Category Archives: Genetic Medicine

Six vaccine candidates in clinical trials for COVID-19 employ viruses to deliver genetic cargo that, once inside our cells, instructs them to make SARS-CoV-2 protein. This stimulates an immune response that ideally would protect recipients from future encounters with the actual virus. Three candidates rely on weakened human adenoviruses to deliver the recipe for the spike protein of the pandemic coronavirus, while two use primate adenoviruses and one uses measles virus.

Most viral vaccines are based on attenuated or inactivated viruses. An upside of using vectored vaccines is that they are easy and relatively cheap to make. The adenovirus vector, for example, can be grown up in cells and used for various vaccines. Once you make a viral vector, it is the same for all vaccines, says Florian Krammer, a vaccinologist at the Icahn School of Medicine at Mount Sinai. It is just the genetic information in it that is different, he explains.

Once inside a cell, viral vectors hack into the same molecular system as SARS-CoV-2 and faithfully produce the spike protein in its three dimensions. This resembles a natural infection, which provokes a robust innate immune response, triggering inflammation and mustering B and T cells.

But the major downside to the human adenoviruses is that they circulate widely, causing the common cold, and some people harbor antibodies that will target the vaccine, making it ineffective.

CanSino reported on its Phase II trial this summer of its COVID-19 vaccine that uses adenovirus serotype 5 (Ad5). The company noted that 266 of the 508 participants given the shot had high pre-existing immunity to the Ad5 vector, and that older participants had a significantly lower immune response to the vaccine, suggesting that the vaccine will not work so well in them.

With vectors you are always trying to find the sweet spot. Too weak, and they dont work. Too strong, and they are too toxic.

Nikolai Petrovsky, Flinders University

The problem with adenovirus vectors is that different populations will have different levels of immunity, and different age groups will have different levels of immunity, says Nikolai Petrovsky, a vaccine researcher at Flinders University in Australia. Also, with age, a person accumulates immunity to more serotypes. Being older is associated with more chance to acquire Ad5 immunity, so those vaccines will be an issue [with elderly people], Krammer explains. Moreover, immunity against adenoviruses lasts for many years.

A lot of people have immunity to Ad5 and that impacts on how well the vaccine works, says Krammer. In the US, around 40 percent of people have neutralizing antibodies to Ad5. As part of her work on an HIV vaccine, Hildegund Ertl of the Wistar Institute in Philadelphia previously collected serum in Africa to gauge resistance levels to this and other serotypes. She found a high prevalence of Ad5 antibodies in sub-Saharan Africa and some West African countries80 to 90 percent. A different group in 2012 reported that for children in northeast China, around one-quarter had moderate levels and 9 percent had high levels of Ad5 antibodies. I dont think anyone has done an extensive enough study to do a world map [of seroprevalence], notes Ertl.

J&Js Janssen is using a rarer adenovirus subtype, Ad26, in its COVID-19 vaccine, reporting in July that it protects macaques against SARS-CoV-2 and in September that it protects against severe clinical disease in hamsters. Ad26 neutralizing antibodies are uncommon in Europe and the US, with perhaps 1020 percent of people harboring antibodies. They are more common elsewhere. In sub-Saharan Africa, the rates are ranging from eighty to ninety percent, says Ertl.

Also critical is the level of antibodies in individuals, notes Dan Barouch, a vaccinologist at Beth Israel Deaconess Medical Center and Harvard Medical School. For instance, there was no neutralizing of Ad26-based HIV and Ebola vaccines in more than 80,000 people in sub-Saharan Africa, he says. Ad26 vaccine responses do not appear to be suppressed by the baseline Ad26 antibodies found in these populations, because the titres are low, Barouch writes in an email to The Scientist. Barouch has long experience with Ad26-based vaccines and collaborates with J&J on their COVID-19 vaccine.

The Russian Sputnik V vaccine, approved despite no published data or Phase 3 trial results, starts with a shot of Ad26 vector followed by a booster with Ad5, both of which carry the gene for the spike protein of SARS-CoV-2. This circumvents a downside of viral vector vaccines, specifically, once you give the first shot, subsequent injections will be less efficacious because of antibodies against the vector. Ertl says she has no idea of the proportion of the Russian population with Ad26 or Ad5 antibodies, and there seems to be little or no published data from countries that have expressed interested in this virus, such as Venezuela and the Philippines.

