IND Applications approved by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors

Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed her congratulations and gratitude to the entire team. She highlighted the significance of Immunofoco’s achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China. Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells. About 90% of the patients with gastrointestinal tumors exhibit EpCAM expression, which satisfies a broader clinical need. With the US/CN approval of this IND application, IMC001 is now poised to undertake further clinical trials and forge international collaborations, positioning itself as a promising new therapeutic option for patients with advanced GI tumors on a global scale.
Share:
More News
Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase
“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to
Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”
“At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time,” said