Targovax Announces That the FDA Has Granted Authorization to Initiate Clinical Trials With the Enhanced TG01 RAS Vaccine in the USA

Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that the US FDA has approved an IND application for TG01 combined with QS-21 STIMULON, which allows the preparations to initiate clinical trials in the USA to proceed.

In May, an IND application for the enhanced TG01 mutant RAS cancer vaccine, with QS-21 STIMULON as adjuvant, was filed with the US FDA. The FDA has now approved this IND application, which means that the new and improved TG01 version has been authorized to proceed with clinical studies in the USA.

Targovax has previously demonstrated promising clinical data for an earlier version of TG01 in KRAS mutant pancreatic cancer. For technical and commercial reasons, Targovax has made significant improvements in TG01 to strengthen immune activation and simplify handling at the hospital and improve patient convenience.

In this new format, TG01 will be co-administered with the FDA approved adjuvant QS-21 STIMULON, provided by collaboration partner Agenus. QS-21 STIMULON is expected to enhance TG01 efficacy by driving stronger and broader mutant RAS immune responses. TG01 and QS-21 STIMULON will be mixed and dosed as a single injection, rather than two separate injections as in prior trials. Moreover, the injection will be given sub-cutaneously instead of intra-dermally. These modifications will make the administration of TG01 more patient friendly and simpler to manage for healthcare personnel.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, said: “This IND is a major milestone for our KRAS program, and it is the first time a TG vaccine receives approval to initiate clinical studies in the USA. We are confident that the significant upgrades we have made to TG01 will strengthen the clinical benefit for patients, simplify administration, and make TG01 a more attractive product overall. We are now working actively with academic centers to start collaborative clinical studies with the new and improved TG01 vaccine in mutant RAS cancer patients in 2022.”