ImmuneOncia Therapeutics (424870.KQ) surged by its daily limit after announcing an expansion of its pancreatic cancer trial for IMC-002, a next-generation CD47 antibody drug candidate. The company added patients with pancreatic ductal adenocarcinoma (PDAC), a hard-to-treat cancer, to a Phase 1b trial that had targeted biliary tract cancer and triple-negative breast cancer. Expectations for a broader range of approved indications for IMC-002 and for a possible future technology licensing deal drove the stock higher.
Shares rose 810 won, or 29.94%, to 3,515 won on the 15th, hitting the daily price ceiling, according to the Korea Exchange. Buying interest appeared to build after the company disclosed approval of a change to its investigational new drug (IND) application for IMC-002 after the market closed the previous day, followed by a related announcement on the 15th. The stock had already jumped more than 10% in after-hours trading the previous day once news of the trial expansion emerged.
The approval allows the company to widen the pool of patients receiving the drug in the ongoing Phase 1b trial of IMC-002 to include pancreatic cancer patients. ImmuneOncia is currently running a trial evaluating the safety, tolerability, pharmacokinetics and early anti-tumor activity of IMC-002 in patients with advanced cancer who have failed standard treatment. The IND change adds a new cohort of PDAC patients, allowing the company to administer IMC-002 together with lenvatinib and assess safety and efficacy in those patients. That moves the company to the stage of verifying in actual patients the combination effect it confirmed in preclinical tests using pancreatic cancer cells.
IMC-002 targets CD47, a protein cancer cells use to evade attack by immune cells. CD47 sends macrophages a kind of "don't eat me" signal that prevents cancer cells from being engulfed. IMC-002 is an immuno-oncology drug that blocks this signal, prompting macrophages to recognize and eliminate cancer cells.
The fact that CD47 is present not only on cancer cells but also on normal cells such as red blood cells has long been considered a challenge in developing CD47 antibodies, because attacking normal blood cells can cause hematological toxicity such as anemia. ImmuneOncia adjusted the binding affinity of IMC-002 so that it binds selectively to cancer cells rather than to normal red blood cells. Preclinical studies confirmed results showing reduced red blood cell binding and hemagglutination while improving selectivity for cancer cells.
In the new pancreatic cancer cohort, IMC-002 will be given in combination with lenvatinib, a multi-targeted tyrosine kinase inhibitor. In in vitro tests using pancreatic cancer cells, administering the two drugs together increased the ability of macrophages to engulf cancer cells compared with either drug alone.
"We will carry out this trial successfully to offer new hope of treatment to pancreatic cancer patients and at the same time make it a key stepping stone for global technology licensing," said Kim Heung-tae, chief executive of ImmuneOncia.
