[Edaily Reporter NA EUN-KYUNG ] Attention is focused on the circumstances surrounding #ImmuneOncia Therapeutics, Inc., an affiliate of Yuhan(000100), which has received a notice of intent to be designated as a company with inadequate disclosure from the Korea Exchange. It has been confirmed that the notice stems from a delay in disclosing information related to the expansion of the clinical trial population for an immunotherapy candidate. The company explained that this action is not due to a clinical trial suspension or safety concerns.

According to the Korea Exchange on the 2nd, the KOSDAQ Market Division issued a notice on the 28th to ImmuneOncia Therapeutics, Inc. regarding its designation as a company with inadequate disclosure, citing two instances of non-compliance with disclosure requirements. The disclosures in question pertain to the application for approval of changes to the Investigational New Drug (IND) application for the next-generation CD47 antibody candidate “IMC-002” and the subsequent approval of those changes.

ImmuneOncia Therapeutics, Inc. submitted an application to the Ministry of Food and Drug Safety (MFDS) on July 1 to amend the clinical trial plan for IMC-002 and received approval on August 4. However, the company did not disclose either of these facts until September 14—75 days after the application date and 41 days after the approval date.

The clinical trial protocol amendment that was the subject of this disclosure delay is intended to expand the indications for IMC-002. ImmuneOncia Therapeutics, Inc. decided to add a pancreatic ductal adenocarcinoma (PDAC) patient group to the “ENBRIGHT” Phase 1b clinical trial, which is being conducted in patients with advanced cancer who have failed standard treatment. This move is intended to evaluate the potential for treatment in pancreatic cancer, following the existing indications of liver cancer, breast cancer, and bile duct cancer.

This information was already disclosed to the market last September. At that time, ImmuneOncia Therapeutics, Inc. announced in a press release that the Ministry of Food and Drug Safety had approved the amendment to the clinical trial plan and that it planned to add a pancreatic cancer patient cohort. Therefore, this notice of designation is not due to the emergence of new adverse clinical developments, but rather results from a delay in disclosing the previously announced clinical trial expansion.

IMC-002 is an immunotherapy candidate that targets the CD47 protein, which cancer cells use to evade attack by immune cells. CD47 acts as a kind of “do not eat me” signal that cancer cells send to macrophages; blocking it can induce macrophages to eliminate the cancer cells.

In the newly added pancreatic cancer patient cohort, the company will evaluate a combination therapy of IMC-002 and “lenvatinib,” a multi-target tyrosine kinase inhibitor. The strategy aims to enhance anticancer efficacy by having IMC-002 block the cancer cells’ immune evasion signal while lenvatinib promotes the phagocytosis of cancer cells by macrophages.

The company previously announced that in vitro experiments using pancreatic cancer cell lines confirmed that the combination of the two drugs increased the ability of macrophages to phagocytose cancer cells compared to monotherapy. However, these results were obtained in the preclinical stage, and the safety and efficacy in actual pancreatic cancer patients must be verified through future clinical trials. ImmuneOncia Therapeutics, Inc. plans to begin enrolling patients this month at Samsung Seoul Hospital in Gangnam-gu, Seoul.

ImmuneOncia Therapeutics, Inc.’s designation as a company with “inadequate disclosure” has not yet been finalized. Following the company’s defense and the exchange’s review process, a decision on the final designation and the imposition of penalty points is expected by the 20th of this month.

When ImmuneOncia Therapeutics, Inc. announced the expansion of its clinical trials last September, it cited pancreatic cancer as a cancer type with high unmet medical needs. At the time, Kim Heung-tae, CEO of ImmuneOncia Therapeutics, Inc., stated, “Based on the excellent safety profile of IMC-002 and its synergy with lenvatinib (brand name ‘Lenvima’), we will successfully conduct this clinical trial to offer new hope for treatment to pancreatic cancer patients and, at the same time, use it as a key stepping stone for global technology exports.”