On May 14, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that an abstract relating to the dose escalation part of the ONCOS-102 and durvalumab trial in primary ovarian and colorectal cancer that has spread to the peritoneum has been selected for presentation at a Poster Discussion Session during ASCO (Free ASCO Whitepaper) 2020 (Press release, Targovax, MAY 14, 2020, View Source [SID1234558099]).

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The study is an open label, exploratory phase I/II trial assessing the intra-peritoneally delivered ONCOS-102 in combination with systemically administered checkpoint inhibitor durvalumab in patients with platinum-resistant ovarian or colorectal cancers that have metastasized to the peritoneal cavity. The trial is designed with a dose-escalation phase assessing three different dosing levels, followed by an expansion phase with a total of up to 78 patients enrolled into separate groups of ovarian and colorectal cancer.

In the ASCO (Free ASCO Whitepaper) abstract, safety, immune activation and clinical response data for the three dose escalation cohorts will be presented. A total of 17 patients were enrolled, 4 in cohort A (low dose), 5 in cohort B (middle dose) and 8 in cohort C (high dose). No dose-limiting toxicities were observed, and the combination had an acceptable safety profile. Therefore, the high-dose level was selected for the expansion phase of the trial, which is currently enrolling patients. Preliminary analyses indicate that the treatment is triggering immune activation and has clinical activity, which were more pronounced in cohort B and C.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very proud that ONCOS-102 was chosen as the oncolytic virus of choice for this trial and we are equally pleased that the scientific committee has selected our ONCOS-102 and durvalumab combination abstract for a poster discussion at the upcoming ASCO (Free ASCO Whitepaper) meeting. Although it is too early in the trial to interpret the clinical data, we are happy to have moved into the expansion phase following successful completion of the dose escalation phase. This is an important clinical trial as it addresses a disease with a very high unmet medical need while potentially opening up intra-peritoneal administration as an alternative delivery route for ONCOS-102."

Poster discussion sessionAbstract title:

Developmental Therapeutics-ImmunotherapyPhase I/II study to evaluate systemic durvalumab + intraperitoneal (IP) ONCOS-102 in patients with peritoneal disease who have epithelial ovarian (OC) or metastatic colorectal cancer (CRC): Interim phase I clinical and translational results.

Date / time:

29 May 2020, 8-11AM CDT

Abstract / Poster:

3017 / 81

The abstract can be found here View Source

The trial is a collaboration between Targovax, AstraZeneca, Cancer Research Institute (CRI) and Ludwig Cancer Research.