Author: Alta Berri

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Immunovant Appoints Pete Salzmann as Chief Executive Officer

NEW YORK and BASEL, Switzerland, June 5, 2019 /PRNewswire/ — Immunovant, a biopharmaceutical company focused on developing innovative therapies for patients living with debilitating autoimmune diseases, today announced the appointment of Pete Salzmann, M.D. as Chief Executive Officer.

“We are incredibly excited to have Pete join Immunovant as the company advances the development of IMVT-1401,” said Frank Torti, M.D., Vant Investment Chair at Roivant Pharma and Chairman of the Board at Immunovant. “Pete’s track record of starting and expanding new businesses, launching and growing products, and building and leading high-performing teams is fully aligned with the expected next stages of growth for Immunovant and IMVT-1401.”

Dr. Salzmann brings to Immunovant 20 years of experience from various leadership roles at Eli Lilly and Company, where he most recently served as Global Clinical Development Leader for baricitinib (Olumiant®). He was responsible for designing and executing comprehensive indication development strategy and overseeing clinical trials of baricitinib. During his tenure at Lilly, Dr. Salzmann was instrumental in bringing a number of highly-successful drugs to market, including Taltz® in the U.S., and led the launch and commercialization of products in major markets across a wide range of therapeutic categories, including immunology. Dr. Salzmann also served as a General Manager and started or expanded multiple Lilly businesses in major markets around the world, including China. Prior to joining Lilly, Dr. Salzmann was an attending physician at the University of California, San Francisco.

This appointment comes at a significant time for the company. On May 23, 2019, Immunovant announced that it initiated dosing in ASCEND-GO 1, an open label, single-arm Phase 2a clinical trial evaluating IMVT-1401 in patients with moderate-to-severe active Graves’ ophthalmopathy (GO). Immunovant also expects to initiate ASCEND-GO 2, a randomized, dose-ranging Phase 2b clinical trial evaluating IMVT-1401 in patients with GO, later this quarter. In addition to GO, IMVT-1401 is under development for the treatment of myasthenia gravis (MG). Immunovant anticipates initiating a Phase 2a clinical trial of IMVT-1401 for the treatment of MG later this quarter.

“I am delighted to be joining Immunovant at this exciting time,” said Dr. Salzmann. “The Immunovant team has made extraordinary progress with IMVT-1401, which I believe has the potential to be a truly transformative treatment for multiple autoimmune diseases. Together with the leadership team and all of Immunovant’s employees, I look forward to building on this foundation and continuing our pace of innovation and effective execution.”

Dr. Salzmann holds an M.B.A. from Stanford University, Graduate School of Business, an M.D. from University of Chicago, Pritzker School of Medicine, and a B.A. in Chemistry from Northwestern University.

About Immunovant

Immunovant, a member of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing innovative therapies that are designed to not only treat the symptoms, but also modify the course, of autoimmune disease. Immunovant’s lead program is IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody in development for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

About Roivant Pharma

Roivant Pharma is the biopharmaceutical business unit of Roivant Sciences. Roivant Pharma is focused on end-to-end biopharmaceutical company creation, launch, and oversight. Roivant Pharma companies include Altavant, Aruvant, Axovant, Dermavant, Enzyvant, Genevant, Immunovant, Metavant, Myovant, Respivant, Urovant, and Arbutus.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization.

Media Contacts:

Immunovant

Brad Middlekauff

brad.middlekauff@immunovant.com

Roivant

Paul Davis

paul.davis@roivant.com

Immunovant Initiates Dosing in ASCEND-GO 1, a Phase 2a Trial of IMVT-1401 in Patients with Graves’ Ophthalmopathy (GO)

  • IMVT-1401, a fully human anti-FcRn antibody administered via subcutaneous injection, is the only anti-FcRn antibody known to be in clinical development for the treatment of GO
  • Immunovant plans to initiate ASCEND-GO 2, a separate Phase 2b dose-ranging clinical trial of IMVT-1401 in patients with GO, later this quarter
  • IMVT-1401 is also being evaluated in ASCEND-MG, an ongoing Phase 2a clinical trial for the treatment of myasthenia gravis
  • Clinical development for IMVT-1401 in a third indication is expected to start in 2H 2019

NEW YORK and BASEL, Switzerland, May 23, 2019 /PRNewswire/ – Immunovant, a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients living with debilitating autoimmune diseases, today announced that it has initiated dosing in ASCEND-GO 1, an open label, single-arm Phase 2a clinical trial evaluating IMVT-1401 in patients with moderate-to-severe active Graves’ ophthalmopathy (GO). IMVT-1401 is a novel, fully human monoclonal antibody that selectively binds and inhibits the neonatal Fc receptor (FcRn) and is designed to be delivered by subcutaneous injection.

