The Bio Report

Artificial intelligence is all the rage in drug discovery today, but there are efforts to apply to technology to other aspects of the drug development continuum to improve decision making and increase efficiency. One such example is Phesi, which has developed an artificial intelligence platform to improve clinical site selection, evaluate protocol designs and patient inclusion criteria, and manage the implementation of trials. We spoke to Gen Li, founder and president of Phesi, about his company’s AI platform, how it works, and the case for the use of artificial intelligence as a tool to improve drug development.

Antibody-drug conjugates marry the precise targeting of an antibody to a cytotoxic payload. That has the potential to provide a powerful treatment approach to a variety of cancers with less toxicity than systemically delivered chemotherapy. The problem has been producing large quantities of antibody-drug conjugates in a consistent manner where all the pieces are where they belong. Sutro Biopharma has developed a technology platform that allows it to precisely design and consistently manufacture these molecules. We spoke to Bill Newell, CEO of Sutro, about the promise of antibody-drug conjugates, the company’s platform technology, and its lead therapeutic candidates.

While much of the focus of drug developers looking to act on the genetic mechanisms underlying diseases has focused on the genes that code for proteins, Syros Pharmaceuticals is looking to the regulatory regions of the genome. This is the noncoding part of the genome that controls the expression of genes, turning them on or off, or modulating their level of activity. We spoke to Eric Olson, chief scientific officer of Syros Pharmaceuticals, about the company’s discovery platform, its pursuit of cancer and monogenic diseases, and the lead programs in its pipeline.

Anixa Biosciences is harnessing the immune system to both diagnose and treat cancer. It recently announced a licensing agreement with the Cleveland clinic for a novel breast cancer vaccine that is being developed for both therapeutic and prophylactic use. It’s lead candidate is a CAR-T cell therapy in development for ovarian and other solid tumors. We spoke to Amit Kumar, president and CEO of Anixa, about the company’s strategy to pursue both therapeutic and diagnostic products, its partnerships with leading research institutes, and its development strategy going forward.

There’s growing interest in cannabinoids for their therapeutic potential in a range of conditions, but one challenge therapeutic developers face is a reliable and consistent supply. Teewinot Life Sciences is using synthetic biology to produce a range of cannabinoids. We spoke to Michael Luther, president and CEO of Teewinot Life Sciences, about the companies process for producing cannabinoids, its business model, and the therapeutic and consumer areas it plans to pursue.

Much has been made about a cancer moonshot, but in the world of oncology, rocket fuel is rarely a topic of conversation except maybe as a metaphor. EpicentRx, though, is looking to rocket fuel as a source for its lead experimental therapy RRx-001. It believes this high-energy molecule, derived from rocket fuel, has the potential to improve immunotherapies and radiotherapies, as well as having anticancer activity on its own. We spoke to Corey Carter, president and CEO of EpicentRx about how RRx-001 came about, how it works, and the company’s oncolytic viral pipeline also in development.

The complexity of individual tumors creates a challenge for physicians to determine the optimal treatment for any given patient. This complexity may also require a combination of therapies to target the multiple pathways a given cancer may exploit to grow and spread. My Personalized Therapeutics is taking a model systems approach to pair patients to customized drug regimens by using fruit fly models of a patient’s cancer to screen hundreds of FDA approved therapies and combinations. We spoke to Laura Towart, co-founder and CEO of My Personalized Therapeutics, about the company’s Personalized Discovery Process, how it works, and why it may lead to better outcomes for cancer patients.

As biomedical data proliferates and the life sciences becomes more closely integrated with data science, the ability for researchers to access, use, and learn from the growing universe of information requires new tools. InveniAI is seeking to address this need with its artificial intelligence platform for biopharmaceutical companies to both monitor innovation and to enhance their own drug development capabilities. We spoke to Krishnan Nandabalan, president and CEO of InveniAI, about the company, how its artificial intelligence platform is being used, and what he expects the ultimate payoff from this technology will be.

The convergence of information technology with the life sciences is opening up new ways of approaching the challenges of drug discovery and development. While much has been made about approaches that seek to leverage artificial intelligence, Nanome is bringing virtural reality into the process. With the company’s technology, scientists can take a fantastic journey to view and manipulate proteins, compounds, and other molecules at a nanoscale. We spoke to Steve McCloskey, founder and CEO of Nanome, about the company’s virtual reality platform, how scientists can use it to collaborate in real time, and its potential to change the way researchers discover and develop drugs.

The high cost of developing therapies impedes the pharmaceutical industry’s ability to bring innovative products to market, but also leaves potentially valuable discoveries languishing on university shelves. The Swiss non-profit foundation Molecule is trying to alter the landscape by establishing an online marketplace to create shared ownership of intellectual property and provide a new funding mechanism for early-stage experimental therapies that could also lead to distributed research and development of promising drugs. We spoke to Paul Kohlhaas, founder of Molecule, about the market it is developing, how it would work, and the challenges it will need to overcome to make it a reality.

