Targovax announces interim results from Phase I trial of ONCOS-102 in checkpoint inhibitor refractory melanoma

One of the first six patients showed a complete response to the treatment

Oslo, Norway, 27 September 2018 - Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors, today announces interim tumor response data from the first six patients treated with ONCOS-102 followed by the checkpoint inhibitor (CPI) pembrolizumab (KEYTRUDA®) in patients with advanced melanoma whose disease has progressed after prior CPI treatment. Results show that one of the six patients had a complete response to the treatment.

One of the main aims of the trial has been achieved, which is to demonstrate that ONCOS-102 has the potential to immune activate CPI refractory patients to respond to PD-1 blockade. Complete responses are rarely seen in this patient population. The patients received three ONCOS-102 injections prior to KEYTRUDA® treatment, which may be insufficient in highly advanced disease. As such, Targovax and the investigators now intend to optimize the dosing schedule by increasing the number of ONCOS-102 injections and expand the trial with additional patients.

Dr. Magnus Jäderberg, CMO of Targovax, said: “Given the limited number of patients who have completed the study to date, it is encouraging to already see a complete response to ONCOS-102 primed KEYTRUDA® treatment in this CPI refractory patient population. This case is particularly interesting, as the patient became refractory to KEYTRUDA® before entering our trial. At the same time, five patients progressed, which we believe may be partly due to an insufficient number of ONCOS-102 injections. Consequently, we have agreed with the investigators to expand the trial with additional patients, who will receive an increased number of ONCOS-102 injections. The complete response, combined with the optimized dosing regimen, makes us optimistic that we may demonstrate the full potential of ONCOS-102 in the checkpoint inhibitor refractory setting.”

The results will be presented at a KOL event hosted by Targovax in New York City on 11 October 2018, which will also be available by webcast. Invitation and full event details has been issued separately and is posted on www.targovax.com.

Conference call

At 14:00 CET (08:00 EST) today, Targovax will host a conference call to answer questions about the results. Call-in details can be found below.Call-in numbers:

Norway Toll-Free Number: 80062196
Norway Toll Number: +47 23500243
UK Toll-Free Number: 08003589473
UK Toll Number: +44 3333000804
US Toll-Free Number: +1 855 85 70686
US Toll Number: +1 6319131422

Access code: 60258218#

Please make sure to dial in at least 5-10 minutes ahead to complete your registration.

See attached list for more dial-in numbers:

http://events.arkadin.com/ev/docs/NE_W2_TF_Events_International_Access_List.pdf  

About the trial

In this open label trial running in three centers in the USA, patients that have progressed on CPI treatment receive three intra-tumoral ONCOS-102 injections during the first week, followed by eight infusions of the programmed cell death protein 1 (PD-1) blocking CPI pembrolizumab (KEYTRUDA®). As reported in December 2017 and January 2018, the first planned safety review passed without any issues. Both local and systemic immune activation, which includes T-cell tumor infiltration and increased PD-1 expression on CD8+ T-cells, has been confirmed in all evaluated patients.

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com

Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no

Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Email: Targovax@fticonsulting.com  

About Targovax

Activating the patient's immune system to fight cance

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 is used as a therapeutic cancer vaccine and 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 lead indication is mesothelioma, where the virus is currently being tested in a randomized phase II trial, with a phase Ib safety lead-in cohort. Another trial, in advanced melanoma, is expected to produce important proof of concept data for checkpoint inhibitor refractory patients within the next 6-12 months.

Targovax is also developing a neo-antigen cancer vaccine targeting tumors that express mutated forms of RAS - mutations known to drive cancer. The TG vaccine program has shown a signal of efficacy in a 32-patient trial with TG01 in resected pancreatic cancer. A next generation product candidate, TG02 is currently tested as monotherapy and will also be tested in combination with Keytruda® (an anti-PD1 Check point inhibitor, CPI).