Clinical assessments three-months post-treatment report no serious adverse events and reduced seizure frequency to date in first trial participant

Data Safety Monitoring Board clears advancement of trial to continue enrollment

Pioneering cell therapy approach could provide a disease-modifying treatment for drug-resistant focal epilepsy

Data presented at ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic and Cellular Technologies

SAN FRANCISCO, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, today announced the presentation of a clinical case study from the initial dose cohort of the Phase 1/2 first-in-human epilepsy clinical trial of its lead program, NRTX-1001. The data from three months post-cell therapy administration to the first patient in this study show that there were no serious adverse events associated with NRTX-1001 treatment and that the patient has thus far experienced reduced seizure frequency from an average prior history of 30+ seizures per month to four seizures in total during three months of follow-up to date. The data are being presented by Catherine Priest, Ph.D., Neuronas chief development officer at the ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic and Cellular Technologies being held in Madison, WI, September 21 -23, 2022.

The reduced number of seizures reported by the first person to receive NRTX-1001 is very encouraging, and we remain cautiously optimistic that this reduction in seizure frequency will continue and extend to others entering this cell therapy trial. NRTX-1001 administration has been well tolerated thus far in the clinic, which is in line with the extensive preclinical safety data collected by the Neurona team, said Cory R. Nicholas, Ph.D. Neuronas president and chief executive officer. With recent clearance from the Data Safety Monitoring Board we are excited to continue patient enrollment. We are very grateful to these first participants, and thank the clinical teams for the careful execution of this pioneering study.

In addition to the preclinical data supporting the clinical program, the presentation highlights initial data from the first patient treated in Neuronas clinical trial who received a starting dose of NRTX-1001. The patient is a young adult male with a 9-year history of seizures and was diagnosed with unilateral mesial temporal lobe epilepsy (MTLE). In the six months prior to the administration of NRTX-1001, the patient experienced an average of 32 seizures per month, despite being on several antiepileptic medications. The patient received NRTX-1001, and the treatment was well tolerated; there have been no serious adverse events to date. The patient has reported having four seizures during the first three months since receiving NRTX-1001.

The clinical trial is funded in part by the California Institute for Regenerative Medicine (DISC2-10525; TRAN1-11611; CLIN2-13355).

About Neuronas Clinical Trial of NRTX-1001 for Mesial Temporal Lobe Epilepsy (MTLE)Neuronas multicenter, Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of a single administration of NRTX-1001 for drug-resistant MTLE. The first stage of the trial is an open-label dose-escalation study in up to 10 people with MTLE, with five patients to be treated at a starting dose and five at a higher dose. Patients treated with a single infusion of NRTX-1001 cells will be monitored for safety, tolerability, and effects on their epilepsy disease symptoms. Patient recruitment is underway at epilepsy centers across the United States. For more information, please visit http://www.clinicaltrials.gov (NCT05135091). The first part of the clinical trial is supported by a recently announced $8.0 million grant from the California Institute for Regenerative Medicine (CIRM; CLIN2-13355).

About NRTX-1001NRTX-1001 is a regenerative neural cell therapy candidate derived from human pluripotent stem cells. The fully-differentiated neural cells, called interneurons, secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Delivered as a one-time dose, the human interneurons are intended to integrate and innervate on-target, providing long-term GABAergic inhibition to repair hyper-excitable neural networks.

About Mesial Temporal Lobe Epilepsy (MTLE)An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite treatment with approved drugs, which means that there is a huge unmet medical need in this community. MTLE is the most common type of focal epilepsy in adults and primarily affects the internal structures of the temporal lobe, where seizures often begin in a structure called the hippocampus. For people with seizures that are resistant to anti-seizure drugs, epilepsy surgery, where the damaged temporal lobe is surgically removed or ablated by laser, can be an option. However, the current surgical options are not available or effective for all, are tissue-destructive, and can have significant adverse effects.

About NeuronaNeuronas regenerative cell therapy candidates have single-dose curative potential. Neurona is developing off-the-shelf, allogeneic neuronal, glial, and gene-edited cell therapy candidates that are designed to provide long-term repair of dysfunctional neural networks for multiple neurological disorders. For more information about Neurona, visit http://www.neuronatherapeutics.com

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Multi-Year Deal to Focus on Phase 3 Clinical Trial Supplies and Commercial Manufacturing

KING OF PRUSSIA, Pa., Sept. 20, 2022 /PRNewswire/ -- The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the unique requirements associated with commercializing cell and gene therapies, and jCyte, a clinical-stage biotech company focused on preserving and restoring vision in patients with retinitis pigmentosa (RP) and other retinal degenerative diseases, today announced a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte's U.S. Food & Drug Administration's Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell. Under the terms of the agreement, CBM will provide Phase 3 clinical trial supplies and commercial drug product following Biologics License Application (BLA) approval of jCyte's proprietary jCell platform technology. CBM will also provide all BLA-enabling Chemistry, Manufacturing and Controls (CMC) work to support the program through regulatory approval and commercialization.

