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Targovax presents further positive clinical data from TG01 phase I/II trial at 2017 ASCO annual meeting
Oslo, Norway, 6 June 2017: Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target treatment-resistant solid tumors, today announces that it presented clinical data from the phase I/II clinical trial evaluating TG01 in resected pancreatic cancer in a poster presentation at the American Society of Clinical Oncology Annual Meeting 2017 (ASCO) on Saturday, June 3rd 2017.
The study evaluated safety, immunological response and overall survival of TG01/GM-CSF and gemcitabine as an adjuvant therapy for treating patients with resected RAS-mutant adenocarcinoma of the pancreas. The data show that:
- TG01/GM-CSF generated early immune responses in 89% of patients (17/19) with resected pancreatic cancer. 95% of patients (18/19) showed immune activation in either DTH and/or PBMC tests. This demonstrates that TG01 vaccination activates mutant RAS specific T cells
- Overall survival was encouraging in view of published reports with a median overall survival of 33.1 months
- The regimen was generally well tolerated although some late, manageable allergic reactions were seen
Magnus Jaderberg MD, Chief Medical Officer of Targovax, said, "These data provide support of TG01-immunotherapy for the treatment of resected pancreatic cancer. This is a key milestone for Targovax and we look forward to defining the next step in development for this combination therapy. Targovax is also evaluating TG02, the second TG cancer immune activator, in colorectal cancer. We recently announced the initiation of this phase Ib trial, and the readout expected in the second half of 2018 will provide important mechanistic data, not just for TG02, but for the entire TG technology platform."
Please see the poster attached.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Media and IR enquires:
Jan Petter Stiff - Crux Advisers (Norway)
Phone: +47 995 13 891
Julia Phillips/Simon Conway - FTI Consulting (International)
Phone: +44 20 3727 1000
TG01 is an injectable antigen-specific cancer immunotherapy targeted to treat patients with KRAS mutations, found in more than 85% of pancreatic adenocarcinomas. TG01 consists of a mixture of 7 synthetic peptides that represent 7 of the most common codon 12 and 13 mutations in p21RAS associated with human cancer. TG01 induces RAS mutant-specific T-cell responses which are enhanced by co-administration of GM-CSF (recombinant human granulocyte macrophage-colony stimulating factor). TG01 was the first therapeutic peptide vaccine targeting RAS that entered clinical trials. Earlier studies demonstrate that adjuvant vaccination with TG01/GM-CSF given as monotherapy to pancreatic cancer patients after tumor resection induce immune response in 100% of patients.
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 an immune activator that selectively target cancer cells. In phase I it has shown to immune activate at lesional level which was associated with clinical benefit. We expect proof of concept data for this platform in 2017 from a clinical trial of lead product 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 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, we have other products in early stages of development.
In July 2016, the Company listed its shares on Oslo Axess. In March 2017, the shares were upgraded to Oslo Børs, the main Oslo Stock Exchange.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.