFO [4]

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Thanks, Chuck. I will provide an overview of our Q3 financial performance for the total company, and provide some additional color on the performance of each of our segments, and give some initial thoughts on potential scenarios for our Q4.

Starting with the overall third quarter financial performance. Adjusted EPS was $1.39 versus $1.21 one year ago, with foreign exchange positively impacting EPS by $0.07. Most of the foreign exchange impact was due to nonoperating foreign exchange related to our cash pooling arrangement. GAAP EPS for the quarter was $0.92 compared with $1.15 in the prior year. The biggest driver for the decrease in GAAP EPS was $400,000 in realized and unrealized gains on our investment in ChemoCentryx compared to the $12.3 million in unrealized gains in the prior year. Q3 revenue was $194.7 million, an increase of 5% year-over-year on a reported basis. Organically, revenue increased 6%, with foreign exchange translation having an unfavorable impact of 1% and less than 1% growth contribution from acquisitions.

By geography, the U.S. grew in the low double digits, while Europe declined approximately 7% and China grew mid-single digits. As for the rest of Asia, organic growth was in the mid-teens. By end market, which excludes Asia, our Diagnostics division and other OEM customers, biopharma growth was in the low teens, while academic sales decreased by the low single digits.

Moving on to the details of the P&L. Total company adjusted gross margin was 71.5% in the quarter compared to 71.3% in the prior year. The increase was due to volume leverage, partially offset by foreign currency headwinds and, to a lesser extent, the B-MoGen acquisition. Adjusted SG&A in Q3 was 26.8% of revenue, a 90 basis point improvement compared to the prior year, with volume leverage partially offset by investments in our core business to drive near and long-term growth. R&D expense in Q3 was 8.2% of revenue, 20 basis points lower than the prior year, primarily due to volume leverage. The resulting adjusted operating margin for Q3 was 36.5%, an increase of 130 basis points from the prior year period and 310 basis points higher than our second fiscal quarter result.

Looking at our numbers below operating income. Net interest expense in Q3 was $4.2 million, decreasing $0.7 million compared to the prior year period. The decrease was due to a substantial reduction of our bank debt during the first half of fiscal 2020. Our bank debt on the balance sheet as of the end of Q3 stood at $420 million. Other adjusted nonoperating income was $3 million for the quarter compared to $1.5 million of other expense from Q3 last year, primarily reflecting the foreign exchange impact related to our cash pooling arrangements. For GAAP reporting, other nonoperating income includes realized and unrealized gains from our investment in ChemoCentryx.

Moving further down the P&L, our adjusted effective tax rate in Q3 was 21.3%, and we are anticipating Q4's rate to be closer to our year-to-date adjusted tax rate of 21.6%.

Turning to cash flow and return of capital. $49.5 million of cash was generated from operations in the quarter, up 25% over Q3 of last year. We also added to our cash position by monetizing approximately $30 million of our ChemoCentryx investment during the quarter. In Q3, our net investment in capital expenditures was $9.3 million, mostly driven by construction of our new GMP protein factory, which remains on schedule for completion by the end of the calendar year. And during Q3, we returned capital to shareholders with $12.3 million of dividends and approximately $50 million of share buybacks, leaving 39.4 million average diluted shares outstanding at the end of the quarter.

Next, I'll discuss the performance of our reporting segments, starting with the Protein Sciences segment. Q3 reported sales were $145.5 million, with reported revenue increasing 6%. Organic growth was also 6%, with foreign exchange having an unfavorable impact of 1% on revenue growth and acquisitions contributing 1% to revenue growth. Growth in the segment was driven by strong demand for protein reagents and both our Biologics and Simple Plex instrument platforms, partially offset by the impacts of COVID-19 customer shutdowns. Operating margin for the Protein Sciences segment was 44.7%, a decrease of 40 basis points year-over-year due to unfavorable foreign exchange and the B-MoGen acquisition.

Turning to the Diagnostics and Genomics segment. Q3 reported sales were $49.4 million, an increase of 5% from the prior year. Organically, revenues also grew 5%, with foreign exchange translation having an immaterial impact on revenue. Our Genomic divisions RNAscope contributed solid double-digit growth in the Americas, but this growth was partially offset by COVID-19 customer shutdowns in China as well as Europe. Exosome Diagnostics contributed approximately 3% to the segment's growth in Q3, with Medicare collections over $1 million following the final lab coverage decision by NGS in December.

Moving on to operating margin for the Diagnostics and Genomics segment, at 14.3%, the segment's operating margin improved from 7.6% reported in the prior year. The increase reflects a near double in operating profit due to less dilution from Exosome Diagnostics, volume leverage from our Genomics division and productivity gains from our diagnostic tools division. As many of you know, it is not our policy to provide specific annual or quarterly guidance, but instead provide some high level color, and how we anticipate our business to perform relative to our longer-term strategic plan. Clearly, the evolving COVID-19 pandemic and related customer impact was not contemplated in our long-term strategic plan nor a shorter-term annual plan. Therefore, I thought it'd be helpful to provide some color on the impact we've seen from COVID-19 so far in April and possible scenarios of how it could play out for our Q4.

