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AbelZeta Gains FDA IND Clearance for Bispecific CAR-T C-CAR039 in LBCL

Shots: AbelZeta has received FDA clearance for the IND application for C-CAR039 (prizloncabtagene autoleucel), an anti-CD20/CD19 bispecific CAR-T therapy, for r/r large B-cell lymphoma (LBCL) AbelZeta regained global development, regulatory, manufacturing, & commercialization rights to C-CAR039 in Jul 2026 & is working with the FDA to finalize clinical protocols for 3L or later LBCL pts…
August 18, 2026

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Ractigen Therapeutics Reports IND Clearance of RAG-1C for Proliferative Vitreoretinopathy

Shots: The US FDA has granted IND clearance for RAG-1C for the prevention & treatment of Proliferative Vitreoretinopathy (PVR) The P-I trial will assess the safety, tolerability, PK, & preliminary efficacy of RAG-1C in patients undergoing surgery for retinal detachment who are at high risk of developing PVR RAG-1C is an intravitreal saRNA therapy using Ractigen’s…
August 3, 2026

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The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors

Shots: The US FDA has granted IND clearance to initiate the P-I trial assessing the safety, tolerability, PK, & anti-tumor activity of Harbour Biomed's HBM7004 in advanced solid tumors  Preclinical studies showed that HBM7004 induced B7H4-dependent intratumoral T-cell activation, strong anti-tumor activity, in vivo stability, & reduced systemic toxicity, while combination with a B7H4x4-1BB BsAb…
May 8, 2026

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BriaCell Therapeutics Reports US FDA IND Clearance to Initiate P-I/II Trial of Bria-BRES+ in Breast Cancer

Shots: The US FDA has granted clearance to initiate P-I/II trial of BriaCell's Bria-BRES+ for the treatment of metastatic breast cancer At AACR, the preclinical data showed that Bria-BRES+ activated adaptive & innate immunity, incl. naïve T cells, dendritic cells, & NK cells, potentially enhancing efficacy & preventing immune escape in metastatic breast cancer…
May 6, 2026

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Laguna Biotherapeutics Reports the US FDA IND Clearance for LGNA-100 to Treat High-Risk Pediatric Leukemias

Shots: The US FDA has granted IND clearance to LGNA-100, Laguna Biotherapeutics’ lead clinical candidate from the QUAIL platform, to initiate the P-I trial The P-I single ascending dose study will assess safety, tolerability, & mechanism of LGNA-100 via IV infusion in pediatric & young adults with high-risk acute leukemias & MDS post αβ-depleted HSCT…
April 30, 2026

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NEWS

Henlius Receives NMPA IND Clearance for HLX05-N (Biosimilar, Erbitux)

Shots: The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC) HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions Cetuximab is an anti-EGFR monoclonal…
April 15, 2026

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