Clinical Trial of Vaccine, IO102, Plus Keytruda in Advanced NSCLC Patients Planned

Clinical Trial of Vaccine, IO102, Plus Keytruda in Advanced NSCLC Patients Planned

IO Biotech and Merck & Co  recently signed an agreement to assess IO Biotech’s lead candidate IO102, an anti-cancer vaccine, in combination with Keytruda (pembrolizumab) in patients with metastatic non-small cell lung cancer (mNSCLC).

Under the agreement, conducted through a Merck subsidiary, IO Biotech will conduct the Phase 1/2 clinical trial evaluating the combination therapy, the company states in a press release. Merck, known as MSD outside North America, will provide Keytruda.

The planned trial, possibly opening this year, will be an open-label, randomized study of the safety and efficacy of IO102 plus Keytruda, with or without chemotherapy, as a first-line treatment for mNSCLC patients.

IO102 is an IDO-derived immune modulating therapy with a dual mode of action, in that it aims to kill both cancer cells and normal cells with immunosuppressive functions. This action could increase the effector responses of surrounding T-cells.

IDO stands for indolamine 2,3 dehydrogenase, an enzyme involved in immune system regulation. IDO inhibitors increase an amino acid (tryptophan) that is critical for T-cell responses, and that reduces the activity of immunosuppressive cells in the tumor environment.

IDO-derived therapies have been shown to have a favorable safety profile, and IO101 — a forerunner to IO102 — showed signs of promising anti-tumor activity in a prior, investigator-initiated clinical trial in advanced NSCLC patients, the company reports on its website.

According to IO Biotech, IO102 could potentially be a suitable, safe and effective add-on treatment to checkpoint inhibitors like Keytruda.

Keytruda is a monoclonal antibody designed to identify and block the PD-1 receptor, allowing T-cells (white blood cells involved in the immune response) to better “find” and eliminate cancer cells.

“We believe there is a strong mechanistic rationale to explore the combination of an IDO-derived immune modulating therapy, anti-PD-1 antibody and chemotherapy,” Mai-Britt Zocca, PhD, chief executive officer and founder of IO Biotech, said in the release. “Through this collaboration, we expect to get a diverse set of clinical data to understand the potential of IO102 to improve durability and response rates in combination with one of the leading treatments within immuno-oncology.”

Keytruda was granted accelerated approval by the U.S. Food and Drug Administration (FDA) as a first-line therapy for metastatic non-squamous NSCLC, in combination with chemotherapy — Alimta (pemetrexed) and Paraplatin (carboplatin) — in May 2017.

The approval, for patients with all PD-L1 levels, was based on data from the KEYNOTE-021 Phase 1/2 clinical trial (NCT02039674), published in The Lancet Oncology.

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