"jCyte is conducting truly advanced, groundbreaking research into treating patients with RP and other retinal degenerative diseases, and we are honored to partner with them during this critical phase of their clinical trial program as they prepare for BLA submission and commercialization," said Joerg Ahlgrimm, Chief Executive Officer of Center for Breakthrough Medicines. "We have built world-class technical teams combined with industry-leading product and process development, manufacturing, and testing capabilities, all located within a single manufacturing facility. Our unique and focused approach simplifies and expedites the completion of critical product and process development work and subsequent manufacturing campaigns, thereby shortening the time to market entry for cell therapies such as jCell. We look forward to working closely with the jCyte management team to fulfill our joint mission of safely getting their innovative cell therapy (jCell) to the many patients suffering from RP and other retinal degenerative diseases who have significant unmet medical needs and no available treatment options."

"We have made tremendous progress in advancing our innovative cell therapy program to this key stage of clinical development, and CBM's broad manufacturing capabilities, dedicated and experienced team, flexibility to fit our needs, and ability to provide fully dedicated manufacturing suites and analytical testing services tailored to our final drug manufacturing process made them an ideal partner to support our program," said Dr. Shannon Blalock, Chief Executive Officer of jCyte. "RP affects approximately one in 3,500 people worldwide. Our goals are to make jCell the first cell therapy approved to address this devastating condition and the first-line agent of choice. Partnering with a patient-focused, fully integrated, mission-centric CDMO like CBM will help ensure we achieve our goals."

RP is a rare genetic disease that is typically diagnosed in children and adolescents. It causes progressive vision loss leading to legal blindness by early adulthood. Nearly 2 million people suffer from the disease worldwide, including approximately 100,000 people in the U.S., which makes RP the leading cause of inherited blindness.To date, there is no approved treatment for 99% of RP patients.

jCell is a first-in-class investigational treatment for RP involving a simple, minimally invasive intravitreal injection, which can be easily administered within an ophthalmologist's office. The principal mechanism of action is the sustained release of established neurotrophic factors which have been shown to reduce photoreceptor cell death and promote the function of surviving photoreceptors. jCell therapy aims to preserve vision by intervening in the disease process at a time when host photoreceptors' function can be protected and potentially restored.

About The Center for Breakthrough Medicines (CBM)

CBM is a purposed built cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia's Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development for cell therapy, plasmid DNA, and viral vector manufacturing, as well as cell banking, cell processing, and a full suite of complimentary testing and analytical capabilities. Through a fully integrated, end-to-end solution, CBM accelerates time to market without compromising quality.

About jCyte, Inc.

jCyte, Inc. is a clinical-stage biotech company focused on developing its first-in-class regenerative cell therapy, jCell, for retinitis pigmentosa (RP) and other retinal degenerative diseases. The Company is pioneering a new era of regenerative therapies to address the significant unmet medical needs of patients suffering from a broad set of retinal degenerative conditions. For more information, visit http://www.jcyte.com.

SOURCE Center for Breakthrough Medicines

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Center for Breakthrough Medicines (CBM) and jCyte Announce Strategic Partnership to Manufacture jCyte's Innovative Cell Therapy for Treatment of...

The University of Kentucky (UK) Gluck Equine Research Center has announced the 2022 inductees to the Equine Research Hall of Fame. This prestigious award is an international forum to honor outstanding achievements in equine research and those who have made a lasting tribute benefiting equine health. To celebrate this legacy the UK Gluck Equine Research Foundation will induct four scientists into the UK Equine Research Hall of Fame Oct. 26 at Kroger Field, in Lexington.

Peers of the four individuals and past awardees nominated them for their outstanding achievements in equine research. The inductees are Lisa Fortier, DVM, PhD, Dipl. ACVS, Katrin Hinrichs, DVM, PhD, Dipl. ACT, Jennifer Anne Mumford, PhD, and Stephen M. Reed, DVM, Dipl. ACVIM.

In research, we always stand on the shoulders of those who go before us with great discoveries, said Nancy Cox, UK vice president for land-grant engagement and College of Agriculture, Food and Environment dean. This years recipients have made substantial contributions that will ensure an excellent future for equine research..

The success of Kentuckys horse industry is inseparable from the decades of hard work by outstanding equine researchers, said Stuart Brown, DVM, chair of the Gluck Equine Research Foundation. Though impossible to measure, it is a unique privilege to recognize the impact made by these four scientists in advancing the health and well-being of the horse and, on behalf of the entire equine community, show our appreciation.

Over the past 30 years Fortier has garnered an international reputation for significant contributions in equine joint disease, cartilage biology, and regenerative medicine. She has focused her research on early diagnosis and treatment of equine orthopedic injuries to prevent permanent damage to joints and tendons. She is perhaps best known for her work in regenerative medicine, pioneering the use of biologics such as platelet rich plasma, bone marrow concentrate, and stem cells for use in horses and humans. Fortiers lab has also been instrumental in breakthroughs related to cartilage damage diagnosis and clinical orthopedic work. A testament to her impact is that 87% of U.S. equine veterinarians now use biologics for regenerative medicine in their equine patients.

