WORCESTER, Mass. and MUNICH, Germany, Nov. 23, 2020 (GLOBE NEWSWIRE) — Mustang Bio, Inc.. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical firm targeted on translating at this time’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, strong tumors and uncommon genetic ailments, and Minaris Regenerative Drugs GmbH (“Minaris”), a number one contract improvement and manufacturing service supplier for the cell and gene remedy business, at this time introduced that they’ve signed an settlement to allow know-how switch and GMP medical manufacturing of Mustang’s MB-107 lentiviral gene remedy program for the therapy of X-linked extreme mixed immunodeficiency (“XSCID”), also referred to as bubble boy illness, in Europe.
Underneath the phrases of the settlement, Minaris will carry out know-how switch of the manufacturing and analytical processes, in addition to their adoption to the European regulatory setting, for the GMP-compliant manufacturing of the drug product at its web site in Ottobrunn, Germany, with the purpose of supplying medical trials in Europe.
“We stay up for a productive and profitable partnership with Mustang the place Minaris will be capable to assist them with our intensive expertise within the medical and business manufacturing of autologous gene therapies,” mentioned Dusan Kosijer, Managing Director of Minaris. “We’re desirous to work along with Mustang within the battle towards this devastating illness.”
“This settlement with Minaris is a crucial step in supporting enlargement of our MB-107 pivotal medical trial into Europe,” mentioned Manuel Litchman, M.D., President and Chief Government Officer of Mustang. “We stay up for working with Minaris to develop our geographic footprint and produce this potential life-saving remedy to XSCID sufferers in want internationally.”
MB-107 is at present being assessed in a Section 1/2 medical trial for XSCID in newly identified infants underneath the age of two at St. Jude Youngsters’s Analysis Hospital, UCSF Benioff Youngsters’s Hospital in San Francisco and Seattle Youngsters’s Hospital. Mustang submitted an investigational new drug software (“IND”) to the FDA to provoke a pivotal multi-center Section 2 medical trial of MB-107 on this identical affected person inhabitants. The trial is predicted to enroll 10 sufferers who, along with 15 sufferers enrolled within the present multi-center trial led by St. Jude, will probably be in contrast with 25 matched historic management sufferers who’ve undergone hematopoietic stem cell transplantation. The first efficacy endpoint will probably be event-free survival. The initiation of this trial is predicted quickly. Mustang is concentrating on topline knowledge from this trial within the second half of 2022.
The FDA granted Uncommon Pediatric Illness, Orphan Drug and Regenerative Drugs Superior Remedy Designations to MB-107 for the therapy of XSCID in newly identified infants.
About X-linked Extreme Mixed Immunodeficiency (“XSCID”)
X-linked extreme mixed immunodeficiency is a uncommon genetic dysfunction that happens in roughly 1 per 225,000 births. It’s characterised by the absence or lack of perform of key immune cells, leading to a severely compromised immune system and loss of life by one yr of age if untreated. Sufferers with XSCID don’t have any T-cells or pure killer cells. Though their B-cells are regular in quantity, they don’t seem to be practical. Consequently, XSCID sufferers are normally affected by extreme bacterial, viral or fungal infections early in life and sometimes current with interstitial lung illness, power diarrhea and failure to thrive.
The particular genetic dysfunction that causes XSCID is a mutation within the gene coding for the frequent gamma chain (“γc”), a protein that’s shared by the receptors for no less than six interleukins. These interleukins and their receptors are vital for the event and differentiation of immune cells. The gene coding for γc is named IL-2 receptor gamma, or IL2RG. As a result of IL2RG is situated on the X-chromosome, XSCID is inherited in an X-linked recessive sample, leading to nearly all sufferers being male.
About Mustang Bio
Mustang Bio, Inc. is a clinical-stage biopharmaceutical firm targeted on translating at this time’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, strong tumors and uncommon genetic ailments. Mustang goals to amass rights to those applied sciences by licensing or in any other case buying an possession curiosity, to fund analysis and improvement, and to outlicense or convey the applied sciences to market. Mustang has partnered with high medical establishments to advance the event of chimeric antigen receptor T cell (CAR T) therapies throughout a number of cancers, in addition to a lentiviral gene remedy for XSCID. Mustang is registered underneath the Securities Alternate Act of 1934, as amended, and recordsdata periodic studies with the U.S. Securities and Alternate Fee (“SEC”). Mustang was based by Fortress Biotech, Inc. (NASDAQ: FBIO). For extra info, go to www.mustangbio.com.
About Minaris Regenerative Drugs
Minaris Regenerative Drugs is a worldwide contract improvement and manufacturing group (CDMO) for cell and gene therapies. We provide our purchasers excessive worth medical and business manufacturing companies, improvement options, and applied sciences. We’re pioneers within the subject with greater than 20 years’ expertise offering excellent high quality and reliability. Our services within the US, Europe, and Asia enable us to produce sufferers worldwide with life-changing therapies. Minaris Regenerative Drugs is wholly owned by Showa Denko Supplies Co., Ltd. For extra info, please go to www.rm.minaris.com.
Ahead‐Trying Statements
This press launch could comprise “forward-looking statements” inside the which means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Alternate Act of 1934, every as amended. Such statements embrace, however aren’t restricted to, any statements referring to our development technique and product improvement packages and every other statements that aren’t historic information. Ahead-looking statements are based mostly on administration’s present expectations and are topic to dangers and uncertainties that would negatively have an effect on our enterprise, working outcomes, monetary situation and inventory worth. Elements that would trigger precise outcomes to vary materially from these at present anticipated embrace: dangers referring to our development technique; our skill to acquire, carry out underneath, and preserve financing and strategic agreements and relationships; dangers referring to the outcomes of analysis and improvement actions; dangers referring to the timing of beginning and finishing medical trials; uncertainties referring to preclinical and medical testing; our dependence on third-party suppliers; our skill to draw, combine and retain key personnel; the early stage of merchandise underneath improvement; our want for substantial further funds; authorities regulation; patent and mental property issues; competitors; in addition to different dangers described in our SEC filings. We expressly disclaim any obligation or enterprise to launch publicly any updates or revisions to any forward-looking statements contained herein to replicate any change in our expectations or any adjustments in occasions, situations or circumstances on which any such assertion is predicated, besides as required by legislation, and we declare the safety of the secure harbor for forward-looking statements contained within the Personal Securities Litigation Reform Act of 1995.
Minaris Regenerative Drugs Contact:
Luc St-Onge, Ph.D.
World Head of Gross sales and Advertising and marketing
Minaris Regenerative Drugs GmbH
E-Mail: press@rm.minaris.de
Cellphone: +49 (0)89 700 9608-0
Mustang Bio Contacts:
Jaclyn Jaffe and William Begien
Mustang Bio, Inc.
(781) 652-4500
ir@mustangbio.com
Investor Relations Contact:
Daniel Ferry
LifeSci Advisors, LLC
(617) 430-7576
daniel@lifesciadvisors.com
Media Relations Contact:
Tony Plohoros
6 Levels
(908) 591-2839
tplohoros@6degreespr.com
