Category Archives: Genetic Medicine

Novartis is building out its pipeline of experimental brain drugs, announcing Thursday plans to acquire a privately held biotech focused on neuroscience.

For $210 million up front, and as much as $560 million in milestone payments, Novartis will take control of Cambridge, Massachusetts-based Cadent Therapeutics and its three clinical-stage drugs. The companies expect their deal to close early next year.

Novartis already had access to one of the drugs, known as MIJ821, because of a licensing agreement with Luc Therapeutics, the precursor company to Cadent. Thursday's acquisition would square away the milestone and royalty commitments tied to that program, which is aimed at treatment-resistant depression. Cadent's two other drugs, CAD-9303 and CAD-1883, have been respectively studied in schizophrenia and movement disorders.

The deal comes at a time when neuroscience appears to be regaining some traction with pharmaceutical firms and their investors, which had pulled back en masse due to a series of drug failures. In the last couple years, Merck & Co. licensed a pair of neurodegenerative drugs, AbbVie went searching for Parkinson's treatments, and a neurology biotech that spun out from Pfizer raised nearly half a billion dollars by merging with a blank check company.

Novartis has remained more active in neuroscience than many of its big pharma peers. Among its marketed products are Gilenya, a blockbuster treatment for multiple sclerosis, Mayzent, a newer therapy for MS, and Zolgensma, a genetic medicine for a rare neuromuscular disease. Novartis also helps Amgen develop and sell the migraine medication Aimovig.

On the experimental side, Novartis is targeting a range of neurological conditions, from Huntington's disease to ALS to rare illnesses. The list would grow larger with Cadent's drugs onboard.

"The area is challenging, but the unmet need is really huge," Gopi Shanker, the interim co-head of neuroscience at the Novartis Institutes for BioMedical Research, said in an interview with BioPharma Dive. "So this is kind of a reiteration of our commitment to patients suffering from psychiatric and neurological diseases."

Cadent's drugs are so-called allosteric modulators, meaning they amplify or stifle what certain proteins do. MIJ-821 and CAD-9303, for example, have opposite effects on a protein that serves an important role in memory and brain function. The drugs now give Novartis a foothold in schizophrenia and a deeper presence in movement disorders.

Shanker notes that, in schizophrenia, the current standard-of-care antipsychotics only address symptoms like delusions and hallucinations. But there are other symptoms, including cognitive impairment as well as "negative" symptoms like social withdrawal and inability to feel pleasure, which have fewer treatment options. The hope is that CAD-9303 can help on that front.

"Mechanistically, CAD-9303 is well positioned to address these two groups of symptoms," Shanker said. "We're hoping that, together with antipsychotics, this drug can really bring transformative benefit for patients. And so that's what we'd have to demonstrate in the clinical trials."

CAD-1883, meanwhile, regulates activity in the cerebellum and has been studied in spinocerebellar ataxias and essential tremor two diseases that have been part of multibillion-dollar deals in recent years. Shanker said the drug could be useful in a variety of movement disorders, and that Novartis will decide which of those disorders to go after once the acquisition closes.

If completed, the deal would bring an end to a winding journey for Cadent.

The company was originally formed in 2010 as Mnemosyne Pharmaceuticals. But by 2015, it had changed its name to Luc Therapeutics and moved to Cambridge to focus on developing psychiatric drugs. The same year saw Luc sell that exclusive license for MIJ-821 to Novartis.

Then in 2017, Luc acquired Ataxion, an Atlas Venture-backed biotech, and the combination gave rise to Cadent.

The following year, Cadent raised $40 million in a Series B financing round led by Cowen Healthcare Investments and Atlas Venture, with participation from several other groups, including the Novartis Institutes for Biomedical Research.

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Novartis acquires a small biotech and its trio of brain drugs - BioPharma Dive

For all the devastation the Covid-19 pandemic has caused, there is finally a bright spot: For the first time ever, drug companies created a vaccine against a novel pathogen within a year of its discoveryabout a tenth of the time it usually takes. Regulatory authorities in the US, the UK, the EU, and Canada have all authorized the Pfizer/BioNTech Covid-19 vaccine, a world-first for a vaccine based on messenger RNA. President-elect Joe Biden received his Pfizer jab on Dec. 21. A few days earlier, on Dec. 18, the US also authorized Modernas mRNA vaccine.

