FDA's Upcoming Review on Cancer Treatments and Industry Shifts in Biotech and Pharma

The Food and Drug Administration (FDA) is set to convene a panel of expert advisers on September 26 to evaluate the use of Bristol Myers Squibb’s Opdivo and Merck & Co.’s Keytruda in the treatment of gastrointestinal cancer. The advisory committee will focus on assessing PD-L1 expression as a predictive biomarker for the effectiveness of these drugs in this context, both of which are already broadly approved. The FDA pointed out that current data suggest PD-L1 expression is significant, but the clinical trials for these drugs have measured it differently. The agency is seeking expert advice on how to interpret this data and whether the use of these immunotherapies should be restricted based on PD-L1 levels.

In other industry news, Tome Biosciences, a notable startup in the genetic medicine field, is scaling back its operations and exploring strategic options. CEO Rahul Kakkar confirmed this in an email statement, explaining that despite the company's scientific advancements, investor sentiment in the gene editing sector has drastically shifted, particularly affecting preclinical companies. Tome Biosciences had raised $213 million in venture funding last December and is currently in confidential discussions with multiple parties. Reports suggest that the company is facing challenges in raising additional funds and might even wind down its operations entirely.

Meanwhile, prescriptions for RSV vaccines from GSK and Pfizer have shown a slight uptick over the past two weeks, although overall numbers remain low as the fall vaccination season approaches. Analysts are monitoring these prescription trends closely, given that the vaccines generated significant revenue for their manufacturers last year. Moderna, which received U.S. approval for its own RSV shot earlier this year, is expected to capture only a minor portion of the market, according to Jefferies analyst Michael Yee.

Skye Bioscience has commenced patient screening for a Phase 2 trial of an experimental obesity drug, nimacimab, which works by blocking a cannabinoid receptor. The trial will evaluate the drug both on its own and in combination with Novo Nordisk’s Wegovy over a 26-week treatment period. Skye Bioscience believes that inhibiting cannabinoid signaling can enhance energy expenditure and regulate hunger. An earlier cannabinoid receptor blocker, rimonabant, was approved in Europe under the name Acomplia but was later withdrawn due to psychiatric side effects. Skye claims that nimacimab is less active in the brain, which should minimize these adverse effects.

Lastly, Ambrosia Biosciences, a new biotech startup, has secured $16 million in a Series A financing round aimed at discovering and developing oral drugs for obesity. The funding round was led by BVF Partners and Boulder Ventures and was announced on Tuesday. Ambrosia was founded by former employees of Array BioPharma, which was acquired by Pfizer in 2019. Pfizer's recent shutdown of Array’s research and development facility in Boulder, Colorado, provided an opportunity for these former employees to reunite and form the new company.

These developments highlight the dynamic and ever-evolving nature of the biotech and pharmaceutical industries, as companies navigate financial challenges, regulatory scrutiny, and competitive markets in their quest to bring innovative treatments to patients.

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