Bluesphere Bio Inc. has received FDA clearance of its IND application for BSB-1001 for patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia and myelodysplastic syndromes, in conjunction with allogeneic hematopoietic stem cell transplantation (alloHSCT).
Fibrogen Inc. has received IND clearance from the FDA allowing the company to initiate a phase I trial of FG-3165, a galectin-9 (Gal9)-targeted monoclonal antibody under development for treatment of solid tumors characterized by high levels of Gal9 expression.
7 Hills Pharma Inc. has been awarded $4.7 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support its cell/gene therapy development program.
Merck KGaA has announced it is advancing M-3554, a potential first-in-class anti-GD2 antibody-drug conjugate (ADC), toward the clinic. M-3554 links an exatecan payload with an anti-GD2 antibody.
Almac Discovery Ltd. has nominated a new preclinical candidate molecule, ALM-401, a first-in-class bispecific antibody-drug conjugate (ADC) targeting EGFR/ROR1. It is being developed for the treatment of refractory lung cancer characterized by dual expression of ROR1 and EGFR.
Actym Therapeutics Inc. has obtained IND clearance from the FDA to begin a phase I trial of ACTM-838. The first-in-human study will enroll patients in the U.S. and Australia with advanced solid tumors who have failed prior lines of therapy and have no clinically beneficial treatment options.
Programmed cell death protein 1 (PD-1) is among the immune checkpoint molecules better explored in immunotherapy for cancer. However, it is necessary to obtain novel therapies where preclinical efficacy and safety data could translate into enhanced predictability of human efficacy, pharmacokinetics and side effects.
Georgiamune Inc. has gained FDA clearance for its IND application for GIM-531, a first-in-class oral regulatory T cell (Treg) inhibitor that enables the restoration of a strong immune response against cancer.
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