TARGOVAX: 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.

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Dette er baseret på 6 patienter med indledelse dosering - og korrekt dosering er netop en afgørende faktor i alle studier for at opnå den optimale effekt. ONCOS-102 virker og CPI refraktive patienter (non responsers) kan beviseligt fortsætte behandlingen. Magnus Jaderberg udtaler sig positivt omkring udfaldet af denne begrænsede polulation og selskabet vil nu ændre på behandlingsparadigmet, en normal strategi efter analyse af preliminære data.

Målet er at skabe sammenhæng mellem immunrespons og CPI respons og ONCOS-102 er allerede tidligere blevet vurderet som en sikker behandling. Målet er nu at øge antallet af patienter, der responderer gennem en øget administrering af ONCOS-102.

Som nævnt af anden skribent er complete response svært sjælden for denne type behandling og vi får yderligere information i New York 11 Oktober. ONCOS-102 (og muligvis kan vi generalisere for ONCOS som platform) har nu ikke bare vist immunresponse, de har også vist at de kan fjerne svulsten .. ekke bare lidt, men fuldstændigt.

Ser frem til at høre selskabets detaljer omkring dette på conference call @ 14:00 hours lokal tid og vil dele yderligere perspektivering hvis nødvendigt.