Targovax initiates first clinical trial with TG02, the second product from its RAS-peptide immunotherapy platform
- Category: Vaccines
- Published on Thursday, 20 April 2017 11:10
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First patient enrolled in a Phase Ib trial in patients with locally recurrent RAS-mutated rectal cancer
OSLO, Norway I April 20, 2017 I Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, announces that it has recruited the first patient in an exploratory Phase Ib clinical trial of TG02 in patients with locally recurrent RAS-mutated rectal cancer scheduled to have surgery. The trial is being conducted at clinical sites in Australia and New Zealand.
In this open label, non-randomized trial, ten patients will receive TG02 as monotherapy and then followed by ten patients receiving TG02 in combination with pembrolizumab, a PD-1 checkpoint inhibitor. The trial's primary objective is to investigate the safety and immune activity in peripheral blood and at the tumor level.
TG02 is the second TG cancer immune activator to enter the clinic from the Company's peptide-based immunotherapy platform. It contains a proprietary mixture of eight synthetic peptides representing fragments of the most frequent RAS mutations seen in rectal cancer. Studies to date have shown that the Company's lead immune activator for RAS-mutated cancer, TG01, induces immune responses in cancer patients with resected pancreatic cancer, which may translate clinically to a survival benefit.
Mutations in RAS, a family of structurally related proteins that regulate cell growth, are seen in about 50% of colorectal cancers, and nearly all patients with recurrent disease. They are associated with a limited response to chemotherapy and poor prognosis. Previous and ongoing clinical studies have shown that TG peptides are able to induce RAS mutation specific immune responses. Targovax is the only company with RAS-mutated specific immune activators in clinical development.
Magnus Jaderberg MD, Chief Medical Officer at Targovax said, "We are excited to have initiated this study in patients with locally recurring RAS-mutated rectal cancer. This will be the first time our TG02 immune activator will be tested in humans and, while the study's primary objective is to study safety, we will also be looking at signs of anti-tumour immune activation, thus providing important mechanistic data not just for TG02 but for the entire TG technology platform. In addition, it will give us an indication on how this novel immunotherapy can be enhanced in combination with a checkpoint inhibitor."
Arming the patient's immune system to fight cancer
Targovax 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, an emerging class of biological therapy. ONCOS exclusively uses an adenovirus that has been engineered to be a tumor-targeted immune activator. The platform has the potential to generate therapies with superior efficacy and safety compared to the first approved oncolytic virus therapy, Imlygic®, launched by Amgen. We continue to expect key proof of concept data for this platform in 2017 from a clinical study of lead program ONCOS-102 in patients with refractory malignant melanoma.
The second platform, TG peptides (TG), solely targets tumors that express mutated forms of the RAS protein. Mutations to this 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 a patient's immune system to identify and then destroy tumors bearing any RAS mutations. In early 2017, key proof of concept data for the TG platform from a clinical study 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, we have other products in early stages of development.