Therapy Areas
Hanx Biopharmaceuticals' HX009 receives Investigational New Drug approval to start clinical trial
23 May 2023 -

Hanx Biopharmaceuticals, Inc. (HanxBio), a China-based global biopharmaceutical company, announced on Monday that it has received Investigational New Drug (IND) approval to commence a clinical trial for the potentially first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb), HX009, in subjects with relapsed/refractory Lymphoma.

This is a Phase IB/II clinical study to be conducted in the United States to evaluate HX009 in the treatment of lymphoma patients who have failed standard therapy.

HX009 has been studied in Australia and China in both solid tumour and lymphoma indications. The approval by FDA to start a clinical trial in US strengthens the development of HX009 globally, and is claimed to enhance the company's position in the field of bispecific antibody research.

Dr Lei Zhang, HanxBio CMO, said, 'We are very pleased that our HX009 program has received clinical trial research approval from the US FDA. Although immune checkpoint inhibitors (ICIs) have shown great promises in a wide range of oncology indications, there still remains many challenges including in lymphoma. Therefore, it is of great value to develop the next generation of ICIs, including BsAb, such as dual targeting CD47 and PD-1 BsAb like HX009. We look forward to rapidly advancing the clinical development of HX009, bringing new treatment options to patients to meet unmet medical needs.'