An alternative is look to our nearest relatives. Chimp adenoviruses were the focus of vaccine interest by Ertl for HIV and by Adrian Hill at the University of Oxford for malaria. About one percent of people have antibodies to the chimp adenovirus, probably because of cross reactivity, which is why we use it, explains Hill, referring to the COVID-19 vaccine candidate ChAdOx1 nCoV-19, which has shown antibody and T cell responses in an early phase clinical trial. This candidate, which also encodes the instructions for producing SARS-CoV-2 spike protein, is now in Phase 3 trials in the UK, US, South Africa, and Brazil and is to be manufactured by AstraZeneca.

Unfortunately, says Ertl, use of the attenuated chimp virus in a COVID-19 vaccine means it cannot now be used for malaria, because those vaccinated for the coronavirus will have antibodies against the vector. But there are other simian vectors. In Italy, a Phase 1 trial of a COVID-19 vaccine with a gorilla adenovirus vector has begun recruiting healthy volunteers. Ertl says that having multiple adenoviruses from different species is a good thing, because it broadens the range of diseases we could tackle. It could also allow animal virus vectors for COVID-19 vaccines to be used in places where human adenovirus immunity is high.

Not everyone is enthusiastic about vector-based vaccines. Their reactogenicity profile is not great, says Petrovsky, meaning they stimulate a strong immune response. Even [President Vladimir] Putin commented that his daughter had a fever [after taking Sputnik V]. Generally, fevers are a no-no for a vaccine. He says headache and fever have been relatively common in early results from vaccines based on viral vectors. Some people are prone to having convulsions from fevers, so extreme reactions cannot be ruled out, he adds.

Petrovsky says children generally react more strongly to vaccines than adults do, and that could be a huge drawback in countries with young populations such as India. With vectors you are always trying to find the sweet spot, says Petrovsky, which is their Achilless heel. Too weak, and they dont work. Too strong, and they are too toxic. Petrovsky is involved in the development of Covax-19, a recombinant proteinbased vaccine plus adjuvant that is in early clinical trials and was developed by his company Vaxine Pty in Australia.

So far, there is not much experience with vector-based vaccines on the market. The European Medicines Agency granted market authorization in May for a new Ebola vaccine that consists of a prime shot with an Ad26 vector, and a booster with an attenuated poxvirus (MVA). An HIV vaccine trial based on Ertls research was to have started this fall, but has been delayed until next year due to COVID-19. We dont have post-licensing experience, says Ertl, in relation to vector-based vaccines, but these things have been in multiple trials, so we have a reasonably good idea about what doses are tolerated and about safety concerns.

In August, a trial in France and Belgium began recruiting volunteers to test a COVID-19 vaccine based on a replicating measles vaccine virus. This so-called Schwartz strain was weakened in the 1960s by serial passaging on chicken cells. The virus expresses the full-length spike protein of SARS-CoV-2 and has been tested in mice, say scientists at the Pasteur Institute in France who licensed the vector technology to Themis in Austria. It was previously tested on mice for SARS and for MERS.

It was shown previously that pre-existing immunity to measles acquired by infection in the elderly or vaccination in young people did not dampen responses to a Chikungunya vaccine based on this same vector. The measles vector goes into cells, then makes more measles vaccine. It will come out again, infect more cells, but after a few cycles it stops, says vaccine scientist Christiane Gerke of the Pasteur Institute who is leading the COVID-19 vaccine trial. That the measles strain replicates distinguishes it from the adenovirus vectors and could explain why pre-existing antibodies do not matter. So long as measles antibodies at the start do not eliminate all of the vaccine, then the vaccine replicates itself, says Gerke.

The live nature of the measles vaccine strain means that it could not be given to immunocompromised individuals. However, the Swartz strain has about 50 mutations and measles vaccine strains have never escaped these attenuation shackles and caused disease in healthy people. It is a promising candidate, says Krammer, though a little behind the others. The Pasteur Institute could not confirm whether volunteers had begun receiving the vaccine. In June, Themis was acquired by Merck, a company with a significant vaccine portfolio.

