Feb 10, 2017

ImmuNext Receives SBIR ‘Fast Track’  Award for Pre-Clinical Development of VISTA Agonists

ImmuNext received an SBIR Fast Track award for up to $3,289,307 from the National Institutes of Health for pre-clinical development of its proprietary VISTA Agonist antibodies for the treatment of autoimmune diseases.

Jan 9, 2017

Sanofi and ImmuNext Enter into Agreement to Develop Treatments for Autoimmune Diseases

BRIDGEWATER, N.J. and LEBANON, N.H., Jan. 9, 2017 /PRNewswire/ –Sanofi and ImmuNext, Inc., announced today an agreement focused on the development of a novel antibody with the potential to treat a range of autoimmune diseases including Lupus and Multiple Sclerosis. Under the terms of the agreement, ImmuNext will grant Sanofi an exclusive, worldwide license to develop and commercialize INX-021, a CD40L monoclonal antibody in preclinical development that suppresses the activity of a cellular pathway that is overactive in many autoimmune diseases. In addition, Sanofi and ImmuNext will initiate a research collaboration to support clinical trials. ­

Potential milestone payments to ImmuNext under the agreement could total $500 million. ImmuNext is also eligible to receive tiered royalties up to double digits on sales of products.

“The immunoregulatory molecule, CD40L, is critical to the progression of a wide spectrum of autoimmune diseases,” said Randolph Noelle, Ph.D., co-founder and Chief Scientific Officer of ImmuNext and Professor of Microbiology and Immunology, Geisel School of Medicine, Dartmouth College. Antibodies that block the function of CD40L have proven in pre-clinical models of autoimmunity to be amongst the most effective agents in treating disease. The development of anti-CD40L for the treatment of autoimmune diseases offers a unique opportunity to silence disease progression and offer long-term remission.”

“Sanofi is committed to expanding our pipeline of specialty care products in multiple sclerosis, where we have established a strong foundation, and immunology, where we are poised to launch new treatments this year for atopic dermatitis and rheumatoid arthritis,” said Frank Nestle, Global Head of Immunology & Inflammation Research Therapeutic Area and also North America Chief Scientific Officer. “We are excited to collaborate with Dr. Noelle and the team at ImmuNext on this promising endeavor.”

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About ImmuNext, Inc.
ImmuNext develops compounds on the cutting edge of immunotherapy for cancer and autoimmune diseases. Our lead product, anti-VISTA, is partnered with Janssen for the treatment of cancer. Our second product, VISTA agonists, is partnered with Hoffmann-La Roche for the treatment of autoimmune diseases. Other programs include a CD40 agonist for neoantigen cancer vaccines and a novel immuno-metabolic target, in each case establishing new classes of compounds.

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “looks forward” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contacts
Media Relations Sanofi
Name: Ashleigh Koss
Tel. 908-981-8745
mr@sanofi.com

Investor Relations Sanofi
George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com

ImmuNext Contact
Name: David DeLucia
info@ImmuNext.com

Dec 20, 2016

ImmuNext Enters into a Strategic Alliance with Roche for up to $400M to Develop Novel Therapies for Autoimmune Diseases

LEBANON, N.H.–(BUSINESS WIRE)–ImmuNext, Inc., today announced that it has entered into an agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche) focused on the development of novel therapeutics that modulate the immune system for the treatment of inflammation and autoimmune diseases.

Under the terms of the agreement, ImmuNext will grant Roche a worldwide, exclusive license to develop and commercialize therapeutics that agonize the V-region immunoglobulin-containing suppressor of T-cell activation (VISTA) signaling pathway. VISTA is a negative checkpoint regulator.

Potential payments to ImmuNext under the agreement include payments for achieving certain preclinical, development and commercial milestones, which could total more than $400 million. ImmuNext is also eligible to receive tiered royalties up to double digits on sales of products. Read more…

May 9, 2016

ImmuNext Receives $1,800,000 Award for Pre-Clinical Development of Anti-CD40L

ImmuNext received a $1,800,000 STTR Phase 2B award from the Nation Institutes of Health for pre-clinical development of its proprietary anti-CD40L antibody for the treatment of autoimmune diseases such as lupus, inflammatory bowel disease and multiple sclerosis.

Febuary 02, 2016

ImmuNext’s anti-VISTA Antibody Enters the Clinic for Cancer

ImmuNext announced today that the first patient has been dosed in a Phase 1 clinical trial of the anti-VISTA antibody, JNJ-61610588. JNJ-61610588 is the first anti-VISTA antibody to enter the clinic.

The compound is a monoclonal antibody designed for the treatment of cancer, and was developed as part of the license and collaboration agreement with Janssen Biotech, Inc. Janssen Research & Development is running the study.

The Phase I trial will enroll patients with advanced solid tumors. The initial portion of the study is designed to evaluate safety, pharmacokinetics, and pharmacodynamics of ascending doses of JNJ-61610588.

Additional information may be found at clinicaltrials.gov, using identifier NCT02671955.

