- The US FDA grants ONCOS-102 Fast Track designation for PD-1-refractory advanced melanoma
- Fast Track designation further strengthens the opportunity for accelerated approval for ONCOS-102 in melanoma
Oslo, Norway 22 June 2021 – Targovax ASA (OSE: TRVX), a clinical stage immune-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that its lead clinical candidate ONCOS-102 has received Fast Track designation in PD-1-refractory advanced melanoma from the US FDA.
The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses. Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma. This Fast Track approval comes in addition to ONCOS-102´s existing Fast Track designation in malignant pleural mesothelioma.
The FDA Fast Track designation is awarded to therapies with 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.
Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said: “Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need. Fast Track simplifies and expedites the regulatory interactions and review process, and further supports the rationale for initiating a Phase 2 trial to target accelerated approval for ONCOS-102 in PD-1-refractory advanced melanoma”.
For further information, please contact:
Oystein Soug, CEO
Phone: +47 906 56 525
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773
Kim Sutton Golodetz – LHA Investor Relations (US)
Phone: +1 212-838-3777
Activating the patient’s immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors. Targovax aims to unlock greater clinical benefits in cancer patients by deploying multifunctional platforms to target key immune regulators and oncogenic drivers. Targovax’s focus is to “activate the patient’s immune system to fight cancer”, thus extending and transforming the lives of cancer patients. Targovax’s pipeline aims at different cancer indications, including melanoma, mesothelioma and colorectal cancer. The products are designed to harness the patient’s own immune system to fight the cancer, whilst also delivering a favorable safety and tolerability profile.
Targovax’s lead clinical candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system to fight the cancer. On the back of very encouraging data in several indications, in monotherapy and in multiple combination, the next development steps for ONCOS-102 will involve a clinical trial with registration intent in checkpoint inhibitor refractory melanoma.
This information is considered to be inside information pursuant to the EU Market Abuse Regulation, and is subject to disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act. The stock exchange announcement was published by Renate Birkeli, Investor Relations, Targovax ASA.