04/08/2025 Alphamab's IND application for JSKN022 was accepted by China's CDE (Ref) Alphamab Oncology's IND application for JSKN022 (PD-L1 x integrin αvβ6 bispecific antibody-drug conjugate) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company plans to initiate a first-in-human trial of JSKN022 for the treatment of advanced malignant solid tumors The Ph1 trial will evaluate the safety, tolerability, PK/P

31/07/2025 MaxCyte and Anocca AB signed a Strategic Platform Licensing Agreement to advance TCR-T cell therapies (Ref) MaxCyte signed a Strategic Platform License Agreement (SPL) with Anocca AB in which Anocca AB will deploy MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support the scalable development and manufacturing of its TCR-T cell therapy pipeline. Anocca AB obtained non-exclusive research, clinical and commercial rights to use MaxCyte’s Flow Elect

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma (Ref) The US FDA granted the Fast Track designation to Calidi Biotherapeutics' CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma. Guy Travis Clifton, CMO, Calidi: “FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA (Ref) The US FDA issued a Complete Response Letter (CRL) regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the treatment of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form due to the following reasons: The Ph1