ONCOS-102 in checkpoint inhibitor refractory melanoma

The trial is exploring safety, immune activation, and clinical response, of ONCOS-102 and Keytruda® (pembrolizumab), an anti-PD1 checkpoint inhibitor (CPI), in patients with advanced or unresectable melanoma whose tumors have continued to grow following prior CPI therapy. The trial was conducted at the Memorial Sloan Kettering Cancer Center in New York, USA, Fox Chase Cancer Center in Philadelphia, USA and University of Maryland Comprehensive Cancer Center in Baltimore, USA. Identifier: NCT03003676

The results were announced 1 December 2020 and showed impressive objective responses as well as effects on non-injected lesions:

  • Tumor responses observed in 7 out of 20 evaluable patients, resulting in best objective response rate (ORR) of 35%
  • Systemic effects observed in multiple patients, including two examples where a non-injected lesion completely regressed
  • Confirmed the ability of ONCOS-102 to reactivate CPI refractory tumors

For more information, please see press release here.

Based on these promising results, Targovax intends to start with a platform trial, where ONCOS-102 will be tested in various combinations, including anti-PD1, double checkpoint and potentially also other novel immunotherapies to improve the ORR even further. Targovax received Fast Track designation from the US Federal Drug Administration (FDA) in June. Receiving this designation is an endorsement by the US FDA of the strength of the ONCOS-102 data package in melanoma. The FDA Fast Track designation is awarded to therapies with the potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast Track products have high likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application for rolling review to shorten the approval timeline.

ONCOS-102 is still in development in melanoma. We are not supplying the product outside trials such as expanded or compassionate uses basis until further data have been generated.

Abscopal effect when combining oncolytic adenovirus and checkpoint inhibitor in a humanized NOG mouse model of melanoma

Targovax has built on the previous immune activation and anti-tumor findings and showed that the combination of ONCOS-102 and Keytruda can generate systemic responses that reduce the size of non-injected lesions, i.e. abscopal anti-tumor effect. This work was performed in a humanized melanoma mouse model with tumors inoculated dorsally on both sides of the animals. After the tumors were established, ONCOS-102 was injected directly into the tumor on one side only, followed by systemic treatment with Keytruda. By Day 40, tumors on the non-injected side of the animals had shrunk by an average of 70%.