Survival rate of 68% from first patient cohort vs published historical rate of 30-53% suggests signal of clinical efficacy for the drug candidate
Full data set from first patient cohort to be submitted for presentation at ASCO annual meeting in June
Oslo, Norway, 2 February 2017 - Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces encouraging overall survival data from an analysis of the first cohort of patients in its ongoing, phase I/II clinical trial evaluating TG01 (co-administered with GM-CSF) in resected pancreatic cancer given in combination with chemotherapy, gemcitabine, the current standard of care, study CTTG01-01.
Data from this patient cohort showed that 68% of evaluated patients (13/19) were still alive after two years if survival is counted from time of resection which occurred on average two months prior to first treatment, or 12/19 if counted from time of first treatment. While the cohort is small and there is no control arm, this rate compares favorably with the available published historical two-year survival rates of resected cancer patients treated with gemcitabine alone of between 30% and 53% (J Neoptolemos 2010, J van Loethem 2010, H Oettle 2013, M Sinn 2015, K Uesaka 2016; In these reported studies Overall Survival measured either from surgery or treatment randomization).
Dr Magnus Jäderberg, Chief Medical Officer of Targovax commented:
"We are encouraged by the two-year overall survival rate of patients treated with TG01 in this trial, versus the expected rate from published historical data when treating with gemcitabine alone, the current standard of care. Whilst acknowledging the small size of this first patient cohort and the lack of a control arm, we are encouraged by what seems to be a signal of efficacy in this highly malignant and difficult to treat cancer. This key milestone for Targovax also triggers a further iteration of plans for the future clinical development of TG01. We have submitted an abstract to the ASCO annual meeting in June when we plan to present the full data."
CTTG01-01 is an open label study conducted in four centres in the UK and Norway. A first cohort of 19 patients each received 36 injections of TG01/GMCSF synchronised with six cycles of gemcitabine and have now completed the study. The main objectives of the study are an assessment of safety and immune activation. The secondary objective is to assess efficacy (disease-free survival and overall survival) at two years. The Company has received consent to enable the reporting of overall survival for all patients in the cohort. CTTG01-01 has been financially supported, in part, by The Research Council of Norway and Innovation Norway.
TG01 is Targovax's first product to arise from its TG-Peptide platform. The platform yields injectable peptide-based onco-immunotherapies that are designed to treat patients whose tumors express RAS mutations. These mutations are associated with poor prognosis when present. By inducing immune responses in such cancer patients, TG-peptide immunotherapies have the potential to prolong the time to disease progression and to increase survival. RAS mutations are common in a number of cancers. Published data reports 85% of pancreatic cancer cases have such mutations.
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Arming the patient's immune system to fight cancer
Targovax is a clinical stage company focused on developing 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 has arisen from 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, recently launched by Amgen. We expect proof of concept data related to immune activation in tumor tissue in 2017 from the clinical trial of ONCOS-102 in combination with CPI in patients with refractory malignant melanoma.
The second platform, TG-Peptides, 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.
The development pipeline has three novel therapeutic candidates in clinical development covering six indications and has already demonstrated promising safety and tolerability data and early signs of clinical response.
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. Our portfolio of future opportunities comprises a number of early stage development candidates in addition to the three outlined above.
In July 2016 the Company listed its shares on Oslo Axess, securing funding for further development of the Company's ongoing and planned trials.
 Granulocyte macrophage colony-stimulating factor