Positive feedback from MHRA provides alignment on the preclinical, manufacturing, clinical & regulatory pathway for ZI-MA4-1 and supports planned CTA submission
“Receiving positive scientific advice from the MHRA is an important milestone as we prepare to bring ZI-MA4-1 into the clinic,” said Namir Hassan, CEO of Zelluna. “With the involvement of world-class investigators and centres such as The Christie and The Royal Marsden, we are building strong momentum towards initiating a UK-based trial that could generate the first safety and efficacy data in 2026. This progress showcases the talent and dedication of our team, and our shared commitment to advancing a novel, scalable and accessible “off the shelf” cell therapy for patients with solid tumours.”
Share:
More News
“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us