Fortier earned her bachelors and DVM degrees from Colorado State University. She completed her residency at Cornell University, where she also earned a PhD and was a postdoctoral fellow in pharmacology. She now holds the James Law professor of surgery position at Cornells College of Veterinary Medicine. She is the editor-in-chief of the Journal of the American Veterinary Medical Association and serves on the Horseracing Integrity and Safety Authority Racetrack Safety Standing Committee.

Hinrichs devotes her career to research primarily in equine reproductive physiology and assisted reproduction techniques. Specifically, her focus has included equine endocrinology, oocyte maturation, fertilization, sperm capacitation and their application to assisted reproduction techniques.

Hinrichs 40 years of research have led to several significant basic and applied research achievements. The applied accomplishments include producing the first cloned horse in North America and developing the medical standard for effective intracytoplasmic sperm injection and in vitro culture for embryo production in horses. She has mentored more than 85 veterinary students, residents, graduate students, and postdoctoral fellows in basic and applied veterinary research. Her laboratories have hosted approximately 50 visiting scholars from throughout the world.

Hinrichs earned her bachelors and DVM degrees from the University of California, Davis. She completed residency training in large animal reproduction at the University of Pennsylvanias New Bolton Center and earned a PhD at the University of Pennsylvania.

A posthumous inductee, Mumford earned international respect as one of the most prominent researchers of equine infectious diseases, in particular equine viral diseases. Her distinguished career at the Animal Health Trust, in Newmarket, U.K., began when she became the first head of the newly established equine virology unit. Her work focused on the leading causes of acute infectious respiratory disease in the horse, primarily equine herpesvirus and equine influenza virus, and, to a lesser extent, Streptococcus equi, the causative agent of equine strangles.

Mumford made numerous significant contributions in these areas, including developing improved vaccines, diagnostics, and international surveillance. She also helped establish research groups in the related fields of equine genetics and immunology.

During Mumfords more-than-30-year career, she established the Animal Health Trust as one of the worlds leading centers for the study of the biology, epidemiology, immunology, and pathology of diseases, including equine herpesvirus rhinopneumonitis and equine influenza, as well as bacterial diseases, including Streptococcus and Clostridium.

Reeds nominators credited him as the last word in equine neurology. Reed is widely recognized as one of the most prominent equine neurologists worldwide. His list of 180 peer-reviewed publications includes significant contributions to equine medicine, neurology, physiology, and pathophysiology, and has earned him worldwide recognition throughout the equine community. He has shared in his achievements as a mentor and role model for hundreds of aspiring equine practitioners.

One of the most unique and refreshing things about Dr. Reed is he absolutely embodies the need and overlap of discovery science with clinical assessments to further our understanding of equine neurologic disease, wrote Jennifer Janes, DVM, PhD, associate professor of veterinary pathology at the UK Veterinary Diagnostic Laboratory, in her letter of support for the nomination. This mission has served as the foundation and pillars of his long career in equine veterinary medicine.

Reed earned his bachelors and DVM degrees from The Ohio State University. He completed internship and residency training in large animal medicine at Michigan State University.

Established in 1990, the UK Equine Research Hall of Fame honors international scientific community members who have made equine research a key part of their careers, recognizing their work, dedication, and achievements. Nominees can be living or deceased, active in or retired from the field of equine research.

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2022 UK Equine Research Hall of Fame Inductees Announced The Horse - TheHorse.com

Are you someone who likes to educate or entertain yourself with podcasts while going about your day? If so, be sure to check out the AVMA journals new podcast series.

Veterinary Vertex is a weekly podcast that takes you behind the scenes of the clinical and research discoveries published in JAVMA and AJVR. Tune in to learn about cutting-edge veterinary research and gain in-depth insights you wont find anywhere else. Come away with knowledge you can put to use in your own practice along with a healthy dose of inspiration to remind you what you love about veterinary medicine.

Each week, the journals editors talk with the author or authors of a topical manuscript published recently in JAVMA or AJVR. Join them as they learn more about the authors clinical and research discoveries, as well as personal successes that have helped bring each author to their current career prowess.

For example: The first Veterinary Vertex episode, released Tuesday, offers a wide-ranging conversation with veterinary oncologist Dr. Nicole P. Ehrhart, one of the authors of Regenerative medicine 2.0: Extracellular vesiclebased therapeutics for musculoskeletal tissue regeneration.

Dr. Ehrhart talks about translational and regenerative medicine, including how she discovered her passion for this field of inquiry through an unplanned volunteer experience early in her career. She also shares details of how she came to drive the process to implement surveillance testing for COVID-19 in her state of Colorado.

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Science on the go: Catch the Veterinary Vertex podcast - American Veterinary Medical Association

The library will be named the Elaine Boyd Library, and the pledge will support library improvements and student services.

RMU alum Russ Olsen (82) has made a multi-million dollar pledge to Robert Morris University designated for the Robert Morris University Library.

Olsens pledge, made in honor of his stepmother Elaine Boyd, will support improvements to the library along with ongoing student support and services. The library will now be named the Elaine Boyd Library.

This is a great day for Robert Morris University. Our library is the intellectual heart of the university, and a key driver in the academic success of our students, said RMU President Michelle Patrick. Through his incredible generosity, Russ has ensured that the Elaine Boyd Library will continue to meet the needs of our students and the entire campus community far into the future.

