Hanmi Pharmaceutical and Beijing Hanmi Make Strides in Cancer Immunotherapy Trials with BH3120

Advancements in Cancer Immunotherapy: The BH3120 Clinical Trials

In a significant advancement for cancer treatment, Hanmi Pharmaceutical and Beijing Hanmi have recently made noteworthy strides in the clinical trials of BH3120, a next-generation immunotherapy designed to combat various forms of cancer. This cutting-edge treatment was showcased during a prominent session at the Society for Immunotherapy of Cancer (SITC) conference held from November 6 to 10 in Houston, Texas.

BH3120 represents a pioneering approach in the field of oncology, built upon Hanmi's proprietary dual antibody platform known as Pentambody. This innovative technology allows a single antibody to simultaneously target two distinct antigens. Specifically, BH3120 is engineered to attack PD-L1 found on cancer cells while also engaging 4-1BB on immune cells. This dual-targeting mechanism facilitates a robust immune response, essentially acting as a therapeutic bridge that promotes the immune system's ability to recognize and eliminate tumor cells effectively.

The preclinical studies of BH3120 have indicated promising results, demonstrating potent anti-cancer activity alongside a unique dissociation of immune response in the tumor microenvironment compared to normal tissues. This distinct mechanism positions BH3120 as a potential breakthrough in creating safer, more effective cancer therapies, especially given that some previous candidates directed against 4-1BB struggled with efficacy or safety concerns.

During the SITC presentation, researchers from Hanmi detailed the background, design, and current status of BH3120. This ongoing phase 1 clinical trial is designed to evaluate the safety and tolerability of BH3120 as a monotherapy in patients suffering from advanced or metastatic solid tumors. So far, the phase 1 trial has progressed smoothly, moving through cohort 3 (1 mg/kg) of the dose-escalation phase, with no dose-limiting toxicities (DLT) or serious adverse reactions reported thus far.

Dr. Dong-wan Kim, the head of the Clinical Trials Center at National University Hospital in Seoul and the principal investigator of the BH3120 phase 1 trial, expressed optimism regarding the outcomes. He stated, “The BH3120 phase 1 clinical trial is a crucial step in verifying the potential of this next-generation immunotherapy. We are hopeful for positive results that will support future investigations into BH3120 as an effective and safe treatment option for various cancers, minimizing the side effects commonly associated with current immunotherapies.”

Additionally, Hanmi is conducting another phase 1 trial to explore the safety and efficacy of BH3120 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced or metastatic solid tumors. In September, both the Ministry of Food and Drug Safety of Korea and the U.S. Food and Drug Administration approved modifications to the trial plan to include the combination therapy approach. The large-scale clinical development is expected to commence at the beginning of the following year, with Hanmi serving as the primary sponsor while MSD will provide KEYTRUDA for the trial.

Young Su Noh, director of the oncology clinical team at Hanmi, emphasized the significance of the BH3120 trial. He remarked, “This trial marks a milestone as it is our first global clinical research project utilizing our patented Pentambody dual antibody platform in immuno-oncology, which is at the forefront of cancer treatment innovation.” He added, “We are dedicated to advancing a next-generation immunotherapy capable of overcoming the shortcomings of existing treatments and enhancing therapeutic efficacy.”

With the promising developments surrounding BH3120, the global oncology community remains hopeful for a new standard of care in cancer treatment that addresses the needs of patients more effectively than current options. As research continues to evolve, the potential for BH3120 to redefine cancer therapeutic strategies becomes increasingly apparent.