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.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47-922-61-624
Email: renate.birkeli@targovax.com
Media and IR enquires:
Andreas
Tinglum - Corporate Communications (Norway)
Phone: +47-9300-1773
Email: andreas.tinglum@corpcom.no
Simon Conway/Stephanie Cuthbert - FTI Consulting
(International)
Phone: +44-20-3727-1000
Email: Targovax@fticonsulting.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.
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