On May 22, 2023 Hanx Biopharmaceuticals, Inc. (HanxBio) reported that it has received Investigational New Drug (IND) approval to begin a Phase IB/II clinical trial of its potential first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb), HX009, in patients with relapsed/refractory lymphoma (Press release, HanX Biopharmaceuticals, MAY 22, 2023, View Source [SID1234655954]). This Phase IB/II study, being conducted in the United States, will evaluate HX009 in patients with lymphoma who have failed standard therapy.

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This marks another important milestone in the development of HX009 and the company’s drug development program. HX009 has been studied in solid tumors and lymphoma indications in Australia and China. The FDA’s approval of clinical trials in the United States strengthens HX009’s global development and enhances the company’s position in bispecific antibody research.

Dr. Lei Zhang, CMO of HanxBio, said: "We are pleased that our HX009 program has received approval from the U.S. FDA for investigational clinical trials. While immune checkpoint inhibitors (ICIs) have shown great promise in a wide range of oncology indications, many challenges remain, including in lymphoma. Therefore, there is significant value in developing next-generation ICIs, including BsAbs, such as dual CD47 and PD-1 BsAbs like HX009. We look forward to rapidly advancing HX009’s clinical development and bringing new treatment options to patients to address unmet medical needs."