Nantes – OSE Immunotherapeutics (FR0012127173) and the
French cooperative group ARCAGY-GINECO today announced that the French National
Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethic
Committee (CPP) approved the initiation of a new Phase 2 clinical trial evaluating Tedopi® in
patients with recurrent ovarian cancer (the TEDOVA trial). Tedopi® will be evaluated alone
and in combination with Merck’s Keytruda® (pembrolizumab), an immune checkpoint
inhibitor, as maintenance treatment in ovarian cancer patients after chemotherapy.
The three arm TEDOVA study will evaluate neo-epitope-based vaccine Tedopi® as a maintenance
treatment, alone or in combination with anti-PD-1 Keytruda®, versus the best supportive care in
platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based
chemotherapy.
The clinical trial is sponsored by the “Association de Recherche sur les CAncers dont GYnécologiques
(ARCAGY-GINECO)” on behalf of GINECO, lead group for the TEDOVA trial of the European Network for
Gynaecological Trial Groups (ENGOT). It will be supported in part by a research grant from the
Investigator-Initiated Studies Program of MSD (Merck Sharp & Dohme Corp), a subsidiary of Merck &
Co., Inc.”, which will provide Keytruda® (pembrolizumab), and by OSE Immunotherapeutics which will
provide Tedopi® for the study as well as partial financial support.
Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: “This new clinical
development program for Tedopi® in ovarian cancer demonstrates the interest in exploring the
potential of a PD-1-targeted checkpoint inhibitor combination strategy for combating oncology
indications with significant unmet medical needs. We are very pleased to collaborate with the oncology
group ARCAGY – GINECO to advance a new therapeutic pathway for patients suffering from a
particularly aggressive cancer.”
Dr Alexandra Leary, Chief Investigator of TEDOVA study from Gustave Roussy cancer center, adds: “Our
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 selftolerance. TEDOVA is the first trial evaluating such an innovative approach in ovarian cancer and has
received enthusiastic support from the international gynecological oncology community.”
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 French
Cooperative Group in Oncology labelled by INCa (Institut National du Cancer or French NCI) developing and
conducting gynecological and metastatic breast cancer clinical trials at the national and international level. The
GINECO group was founded in 1993 and is member of international consortia such as ENGOT and GCIG
(Gynecologic Cancer InterGroup).
ABOUT ENGOT
ENGOT (European Network for Gynecological Oncological Trial groups) is a research network of the European
Society of Gynecological Oncology (ESGO) and was founded in 2007. ENGOT is a platform that guarantees that
the European spirit and culture is incorporated into the medical progress in gynaecological oncology, and that all
European patients and countries can participate in an active way in clinical research and progress. The ultimate
goal is to bring the best treatment to gynecological cancer patients through the best science and enabling every
patient in every European country to access a clinical trial. Currently, ENGOT includes 21 cooperative groups
from 25 European countries.
ABOUT MSD
Today’s MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck &
Co., Inc., Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer
care and animal health products, we work with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through
far-reaching policies, programs and partnerships. For more information, visit www.msd.com
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering
therapies to control the immune system for immuno-oncology and autoimmune diseases. The company’s
immunology research and development platform is focused on three areas: T-cell-based vaccination, ImmunoOncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class clinical and
preclinical portfolio has a diversified risk profile:
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 Cell Lung Cancer post checkpoint inhibitor failure.
In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination.
Due to the COVID-19 crisis, accrual of new patients in TEDOPaM should restart in 2021.
– 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 in August 2020,
clinical trial expected to start in Q1 2021.
Immuno-oncology platform
– BI 765063 (OSE-172, anti-SIRPα mAb on SIRPα/CD47 pathway): developed in partnership with Boehringer
Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors.
– 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): positive Phase 1 results; ongoing Phase 1/2 in renal transplant,
Phase 2-ready asset in a niche indication in autoimmune diseases.
– 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 2
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.
Contacts:
OSE Immunotherapeutics
Sylvie Détry
[email protected]
+33 153 198 757
ARCAGY-GINECO
www.arcagy.org
www.twitter.com/ArcagyGineco
Bénédicte Votan
[email protected]
U.S. Media: LifeSci Communications
Darren Opland, Ph.D.
[email protected]
+1 646 627 8387
U.S. and European Investors
Chris Maggos
[email protected]
+41 79 367 6254