SOURCE: NovImmune SA

Novimmune SA

November 02, 2015 09:00 ET

Novimmune Announces Presentations at 2015 American College of Rheumatology (ACR) Annual Meeting

Four Abstracts to Be Presented on NI-0501 for Treatment of Hemophagocytic Lymphohistiocytosis (HLH); Poster on NI-0101 for Rheumatoid Arthritis

GENEVA, SWITZERLAND--(Marketwired - Nov 2, 2015) - Novimmune, a Swiss biotech company focused on the discovery and development of antibody-based drugs for the targeted treatment of inflammatory diseases, immune-related disorders and cancer, today announced plans for several presentations at the upcoming 2015 Annual Meeting of the American College of Rheumatology (ACR) in San Francisco, California on November 6-11. The Company will present four abstracts on Novimmune's NI-0501, which targets interferon-gamma IFNγ and is the first treatment developed specifically for Hemophagocytic Lymphohistiocytosis (HLH). The secondary form of HLH can be associated with inflammatory/autoimmune conditions. Novimmune is also presenting a poster on NI-0101, which targets Toll-like receptor 4.

"Discovering a safe and effective treatment for Hemophagocytic Lymphohistiocytosis, or HLH, is a core focus for us at Novimmune, so we are proud that four abstracts will be presented at ACR relating to our new drug, NI-0501, the first treatment specifically developed for HLH," said Novimmune Chief Executive Officer Jack Barbut. "We currently are testing NI-0501 as a first-line treatment for HLH at five investigational sites in the US and 14 sites in five European countries. In addition, a poster at ACR relates to translational data and phase 1 study results for NI-0101, our treatment for Rheumatoid Arthritis. We remain committed to further developing new and existing therapies to provide treatment options for patients dealing with devastating diseases like HLH and painful, debilitating autoimmune and inflammatory diseases."

Oral and poster abstract presentations on hemophagocytic lymphohistiocytosis (HLH) are as follows:

(1) Abstract Number: 3076

Interferon Gamma (IFNg) is the Driving Mediator of Secondary Hemophagocytic Lymphohistiocytosis (sHLH) in TLR9-Mediated Pathogenesis in Mice and is Correlated to Disease Parameters in Children

Cristina de Min1, Vanessa Buatois1, Laurence Chatel1, Laura Cons2, Francoise Richard3, Claudia Bracaglia4, Fabrizio De Benedetti Sr.5, Marie Kosco-Vilbois1 and Walter Ferlin1, 1Novimmune S.A., Geneva, Switzerland, 2Novimmune S.A., Plan-Les-Ouates, Geneva, Switzerland, 3Novimmune SA, Geneva, Switzerland, 4Pediatric Medicine, Division of Rheumatology, Rome, Italy, 5Division of Rheumatology, Department of Pediatric Medicine, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy.

Session Information
Date: Tuesday, November 10, 2015
Session Title: ACR Plenary Session III: Discovery 2015
Session Type: ACR Plenary Session
Session Time: 11:00AM-12:30PM

(2) Abstract Number: 2433

Anti Interferon-Gamma (IFNg) Monoclonal Antibody Treatment in a Child with NLRC4-Related Disease and Severe Hemophagocytic Lymphohistiocytosis (HLH)

Claudia Bracaglia1, Giusi Prencipe1, Antonio Gatto2, Manuela Pardeo1, Geneviève Lapeyre3, Luigi Raganelli1, Emiliano Marasco2, Antonella Insalaco2, Walter Ferlin3, Robert Nelson3, Cristina de Min3 and Fabrizio De Benedetti Sr.1, 1Department of Pediatric Medicine, Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, IRCCS, Rome, Italy, 2Pediatric Medicine, Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, IRCCS, Rome, Italy, 3Novimmune S.A., Geneva, Switzerland.

Session Information
Date: Tuesday, November 10, 2015
Session Title: Pediatric Rheumatology-Clinical and Therapeutic Aspects Posters (ACR): Imaging and Novel Clinical Interventions
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM

(3) Abstract Number: 3096

Interferon-Gamma (IFNg) in Macrophage Activation Syndrome (MAS): CXCL9 Levels as a Biomarker for IFNg Production in MAS

