The Bio Report

Whether in an operating room or in a trauma situation, the ability to quickly stop bleeding represents a critical need in healthcare. At the end of December, Cresilon filed for U.S. Food and Drug Administration approval to market its hemostatic gel to rapidly stop bleeding. The filing follows the launch of Vitigel, Cresilon’s hemostatic gel for the animal health market. We spoke to Joe Landolina, co-founder and CEO of Cresilon, about how he developed the plant-derived gel, the significant need he is seeking to address, and how the gel is able to halt bleeding in a matter of seconds.

In cancer, synthetic lethality refers to a state in which two genetic mutations that alone may allow a cancer cell to survive will kill it when they exist simultaneously. Cyteir Therapeutics is seeking to exploit that strategy with what it calls next-generation synthetically lethal therapies to treat a wide range of cancers. We spoke to Markus Renschler, president and CEO of Cyteir therapeutics, about synthetic lethality, Cyteir’s pipeline, and life as a small public biotech in 2022.

AI Dynamics is seeking to make AI accessible. Though its NeoPulse platform can be used across industries, the life sciences is one of the key markets the company is targeting with its technology being used to do everything from target identification for drug development to diagnosing and triaging TB patients by the sounds of their cough. We spoke to Rajeev Dutt, CEO and president of AI Dynamics, about the company’s core AI technology, how it seeks to make AI accessible, and why he believes it can transform drug development and healthcare by moving the needle on costs.

Social anxiety disorder can cause debilitating physical and emotional manifestations when a person is doing such things as meeting new people, speaking in public, or interviewing for a job. It can cause sweating, a rapid heartbeat, shortness of breath, and dizziness. The fear of embarrassment and humiliation can lead to depression and even addiction. VistaGen Therapeutics is developing intranasally delivered therapies for CNS disorders that can provide rapid relief at the onset of an episode much like someone with asthma might use a rescue inhaler. We spoke to Shawn Singh, CEO of VistaGen, about social anxiety disorder, the need for innovative approaches to treat that and other CNS conditions, and the potential for rapid onset therapies to treat a range of mental health conditions.

Humacyte’s human acellular vessels are experimental, engineered, off-the-shelf replacement vessels that are being developed for vascular repair, reconstruction, and replacement. The vessels are designed to overcome long-standing limitations in vessel tissue repair and replacement. Though not yet approved, the manufactured vessels are getting a real-world test as the company has been providing them to hospitals in Ukraine to treat wounded civilians and soldiers with vascular injuries. We spoke to Laura Niklason, CEO of Humacyte, about the company’s human acellular vessels, how they are produced, and the potential needs they can address.

The emergence of tyrosine kinase inhibitors represented a major advance in the fight against cancer, but the ability of tumors to mutate and develop resistance to these therapies remains a challenge. Theseus Pharmaceuticals is developing what it calls “pan-variant” kinase inhibitors in the hopes of outsmarting tumors by anticipating the range of kinases that may drive their spread and growth as they change. We spoke to Tim Clackson, president and CEO of Theseus Pharmaceuticals, about its structural-based approach to drug development, how it determines the appropriate targets for its pan-variant kinase inhibitors, and why it believes its next-generation TKIs can overcome the challenge of drug resistance.

The emerging understanding of the role the microbiome plays in wellness and disease is opening up a large number of potential therapeutic targets in the millions of genes that drive the microorganisms that live within the body. Eligo Bioscience is developing a new class of precision medicines that uses gene editing to address the expression of pathogenic genes in the microbiome to treat not only infectious disease, but other conditions such as inflammatory diseases and cancer as well. We spoke to Xavier Duportet, CEO of Eligo Bioscience, about the company’s use of synthetic DNA to target bacterial genes, its platform technology, and the wide range of conditions that can be addressed through this approach.

While cancer immunotherapies have been promising, CAR T cell therapies have been costly, effective on less than half of patients, and focused on hematologic cancers. Cytovia Therapeutics is enlisting natural killer cells, part of the innate immune system, to develop off-the-shelf immunotherapies to treat liquid and solid tumors. The company is leveraging a cluster of technologies to produce CAR NK cell therapies, edited NK cells to enhance their targeting, and NK engagers to redirect NK cells toward tumor targets. We spoke to Daniel Teper, co-founder and CEO of Cytovia, about the case for NK immunotherapies, Cytovia’s platform technologies, and the company’s pipeline of therapies in preclinical development.

Neurodegenerative diseases such as ALS, Alzheimer’s disease, and frontotemporal dementia have been difficult conditions for drug developers to target. Coya Therapeutics is approaching these conditions as diseases of immune system dysfunction to address the neuroinflammation that underlies them We spoke to Adrian Hepner, president and chief medical officer of Coya, about the role a hyper immune response plays in the progress of neurodegenerative diseases, how the company’s experimental regulatory T cell therapy works to halt that, and its pipeline in development.

The introduction of precision medicine has revolutionized the treatment of cancer and other diseases, but mental health conditions have not benefitted from the same type of treatment innovation. Alto Neuroscience is working to move psychiatry away from a trial-and-error approach to develop targeted medicines with the use of biomarkers to match the right drug to the right patient. We spoke to Amit Etkin, founder and CEO of Alto Neuroscience, about its efforts to develop precision medicines for mental health disorders, its AI platform for biomarker discovery, and its therapeutic pipeline in development.

