ROCKVILLE, M.D. and SUZHOU, China, February 21，2024 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that it has entered into a clinical trial collaboration and supply agreement with ImmVirX Pty Limited (“ImmVirX”) to evaluate the combination therapy of ImmVirX’s investigational oncolytic virus IVX037 with Innovent’s TYVYT® (sintilimab injection), the Chinese market-leading anti-PD-1 inhibitor.

ImmVirX is conducting a first-in-human Phase 1 clinical trial (NCT05427487) of intratumoral IVX037 in Australia. Initial results from Part 1a of the trial indicate that multiple injections of IVX037 have been well tolerated and show early signs of inducing potentially beneficial inflammatory cytokines/chemokines, such as CXCL10, with antitumor activity observed in the injected lesions of some subjects.

Part 1b of the trial, set to begin in mid-2024, evaluates the anticancer activity and tolerability of intratumorally administered IVX037 in combination with intravenously injected sintilimab in patients with advanced colorectal, ovarian and gastric cancer. Approximately 45 patients will be enrolled. Under the collaboration agreement, Innovent will provide clinical drug supplies of TYVYT® (sintilimab injection) in this multi-center trial in Australia.

Dr. Hui Zhou, Senior Vice President of Innovent, stated: “We believe that there may be potential benefits in combining IVX037 with our anti-PD-1 therapy, TYVYT® (sintilimab injection), because they play complementary roles in mobilizing the immune system to fight cancer. We are pleased to be collaborating with ImmVirX and look forward to seeing encouraging results from this study.”

Dr. Malcolm McColl, CEO and Co-Founder of ImmVirX, stated: “We are excited to collaborate with Innovent on this clinical trial to explore the combination of IVX037, our receptor targeted oncolytic virotherapy, with the checkpoint inhibitor TYVYT® (sintilimab injection) in hard-to-treat cancers. We are pleased to have this opportunity to work with a leader in the global oncology field to evaluate the potential synergy of these two immunotherapies in very common cancer types. We believe the cancer killing and immune stimulating activity of IVX037 when used in combination with checkpoint inhibitors has the potential to drive meaningful responses in cancer types that are generally refractory to checkpoint inhibitor monotherapy.”
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