These nucleic acid vaccines, which use cells existing infrastructure to manufacture their own medicine, appear poised to kickstart new era of rapid-response vaccine development. But their success wouldnt have been possible without a supportive technology that allows the shots to reach the right destination in the body: tiny bits of fat called lipid nanoparticles.

More than mRNA vaccines themselves, these lipid nanoparticles may portend big changes in pharmaceutical development. They can carry big molecular cargo like mRNA and other nucleic acids and deliver them with specificity. That ability to deliver targeted therapies could unleash a new wave of drugs with the potential to cure previously untreatable diseases.

Im convinced that in the next 50 to 100 years well be able to solve all the [medical] problems that we have not yet, says Sylvia Daunert, a biochemist studying nanoparticles at the University of Miami. She believes that future therapeutics will coax the body into making the tools it needs to repair itselflike a molecular surgeon traveling through the body to the point of need. Its not just The Magic School Bus, its a reality.

Scientists have thought for decades that targeted drug delivery is the future of medicine. The problem has been figuring out how to get drugs into some cells while avoiding others.

For the latter half of the 20th century, the pharmaceutical industry was focused on small molecule drugs. The advantage of these medicines is theyre small enough to wiggle their way through cell membranes, which are composed of a protective double layer of lipids. The downside is they dont discriminate.

Drugs go everywhere in your body, but a very small proportion gets to where you want to go.

Thats a big problem because the drugs go everywhere in your body, but a very small proportion gets to where you want to go, says Pieter Cullis, a biochemist focusing on lipid nanoparticles at the University of British Columbia in Vancouver, Canada.

The solution, some scientists thought, was lipid nanoparticles. Our bodies use little packages of fat bubbles to ferry in nutrients and ferry out waste all the time, using proteins on the outside of these packages like shipping addresses to designate the internal materials final destination. So in the 1980s, scientists started making their own lipid envelopes for drugs, ultimately using them to deliver a handful of small molecule-based anti-cancer drugs that would target onlytumor tissue.

But small molecule drugs cant effectively treat a huge number of conditions. So in the 1990s, the industry started working on a new wave of drugsbig ones. And those big drugs needed new, bigger packages.

These big, so-called biological drugs take advantage of systems already existing in bodies: Antibodies can attack foreign or misfiring cells that shouldnt be there; nucleic acids like DNA and mRNA can provide recipes for our cells to make their own medicine.

Antibodies dont need to penetrate the cell membrane, but nucleic acids do. Scientists werent sure how to package them correctly. Molecules of this size are far too big to make it through cells protective membranes on their own; where small molecule drugs may have a molecular weight of 500 Daltons (a biological unit that describes the number of atoms in a molecule), nucleic acids may be in a range of hundreds of thousands of Daltons, Cullis explained.

And nucleic acid drugs, including mRNA therapies, introduced an extra challenge: Injecting any kind of foreign genetic material into the body triggers a swift immune response. To patrolling immune cells, these therapies look like another viral or bacterial threat, so they dismantle it within hours.

So scientists went back to the drawing board.

Instead of putting these drugs in a tiny bubble of fat, they designed lipid nanoparticles that are more like globules, which can bind with a nucleic acid and carry it to its targeted destination.

It wasnt an easy process. To get nucleic acids to bond with fats, they need opposing charges, like a magnet. But nucleic acids all have a negative charge, and positively charged fats dont exist in nature. In the early 1990s, University of California, Irvine, biophysicist Philip Felgner invented a positively charged lipid particle in the labbut in living creatures, they wouldnt work: Cationic lipids are just really toxic, Cullis says. They rip membranes apart.

Eventually, Cullis and his team at the University of British Columbia worked with Inex Pharmaceuticals (now Tekmira Pharmaceuticals), Alnylam Pharmaceuticals, and Acuitas Therapeutics to come with a solution (Pieter co-founded Inex and Acuitas): They could bind the negatively charged nucleic acid to the positively-charged lipid particle in a slightly acidic solution. Then, they could raise the pH to make it more neutral, like inside our bodies, while adding in a few more fat globules to surround the package. The mRNA stayed attached and intact, and the protective layer of lipids outside wouldnt damage the cell membrane.

