https://newsweb.oslobors.no/message/573458
The ONCOS-102 phase 1b melanoma study is published in the prestigious scientific journal Clinical Cancer Research
· ONCOS-102 in combination with PD-1 checkpoint inhibitor (CPI) Keytruda
demonstrated strong ORR of 35% in PD-1 CPI resistant melanoma, correlating with
robust and persistent immune activation
· A phase 2 trial is under planning, where ONCOS-102 will be tested in a
triple-combination with both PD-1 and CTLA-4 CPIs
Oslo, Norway, 20 October 2022 - Targovax ASA (OSE: TRVX), a clinical-stage
immuno-oncology company developing immune activators to target solid tumors,
today announces that the completed ONCOS-102 phase 1b study in PD-1 CPI
resistant advanced melanoma has been published in the prestigious oncology
journal Clinical Cancer Research, published by the American Association for
Cancer Research (AACR).
PD-1 CPI resistant advanced melanoma is a major unmet medical need affecting up
to 25,000 patients per year in the major markets. The diagnosis is associated
with a poor prognosis and there are currently no approved treatment options
available.
In this phase 1b trial, ONCOS-102 was given intra-tumorally to 21 PD-1 CPI
resistant melanoma patients, followed by re-treatment with the PD-1 CPI
Keytruda. It is anticipated that local injection of ONCOS-102 will induce an
inflammatory immune response in the tumor microenvironment and drive systemic T
-cell activation, which in turn can re-sensitize the patient to PD-1 CPI
therapy.
As expected, ONCOS-102 generated strong and durable immune activation in the
treated patients, which translated into a promising objective response rate
(ORR) of 35%. Importantly, the clinical efficacy was associated with continuous
replication of ONCOS-102 within the tumor, statistically significant increase in
T-cell infiltration, and broad and persistent upregulation of immunological
pathways in responding patients.
Dr. Alexander Shoushtari, Memorial Sloan Kettering Cancer Center, New York said:
“Checkpoint inhibitors have had a significant impact on the way we treat
melanoma; however, a subset of patients still does not respond or become
resistant to treatment. Therefore, there is a high medical need for immune
activating agents to overcome resistance to checkpoint blockade. Although this
was a small study, the 35% ORR and substantial activity in non-injected lesions
is promising, particularly as there is a clear correlation with immunological
biomarker data. We look forward to continuing to work with Targovax in the
upcoming phase 2 trial, which will allow us to validate these findings in a
larger patient cohort as well as to test ONCOS-102 in interesting new
combinations.”
Dr. Lone Ottesen, Chief Medical Officer of Targovax ASA, said: “We are very
happy that our strong ONCOS-102 results in melanoma have been acknowledged by
publication in a high-impact scientific journal. For Targovax, this data set
provides an important clinical proof-of-concept and the translational analyses
have validated and deepened our understanding of the ONCOS-102 mechanism of
action. These findings have allowed us to design a robust phase 2 trial, which
will include combination with the second-generation Fc-enhanced CTLA-4 CPI
botensilimab. CTLA-4 was strongly up-regulated in response to ONCOS-102
treatment in the phase 1b study, and we believe this combination has the
potential to boost response rates up and above 35%, and thereby establish ONCOS
-102 as a leading product candidate in PD-1 resistant melanoma.”