Russ Olsen most recently served as Chief Executive Officer of Triad Life Sciences, Inc., an emerging regenerative medicine company with a groundbreaking FDA-cleared technology platform engineered to address unmet clinical needs in complex surgical wounds, chronic stalled wounds, and burns. Russ graduated from Robert Morris University in 1982 with a degree in Management and has over 35 years of experience in executive management, sales, and marketing. He gained much of his executive management experience while holding senior positions in marketing, business development, and sales for Fortune 500 companies.

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Russ Olsen Makes Multi-Million Dollar Pledge in support of the Robert Morris University Library - Robert Morris University

A review paper by scientists at the University of Oxford discussed possible benefits of using humanoid musculoskeletal robots and soft robotic systems as bioreactor platforms in producing clinically useful tendon constructs.

The new review paper, published on 15 Sep 2022 in the journal Cyborg and Bionic Systems, summarizes current trends in tendon tissue engineering and discusses how conventional bioreactors are unable to provide physiologically relevant mechanical stimulation given that they largely rely on uniaxial tensile stages. The paper then highlights musculoskeletal humanoid robots and soft robotic systems as platforms for providing physiologically relevant mechanical stimulation that could overcome this translational gap.

Tendon and soft tissue injuries are a growing social and economic problem, with the tendon repair market in the United States being estimated at $ 1.5 billion USD. Tendon repair surgeries have high rates of revision, with upwards of 40% of rotator cuff repairs failing post-operatively. Production of engineered tendon grafts for clinical use is a potential solution for this challenge. Conventional tendon bioreactors mainly provide uniaxial tensile stimulation. The lack of systems which recapitulate in vivo tendon loading is a major translational gap.

The human body provides tendons with three-dimensional mechanical stress in the form of tension, compression, torsion, and shear. Current research suggests that healthy native tendon tissue requires multiple types and directions of stress. Advanced robotic systems such as musculoskeletal humanoids and soft robotics promising platforms that may be able to mimic in vivo tendon loading explained author Iain Sander, a researcher at the University of Oxford with the Soft Tissue Engineering Research Group.

Musculoskeletal humanoid robots were initially designed for applications such as crash test dummies, prostheses, and athletic enhancement. They attempt to imitate human anatomy by having similar body proportions, skeletal structure, muscle arrangement, and joint structure. Musculoskeletal humanoids such as Roboy and Kenshiro use tendon-driven systems with myorobotic actuators that mimic human neuromuscular tissue. Myorobotic units consist of a brushless dc motor which generates tension like human muscles, attachment cables which act as the tendon unit, and a motor driver board with a spring encoder, which act as the neurologic system by sensing variables including tension, compression, muscle length, and temperature. Proposed advantages of musculoskeletal humanoids include the ability to provide multiaxial loading, potential for loading in consideration of human movement patterns, and provision of loading magnitudes comparable to in vivo forces. One recent study has demonstrated the feasibility of growing human tissue on a musculoskeletal humanoid robot for tendon engineering.

Biohybrid soft robotics is focused on developing biomimetic, compliant robotic systems which permit adaptive, flexible interactions with unpredictable environments. These robotic systems are actuated through a number of modalities, including temperature, pneumatic and hydraulic pressure, and light. They are made of soft materials including hydrogels, rubber, and even human musculoskeletal tissue. These systems are already being used to provide mechanical stimulation to smooth muscle tissue constructs and have been implemented in vivo in a porcine model. These systems are attractive for tendon tissue engineering given that: i) their flexible, compliant properties allow them wrap around anatomic structures, mimicking the configuration of native tendon ii) they are capable of providing multiaxial actuation and iii) a number of the techniques used in soft robotics overlap with current tendon tissue engineering practices.Looking forward, the team envision advanced robotic systems as platforms which will provide physiologically relevant mechanical stimulus to tendon grafts prior to clinical use. There are a number of challenges to consider as advanced robotic systems are implemented. Firstly, it will be important for future experiments to compare technologies proposed in this review to conventional bioreactors. With development of systems capable of providing multiaxial loading, it will be important to find methods for quantifying strain in 3D. Finally, advanced robotic systems will need to be more affordable and accessible for widespread implementation.

An increasing number of research groups are showing that it is feasible to use advanced robotics in combination with living cells and tissues for tissue engineering and bioactuation applications. We are now at an exciting stage where we can explore the different possibilities of incorporating these technologies in tendon tissue engineering and examine whether they can really help improve the quality of engineered tendon grafts, said Pierre-Alexis Mouthuy, the review articles senior author. In the long term, these technologies have potential to improve quality of life for individuals, by decreasing pain and risk of tendon repair failure, for healthcare systems, by reducing the number of revision surgeries, and for the economy, by improving workplace productivity and lowering healthcare costs.

Authors of the paper include Iain Sander, Nicole Dvorak, Julie Stebbins, Andrew J Carr, Pierre-Alexis Mouthuy.

This work has been completed with the financial support of the United 16 Kingdoms Engineering and Physical Sciences Research Council (project number: 17 P/S003509/1), and the Rhodes Trust.