Acuitas Therapeutics licensed the technology to Pfizer/BioNTech for their Covid-19 vaccine. Modernas is similar, having licensed the technology from Acuitas in the past, but is now tailored for its own vaccine.

Thats an incredible breakthrough, and work including Cullis has directly led to the success of these first mRNA vaccines. But these lipid nanoparticle assemblies could also help deliver other drugs that have previously never been able to reach the right cells in patients bodiesor the right patients.

Pharmaceutical companies typically invest the most in drugs that have the biggest potential customer base. That means a smaller group of people with rare but severe diseases are often left out of the drug development process. When a drug company makes a product that does target them, the lower demand results in higher prices.

Other RNA-based therapeutics, bonded to lipid nanoparticles, could target those more specialized diseases. Alnylam Pharmaceuticals, for example, developed one such drug called Onpattro, which treats transthyretin-mediated amyloidosis, a genetic disease that deteriorates tissue in the heart. Its caused by a misshapen protein formed in the liver. Instead of containing mRNA, it contains silencing RNA, or siRNA. This code tells cells in the liver not to produce the faulty protein associated with the disease.

In theory, lipid nanoparticles could be used to deliver immunotherapies for cancer, too. If scientists can figure out the unique antigens given off by a persons cancer, they can use nucleic acids coding for that antigen to generate an immune response that attacks the tumor, says Francis Szoka, a bioengineer at the University of California San Francisco.

Not that itll be easy. For every new drug or vaccine, scientists still need to figure out how to get nanoparticles to where they need to be. Each kind of cell looks for different protein markers before letting in a medical messenger; identifying those proteins is the next hurdle.

The reality is we got lucky, Cullis says. When his group was designing his drug for liver cells, they found that a protein called APOE lipoprotein got stuck to their lipid nanoparticles almost right away, which helped it make it to the liver cells it needed. It wasnt something they intentionally engineered their particles for. (There hasnt been data collected on whether this same process helps the mRNA of Covid-19 vaccines to get into our muscle cells, but its likely this is the case.)

Figuring out how to get these particles into other kinds of cells, like tumor cells, is going to be harder. Compared to this year, though, scientists will think its a cakewalk.

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The first Covid-19 vaccines have changed biotech forever - Quartz

BOSTON, Dec. 22, 2020 /PRNewswire/ --Valo Health, LLC (Valo), has announced an exclusive drug discovery and development partnership with Global Genomics Group, (G3), giving Valo access to the largest and most-detailed cardio-metabolic dataset in the world. Since the inception of the partnership, Valo has identified subpopulations across the cardiometabolic spectrum that have not been resolved before now, and are leading to the discovery of underlying genetics, biomarkers, and new disease-modifying targets. Using its Opal Computational Platform, Valo has been able to identify six validated targets and approximately 20 early potential targets and disease subpopulations.

"This partnership fits perfectly into Valo's strategy to utilize deep clinical human disease data with the powerful platform we have built to redefine diseases and identify sub diseases and patient populations," said Brett Blackman, Valo's Chief Innovation Officer."At the heart of Valo is our strong belief that human-centric data, coupled with leading-edge computation, will transform and accelerate how drugs are discovered and developed."

Valo is using their machine learning algorithms and G3's high dimensional best-in-class patient data to resolve never before patient-disease subpopulations that guide their discovery of novel targets. This provides confidence in identifying the right patient population to develop a disease-modifying medicine at the start of a discovery program. Valo's Opal Computational Platform takes the novel target and rapidly creates clinical candidates to test in those populations, dramatically cutting time and cost while increasing the probability of a drug's success.

"Working with Valo we are poised to transform and de-risk drug development, based on genetic validation of drug targets and on the use of biomarkers to conduct precision clinical trials in the right patient populations," said Szilard Voros, CEO, and co-founder of Global Genomics Group (G3). "For years, everyone has been talking about genetics -and biomarker-driven clinical trials - with Valo, we are actually now doing it."

G3's proprietary data comes from the Genetic Loci and the Burden of Atherosclerotic Lesions (GLOBAL) clinical study (NCT01738828) and represents one of the largest such disease-centric data sets in the world, designed and executed by G3. The GLOBAL study generated extremely large and complex data sets including whole genome sequencing and phenotypic associations to identify and link biological target (genotype) - phenotype - biomarker(s) as well as 3 billion data points from each of the nearly 8,000 patients with cardiovascular disease and from control subjects. G3 has over 320K blood samples and 8,000 advanced CT imaging datasets for evaluation, all standardized, normalized, and curated.

