FDA clears IND application for IKS014 in patients with advanced HER2+ solid tumours
Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics commented, “The FDA clearance of our IND application for IKS014 represents a significant milestone in our mission to address the critical unmet needs of patients with HER2-positive cancers, particularly those who have exhausted current standard-of-care options. Early clinical data has been extremely encouraging, and we are excited to expand our program to reach more patients. The early efficacy signals that have been observed, particularly in patients that have relapsed after receiving prior treatments of Kadcyla and Enhertu, suggest IKS014 could potentially offer a new treatment option for patients who currently have limited alternatives. We look forward to working with our clinical partners to further evaluate the potential of IKS014.”
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