Mesenchymal stem cells may be a powerful way to treat a range of medical conditions but realizing the therapeutic potential of these cells has been hampered in part by the challenges of manufacturing a consistent product at scale. Cynata Therapeutics believes its platform technology addresses these challenges. The company lead cell therapy candidate is being developed to treat graft vs. host disease, a potentially deadly response to the transplantation of cells from a donor. We spoke to Ross MacDonald, CEO of Cynata, about the company’s platform technology, the potential for these therapies, and the indications the company is pursuing.

The placebo response in clinical trials can derail a promising experimental therapy that might benefit patients. In cases where trials rely on subjective endpoints or patient-reported outcomes, the placebo response can be more pronounced. Tools4patient has developed a means of identifying patients who are likely to be placebo responders and allow trial sponsors to take steps to account for that in clinical studies. We spoke to Erica Smith, vice president of business development at Tools4Patient, about the placebo response, the consequence this phenomenon has on drug development, and how the company is seeking to address this problem.

Artificial intelligence is being embraced the pharmaceutical industry as a way to reduce the time and cost of drug development. BioXcel Therapeutics is using AI to leverage as a means to identify new targets for approved drugs and clinically-validated drug candidates with a focus on oncology and neurology. We spoke to Vimal Mehta, CEO and founder of BioXcel Therapeutics, about the company’s AI platform, what makes it unique, and its pipeline of repurposed therapies.

The ability to capture and parse data in real-time and at a vast scale is transforming our approach to biomedical research and has the potential to change the way we think about the causes of disease, public health, and medical interventions. Paul Glimcher, president and CEO of Datacubed Health and professor of Neural Science, Economics and Psychology, at New York University, where he directs the Institute for the Study of Decision Making, is conducting an ambitious study known as The Human Project. The study will gather data on the everyday habits and health of 10,000 New Yorkers over 20 years to find critical connections between biology, behavior, and the environment to drive evidence-based public policies to improve lives. Through his company Datacubed Health, he’s using the same technologies to drive patient-centered research. We spoke to Glimcher about his work, how technology is changing the nature of health research, and how he sees digital technology transforming the healthcare continuum from discover

Cidara Therapeutics is developing new anti-infectives using its Cloudbreak platform to develop antiviral conjugates that both directly kill pathogens and also enlist a patient’s immune cells to attack and eliminate them. The company is advancing its first therapy developed through the platform to the clinic, CB-012, an experimental therapy that is being developed to both treat and prevent flu infections. We spoke to Jeff Stein, CEO of Cidara, about the therapy, how it works, and the need the company is trying to address.

Roivant Sciences doesn’t fit easily into conceptions of drug companies, venture capital firms, or accelerators. It is building highly-focused drug development companies around promising undervalued assets it licenses. In five years’ time, it’s raised more than $3 billion, amassed a broad pipeline of more than 35 therapies, and has more than 800 employees. We spoke to Eric Venker, chief operating officer of Roivant, about the company’s business model, how it leverages its resources, and how it may be changing the industry’s approach to drug development.

Advances in precision medicine have helped to reshape the cancer landscape with the development of diagnostics to determine whether a patient may benefit from a specific drug. Little progress, though, has been made outside of the area of oncology to avoid the waste of time and money on therapies that won’t work for an individual patient. Scipher Medicine is working to change that for the treatment of autoimmune diseases by identifying which patients would benefit from which drugs. We spoke to Alif Saleh, CEO of Scipher, about the company’s approach, the opportunity it is addressing, and how he sees the area of precision medicine evolving.

Concerns about the threat posed by the growth of drug-resistant pathogens has often focused on the need to reinvigorate our arsenal of antibiotics, but health authorities are paying new attention to the rise of invasive fungal infections. Globally, about 1.5 million people each year die from these infections. There’s been a lack of investment and innovation in new types of antifungals and the worry is growing about the emergence of fungal strains that are resistant to existing treatments. We spoke to Ciara Kennedy, president and CEO of Amplyx, about the need for new antifungals, why this problem is emerging, and her company’s first-in-class experimental therapy to fight fungal infections.

The effort to cost-effectively accelerate the development of new therapies has led to the rise of new business models that seek to provide expertise, capital, and access to professional networks that can help early-stage companies navigate pitfalls and overcome challenges. Xontogeny is a bit of a hybrid in its approach, preferring the term aggregator to accelerator or incubator. We spoke to Chris Garabedian, chairman and CEO of Xontogeny, about the company’s approach, what it looks for in the biotechs it backs, and what he’s learned from his own experience as a biotech executive that he thinks will benefit others.

Agenus is an immuno-oncology company with a long history and a broad portfolio. To help fund its pipeline, it entered into a significant alliance with Gilead Sciences in December 2018 and has used an unusual funding mechanism by raising money through what it described as the first asset-backed digital-security offering. We spoke to John Castle, head of translational medicine and bioinformatics at Agenus, about the company’s approach to managing and prioritizing its pipeline, its use of artificial intelligence, and the recent deals it’’s done to fund development.