Farma

domboshawa
24.05.2018 kl 13:12 6816

Targovax- TG01 strengthens 2-year survival rate

Median overall survival was 33.4 months compared to 27.6 months in the ESPAC4
trial

An optimized dosing regimen has now been defined for the planned randomized
trial
Oslo, Norway, 24 May 2018 - 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."

https://newsweb.oslobors.no/message/452076

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