MHRA and REC approved CTA for Ph 1 ZIMA-101 trial of ZI-MA4-1 in patients with advanced solid cancers
“The MHRA and Ethics Committee approvals represent a significant milestone for Zelluna and reflects the strength of the work the team has delivered across science, manufacturing, and regulatory execution,” said Namir Hassan, CEO of Zelluna ASA. “Importantly, this first-in-human study is designed not only to evaluate ZI-MA4-1 as a product candidate, but also to generate critical clinical insight into the broader potential of our TCR-NK platform. We now move into an important phase of clinical execution and learning for Zelluna as we initiate our first clinical programme and begin to generate clinical insights into the broader potential of our TCR-NK platform”
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