INSTIL BIO (UK) LIMITED

MINNEAPOLIS and ST. PAUL, Minn., July 17, 2024. Today, Myogenica, a University of Minnesota startup company, announced U.S. Food and Drug Administration approval for an Investigational New Drug (IND) application for MyoPAXon — an induced pluripotent stem cell-derived muscle stem cell product to regenerate skeletal muscle. A pending clinical trial would evaluate the safety, tolerability and engraftment of MyoPAXon in patients with Duchenne muscular dystrophy (DMD). Dr. Peter Kang, a pediatric neuromuscular neurologist and director of the Greg Marzolf Jr. Muscular Dystrophy Center at the University of Minnesota Medical School, would lead the proposed early-stage clinical trial. Kang and the clinical research team plan to administer intra-muscular injections of MyoPAXon in non-ambulatory adult DMD patients and monitor any potential site reactions or immune response and assess for the presence of dystrophin-producing myofibers. "We believe stem cells have enormous potential as a tool for muscle regeneration in muscular dystrophy and the timing is perfect to move toward a human clinical trial of this type of therapy in Duchenne muscular dystrophy," said Kang. If the proposed trial provides positive outcomes, the team will plan on initiating a mid-stage study targeting other muscles and evaluating muscle function. Because MyoPAXon is not specific for any genetic mutation, it has potential use as a treatment for a range of other muscular dystrophies, as well as other muscle degenerative conditions. The clinical translation of MyoPAXon is the culmination of years of work by an interdisciplinary research team at the University of Minnesota, encompassing the lab of Dr. Rita Perlingeiro, the Molecular and Cellular Therapeutics cGMP facility, the Center for Translational Medicine, and the Greg Marzolf Jr. Muscular Dystrophy Center. In addition to co-funding the proposed clinical trial, Duchenne UK was instrumental in contributing over $900,000 to fund the IND enabling studies of MyoPAXon led by Perlingeiro. This project also received funding from the Department of Defense, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, MyDirectives, and the Greg Marzolf Jr. Foundation. Myogenica, co-founded by Perlingeiro, is the exclusive licensee of the intellectual property that underpins MyoPAXon. "After many years of basic and preclinical work, we are thrilled to finally have the FDA approve an IND application for an iPSC-derived myogenic cell product. This has been a tour de force and we are excited with what the future holds," said Perlingeiro. The University of Minnesota is an equity holder and is entitled to receive royalties under a license agreement with Myogenica. These interests have been reviewed and managed by the University of Minnesota in accordance with its conflict of interest policies. SOURCE Myogenica Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

MINNEAPOLIS and ST. PAUL, Minn., July 17, 2024 /PRNewswire/ -- Today, Myogenica, a University of Minnesota startup company, announced U.S. Food and Drug Administration approval for an Investigational New Drug (IND) application for MyoPAXon — an induced pluripotent stem cell-derived muscle stem cell product to regenerate skeletal muscle. A pending clinical trial would evaluate the safety, tolerability and engraftment of MyoPAXon in patients with Duchenne muscular dystrophy (DMD). Dr. Peter Kang, a pediatric neuromuscular neurologist and director of the Greg Marzolf Jr. Muscular Dystrophy Center at the University of Minnesota Medical School, would lead the proposed early-stage clinical trial. Kang and the clinical research team plan to administer intra-muscular injections of MyoPAXon in non-ambulatory adult DMD patients and monitor any potential site reactions or immune response and assess for the presence of dystrophin-producing myofibers. "We believe stem cells have enormous potential as a tool for muscle regeneration in muscular dystrophy and the timing is perfect to move toward a human clinical trial of this type of therapy in Duchenne muscular dystrophy," said Kang. If the proposed trial provides positive outcomes, the team will plan on initiating a mid-stage study targeting other muscles and evaluating muscle function. Because MyoPAXon is not specific for any genetic mutation, it has potential use as a treatment for a range of other muscular dystrophies, as well as other muscle degenerative conditions. The clinical translation of MyoPAXon is the culmination of years of work by an interdisciplinary research team at the University of Minnesota, encompassing the lab of Dr. Rita Perlingeiro, the Molecular and Cellular Therapeutics cGMP facility, the Center for Translational Medicine, and the Greg Marzolf Jr. Muscular Dystrophy Center. In addition to co-funding the proposed clinical trial, Duchenne UK was instrumental in contributing over $900,000 to fund the IND enabling studies of MyoPAXon led by Perlingeiro. This project also received funding from the Department of Defense, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, MyDirectives, and the Greg Marzolf Jr. Foundation. Myogenica, co-founded by Perlingeiro, is the exclusive licensee of the intellectual property that underpins MyoPAXon. "After many years of basic and preclinical work, we are thrilled to finally have the FDA approve an IND application for an iPSC-derived myogenic cell product. This has been a tour de force and we are excited with what the future holds," said Perlingeiro. The University of Minnesota is an equity holder and is entitled to receive royalties under a license agreement with Myogenica. These interests have been reviewed and managed by the University of Minnesota in accordance with its conflict of interest policies. SOURCE Myogenica Inc.

