New dose-escalation data from Verastem Oncology’s phase I/II cancer study in China prompted the company to say it was encouraged by the efficacy results. However, investors felt otherwise, as the stock lost about 20% of its value the day the initial results were released.
Biontech SE and Bristol Myers Squibb Co. are teaming up to develop Biontech’s BNT-327 in a deal possibly worth over $11 billion. BNT-327 is in the hot new class of bispecific antibodies targeting programmed death-1 (PD-1) or its ligand (PD-L1) and vascular endothelial growth factor (VEGF). The bispecifics take advantage of two well established mechanisms of action that help tumors grow; PD-1/PD-L1, which tells immunogenic T cells not to attack the tumor, and VEGF, which tumors excrete to produce new blood vessels to supply oxygen and other nutrients to the tumor.
For the second time in as many months, the lack of statistically significant overall survival data sent shares of Summit Therapeutics Inc. sliding, despite otherwise positive findings for PD-1/VEGF bispecific candidate ivonescimab in non-small-cell lung cancer. But analysts noted the stock reaction overlooks the consistency of the efficacy data to date, as well as the fact that the phase III Harmoni study marks the first pivotal trial testing ivonescimab in a global population.
Silexion Therapeutics Corp. has released preclinical data demonstrating the efficacy of its next-generation RNA interference (RNAi) therapeutic candidate, SIL-204, against human pancreatic, colorectal and lung cancer cell lines.
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
Avenzo Therapeutics Inc. has announced IND clearance by the FDA for AVZO-1418 (DB-1418), an EGFR/HER3 bispecific antibody-drug conjugate (ADC). A first-in-human phase I/II study will begin later this year and will evaluate AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.
The recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma.
ALX Oncology Holdings Inc. is set to begin phase I studies around the middle of this year with ALX-2004, an antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, following IND clearance last month.
Galvanize Therapeutics Inc.’s Aliya pulsed electrical field system could enable surgeons to perform a biopsy and ablate lung tumors at the same time, a study in the Journal of Surgical Oncology indicates.
Pfizer Inc. is paying $1.25 billion up front and up to $4.8 billion in milestone payments to gain global, ex-China rights to SSGJ-707, a PD-1/VEGF bispecific antibody from 3Sbio Inc. that recently won China clearance for a phase III study in lung cancer as a potential first-line monotherapy. Announced after U.S. market hours May 19, the exclusive agreement for SSGJ-707 spells up to $6.15 billion combined for Shenyang, China-based 3Sbio, along with separate tiered double-digit royalty payments on sales of SSGJ-707, if approved.