Success with viral vectors has implications for vaccine development overall. It took a very long time for viral vectors to end up on the market, which they did with the Ebola vaccines, says Krammer. The way I see it, this is going to speed up vaccine development in general. That is, as long as there is a successful outcome with a COVID-19 vaccine. Any misstep by a regulator with one of these vaccines could retard the potential of vector-based vaccines for multiple diseases, says Krammer.

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Vector-Based Vaccines Come to the Fore in the COVID-19 Pandemic - The Scientist

Summary

An international team of investigators led by Memorial Sloan Ketterings Robert Motzer has identified biological attributes of kidney cancer tumors that correlate with better responses to immunotherapies and targeted therapies.

Treatments for kidney cancer have improved considerably over the past few decades. In 1988, when Memorial Sloan Kettering oncologist Robert Motzer started researching the disease, the average survival was less than one year. There were no approved therapies at the time besides surgery. By 2005, with the development of targeted drugs such as sunitinib (Sutent), survival nearly tripled. Today, with the addition of immunotherapy drugs to these regimens, people with kidney cancer are living even longer, and some even seem to be cured.

Despite this clear progress, it remains difficult to predict who will respond to these therapies, and what underlying biological factors influence these responses. To help answer these questions, an international team of investigators led by Dr. Motzer performed an in-depth study of kidney cancer tumors from nearly 900 people who were treated as part of a large, phase III clinical trial.

That trial compared two different treatments: a combination of avelumab (an antiPD-L1 immunotherapy) and axitinib (a drug targeting tumor blood vessels), versus sunitinib (another blood vessel-targeting drug) given alone. People with advanced renal cell carcinoma who received the combination did better (in terms of the length of time their cancer shrunk or did not get worse) than people who received sunitinib alone. On the basis of these results, the US Food and Drug Administration approved the combination of avelumab (Bavencio) and axitinib (Inlyta) to treat kidney cancer in May 2019, establishing a new standard of care for this disease.

While that might seem like crossing the finish line, Dr. Motzer and his colleagues wanted to extract all the useful information they could out of the clinical trial data.

Oftentimes, when a drug is approved, theres not really an effort on the part of pharmaceutical companies to understand the underlying biology of tumors collected from patients treated on the pivotal trial, Dr. Motzer says. With this study, which we conducted in partnership with Pfizer, we wanted to take a deep dive into the biology so that we could generate new avenues of research to keep the field moving forward.

The results of this deep dive including identification of several novel biomarkers of response were reported on September 7in the journal Nature Medicine.

Based on a phase III clinical trial led by MSK medical oncologist Robert Motzer, the FDA approved the combination of avelumab and axitinib to treat people with advanced kidney cancer.

Among the variables the team analyzed were levels of a biomarker called PD-L1 (a common immunotherapy target) and the number of mutations present in the tumor (dubbed tumor mutation burden or TMB). Both these measures have been associated with improved responsiveness and better survival in other cancer types. Somewhat surprisingly, neither measure correlated to a better response to the immunotherapy and targeted therapy combination in this trial.

In addition to these well-known biomarkers, the scientists also looked for patterns of gene activity and specific genetic mutations that correlated with treatment response. Here, they found clear contenders.

In particular, they identified a set of 26 genes whose activity correlated with progression-free survival (PFS) in the combination arm of the trial. They dubbed this the Renal 101 Immuno signature. They also identified mutations in 11 other genes that were associated with differences in PFS in the combination arm.

Likewise, in the sunitinib-only arm, the investigators found a specific pattern of gene activity that correlated with longer progression-free survival. Because the genes are mostly involved in generating new blood vessels, a process called angiogenesis, they dubbed this the Renal 101 Angio signature.

By testing for these specific markers in tumors, doctors could potentially personalize treatments for patients based on whether they are more or less likely to respond. The gene signatures and mutations also provide scientists with new avenues of biological research to understand how these genes are contributing to the response.

My priority right now as a clinical investigator in kidney cancer is to help facilitate this kind of collaborative translational research between clinicians and laboratory scientists so that we can identify why these new combinations are working and maybe develop even better treatments as a result, he says.

