Axcynsis Therapeutics Pte Ltd. has gained IND clearance from the FDA for AT03-65 for the treatment of patients with CLDN6-positive solid tumors. Axcynsis is planning to initiate a phase I trial in the U.S. during the current quarter in patients with advanced CLDN6-positive solid tumors.
With positive data in hand from its phase IIb trial testing immunotherapy candidate OST-HER2 in osteosarcoma, OS Therapies Inc. anticipates a regulatory filing this year seeking accelerated approval from the U.S. FDA, putting the firm on track to receive a potentially profitable rare pediatric disease priority review voucher that could help fund further R&D work. Should OST-HER2 go on to win approval, it would mark the first new therapy in more than 40 years for osteosarcoma, an aggressive bone cancer characterized by high rates of metastases, often to the lungs, and disease recurrence.
A new study published in the Journal for Immunotherapy of Cancer has presented a promising advancement in chimeric antigen receptor (CAR) T-cell therapy for non-Hodgkin lymphoma (NHL).
A recent study has introduced a novel class of antibody-drug conjugates (ADCs) targeting trophoblast cell surface antigen 2 (TROP2), a protein overexpressed in pancreatic ductal adenocarcinoma (PDAC), one of the deadliest forms of cancer.
Eterna Therapeutics Inc. has released promising results from a preclinical study of its lead cell therapy product, ERNA-101, showing it reduced tumor burden and extended survival in mice with ovarian cancer.
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYS-6041, an antibody-drug conjugate, for advanced solid tumors.
Normunity Inc. has closed a $75 million series B financing to support its pipeline of novel anticancer therapies targeting untapped drug mechanisms. Proceeds from the financing will be used to advance Normunity’s lead program, NRM-823, a first-in-class T-cell engager.
Zai Lab Ltd. has entered into a new strategic collaboration and worldwide license agreement with Medilink Therapeutics (Suzhou) Co. Ltd. to use Medilink’s TMALIN antibody-drug conjugate (ADC) platform.