The Taiwan Food and Drug Administration (TFDA) has cleared an investigational new drug (IND) application from HanchorBio to begin a first-in-human study of HCB101 in advanced solid tumours or relapsed and refractory non-Hodgkin lymphoma patients.
The open-label, multi-centre study intends to assess HCB101’s pharmacokinetics, tolerability, safety, and clinical anti-tumour activity in patients with these diseases.
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Patients in the trial will receive intravenous injections of the drug candidate weekly.
HCB101 is an extracellular domain of SIRPα that fuses to the Fc region of the immunoglobulin IgG4.
The drug has also been found to trigger distinct gene expression profiles inside the tumour and its microenvironment, as demonstrated in quantitative RNA transcriptional analysis.
HanchorBio president and chief scientific officer Sean Juo said: “With a strong pipeline targeting both the adaptive and innate immunity and the Fc-based designer biologics (FBDB) platform we have built, HanchorBio is well positioned to make important impacts in delivering innovative, cutting-edge immunotherapies.
“Leveraging the ‘do not eat’ signal pathway, HCB101 has demonstrated superior anti-tumour efficacy in our extensive preclinical studies of murine xenograft tumor models when comparing head-to-head with other agents currently being investigated in clinical trials that target the same pathway.”
HanchorBio clinical operations head Dora Weng said: “IND approval from TFDA within 23 working days (a speed record) is a testament to our in-house drug development capabilities and strong clinical operations through our partnership with global CRO companies.
“Our team already initiated this clinical trial in the US, and I look forward to enrolling the first subject soon.”
HanchorBio also said that the process for initiating US trial sites is due to be completed later this year.
HanchorBio founder, chairman and CEO Scott Liu said: “HCB101 project was initiated in December 2021, and the US IND was submitted in March 2023; the 2.3 year from inception to IND was a record for a biotech company of our size.”