Let me begin with the headwinds we've seen so far in April. With most academic institutions shut down in the Americas and Europe and some nonessential research put on pause by biopharma, our run rate in reagent and assay businesses in these geographies has dropped off considerably from prior year levels in the range of minus 20% to minus 40%, depending on the product line and specific regions. Encouragingly, there have been recent talk in both Europe and the U.S. about slowly and systematically opening up universities for professors to conduct their research, even if uncertain about students returning in the fall. Obviously, when it is safe to do so and this talk becomes action, our run rates will gradually improve as researchers return to their labs.

Chuck has already mentioned the headwinds we face in Asia outside of China due to reoccurrences of the virus in places like Japan and Singapore as well as the full walk-down in India. However, China is looking like a nice tailwind for us in Q4 with growth rebounding well into the double digits. Other tailwinds for Q4 include our Biologics and Simple Plex instrument product lines. Just as they led our growth in Q3, these platforms have started out just as strong in April, and we expect a high demand for them to continue, especially the Simple Plex platform, which is specific to COVID-19 treatment-related needs.

And finally, we should experience some tailwinds from all the other COVID-19 initiatives that Chuck previously discussed. But as many of these products are still currently under development, knowing exactly how much they will contribute to Q4 revenue is difficult to project. All this being said, our best estimate of how these variables will play out, results in a Q4 organic growth being somewhere in the range between minus 10% and minus 20%. Because we do not anticipate that our higher-margin reagent business so -- because we do anticipate that our higher-margin reagent business will be more severely impacted by the shutdown. This will likely have a material negative impact on gross margins for the quarter. Our operating margin will likely be further pressured by our operating cost base being relatively flat to prior year on much lower revenues. Right now, we are assuming that we have seen the worst impact from COVID-19 in April, and that conditions will gradually improve from here. And when they do, we will emerge as an even stronger company as we continue down our path of executing on our strategic plans and key growth initiatives.

In summary, despite unprecedented conditions created by COVID-19, we delivered 6% organic growth in the third quarter. We are in a position of financial strength with cash and short-term investments in excess of $250 million and a leverage ratio of just 1.4x. One thing this global pandemic has clearly highlighted is the need for life sciences research, and we believe that global demand for our tools, which enable drug discovery and production, genomic and proteomic analysis and diagnostic solutions will emerge from this pandemic stronger than when it began. Our global teams and product portfolio are positioned to capture that stronger demand in addition to our original growth plans when the virus-related headwinds subside. With that, that concludes my prepared comments, and I will turn the call back over to the operator for the line for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Puneet Souda with Leerink Partners.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [2]

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So Chuck, first of all, congrats on a solid quarter here despite the disruption. And it's good to see the resiliency in China and very tough compares that you had already from last year. So in April, if you could -- thanks for the comments, but I wanted to understand how is -- how do you view the recovery here for academic and biopharma segments, just sort of given the behavior academic has been impacted more heavily? Any sort of early signs in the latter part of April that you're seeing here that give you a better picture into May in either of the biopharma segments or the academic segments? Then I have a couple of questions.

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [3]

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Sure. Well, biopharma is still pretty resilient. And I think as we talked about, I think we have some upside even there with a lot of instrumentation that is hotter than ever. Biologics is doing really well. We are starting to see that drift into cell and gene therapy qualification. So we expect that platform to continue to do well. Simple Western is a little bit under pressure because unlike biologics, it's kind of 50-50 with academia. So a little softer. It's anyone -- yes, when things start opening up. I mean, you're hearing it already state-by-state, including lawsuits. There's a lot of fatigue out there. People want to go back to work. And with that, labs will reopen. And I think people are also getting creative with what they can start doing. And then we are seeing more activity online and a lot of webinar activity. And so end of April, maybe not so much material. By May, we're hoping some. Certainly, the -- in Q1, we expect to see things starting to come back. So we're hoping this is more of a V versus a long U. And that's kind of where we're looking at it.

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James T. Hippel, Bio-Techne Corporation - Senior VP of Finance & CFO [4]

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Another way -- another way to think about it too is we're gradually opening up the economy to go back to work. A lot of it is going to require social distancing practices while at work. There's an argument that can be made that in labs, in general, it's potentially easier for those practices to be put in place, perhaps in other types of industries. So another reason why we think that once the economy does, it starts to gradually reopen up life science research will be one of the earlier phases of that.

