Neovacs S.A.. (2/3/17). "Press Release: Neovacs Announces Independent Data and Safety Monitoring Board Supports Continuation of Phase IIb Clinical Trial for IFNa Kinoid in Lupus". Paris.

	Region	SEVERAL
	Organisation	Neovacs S.A. (Euronext Growth Paris: ALNEV)
	Group	Neovacs (Group)
	Organisation 2	Data and Safety Monitoring Board (DSMB)*
	Product	IFNalpha-Kinoid (IFNa-Kinoïd)
	Product 2	clinical research
	Person	Croughs, Thérèse (Neovacs 201509 CMO)
	Person 2	Maggos, Chris (BioConfidant / Cohesion Bureau 202303 Managing Director + Founder before LifeSci Advisors + Addex)

Neovacs (Alternext Paris: ALNEV), a leader in active immunotherapy for the treatment of autoimmune diseases, today announces that it received a positive data review from the Independent Data and Safety Monitoring Board (IDSMB) that allows the Company to continue the Phase IIb clinical trial with lead product candidate, IFNa Kinoid for the treatment of Lupus.

Dr. Thérèse Croughs, Chief Medical Officer of Neovacs, comments: "We are satisfied that the IDSMB, following the second data review meeting, has issued a favorable opinion regarding the continuation of our Phase IIb clinical study in Lupus, which is a rare disease with a high unmet medical need. Importantly, we have already recruited more than two thirds of the patients out of the planned 178 into the study.

The IDSMB is an independent oversight committee composed of multidisciplinary and international experts that has been assembled according to study protocol in order to implement a regular review of the data collected throughout the trial and to ensure that the study is conducted appropriately. This committee is also informed of new relevant data from the protocol and/or other ongoing studies with IFNa Kinoid, and may also decide to interrupt or modify the clinical trial based on the data reviewed.

This Phase IIb trial is a randomized, multicenter, international clinical study that was initiated in September 2015. The ongoing study is evaluating IFNa Kinoid versus placebo in the treatment of systemic lupus erythematosus (SLE). Its objective is to assess the biological and clinical efficacy of IFNa Kinoid, the most advanced product candidate in Neovacs’ pipeline, in patients who have moderate to severe SLE. The trial is planned to include 178 patients in 21 countries in Latin America, Asia, Europe, and USA.

About Lupus

Systemic lupus erythematosus (SLE) or lupus erythematosus is a debilitating, chronic autoimmune disease whose etiology remains unknown. SLE is characterized by a loss of tolerance of self-antigens, with the production of autoantibodies, especially antinuclear antibodies that attack healthy tissues and cause inflammatory reactions in different parts of the body. The disease can affect multiple organs (skin, kidneys, joints, heart, lungs, central nervous system, etc.) and is characterized by heterogeneous clinical signs (skin rashes, arthritis, photosensitivity, nephritis, neurological disorders, anemia, thrombocytopenia, etc.), which vary from one person to another and change during the progression of the disease. Systemic lupus erythematosus affects mostly women.

About Neovacs Technology

Neovacs targets pathologies associated with an overproduction of endogenous cytokines. This technology is based on active immunotherapy to generate an immune response through the administration of an immunogenic complex involving the target cytokine to a carrier protein. The intramuscular injection of this Kinoid induces an immune response and stimulates the production of polyclonal antibodies against the target cytokines. It is thus possible to block cytokine overproduction and its pharmacological effects. Several autoimmune and inflammatory diseases (e.g. systemic lupus erythematosus, dermatomyositis, Type 1 diabetes etc.) are characterized by a disorder of cytokines that are found to be produced in excess (ex: IFNa), promoting inflammation and dysregulation of the immune system.

About Neovacs

Listed on Alternext Paris since 2010, Neovacs is today a leading biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. On the basis of the company’s proprietary technology for inducing a polyclonal immune response (covered by five patent families that potentially run until 2032) Neovacs is focusing its clinical development efforts on IFNa-Kinoid, an immunotherapy being developed for the indication of lupus, dermatomyositis and also in preclinical trial for Type 1 diabetes. Neovacs is also conducting preclinical development works on other therapeutic vaccines in the fields of auto-immune diseases, oncology and allergies. The goal of the Kinoid approach is to enable patients to have access to safe treatments with efficacy that is sustained in these life-long diseases. www.neovacs.fr

Contacts

NEOVACS – Corporate Communication & Investor Relations
Charlène Masson
+33 1 53 10 93 14
cmasson@neovacs.com

LIFESCI ADVISORS – Investor Relations / Financial Communications
Chris Maggos
+41 79 367 6254
chris@lifesciadvisors.com

Record changed: 2023-06-05