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UTR Therapeutics

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots:The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancerUTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…

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Makana Therapeutics & Tonix Pharmaceuticals

Makana Therapeutics Collaborates with Tonix Pharmaceuticals for TNX-1500

Shots:Makana Therapeutics has collaborated with Tonix Pharmaceuticals for TNX-1500 (anti-CD40L mAb) to reduce rejection of Makana’s genetically engineered (GE) pig organs in xenotransplantationPreclinical R&D collaboration may extend across Makana’s kidney, heart, & islet cell transplant programs, with an aim to support the US FDA’s IND submission for compassionate use in xenotransplantation ptsMakana’s…

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Bioheng Therapeutics

Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Shots:The US FDA approved Bioheng’s IND application for CTD402 to treat pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) CTD402 will be evaluated in a P-Ib/II single-arm, open-label, dose-finding study to optimize dosing and accelerate clinical development CTD402 is a CD7-targeted universal CAR-T (UCAR-T) cell therapy that is genetically…

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Fapon Biopharma

Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors

Shots:The company received the US FDA’s approval on the IND application of FP008 to treat pts with solid tumors refractory to anti-PD-1 therapy FP008 exhibited safety, PK, and developability in cynomolgus monkey; currently seeking global strategic partnerships to co-develop FP008 through clinical trials & commercialization FP008 is an anti-PD-1×IL-10M fusion protein with a…

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The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors

Shots: The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer  HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity…

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