Three giants have produced new phase III study data for their already approved, big name therapies. Two were positive and the third was stopped for futility.
Ractigen Therapeutics Co. Ltd. has submitted a clinical trial application in Australia seeking to conduct a phase I study of RAG-01, a small activating RNA (saRNA) drug candidate, in patients with non-muscle-invasive bladder cancer who have not responded to Bacillus Calmette-Guérin (BCG) therapy.
Janssen Pharmaceutica NV had disclosed new pyrrolidinone derivatives acting as NF-κB-inducing kinase (NIK; MAP3K14) inhibitors and reported to be useful for the treatment of cancer.
Kinesin-like protein KIF18A inhibitors reported to be useful for the treatment of cancer have been detailed in a recent GT Apeiron Therapeutics patent.
Biotheryx Inc. has developed new proteolysis targeting chimeras (PROTACs) comprising a E3 ubiquitin ligase binding moiety covalently bonded to a CDK protein-targeting moiety through a linker.
While early stage and involving a relatively small patient population, the interim phase Ib readout from the combination cohort testing estrogen receptor (ER)-targeting candidate vepdegestrant in combination with CDK4/6 inhibitor Ibrance (palbociclib) in heavily pretreated patients with ER-positive/HER2-negative breast cancer was impressive enough to prompt partners Arvinas Inc. and Pfizer Inc. to expand development work on the program. The results also struck a chord on the Street, with shares of Arvinas (NASDAQ:ARVN) gaining 31% on the day.
South Korean pharmaceuticals Celltrion Inc. and Cyron Therapeutics Co. Ltd. are teaming up to discover and develop bispecific and trispecific antibodies, collectively called polyspecific antibodies, under the ₩1.158 trillion (US$882.38 million) joint research agreement inked on Dec. 6. Under the terms, privately held Daegu-based Cyron will discover and develop at least three polyspecific antibodies for blood and solid cancers pre-selected by Incheon-based Celltrion via Cryon’s CD-3 targeting T-cell engager platform that helps engage T cells to attack cancer cells.
The oral drug inavolisib, when added to two other therapies, significantly improved progression-free survival in the first-line phase III treatment of advanced hormone receptor-positive, HER2-negative breast cancer in which patients have a PIK3CA mutation.
Replimune Group Inc.’s lead candidate, RP-1 (vusolimogene oderparepvec), took a solid hit as it missed both primary endpoints in the Cerpass phase II study of skin cancer. Despite some better results from the study and good news from other studies along with a plan to drop some programs, the company’s stock still suffered.
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