Additional Data Announced from Ph 2b Trial of IGV-001 in Newly Diagnosed GBM
“With the FDA’s recent feedback, we will be finalizing the protocol for a Phase 3 study focused on patients with uMGMT ndGBM, a population that has lacked meaningful treatment innovation in decades and where we saw a clinically meaningful benefit in the Phase 2b study,” said John P. Furey, Executive Chair of the Imvax Board of Directors. “We are also actively pursuing financing to support the initiation of this planned Phase 3 trial in 2027.”
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Akeso, Inc. announced that AK158D1, its investigational next-generation bispecific antibody-drug conjugate (ADC) targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA). The trial will assess the candidate in patients with advanced malignant solid tumors.
“This financing marks a significant milestone as we execute upon our vision of harnessing the power of macrocycles to transform the treatment of cancer,” said David J. Earp, J.D., Ph.D., president and chief executive officer of Circle Pharma. “Momentum around our cyclin D1 program has continued to build as CID-165
“FDA Fast Track designation for KST-6051 is an important regulatory milestone for Kestrel, based on the strength of our preclinical data package. This designation will allow us to work more closely with the FDA as we advance KST-6051 through our ongoing Phase 1 study, with the goal of bringing a
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Today’s deal secures a promising T cell engager and advances GSK’s leadership goals in blood cancer. The agreement complements our existing portfolio in multiple myeloma, adding a new potential option to address the different needs of patients facing this