​​ReNetX Bio Announces Initiation of Patient Dosing in the First Phase 1 Clinical Trial of Fusion Protein AXER-204

14-Aug-19

Information about the Phase 1 RESET Study
ClinicalTrials.gov NCT03989440
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PRESS RELEASES

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11-Feb-21
ReNetX Founder Steve Strittmatter Wins 2021 King Faisal Prize for Medicine

NEW HAVEN, Conn., Feb. 11, 2021 -- ​Stephen Strittmatter has been awarded the 2021 King Faisal Prize for Medicine in recognition of his pivotal contributions to the field of neural repair, including the identification of a Nogo Receptor pathway that plays a central role in determining the ability of axons to extend and re-connect after injury. 

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13-Jan-21
ReNetX Bio Adds Financial Expertise to its Board of Directors, Appointing Sean Cassidy, MBA

NEW HAVEN, Conn., Jan. 13, 2021 -- ​ReNetX Bio announces the addition of Sean Cassidy, MBA, to its Board of Directors. Mr. Cassidy is the Chief Financial Officer of Arvinas (NASDAQ: ARVN) where he negotiated and closed multiple license and collaboration agreements with leading pharmaceutical companies including Merck, Genentech, a subsidiary of Roche, Pfizer, and Bayer Pharmaceuticals.

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22-Oct-20
ReNetX Bio Awarded $3M SBIR Phase II Grant to Advance Treatment for Chronic Spinal Cord Injury

NEW HAVEN, Conn., Oct. 22, 2020 -- ​ReNetX Bio has been awarded a $3 million SBIR Phase II grant from the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS). ReNetX will use the award, combined with an earlier $7 million commitment from the Wings for Life Foundation, to advance their lead drug candidate, fusion protein AXER-204, to a clinical trial for preliminary efficacy. The drug is one of the only therapies in development for chronic spinal cord injury (SCI) that has received this funding from the NINDS.​

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​25-Sep-20
ReNetX Adds Strategic Drug Development Regulatory Expert to Scientific Advisory Board

NEW HAVEN, Conn., Sep. 25, 2020 -- ​ReNetX Bio has announced the addition of Dr. Kevin Malobisky to their Scientific Advisory Board. Dr. Malobisky, currently the Chief Regulatory and Strategic Operations Officer at Tavanta Therapeutics, brings over 30 years of executive leadership and global drug development experience to the advisory role.​

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13-Jul-20
ReNetX Bio Announces Key Scientific Publication Validating Preclinical Translation with Lead Molecule

NEW HAVEN, Conn., July 13, 2020 -- ​ReNetX Bio announces the publication of a key article in Brain validating the company’s novel approach to addressing damage in the central and ocular nervous system and the potential to reverse damage from neurological disorders.

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08-Jan-20
ReNetX Bio Receives Fast Track Designation From U.S. FDA​

NEW HAVEN, Conn., Jan. 08, 2020 (GLOBE NEWSWIRE) -- ​ReNetX Bio announced today that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track Designation for ReNetX Bio’s clinical therapy (AXER-204) for the potential treatment of Chronic Spinal Cord Injury (SCI). ReNetX Bio is currently conducting a Phase 1/2 clinical trial “RESET” in patients with SCI, with topline results expected in 2021. ​

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More Press Releases

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19-Jun-19
ReNetX Bio, Inc. Announces U.S. FDA Authorization to Proceed for IND Application to Treat Patients with Chronic Spinal Cord Injury​

​NEW HAVEN, Conn.,  June 19, 2019 (PRNewswire) -- ​ReNetX Bio has announced that the U.S. Food and Drug Administration (FDA) has allowed the Company's Investigational New Drug (IND) application for its lead drug candidate, fusion protein AXER-204. Recruitment will begin immediately for the Phase 1 first-in-human trial of AXER-204 for the treatment of chronic spinal cord injury (SCI).​​

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07-May-18
New Haven-Based ReNetX Bio, Inc. Closes Series A Funding and Expands Upon New Haven Roots​

​NEW HAVEN, Conn.,  May 07, 2018 (PRWEB)  -- The Economic Development Corporation of New Haven announced today that New Haven-based ReNetX Bio, Inc., a private biotech company, has closed on its Series A funding and also solidified the relationship that the company has had with the city. The company plans to begin clinical trials on its drug within the year.

