The Bio Report

Earlier this year Paige, a company developing artificial-intelligence driven pathology platforms for the diagnosis of cancer, raised $100 million in a series C venture round. The funding came a month after the company, a spin-out of Memorial Sloan Kettering Cancer Center, scored its first two European approvals for its breast cancer and prostate cancer offerings. We spoke to Leo Grady, CEO of Paige, about how the company’s artificial intelligence platform works, why it may lead to the identification of new biomarkers, and the potential for AI to change the way cancer patients are diagnosed.

While cell and gene therapies represent an area of great therapeutic promise, current manufacturing process are expensive and difficult to scale. As a result, this creates bottlenecks that limit patient access to these therapies and hamper the growth of the sector. Ori Biotech has developed an automated and scalable manufacturing platform for cell and gene therapies that seeks to increase capacity and quality while reducing costs. We spoke to Farlan Veraitch, co-founder and chief scientific officer of Ori, about the challenges of manufacturing cell and gene therapies, how the company’s platform addresses those issues, and why it is initially focusing on CAR-T cell therapies.

There’s been a growing industry effort to explore the use of psychedelics for their medicinal benefits. While much of these efforts have looked to these drugs to treat a range of psychiatric conditions, Eleusis sees a broader potential for them. While the company is pursuing psychedelics as potential treatments for major depressive disorder, it also is developing psychedelic candidate in other indications because of their anti-inflammatory properties. We spoke to Shlomi Raz, CEO of Eleusis, about of the case for psychedelics as treatments for inflammatory conditions, how they work, and what challenges the development of these drugs pose.

Regulatory T cell therapies have been pursued as treatment for cancers, but Sonoma Biotherapeutics believes these cells can be harnessed to delivery lasting and potential curative treatments for autoimmune and degenerative diseases. We spoke to Jeff Bluestone, CEO of Sonoma, about regulatory T cell therapies, why they may have broad application in a range of conditions, and what challenges will need to be overcome to usher in an area of cell therapies beyond cancer.

For more than 15 years, Longhorn Vaccines & Diagnostics has been designing and developing products for potential pandemics in developing economies. The recent COVID-19 pandemic, though, put the scalability of the company’s technology to the test as it landed big contracts in the United States for COVID-19 testing. We spoke to Jeff Fischer, president of Longhorn, about the benefits of the company’s technology for gathering and transporting diagnostic samples, how it’s used partnerships to scales it business with speed, and why the pandemic has forever changed the company.

There are many reasons why the sharing of medical data that could be used to gain new insight into diseases can be hampered. Privacy concern, regulatory burdens, and the need to manage security risks are among the significant impediments. Syntegra believes it can solve these problems through its artificial intelligence technology that creates synthetic datasets designed to mirror the statistical properties of real datasets while removing all links to the original patients behind the data. We spoke to Michael Lesh, co-founder and CEO of Syntegra, about the obstacles to data-sharing, how synthetic datasets are developed, and why they might accelerate the pace and lower the cost of research.

While checkpoint inhibitors represent a class of promising new therapies to treat cancer, the efficacy of these immunotherapies have been limited because of the ability of cancers to develop resistance. In part, that’s because of the multiple mechanisms cancers have to evade the immune system. Compugen is using a computational discovery platform to identify proteins and pathways that drive immune resistance mechanisms to checkpoint inhibitors. We spoke to Anat Cohen-Dayag, CEO of Compugen, about the company’s discovery platform, its efforts to develop new treatments that address patients who don’t respond to current checkpoint inhibitors, and its clinical pipeline in development.

The raging pandemic defined 2020, but it was a big year for biotech as the industry saw soaring stocks, record investment, and an impressive number of new drug approvals despite disruptions from COVID-19. We continue our annual tradition of sitting down with Adam Feuerstein, senior writer for Stat and the publication’s national biotech columnist, to discuss the year that was in biotech, the trends that drove the numbers, and what’s ahead in 2021.

The case for precision medicine to treat cancer has been clear. Understanding the molecular underpinnings of a patient’s cancer can allow doctors to use targeted therapies that can best address their particular tumor type. The people behind One Health believe it should be no different for dogs. The company, which bills itself as the world’s first canine cancer care organization, is seeking to bring precision cancer care to our four-legged friends. We spoke to Christina Lopes, founder and CEO of One Health, about the state of canine cancer care, the company’s FidoCure service and the market for state-of-the art medicine for dogs.

As potential vaccines for COVID-19 approached approval, the focus has been on the safety and efficacy of candidates. Now that vaccines have been approved, attention has been shifting to the complex logistical challenges of manufacturing, distributing, and delivering vaccines to patients. The process has opened up visibility into many aspects of the supply chain that are usual taken for granted. One of those aspects are the vials used to store that vaccines and the threat that a shortage of glass bottles could cripple distribution efforts. SiO2 Material Science, which won a $143 million U.S. government contract for vials and syringes, is applying semiconductor technology to create plastic containers with a nano coating of glass inside. We spoke to Christopher Weikart, head of scientific affairs and chief scientist for SiO2 Material Science, the considerations that go into a vaccine vial, the technology SiO2 is using, and why it offers advantages over traditional glass and plastic.