In the ASCEND-GO 1 trial, an expected eight patients will receive six weekly subcutaneous injections of IMVT-1401: 680 mg for the first two administrations, followed by 340 mg for the final four administrations. The primary endpoints for this clinical trial are safety and tolerability. Changes from baseline in levels of anti-TSHR antibodies, total IgG antibodies and IgG antibody subclasses will also be measured. This trial has been designed without use of any intravenous induction dosing. Immunovant also expects to initiate ASCEND-GO 2, a randomized, dose-ranging Phase 2b clinical trial evaluating IMVT-1401 in patients with GO, later this quarter.

GO is a serious and disfiguring disease, potentially resulting in blindness. There are no FDA-approved therapies for GO today.

“We believe that IMVT-1401, by depleting the autoantibodies that cause Graves’ ophthalmopathy, may offer a targeted treatment option for patients. In addition, IMVT-1401 is designed to be delivered in a convenient subcutaneous injection, avoiding the need for intravenous infusions. We look forward to gaining further insights from the Phase 2 ASCEND-GO program,” said Sandeep C. Kulkarni, Chief Operating Officer of Immunovant.

For more information about this clinical trial, please visit www.clinicaltrials.gov. The clinicaltrials.gov identifier is NCT03922321.

About Graves’ Ophthalmopathy

Graves’ ophthalmopathy, also known as thyroid eye disease, is an autoimmune disorder that affects the muscles and other tissues around the eyes. GO has an estimated annual incidence of 16 per 100,000 women and 2.9 per 100,000 men in North America and Europe. Approximately one in 20 patients with Graves’ disease will present with moderate-to-severe GO, which is characterized by swelling and redness of the eyelids, proptosis (protrusion of the eyeball), double vision, and, in severe cases, corneal ulceration and decreased visual acuity. GO is most commonly caused by IgG autoantibodies that form against the thyroid-stimulating hormone receptor (TSHR). These antibodies, which also cause Graves’ disease, activate certain cell types, such as fibroblasts and adipocytes, that are present in the extraocular space, promoting inflammation and swelling that result in the clinical manifestations of the disease. There are no therapies approved by the Food and Drug Administration (FDA) for the treatment of GO.

About IMVT-1401

IMVT-1401 (formerly RVT-1401) is a novel, fully human monoclonal antibody being investigated for the treatment of IgG-mediated autoimmune diseases. IMVT-1401 is the product of a multi-step, multi-year research program, conducted by our collaboration partner, HanAll BioPharma, to design a highly specific anti-FcRn antibody optimized for delivery as a subcutaneous injection. These efforts have resulted in a product candidate that has been dosed at small volumes and with a small gauge needle. Immunovant intends to develop IMVT-1401 for debilitating autoimmune diseases in which there is robust evidence that pathogenic IgG antibodies drive disease manifestation and in which reduction of IgG antibodies should lead to clinical benefit. Immunovant has in-licensed the rights to develop, manufacture and commercialize IMVT-1401 in the United States, Canada, Mexico, the EU, the United Kingdom, Switzerland, the Middle East, North Africa and Latin America. In additional to GO, IMVT-1401 is also in Phase 2a clinical development for the treatment of myasthenia gravis.

About Immunovant

Immunovant, a member of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing innovative therapies that are designed to not only treat the symptoms, but also modify the course, of autoimmune disease. Immunovant’s lead program is IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody in development for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization.

Immunovant to Present Phase 1 Clinical Trial Results at 2019 American Academy of Neurology Annual Meeting

  • First poster presentation on IMVT-1401, a fully human anti-FcRn antibody given by subcutaneous injection, in healthy subjects
  • IMVT-1401 currently in Phase 2a clinical development for the treatment of myasthenia gravis

NEW YORK and BASEL, Switzerland, May 9, 2019 /PRNewswire/ – Immunovant, a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients living with debilitating autoimmune diseases, today announced that it will present the first detailed findings in healthy subjects for IMVT-1401 (formerly RVT-1401) in a poster session at the 2019 American Academy of Neurology (AAN) Annual Meeting, being held May 4-10, 2019, at the Pennsylvania Convention Center in Philadelphia, PA.