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [5]

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Well, I know in our own labs, which is remarkably a lot like every other lab, that we're pretty social distant anyway. People aren't just on top of one another in these labs. So I think there's a good -- it's just going to take time for people to acknowledge that and kind of get into it. But the world is going to be different. There will be masks that work for quite some time, I'm sure, and a lot of different things. But a lot of our people wore that stuff and gloves anyway. So I don't think there's been too much issue there. Pretty amazing to see China just kind of turned back on. If there any good data point that if you come back and follow good social distancing, everybody wears a mask, it looks like there's a good promise that we don't have a reescalation. So anyone guess over what happens with wave 1, 2, 3 over the next coming years. I'm sure there'll be some of that, too, but we're very, very optimistic that when this is all done, the paltry $40 billion NIH budget is going to go up dramatically. So it's a rounding year compared to what's been lost and what's been thrown around here for stimulus. So research is going to go up, and we're perfectly positioned. And by the way, we're going to be plugging some of this hole too with COVID-19 projects, which we alluded to. I wish we had more positive press release type news to give you, but we're working on many projects here than some that could really scale. But it's too early to tell you. If and when we come out with tests, serological or other, you'll know that it will have the R&D systems brand-new quality behind them. So it won't -- it will be something remarkable and with high sensitivity and specificity, and we're working on technology platforms around what we're good at, antibodies and proteins that can be differentiated from everybody out there and who is chasing the stuff. So stay tuned, more to come.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [6]

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Okay. That's helpful. So following on that, in COVID research, I know it's tough to quantify this, but do you expect to see any benefit from the $25 billion COVID testing and testing research allocation for the -- as part of the coronavirus relief fund? And what's your expectation here? Just in terms of the portfolio, the breadth of the portfolio that you have, from antibodies to cytokines. I mean, how should we think about what parts of the portfolio are likely to benefit when that NIH -- potential NIH increase that could happen in 2021? And so what parts of the portfolio should we expect to benefit from that because there is some expectation that could be directed more towards infectious diseases versus other traditional oncology research and other areas?

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [7]

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Well, it's anyone's guess how much will go one way versus the other in infectious diseases, but in terms of our portfolio, all of it. I can't imagine that there won't be an amazing interest continuing in the proteins that were developed. We're selling a lot of proteins that things are going up a lot in a lot of categories that are used in this research, and also with antibodies. And poly through monos, it's been pretty exciting. We almost can't keep up in some areas. So we're working on scalable solutions that can resupport partners for things like serological. For -- there's been a lot of relaxation with the FDA to try and have something work out there, and there's been some negativity around that. But I can guarantee you that we're on top of this and involved in many fronts and our reagencies are going to do really well. The tools are going to do well. You got to measure this stuff. We are the worldwide leader in ELISA Kits. And ELISA Kit is the best way to do a serologic. It's the cheapest, it's fast. Everybody has automation. So we're a world leader in Luminex with many partners. Luminex is another way to attack a lot of stuff in there. Everyone's got their flavor of these different partnerships and deals. And it's just become so vast. And like we talked about here, when do you see a new $1 trillion plus market open up overnight? And it's -- there are a lot of opportunities here, and we get the best of both worlds to chase the new market, but also do something wonderful for society. We're going to help eradicate this virus. We're involved on more fronts than we can even tell you. In terms of resources pivoted, virtually over 200 employees have been refocused around these projects in the company. And they may not all work out. We may win in some, lose in others or be a fast follower in others, but a lot of it or more, been around a lot of innovation, a long time. And these things always lead the stuff. And the funding is going to trickle down to touch many parts of our business. There's no doubt in my mind. It's hard to quantify right now, but it's going to be -- you got to look beyond Q4 and even Q1. You got to look into next year and the year after, we're going to be stronger than ever with the base business, and we're going to have all this incremental new business on top of it. And then we still have our cell and gene therapy and Exosome Diagnostics platform is just starting to ramp. So for us, it's a better story than ever. As we start looking out 1, 2, 3 years, I mean, in our opinion, in Q3. Our Q3 results just kind of make that indicative. We had a pretty darn good quarter.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [8]

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Yes. Last one, if I could ask on China. That was a surprisingly good quarter given sort of compared to what we were heading into. The shape of resiliency that you're seeing there currently, what's your expectation? How long do you think -- I mean, sort of how long is that sustainable? There are some questions being raised on the recurrence of the virus. Obviously, China was ahead of the curve. So what are you hearing from your team on the ground there?