There are many approved or experimental therapies in development for a range of indications that, because of their mechanisms of action, have been pursued as potential therapies to treat patients with COVID-19. One of the most advanced candidates in this category is lenzilumab, an experimental monoclonal antibody that’s in development for certain cancers and other conditions. The antibody has the potential to neutralize a cytokine known as GM-CSF, which can trigger a severe immune reaction and cause hyperinflammation as a result of a cytokine storm. It is this immune response that underlies the most serious cases of COVID-19 virus. We spoke to Cameron Durrant, chairman and CEO of Humanigen, about lenzilumab, how it was recognized as a potential treatment for COVID-19, and the path forward for the therapy.

One of the challenges of conducting clinical trials is finding enough patient to include in a control arm of a study. This can slow the pace of drug development and increase its costs. Unlearn.AI is seeking to change that by using its artificial intelligence platform to create digital twins of trial participants that can serve as control arms in studies. We spoke to Charles Fisher, founder and CEO of Unlearn, about the concept of digital twins, the potential to accelerate clinical trials with their use, and why the company is focusing on the area of complex neurologic diseases.

Traditional efforts to treat autoimmune conditions have focused on inhibiting proteins involved in the immune response. Abivax is developing therapies that modulate RNA to enhance the body’s natural machinery to disrupt the production of cytokines, the proteins that signal the immune system to mount an attack in the first place. The company’s approach to modulating RNA may not only have utility in autoimmune conditions like inflammatory bowel disease, but in other indications including infectious disease and cancer. We spoke to Hartmut Ehrlich, CEO of Abivax, about the company’s lead therapeutic, how it works, and why the approach can have implications in a broad range of diseases.

Jo Bhakdi wants to build a future where people are protected against most diseases through early detection. His company Quantgene, which marries artificial intelligence with the ability to detect cell-free DNA in the blood with great sensitivity, believes it can help extend the lives of its customers by ten years within ten years. Quantgene is offering both its Serenity subscription service to consumers, as well as other offerings to therapeutic developers to support R&D using its technology. We spoke to Bhakdi, founder and CEO of Quantgene, about his unusual path to becoming a precision medicine CEO, how he expects technology to transform healthcare, and why he believes the company will be able to extend the lives of its customers through early detection of disease.

A gatekeeper of cellular metabolism known as mTORC1 underlies a wide range of age-related diseases. Navitor Pharmaceuticals is developing therapies that can modulate the mTORC1 complex and allow for a new approach to treating a wide range of diseases including autosomal dominant polycystic kidney disease and major depressive disorders. We spoke to Tom Hughes, president and CEO of Navitor, about mTORC1, the company’s platform technology, and why it has implications for a wide range of seemingly unrelated conditions.

Whether it is cells engineered to provide therapeutic benefits or biomanufacturing processes to replace energy-intensive and toxic chemical byproducts of industrial manufacturing, getting the right cell for the job is essential. Berkeley Lights has developed platform technologies that allow researchers to rapidly screen large numbers of cells and analyze them to identify the best cells for their purposes. We spoke to Eric Hobbs, CEO of Berkeley Lights, about the company’s platform technology, how it works, and how it can help accelerate the emergence of the new bioeconomy.

Glen de Vries in his new book "The Patient Equation" says that despite the digital revolution in the way we can capture and analyze data, not much has changed for decades in the how clinical trials are conducted. We spoke to de Vries, co-founder and co-CEO of the clinical trials data platform Medidata, about how clinical trials need to evolve, how technology can be used to improve patient access, and how it can capture new types of data to better answer questions about the safety and efficacy of therapies.

While immunotherapies carry great promise for improving outcomes for people with cancer, the ability of cancers to evade the immune system and develop resistance limits their benefits as monotherapies. BioEclipse Therapeutics is developing therapies that marry activated immune cells with oncolytic viruses. Together, they provide a synergistic effect that attacks cancers while providing protection against relapse and recurrence. We spoke to Pamela Contag, co-founder and CEO of BioEclipse, about the ability of cancers to return after treatment with immunotherapies, BioEclipse’s efforts to develop a multi-mechanistic immunotherapy to overcome that challenge, and why its approach may have broad application across a range of cancers.

While the potential for precision medicine has excited drug developers and clinicians with the promise of delivering more meaningful therapies to patients, the advent of these medicines has largely come in the area of cancer. As the understanding of the biology of other diseases is better understood, efforts to develop precision medicines are advancing into new areas. We spoke to Rachel Laing, managing director of the life sciences consulting firm Bionest, about the state of precision medicine, what can be learned from the experience in cancer, and what it will take to make precision medicine approaches the way we treat diseases broadly.

Zea Biosciences is not a typical contract manufacturing organization. The company uses plants to grow recombinant proteins for biologic therapies. To produce a consistent and predictable product, Zea uses a data-intensive approach and grows plants in clean rooms. The end result is a high-scalable platform that is cost-efficient. We spoke to Jim Wilson, CEO of Zea Biosciences, about the company’s approach to producing biologics in plants, why it is a data-intensive process, and the advantages it provides over traditional biomanufacturing.