The paper, " Advanced Robotics to Address the Translational Gap in Tendon Engineering," was published in the journal Cyborg and Bionic Systems on 15 Sep 2022, at DOI: https://doi.org/10.34133/2022/9842169.

Reference: Iain L. Sander1,2*, Nicole Dvorak1 , Julie A. Stebbins1,2, Andrew J. Carr1 , Pierre-Alexis Mouthuy1,3

Title of original paper: Advanced Robotics to Address the Translational Gap in TendonEngineering

Journal: Cyborg and Bionic Systems

DOI: https://spj.sciencemag.org/journals/cbsystems/2022/9842169/

Affiliations:

A brief introduction about authors

Iain Sander:

Iain Sander is a graduate student in the Mouthuy Soft Tissue Research Group at the University of Oxford, where he completed his M.Sc in Musculoskeletal Sciences as a Rhodes Scholar. He is currently completing his medical training at the University of Alberta in Canada. His research interests include clinical gait analysis, regenerative medicine, tendon injury, and tendon tissue engineering.

Nicole Dvorak:

Nicole Dvorak a graduate student in the Mouthuy Soft Tissue Research Group at the University of Oxford and is currently completing her D.Phil in Musculoskeletal Sciences funded through the NIHR Oxford Biomedical Research Centre. She previously completed an M.Sc. in Medical and Pharmaceutical Biotechnology at the IMC FH Krems, Austria. Her research interests include tissue engineering and regenerative medicine.

Julie Stebbins:

Dr. Julie Stebbins is a clinician-scientist and director of the Oxford Gait Laboratory. She has published extensively on clinical gait analysis, helped develop the Oxford Foot Model for gait analysis, and serves as Deputy Editor of Gait and Posture. Julie has been sought out internationally for her expertise in clinical gait analysis and helped set up the first gait lab in Ethiopia.

Andrew Carr:

Prof. Carr is the former department head of the University of Oxfords Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences. He is an orthopaedic surgeon who helped develop the Oxford Knee partial knee replacement, which has been implanted in over 2 million patients globally. He has authored over 450 papers, including more than 25 which have been featured in the Lancet and BMJ.

Pierre-Alexis Mouthuy

Prof. Pierre-Alexis Mouthuy is an Associate Professor in the University of Oxfords Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, where he leads the Mouthuy Soft Tissue Research Group. He leads the multidisciplinary Humanoid Bioreactor Project, aimed at growing human tendon on musculoskeletal humanoid robots, and has secured over 1.2 million GBP in funding for this project. He is a recognized researcher in the fields of biomaterials, tissue engineering, and robotics.

Cyborg and Bionic Systems

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Advanced robotics to address the translational gap in tendon engineering - EurekAlert

Humacyte, Inc

Lt. General Bruce Green, M.D., USAF-ret. Joins Board of Directors

Cindy Cao, Ph.D. Appointed as Chief Regulatory Officer

DURHAM, N.C., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, today announced the appointments of two distinguished healthcare professionals to the Companys Board of Directors and leadership team. Lt. General Bruce Green, M.D., USAF-ret., former Surgeon General of the U.S. Air Force, joins as a member of the Board of Directors. In addition, pharma industry veteran Yang (Cindy) Cao, Ph.D. joins as the Companys Chief Regulatory Officer. Current Chief Regulatory Officer, Bill Tente, will remain with Humacyte as an Executive Advisor, partnering on key regulatory initiatives for the organization with Dr. Cao and team.

Bruce and Cindy are each accomplished medical and industry professionals with significant and complementary experience in public health, drug, and biotechnology development, as well as deep relationships with the governing authorities in their respective fields, said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. We are delighted to welcome them to the Humacyte leadership team, and look forward to their guidance as we advance our Human Acellular Vessels(HAV) toward regulatory approval.

General Green said, With its off-the-shelf availability and resistance to infection, Humacytes HAV technology has enormous potential to aid in the care of vascular trauma, particularly in combat and natural disaster scenarios. This potential is evidenced by the recent case studies from Humacytes humanitarian relief effort where war victims have been treated at multiple front-line Ukrainian hospitals. I am honored to join the Humacyte Board and look forward to working with the leadership team to help bring this important advancement to market.

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Dr. Cao said, Humacytes platform for implantable bioengineered human tissues could potentially lead to first in class regenerative medicine, with compelling applications in vascular trauma repair, arteriovenous access for hemodialysis and peripheral arterial disease. I am very excited to join the talented Humacyte team, and eager to begin working toward regulatory interactions and market authorization submissions of this critical product candidate to benefit the patients in need.

