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Targovax announces clinical collaboration with Agenus for upcoming ONCOS-102 phase 2 melanoma trial

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  • Targovax and Agenus have entered into a clinical collaboration agreement for the ONCOS-102 melanoma phase 2 multi-cohort trial 
  • ONCOS-102 will be tested in combination with the two checkpoint inhibitors balstilimab (anti-PD1) and botensilimab (second generation anti-CTLA4) in patients with anti-PD1 refractory malignant melanoma 

Oslo, Norway, 11 May 2022 – Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that it has entered into a clinical collaboration and supply agreement with Agenus Inc. (NASDAQ: AGEN) to combine Targovax’s oncolytic immunotherapy ONCOS-102 with two of Agenus´ checkpoint inhibitors in a multi-cohort phase 2 trial to treat anti-PD1 refractory malignant melanoma.   

Targovax has previously reported a highly competitive 35% objective response rate (ORR) for ONCOS-102 in a phase 1 trial in anti-PD1 refractory melanoma. Importantly, deep translational analyses revealed broad and powerful ONCOS-102-induced immune activation, which correlated with tumor responses and demonstrated strong scientific evidence for additional combination treatments beyond anti-PD1 blockade. Based on these encouraging clinical findings, Targovax is preparing for a multi-cohort phase 2 trial to test ONCOS-102 with novel immunotherapy combinations in a larger number of patients.  

Agenus is an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections. Agenus and Targovax plan to test ONCOS-102 in combination with Agenus´ two proprietary checkpoint inhibitors, balstilimab and botensilimab. Balstilimab is an anti-PD1 blocking antibody currently in clinical development in several solid tumors. Botensilimab is an Fc-enhanced anti-CTLA4 antibody that has shown promising activity in early trials in several treatment-resistant solid tumors as monotherapy and in combination with balstilimab.     

Dr. Lone Ottesen, Chief Medical Officer of Targovax, said: “The excellent efficacy, immune activation potency and safety profile of ONCOS-102 argues strongly for moving into later stage development in combination with complementary immunotherapies. Based on our clinical biomarker and genomic data, we firmly believe we can further boost response rates in anti-PD1 refractory melanoma patients with novel combinations. I am particularly excited about the opportunity to work with Agenus´ new anti-CTLA4 candidate botensilimab, which has the potential to significantly improve on both efficacy and toxicity compared to ipilimumab, as well as enhancing the systemic activity of ONCOS-102.” 

Under the agreement, Targovax will be the sponsor and responsible for operational execution of the combination trial, and Agenus will provide drug supply and scientific support. Following demonstration of competitive clinical efficacy in the planned phase 2 study, the parties intend to extend the collaboration into a registrational development program. 

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: “We are thrilled to extend our existing relationship with Agenus. We were looking for a  collaboration partner with a portfolio of innovative, complementary immunotherapies, and in Agenus we have found the perfect fit. Together, we will test novel and differentiated combination treatments in melanoma with the goal to achieve response rates beyond the already observed 35% ORR. We are confident this will confirm ONCOS-102 as a leading candidate to address the growing unmet medical need for immune activators that can effectively reverse resistance to checkpoint inhibitor therapy.”

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, 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 immunotherapy and chemotherapy combinations, the next development step for ONCOS-102 will be to further improve immune activation and clinical response in melanoma patients resistant to PD1 checkpoint blockade.

Building on successful phase 1/2 studies demonstrating clinical benefit and providing deep mechanistic insights, Targovax is expanding its ONCOS program into delivery of circular RNA and targeting KRAS mutant cancers with the aim of establishing a platform for development of a rich pipeline of innovative future immunotherapy product candidates.

About Agenus

Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary MiNK Therapeutics), adjuvants, and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

This information is considered to be inside information pursuant to the EU Market Abuse Regulation, and is subject to disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act. The stock exchange announcement was published by Renate Birkeli, Investor Relations, Targovax ASA.