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Deep Dive into Biology of Kidney Tumors Identifies Markers of Response to Immunotherapy - On Cancer - Memorial Sloan Kettering

22nd Annual H.C. Wainwright Global Investor Conference presentation at1:30 p.m. ET on September 16TH

Oppenheimer Fall Healthcare LifeSciences & Medtech Summit Fireside Chat at 10:00 a.m. ET on September 23 RD

PITTSBURGH, Sept. 08, 2020 (GLOBE NEWSWIRE) -- NeuBase Therapeutics, Inc. (NASDAQ: NBSE) (NeuBase or the Company), a biotechnology company accelerating the genetic revolution using a new class of synthetic medicines, announced today that Dietrich A. Stephan, Ph.D., Chief Executive Officer of NeuBase, will present a corporate overview at the virtual H.C. Wainwright 22nd Annual Global Investment Conference, as well as participate in a fireside chat at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, which are both being held in September 2020.

About NeuBase TherapeuticsNeuBase is accelerating the genetic revolution using a new class of synthetic medicines. NeuBases designer PATrOL therapies are centered around its proprietary drug scaffold to address genetic diseases at the source by combining the highly targeted approach of traditional genetic therapies with the broad organ distribution capabilities of small molecules. With an initial focus on silencing disease-causing mutations in debilitating neurological, neuromuscular and oncologic disorders, NeuBase is committed to redefining medicine for the millions of patients with both common and rare conditions. To learn more, visit http://www.neubasetherapeutics.com.

NeuBase Investor Contact:Dan FerryManaging DirectorLifeSci Advisors, LLCDaniel@lifesciadvisors.comOP: (617) 430-7576

NeuBase Media Contact:Cait Williamson, Ph.D.LifeSci Public Relationscait@lifescipublicrelations.com OP: (646) 751-4366

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NeuBase Therapeutics to Present at Upcoming Investor Conferences in September 2020 - GlobeNewswire

CAMBRIDGE, Mass. and NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, today announced the appointment of Rachel Humphrey, M.D., as Chief Medical Officer. Karsten Witt, M.D., who has been Senior Vice President of Clinical Development and acting Chief Medical Officer since May 2019, will continue to serve the Company as Senior Vice President (SVP), Non-Clinical Development.

Rachel has pioneered the clinical development of numerous first-in-class oncology drugs spanning the broad landscape of oncology therapeutics, including first generation kinase inhibitors and immune checkpoint blockers. Her expertise in the field makes her the ideal person to lead Black Diamonds strategy of using population-level cancer genome data to develop drugs that target rare and recurrent driver mutations across tumor types, said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. Rachels leadership and oncology drug development experience will be essential as we advance BDTX-189 through clinical development and move our early stage pipeline programs into the clinic. Id also like to thank Karsten for his tremendous contributions to Black Diamond to date, particularly his leadership in advancing BDTX-189 into the clinic, and we welcome his continued insights as he transitions to his new role.

Black Diamonds innovative platform and drug discovery engine, coupled with a tumor-agnostic approach to drug development, has produced a uniquely compelling pipeline with the potential to target a broad range of cancers unaddressed by currently approved therapies, said Dr. Humphrey. Im thrilled to join the dynamic team at Black Diamond to execute on the vision of extending precision oncology therapies for patients with genetically defined cancers for whom limited treatment options currently exist.

Dr. Humphrey joins Black Diamond from CytomX Therapeutics, Inc., where she served as Chief Medical Officer and as a member of its Board of Directors. While at CytomX, she supervised the clinical development of ProbodyTherapeutics for the treatment of cancer. Previously, she held numerous senior leadership roles in cancer drug development, including Vice President (VP), Head of Immuno-Oncology at Eli Lilly and Company, SVP and Head of Immuno-Oncology at AstraZeneca, Executive VP and Chief Medical Officer at Mirati Therapeutics, and VP, Clinical Development at Bristol-Myers Squibb (BMS). Rachel also held multiple positions in global clinical development at Bayer. Rachels career is notable for, among other achievements, her overall supervision of the early and late-stage clinical development of ipilimumab (Yervoy) at BMS and sorafenib (Nexavar) at Bayer. Rachel received her M.D. from Case Western Reserve University and her B.A. from Harvard University. She received her training in internal medicine at The Johns Hopkins Hospital and started her career as an oncology fellow and staff physician at the National Cancer Institute in Bethesda, MD. She is also the lead singer and one of the co-founders of the band, The Checkpoints, a blues band made up of luminaries in immuno-oncology, including the Nobel Laureate, Jim Allison, and is featured in the movie Jim Allison: Breakthrough, which was released in the fall of 2019.

