TILT Biotherapeutics Announces First US Patient Dosed in Immunotherapy Clinical Trial in Ovarian Cancer

TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapies, announces that the first US patient has been dosed in its ovarian cancer trial (NCT05271318), using its oncolytic adenovirus, TILT-123, that has the potential to be first-in-class for this indication.

This open-label, phase I, dose-escalation, multicenter, and multinational, clinical trial of TILT-123 in combination with MSD’s (a tradename of Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), is for platinum resistant or refractory ovarian cancer (PROTA, also called TILT-T563). The US patient, treated at the Mayo Clinic, should complete enrollment in the first cohort of three patients, the other two located in Finland. The Phase I trial is expected to enroll up to 15 patients.

The company’s European and US open phase I clinical programs now cover several cancer types including ovarian cancer, head and neck cancer, and melanoma. In September, the company announced a new collaboration and supply agreement with MSD to evaluate TILT-123 in combination with KEYTRUDA in patients with immune checkpoint inhibitor refractory non-small cell lung cancer.

TILT Biotherapeutics’ CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients with earlier versions of oncolytic viruses, said, “Ovarian cancer is a killer disease with a pressing need for better therapies. There are no oncolytic viruses or check point inhibitors approved for use in that indication. The first US patient dosed is a significant milestone as we strive to make a difference using our armed oncolytic viruses in this difficult to treat disease. It’s a pleasure to work with the prestigious Mayo Clinic to deliver such innovation with impact. We are investing in our own US operations and opening US trial sites by the end of the year, as we advance towards Phase 2 trials.”

The heart of TILT’s innovative approach revolves around the use of cancer cell specific oncolytic adenoviruses, armed with cytokines and other molecules to boost the patient’s T-cell immune response to better enable it to find and destroy cancer cells.

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KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About TILT Biotherapeutics

TILT Biotherapeutics is a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary oncolytic adenoviruses armed with molecules including cytokines that can stimulate, or suppress, T cells. The company’s patented TILT^® technology, which can be delivered locally and systemically, modifies the tumor microenvironment, and eliminates its ability to suppress immune responses to cancer, thereby enhancing T-cell therapies such as immune checkpoint inhibitors, tumor infiltrating lymphocyte (TIL) therapy, and CAR T therapies.

TILT’s lead asset, TILT-123, is a 5/3 chimeric serotype adenovirus armed with two human cytokines: TNF alpha and IL-2. TILT-123 has demonstrated a 100% response rate in pre-clinical cancer models in vivo, and it is currently in Phase I clinical trials.

The Company’s pioneering approach has been recognized by industry leaders including with the Merck KGaA and Pfizer Alliance, who are collaborating to investigate TILT-123’s therapeutic effect in combination with the PD-L1 inhibitor, Avelumab (Bavencio^®), in Head and Neck cancer (NCT05222932). The Company has two collaborations with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA, investigating TILT-123 in combination with pembrolizumab (KEYTRUDA^®) in Ovarian Cancer (NCT05271318) and in refractory non-small cell lung cancer. In 2019, TILT established an additional partnership with Biotheus, a privately held Chinese company based in Zhuhai, Guangdong, China, for the development and commercialization of TILT’s proprietary oncolytic virus TILT-123 in Greater China.

Based in Helsinki, Finland, the company was established in 2013 as a spin-out from the University of Helsinki. It has funding from Lifeline Ventures, Finnish Industry Investment (TESI), angel investors, Business Finland, and the European Innovation Council.

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