Targovax announces completed enrollment of ONCOS-102 trial in mesothelioma
- The trial is now fully recruited, with a total of 31 patients enrolled
- Data read-outs expected around New Year
Oslo, Norway, 8 May 2019 - Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, today announces that it has completed patient enrollment in the phase Ib/II trial of ONCOS-102 in combination with chemotherapy in unresectable malignant pleural mesothelioma (MPM).
The trial consists of a phase Ib safety lead-in part followed by a randomized, open label phase II part, assessing the combination of ONCOS-102 and standard of care (SoC) chemotherapy (pemetrexed and cisplatin) vs SoC chemotherapy alone in first or second/third line patients with unresectable MPM. In May 2018, Targovax reported no safety issues, strong innate and adaptive immune activation and 50% disease control rate (DCR) for the six patients in the phase Ib safety lead-in cohort - see link to press release here.
The enrollment of 25 patients into the randomized phase II part of the trial has now been completed, with a total of 31 patients on the trial who will be evaluated for safety, immune response and efficacy. There are 20 patients in the experimental arm combining ONCOS-102 with chemotherapy and eleven patients in the chemotherapy only control group. The patients in the part I safety cohort form part of the experimental arm.
The aim of the trial is to assess safety and tolerability, immunological activation and 6-month overall response rate (ORR) of the combination of ONCOS-102 and SoC chemotherapy compared to SoC chemotherapy alone. Data read out is expected around New Year.
Magnus Jäderberg, CMO of Targovax, said: "We are very pleased to have completed enrollment of our mesothelioma trial. ONCOS-102 is currently the most clinically advanced oncolytic virus in this difficult to treat cancer, and therefore a high priority for us. The randomized ORR and immune data from this study will indicate whether the ONCOS-102 and chemotherapy combination gives patients a benefit over chemotherapy. The clinical and immune data will guide the further development of ONCOS-102 in mesothelioma."
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
Activating the patient's immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.
Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It has been shown to activate the immune system to generate tumor-specific immune responses. In phase I trials, ONCOS-102 induced both local and systemic innate and adaptive immune activation, which has been associated with clinical benefit. ONCOS-102’s targeted path-to-market indication is mesothelioma, where the virus is currently being tested in a randomized phase II trial. Another trial, in checkpoint inhibitor refractory advanced melanoma, is expected to produce important proof-of-concept immune activation data in heavily pre-treated patients.
Targovax is also developing a neoantigen cancer vaccine targeting tumors with oncogenic RAS–mutations, which are known to drive cancer. The TG vaccine program has shown strong RAS-specific immune activation and a signal of clinical efficacy in a 32-patient trial with TG01 in resected pancreatic cancer. A next generation product candidate, TG02 is currently tested in a phase I trial in colorectal cancer, both as monotherapy and in combination with Keytruda (an anti-PD1 check point inhibitor).