Endometrial cancer (EC) accounts for 20% to 30% of most malignant tumors of the female reproductive system, making it one of the most common. Furthermore, the 5-year survival rate of patients with early-stage EC is 90%, but this number decreases to 20% in late-stage disease.
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
CDR-Life Inc. has expanded its pipeline of novel T-cell engagers (TCE) with the addition of CDR-813 and CDR-505. CDR-813 is a highly potent and selective TCE candidate targeting tumors expressing PRAME (preferentially expressed antigen in melanoma) in HLA-A*02:01 patients.
Day One Biopharmaceuticals Inc. has entered into an exclusive licensing agreement with Mabcare Therapeutics for MTX-13, a novel antibody-drug conjugate (ADC) targeting protein-tyrosine kinase 7 (PTK7). Under the agreement, Day One has exclusive rights to develop, manufacture and commercialize MTX-13 (now DAY-301), worldwide, excluding Greater China.
Context Therapeutics Inc. has received FDA clearance of its IND application for CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody.
Acrivon Therapeutics Inc.’s $130 million financing disclosed April 9 hiked confidence in then-pending data with ACR-368 (prexasertib), the selective small-molecule inhibitor that targets checkpoint kinase 1 (CHK1) and CHK2. Undergoing tests in a potentially registrational phase II trial across multiple tumor types, ACR-368 also raised the stakes for Boundless Bio Inc., which is developing CHK1 inhibitor BBI-355.
Acrivon Therapeutics Inc.’s $130 million financing disclosed April 9 hiked confidence in then-pending data with ACR-368 (prexasertib), the selective small-molecule inhibitor that targets checkpoint kinase 1 (CHK1) and CHK2. Undergoing tests in a potentially registrational phase II trial across multiple tumor types, ACR-368 also raised the stakes for Boundless Bio Inc., which is developing CHK1 inhibitor BBI-355.
Alterome Therapeutics Inc. has closed a $132 million series B financing to support the advancement of its pipeline of next-generation, small-molecule targeted cancer therapies into the clinic, including a highly specific AKT1 E17K inhibitor and a KRAS selective inhibitor.
Context Therapeutics Inc. has submitted an IND application to the FDA to begin a first-in-human phase I study of CTIM-76 in patients with claudin 6 (CLDN6)-positive gynecologic and testicular cancers.