NEW YORK, May 14, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, announced today a presentation at the European Hematology Association 2024 Congress, to be held June 13-16 in Madrid, Spain. “We’re excited to share the latest updated interim results from our Phase 1 trial evaluating our gamma-delta T cell therapy INB-100 after haploidentical stem cell transplantation for patients with leukemia at the upcoming EHA congress,” said Trishna Goswami, M.D., Chief Medical Officer, IN8bio. “The data to date suggest that our approach could potentially increase survival and reduce the risk of cancer recurrence in adult patients with newly diagnosed or relapsed ALL, CML, AML, or MDS without causing severe graft-versus-host disease. We look forward to sharing greater details and our latest progress with the hopes of expanding the current treatment options for cancer patients.” Details of the poster presentation are as follows: Title: INB-100: Pilot Study of Donor Derived, Ex-Vivo Expanded/Activated Gamma-delta T Cell Infusion Following Haploidentical Hematopoietic Stem-Cell Transplantation and Post-Transplant Cyclophosphamide Presentation Date/Time: Friday, June 14, 2024, 10:00 a.m. CESTSubmission ID: EHA-2057Poster Session: P1460Abstract Topic: Gene therapy, cellular immunotherapy and vaccination – ClinicalPresenter: Dr. Joseph P. McGuirk, M.D., Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and Cellular Therapeutics, Medical Director, Blood and Marrow Transplant, The University of Kansas Cancer Center Abstracts are available at https://ehaweb.org/congress/eha2024-hybrid-congress/eha2024-hybrid-congress. A copy of the poster presentation will be available at https://in8bio.com after the poster session begins. For more information about the study, visit www.clinicaltrials.gov (NCT03533816). About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company’s lead program INB-400 is in a Phase 2 trial in glioblastoma multiforme (GBM). Additional programs include Phase 1 trials in solid and hematologic tumors, including INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. For more information about IN8bio, visit www.IN8bio.com. Forward-Looking StatementsThis press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the ability of IN8bio’s gamma-delta T cell therapy INB-100 to increase survival and reduce the risk of cancer recurrence in adult patients with newly diagnosed or relapsed ALL, CML, AML, or MDS without causing severe graft-versus-host disease; and IN8bio’s ability to expand the current treatment options for cancer patients. IN8bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates, including patient enrollment and follow-up and IN8bio’s ability to meet anticipated deadlines and milestones; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; uncertainties related to regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 9, 2024, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances, or otherwise, except as otherwise required by law. Company ContactIN8bio, Inc.Glenn Schulman, PharmD, MPH+1 203.494.7411gdschulman@IN8bio.com InvestorsMeru AdvisorsLee M. Sternlstern@meruadvisors.com Media ContactKimberly HaKKH Advisors917.291.5744kimberly.ha@kkhadvisors.com