Lt. General Green was commissioned through the Health Professions Scholarship Program and entered active duty in 1978 after earning his Doctorate of Medicine at the Medical College of Wisconsin in Milwaukee. He completed residency training in family practice at Eglin Regional Hospital, Eglin AFB, Fla., in 1981, and in aerospace medicine at Brooks AFB, Texas, in 1989. He is board certified in aerospace medicine. An expert in disaster relief operations, General Green planned and led humanitarian relief efforts in the Philippines after the Baguio earthquake in 1990 and in support of Operation Fiery Vigil following the 1991 eruption of Mount Pinatubo. General Green has served as commander of three hospitals and the Wilford Hall Medical Center. As command surgeon for three major commands, he planned joint medical response for operations Desert Thunder and Desert Fox, and oversaw aeromedical evacuation for operations Enduring Freedom and Iraqi Freedom. General Green served as Assistant Surgeon General for Health Care Operations and Deputy Surgeon General, and was appointed Air Force Surgeon General in 2009. General Green earned a B.S. in chemistry at the University of Wisconsin-Parkside and an M.D. at the Medical College of Wisconsin. General Green is also a graduate of the Air Command and Staff College, and earned a masters degree in public health from Harvard University.

Dr. Cao brings over twenty years of drug discovery and development experience in pharmaceutical and biotech companies, including Bristol-Myer Squibb, Novartis, Novo Nordisk and Sanofi. Prior to joining Humacyte, Dr. Cao served as Senior Vice President and Head of Regulatory Affairs and Quality Assurance at Ascentage Pharma. Dr. Cao has also served in global and US executive leadership roles in Regulatory Affairs at pharmaceutical and biotech companies, and has functioned as an Executive Leadership Team member in multiple previous positions. Dr. Cao has extensive expertise in global and US regulatory strategy and policy on biologics, small molecules, and devices, and has provided guidance to development teams in various therapeutic areas including oncology, immunology, metabolic disorders, hematology and cardiovascular diseases. Before her industry roles, Dr. Cao was an Assistant Professor at the Huntsman Cancer Institute, conducting basic research in oncology and inflammation. Dr. Cao holds a B.S. in genetics from Fudan University in Shanghai China, a Ph. D. in biomedical sciences from University of New Mexico, and completed an NIH-sponsored post-doctoral fellowship at the University of Utah.

About HAV

Human Acellular Vessels (HAV) are investigational engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations in vessel tissue repair and replacement it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue. The HAV is currently being evaluated in two Phase 3 trials in arteriovenous access and a Phase 2/3 trial for vascular trauma, and has been used in nearly 500 patient implantations. Humacytes 6mm HAV for AV access for performing hemodialysis was the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), and has also received FDA Fast Track designation. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.

About Humacyte

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and complex tissue and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries and chronic conditions. Humacytes initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacytes 6mm HAV for arteriovenous (AV) access for performing hemodialysis was the first product candidate to receive the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation, and has also received FDA Fast Track designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visitwww.Humacyte.com.

Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com

Humacyte Media Contact:

Elizabeth Miller, M.D.LifeSci Communications LLC+1-646-791-9705emiller@lifescicomms.com

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Humacyte Expands Board of Directors and Leadership Team with New Appointments - Yahoo Finance

Stem cell therapy, which can avert or delay total knee replacement surgeries in patients suffering from acute knee osteoarthritis, has been launched in India by Bengaluru-based biotech company Stempeutics under the brand name StemOne.

A group company of the Manipal Education and Medical Group, Stempeutics has partnered with pharma major Alkem for marketing of the therapy, which promises to be disease modifying.

StemOne was granted approval by the Central Drugs Standards Control Organisation recently.

Life-changing potential

The therapy, priced at Rs 1.25 lakh, may offer 35 million patients across the country a chance of substantially improvingtheir quality of life without going under the scalpel.

Knee osteoarthritis is a chronic disease that affects a large number of the elderly and the obese and is characterised by degeneration of the cartilage inside the knee, which leads to pain, stiffness and tenderness.

The latest drug, which will be in the form of an intra-articular injection, can be given on an outpatient basis without the need for anaesthesia.

Stempeutics and Alkem said in a joint statement that clinicaltrials held in India have demonstrated significant improvement in pain relief and physical functions, as well as indicators towards decreased progression of the disease and improvements in joint structure.

The allogeneic or off-the-shelf drug could provide an alternative to traditional treatment and surgery or delay the progression of knee osteoarthritis to minimise the need for multiple surgical interventions, it added.

Benefits over traditional treatment

While conventional treatments such as physiotherapy or drugs offer temporary relief from the clinical symptoms of knee osteoarthritis, restoration of normal cartilage function has been difficult to achieve, and in extreme cases, a total knee replacement may be required, said BN Manohar, managing director of Stempeutics, in an interaction with Moneycontrol.

Also read|Cancer treatment costs: Little respite from new list of essential drugs

Currently, treatment options available include NSAIDs, glucosamine & chondroitin sulphate, Diacerin (IL-1 inhibitor), Hyaluronic Acid injections, steroid injections, PRP injections and, ultimately, total knee replacement.

But total knee replacements are expensive and may not always be successful. In such a situation, stem cell therapy has emerged as a ray of hope over traditional approaches aimed at restoration of cartilage function in the knee, said Manohar.

It is estimated that Rs 4,000 crore is spent annually on total knee replacement surgeries in India.

Our product is something novel, launched for the first time in India, and one of the firsts globally, said Manohar, adding that it took about 13-14 years to develop StemOne and get regulatory approval.