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10-Apr-18
ReNetX Bio Invited to Present Breakthrough at Leading Spinal Cord Injury Symposium​

​NEW HAVEN, Conn., April 10, 2018 (GLOBE NEWSWIRE) -- Thanks to the promise of its NoGo Trap therapeutic for treating chronic spinal cord injury (SCI), New Haven-based startup ReNetX Bio has been invited to present as part of a “Clinical Trials 360” symposium at the upcoming American Spinal Cord Injury Association (ASIA) meeting. ​

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07-Nov-17
​ReNetX Bio Receives $7M Commitment from Wings for Life to Bring​ Spinal Cord Treatment to Trial

NEW HAVEN, Conn., Nov. 07, 2017 (GLOBE NEWSWIRE) -- The Wings for Life foundation has made a significant commitment to ReNetX Bio, a New-Haven, Conn. based biotech startup that is advancing a cutting-edge therapy for chronic spinal cord injury to clinical trial. The foundation’s support is a testament to the promising research results from ReNetX Founder and Scientific Advisor Stephen Strittmatter, MD, PhD, Vincent Coates Professor of Neurology at Yale. His discovery of proteins which limit nerve fiber growth after injury, and subsequent development of a molecule to block receptors for these proteins, have formed the basis of a therapeutic that offers the first real hope to patients with chronic spinal cord injury.​

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10-Oct-17
​​Leading Spinal Cord Injury Experts Join ReNetX Scientific Advisory Board

​NEW HAVEN, Conn., Oct. 10, 2017 (GLOBE NEWSWIRE) -- ReNetX Bio, a company developing first-in-class therapeutics to treat injury to the central nervous system, is expanding its Scientific Advisory Board with key opinion leaders specializing in spinal cord injury. 

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24-Jul-17
ReNetX Bio Launched to Advance Innovative Neuro-Regenerative Technology Developed at Yale University: Company Appoints Erika R. Smith as CEO

NEW HAVEN, Conn., July 24, 2017 (GLOBE NEWSWIRE) -- ReNetX Bio, a company developing first-in-class therapeutics to treat injury to the central nervous system, today announced its launch as a new company with the appointment of Erika Smith as Chief Executive Officer. The company also announced the initiation of a Series A financing round to fund its first clinical trial of its lead therapeutic candidate, Nogo Trap, in patients with chronic spinal cord injury.

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IN THE MEDIA

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4-May-21
ReNetX CEO Erika Smith to Present at Yale Innovation Summit

From May 18-May 21, The Yale Innovation Summit will hold its 7th year of a “Shark Tank” style entrepreneurship event. This year’s event will be virtual and Smith is one of several presenters.​

[Update]  ReNetX wins top honors.

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11-Mar-21
Wall Street Journal: ​Biotech Companies Seek to Restore Functions to Spinal-Cord Injury Patients

Biotechnology companies and researchers are studying treatments that could help patients with spinal-cord injuries recover abilities to move and function that they have lost. Scientists and entrepreneurs are hoping that one or more of the treatments under study will emerge as a success that catalyzes additional research and investment in the field. “If any one intervention succeeds and is approved by the FDA, it will have a huge snowball effect for additional therapeutics,” said Stephen Strittmatter, co-founder of ReNetX and the Vincent Coates professor of neurology and professor of neuroscience at Yale University School of Medicine. Nerve cells transmit signals through wirelike projections known as axons. Spinal-cord injury patients can suffer damage to axons and the myelin that insulates them. New Haven, Conn.-based ReNetX, whose investors include Connecticut Innovations, is testing a drug designed to promote axon growth by binding to three proteins that normally inhibit this growth. An initial or Phase 1 study of the drug indicated the treatment is safe, and ReNetX has just initiated a Phase 2 trial of the drug in chronic spinal-cord injury patients, Dr. Strittmatter said.​

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10-Dec-19
Erika Smith of ReNetX Named 2019 BioCT Entrepreneur of the Year

BioCT, the state bioscience booster organization, honored Erika Smith, ReNetX CEO, for her leadership in advancing the company.​ The award honors entrepreneurs in the Connecticut community whose accomplishments are also having impact beyond the borders of the state.

