- The US FDA grants ONCOS-102 Fast-Track designation for malignant pleural mesothelioma
- Fast-Track opens the potential for expedited development and review with the US FDA
Oslo, Norway 15 February 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 malignant pleural mesothelioma from the US FDA.
The US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre-clinical and clinical efficacy associated with broad immune activation observed to date. Receiving this designation is an endorsement by the US FDA of the strength of the ONCOS-102 data package.
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 improved likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application early to shorten review time.
The Fast-Track approval comes in addition to ONCOS-102´s existing Orphan Drug Designation (ODD) with both the US FDA and European EMA in the mesothelioma indication, which provides ONCOS-102 market exclusivity for 7 and 10 years in the USA and EU, respectively, from the date of BLA grant.
Dr. Ingunn Munch Lindvig, VP Regulatory Affairs, said: “Securing this Fast-Track designation is a very important milestone for the ONCOS-102 program. Most importantly Fast-Track validates the strong potential of ONCOS-102 as a future treatment option for solid tumors with high unmet medical need”.
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For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
Media enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no
IR enquires:
Kim Sutton Golodetz – LHA Investor Relations (US)
Email: kgolodetz@lhai.com
Phone: +1 212-838-3777
About Targovax
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 with targeted therapeutic cancer immunotherapies. The Group’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. Further, the products are well positioned for combinations with other treatment approaches, including other immunotherapies, surgery, radiation and chemotherapy.
Targovax’s lead product 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. ONCOS-102 is currently being tested in mesothelioma, melanoma and colorectal cancer and has already shown promising clinical results both as monotherapy and in combination with chemotherapy, and a checkpoint inhibitor.