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [9]

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Well, we have our whole team in, and we have our management in, too, including our leaders had to go in and go through quarantine to get back in the country. The country has got very, very strict guidelines to get in. So they're not letting anybody in without going through quarantine. So that's a big part of why they're staying safer probably. Everybody is wearing masks, according to our team. If you're -- China is one of those countries where there's a lot of lines in and so social distance up to this point was a very small distance. It's going to change and it is changing. And there's not been a material resurgence. So if there's no resurgence, we think it's, like we said, back to double-digit or higher already this quarter. So nothing but up. If there's a resurgence and there's new rules going in place, we'll have to adjust. But right now, there's nothing to worry about there. I'm frankly, much more concerned about what happens in India. And Japan and Korea are both a little behind the curve right now as well. So although we had a wonderful Q3, it's because really, they were just late to the game of the lockdowns. So as they work through their lockdowns this quarter, we'll have that hit, but hopefully, they'll have the same coming out that China did. But judging what we're seeing in Brazil right now, I don't like seeing that because I think India is really at risk. But -- and that's a big growth platform for not this year per se materially, but looking 5 years out, so it could put some risk into that. But I think Korea and Japan will be fine after a quarter here. And I think China is moving forward. We don't see a real hit. Europe is a slower recovery and it's country-by-country. We were having an outstanding quarter until this hit. And -- but I do think we are on track with a lot of fixing of Europe already, execution-wise, which is in place. And so as they go back to work and labs reopen, I think we'll be in a much better spot in Europe as well. U.S. has been phenomenal. So -- and it remains so. And this is where we're going to see a lot of our COVID-19 incremental growth this quarter and beyond. So hopefully, we'll have nothing to show but extra positive news there. So this is almost sadly the event we're looking for, for Ella. Ella is finally going to see its day. And we're up -- we expect 75% growth in Ella this quarter and probably a double for next year again. So it's going to become a material platform, finally, when this is all said and done. So -- and our ability to get it through all the FDA-related clearances has become easier, obviously. So...

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Operator [10]

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Our next question comes from the line of Catherine Schulte with Baird.

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Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [11]

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Congrats on a nice quarter. I guess, first, just going back to China. We've heard from other companies that academic and government labs have lagged in terms of reopening. Sounds like you are not seeing that, but just curious to hear, what was the low watermark for activity in China? Was that at 1 point down 20% to 40% as well? And what did that path to recovery look like?

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [12]

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It never went negative. And we ended mid-single digit. We were expecting -- we do it like everyone, we got a monthly flash. We had a monthly process, and we were expecting maybe minus 2, minus 3. That's the team was thinking, but it never got down there, and we ended up mid-single digit. I think you're seeing a difference us versus others. And other peers have a lot heavier instrumentation level in their portfolio than we do. We're also not that big, right? So on the reagents front and the things that can back up to speed quick in lab, that's kind of us. So it's a quicker recovery. If you're dealing in mass spec and HPLC and things like that, it's going to be slower. So I think you're seeing some of that. And -- but we were on a nice growth level anyway. So I'm not surprised to see this as long as labs are back at work. The kind of research they do with us with a lot of reagents level testing is something that will snap back quickly, which we also expect to see as well following in Europe and U.S. that's why we made the comments that we did about a fast recovery once labs reopen.

--------------------------------------------------------------------------------

James T. Hippel, Bio-Techne Corporation - Senior VP of Finance & CFO [13]

View post:
Edited Transcript of TECH earnings conference call or presentation 30-Apr-20 1:00pm GMT - Yahoo Finance

-New, 100 million facility will more than double existing production capacity

-Supports large-scale commercial manufacturing of viral and gene therapy products

DARMSTADT, Germany, April 21, 2020 /PRNewswire/ -- Merck, a leading science and technology company, today announced a second Carlsbad, California, U.S.A.-based facility for its BioReliance viral and gene therapy service offering. The new, 100 millioncommercial facility is expected to open next year.

Building on Merck's success in helping customers commercialize their gene therapies made possible by viral vectors, the company's expansion will help innovators produce at a scale that ensures these therapies reach more patients in need

"Viral vector manufacturing has transitioned from a niche industry to the cornerstone of the future of biopharmaceuticals," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. "Few companies have the scale and quality systems in place for manufacturing commercial viral vector products. Building on our success in helping customers commercialize their gene therapies made possible by viral vectors, our expansion will help innovators produce at a scale that ensures these therapies reach more patients in need."

Merck's Life Science business sector facility in Carlsbad manufactures gene therapies for its customers globally. Gene therapy involves the delivery of a genetic payload into patient cells to produce a therapeutic effect such as correction of a mutated gene or retargeting of an immune cell to fight cancer. Diseases such as hemophiliaand cancer are being investigated using this technique where a single dose may cure the disease. Viral vectors are often called the most complex therapeutic manufactured today.The gene therapy market, which accounted for $1 billion in 2018, is expected to reach $10 billion by 2026, according to a recent Biotech Forecasts global market analysis and industry forecast.

Merck's new, 140,000-square-foot manufacturing facility will support viral and gene therapy production at the 1000-liter scale using its Mobius single-use equipment. The site is part of the Life Science business' expanding product and service offering to the viral and gene therapy marketplace. Merck has close to three decades of experience in cell and gene therapy, and its Carlsbad, California, U.S.A site has been involved in the gene therapy area since 1997, near the time that clinical trials for gene therapy began. In the interim, the company manufactured viral vectors for two cell and gene therapy products.

