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First patient treated in dose expansion cohort of Targovax’s ONCOS-102 trial in melanoma

Monday, February 11, 2019
  • Trial extended in checkpoint inhibitor refractory melanoma with up to 12 additional patients receiving an increased dosing regimen of 12 ONCOS-102 injections and 8 cycles of Keytruda

  • First patient in dose expansion cohort has received the first ONCOS-102 injection

Oslo, Norway, 11 February 2019 – Targovax ASA (OSE: TRVX),  a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, today announces that the first patient has received ONCOS-102 in the dose expansion cohort of the ongoing phase I trial in checkpoint inhibitor (CPI) refractory advanced melanoma, assessing ONCOS-102 in combination with the CPI Keytruda.

In September 2018, Targovax reported interim data for the first six patients of the ongoing ONCOS-102 trial in CPI refractory advanced melanoma, showing strong immune activation and one patient with a complete response ( see press release here). Results suggested that patients might benefit from more injections of Targovax’s oncolytic virus, and therefore a second dose cohort of  twelve additional patients who will receive  twelve, rather than three, ONCOS-102 injections has been initiated. The first patient on this extended dosing regimen has received the first ONCOS-102 injections and is ready for combination therapy with Keytruda. This also means that the first dosing cohort of the trial has been closed, with a total of nine patients enrolled.

Magnus Jäderberg, CMO of Targovax, said: “We are very pleased that the proposed dose expansion cohort of our melanoma trial has been approved and is now underway. The results seen to date with only three injections of ONCOS-102 are promising, and we are confident that by increasing to twelve injections we will release the full potential of ONCOS-102 to reactivate these patients to respond to Keytruda treatment”.

This phase I open label clinical trial enrolls advanced or unresectable melanoma patients who have progressed after PD-1 blockade. The trial has been extended with a new dose cohort where patients will receive four intra-tumoral ONCOS-102 over a 15-day period followed by Keytruda infusions in combination with intra-tumoral ONCOS-102 injections every three weeks for eight cycles. Up to twelve patients will be enrolled in the new dose cohort. In the first dose cohort the patients were scheduled to receive three intra-tumoral ONCOS-102 injections during the first week, followed by eight infusions of Keytruda. Nine patients were enrolled in the first dose cohort. The trial is enrolling patients at three sites in the US.

For further information, please contact:

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

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

Simon Conway/Stephanie Cuthbert – FTI Consulting (International)
Phone: +44 20 3727 1000

About Targovax

Activating the patient’s immune system to fight cancer

Targovax (OSE:TRVX) is a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It has been shown to activate the immune system to generate tumor-specific immune responses. In phase I trials, ONCOS-102 induced both local and systemic innate and adaptive immune activation, which has been associated with clinical benefit. ONCOS-102’s targeted path-to-market indication is mesothelioma, where the virus is currently being tested in a randomized phase II trial. Another trial, in checkpoint inhibitor refractory advanced melanoma, is expected to produce important proof-of-concept immune activation data in heavily pre-treated patients.

Targovax is also developing a neo-antigen cancer vaccine targeting tumors with oncogenic RAS–mutations, which are known to drive cancer. The TG vaccine program has shown strong RAS-specific immune activation and a signal of clinical efficacy in a 32-patient trial with TG01 in resected pancreatic cancer. A next generation product candidate, TG02 is currently tested in a phase I trial in colorectal cancer, both as monotherapy and in combination with Keytruda  (an anti-PD1 check point inhibitor).