Targovax announces publication of the two abstracts accepted for poster presentation at ASCO 2022

• The first poster summarizes the complete efficacy and immunological study data for the Targovax-sponsored mesothelioma trial, showing strong 30-month survival rate of 34.3% in the ONCOS-102-treated group vs. 18.2% in the control group
• The second poster presents clinical data from the externally sponsored trial exploring intra-peritoneal (IP) delivery in colorectal or ovarian cancer with peritoneal metastasis, showing that ONCOS-102 generated immune responses and was safe to administer IP in combination with a PD-L1 checkpoint inhibitor

Oslo, Norway, 27 May 2022 – Targovax ASA (OSE: TRVX), today announces publication of the two ONCOS-102 abstracts accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 3-7 June 2022. The posters will present clinical results from the completed phase 1/2 trials in malignant pleural mesothelioma and in heavily pre-treated, MS-stable colorectal or ovarian cancer with peritoneal metastasis.

First poster title: Final survival outcomes and immune biomarker analysis of a randomized, open-label, phase I/II study combining oncolytic adenovirus ONCOS-102 with pemetrexed/cisplatin (P/C) in patients with unresectable malignant pleural mesothelioma (MPM)
Session Title: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Time: Monday 6 June 2022, 8:00-11:00 AM CDT, Abstract 8561
Presenter: Dr Santiago Ponce, Medical Oncology, Hospital 12 Octubre, Madrid, Spain

The poster summarizes the overall findings from the completed, randomized phase 1/2 trial in 31 patients with MPM; 20 patients received intra-tumoral (IT) ONCOS-102 in combination with standard of care (SoC) chemotherapy and 11 patients in a control group received SoC chemotherapy only.

In the randomized part of the trial, the 30-month overall survival (OS) rate was 34.3% in the ONCOS-102 treated group (n=14) vs. 18.2% in the SoC-only control group (n=11). In first-line patients, the ONCOS-102 group achieved a median overall survival (mOS) of 25.0 months (n=8) vs. 13.5 months mOS in the SoC-only control group (n=6). The ONCOS-102 first-line mOS compares favorably to SoC historical control studies reporting mOS of 12-16 months1, as well as the combination of nivolumab and ipilimumab which demonstrated mOS of 18.1 months in a phase 3 trial that led to FDA approval2. Tumor biopsy immune cell analyses revealed strong T-cell infiltration induced by ONCOS-102 in patients with partial response (PR) or stable disease (SD), but not in progressors. These observations were confirmed by RNAseq gene expression analysis. The breadth and strength of immune response induced by ONCOS-102 correlated with both tumor response and survival. Further clinical trials in MPM are clearly warranted to validate these positive findings in a larger patient cohort.

Second poster title: Study to evaluate intraperitoneal (IP) ONCOS-102 with systemic durvalumab in patients with peritoneal disease who have epithelial ovarian (OC) or metastatic colorectal cancer (CRC): Phase 2 results
Session Title: Development Therapeutics, Immunotherapy
Time: Sunday 5 June 2022, 8:00-11:00 AM CDT, Abstract 2600
Presenter: Dr Dmitriy Zamarin, Memorial Sloan Kettering Cancer Center, New York, USA

The poster reports clinical data from the ONCOS-102 phase 1/2 combination trial with anti-PD-L1 checkpoint inhibitor durvalumab in heavily pre-treated, MS-stable CRC (n=36) or OC (n=19) with peritoneal metastases. This is a patient population with few treatment alternatives that only offer marginal efficacy and where checkpoint inhibitor monotherapy does not have any meaningful activity. The trial was managed by an external consortium with Ludwig Cancer Research as sponsor, where Targovax was a collaboration partner.

This is the first time ONCOS-102 has been administered IP and in combination with an anti-PD-L1 checkpoint inhibitor. IP delivery of ONCOS-102 was demonstrated to be feasible and well-tolerated, both as monotherapy and in combination with systemic durvalumab. Whereas the initial OC cohort did not meet the efficacy criteria and was closed, the initial CRC cohort met the efficacy criteria and was expanded. In the full CRC cohort (n=36) two patients remained progression free at the end of the study (week 24), but the primary efficacy endpoint of 4 patients remaining progression free at week 24 was not met.  

Tumor biopsy immune cell analysis showed increased T-cell infiltration in several patients, confirming that IP administered ONCOS-102 can induce immune activation in heavily pre-treated, immunologically silent solid tumors. Of note, the selected IP dose was the same as used for IT delivery of ONCOS-102 (3x1011 V.P.), although IP delivery is expected to result in lower tumor exposure to the virus relative to IT. Hence, higher doses of IP delivered ONCOS-102 could potentially enhance both the immunological response and clinical activity.

Dr. Lone Ottesen, Chief Medical Officer of Targovax, said: “We are very pleased to have two ONCOS-102 studies accepted for presentation at ASCO this year, which is a very important forum to showcase and discuss our clinical data with international experts in the field. In our exploratory clinical program we have now demonstrated that ONCOS-102 can be delivered safely intra-tumorally and intra-peritoneally in combination with PD-1 and PD-L1 checkpoint inhibitors, as well as chemotherapy. Importantly, we have also seen robust immunological and clinical activity in solid tumors of different origins. This gives us confidence to bring ONCOS-102 forward into later stage development, with the first step being a multi-cohort phase 2 trial in PD1-refractory melanoma where we will test several I-O combinations, including the second-generation anti-CTLA4 checkpoint inhibitor botensilimab.”

About ASCO
American Society of Clinical Oncology Annual Meeting, ASCO 2022 will be held in McCormick Place, Chicago, Illinois, United States between 3-7 June 2022.

The 2022 ASCO Annual Meeting Program will offer presentations on the latest research in cancer care. This year's program will feature sessions complementing the meeting's theme: Advancing Equitable Cancer Care Through Innovation.

References
1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas 2020 SITC 2020 poster
2 Baas et al. The Lancet, 2021

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: erik.wiklund@targovax.com

Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com

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

About Targovax

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, multiple myeloma and colorectal cancer, 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 to fight the cancer. On the back of very encouraging clinical data in several indications, both as monotherapy and in combinations, ONCOS-102 will progress into a phase 2 trial in multiple combinations in melanoma patients resistant to PD1 checkpoint blockade.

Building on successful studies demonstrating clinical efficacy and providing deep mechanistic insights, the ONCOS 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.