ImmunOncia's 'IMC-002' Receives Additional Phase 1b Approval for Pancreatic Cancer Clinical Trial
MFDS Approves Addition of Pancreatic Cancer Cohort for IMC-002 and Lenvatinib Combination
Enhanced Macrophage Phagocytosis Observed with Combination Therapy in Pancreatic Cancer Cell Line Studies
Patient Enrollment to Begin in October at Samsung Medical Center
ImmunOncia announced on September 15 that it has received approval from the Ministry of Food and Drug Safety (MFDS) for an amendment to the Phase 1b clinical trial protocol (IND) of its next-generation CD47 antibody drug candidate, 'IMC-002'.
With this amendment, a pancreatic ductal adenocarcinoma (PDAC) cohort has been added to the clinical trial evaluating the safety and efficacy of IMC-002 in patients with advanced cancers who have failed standard treatment. This expands the indications to include pancreatic cancer, in addition to the existing indications for liver cancer, breast cancer, and biliary tract cancer.
In the pancreatic cancer cohort, IMC-002 will be administered in combination with lenvatinib, a multi-targeted tyrosine kinase inhibitor (TKI). The strategy aims to enhance the phagocytic activity of macrophages against cancer cells by having IMC-002 block the CD47 "don't eat me" signal on tumor cells while lenvatinib activates the "eat me" signal.
ImmunOncia explained that, in in vitro studies using the BxPC3 pancreatic cancer cell line, the combination of the two drugs increased the phagocytic activity of macrophages against cancer cells compared to monotherapy.
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Heungtae Kim, CEO of ImmunOncia, stated, "Pancreatic cancer is one of the cancer types with significant unmet medical needs. Based on the safety profile of IMC-002 and its potential for combination with lenvatinib, we aim to successfully carry out this clinical trial, offering a new treatment option to pancreatic cancer patients and laying the foundation for global technology licensing." Patient enrollment for the pancreatic cancer cohort is scheduled to begin at Samsung Medical Center in October.
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