Lebanon, NH -- (ReleaseWire) -- 04/20/2020 -- Celdara Medical, a clinical-stage biotechnology company focused on delivering products to patients, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and The Geneva Foundation, 501(c)3 non-profit organization that advances military medical research. This collaboration is focused on the development of a therapeutic antibody cocktail candidate for the treatment of Sudan virus, using established animal models to test efficacy against viral infection. There are currently no available therapeutic countermeasures as a part of the U.S. Strategic National Stockpile for Sudan virus. "The advancement of this product will increase preparedness for an emerging infectious disease of global concern," said John M. Dye, Ph.D., Chief of Viral Immunology at USAMRIID, whose research is supported by The Geneva Foundation.

The development of therapeutics targeting Ebolavirus and other filoviruses is an urgent health priority. Prior to 2014, Sudan virus was responsible for the largest recorded ebolavirus outbreak with greater than 400 cases in Gulu, Sudan in 2000. According to the Centers for Disease Control and Prevention (CDC), the aggregate human fatality rate for Sudan virus from all previous outbreaks is 52 percent. The unpredictable nature of filovirus outbreaks requires the development of a rapidly deployable therapeutic strategy that is both safe and protective against each of the disease-causing viral species. USAMRIID, in collaboration with Albert Einstein College of Medicine and The Geneva Foundation, discovered an antibody cocktail CM-JLD, to combat this potentially pandemic virus. It is a much needed therapeutic candidate that is undergoing development to ensure global protection in the event of an outbreak of Sudan virus. Highlighted by Jonathan Lai, Ph.D., Professor of Biochemistry at Albert Einstein College of Medicine, "Sudan virus does not receive as much attention as its bigger brother, Ebola virus, but it still has the potential to cause large and deadly outbreaks."

Celdara Medical, LLC is an experienced biopharma developer focused on launching promising products to the patients who need it the most. Celdara has a robust pipeline in medical countermeasures and is proud to partner with USAMRIID and The Geneva Foundation to develop CM-JLD. Brandy Houser, Ph.D., site head in New York, NY and the development lead for the program at Celdara Medical commented, "In parallel with ongoing efficacy studies, additional development is underway in order to ensure regulatory compliance and manufacturing capacity in order to best serve the Strategic National Stockpile and Americans as a whole."

This work was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award number R44AI136273.

About Celdara Medical, LLC
Celdara Medical gives hope and health to patients by transforming academic innovations into medicines with the potential to cure the world's most challenging diseases. Celdara Medical is a recognized leader with a rich stable of discoveries, developed in concert with premiere research institutions in the US, EU, and beyond. We secure lasting partnerships with inventors and their institutions and provide the developmental, financial, and business acumen to bridge the gaps between discovery and clinical impact. With robust funding options, operations in greater Boston, NYC, and Washington, DC, growing affiliates in Seattle and Indianapolis, a wealth of opportunities in our pipeline, and partnerships with industry leaders worldwide, Celdara Medical navigates the path from science to medicine, accelerating innovation to improve human health.

Disclosure: Dr. Jonathan Lai is a Scientific Founder of the Sudan virus countermeasure project at Celdara Medical, the company that is advancing CM-JLD for clinical application.

Celdara Medical Contact:
press@celdaramedical.com
 
[The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.]

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Lebanon, NH -- (ReleaseWire) -- 03/25/2020 -- Celdara Medical announces the publication of new translational research in the American Journal of Transplantation indicating that a novel polymer therapeutic candidate, APP-103TM, is able to preserve kidney function in preclinical models of kidney ischemia reperfusion injury, including transplantation. The results of the study, led by experts at Brigham and Women's Hospital and Beth Israel Deaconess Medical Center, provides a potential opportunity for expanded criteria kidney donation and much-needed hope for the roughly 750,000 Americans suffering from End-Stage Renal Disease (ESRD) who are awaiting a life-saving transplant.

End-Stage Renal Disease is the final stage of progressive and chronic loss of kidney function due to genetic and lifestyle factors. The best current treatment is a kidney transplant, but unfortunately, there is a shortage of donor organs leaving more than 100,000 ESRD patients on the US transplant waiting list each year. The majority of these patients will perish before receiving a kidney transplant. Currently, the only alternative to transplantation is dialysis, which consumes an estimated 7% of the medicare budget and costs approximately eight times more than kidney transplant.

