New York, NY and Paris, France (Press Release) – Cytovia Thera­peutics ("Cytovia"), an emerging bio­pharma­ceu­tical com­pany, an­nounces to­day that it has entered a re­search and licensing agree­ment with Inserm to de­vel­op NK engager bi-specific anti­bodies and iPSC CAR NK cell ther­apy targeting CD38, a key marker of mul­ti­ple myeloma. The licensing agree­ment has been negotiated and signed by Inserm Transfert, the private sub­sid­i­ary of Inserm, on behalf of Inserm (the French National In­sti­tute of Health and Medical Re­search) and its academic part­ners. Cytovia is licensing Inserm's CD38 anti­body and Chimeric Antigen Receptor (CAR) pat­ent and applying its pro­pri­e­tary NK engager bispecific anti­body and iPSC CAR NK tech­nology plat­forms. The re­search agree­ment will in­clude eval­u­a­tion of the thera­peutic can­di­dates at Hôpital Saint-Louis’ Re­search In­sti­tute (Inserm Unit 976) under the leadership of Pro­fessors Armand Bensussan and Jean-Christophe Bories.

Dr Daniel Teper, Cytovia's Chairman and CEO commented: "We are delighted to part­ner with one of the top centers of excellence in the world for re­search and treat­ment in he­ma­tol­ogy. CD38 is a val­i­dated target and Natural Killer cells have sig­nif­i­cant cyto­tox­icity to Myeloma cells. We are looking for­ward to bringing promising new op­tions to address the unmet needs of patients with Multiple Myeloma and aim for a cure."

Professor Armand Bensussan, Director of The Immuno-Oncology Re­search In­sti­tute at Hôpital Saint-Louis added: "We have dem­onstrated the selectivity of our novel CD38 anti­body in kill­ing myeloma cells but not nor­mal cells such as NK, T, and B cells. The activation of NK cells through NKp46 may en­hance the ef­fi­cacy of the bispecific anti­body in patients not re­spon­sive to CD38 mono­clonal anti­body ther­apy. CD38 CAR NK is a promising ap­proach for re­lapsed / re­frac­tory patients and an alter­na­tive to CAR T ther­a­pies."

About Multiple Myeloma

Multiple Myeloma is a cur­rently incurable can­cer, affecting a type of white blood cell known as plasma cells. It leads to an accumulation of tumor cells in the bone mar­row, rapidly outnumbering healthy blood cells. Instead of producing beneficial anti­bodies, can­cer­ous cells re­lease ab­nor­mal pro­teins causing sev­er­al com­pli­ca­tions. While symp­toms are not always present, the majority of patients are diag­nosed due to symp­toms such as bone pain or fracture, low red blood cell counts, fatigue, high cal­cium levels, kidney prob­lems, and in­fec­tions. According to the World Cancer Re­search Fund, Multiple Myeloma is the sec­ond most common blood can­cer, with nearly 160,000 new annual cases world­wide, in­clud­ing close to 50,000 in Europe. 32,000 in the US, and 30,000 in Eastern Asia. Over 95% of cases are diag­nosed late, with a 5-year sur­vival rate of 51%. Initial treat­ment com­prises of a com­bi­na­tion of dif­fer­en­t ther­a­pies, in­clud­ing bio­logical and targeted ther­a­pies, corticosteroids, and chemo­ther­apy, with the op­tion for bone mar­row trans­plants for eli­gible patients. Immunotherapy and cell ther­apy are the most promising new treat­ment op­tion for Multiple Myeloma, with the po­ten­tial for long term can­cer remission.

About CAR NK cells

Chimeric Antigen Receptors (CAR) are fusion pro­teins that com­bine an extracellular an­ti­gen rec­og­ni­tion domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified ge­net­ic­ally to allow insertion of a CAR. CAR-NK cell ther­apy has dem­onstrated ini­tial clin­i­cal rel­e­vance without the lim­i­ta­tions of CAR-T, such as Cytokine Release Syndrome, neurotoxicity or Graft vs Host Disease (GVHD). Induced Pluripotent Stem Cells (iPSC) - derived CAR-NKs are nat­u­rally allo­geneic, avail­able off-the-shelf and may be able to be admin­istered on an outpatient basis. Recent inno­va­tive de­vel­op­ments with the iPSC, an inno­va­tive tech­nology, allow large quantities of ho­mo­ge­neous ge­net­ic­ally modified CAR NK cells to be pro­duced from a master cell bank, and thus hold prom­ise to ex­pand access to cell ther­apy for many patients.

About Cytovia

Cytovia Thera­peutics Inc is an emerging bio­technol­ogy com­pany that aims to ac­cel­er­ate patient access to trans­formational immuno­therapies, addressing sev­er­al of the most chal­leng­ing unmet med­i­cal needs in can­cer and severe acute infectious dis­eases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging mul­ti­ple ad­vanced pat­ented tech­nolo­gies, in­clud­ing an induced pluripotent stem cell (iPSC) plat­form for CAR (Chimeric Antigen Receptors) NK cell ther­apy, next-gener­a­tion pre­ci­sion gene-editing to en­hance targeting of NK cells, and NK engager multi-functional anti­bodies. Our ini­tial prod­uct port­folio focuses on both hema­to­logical malig­nan­cies such as mul­ti­ple myeloma and solid tumors in­clud­ing hepato­cellular carcinoma and glio­blas­toma. The com­pany part­ners with the Uni­ver­sity of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew Uni­ver­sity of Jerusalem, and CytoImmune Thera­peutics. Learn more at www.cytoviatx.com

About Inserm

Founded in 1964, the French National In­sti­tute of Health and Medical Re­search (Inserm) is a pub­lic science and tech­nology in­sti­tute, jointly supervised by the French Ministry of National Education, Higher Education and Re­search, and the Ministry of Social Affairs, Health and Women’s Rights. Inserm is the only French pub­lic re­search in­sti­tute to focus entirely on human health and position itself on the path­way from the re­search laboratory to the patient’s bedside. The mis­sion of its scientists is to study all dis­eases, from the most common to the rarest. With an ini­tial 2020 budget of €927.28 mil­lion, Inserm sup­ports nearly 350 laboratories through­out France, with a team of nearly 14,000 re­searchers, engi­neers, technicians, and post-doctoral students. www.inserm.fr

Source: Cytovia Thera­peutics and Inserm.