About BDTX-189

BDTX-189 is an orally available, irreversible small molecule inhibitor that is designed to block the function of an undrugged family of oncogenic proteins defined by driver mutations across a range of tumor types, and which affect both of the epidermal growth factor receptor (EGFR) and the tyrosine-protein kinase, ErbB-2, or human epidermal growth factor receptor 2 (HER2). These mutations include extracellular domain allosteric mutations of HER2, as well as EGFR and HER2 kinase domain exon 20 insertions, and additional activating oncogenic drivers of ErbB. The ErbB receptors are a group of receptor tyrosine kinases involved in key cellular functions, including cell growth and survival. BDTX-189 is also designed to spare normal, or wild type EGFR, which we believe has the potential to improve upon the toxicity profiles of current ErbB kinase inhibitors.

Currently, there are no medicines approved by the U.S. Food and Drug Administration to target all of these oncogenic mutations with a single therapy.

About Black Diamond

Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Companys proprietary technology platform, Mutation-Allostery-Pharmacology (MAP) platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families, and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations. Black Diamond was founded by David M. Epstein, Ph.D. and Elizabeth Buck, Ph.D., and, beginning in 2017, together with Versant Ventures, began building the MAP platform and chemistry discovery engine.For more information, please visit http://www.blackdiamondtherapeutics.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding future plans or expectations for the Mutation-Allostery-Pharmacology platform, including the potential of the Companys strategy and product candidates, and the continued development and advancement of the Companys pipeline, including BDTX-189 and early-stage pipeline programs. Any forward-looking statements in this statement are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Companys product candidate development activities and planned clinical trials, the Companys ability to execute on its strategy, regulatory developments in the United States, the Companys ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Companys clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in its 2019 annual report on Form 10-K filed with the United States Securities and Exchange Commission and its other filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts:

For Investors:Natalie Wildenradtinvestors@bdtherapeutics.com

For Media:Kathy Vincent(310) 403-8951media@bdtherapeutics.com

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Black Diamond Therapeutics Announces the Appointment of Rachel Humphrey, M.D., as Chief Medical Officer - GlobeNewswire

The first outbreak of polio in the United States struck Rutland County, Vermont, in the summer of 1894. The disease began with fever, sore throat, and fatigue; it sometimes went on to damage the brain and spinal cord, paralyzing or even killing its hosts. Charles Caverly, a local physician, chronicled the devastation using detailed maps and notes. Boy, 10 years; died within twenty-four hours with convulsions, he wrote. Boy, 10 months; died on sixth day, all extremities paralyzed.... Girl, 11 years; died on third day, no paralysis noted.... Male, 22 years; died on third day, both legs paralyzed. Within weeks, a hundred and thirty-two people, mostly children, had been paralyzed, and eighteen had died.

In the coming decades, polio became a familiar menace. Summer, when the virus exacted its heaviest toll, was dubbed polio season. The virus crippled children and adults, often paralyzing their respiratory muscles and confining thousands to iron lungs. In 1916, New York City recorded nine thousand cases of polio and six thousand deaths. In August of 1921, Franklin Roosevelt, then a thirty-nine-year-old lawyer, fell off a sailboat and into the icy waters of the Bay of Fundy; the next day, he noticed lower-back pain, and within a week he could no longer stand. The pace and size of outbreaks accelerated. Even though the polio death rate declined in the decades that followed, owing to advances in medical care, the virus still disabled more than thirty-five thousand people a year during the nineteen-forties. In 1952the year the virus peaked in Americanearly sixty thousand people were infected, and more than three thousand died. Parents refused to let their kids play outside. Cities introduced social-distancing measures. Summer camps were cancelled; schools were shut down; bars and theatres closed.