This expansion underscores Merck's continued investment in viral and gene therapies from clinical to commercial scale and marks the second major investment at its Carlsbad facility in recent years. In 2016, the investments resulted in nearly doubling its former production capacity. The upgraded facility grew from 44,000 square feet to 65,000 square feet. Today, the Carlsbad site is home to 16 modular viral bulk manufacturing cleanroom suites with single-use equipment and two fill/finish suites for gene therapy, viral vaccine and immunotherapy products. With the expansion, the company will add 11 suites, bringing the total to 27, used in various steps of manufacturing.

In addition to contract development and manufacturing services for viral vectors, Merck also provides seamless manufacturing and testing services at its pharma and biopharma testing sites globally.

Merck recognizes that cell and gene therapy has resulted in major advancements in medicine. The company supports these therapies under consideration of ethical and legal standards; it has established an independent, external Bioethics Advisory Panel. This panel provides guidance on various topics, including gene editing and stem cells usage, in which its businesses are involved. The company has also defined a clear operational position taking into account scientific and societal issues.

Story continues

All Merck news releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About MerckMerck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck generated sales of 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Performance Materials.

Photo - https://mma.prnewswire.com/media/1156781/Merck_Gene_Therapy.jpg

SOURCE Merck

Read more:
Merck Boosts Commercial Viral Vector and Gene Therapy Manufacturing Capacity - Yahoo Finance

Scientists are trying to tackle the lack of diversity seen in genomics research, but even ambitious efforts, like the NIHs All of Us program, often fall short, especially when it comes to the inclusion of Indigenous communities. This is one of the reasons why the Decolonize DNA Day conference is taking place on April 24th, one day before the National DNA Day.

Traditionally, National DNA Day is an annual celebration of the discovery of DNA's double helix structure (1953) and the completion of the Human Genome Project (2003).

I was having conversations with colleagues on what would it mean to decolonize DNA, says Krystal Tsosie, an Indigenous (Din/Navajo) PhD student at Vanderbilt University. As an Indigenous academic, we always talk about what it means to Indigenize and re-Indigenize different disciplines of academia that have been historically more white-centred or white-dominated... and what it would mean to remove the colonial lens.

In collaboration with Latrice Landry and Jerome de Groot, Tsosie co-organized the Decolonize DNA Day Twitter conference to help re-frame narratives around DNA. Each speaker will have an hour to tweet out their "talk" and lead conversations on various topics, including how DNA ancestry testing fuels anti-Indigeneity and how to utilize emerging technologies to decolonize precision medicine.

There is a divide between people who are doing the science or the academic work, and the people who we want to inform, says Tsosie. Twitter is a great way to bridge that divide.

The Decolonize DNA Day conference is simply one effort to Indigenize genomics. Tsosie is also a co-founder of the Native BioData Consortium, a non-profit organization consisting of researchers and Indigenous members of tribal communities, focused on increasing the understanding of Native American genomic issues.

We dont really see a heavy amount of Indigenous engagement in genetic studies, which then means that as precision medicine advances as a whole [] those innovations are not going to be applied to Indigenous people, says Tsosie. How do we get more Indigenous people engaged?

Some of the answers can be found in a recent Nature Reviews Genetics perspective, penned by Indigenous scientists and communities, including those from the Native BioData Consortium. The piece highlights the actions that genomics researchers can take to address issues of trust, accountability, and equity. Recommended actions include the need for early consultations, developing benefit-sharing agreements, and appropriately crediting community support in any academic publications.

By switching power dynamics, were hoping to get genomic researchers to work with us, instead of against us, says Tsosie.

See the original post:
The brain's imprint on the skull shows what separates humans from other primates - Massive Science

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Regenxbio (RGNX) is a pioneer in gene therapies with a wide set of licensing agreements and an internal pipeline. The company focuses on adeno-associated virus (AAV) gene therapies for gene replacement and antibody delivery pursuing markets in retinal, neurodegenerative, and liver diseases. With a market cap of ~$1.3B (enterprise value of ~$1B), ~$400M of cash on the balance sheet, and ~$35M in revenue, Regenxbio is well-positioned to complete its milestones around manufacturing and clinical development into 2020.

The core investment thesis for Regenxbio is described below.

Validated technology platform to develop successful AAV gene therapies:

Strong financial position:

Undervalued internal assets:

From its 52-week high, Regenxbio's stock is down over 40%. The stock reached a low point from COVID-19 development. This is likely due to a lack of near term catalysts for the stock. With additional data for their lead asset in wet AMD coming in the first half of 2020, the initiation of phase II trials for the asset, and the sales ramp up for Zolgensma, the stock has a few potential catalysts coming up. As a result, there is an attractive entry point for investors to become an owner in Regenxbio.