July 29, 2014

ImmuNext Extends and Expands Collaboration with Janssen to Develop Novel Immunotherapies for the Treatment of Cancer

ImmuNext, Inc. today announced that it has extended and expanded its collaboration with Janssen Biotech, Inc., focused on the development of novel therapeutics that modulate the immune system for the treatment of cancer.

ImmuNext has extended its collaborative effort with Janssen to carry out research and development of cancer therapeutics that antagonize the VISTA signaling pathway. VISTA is a novel negative checkpoint regulator. Janssen will be responsible for clinical development and commercialization of all products under the agreement.

In addition, ImmuNext has expanded the collaboration with Janssen to now include discovery of new targets for modulation of the immune system for the treatment of cancer.

“We have made great progress in our collaboration with Janssen, a global leader in the field of oncology, and we look forward to continuing our collaborative efforts to develop innovative immunotherapies to improve the lives of cancer patients,” commented David DeLucia, ImmuNext’s chief executive officer.

May 20, 2014

ImmuNext and Janssen Biotech Achieve Second Milestone on Schedule

ImmuNext and Janssen Biotech, a subsidiary of Johnson and Johnson, have achieved the second milestone in their collaboration to develop anti-VISTA antagonists for the treatment of cancer. ImmuNext has received the second milestone payment as scheduled.

February 14, 2014

ImmuNext Receives $2,000,000 Award to Develop VISTA Agonists to Treat Autoimmune Disease

ImmuNext Received a $2,000,000 STTR Phase 2 award from the Nation Institutes of Health for pre-clinical development of its proprietary VISTA-Ig fusion protein for the treatment of autoimmune diseases such as lupus and multiple sclerosis. The use of negative checkpoint regulator agonists represent a new class of drugs to treat autoimmunity.

November 1, 2013

New Hampshire Business Review:

“Dartmouth prof’s biomed firm follows more entrepreneurial path for anti-cancer discovery”, an article about the history of ImmuNext.

Read article

October 14, 2013

New York Times:

“Breaking Through Cancer’s Shield”, a description of the impact on negative checkpoint regulators on cancer treatment (PD1).

Read article

September 10, 2013

ImmuNext and Janssen Biotech Achieve First Milestone on Schedule

ImmuNext and Janssen Biotech, a subsidiary of Johnson and Johnson, have achieved the first milestone in their collaborative effort to carry out research and development of cancer therapeutics that antagonize the VISTA signaling pathway. ImmuNext has received the first milestone payment as scheduled.

 

January 30, 2013

ImmuNext Receives $3,000,000 Award to Develop Proprietary CD40L Antibody

ImmuNext received a $3,000,000 SBIR Phase 2 award from the National Institutes of Health for pre-clinical development of its proprietary anti-CD40L antagonists for the treatment of autoimmune disease and graft tolerance. The CD40L target was discovered in the laboratory of ImmuNext co- founder Dr. Randolph Noelle.

 

September 5, 2012

ImmuNext Enters into a Strategic Partnership with Janssen, a subsidiary of Johnson and Johnson, to Develop Novel Immunotherapies for the Treatment of Cancer

ImmuNext, Inc., today announced that it has entered into an agreement with Janssen Biotech, Inc., focused on the development of novel therapeutics that modulate the immune system for the treatment of cancer.

Under the terms of the agreement, ImmuNext will grant Janssen a worldwide, exclusive license to develop and commercialize therapeutics that antagonize the V-region immunoglobulin-containing suppressor of T-cell activation (VISTA) signaling pathway. VISTA is a newly identified negative checkpoint regulator.

Potential payments to ImmuNext under the agreement include an upfront payment, plus payments for reaching certain development and commercial-based milestones, which could total more than $150 million. ImmuNext is also eligible to receive royalties on sales of products and sponsored research support.

ImmuNext and Janssen will engage in a collaborative effort to carry out research and development of cancer therapeutics that antagonize the VISTA signaling pathway. Janssen will be responsible for clinical development and commercialization of all products under the agreement.

“VISTA is an exciting, novel, negative checkpoint regulator that we anticipate will be a key target for enhancing immunity to solid and liquid cancers,” stated Randolph Noelle, Ph.D, ImmuNext’s chief scientific officer.

“We look forward to working with Janssen, a global leader in the field of oncology, to develop innovative immunotherapies to improve the lives of cancer patients,” commented David DeLucia, ImmuNext’s chief executive officer.

The ImmuNext technology is based on discoveries made in Dr. Noelle’s labs at the Geisel School of Medicine at Dartmouth and King’s College, London.

ImmuNext was represented by transaction counsel Charles Hoyng, PhD, of Latham Watkins, intellectual property counsel Robin Teskin of Hunton Williams, business development consultant, Chris Krueger and corporate counsel MaryLiz Geffert of McLane, Graf, Raulerson & Middleton.

About ImmuNext, Inc.

ImmuNext is developing novel therapeutics that modulate the immune system to treat cancer and autoimmune diseases. We are targeting critical immuno-regulatory molecules that either promote or suppress immune responses to restore immune homeostasis and cure disease. Using antibody-based therapeutics and novel recombinant fusion proteins, we are developing a spectrum of newly identified molecules to achieve disease remission.

ImmuNext, Inc.
David DeLucia, Chief Executive Officer
info@immunext.com