- ONCOS-102 in combination with PD-1 checkpoint inhibitor (CPI) Keytruda demonstrated strong ORR of 35% in PD-1 CPI resistant melanoma, correlating with robust and persistent immune activation
- A phase 2 trial is under planning, where ONCOS-102 will be tested in a triple-combination with both PD-1 and CTLA-4 CPIs
Oslo, Norway, 20 October 2022 – Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target solid tumors, today announces that the completed ONCOS-102 phase 1b study in PD-1 CPI resistant advanced melanoma has been published in the prestigious oncology journal Clinical Cancer Research, published by the American Association for Cancer Research (AACR).
PD-1 CPI resistant advanced melanoma is a major unmet medical need affecting up to 25,000 patients per year in the major markets. The diagnosis is associated with a poor prognosis and there are currently no approved treatment options available.
In this phase 1b trial, ONCOS-102 was given intra-tumorally to 21 PD-1 CPI resistant melanoma patients, followed by re-treatment with the PD-1 CPI Keytruda. It is anticipated that local injection of ONCOS-102 will induce an inflammatory immune response in the tumor microenvironment and drive systemic T-cell activation, which in turn can re-sensitize the patient to PD-1 CPI therapy.
As expected, ONCOS-102 generated strong and durable immune activation in the treated patients, which translated into a promising objective response rate (ORR) of 35%. Importantly, the clinical efficacy was associated with continuous replication of ONCOS-102 within the tumor, statistically significant increase in T-cell infiltration, and broad and persistent upregulation of immunological pathways in responding patients.
Title: Pilot Study of ONCOS-102 and Pembrolizumab: Remodeling of the Tumor Microenvironment and Clinical Outcomes in Anti–PD-1–Resistant Advanced Melanoma
For the full publication, please see link: AACR_Pilot Study of ONCOS-102 and Pembrolizumab.pdf
Prinicpal Investigator and lead author Dr. Alexander Shoushtari, Memorial Sloan Kettering Cancer Center, New York said: “Checkpoint inhibitors have had a significant impact on the way we treat melanoma; however, a subset of patients still does not respond or become resistant to treatment. Therefore, there is a high medical need for immune activating agents to overcome resistance to checkpoint blockade. Although this was a small study, the 35% ORR and substantial activity in non-injected lesions is promising, particularly as there is a clear correlation with immunological biomarker data. We look forward to continuing to work with Targovax in the upcoming phase 2 trial, which will allow us to validate these findings in a larger patient cohort as well as to test ONCOS-102 in interesting new combinations.”
Dr. Lone Ottesen, Chief Medical Officer of Targovax ASA, said: “We are very happy that our strong ONCOS-102 results in melanoma have been acknowledged by publication in a high-impact scientific journal. For Targovax, this data set provides an important clinical proof-of-concept and the translational analyses have validated and deepened our understanding of the ONCOS-102 mechanism of action. These findings have allowed us to design a robust phase 2 trial, which will include combination with the second-generation Fc-enhanced CTLA-4 CPI botensilimab. CTLA-4 was strongly up-regulated in response to ONCOS-102 treatment in the phase 1b study, and we believe this combination has the potential to boost response rates up and above 35%, and thereby establish ONCOS-102 as a leading product candidate in PD-1 resistant melanoma.”
For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773
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 thereby bring benefit to cancer patients with few available treatment alternatives. Targovax is assessing 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 studies demonstrating clinical efficacy and providing deep mechanistic insights, the Targovax platform is being expanded into delivery of circular RNA (circRNA). In addition, Targovax has a KRAS immunotherapy program, with lead cancer vaccine candidate, TG01, due to enter the clinic in the second half of 2022. This provides Targovax with a rich pipeline of innovative future immunotherapy product candidates to follow ONCOS-102.