Hanmi Pharm starts P1T on its next-gen immuno-oncology drug

A new drug candidate that uses the company’s next-generation, bispecific antibody platform technology ‘Pentambody’

Clinical trial protocol was approved in the US in May last year

On the 22nd, Hanmi Pharm announced that it has recently received approval to initiate a domestic Phase I trial for its next-generation immuno-oncology drug ‘‘BH3120(PD-L1/4-1BB BsAb)’ from the Ministry of Food and Drug Safety.

 

In May, the company had previously received approval from the US FDA for the same drug candidate after submitting an Investigational New Drug Application.

 

BH3120, which is be codeveloped by Hanmi Pharm and Beijing Hanmi Pharm, is a new drug candidate that applies the company’s, bispecific antibody platform technology ‘Pentambody’ that allows for one antibody to bind to two targets at once.

 

The drug offers the benefit of providing both immunotherapy (that activates immune cells) and targeted therapy (that specifically targets cancer cells).

 

BH3120 is an immunoglobulin G (IgG) like dual antibody designed that has biased binding affinities against PD-L1 and 4-1BB.

 

The different binding affinities that were designed based on various studies are expected to induce better efficacy and safety.

 

BH3120 has a dual antibody mechanism of action that targets both 4-1BB and the PD-L1 expressed on the surface of cancer cells that specifically elicit antitumor activities in the tumor microenvironment (TME), and has shown a potent antitumor effect by activating immune cells within cancerous tissues.

 

In addition to BH3120’s benefits as monotherapy, Hanmi Pharm also confirmed the drug’s strong synergistic effect as combined therapy, as its use in combination with a PD-L1 inhibitor resulted in the disappearance of cancerous tissue.

 

No toxicity or immune system-related side effects were observed with BH3120 in the safety study that was conducted on primates and was confirmed to have a superior safety profile compared to same-class competitors that are currently being developed.

 

The company presented its study results at the American Association for Cancer Research (AACR) Annual meeting that was held in April this year.

 

The results showed that a clear decoupling of immune activity between cancer and normal tissues was observed, signifying the possibility of the development of a new immuno-oncology drug that minimizes the side effects of existing immuno-oncology drugs Based on the preclinical study results, the company plans to start a global Phase I trial on BH3120 in the US and Korea within this year.

 

An official from Hanmi Pharm said, “BH3120 is the first project that uses the next-generation bispecific antibody platform technology ‘Pentambody’ for a global clinical trial.

 

We believe ‘Pentambody’ will follow Hanmi’s proprietary ‘Lapscovery’ technology and continue to create future value for the company.