• Data position the company to start potential registrational trials with two drugs in two tumor types

Novo Seeds, the early stage investment and company creation team of Novo Holdings, today announced that its portfolio company IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win® technology, announced the successful outcome of a scheduled interim analysis of the ongoing Phase 2 trial (IO102-012/KEYNOTE-764) of its lead cancer therapeutic vaccine, IO102, in non-small cell lung cancer (NSCLC).

In this randomized trial, IO102 is being tested in combination with Merck’s anti-PD1 therapy, Keytruda (pembrolizumab) as a first-line therapy in patients with metastatic NSCLC. The interim analysis was designed as a futility analysis. The Safety Monitoring Committee has recommended to continue the trial without modifications as the futility boundary was successfully passed.

IO Biotech’s lead candidate, IO102, is an Indoleamine 2,3-dioxygenase (IDO)-derived immune modulating therapy with a dual mode of action – killing both cancer cells and immune-suppressive cells. IO Biotech’s IDO-derived immune modulating therapies previously demonstrated both a favorable safety profile and promising anti-tumor activity in its first human clinical trial of heavily pre-treated patients with NSCLC.

Emmanuelle Coutanceau, Partner at Novo Seeds, commented: “IO Biotech was founded on excellent science, by a strong team with existing, promising data. Novo Seeds’ strategy is to invest in breakthrough innovation with the ultimate goal of developing medicines that can transform patients’ lives. As a supporter of IO Biotech from the early and pre-seed stages, we are encouraged by the validation the interim analysis offers, which underscores the potential of the company’s lead therapeutic vaccine, IO102, as an effective new treatment option for patients suffering from one of the leading causes of cancer death.”

Mai-Britt Zocca, PhD, CEO and Founder of IO Biotech, said: “The year 2020 will be a transformational year for IO Biotech.  We are pleased by the data generated thus far in the ongoing trial of our off-the-shelf subcutaneous injectable treatment for patients with lung cancer. Additionally, the exciting data being generated in the ongoing melanoma trial with our proprietary T-win cocktail that includes IO102 and IO103 (our two clinical lead programs based on targeting IDO and PD-L1) will allow the company to initiate pivotal trials in two indications with two drugs. We continue to demonstrate long term durability of drug effect with a very attractive safety profile for each of our clinical stage candidates, whether alone or in any combination.”