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.

Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
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Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
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