The Bio Report

Kinase inhibitors have given rise to an era of precision medicine for the treatment of cancer, but the ability of cancer cells to mutate enables tumors to develop resistance to existing therapies. Nuvalent is developing therapies that both target the original tumor as well tumors with emergent resistance. We spoke to James Porter, CEO of Nuvalent, about how it designs drugs that address the challenges of both kinase resistance and selectivity, its pipeline in development, and why it’s critical that its experimental therapy for non-small cell lung cancer can penetrate the brain.

Each year, an estimated 400,000 people in the United States will be diagnosed with Lyme disease, a billion-dollar healthcare problem caused by a bacterial infection that is transmitted through the bite of a tick. The condition can cause joint pain and fatigue, but is treatable with antibiotics. Left untreated, though, it can progress and cause more serious symptoms including facial palsy, an irregular heartbeat, and nerve pain. Tarsus Pharmaceuticals is developing a human formulation of the antiparasitic lotilaner, to prevent Lyme disease. We spoke to Bobby Azamian, CEO of Tarsus, about Lyme disease, the case for the company’s experimental prophylactic drug TP-05, and why you may already have been using a form of the drug to protect a four-legged member of your household.

In February, the U.S. Food and Drug Administration approved the first tumor-infiltrating lymphocyte, or TIL therapy, for solid tumors. The approval was hailed as a milestone that points the path forward for a new class of cell therapies for solid tumors. We spoke to Jason Bock, CEO of CMTC, the joint venture between Resilience and MD Anderson Cancer Center, about the emerging area of TIL therapies, the significance of the first approved therapy in the class, and how they may address existing limitations of CAR-T therapies.  

Lipids have long been used as drug delivery vehicles, but HighField Biopharmaceutics is repurposing lipids as drugs to fight cancer. The company’s technology platform is seeking to change the immunotherapy landscape with new treatments that are better targeted, more potent, and less toxic. We spoke to Don Wyatt, chief business officer for HighField Biopharmaceuticals, about the tumor microenvironment, HighField’s platform technology, and how it is developing lipid-based medicines to overcome challenges of existing immunotherapies.

Jeremiah Robison’s daughter Sofia was born with cerebral palsy, a congenital movement disorder. Watching her physicians use body monitors to measure her gait, and later apply functional electrical stimulation as physical therapy, gave him an idea to combine the two to create a sleeve that could be worn on her leg to improve her ability to walk. Now Cionic, the company he co-founded, is producing its Neural Sleeves to help people with a variety of mobility impairments better navigate the world. We spoke to Robison, CEO of Cionic, about the Neural Sleeve, how functional electronical stimulation helps people with movement disorders walk, and how the use of adaptive algorithms continuously optimizes the stimulation it delivers.

Physicians treating people with burns typically incorrectly assess the depth of burn wounds in about 25 to 30 percent of cases. That, in part, is due to a lack of diagnostic tools to assess the severity of a burn and to determine the best approach to treatment. Spectral AI has developed the DeepView System, a predictive device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical interventions. We spoke to Pete Carlson, CEO of Spectral AI, about the company’s AI-driven DeepView System, how it works, and how it changes outcomes for patients.

New York City is not the first place that comes to mind when thinking of biotech clusters, but the Big Apple has been a growing center of biomedical innovation with its mix of academic research hospitals, finance, and growing number of biopharmaceutical companies. One place that’s seeking to serve as both a home to innovative companies and facilitate collaborations is Cure, which describes itself as a healthcare innovation campus. We spoke to Seema Kumar, CEO of Cure, about how it operates, its various initiatives, and what can be done to accelerate the movement of innovative technologies from the lab to the marketplace.

Murray Aitken from IQVIA discusses the growth in biopharma R&D funding and drug launches in 2023. He talks about the increase in M&A activity, the new patent cliff, and trends for 2024, including Chinese innovation and financing opportunities.

In January 2023, AstraZeneca agreed to acquire CinCor Pharma, the CinRx cardio-renal disease therapy subsidiary, for $1.3 billion. The deal included a potential additional $500 million milestone payment. The price represented a 121 percent premium to CinCor’s market value at the time and could grow to more than a 200 percent premium if the milestone is met. The sale represented validation of CinRX’s portfolio approach to build multiple biotech companies supported with a dedicated funding mechanism. We spoke to Jon Isaacsohn, founder and CEO of CinRx, about the company’s portfolio approach, how its business model allows it to accelerate the development of needed medicines, and its efforts to develop new obesity therapies.

Antibody-drug conjugates can deliver chemotherapy directly to tumors but more than 95 percent of the dose often ends up in healthy tissues, decreasing efficacy and increasing toxicity. Mythic Therapeutics FateControl technology improves the uptake of ADCs in cancerous cells while avoiding the release of their toxic payloads in healthy ones. This promises to increase efficacy of these therapies in a wide range of cancers without causing unacceptable side-effects. We spoke to Brian Fiske, co-founder, chief scientific officer of Mythic, about the challenges that have held back the benefits of ADCs, how the company’s FateControl technology addresses those, and how it is thinking of building a pipeline of ADCs across indications.