Data position the company to start potential registrational trials with two drugs in two tumor types
- Data position the company to start potential registrational trials with two drugs in two tumor types
Copenhagen, Denmark, 25 February 2020 – 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.”
ENDS
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About Novo Holdings A/S
Novo Holdings A/S is a private limited liability company wholly owned by the Novo Nordisk Foundation. It is the holding and investment company of the Novo Group, comprising Novo Nordisk A/S and Novozymes A/S, and is responsible for managing the Novo Nordisk Foundation’s assets.
Novo Holdings is recognized as a leading international life science investor, with a focus on creating long-term value. As a life science investor, Novo Holdings provides seed and venture capital to development-stage companies and takes significant ownership positions in growth and well-established companies. Novo Holdings also manages a broad portfolio of diversified financial assets. Further information: http://www.novoholdings.dk
About IO Biotech
IO Biotech is a clinical stage biotech company developing disruptive immune therapies for the treatment of cancer. The pipeline of first-in-class immune modulating anti-cancer therapies is developed by a unique technology platform, T-Wwin®, enabling the activation of T cells that are specific for immune-suppressive molecules. IO Biotech has a proven track record of progressing preclinical and clinical compounds. The two lead compounds targeting IDO and PD-L1 are in clinical development and several pipeline compounds are in pre-clinical phase. For further information, please visit www.iobiotech.com.
About the Study
IO102-012/KEYNOTE-764 is an Open-label, Randomized, Phase 1/2 Trial Investigating the Safety and Efficacy of IO102 in Combination with Pembrolizumab, with or without Chemotherapy, as first-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer. This global clinical trial is planned to accrue 108 patients across around 20 sites in the U.S. and Europe.
The IO102-012/KN-764 trial is part of a collaborative agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada). The clinical trial is sponsored by IO Biotech. The rights to the study results will be shared, and IO Biotech has retained global commercial rights to IO102.
About NSCLC
According to the American Cancer Society (ACS), lung cancer is the leading cause of cancer death. Each year, more people die of lung cancer than colon, breast and prostate cancers combined. The two main types of lung cancer are non-small cell lung cancer and small cell lung cancer. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all cases. According to the ACS, the five-year survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be six percent.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About T-win® Technology Platform
IO Biotech’s proprietary T-win technology platform enables identification of compounds with dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses. The company’s compounds are administered as “off-the-shelf” subcutaneous injections, distinguishing these treatments from many immuno-oncology therapies.
