Hanmi Pharmaceutical collaborates with Merck (MSD) to evaluate the combination therapy of its immune anticancer drug candidate and MSD's immune anticancer drug "Keytruda" (ingredient name pembrolizumab).
Hanmi Pharmaceutical announced on the 19th that it has signed a clinical trial collaboration and supply agreement with MSD for the combination therapy using the immune anticancer drug candidate "Laps Interleukin-2 (IL-2) Analog (HM16390)" with Keytruda.
Hanmi Pharmaceutical leads the Phase 1 clinical trial to assess the safety and efficacy of the combination therapy of HM16390 and Keytruda. MSD will supply Keytruda free of charge for this trial.
Hanmi Pharmaceutical's HM16390 is a newly designed drug candidate that regulates IL-2, a protein that modulates the immune response in our body. It aids in the proliferation and activation of T cells. Existing therapies, including Proleukin (aldesleukin), have therapeutic effects, but the side effects such as vascular leakage and cytokine storms are severe, making their use very limited. Other IL-2 candidates being developed by different pharmaceutical companies also still have limitations.
To address these issues, Hanmi Pharmaceutical has introduced precision control technology into HM16390. In particular, it adjusts the binding ability to IL-2's alpha receptor, minimizing side effects while maintaining anticancer efficacy. Through this, it aims to help immune cells penetrate well into the surrounding environment of tumor cells and convert unresponsive tumors (cold tumors) into responsive, sensitive tumors (hot tumors).
The company also designed the long-acting drug platform "Lapscovery" to reduce the dosing frequency while prolonging the effect. It is currently being developed in a subcutaneous injection (SC) form that is effective with just one administration.
The efficacy of HM16390 has been confirmed through preclinical animal experiments. According to the animal experiment results disclosed last November at the Society for Immunotherapy of Cancer (SITC) in the U.S., HM16390 successfully achieved complete remission, wherein the cancer completely disappeared. Currently, HM16390 is under consideration for its potential in monotherapy and combination therapy targeting solid tumors, and a global Phase 1 clinical trial is underway in South Korea and the United States.
This contract marks Hanmi Pharmaceutical's third collaboration with MSD. Previously, Hanmi conducted joint research with MSD on various immune anticancer drug candidates, including the bispecific antibody "BH3120" and CCR4 antagonist "tibumersiren."
No Young-soo, Head of Clinical Affairs at Hanmi Pharmaceutical, said, "Hanmi Pharmaceutical has secured competitive candidates in the field of immune anticancer drugs," and noted, "We plan to continuously share research outcomes at various conferences this year."