OSLO, Norway, July 8, 2019 /PRNewswire/ -- Targovax ASA
(OSE: TRVX), a clinical stage biotechnology company developing
oncolytic viruses to target hard-to-treat solid tumors, today
announces that clinical responses were observed in 3 out of 9
patients in part 1 of the ONCOS-102 and Keytruda combination trial
in anti-PD1 checkpoint inhibitor (CPI) refractory advanced
melanoma, corresponding to an overall response rate (ORR) of
33%.
In this trial, ONCOS-102 immune activation is being tested in
patients with advanced, unresectable melanoma who have had disease
progression on treatment with anti-PD1 CPI. This is a particularly
challenging patient population, with few treatment alternatives
available. The nine patients in part 1 of the trial were given
three intra-tumoral ONCOS-102 injections during the first week,
followed by re-challenge with the anti-PD1 CPI Keytruda. The
primary and secondary endpoints of the trial are to assess safety,
immune activation and clinical responses of ONCOS-102 and Keytruda
combination treatment. The main scientific aim is to test the
hypothesis that ONCOS-102 can immune activate anti-PD1 resistant
patients to respond to re-challenge with an anti-PD1 CPI.
Part 1 safety data shows that the sequential ONCOS-102 and
Keytruda treatment regimen is well tolerated. The efficacy is also
very encouraging, with three of nine patients demonstrating a
clinical response (33% ORR); one patient had a complete response
(CR) and two patients had partial responses (PR) according to
RECIST1.1 and irRECIST assessment criteria. Although the patient
number is small, these results compare favorably to reports from
other explorative immunotherapy trials in this hard-to-treat
population. Importantly, the data also confirms the hypothesis that
ONCOS-102 is able to immune activate treatment resistant tumors to
respond to re-challenge with an anti-PD-1 CPI.
ONCOS-102 was also seen to induce profound innate and adaptive
immune activation. By week three, prior to starting Keytruda
treatment, systemic increases in pro-inflammatory cytokines were
observed in all nine patients (IL-6, TNFα and/or IFNγ),
demonstrating potent systemic immune activation in response to the
intra-tumoral ONCOS-102 injections. At the tumor level, increased
infiltration of CD8+ T-cells were found in eight out of nine
patients and the relative level of activated CD8+ T-cells (GrzB+)
increased in all nine patients. Examples of increased T-cell
infiltration into lesions not injected with ONCOS-102 were also
observed. In addition, T-cells recognizing specific tumor antigens
were found in circulation in four patients (MAGE-A1 and/or
NY-ESO-1). These data suggest that the initial innate immune
activation is translated into systemic anti-tumor immune
responses.
Part 2 of the trial is currently enrolling patients, where
safety and efficacy of a more intensive treatment regimen of twelve
ONCOS-102 injections will be evaluated. The trial is running at
Memorial Sloan Kettering Cancer Centre in New York, Fox Chase Cancer Centre,
Philadelphia, and the University of Maryland, Baltimore.
Dr. Alexander Shoushtari,
Principal Investigator, Memorial Sloan Kettering Cancer Centre,
New York said: "It is
encouraging to see clinical responses in this hard-to-treat
population of advanced melanoma. Earlier this year, we decided to
expand the trial to test a more intensified schedule of ONCOS-102,
and it will be interesting to see whether this regimen can generate
more and deeper clinical responses."
Dr. Magnus Jäderberg, CMO of Targovax, said: "We are very
pleased to confirm our hypothesis that ONCOS-102 has the potential
to immune activate checkpoint inhibitor resistant patients to
respond to PD-1 blockade with Keytruda. It is promising to see this
level of clinical responses after only three ONCOS-102 injections,
including a complete response, which is rare in this heavily
pre-treated patient population. Based on our experience so far, we
speculate that patients will benefit from receiving more ONCOS-102
injections over a longer period of time and we will follow with
interest the effect of the intensified dosing regimen in the second
patient cohort of the trial."
CONTACT:
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
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SOURCE Targovax