Targovax announces that first combination trials with ONCOS-102 have passed their initial, planned, independent safety reviews
Oslo, Norway, 11 December 2017 - Targovax ASA (OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, announces that clinical trials investigating ONCOS-102 in the treatment of melanoma and mesothelioma have successfully passed their respective first, planned, independent safety reviews. These are the first studies to investigate ONCOS-102 in combination with other drugs.
The safety reviews of ONCOS-102 in the first four patients in the melanoma trial and first three patients in the mesothelioma trial have been completed without any safety concerns. The review reports conclude that, to date, ONCOS-102 has been well-tolerated in combination with either checkpoint inhibitor (KEYTRUDA®), or chemotherapy (pemetrexed/cisplatin), and both trials were recommended to be continued by the study-specific safety committees.
The melanoma trial is an open-label phase I trial exploring the safety, immune activation and clinical response of sequential treatment with ONCOS-102 and the checkpoint inhibitor KEYTRUDA®(pembrolizumab, an anti-PD-1 monoclonal antibody) in patients with advanced or unresectable melanoma, whose tumors have continued to grow despite checkpoint inhibitor therapy. The goal of the trial is to investigate whether the immune system of patients, who have already failed to respond to checkpoint inhibitors, can be reactivated by priming with ONCOS-102 and whether this reactivation enables them to respond to subsequent retreatment with a checkpoint inhibitor.
The mesothelioma trial is a randomized phase II, open-label, multi-center trial with a phase Ib safety lead-in of ONCOS-102 and standard of care pemetrexed/cisplatin (chemotherapy) in patients with unresectable malignant pleural mesothelioma. The trial will include six patients in a lead-in to evaluate safety, followed by a randomized part of the trial to compare the combination treatment with the standard of care chemotherapy.
Dr Magnus Jäderberg, CMO of Targovax, said: "We are pleased that the first combination trials of ONCOS-102 have passed the initial safety reviews without any issues. As such, ONCOS-102 appears to be well-tolerated in combination with both checkpoint inhibition and chemotherapy, and we can proceed with the trials as planned. Our plan now is to evaluate immune responses in the first subset of patients".
Immune response data readout schedule
Over the coming weeks and months, Targovax expects to release immune response data in a subset of patients for these two trials, in addition to the TG02 RAS neo-antigen vaccine trial in colorectal cancer, according to the following schedule:
- In December: TG02 in colorectal cancer
- In January: ONCOS-102 in melanoma
- In February: ONCOS-102 in mesothelioma
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
About Targovax
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.