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.
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.
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.
GSK plc is plunking down $1 billion cash to take over Aiolos Bio Inc., with the promise of as much as $400 million in regulatory milestone payments along with tiered royalties. The deal gives London-based GSK asthma candidate AIO-001, a phase II-ready, long-acting antibody that binds to the human thymic stromal lymphopoietin (TSLP) ligand to inhibit TSLP signaling and relieve inflammation. GSK said AIO-001 could redefine the standard of care in asthma via the prospect of dosing every six months.
Merck & Co. Inc.’s deal to pay $23 in cash for Harpoon Therapeutics, bringing the equity value to about $680 million, further invigorated the delta-like ligand 3 (DLL3) development zone, where Amgen Inc. enjoys a lead with its prospect tarlatamab in the same class. DLL3 is an inhibitor ligand of the Notch pathway associated with tumorigenesis.
Allogene Therapeutics Inc.’s decision to preferentially pursue first-line treatment of large B-cell lymphoma (LBCL) with CAR T cemacabtagene ansegedleucel (cema-cel, previously known as ALLO-501A) met mixed reviews on Wall Street.
Umoja Biopharma Inc.’s gene delivery platform that combines a third-generation lentiviral vector gene approach with a novel T-cell targeting and activation surface complex brought Abbvie Inc. to the table for a pair of deals that could be worth as much as $1.44 billion.
With positive initial phase I/II data in hand from two trials, Dyne Therapeutics Inc. plans to report more findings and start enrolling registrational cohorts in both studies by the end of this year for DYNE-101 in myotonic dystrophy type 1 (DM1) and a study called Deliver with DYNE-251 in Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping.
Longboard Pharmaceuticals Inc.’s positive – and then some – phase Ib/IIa top-line data with 5-HT2C receptor superagonist bexicaserin (LP-352) in developmental and epileptic encephalopathies (DEEs) sparked Wall Street speculation about competitive odds as well as the shape of the firm’s upcoming phase III effort.
Pharma-biotech pairings continued apace in the antibody-drug conjugate (ADC) space, with 2023 capped by Legochem Biosciences Inc. signing a $1.7 billion licensure deal with Johnson & Johnson arm Janssen Biotech Inc. for the former’s Trop2-directed compound, the second-biggest Korean technology transfer agreement.
