On October 20, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target solid tumors, reported 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) (Free AACR Whitepaper) (Press release, Targovax, OCT 20, 2022, View Source [SID1234622212]).

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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."