- The US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) Application for the combination of TG01 and QS-21 STIMULON™
- The IND is a major milestone for the TG mutant RAS program, and represents the first time that a TG vaccine is authorized for clinical trials in the USA
Oslo, Norway, 23 June 2022 – 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.”
About QS-21 STIMULON
In March 2022, Targovax announced a collaboration with Agenus to utilize the proprietary adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 STIMULON has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and commercially as a component of the Shingrix® and Mosquirix™ vaccines. QS-21 STIMULON is expected to further potentiate TG by driving stronger anti-RAS T-cell responses and is routinely co-administered with vaccines sub-cutaneously.
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’s focus is to activate the patient’s immune system to fight cancer, and thereby bring benefit to cancer patients with few available treatment alternatives. Targovax is assessing its product candidates in different cancer indications, including melanoma, mesothelioma, multiple myeloma and colorectal cancer, and has demonstrated 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 clinical data in several indications, both as monotherapy and in combinations, ONCOS-102 will progress into a phase 2 trial in multiple combinations in melanoma patients resistant to PD1 checkpoint blockade.
Building on successful studies demonstrating clinical efficacy and providing deep mechanistic insights, the ONCOS platform is being expanded into delivery of circular RNA (circRNA). In addition, Targovax has a KRAS immunotherapy program, with lead cancer vaccine candidate, TG01, due to enter the clinic in the second half of 2022. This provides Targovax with a rich pipeline of innovative future immunotherapy product candidates to follow ONCOS-102.