The therapy has two major benefits, explained Manohar. It reduces pain in patients, eases their day-to-day living and also maintains the cartilage, preventing further deterioration.

Manohar insisted that even though the price may be higher than other invasive therapies such as intra-articular steroids, it prevents disease progression, something that other therapies dont.

Total knee replacement surgery, on the other hand, for patients in whom this therapy may be indicated, costs at least Rs 2 lakh and this therapy would therefore be cost-effective for them, he said.

Insurance and regulatory approvals

The company is now also trying to get the therapy covered by private insurance and Manohar said that since this therapy is in the category of regenerative medicine, considered a new class of therapeutics, even the regulatory process is still evolving.

The firm took around 14 years to develop and launch the product.

One is the science part to see how the stem cell works and what it can do and what it cannot do and then we need to see the safety of this compound, said the MD.

Manohar added that subsequently, the company carried out multiple sets of clinical trials to assess safety and efficacy and also needed to work with the drug regulators.

Since there is no proper regulatory framework to cover stem-cell based products, the manufacturer had to coordinate with the Indian Council of Medical Research on how it could be regulated. It took some time to develop the guidelines and now stem cells are considered to be a drug, said Manohar.

Other products

Stempeutics is the only company to have launched a stem cell therapy for Critical Limb Ischemia, a peripheral vascular disease, where blood doesnt flow due to blockages in peripheral arteries.

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In some cases, Critical Limb Ischemia can get so bad that patients may need to have their forearms or legs amputated. The therapy for this disease was launched in partnership with Cipla.

Another new product, in the pipeline, targets non-healing diabetic foot ulcers.

Read more:
First time in India: Stem cell therapy to treat knee osteoarthritis - Moneycontrol

All eyes are on the Emerald Isle this week as the Longevity Summit Dublin brings together a host of speakers covering the spectrum of this booming sector. Delegates have been hearing from some of the leading entrepreneurs, companies, investors, and researchers in the field as they address many of the hot-button topics affecting longevity. One of those speakers is the so-called father of genomics Harvard professor of genetics, George Church who closes the conference later today with a keynote on Gene, cell and organ therapies for de-aging.

Longevity.Technology: In addition to his Harvard professorship, Church heads up synthetic biology at the Wyss Institute, where he oversees development of new tools with applications in regenerative medicine. Much of his focus more recently has been on the development of gene therapies targeting age-related disease, a passion that led him to co-found Rejuvenate Bio, with the goal of creating full age reversal gene therapies. We caught up with Church ahead of his Dublin presentation for a brief conversation on longevity.

Dr Churchs name is synonymous with genomic science, and he was a key contributor to the Human Genome Project and technologies including next-generation fluorescent and nanopore sequencing, aimed at understanding genetic contributions to human disease. However, he doesnt feel that those initiatives did a huge amount to move the aging field forward.

They have provided aging researchers with useful reference points to go back and check their work, but the key advances in aging have really been made through the fundamental research on key pathways and drivers of aging, says Church. However, what we can take from those projects was their contribution towards technology improvements that have reduced the cost of DNA sequencing from three billion dollars in 2004 to just three hundred dollars today.

Thanks to technological advances, it was estimated that mapping a human genome cost an estimated $2025 million in 2006, although this was using haploid sequencing unsuitable for phenotype prediction. Skip ahead to today, and start-up Nebula Genomics (a company founded by Church) now offers diploid whole genome sequencing for as little as $300 a remarkable achievement by any standard. (Learn about the differences between haploid and diploid sequencing here.)

Alongside other technical developments, this kind of cost reduction will, Church believes, contribute to making gene therapies viable for everyone to benefit from, not just the wealthy. Public perception of gene therapy has taken a bashing recently thanks to drugs like Zynteglo, which was branded the most expensive medicine in history at $2.8 million per dose earlier this year. But Church doesnt see the same issue being a factor when it comes to future therapies against aging.

Those expensive gene therapies are for rare diseases, and their pricing reflects of the ratio of R&D costs to number of patients, says Church. But aging and its associated diseases affect nearly everyone. When you consider the volume of people that will be able to benefit from an age-reversing therapy, combined with the potentially huge benefits to society that such a treatment would enable, then it is a win-win for governments, healthcare providers and developers alike.

Under current conditions, gene therapies for aging and age-related diseases are likely to take 10 years to get approved, but Church points to how the world acted to fast-track approvals for COVID-19 vaccines in just one year.

The top five vaccines were formulated as gene therapies, and showed how quickly and safely we can move when there are extenuating circumstances, he says. Well, I would say that many more people are dying and in poor health as a result of the effects of aging, so perhaps aging should also be considered an extenuating circumstance.

In addition, Church points out, the cost of the vaccines was around $2 to $20 per dose a figure that healthcare systems around the world could manage if a gene therapy for aging were similarly priced.

So how close are we to seeing an approved gene therapy for aging? Pretty close, thinks Church, while admitting hes biased because of the work going on at Rejuvenate Bio. He co-founded the company in 2019 with his former postdoctoral fellow Noah Davidsohn, with the goal of eliminating aging and age-related diseases and increasing healthspan.

