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Targovax announces that the TG01 study in multiple myeloma at Oslo University Hospital has received regulatory approvals to proceed

  •  The Norwegian Medicines Agency (NOMA) and the Regional Ethics Committee (REK) have today approved the clinical trial application for TG01 in multiple myeloma
  • The Norwegian Medicines Agency (NOMA) and the Regional Ethics Committee (REK) have today approved the clinical trial application for TG01 in multiple myeloma
  • It is expected that the study will open, and the first patient will be enrolled at Oslo University Hospital (OUS) in early 2023

Oslo, Norway, 22 December 2022 – Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target solid tumors, today announces that the planned clinical trial with mutant RAS cancer vaccine TG01 in multiple myeloma has received regulatory approval to proceed from NOMA and REK.  

The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated multiple myeloma patients who continue to have measurable disease after completion of standard of care treatment. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can enhance the clinical response.

The trial will be sponsored by OUS and led by Dr. Fredrik Schjesvold, an international leader in the field and founder of the Oslo Myeloma Center, the largest Myeloma center in the Nordics. Targovax will provide TG01 drug supply, scientific support and a financial contribution through grants awarded from Innovation Norway and the Norwegian Research Council.

Dr. Ingunn Munch Lindvig, VP & Head of Regulatory Affairs, Targovax ASA, said: “We are very pleased that the planned collaborative studies for the TG mutant RAS program continue to obtain the necessary regulatory approvals to proceed in both the EU and USA. The multiple myeloma trial plan is now approved both by the Norwegian regulatory agency NOMA and the ethics committee REK under the new European system, and Oslo University Hospital can proceed with identifying patients for inclusion into the trial.”  

For further information about the study and collaboration structure, please see here

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536

Renate Birkeli, Investor Relations
Phone: +47 922 61 624

Media enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773

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’s focus is to activate the patient’s immune system to fight cancer, and to bring benefit to cancer patients with few available treatment alternatives. Targovax is developing its product candidates in different cancer indications, including melanoma, mesothelioma, and multiple myeloma, 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 against the tumor. Following very encouraging clinical data in several indications, both as monotherapy and in combinations, ONCOS-102 is progressing into a randomized phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor treatment.

Building on successful clinical studies which have provided deep mechanistic insights into the tumor biology and the human immune systems, Targovax is researching circular RNA (circRNA) as novel cancer medicines. In addition, Targovax has a KRAS immunotherapy program, with lead cancer vaccine candidate, TG01, expected to enter the clinic in an enhanced format in the second half of 2022. Together this provides Targovax with a rich pipeline of innovative future immunotherapy product candidates to follow ONCOS-102.   

Source: Targovax