Figure 1: RGNX daily chart (Source: Capital IQ)

The opportunity is that Regenexbio's licensing agreement with AveXis (NVS) on a medicine called Zolgensma to cure spinal muscular atrophy can potentially alone earn Regenxbio $3B-$4B in revenue. Zolgensma is an AAV gene therapy that delivers a transgene of SMN1 to cure the disease. About 20K people in the US have the disorder. With the medicine being priced at a little over $2M per patient, the market potential is well over $40B.

In 2014, Regenxbio licensed their AAV technology to AveXis to cure spinal muscular atrophy. The deal included various milestone payments to Regenxbio and importantly a mid-single to low double-digit royalties on net sales.

This one deal alone beyond the 20 similar deals Regenxbio has and its internal pipeline makes the company an attractive business. A simple DCF analysis with various assumptions, with the most important being including a capital expenditure of $400M for the clinical work with their flagship internal product, supports that Regenxbio is undervalued:

Figure 2: DCF model for RGNX (Source: Internal)

All the modeling done doesn't really help anyone figure out why this opportunity exists? Why is Regenxbio undervalued? Doubts around the Zolgensma scale up? Worries that capital from licensing deals will be wasted on an internal drug pipeline?

It's unprecedented that a drug company's platform is worth a lot more than the internal pipeline of drugs. From Regenxbio's latest corporate presentation, the company's main internal program, RGX-314, is focused on wet AMD:

Figure 3: Overview of Regenxbio's main asset (Source: Corporate Presentation)

RGX-314 is an AAV therapy for wet AMD. The slide describes the problem (leaky blood vessels in the eye) and how large it is (~2M patients) along with the vector (AAV8) and delivery cargo (anti-VEGF Fab). However, the company doesn't mention Eylea or other wet AMD medicines that are already approved. Regenxbio alludes to issues around delivery of drugs like Eylea (REGN), but doesn't go too deep on this slide or the presentation in general about how competitive their RGX-314 program will really be amongst clinicians.

An important point for any gene therapy is delivery whether it's a transgene or a CRISPR protein. A major reason why Regenxbio focused on wet AMD and ophthalmology in general is that delivering something to the eye is a lot easier than delivering something to the brain. RGX-314 is undergoing a phase I/II trial focused on establishing safety; the pivotal trial will come later. For the phase I portion, the company met their primary endpoint and showed safety so far. They have also shown how increasing doses of their gene therapy reduces the number of injections. This is going to be an important experiment and data set to argue for clinicians to switch over from something like Eylea.

The real value in Regenxbio is in its AveXis deal and the various licensing partnerships:

Figure 4: Regenxbio licensing partnerships (Source: Corporate Presentation)

Figure 5: Regenxbio licensing partnerships (Source: Corporate Presentation)

Figure 6: Regenxbio licensing partnerships (Source: Corporate Presentation)

This business model is enabled by Regenxbio's core technology focused on AAV7-10 and natural or close-to-natural variants:

Figure 7: Overview of Regenxbio's platform (Source: Corporate Presentation)

Over the next two years, the key milestones are:

The business can continue to strike up more licensing deals and expand current ones. The margin of safety here is that Regenxbio is undervalued just for its deal with AveXis and its various licensing deals that provide periodic payments based on progress and potentially more royalties if the drugs are approved and commercialized.

This seems to be a case where the market is focusing on the company's internal pipeline. Regenxbio's headline drug is interesting but unlikely to be competitive. Whereas, the business has a wonderful platform and licensing business that is being ignored. Simple valuations show these cash flows are not being fully appreciated. As a result, Regenxbio is going to grow revenue without any additional work and still has the potential to strike again through the 20 or so deals it has.

Figure 8: Key upcoming milestones for Regenxbio (Source: Corporate Presentation)

Regenxbio's lead candidate is focused on wet age related macular degeneration (AMD). The disease is a severe form of macular degeneration, a condition in which layers of macula get progressively thinner. The wet form is caused by abnormal blood vessels grown under the macula and retina where leaky blood vessels cause problems with vision, ultimately leading to blindness. The current standard-of-care is an anti-vascular endothelial growth factor (anti-VEGF) therapy. Patients require monthly injection of anti-VEGF to stop the growth of leaky blood vessels. Wet AMD is not a genetic disease, but it is a large and established market for Regenxbio to capture.

To frame the market opportunity of wet AMD, a few facts are helpful:

196 million people worldwide & 288 million by 2040 have AMD

10% have wet AMD, but is the leading cause of blindness

175,000 new patients annually in US

Growing number of patients due to aging population

Current treatments are regular injections of anti-VEGF

Figure 9: Overview of wet AMD (Source: JMS)

For wet AMD, competition comes from Genentech, Regeneron (REGN), and Adverum (ADVM). Genentech sells Lucentis at a price of $1850 per dose. Regeneron sells Eylea at $1150 per dose. Genentech's Avastin is also used off lab and is becoming more popular due to its cheap price of $60 per dose; the medicine is currently used for metastatic colorectal cancer. For gene therapies in wet AMD, the sole competitor is Adverum Biotechnologies. With 20M people with wet AMD, the total market opportunity for these medicines are in the billions of dollars.