Church believes that gene therapies hold greater promise for age reversal than small molecules, because they might avoid frequent dosing and be more target-specific, while hitting all ten key pathways in one go, so its perhaps no surprise that Rejuvenate Bio is working on therapies that could tackle several age-related conditions at once.

We have already published on work conducted in mice, which showed that four age-related diseases (obesity, type II diabetes, heart failure, and renal failure) can be treated simultaneously with a single combination gene therapy, says Church. And weve gone on to show we can do it with five diseases as well.

But Rejuvenate Bio isnt stopping at mice. The company also has a significant animal health pipeline, which is already engaged in the development and commercialisation of a gene therapy for Mitral Valve Disease (MVD) in dogs.

Our animal health pipeline also gives us a unique advantage in that the results directly inform the direction of our work in our human therapies, and I believe this will allow us to deliver results faster.

The companys lead therapy (RJB-01) targets the FGF21 and sTGFR2 genes, and it is hoped it will deliver cardiovascular, metabolic and renal benefits. Following results from the trial in dogs, it is expected that RJB-01 will move into IND-enabling studies ahead of Phase 1 clinical trials likely next year.

Church is also enthusiastic about the recent uptick in investment and the growing interest in the longevity field.

Its clearly a good thing not only because it helps drive the field forward, but it also validates a lot of the great work that has been done in academia over the years, he says. Not that long ago, people were avoiding the field because of the sketchy image it had. Now we are attracting young, talented scientists, which is what we need to keep progressing.

Read more:
George Church: Learn from COVID and fast-track therapies that reverse aging - Longevity.Technology

The EpiBone team is proud to play a role in driving innovation to transform the future of health and quality of life with cutting-edge technology and research in tissue engineering.

NEW YORK (PRWEB) September 21, 2022

EpiBone CEO and Co-Founder Dr. Nina Tandon participated as a speaker at the White House Summit on Biotechnology & Biomanufacturing for the American Bioeconomy on September 14, 2022. The summit brought together government and private sector leaders as a first step in launching the Biden Administration's National Biotechnology and Biomanufacturing Initiative, a whole-government approach to advancing biotechnology and biomanufacturing to create innovation in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.

The half-day summit included a bioeconomy roundtable discussion with government officials and private sector leaders and two panels, one exploring biotechnology for global change and another discussing biomanufacturing and the bioeconomy. Tandon spoke during the morning roundtable discussion, sharing her perspectives on biotechnology, and its relevance as the future of medicine, as well as the pressing need for government support.

Im humbled to have had the opportunity to speak alongside my colleagues who are all industry luminaries as part of this critical White House Summit roundtable discussing industry advancements that will help move the entire field forward, said Tandon. Biotechnology holds immeasurable possibility to improve the quality and capacity of our lives, and this new White House initiative speaks to that possibility while positioning the US as a global leader in the industry. The EpiBone team is proud to play a role in driving innovation to transform the future of health and increasing quality of life by bringing game-changing tissue engineered products to patients."

As CEO and co-founder of EpiBone, Inc., Tandon bridges the realms of business and science, with decades of experience in tissue engineering and bioreactor design. She has completed a Ph.D. in biomedical engineering and an MBA from Columbia University. Tandon has been named one the 40 under 40 by Crains New York, an Ernst & Young Winning Woman, and one of Goldman Sachs 100 Most Intriguing Entrepreneurs. She is also a WEF Young Global Leader and McKinsey alumni. Tandons passion for science and innovation is dwarfed only by her desire to see the promise of regenerative medicine fully realized.

In her work at EpiBone, Tandon leads the company in its mission to use groundbreaking research to transform skeletal repair. The team uses advanced science and technology to solve problems that once seemed unsolvable, developing processes that uses cells to grow new bone and cartilage tissues. This work has been recently underscored by the successful implantation of all the patients in their first-in-human clinical trial using the most advanced product in their pipeline, a customized living bone graft grown from a patients own cells.

To learn more about Dr. Nina Tandon and the work of the EpiBone team, visit https://www.epibone.com/.

About EpiBoneEpiBone, Inc. is privately-held clinical-stage regenerative medicine company focused on skeletal reconstruction. Sitting at the intersection of biology and engineering, the company harnesses the power of cells to create living solutions that can become a seamless part of a patients body. EpiBone is currently developing a pipeline of bone, cartilage, and compound (bone and cartilage) products.

For more information, please visit: https://www.epibone.com/

DisclaimerThis communication contains forward-looking statements which can generally can be identified by words such as plans, change, will, following, strengthening, developing, the negative of these words and similar words and expressions, which are based on EpiBones current expectations, assumptions, estimates and projections about its business, technology, product development and industry. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and include, without limitation, EpiBones ability to (1) adequately protect or enforce its intellectual property rights, (2) develop and commercialize new products and technologies on a timely basis (or at all), (3) risks associated with acquisitions and strategic investments and (4) attract and retain qualified personnel. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. Additionally, this communication does not constitute an offer to sell or a solicitation of an offer to buy securities.

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EpiBone CEO and Co-Founder Dr. Nina Tandon Selected to Participate in White House Summit - PR Web