Hanmi Pharm Reveals First Clinical Results of 'Pentambadi' Applied Anticancer Drug in China

[Asia Economy Reporter Kim Ji-hee] Hanmi Pharmaceutical announced on the 29th that its Chinese local subsidiary, Beijing Hanmi Pharmaceutical, has disclosed the first clinical data of an immune and targeted anticancer drug applying its self-developed bispecific antibody platform 'Pentambody.'

Hanmi Pharmaceutical's partner, Innovent, presented preliminary data from the Phase 1a clinical trial of the bispecific antibody drug (IBI315·BH2950) at the '2021 Chinese Society of Clinical Oncology (CSCO)' held from the 25th to the 29th. IBI315 is an innovative bispecific antibody drug that simultaneously targets PD-1 on T cell surfaces and HER2 expressed on tumor cells. Beijing Hanmi Pharmaceutical and Innovent established a global partnership for joint development and commercialization in 2017.

A Phase 1 clinical trial is underway to evaluate the safety, tolerability, and efficacy in patients with HER2-expressing advanced solid tumors. The current announcement includes data from the dose escalation phase. As of the end of May this year, 27 patients received one of the seven pre-specified doses. No dose-limiting toxicities (DLT) were observed, and the maximum tolerated dose (MTD) was not reached.

According to the company, the objective response rate (ORR) among 15 patients who completed at least one tumor assessment after treatment at active dose levels was 20%. In patients who showed clinical responses, higher proliferation and activation of peripheral immune cells were confirmed.

Professor Shi Chun Hu from Fudan University Shanghai Cancer Center stated, “The satisfactory safety and preliminary data of IBI315 confirmed so far support the concept of bispecific antibodies designed for immune and targeted therapies,” and added, “I am confident that more positive clinical outcomes will be derived in various HER2-expressing solid tumors.”

Vice President and Head of Clinical Development at Innovent, Huizhou, said, “We will immediately initiate a Phase 1b clinical trial to evaluate the efficacy of IBI315 as monotherapy and combination therapy in HER2-positive and low-expressing solid tumors.”

Pentambody is a next-generation ‘bispecific antibody platform technology’ where a single antibody simultaneously binds to two different targets. Beijing Hanmi Pharmaceutical is currently developing various bispecific antibody drugs targeting different molecules using the Pentambody technology. The company explained that it has structural features similar to natural immunoglobulin G (IgG), which provides advantages in immunogenicity, safety, and high production efficiency.

Hanmi Pharmaceutical President Kwon Se-chang said, “We have confirmed the potential to create global innovative drugs through our proprietary bispecific antibody technology in the emerging field of next-generation immune oncology,” and added, “We will actively collaborate with our partners and continue research and development to commercialize new drugs that produce simultaneous synergy in immune and targeted anticancer therapies.”

This content was produced with the assistance of AI translation services.