On April 15, 2019 Tessa Therapeutics, a clinical-stage immunotherapy company focused on autologous and off-the-shelf, allogeneic therapies targeting solid tumors, reported that it has entered into an agreement with Merck (known as MSD outside the US and Canada), through a subsidiary, to evaluate Tessa’s armored human papillomavirus-specific T cell (HPVST) therapy, or TT12, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with recurrent or metastatic HPV 16 and 18-positive cervical cancer (Press release, Tessa Therapeutics, APR 15, 2019, View Source [SID1234535137]).

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Under the agreement, Tessa will conduct a multi-center Phase 1b/2 trial to evaluate the safety and efficacy of the combination. The trial is planned for initiation in the United States, Singapore and South Korea. "We are very excited to work with Merck to evaluate the potential of KEYTRUDA in combination with Tessa’s VST therapy for cervical cancer," said Mr. Andrew Khoo, Tessa Therapeutics CEO and Co-Founder. "Cervical cancer is a major cause of death in women, especially in some of the most vulnerable parts of the world. Furthermore, the current prognosis and treatment options for patients with metastatic cervical cancer are poor. We look forward to developing this novel combination further, which has the potential to bring more effective treatment options for such patients." Tessa’s TT12 is an autologous cell therapy product composed of HPVSTs that have been trained to target HPV 16/18 antigens and genetically modified with a decoy TGF-β receptor to overcome the suppressive tumor microenvironment. The safety and optimal dose selection of armored HPVSTs in combination with another anti-PD-1 antibody is currently being evaluated in a separate, ongoing investigator-sponsored Phase 1 trial in the United States, in patients with relapsed HPV-associated cancers. Preliminary results from this trial show that armored HPVSTs and its combination with anti-PD-1 are well-tolerated, have minimal toxicities and early signs of efficacy. Dr. Ivan D. Horak, M.D., Tessa Therapeutics President of Research and Development said, "Tessa’s TT12 Phase 1 study has shown encouraging results, supporting the effectiveness of armoured HPVSTs in targeting HPV-positive tumors and the addition of anti-PD-1 may remove potential immune inhibition that can hamper the tumor-killing activity of the HPVSTs. Bringing this therapy into a Phase 1b/2 trial and the expansion of clinical sites into Asia reflect our desire to bring novel therapies to more cancer patients globally, as well as our belief in the therapy’s potential to improve the clinical outcomes of patients with advanced stages of HPV-positive tumors." KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA. About Cervical Cancer and Armored HPVST Immunotherapy According to the World Health Organization, cervical cancer is the fourth most common cancer in women worldwide and second most common in less developed regions. Cervical cancer is caused by sexually acquired infection with certain types of human papillomavirus (HPV), with two HPV types (16 and 18) accounting for 70% of cervical cancers and pre-cancerous cervical lesions. Various studies have reported poor outcome of patients with metastatic cervical cancer. Currently, the median survival time for metastatic cervical cancer is only 8 to 13 months[1] and the 5-year survival rate is 16.5% compared to 91.5% for localized cervical cancer[2]. Contrary to patients with early-stage cervical cancer and locally advanced cervical cancer who have access to conventional treatments including surgery, chemotherapy, or radiotherapy, patients with metastatic cervical cancer have no standard treatment because of its heterogeneous manifestations. T cells are a critical part of the body’s immune system that play a central role in fighting virus infections and cancers. Virus-Specific T cells (VSTs), in particular, have the ability to recognize and kill infected cells while activating other parts of immune system for a coordinated response. HPVSTs are produced by collecting patient’s blood and selectively expanding T cells which recognize HPV 16/18 antigens. To increase durability in the tumor microenvironment, the HPVSTs are armored by modifying the cells to express a decoy TGF-β receptor. The armored HPVSTs are expanded before undergoing strict quality control prior to infusion back into the patient.