Anavex Life Sciences Corp.’s stock (NASDAQ:AVXL) sunk 35% on Jan. 2 after a phase II/III study failure in Rett syndrome but posted a next-day rebound of 8% on Jan. 3 with shares closing at $6.53 each. Top-line data from the randomized, double-blind, placebo-controlled study of the company’s lead asset, Anavex 2-73 (blarcamesine), showed improvement but did not reach statistical significance on the co-primary endpoint, the Rett Syndrome Behaviour Questionnaire.
The spate of recent deals involving antibody-drug conjugates (ADC) continues in a field composed of record-breaking agreements in 2023. The newest of the deals were focused on Asia. GSK plc entered a license deal for the exclusive rights for clinical development and commercialization of Hansoh Pharmaceutical Co. Ltd.’s B7-H3-targeted ADC, HS-20093. Also, South Korea’s Dong-A ST Co. Ltd. is expanding into the ADC space by acquiring Abtis Co. Ltd. and its Abclick platform for ADC drug development.
Allorion Therapeutics Inc. could receive $40 million in up-front and near-term payments from Astrazeneca plc in the companies’ exclusive option and global license deal. The two plan to develop and commercialize an L858R mutated allosteric inhibitor for treating EGFR inhibitor-mutant non-small-cell lung cancer.
Cytokinetics Inc. received a slightly last minute Christmas gift in the form of positive top-line data from the pivotal phase III study of aficamten in treating symptomatic obstructive hypertrophic cardiomyopathy.
The spate of recent deals involving antibody-drug conjugates (ADC) continues in a field composed of record-breaking agreements in 2023. The newest of the deals were focused on Asia. GSK plc entered a license deal for the exclusive rights for clinical development and commercialization of Hansoh Pharmaceutical Co. Ltd.’s B7-H3-targeted ADC, HS-20093. Also, South Korea’s Dong-A ST Co. Ltd. is expanding into the ADC space by acquiring Abtis Co. Ltd. and its Abclick platform for ADC drug development.
Compugen Ltd. has entered another collaboration, this time exclusively licensing a preclinical antibody program against an IL-18 binding protein with Gilead Sciences Inc. Compugen will handle ongoing preclinical development and a phase I study of COM-503 to treat tumors, then Gilead receives to sole right to further continue developing the asset. Compugen is getting an up-front $60 million and is eligible for a $30 million milestone payment should the IND clear in 2024. Compugen also is eligible for $758 million in development, regulatory and commercial milestones, putting the deal value at $848 million.
Invivyd Inc.’s VYD-222 produced positive initial top-line results in the ongoing pivotal phase III Canopy study for preventing symptomatic COVID-19. The results could reach a vulnerable population of patients who are immunocompromised and don’t get the same protection as other patients, the company’s CEO, Dave Hering, told BioWorld.
Reneo Pharmaceuticals Inc. is halting development of its only asset, mavodelpar, after a phase IIb study missed its primary and secondary efficacy endpoints. The selective peroxisome proliferator-activated receptor (PPAR)-delta agonist was being developed to treat to rare genetic mitochondrial diseases.
All treatment groups in Vertex Pharmaceuticals Inc.’s phase II study of the non-opioid VX-548 showed meaningful reductions in pain from baseline in treating diabetic peripheral neuropathy (DPN), pointing the company toward pivotal phase III studies and prompting analysts to applaud enthusiastically.
Degrader-antibody conjugates (DACs) are at the heart of the new deal between C4 Therapeutics Inc. and Merck & Co. Inc. C4 will get $10 million up front, milestones that could total $600 million and about $2.5 billion across the entire collaboration.