Where Genentech's and Regeneron's medicines require multiple doses over the lifetime of a patient, a gene therapy has the potential to be curative and remove the multiple dosing requirement. For wet AMD, over 50% recurrence rate in the first year after treatment has stopped, and over 25% recurrence rate in the second year after treatment has stopped For drugs like Eylea and Lucentis, monthly intravitreal injection creates large burden for patients and create difficulty in dosing for clinicians. These problems allow Regenxbio to potentially capture the market with a gene therapy:

Figure 10: Wet AMD market (Source: Reportlinker)

Regenxbio's lead asset, RGX-314 is pursuing wet AMD. So far the company has shown:

Dose dependent protein expression levels and drug efficacy

Sustained protein expression for over 1.5 years

Long term efficacy demonstrated for Cohort 3 for rescue-free patients

No serious adverse events (SAE), but mild adverse events (AE) such as inflammation

Significant improvement in visual acuity for rescue free patients

Figure 11: Trial design of Regenxbio's lead asset (Source: Corporate Presentation)

RGNX

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Dose

3 x 109 gc/eye

1 x 1010 gc/eye

6 x 1010vg/eye

1.6 x 1011 gc/eye

2.5 x 1011 gc/eye

Rescue Injection Free

Not Available

Mean 4.7 rescue inj.

Not Available

Mean 3.8 rescue inj.

3 / 6 Patients

Mean 1.3 rescue inj.

5 / 12 Patients

Mean 2.2 rescue inj.

9 / 12 Patients

Mean 0.8 rescue inj.

Duration

52 Weeks

52 Weeks

78 Weeks

52 weeks (2H 2020)

52 weeks (2H 2020)

Best Corrected Visual Acuity (BCVA)

In ETDRS letters

Mean: -2.0

Range: -8/+10

Mean: +7

Range: -4/+15

Mean: +8

Range: 0/+21

Mean: +2

Mean: +4

Central Subfield Thickness (m)

Mean: -14

Range -81/+92

Mean: +26

Range -7/+62

Here is the original post:
Regenxbio Is A Leader In Gene Therapies - A Case Where The Platform Is Worth More Than The Pipeline - Seeking Alpha

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

New Protein IDed that May Cause Alzheimers

Scientists at the University of Tokyo tested 19,151 individual genes looking for their effect on amyloid beta levels. Amyloid beta is one of the proteins that accumulates in the brains of Alzheimers patients and is generally viewed as one of the primary drivers of the disease. They identified a new protein using CRISPR/Cas9 gene editing, called calcium and integrin-binding protein 1 (CIB1). They found that cells without functional CIB1 genes generate abnormally high levels of amyloid beta protein. The research was published in FASEB Journal.

We believe this is the first time anyone has used this CRISPR/Cas9 genetic screening technique to look for changes in amyloid beta production, said Yukiko Hori, co-first author and lecturer at the University of Tokyo.

In normal, healthy cells, CIB1 is not directly involved with processing amyloid beta, but it stays attached to another protein, gamma secretase inside cells and at the cell membrane. In cells that dont have CIB1, gamma secretase stays inside the cell longer and doesnt leave the membrane. Amyloid beta undergoes multiple steps before reaching its final form. Normally, gamma secretase processes amyloid beta precursors to help produce the final amyloid beta protein. This happens inside the cell, then gamma secretase moves to the cells outer surface membrane.

Patients diagnosed with early-stage Alzheimers disease have lower levels of CIB1 in their brains, while people with late-stage Alzheimers have higher-than-healthy levels of CIB1.

We cannot say for certain why CIB1 is increased in late-stage Alzheimers disease, said Taisuke Tomita, who runs the research lab where the study was conducted. What is important is that in both the early and late stages of Alzheimers disease, something is abnormal about the regulation of CIB1.

Possible Approach to Improving Gene Therapy

Investigators at the University of Groningen have developed a technique that may improve gene therapies. They use DNA/lipid complexes (lipoplexes). Because the viruses used traditionally in gene therapies can cause an immune response and the cells endosomes tend to degrade DNA or other particles, the lipoplex provides protection. They can fuse with the endosome membrane, which prevents degradation.

Gene Promoters that Can Be Used to Treat Neurological Diseases

Researchers at Princeton Neuroscience Institute have developed new gene promoters that act like switches to turn on gene expression. They can be used in gene therapy, with a particular interest in neurological diseases such as Parkinsons and Alzheimers. Viruses are used to carry genes into cells during gene therapy, typically adeno-associated viruses. The Princeton team used promoters found in herpes viruses, which take up less space than existing promoters and allow the transport of larger genes or multiple genes. They are also long-lasting.

