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).
Researchers from Sun Yat-sen University Cancer Center (SYSUCC) presented data from a study that aimed to assess the role of trophoblast cell-surface antigen-2 (TROP-2) in penile squamous cell carcinoma (PSCC).
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.
Researchers from National Health Research Institutes reported the discovery and preclinical characterization of a novel long half-life Aurora A (AURKA) inhibitor being developed for the treatment of MYC-amplified solid tumors. Lead optimization of a previously reported series of small-molecule Aurora kinase inhibitors led to the discovery of AURKA kinase inhibitor 6K465, which was then developed into the acyl-based prodrug DBPR-728.
Although details are scant, Akeso Pharmaceuticals Inc. reported that its PD-1/VEGF bispecific antibody, ivonescimab (AK-112), demonstrated statistically significant superiority as a first-line therapy for PD-L1-positive non-small-cell lung cancer (NSCLC) compared to Merck and Co. Inc.’s Keytruda (pembrolizumab).
Astrazeneca plc’s blockbuster Enhertu continued to garner attention as new data released at the American Society of Clinical Oncology (ASCO) annual meeting show the antibody-drug conjugate demonstrated strong progression-free survival in metastatic breast cancer patients. Puma Biotechnology Inc. had advances of its own at ASCO with new biomarker findings from a phase II study of alisertib, an aurora protein kinase 2 inhibitor, in endocrine-resistant metastatic breast cancer.
While Servier Pharmaceuticals LLC awaits this summer’s PDUFA date for the IDH-mutant glioma drug vorasidenib, acquired in the buyout of oncology assets from Agios Pharmaceuticals Inc., the latter unveiled positive data from a global phase III study with oral mitapivat in adults with transfusion-dependent alpha- or beta-thalassemia.