As bad as polio was, it wasnt the only infectious disease stalking mid-century America. In the early nineteen-hundreds, tuberculosis began to compete with influenza for the title of the worlds deadliest disease. TB, which is caused by a bacterium that burrows into the lungs and other organs, spreads through coughing, sneezing, and talking; the Industrial Revolution, which brought huge crowds together in urban neighborhoods and workplaces, made it more likely to spread. In some people, TB lies dormant, sometimes for decades. In others, it becomes active, causing a quick and violent death: bedsheets drenched in sweat, sputum mixed with blood, a wasting away so severe that the disease was known as consumption. TBs toll was greatest among vulnerable populations: immigrants, prisoners, the poor. The death rate for minorities was three times higher than for whites. In 1953, the United States saw more than eighty-four thousand new infections, and nearly twenty thousand deaths. In 1962, forty-one years after her husband was diagnosed with polio, Eleanor Roosevelt died, at age seventy-eight, from complications of tuberculosis.

The total elimination of polio in the United States and the near-complete eradication of tuberculosis are two of this countrys greatest public-health success stories. And yet they are strikingly different in their details. Polio was defeated by a silver bullet: Jonas Salk introduced a polio vaccine, administered by injection, in 1955; a few years later, Albert Sabin developed an oral version. As a result, in the nineteen-sixties, the number of polio cases plummeted to fewer than a hundred, and in the seventies it fell to fewer than ten; no one has contracted the virus in the United States since 1979. By contrast, there is no comparable vaccine for tuberculosis. The B.C.G. vaccine, introduced in 1921, is effective against TB only about half the time, and is not given to the vast majority of Americans.

Instead, TB has been beaten back incrementally, using a host of imperfect medical and public-health advances. In the nineteen-forties, Selman Waksman, a microbiologist at Rutgers University, isolated streptomycin, the first antibiotic effective against tuberculosis. Streptomycin had serious side effects, including nerve damage, and quickly led to bacterial resistance; as a result, several other drugs were developed. Used alone, none works particularly well, but a cocktail given over a period of months can cure the infection. Meanwhile, testing for TB became readily available across the United States. (For some people, such as hospital workers, it became required.) Public-health protocols were developed: new cases of TB were reported immediately to departments of health, which moved to isolate patients and trace their contacts. (Those systems remain in place today: as a physician, the first time I wore an N95 mask was while treating a patient with TB.) Along with ongoing improvements in American housing and sanitation, these developments made the virus both less infectious and less deadly. Today, around the world, ten million people contract TB each year, and a million and a half die of it; multidrug-resistant tuberculosis, which is harder to treat, is spreading in some developing countries. But the United States is recording fewer tuberculosis infections now than at any point in the nations history: about nine thousand cases each year, and around five hundred deaths.

In fighting the new coronavirus, we all want a silver-bullet cure: the polio model. In April, the federal government launched Operation Warp Speed, a ten-billion-dollar effort to expedite, through government-industry partnerships, the development, manufacturing, and distribution of a coronavirus vaccine. The goal is ambitious: three hundred million doses by January, 2021. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, believes it is plausible. My hope, my expectation, is that well have not one but multiple vaccines in 2021, he told me.

In the popular imagination, a coronavirus vaccine will bring the pandemic to a decisive end. And yet not all vaccines are as powerful as the one Salk developed. Many vaccines are only partly effective, or work better for some age groups than others; the immunity a vaccine confers can wane with time, and a shot thats hard to manufacture or distribute could remain unavailable to many of us. Last week, the Centers for Disease Control sent a letter to state governments telling them to prepare for the possible distribution of a coronavirus vaccine this fall; it described the progress of Vaccine A and Vaccine Balmost certainly the vaccines being developed by Pfizer and Moderna, respectively. Though these vaccines are promising, there is no guarantee that they will be cure-alls. Unless you have a perfect vaccine, which very few are, youll always have people who end up getting sick, Fauci said. With or without a vaccine, were going to need other treatments.

