Hanx Biopharmaceuticals set to begin US clinical trial of HX009 in lymphoma

Hanx Biopharmaceuticals (HanxBio) has obtained approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) of HX009, enabling the company to initiate a clinical trial in patients with relapsed/refractory lymphoma.

HX009, developed by the Chinese biopharmaceutical company, is a bispecific antibody (BsAb) that targets both CD47 and PD-1 proteins.

The phase 1B/2 clinical trial will be conducted in the US and will assess the efficacy of HX009 in treating lymphoma patients who have not responded to standard therapy.

Hanx Biopharmaceuticals said that the IND approval marks a significant milestone in the development of HX009 and in the company’s overall drug development program. HX009 has previously undergone studies in Australia and China for both solid tumor and lymphoma indications.

The FDA’s approval to commence clinical trials in the US not only reinforces the global development of HX009 but also strengthens its position in the field of bispecific antibody research, said Hanx Biopharmaceuticals.

Dr. Lei Zhang — Hanx Biopharmaceuticals 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.”