Hanmi Pharmaceutical Advances BH3120 Clinical Trials as Innovative Cancer Immunotherapy

Hanmi Pharmaceutical, in collaboration with Beijing Hanmi Pharmaceutical, is making notable strides in the clinical trials of BH3120, a next-generation immunotherapy designed to combat cancer. This innovative treatment is based on Hanmi’s proprietary dual antibody technology, Pentambody, which uniquely enables an antibody to target two different sites simultaneously. As a result, BH3120 can effectively hone in on cancer cells while triggering immune responses to enhance therapeutic outcomes.

On November 25, 2024, during the Society for Immunotherapy of Cancer (SITC) conference in Houston, Texas, Hanmi showcased the latest findings from the ongoing Phase 1 trial of BH3120. This trial is essential for assessing the drug's safety, tolerability, and efficacy as a monotherapy against advanced or metastatic solid tumors. The early results demonstrate a smooth progression through cohort 3, where no dose-limiting toxicities or severe adverse reactions have been observed thus far.

BH3120 aims to target PD-L1 present on cancer cells and 4-1BB on immune cells, essentially operating as a bridging agent that promotes the identification and destruction of tumor cells by immune cells. What sets BH3120 apart from other candidates targeting 4-1BB is its impressive preclinical data, which indicates robust anti-cancer effects without notable harm to normal tissues. This delineation suggests that BH3120 could revolutionize cancer treatments, reducing adverse side effects that often accompany existing therapies.

Dr. Dong-wan Kim, who leads the clinical trials at the Seoul National University Hospital, expressed optimism about the outcomes of this critical trial. He remarked, “The Phase 1 trial represents a crucial step toward realizing the promise of BH3120 as a next-generation immunotherapy. We are hopeful for favorable results that could validate BH3120 as a viable treatment for various cancers.” Alongside the ongoing monotherapy trial, Hanmi is also assessing the combination of BH3120 with MSD’s renowned anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), through an approved modification to the original clinical trial plan. This combination trial will also focus on patients with advanced solid tumors, with full-scale development expected early next year.

Young Su Noh, the Director of Hanmi's ONCO Clinical Team, highlighted the significance of the BH3120 trials as a milestone for the company. He stated, “BH3120 is our first global clinical research project utilizing our proprietary Pentambody platform in immunology, positioning us at the forefront of cancer treatment advancement. Our commitment is to deliver a next-generation immunotherapy that overcomes existing treatment limitations.” As various treatment options are explored, Hanmi Pharmaceutical’s initiative with BH3120 underscores its resolve to enhance cancer care and improve patient outcomes.

In summary, the clinical progress of BH3120 positions it as a potentially significant breakthrough in cancer immunotherapy, offering promising hope for patients while paving the path for further innovations in the field.