About ValoValo Health, LLC (Valo)is a technology company that is using human-centric data and machine learning-anchored computation to transform and accelerate the drug discovery and development process. By integrating data across the drug development lifecycle, the discovery and development of life-changing treatments can be accelerated, with the potential to reduce cost, time, and failure rate. The company's Opal Computational Platform, a fully-integrated, componentized, end-to-end drug development platform, offers a unique approach to therapeutic development, that enables Valo to advance a robust pipeline of candidates across cardiovascular disease, oncology, and neurodegeneration. Headquartered in Boston, MA, Valo has offices in San Francisco, CA, Princeton, NJ, and Branford, CT. To learn more, visit http://www.valohealth.com

About G3 TherapeuticsG3 Therapeutics is a global leader in the application of unbiased biological big data in transforming the drug discovery and drug development process. G3 Therapeutics has assembled a revelatory platform that utilizes deep phenotyping, deep molecular profiling and deep learning for the discovery, genetic validation and development of novel drug targets. G3 Therapeutics' foundational biological big data platform has been built on the GLOBAL Clinical Study (NCT01738828), enrolling over 7,500 individuals from around the world. G3 Therapeutics' deep molecular profiling approach includes whole genome sequencing, as well as the measurement of all other relevant "omics" measurements including DNA methylation, RNA sequencing, proteomics, metabolomics, and lipidomics. G3 Therapeutics has already discovered and patented relevant biomarkers and is starting the development of several novel drugs based on its proprietary platform and discoveries.

SOURCE Valo Health, LLC

https://www.valohealth.com

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Valo Announces Exclusive Partnership with G3 the World's Largest and Detailed Cardio-Metabolic Datasets - PRNewswire

Research has shed new light on the genetic risk factors that make individuals more or less susceptible to severe COVID-19.

The findings by researchers at the Beth Israel Deaconess Medical Center (BIDMC Boston, MA, USA) illuminate the mechanisms underlying COVID-19, and potentially open the door to novel treatments for the disease. A growing body of genetic evidence from patients in China, Europe and the US links COVID-19 outcomes to variations in two regions of the human genome, although the statistical association fails to explain how the differences modulate disease. In order to do that, scientists need to understand which proteins these sections of the genome code for and the role these proteins play in the body in the context of disease.

Over the last decade, the BIDMC researchers have generated exactly such a database - an immense library of all the proteins and metabolites associated with various regions of the human genome. When the researchers looked up one genomic hot spot found to be associated with COVID-19 disease severity, they quickly realized that the very same region was linked to a protein that has recently been implicated in the process by which the SARS-CoV-2 virus infects human cells. The second region was linked to a poorly understood protein that appears to play a role attracting immune cells called lymphocytes to sites of infection, which also merits further study. Early analyses from their work also suggest that these genetic variants and proteins may vary across races. Taken together, these findings provide important contributions as the scientific community works rapidly to understand the mysteries of COVID-19.

Groups are increasingly finding genomic hotspots related to diseases, but its often not clear how they impact the mechanisms of disease, said Robert E. Gerszten, MD, Chief of the Division of Cardiovascular Medicine at BIDMC, who led the study. We leveraged our huge database - its more than 100 terabytes worth of data - to very quickly determine that the protein most highly expressed by that region turned out to be a co-receptor for the virus that causes COVID-19, suggesting that this might be a target for therapeutic interventions. The so-called antibody cocktails currently available mostly target the spike proteins on the virus. In turn, our work identifies which proteins in the human body that SARS-CoV-2 and other coronaviruses latch on to.

Related Links:Beth Israel Deaconess Medical Center (BIDMC)

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Research Sheds New Light on Genetic Risk Factors That Make Individuals More or Less Susceptible to Severe COVID-19 - HospiMedica

John Fauber getting his first shot in the COVID-19 vaccine trial at UW Hospital(Photo: none)

Earlier this week, the drug company AstraZeneca announced that its vaccine was highly effective against COVID-19. Thats great news for society. We now have three vaccines against the disease that aregetting closer to winning approval.