The research team analyzed a novel polymer therapeutic, APP-103 TM, and showed that its use preserves kidney function through reduction of oxidative stress caused by ischemic reperfusion injury (IRI) in preclinical models. APP-103 TM is currently being developed by Celdara Medical to treat delayed graft function (DGF) in expanded criteria kidney donors. This will enable additional organs to be utilized for kidney transplantation. "APP-103 offers a unique and novel treatment targeting site-specific consequences of ischemia-reperfusion injury," states Dr. Stefan Tullius, co-senior study author and Chief of Transplant Surgery at Brigham and Women's Hospital in Boston.

IRI is the result of a required surgical process in kidney transplantation and has been shown to generate a high degree of oxidative stress and subsequent organ injury. APP-103 TM is a site-specific anti-oxidant and anti-inflammatory preclinical drug product that reduces organ damage following the IRI insult. The team has successfully demonstrated efficacy and safety throughout preclinical development. "Our data demonstrates that APP-103, which was developed with supports from the National Institutes of Health, is a novel, nontoxic, and site-activating therapeutic approach that effectively ameliorates the consequences of IRI in solid organ transplantation," says co-senior study author and inventor of APP-103, Dr. Peter M. Kang, MD, Cardiologist and Director of the Cardiovascular Physiology Core at Beth Israel Deaconess Medical Center, also in Boston.

Brandy Houser, Ph.D., Site Head in NYC and the development lead for the APP-103 team at Celdara Medical commented, "Having worked with Stefan and Peter and their respective teams for more than five years, we're very happy to see these important results published. Our parallel translational initiative at Celdara Medical has gone a long way to validating the clinical application and potential of this strategy, while significantly improving manufacturing, form, and formulation. It has also led to the discovery of improved compositions of matter. We are continuing to advance this therapy toward the clinic and are in discussions with strategic and financial partners who have the resources to increase both development speed and probability of success. Our goal remains clear: to help patients gain access to life-saving kidneys."

This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number DK103389.

Disclosure: Dr. Peter Kang is the Scientific Founder of the Anti-Inflammatory Therapeutics project at Celdara Medical, the company that is advancing APP-103 for clinical application. There's a licensing agreement between BIDMC and Celdara for technology that Dr. Peter Kang invented.
 
For the full Journal article, visit: https://doi.org/10.1111/ajt.15794

About Celdara Medical, LLC:
Celdara Medical gives hope and health to patients by transforming academic innovations into medicines with the potential to cure the world's most challenging diseases. Celdara Medical is a recognized leader with a rich stable of discoveries, developed in concert with premiere research institutions in the US, EU, and beyond. We secure lasting partnerships with inventors and their institutions and provide the developmental, financial, and business acumen to bridge the gaps between discovery and clinical impact. With robust funding options, operations in greater Boston, New York, and Washington, DC, growing affiliates in Seattle and Indianapolis, a wealth of opportunities in our pipeline, and partnerships with industry leaders worldwide, Celdara Medical navigates the path from science to medicine, accelerating innovation to improve human health.

Further information about Celdara Medical is available at www.celdaramedical.com.

For more information on this press release visit: http://www.releasewire.com/press-releases/celdara-medical-announces-preclinical-study-demonstrating-improved-kidney-function-in-transplantation-with-novel-polymer-therapy-1283797.htm

Lebanon, NH -- (ReleaseWire) -- 07/10/2019 -- Celdara Medical, LLC today announced the launch of an online resource database for biomedical entrepreneurs: bioentrepreneurresources.com. This database was developed by the DRIVEN Accelerator Hub, an NIH-funded consortium led by Celdara Medical including 10 of the leading research institutions in the Northeast region (NH, VT, ME, DE, and RI). The database is open to biomedical entrepreneurs globally and contains resources from across the country. New resources are added by user submission and curated by DRIVEN.

Through the online database, DRIVEN works to serve biomedical entrepreneurs by providing curated, easy-to-access educational resources. Users can filter by location, web resource, date added to site, user type (e.g. undergrad, grad, postdoc, faculty), type of resource (e.g. expert/coach, networking, webinar, workshop), and the type of skills the resource provides (e.g. project management, leadership, accounting, regulatory, finance).

