- Clinical trial sponsored and conducted by the French oncology cooperative group ARCAGY-GINECO and supported by Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc.,
Kenilworth, NJ , USA, known as MSD outside of the US andCanada , andOSE Immunotherapeutics . - Innovative approach in ovarian cancer, an oncology indication with high unmet medical need.
- First Results expected beginning of 2025.
The three arm TEDOVA study aims at evaluating the neo-epitope-based vaccine Tedopi® as a maintenance treatment, alone or in combination with anti-PD-1 immune checkpoint inhibitor Keytruda®, versus best supportive care in patients with first or second platinum-sensitive recurrent ovarian cancer with controlled disease after platinum-based chemotherapy and who have already received both bevacizumab and a PARP (Poly ADP-Ribose Polymerase) inhibitor.
Dr.
Patients with ovarian cancer do not respond to checkpoint inhibitors (ICI) alone because these tumors are ‘immune cold’. The objective of TEDOVA is to turn ovarian cancer into an ‘immune hot’ tumor using a combination of tumor associated neo-epitopes that have been optimized to break immunological self-tolerance.
This Phase 2 trial, sponsored by the “Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY-GINECO)” on behalf of GINECO, is designed to enroll 180 patients and will be conducted at approximately 30 sites in
Alexis Peyroles, Chief Executive Officer of
ABOUT OVARIAN CANCER
Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40%. In 2018, there were nearly 300,000 new cases diagnosed. Once the first relapse has occurred, ovarian cancer is managed as a chronic disease, requiring iterative lines of platinum-based chemotherapy. After 6 cycles, chemotherapy is stopped and one of the major priorities is to extend “chemotherapy-free” intervals for the patients by proposing maintenance strategies with targeted therapies (PARP inhibitors or bevacizumab). By the time patients with ovarian cancer present with first or second relapse, they will have received BOTH a PARP inhibitor and bevacizumab, thus patients progressing post-PARP inhibitors and bevacizumab represent an area of unmet medical need, they are offered chemotherapy alone with no maintenance strategy. The TEDOVA trial focuses on these women.
ABOUT GINECO
GINECO (Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein) is the
ABOUT ENGOT
ENGOT (
ABOUT MSD
Established in
ABOUT
Vaccine platform
- Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for Step-1 of the Phase 3 trial (
Atalante 1) in Non-Small CellLung Cancer post checkpoint inhibitor failure.
In Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.
In Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.
In Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT. - CoVepiT: a prophylactic second-generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results. Voluntary and temporary Phase 1 enrollment suspension on-going (July 2021).
- BI 765063 (OSE-172, anti-SIRPα mAb on SIRPα/CD47 pathway): developed in partnership with
Boehringer Ingelheim in advanced solid tumors; positive Phase 1 results in monotherapy and BI 765063 dose escalation study ongoing in combination with Ezabenlimab (PD-1 antagonist). - CLEC-1 (novel myeloid checkpoint target): identification of mAb antagonists of CLEC-1 blocking the “Don’t Eat Me” signal that increase both tumor cell phagocytosis by macrophages and antigen capture by dendritic cells.
- BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.
Auto-immunity and inflammation platform
- FR104 (anti-CD28 monoclonal antibody): Licensing partnership agreement with Veloxis in the organ transplant market; ongoing Phase 1/2 in renal transplant (sponsored by the
Nantes University Hospital ); Phase 2-ready asset in an autoimmune disease indication. - OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with
Servier ; positive Phase 1 results; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2a planned in Sjögren’s syndrome (Servier sponsor). - OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
For more information: https://ose-immuno.com/en/
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Contacts | ||
Media | ||
Sylvie Détry sylvie.detry@ose-immuno.com +33 153 198 757 | darren@lifescicomms.com +1 646 627 8387 | gvanrenterghem@lifesciadvisors.com +41 76 735 01 31 |
Investor Relations thomas.guillot@ose-immuno.com +33 607 380 431 | French Media: FP2COM fportejoie@fp2com.fr +33 607 768 283 |
ARCAGY-GINECO
www.arcagy.org
www.twitter.com/ArcagyGineco
Bénédicte Votan
bvotan@arcagy.org
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