OSLO, Norway, 24 May 2018 /PRNewswire/ --Targovax ASA ("Targovax" or "the Company") (OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces the completion of the 32-patient phase I/II clinical trial evaluating TG01 in resected pancreatic cancer in combination with standard of care chemotherapy (gemcitabine). Median overall survival (mOS) for all 32 patients was 33.4 months, which is nearly six months better than the mOS of 27.6 months for gemcitabine alone reported in the recent ESPAC4 trial(1).
The trial enrolled a total of 32 patients, split in two patient cohorts receiving different dosing regimens. The first cohort consists of 19 patients, receiving TG01 injections, before, during and after adjuvant chemotherapy treatment. In February 2017, two-year survival rate of 68% (13/19 patients) and mOS of 33.1 months was reported for this cohort.
The second cohort consists of 13 patients on a reduced dosing regimen, with TG01 injections before and after, but not during, chemotherapy treatment. Two-year survival rate in the second cohort was 77% (10/13 patients), higher than the 68% two-year survival rate reported for the first cohort in 2017, as well as published historical rate of 30-53% for gemcitabine. Median OS in the second cohort has not yet been reached. The dosing regimen used in the second cohort was well tolerated and will be used for continued development.
When combining the results from the two cohorts, mOS for all 32 patients was 33.4 months, strengthening the previously reported signal of clinical efficacy of TG01 treatment in combination with chemotherapy. Targovax will seek to continue to monitor the treated patients in order to assess long-term survival.
Summarizing the top-line data for the 32 patients in this phase I/II trial, the following was observed:
- Median overall survival (mOS) was 33.4 months
- 94% of patients (30/32) were alive one year after surgery
- 72% of patients (23/32) were alive two years after surgery
- 90% of patients (29/32) demonstrated mutant RAS-specific immune activation
The full data set, including immune monitoring, will be further analyzed and presented at a relevant scientific conference.
Professor Daniel H. Palmer, University of Liverpool Cancer Research UK Experimental Cancer Medicine Centre, Liverpool, United Kingdom and lead investigator of the study, commented:
"Pancreatic cancer is a highly malignant, difficult to treat disease and there is a significant need for innovative new treatment approaches. The results from this study are promising and demonstrate that TG01 is generally well tolerated in combination with gemcitabine. We observe a high level of mutant RAS-specific immune activation, and the observed survival rate is encouraging compared with chemotherapy alone. It will now be important to assess the clinical efficacy of the TG01 and standard of care combination treatment in a randomized setting, and we look forward to take part in the development of this innovative immunotherapy going forward".
Øystein Soug, Chief Executive Officer of Targovax commented:
"These more mature survival data represent another important milestone for Targovax. The high rate of immune activation, combined with the encouraging survival data which compares well with the large ESPAC4 trial, further strengthens our belief that our mutant RAS neoantigen vaccine has potential to be a promising new treatment approach in combating mutant RAS tumors, which constitutes up to 30% of all cancers."
(1) Neoptolemos JP et al.; The Lancet; 389:1011-1024 (2017)
About the study
CTTG01-01 is an open label phase I/II trial of TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas. The main objectives of the trail 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 trial. The trial has been conducted in four centres in the UK and Norway.
The first cohort of 19 patients each received up to 36 injections of TG01/GM-CSF, before, during and after six cycles of gemcitabine. The second cohort consists of 13 patients, who received up to 15 injections of TG01/GM-CSF before and after, but not during, gemcitabine treatment. Overall, the treatment is well tolerated in both dosing regimens. Although manageable, some allergic reactions were seen in patients in the first cohort when treating with TG01 and gemcitabine in parallel. No such allergic reactions were seen in the second cohort.
TG01 is Targovax's lead product candidate from its mutRAS neoantigen cancer vaccine program. The product is an injectable peptide-based immunotherapy designed to treat patients with mutant RAS solid tumors. RAS mutations are the most frequently found oncogenic mutations in cancer overall, and are associated with poor prognosis. Published data suggests that more than 90% of pancreatic cancer patients have mutant RAS.
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Renate Birkeli, Investor Relations
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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.
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