HFB200301 activates NK, CD4 T, CD8 T cells by selectively binding to TNFR2. Credit: Alpha Tauri 3D Graphics /Shutterstock.com.

HiFiBiO Therapeutics has dosed the first patient in a Phase Ia/b study of HFB200301 along with tislelizumab for the treatment of advanced solid tumour indications.

The indications are preselected by the company’s proprietary Drug Intelligence Science (DIS) platform.

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The multi-centre, open-label study will evaluate the tolerability and safety of the combined therapy.

HiFiBiO Therapeutics founder, CEO and chairperson Liang Schweizer said: “This marks a major step toward further understanding the therapeutic activity of HFB200301 and how we can best deliver safe and effective treatment strategies for cancer patients where other therapeutic options have failed.”

The company will use the data from the trial to determine the combination dose and dosing regimen for further studies.

Furthermore, the data is used for biomarker strategy to select indications that may benefit the most from HFB200301 as a single agent and as a combination therapy.

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HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that activates CD4 T, CD8 T, and NK cells by selectively binding to TNFR2.

Anti-tumour activity as a single agent and combined with anti-PD-1 was also demonstrated in animal models.

Last August, HiFiBiO signed a clinical trial supply agreement with Novartis to assess its HFB200603 along with tislelizumab to treat advanced solid tumours.

Under the agreement terms, Novartis agreed to supply tislelizumab, and HiFiBiO will maintain control of the HFB200603 programme, along with the global research and development and commercial rights.