Sanofi has announced its Phase 2 clininical trial in Primary Sjögren’s Syndrome (pSjS), which will assess safety, tolerability, pharmacokinetics, and therapeutic efficacy of anti-CD40L antagonist, SAR441344. The study’s details are available at ClinicalTrials.gov, with identifier NCT04572841.
Sanofi Brings Immunext’s Anti-CD40L Antagonist into a Phase 2 Clinical Trial
ImmuNext Enters Option and License Agreement with Curis for the Development and Commercialization of Antagonistic Anti-VISTA Antibodies in Oncology
ImmuNext entered into an exclusive option and license agreement with Curis, Inc., regarding worldwide rights to develop and commercialize antagonistic anti-VISTA antibodies for the treatment of cancer, including a clinical-stage antibody that had previously been in a Phase 1a trial.
“In the years since the original clinical study, the advent of CAR-T therapy and broad expansion of immunotherapy have led to an evolution in the oncology community in the management of ‘on-target’ side effects such as cytokine release and immune-mediated toxicity. We believe the timing is perfect to re-introduce this asset into the clinic and to establish a potentially transformative new therapy for patients,” said Dr. Robert Martell, Head of R&D at Curis.
Curis plans to re-enter the compound into the clinic in 2020.
ImmuNext Partners with Eli Lilly to Develop First in Class Immunometabolism Drug
INDIANAPOLIS, IN, LEBANON, NH — Eli Lilly and Company (NYSE: LLY) and ImmuNext, Inc. today announced a global licensing and research collaboration focused on the study of a preclinical novel target that could lead to potential new medicines for autoimmune diseases by regulating immune cell metabolism.
“Immunology is an important area of research for Lilly, and we seek novel targets that could develop into new medicines for patients suffering with autoimmune diseases,” said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly. “Regulating the metabolism of immune cells is a promising approach to treating these diseases, and we look forward to working with ImmuNext to advance their immunometabolism target.”
Jay Rothstein, Chief Scientific Officer at ImmuNext, states that “We are pleased to work with Lilly to bring forward a first-in-pathway antibody that specifically targets the metabolism of lymphocytes to reprogram rather than suppress the immune system.”
Under the terms of the agreement, ImmuNext will receive an upfront payment of $40 million, and is eligible to receive up to approximately $565 million in development and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales. In return, ImmuNext will grant Lilly an exclusive, worldwide license to develop and commercialize the novel immunometabolism target. In addition, Lilly and ImmuNext will establish a 3-year research collaboration to support the target’s development.
This transaction is subject to customary closing conditions. The transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2019 non-GAAP earnings per share guidance as a result of this transaction.
ImmuNext’s anti-CD40L Antibody SAR441344 Enters Sanofi’s Phase 1 Clinical Trial for Multiple Sclerosis
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.”
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…
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.
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.
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.
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.
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.