Targovax announces early signal of efficacy in ONCOS-102 trial in mesothelioma
Responses observed in three out of six patients
Recruitment into the randomized part of the trial underway
Oslo, Norway, 2 May 2018 - Targovax ASA (OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces encouraging results from its phase I/II trial of ONCOS-102 in mesothelioma, in combination with standard of care chemotherapy, in which clinical responses were observed in three out of the first six patients.
The trial is a randomized phase I/II open label trial, with a six-patient safety lead-in cohort, of ONCOS-102 and pemetrexed/cisplatin, the current standard of care chemotherapy, in patients with unresectable malignant pleural mesothelioma.
The aim of the trial is to assess safety and tolerability, immunological activation and overall response rate of the combination of ONCOS-102 and chemotherapy compared to chemotherapy alone. In February, Targovax reported that the independent Data and Safety Monitoring Board (DSMB) had assessed the safety data from the lead-in cohort, and recommended the trial continue into the randomized phase without modifications. In addition, innate and adaptive immune activation was observed in the first patients analyzed.
Now, overall response rate has been evaluated for all six patients in the safety cohort after six months. Three out of the six patients (50%) responded, with one patient showing a partial response and two patients showing stable disease, according to the Response Evaluation Criteria In Solid Tumors guidelines, RECIST 1.1.
All patients in the safety cohort received ONCOS-102 and chemotherapy combination treatment either as 1st line (three patients), or after previous treatment (three patients, 2nd/3rd line). Two out of three patients in 1st line responded, and one of three patients that had received previous treatment responded.
Based on this early signal of efficacy, and the previous DSMB recommendation, recruitment into the randomized part of the trial is now underway. The trial will include 30 patients when fully recruited, with 20 patients in the experimental group (including the safety cohort) and 10 patients in the control group.
Dr. Luis Paz-Ares, Chair of the Medical Oncology Department at the University Hospital 12 de Octubre, Madrid and Principal Investigator of the trial said: "Mesothelioma is a challenging disease to treat, with few patients surviving beyond 12 months from diagnosis. The three clinical responses observed in the safety lead-in cohort of the ONCOS-102 trial are encouraging. We look forward to entering the randomized part of the trial which will further evaluate the potential of this novel, innovative treatment to benefit more patients in the future."
Magnus Jäderberg, CMO of Targovax, added: " We are very pleased to have completed the safety part of the study, with the DSMB giving us approval to open up the randomized part and start recruiting patients. This is the first time clinical response has been observed for ONCOS-102 in combination with chemotherapy, which is an important milestone for Targovax and the ONCOS program. It will now be interesting to see if this early signal of efficacy is confirmed in the randomized part of the study."
More information about the mesothelioma trial and results will be provided at the Targovax Q1 presentation and webcast on 3 May at 10am CET.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Arming the patient's immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage company focused on developing and commercializing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.
The Company's development pipeline is based on two novel proprietary platforms:
The first platform, ONCOS, uses oncolytic viruses as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. In phase I trials it has demonstrated immune activation at lesional level which was associated with clinical benefit. In an ongoing phase I trial in advanced melanoma we expect important proof of concept data for checkpoint inhibitor refractory patients.
The second platform, TG, are neo-antigen cancer vaccines designed to specifically treat tumors that express mutated forms of RAS. Mutations to the RAS protein are common in many cancers and are known to drive aggressive disease progression and treatment resistance. There is a high unmet medical need for therapies that are effective against tumors that express these mutations. The TG platform's therapeutic potential stems from its ability to enable the patient's immune system to identify and destroy tumors bearing any RAS mutations. In early 2017, key proof of concept data for the TG platform from a clinical trial of TG01 in resected pancreatic cancer patients showed encouraging overall survival and will give guidance for the future clinical development of this platform.
Targovax's development pipeline has three novel therapeutic candidates in clinical development covering six indications.
Both platforms are protected by an extensive portfolio of IP and know-how and have the potential to yield multiple product candidates in a cost-effective manner. Additionally, Targovax has other products in early stages of development.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.