Vittoria Biotherapeutics Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial with VIPER-101, a gene-edited, autologous, chimeric antigen receptor (CAR) T-cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma.
With an initial €8 million (US$8.4 million) in seed funding in the bank, Tessellate Bio has emerged from stealth to tackle cancers that rely on the less well explored synthetic lethality mechanism of alternative lengthening of telomeres.
Injecting a combination of cisplatin and vinblastine – engineered by way of the company’s Dfuserx platform – turned out to be just the ticket for early stage breast cancer in the phase II study called Invincible conducted by Intensity Therapeutics Inc. Shares of the Shelton, Conn.-based firm (NASDAQ:INTS) closed Dec. 8 at $6.88, up $2.68, or 63%, having traded as high as $11.44, thanks to Wall Street’s satisfaction with the data testing INT230-6, which emerged during the San Antonio Breast Cancer Symposium.
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.
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