The online abstract for this research is available in the “Abstracts & Awards” section of the AAN Annual Meeting website, and details for the poster presentation are as follows:

Abstract Title: RVT-1401, a Novel Anti-FcRn Monoclonal Antibody, Is Well Tolerated in Healthy Subjects and Reduces Serum IgG Following Subcutaneous or Intravenous Administration (Program Number: P5.2-079)
Poster Session Name: P5: Immunotherapies: New Targets and Side Effects
Presentation Date & Time: Thursday, May 9, 2019, 11:30 AM – 6:30 PM EDT
Location: Pennsylvania Convention Center, Philadelphia, PA

About IMVT-1401
IMVT-1401 is a novel, fully human monoclonal antibody being investigated for the treatment of IgG-mediated autoimmune diseases. IMVT-1401 is the product of a multi-step, multi-year research program, conducted by Immunovant’s collaboration partner, HanAll BioPharma, to design a highly specific anti-FcRn antibody optimized for delivery as a subcutaneous injection. These efforts have resulted in a product candidate that has been dosed at small volumes and with a small gauge needle. Immunovant intends to develop IMVT-1401 for debilitating autoimmune diseases in which there is robust evidence that pathogenic IgG antibodies drive disease manifestation and in which reduction of IgG antibodies should lead to clinical benefit. Immunovant has in-licensed the rights to develop, manufacture and commercialize IMVT-1401 in the United States, Canada, Mexico, the EU, the United Kingdom, Switzerland, the Middle East, North Africa and Latin America. IMVT-1401 presently is in Phase 2a clinical development for the treatment of myasthenia gravis (ClinicalTrials.gov Identifier: NCT03863080).

About Immunovant
Immunovant, a member of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing innovative therapies that are designed to not only treat the symptoms, but also modify the course, of autoimmune diseases. Immunovant’s lead program is IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody in development for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

About Roivant Sciences
Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization.

Roivant Sciences Enters into Development Partnership with HanAll Biopharma

BASEL, Switzerland, Dec. 19, 2017 /PRNewswire/ — Roivant Sciences and HanAll Biopharma Co., Ltd. announced today that they have entered into a strategic collaboration and licensing agreement to develop, manufacture, and commercialize the anti-FcRn monoclonal antibody HL161 for the treatment of pathogenic IgG-mediated autoimmune diseases.

Under the agreement, HanAll will grant Roivant an exclusive license for the development, manufacture, and marketing of HL161 in the United States, Canada, Mexico, the European Union, the United Kingdom, Switzerland, Latin America, the Middle East, and North Africa. HanAll will receive a one-time upfront payment from Roivant, and will also receive research funding and milestone payments in line with future development progress as well as specified royalty payments after commercialization.

About HL161

HL161 is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). Blockade of FcRn-Immunoglobulin G (IgG) interactions has been shown to lead to the rapid depletion of IgG. HL161 has potential as a treatment for IgG-mediated autoimmune diseases.

About HanAll Biopharma

HanAll Biopharma Co., Ltd., a subsidiary of Daewoong Pharmaceutical Co., Ltd., is a fully integrated biopharmaceutical company based in South Korea focusing on the discovery and development of innovative biological therapeutics in the areas of autoimmune diseases and immuno-oncology. HanAll’s lead pipeline assets are 1) HL161, a fully human monoclonal antibody targeting neonatal Fc Receptor (FcRn) for the potential treatment of pathogenic-IgG mediated autoimmune diseases, 2) HL036, an anti-TNF ophthalmic solution for the treatment of dry eye diseases, and 3) two novel immuno-oncologic projects. HanAll’s ambition is to be a leader in the area of immunology providing new therapeutics to patients with severe immune disorders in cooperation with specialized groups in each research field and through open innovation.

About Roivant Sciences

Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. Roivant partners with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients.

Roivant advances its drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also pursues its mission by incubating and launching innovative healthcare companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit www.roivant.com.

Related links
www.roivant.com
en.hanall.co.kr