Shares of Corbus Pharmaceuticals Inc. (NASDAQ:CRBP) doubled on opening Jan. 26 and ended the day up a whopping 249% as investors got a look at data from a first-in-human study testing next-generation Nectin-4-targeted antibody-drug conjugate (ADC) CRB-701. Licensed from CSPC Pharmaceutical Group for $7.5 million up front in February 2023, CRB-701 has IND clearance from the U.S. FDA, and Corbus plans to start its own clinical testing in the first quarter of 2024.
Analysts from the hosting firm talked up their takeaways on biopharma from the J.P. Morgan (JPM) Healthcare Conference and looked ahead to 2024, anticipating a generally better year than those in the recent past.
Setting the tone for the biopharma industry as it enters a new year, the J.P. Morgan Healthcare Conference (JPM) held each January has once again led to reflections, projections and earnest hopes for improving financial and M&A markets. Despite concerns over valuations, raising money and pricing issues, industry leaders are generally upbeat as the industry moves into 2024. JPM’s Sophie Jones, managing director of health care investment banking, noted in a Jan. 18 webinar sponsored by the Biotechnology Innovation Organization that the conference included more than 700 companies. “It’s morphing now into really the kickoff into everybody’s year.”
Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
“This is a tough business. It’s never a straight line from start to success.” Those words, from Exelixis Inc. CEO Michael Morrissey, during a presentation at the J.P. Morgan Healthcare Conference (JPM), could easily sum up any aspect of the biopharma industry. But with more biopharma firms than ever having reached commercial status, along with the introduction of new therapeutic modalities into the health care market, many are finding the toughest part comes after regulatory approval, whether it’s navigating a competitive landscape, getting payers and physicians on board, or satisfying regulators’ stringent postmarketing requirements. As industry players and observers head home after a busy week in San Francisco, BioWorld offers a brief glimpse at a few firms taking on those post-approval challenges in 2024.
The U.S. FDA is promising to make 2024 a “breakout” 12 months for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. “This is a great year to focus on gene therapy,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA. “I just want to focus on moving ahead gene therapy,” he told attendees of the J. P. Morgan Healthcare Conference on Jan. 8.
Xenon Pharmaceuticals Inc. took to the stage this week at the J.P. Morgan Healthcare Conference to talk up its pipeline, including the phase III program testing XEN-1101 in focal-onset seizures (FOS), due to complete enrollment in the second half of this year. It’s an indication where such other players as Biohaven Ltd. are busy, too. Several million adults are afflicted with FOS in the U.S., with close to a half-million pediatric patients.
Tough times can create great companies if they can navigate the turbulence, a panel of biopharma executives and academics told attendees at the Wuxi Global Forum 2024. Companies must learn how to endure bad periods and thrive during the good times, said Mathai Mammen, CEO of Fogpharma Inc., because those disparate financial and scientific cycles will never go away. Right now, the money part is tough, but the science is thriving
Among the firms updating progress at the J.P. Morgan Healthcare Conference (JPM) in San Francisco this week was Relay Therapeutics Inc., coming off a $30 million financing to boost its Dynamo platform and candidates.
Gene therapy has finally become the “new normal” with serial breakthroughs unlocking “tremendous value” for patients and society, while at the same time the U.S. health care system is shaping up to enable access to these costly treatments, according to Tim Hunt, CEO of the Alliance for Regenerative Medicine.
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