It also was good news for me. I think. Maybe. I hope.

At some point in my adult life, I developed an obsession with numbers especially the kind that might reveal the odds of something happening, such as who will win the presidential election. Orwhether the Packers should go for it on fourth and three.

Or what my chances are of dying of COVID-19.

It was that last one that led me to read a story about the development of coronavirus vaccines a couple months ago and then click on a link for people interested in a clinical trial of the AstraZeneca vaccine through the University of Wisconsin School of Medicine and Public Health.

I signed up, but at the time, I thought my chances of being selected were not much better than winning $1,000 in a scratch-off lottery ticket.

Until I got a call on October 15 from a woman with the universitys office of clinical trials.

I had been selected, though there was a hitch. The study had been put on hold in September because one of the people who got the vaccine in the United Kingdom had developed a serious complication that might have been caused by the vaccine.

When the trial resumed, she said, I could take part.

From what I could tell, that one serious side effect was out of thousands of people who alreadyhad received the vaccine when the trial was paused in early September.

As an unvaccinated69-year-old man, I figured my chances of dying of COVID-19 if I were infected were roughly 1.5to 3in 100, maybe a little better since I dont have any of those unwanted things that doctors often refer to as co-morbidities, such as obesity, diabetes, high blood pressure, asthma or known heart disease.

I plugged all that data into my numbers-jumbled brain and it quickly spit out an answer: Take the vaccine, you idiot.

So there I sat on the morning of Nov. 16, in the coffee shop of UW Hospital and Clinics in Madison, wearing a mask and waiting to meet someone who would take me up to the sixth floor and into an aspect of medicine that I often had written about but never experienced first hand: The world of clinical trials.

Over the next two hours I would go over a 27-page consent form; answer numerous questions about my health; provide a blood sample and a nose swab; and get handed a crisp, $100 bill from a lock box for my participation, which I later donated to the Hunger Task Force. The visit culminated in a painless shot in my left arm either the vaccine or a placebo.

The AstraZeneca vaccine is made differently than the Pfizer and Moderna vaccines, the first two vaccines to announce impressiveeffectiveness resultsthat putthem closer to getting approval.

The AstraZeneca vaccinestarts withan adenovirus that causes colds in chimpanzees but is weakened so it cant do that in people. To that is added genetic material from the coronavirus for the so-called spike protein. That's the protein on thesurface of the virus that enables it to get inside cells and replicate.

With the vaccine, a persons immune system is primed to quickly recognize when it has been infected by the real coronavirus and mount an attack that includes the production of antibodies against the virus.

COVID-19 vaccines are coming at us fast and furiously these days.

First, drugmaker Pfizer announced earlier this month that its vaccine was more than 90% effective, then upping it to 95% days later when more data came in. A week later Moderna announced that its vaccine was 94.5% effective.

On Monday, AstraZeneca announced that interim results showed its vaccine to be either 62% or 90% effective, depending on the dose.

That last caveat is what grabbed my attention. If I didnt get the placebo, the dose I got is the less effective one, which is what has been used so far at UW. The good news is that, regardless of the dose, there were no hospitalizations or severe cases among all the vaccinated participants.

Given all the angst the pandemic has caused for me, my family and the world, my guess is many people would be happy to get whatever protection the AstraZeneca vaccine offered. I sure would be.

But the problem is, I dont know if I got the real vaccine or a placebo.

In the AstraZeneca trial, for every two people who get the real thing, one gets a fake. Not even the researchers know who got what. That is done to prevent any bias from affecting the results.

F. Perry Wilson, an associate professor of medicine at Yale School of Medicine,who was not part of the trial, tried to explain what all this could mean for me.

Since I'm in the arm of the trialthat is 62% effective and since there was a 67% chance that I got the real thing, I have 41% less chanceof getting COVID-19 than the general public, said Wilson who teaches a course at Yale on how to understand medical research.

Of course, it is 0% protection if I got the placebo and 62% protection if I got the real vaccine.

The problem, he said, is when you try to apply data from a large population down to an individual, the brain starts to hurt. It is like a scratch off lottery ticket. You either win or lose.

As more data comes in, it may only get more nuanced for the 800 to 1,000 people who UW wants to enroll in its study. UW is one site for the AstraZeneca trial, which will eventually involveas many as 30,000 to 40,000 people in the U.S.

