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
Activating the patient’s immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing oncolytic viruses 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 activates the immune system to generate tumor-specific immune responses. In a phase I monotherapy trial, ONCOS-102 induced both local and systemic innate and adaptive immune activation, with associated clinical benefit. In an ongoing phase I trial, patients who have progressed on anti-PD1 checkpoint inhibitors and treated with ONCOS-102 in combination with Keytruda, demonstrated responses in three of nine patients (33% ORR) including one complete response. ONCOS-102’s lead indication is mesothelioma, where the virus is currently being tested in a randomized phase I/II trial expected to report around new year 2019-20.