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29-Oct-19
Clinical Trial Enrolling Chronic SCI

Unite 2 Fight Paralysis, October 29, 2019 -- Biotech start-up ReNetX has begun enrolling people with chronic cervical spinal cord injuries in a clinical trial to test a molecular cocktail called Nogo Trap. This is a two-part trial that will eventually include 66 patients. Each participant will be given a dose of Nogo Trap, called AXER-204 by the company. The drug is given via lumbar puncture, a procedure not considered risky but requires admission to the hospital. Part I will evaluate the safety, tolerability, and pharmacokinetics (how the drug acts in the body) of single ascending doses of AXER-204. Part II, set for next year, will look at the same things, but with repeated doses, and also comparing the drug to placebo.

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28-Oct-19
Shepherd Center Treats Two Patients with Chronic Spinal Cord Injury with Potential Restorative Drug in RESET Clinical Trial

ATLANTA, GA, October 28, 2019 -- Shepherd Center recently treated two patients with chronic spinal cord injury in a Phase 1 clinical trial of Fusion Protein AXER-204. Shepherd is the first study site in the United States to have dosed two patients with the investigational drug, which – unlike most similar clinical trials – is focused on patients living with spinal cord injury, rather than those who are newly injured.

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More News

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01-Sep-19
Erika Smith Honored with New Haven BIZ 2019 Innovation Award

New Haven BIZ, September 1, 2019 -- Erika Smith was selected as one of the region's most creative and game-changing entrepreneurs and innovators and shared secrets of success at New Haven BIZ's "60 Ideas in 60 Minutes" event.​

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​28-Jun-19
Murphy Highlights New Haven's ReNetX Bio as "Murphy's Innovator of the Month"

WASHINGTON, June 28, 2019 -- ​U.S. Senator Chris Murphy (D-Conn.) announced on Friday that ReNetX Bio, a biotechnology company in New Haven, has been named “Innovator of the Month.” 

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27-Jul-17
​Yale Scientist Aiming To Reverse Spinal Cord Injuries​

​NEW HAVEN, Conn., July 27, 2017 -- A Yale neurology and neuroscience professor who hopes to regrow neurons in patients with spinal cord injuries has secured enough funding for a human clinical trial.​ 

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25-Jul-17
Drug Aims to Help Treat Spinal Cord Injuries

NEW HAVEN, Conn., July 25, 2017 -- Researchers at ReNetX Bio are hoping a new name, the potential for a new influx of cash on the horizon and a new chief executive officer are the winning combination needed to bring its lead drug candidate to market. ReNetX Bio is looking to guide its drug candidate, Nogo Trap, through its first round of clinical trials. Company officials say Nogo Trap is designed to help patients with chronic spinal cord injury.​

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INTERVIEWS

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Meet Dr. Stephen Strittmatter
Founder of ReNetX Bio
Professor of Neurology & Neuroscience, Yale School of Medicine

U2FP CureCast · CureCast Episode 32: Interview with Dr. Stephen Strittmater about ReNetX

Podcast by Unite 2 Fight Paralysis, Jan 2020
A discussion about the preclinical research,
the mechanistic activity, and the challenges
​ of translating a discovery to clinical relevance

​ Wings for Life Magazine, Dec 11, 2019
 The Wings for Life Foundation has pledged $7M to support ReNetX Bio

​New Haven Register, Aug 4, 2017 by Ed Stannard
Dr. Stephen Strittmatter talks about a new therapy to repair severed nerves in the central nervous system