Biosensor to Detect SARS-CoV-2 in the Air

Researchers at Switzerland-based Empa, ETH Zurich and Zurich University Hospital have developed a sensor that has the potential to identify SARS-CoV-2, the novel coronavirus that causes COVID-19, in the air. The work is led by Jing Wang at Empa, who usually works on measuring and analyzing airborne pollutants. The sensor has reliably shown it can identify the first SARS-CoV virus that was responsible for the SARS pandemic in 2003. It has numerous similarities to SARS-CoV-2. Tests showed that the sensor can clearly distinguish between the very similar RNA sequences of the two viruses, Jing Wang said. And the results appear in minutes.

Possible Gene Therapy for Glaucoma

Glaucoma is a common condition of the eye involved fluid buildup in the front part of the eye. It affects more than 64 million people globally and is the leading cause of irreversible blindness. Current treatments include eye drops, laser or surgery. Researchers at the University of Bristol demonstrated that a single injection of a gene therapy using CRISPR and a gene called Aquaporin 1 targeting the ciliary body, where fluid is produced within the eye, led to reduced eye pressure.

More Evidence Parkinsons is an Autoimmune Disease

A study co-led by investigators at the La Jolla Institute for Allergy and Immunology (LJI) adds to the theory that Parkinsons disease is at least partly an autoimmune disease. The research was published in Nature Communications. Science has known for some time that the clumps of a damaged protein known as alpha-synuclein build up in the dopamine-producing brain cells of Parkinsons disease patients. The clumps lead to death of the cells and cause motor symptoms and cognitive decline.

Once these cells are gone, theyre gone, said Cecilia Lindestam Arlehamn, first author of the study and LJI research assistant professor. So if you are able to diagnose the disease as early as possible, it could make a huge difference.

A 2017 study showed that alpha-synuclein attracted certain type of T-cells, causing them to mistakenly attack brain cells, which potentially contributed to the progression of Parkinsons. The new findings found that the T-cells that react to alpha-synuclein are the most abundant when patients are first diagnosed with the disease. They tend to disappear later in the disease and by 10 years after diagnosis, few patients still have them.

This tells us that detection of T-cell responses could help in the diagnosis of people at risk or in early stages of disease development, when many of the symptoms have not been detected yet, said LJI professor Alessandro Sette, who co-led the research with David Sulzer of the Columbia University Medical Center. Importantly, we could dream of a scenario where early interference with T-cell responses could prevent the disease from manifesting itself or progressing.

See the rest here:
Research Roundup: New Protein Linked to Alzheimer's Identified and More - BioSpace

Scientists are trying to tackle the lack of diversity seen in genomics research, but even ambitious efforts, like the NIHs All of Us program, often fall short, especially when it comes to the inclusion of Indigenous communities. This is one of the reasons why the Decolonize DNA Day conference is taking place on April 24th, one day before the National DNA Day.

Traditionally, National DNA Day is an annual celebration of the discovery of DNA's double helix structure (1953) and the completion of the Human Genome Project (2003).

I was having conversations with colleagues on what would it mean to decolonize DNA, says Krystal Tsosie, an Indigenous (Din/Navajo) PhD student at Vanderbilt University. As an Indigenous academic, we always talk about what it means to Indigenize and re-Indigenize different disciplines of academia that have been historically more white-centred or white-dominated... and what it would mean to remove the colonial lens.

In collaboration with Latrice Landry and Jerome de Groot, Tsosie co-organized the Decolonize DNA Day Twitter conference to help re-frame narratives around DNA. Each speaker will have an hour to tweet out their "talk" and lead conversations on various topics, including how DNA ancestry testing fuels anti-Indigeneity and how to utilize emerging technologies to decolonize precision medicine.

There is a divide between people who are doing the science or the academic work, and the people who we want to inform, says Tsosie. Twitter is a great way to bridge that divide.

The Decolonize DNA Day conference is simply one effort to Indigenize genomics. Tsosie is also a co-founder of the Native BioData Consortium, a non-profit organization consisting of researchers and Indigenous members of tribal communities, focused on increasing the understanding of Native American genomic issues.

We dont really see a heavy amount of Indigenous engagement in genetic studies, which then means that as precision medicine advances as a whole [] those innovations are not going to be applied to Indigenous people, says Tsosie. How do we get more Indigenous people engaged?

Some of the answers can be found in a recent Nature Reviews Genetics perspective, penned by Indigenous scientists and communities, including those from the Native BioData Consortium. The piece highlights the actions that genomics researchers can take to address issues of trust, accountability, and equity. Recommended actions include the need for early consultations, developing benefit-sharing agreements, and appropriately crediting community support in any academic publications.

By switching power dynamics, were hoping to get genomic researchers to work with us, instead of against us, says Tsosie.

Read the original post:
On National DNA Day, scientists are trying to take the colonialism out of genetics - Massive Science