China's HanxBio plans Hong Kong IPO to fund phase 2 solid tumor trial

HanX Biopharmaceuticals is planning a Hong Kong listing to fund the phase 2 trial of its lead solid tumor drug.

The Hangzhou, China-based biotech has not revealed how much it plans to bring in from the IPO but said the top priority for spending the proceeds will be its core product, dubbed HX009. The PD-1/CD47-targeted bispecific is already currently undergoing a phase 1 study in advanced melanoma as well as a phase 1/2 trial for relapsed or refractory Epstein-Barr virus-positive non-Hodgkin lymphoma.

The company is also gearing up to launch a phase 2 trial by the end of this year that will assess HX009 in combination with a “pivotal trial stage drug” for treatment of biliary tract cancer, according to a filing (PDF). While those three studies are all located in China, HanX secured permission from the FDA last year to run a phase 1/2 trial of HX009 in the U.S. for diffuse large B-cell lymphoma.

A preclinical study of HX009 last year indicated the bispecific antibody has a strong affinity toward binding to PD-1 but a weaker affinity to CD47. This characteristic allows better targeting to the tumor microenvironment and minimizes potential hematological toxicity, HanX and its preclinical services partner Crown Bioscience said at the time.

Money from the IPO will also be used to continue the development of its two key products. They include HX301, a multi-targeted kinase inhibitor also know as narazaciclib for which the China rights were licensed from Onconova Therapeutics in 2017 as a potential glioblastoma treatment. The drug is being lined up for a phase 2 trial in combination with the chemotherapy temozolomide in the near future.

There’s also HX044, a preclinical candidate being targeted at PD-1-resistant solid tumors, with other cancer-focused antibodies also listed in the biotech’s preclinical pipeline.

HanX ended September with 153.4 million Chinese yuan ($21 million) in cash and equivalents. The biotech receives royalty payments from sales of pucotenlimab, a China-approved melanoma drug that the company licensed to Lepu Biopharma.