We could get lucky. But we need to be prepared for the possibility that, in the absence of a single-shot cure, it will be the tuberculosis modelincremental, simultaneous progress on multiple frontsthat gets us through the coronavirus pandemic. Its a good thing, then, that vaccine research programs arent the only ones progressing at unprecedented speed. Three kinds of therapies currently in developmentantiviral drugs, antibodies, and immunomodulatorsmay be ready soon. Alone or in combination with a vaccine, they could help us turn the tide.

There are lots of ways to fight back against SARS-CoV-2 and COVID-19, the disease it causes. We can limit the viruss spread in the population at large; we can also build barriers against infection for at-risk people, such as caregivers or essential workers, in particular. We can devise therapies that prevent the newly infected from getting worse, and we can create interventions that target the sickest and give them a fighting chance. By surrounding the virus in this way, we can make it less contagious and lethal, changing the character of the pandemic.

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It Will Take More Than a Vaccine to Beat COVID-19 - The New Yorker

SAN FRANCISCO, Sept. 3, 2020 /PRNewswire/ --Invitae (NYSE: NVTA), a leading medical genetics company, today announced enrollment has begun for a nationwide study to better understand the role of current genetic testing guidelines in ensuring prostate cancer patients receive testing to identify clinically relevant genetic variants that can inform prognosis and support access to targeted therapies. The study is supported by Invitae and is part of the company's ongoing work to increase access to genetic information for men with prostate cancer.

"Currently, germline testing guidelines for patients with prostate cancer have evolved from more than one set of NCCN guidelines and some may still find these guidelines difficult to implement in everyday practice," said Neal D. Shore, M.D., F.A.C.S. from the Carolina Urologic Research Center in Myrtle Beach, South Carolina, and the principal investigator of the study. "Guidelines were established when testing was both more expensive and less accessible and don't address newer therapeutic approvals and trial literature for expanding therapeutic options, missing many patients whose clinical care and treatment choices could benefit from genetic information. Our study is intended to provide a deeper understanding of how these issues impact the care of men with prostate cancer so that we might improve how genetic information can be assessed and utilized for their cancer care and potentially inform their family members."

The use and importance of genetic information in the diagnosis and treatment of prostate cancer has been growing, particularly as the development of targeted treatments continues to accelerate. Despite its utility, guidelines governing testing among prostate cancer patients remain restrictive, and genetic information is underutilized in prostate cancer care. The study will determine whether guidelines are adequate in identifying patients who may benefit from genetic testing.

"Simplifying and possibly expanding current testing guidelines would provide benefits for medical management of men with prostate cancer and offer opportunities for targeted therapies, including PARP inhibitors and qualification for clinical trials," said Robert Nussbaum, M.D., chief medical officer of Invitae. "In addition, the genes involved in prostate cancer include BRCA1 and 2, which as we all know also play an important role in breast and ovarian cancer, and MSH6 and other genes involved in hereditary colon cancer. Widespread testing among men with prostate cancer could have an important role in not only improving their care but also the health of their relatives."

The study will enroll men across the country who have been diagnosed with prostate cancer. Both men who meet and don't meet current testing guidelines will be included to gather data on whether genetic testing results change treatment and recommendations. In addition, the study will also gather data on the patient's experience with genetic testing.

A study presented recentlyby Invitae at the American College of Medical Genetics and Genomics (ACMG) underscored the frequency of actionable variants expanded testing can help uncover. The study of 2,252 men found an overall positive rate of 13% with no statistical differences in rates among stages of disease. Only half of patients with an actionable variant reported a family history suggestive of increased risk. Nearly three-quarters (71%) of positive patients were eligible for management guidelines and/or potentially eligible for approved precision therapies or clinical trials.

An estimated three million men are living with prostate cancer in the U.S., and just under 200,000 are newly diagnosed each year.

Contact [emailprotected] for more information about the study.

About InvitaeInvitae Corporation(NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website atinvitae.com.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the use and importance of genetic testing and information; and the benefits of simplifying and possibly expanding current testing guidelines for men with prostate cancer. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Contact:Laura D'Angelo[emailprotected](628) 213-3283

SOURCE Invitae Corporation

http://www.invitae.com

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Multi-site study to evaluate the role of testing guidelines in ensuring access to genetic information for men with prostate cancer - PRNewswire