The use of protein degraders is a promising area of emerging small molecule therapies. Rather than inhibit disease-causing proteins, degraders use a natural cellular process to break them down. Origami Therapeutics is using its proprietary drug discovery platform to develop novel protein degraders to target neurodegenerative diseases. The approach allows the company to target proteins that are considered undruggable because they lack an identified binding site. We spoke to Beth Hoffman, founder and CEO of Origami, about its platform for developing degraders, its focus on neurodegenerative diseases, and how its looking to potential partners to exploit the full potential of its platform technology.

Cancer immunotherapies have shown great promise, but many tumors can develop resistance as the changing tumor microenvironment can help cancers evade detection and allow cancer cells to proliferate. Teon Therapeutics is developing immno-oncology therapies for difficult to treat cancers that are designed to have the dual effect of restoring immune activity while suppressing cancer cell proliferation. We spoke to Serge Messerlian, CEO of Teon Therapeutics, about what happens when immunotherapies fail, the unique approach Teon is taking, and how the dual activity of its cancer therapies can restore immune activity while suppressing cancer cell proliferation.

Existing anticoagulants can prevent life-threatening blood clots for people with cardiovascular and metabolic diseases. The problem is that because of their mechanism of action, they also work to suppress the body’s ability to stop bleeding as it should. As a result, these therapies can be under utilized by patients who need them. Anthos Therapeutics is developing an experimental monoclonal antibody that can suppress coagulation without disrupting hemostasis, the biological process of stopping bleeding. We spoke to John Glasspool, CEO of Anthos, about the problems of existing anticoagulants, the novel target its monoclonal antibody acts on, and how it is able to uncouple the pathways for thrombosis and hemostasis.

Though the search for eternal youth has long been the fodder for myths and legends, science has been pushing us closer toward extending healthy years of life and has set some people off on efforts to defy death altogether. Peter Ward, in his new book The Price of Immortality: The Race to Live Forever, explores a subculture of immortality seekers who have turned to cryonics, as well as efforts to merge man with technology as a way to escape death. The growing understanding of the biology of aging and advances in regenerative medicine, though, are creating the potential to alter notions of human lifespans. We spoke to Ward about his book, distinguishing science fact from science fiction, and the growing understanding of the biology of aging that offers the potential for extending healthy years of life.

About 15 years ago, Harvard Business School professor Gary Pisano took at look at how small entrepreneurial biotechs fared against large and mature pharmaceutical companies and found the two sectors were about the same when it came to R&D productivity. Now, a new book From Breakthrough to Blockbuster: The Business of Biotechnology finds that the biotechnology industry is far more effective at bringing innovative therapies to market than Big Pharma and offers a prescription for large drug companies to decentralize decision-making to improve their ability to innovate. We spoke to venture investor and former biotech executive Don Drakeman, co-author of the book, about its findings, how decentralized decision-making can produce greater innovation, and lessons from COVID-19.

Poseida Therapeutics is leveraging its set of platform technologies to develop a range of next-generation cell and gene therapies. By using these technologies, alone or in combination, the company said it’s able to overcome limitations of the current generation of cell and gene therapies. The company’s most advanced candidates in its pipeline include a set of allogenic CAR T therapies. We spoke to Mark Gergen, CEO of Poseida, about the company’s efforts to develop off-the-shelf CAR T therapies, its platform technologies, and why it believes its CAR T cells will provide advantages over competitors’ therapies.

Though structure-based drug discovery has been long been used, technologic advances have given this approach greater power. ShouTi believes its next-generation, computational, structure-based drug discovery platform will allow it to develop small molecule drugs that are superior in safety and efficacy to biologic and peptide therapies its seeking to replace. We spoke to Raymond Stevens, CEO of ShouTi, about the company’s structure-based drug discovery platform, how it works, and why he believes it will be able to produce small molecule drugs that will be superior to biologics.

Virus-like drug conjugates, or VDCs, are a new class of cancer therapies Aura Biosciences is developing to target a broad range of solid tumors. These therapies have a dual mechanism of action. They deliver a toxic payload to cancer cells, but also activate a secondary immune mediated response to kill cancer cells. We spoke to Elisabet de los Pinos, CEO of Aura Biosciences, about the company’s VDCs, how they work, and its pipeline in development.

While the emergence of CAR-T therapies have been promising, these autologous cellular therapies are costly to produce since they require taking T cells from a patient being treated, altering them, and then infusing them back into the patient. Cellectis is among a growing list of companies pursuing off-the-shelf CAR-T therapies. The company’s U-CARTs, or universal chimeric antigen receptor T cells, are allogenic products that can be standardized and carry both time and cost advantages. We spoke to André Choulika, CEO of Cellectis, about the company’s off-the-shelf CAR-T therapies, the platform technology behind them, and its programs in development.

Though it’s been nearly 20 years since the Human Genome Project provided a blueprint for human biology, it still left much work to be done to understand health and disease at a molecular level. The Sweden-based Human Protein Atlas, which is seeking to map human proteins in cells, tissues, and organs, recently published significant updates to the open-access resource. We spoke to Mathias Uhlén, director of the Human Protein Atlas, about how the atlas is changing the diagnosis and treatment of disease, what’s known about the human proteome to date, and how this understanding will be essential to brining about an era of precision medicine.