The company will share its latest data with the U.S. Food and Drug Administration, though it may need results from its U.S. trial before the agency will approve its vaccinein the U.S.

By January, the company may have results from its U.S. trial that could confirm or change the effectiveness numbers, said William Hartman, principal investigator for the UW arm of the trial.

He said he knows that, depending on those numbers, people may decide to stay in the trial or drop out so they can get a more effective approved vaccine once one becomes available, which likely will be in the first quarter of 2021.

They have to do what is in the best interest of them and their families, he said.

UW still is accepting people into the trial. For more information, email uwcovidvaccine@clinicaltrials.wisc.edu, call the hotline at (608) 262-8300 or 833-306-0681, or visit the study website.

Email him at john.fauber@jrn.com; follow him on Twitter: @Fauber_MJS.

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I'm a medical writer who just got vaccinated against COVID-19, maybe. You can still join the clinical trial. - Milwaukee Journal Sentinel

Baylor College of Medicine and other institutions joined theHuman Heredity and Health in Africa (H3Africa) Consortium in a collaborative global research project supported by the National Institutes of Health to sequence genomes from regions and countries across Africa. The research paves the way for more broadly representative and relevant studies ranging from basic through clinical genetics.

TheHuman Genome Sequencing Centerat Baylor College of Medicine worked with the H3Africa consortium and local African governments to acquire consented samples from 13 countries across the continent and generate high-coverage whole genome sequence data on 314 individuals representing 50 ethnolinguistic groups. This allowed the researchers to examine rare genetic variants in an accurate and quantifiable way, in addition to the common variants that have been the focus of most of the previous genetic studies in Africans.

Migrations

We found an impressive breadth of genomic diversity among these genomes, and each ethnolinguistic group had unique genetic variants, said senior author, Dr. Neil Hanchard, assistant professor of molecular and human genetics and the USDA/ARS Childrens Nutrition Research Center at Baylor College of Medicine and senior author on the study. There was a great deal of variation among people in the same region of Africa, and even among those from the same country. This reflects the deep history and rich genomic diversity across Africa, from which we can learn much about population history, environmental adaptation and susceptibility to diseases.

The researchers showed more than 3 million novel variants in the genomes sequenced, and were able to use the data to examine historic patterns and pinpoint migration events that were previously unknown.

For the first time, our data showed evidence of movement that took place 50 to 70 generations ago from East Africa to a region in central Nigeria. This movement is reflected in the genomes of a Nigerian ethnolinguistic group and is distinct from previous reports of gene flow between East and West Africa, said Dr. Adebowale Adeyemo, deputy director of the Center for Research on Genomics and Global Health at the National Human Genome Research Institute, and a senior author on the study. This data gives us a more complete picture of the genetic history of Africa.

Forces of natural selection

The researchers found more than 100 areas of the genome with evidence of being under natural selection. A sizable proportion of these regions were associated with genes related to immunity.

When you consider which forces have shaped African genetic diversity, you might think of malaria and sleeping sickness, Hanchard said. Our study suggests that viral infections could also have influenced genomic differences between people, via genes that affect individuals disease susceptibility.

There were also noticeable variations in selection signals between different parts of the continent.

Our findings suggest that adaptation to local environments, diets or pathogens might have accompanied the migration of populations to new geographic regions, said Dr. Dhriti Sengupta, one of the lead analysts from SBIMB, University of Witwatersrand.

The researchers hope their work will lead to wider recognition of the extent of undocumented genomic variation across the African continent, and of the need for continued studies of the many diverse populations in Africa.

Adding genomic data from diverse populations is essential to ensure that all global populations can benefit from the advances in health that precision medicine offers, saidDr. Zan Lombard, associate professor at the Division of Human Genetics of the University of the Witwatersrand, South Africa, and a senior author on the study.

Are you interested in reading all the details of this work? Find them in the journal Nature.

Dr. Richard Gibbs, Donna Muzny and Ginger Metcalf from the Human Genome Sequencing Center at Baylor contributed to this work. Find the complete list of all the contributors and their affiliations, as well as the financial support for this study in thepublication.

By Molly Chiu

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African genomes reveal biological and migration history - Baylor College of Medicine News