Claudia Bracaglia1, Denise Pires Marafon2, Ivan Caiello1, Kathy De Graaf3, Florence Guilhot4, Walter Ferlin4, Sergio Davì5, Grant Schulert6, Angelo Ravelli5, Alexei A. Grom7, Robert Nelson4, Cristina de Min4 and Fabrizio De Benedetti Sr.1, 1Department of Pediatric Medicine, Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, IRCCS, Rome, Italy, 2Pediatric Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy, 3Novimmune S.A., Geneva, Switzerland, 4Novimmune S.A., Geneva, Switzerland, 5Istituto Giannina Gaslini and University of Genova, Genova, Italy, 6Pediatric Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 7Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Session Information
Date: Tuesday, November 10, 2015
Session Title: Pediatric Rheumatology-Clinical and Therapeutic Aspects Posters (ACR): Imaging and Novel Clinical Interventions
Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM- 4:00PM

(4) Abstract Number: 3097

Innovative Approach for the Identification of an Appropriate Dose Regimen of a Targeted Treatment, NI-0501, an Anti-Interferon Gamma (IFNg) Antibody, in Patients with Hemophagocytic Lymphohistiocytosis (HLH)

Cristina de Min1, Philippe Jacqmin2, Christian Laveille3, Robert Nelson1, Florence Guilhot1, Maureen Deehan1, Marie Kosco-Vilbois1, Walter Ferlin1 and Genevieve Lapeyre1, 1Novimmune S.A., Geneva, Switzerland, 2SGS Exprimo, Mechelen, Belgium, 3SGS Exprimo NV, Mechelen, Belgium

Session Information
Date: Tuesday, November 10, 2015
Session Title: Pediatric Rheumatology-Clinical and Therapeutic Aspects III: Miscellaneous Pediatric Rheumatic Diseases
Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM- 4:00PM

(5) Abstract Number: 1661

Translational Data and Phase 1 Study Results of a New Monoclonal Antibody Targeting Toll like Receptor 4 (TLR4) Developed for Rheumatoid Arthritis (RA) Treatment with a Potential for Personalized Medicine

Emmanuel Monnet1, Limin Shang1, Geneviève Lapeyre1, Kathy De Graaf2, Eric Hatterer1, Gaelle Wambiekele1, Walter Ferlin1, Philippe Jacqmin3, Cem Gabay4, Jeremy Sokolove5, Simon Jones6, Ernest H. Choy7, Iain B. McInnes8, Marie Kosco-Vilbois1 and Cristina de Min1, 1Novimmune S.A., Geneva, Switzerland, 2Novimmune S.A., Geneva, Switzerland, 3SGS Exprimo, Mechelen, Belgium, 4Rheumatology, Geneva University Hospital, Geneva, Switzerland, 5Medicine, VA Palo Alto Health Care System and Stanford University, Palo Alto, CA, 6Cardiff Institute of Infection & Immunity, Cardiff, United Kingdom, 7Cardiff University, Institute of Infection and Immunity, Tenovus Building, University Hospital of Wales, Cardiff, United Kingdom, 8Institute of Infection, Immunity and Inflammation, College of Medicine, Veterinary Medicine and Life Sciences, University of Glasgow, Glasgow, United Kingdom

Session Information
Date: Monday, November 9, 2015
Session Title: Rheumatoid Arthritis-Small Molecules, Biologics and Gene Therapy Poster II
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM

About ACR

The American College of Rheumatology (ACR) is an ethically-driven, professional membership organization committed to improving the care of patients with rheumatic disease and advancing the rheumatology subspecialty. Founded in 1934, ACR is a not-for-profit, global medical society that serves over 9,500 physicians, health professionals and scientists worldwide.

About Hemophagocytic Lymphohistiocytosis (HLH)

HLH is a severe immune system disorder caused by an overactive and poorly controlled T cell function that triggers aberrant activation of the immune system. The disease typically arises in pediatric patients and is lethal if untreated. Even with the current best available care, HLH has a high rate of mortality.

Novimmune is currently testing a new drug, NI-0501, as a first-line and second-line treatment for HLH. The drug is the first treatment specifically developed for HLH. NI-0501 is a fully human monoclonal antibody that neutralizes interferon gamma, a cell-signaling protein believed to play a pivotal role in the development of HLH. In the ongoing phase II study, NI-0501 was initially administered to patients showing unsatisfactory response or intolerance to conventional therapies including chemotherapy, immune-suppressive medicines, and immune-depleting drugs. The recently approved amendment to the protocol allows NI-0501 to be administered to patients as a first-line treatment before any other intervention.

The study is currently underway at five investigational sites in the US and 14 sites in five European countries.

About Novimmune

Novimmune SA is a Swiss biopharmaceutical company focused on the discovery and development of antibody-based drugs for the targeted treatment of inflammatory diseases, immune-related disorders, and cancer. The company is headquartered in Geneva. More information is available on the company website at www.novimmune.com.

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