The DRIVEN Accelerator Hub is funded by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number UT2GM130176. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About DRIVEN Accelerator Hub
The DRIVEN Accelerator Hub is an NIH-funded consortium led by Celdara Medical and includes partnerships with leading research institutions in the Northeast region (Brown, Dartmouth, Maine Medical Center, MDI Biological Laboratory, Simbex, University of DE, University of NH, University of RI, University of VT). The mission of the DRIVEN Accelerator Hub is to create quality-adjusted life years (QALYs) and save lives by 1) Increasing the number of quality medical startups 2) Decreasing their time to market and 3) Increasing their probability of success.

In addition to the online resource database, DRIVEN provides tailored consulting to select entrepreneurs through the DRIVEN Partnership Program that culminates in a presentation to the DRIVEN External Advisory Committee, comprised of leading investors and in-licensing professionals. At the conclusion of the program, participants are invited to apply for DRIVEN funding to support pivotal studies. For more information regarding the partnership program, email info@drivenacceleratorhub.com.

About Celdara Medical, LLC
Celdara Medical gives hope and health to patients by transforming academic innovations into medicines with the potential to cure the world's most challenging diseases. Celdara Medical is a recognized leader with a rich stable of discoveries, developed in concert with premiere research institutions in the US, EU, and beyond. We secure lasting partnerships with inventors and their institutions, and provide the developmental, financial, and business acumen to bridge the gaps between discovery and clinical impact. With robust funding options, operations in greater Boston, NYC, and Washington, DC, growing affiliates in Seattle and Indianapolis, a wealth of opportunities in our pipeline, and partnerships with industry leaders worldwide, Celdara Medical navigates the path from science to medicine, accelerating innovation to improve human health.

For more information visit http://www.celdaramedical.com and http://www.bioentrepreneurresources.com.

Contact:
Julie Coleman
jc@celdaramedical.com
617-320-8521

For more information on this press release visit: http://www.releasewire.com/press-releases/celdara-medical-launches-new-website-for-biomedical-entrepreneurs-1244979.htm

Lebanon, NH -- (ReleaseWire) -- 06/05/2019 -- Celdara Medical, LLC today announced that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has awarded a three-year Small Business Innovation Research (SBIR) fast track award to fund the company's advancement of APP-103 for the treatment of acute kidney injury (AKI). This project builds on the inventions of co-collaborator Dr. Peter Kang at the Beth Israel Deaconess Medical Center in Boston.

Dr. Jake Reder, Co-founder and Chief Executive Officer of Celdara Medical, remarked, "We are grateful to the NIDDK for their continued support of this program. APP-103 has unique efficacy in many models of oxidative damage and ischemia reperfusion injury. Its potential to improve clinical outcomes in AKI is outstanding, and the need is entirely unmet."

Dr. Peter Kang, who is also an Associate Professor of Medicine at Harvard Medical School and the scientific founder of the Anti-Inflammatory Therapeutics program at Celdara Medical, noted, "Acute Kidney Injury is a common condition that affects millions of patients. However, we do not have an effective therapy for it. This work will allow us to develop APP-103 from preclinical research to clinical application. I am very excited to be part of it."

Dr. Kang along with Drs. Brandy Houser, Site Head NY/NJ for Celdara Medical, Edward Van Keuren, Associate Professor at Georgetown University, and P. Jack Hoopes, Professor of Surgery and Radiation Oncology at the Geisel School of Medicine at Dartmouth College, are the core team developing APP-103 for the treatment AKI. AKI is common in hospitalized patients (8-16% of hospital admissions) and older adults. Incidence is increasing and outcomes are poor; AKI currently increases mortality fourfold.

Research reported in this press release is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number R44DK117714. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Celdara Medical, LLC
Celdara Medical was founded by Drs. Jake Reder and Michael Fanger in 2008, and is headquartered at the Dartmouth Regional Technology Center (DRTC) in Lebanon, NH. Celdara Medical builds academic and early-stage innovations into high-potential medical companies, identifying discoveries of exceptional value at the earliest stages and moving them toward the market. Celdara Medical partners with inventors and their institutions, providing the developmental, financial, and business acumen required to bridge discovery and profitability. With robust funding options, a diverse and high impact Programmatic pipeline, and partnerships with world-class academic institutions and industry leaders, Celdara Medical navigates all aspects of a complex industry, accelerating science to improve human health. Further information about Celdara Medical is available at www.celdaramedical.com.

About Georgetown University
Georgetown University is one of the world's leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world. We are a vibrant community of exceptional students, faculty, alumni and professionals dedicated to real-world applications of our research, scholarship, faith and service. Established in 1789, Georgetown is the nation's oldest Catholic and Jesuit university. Drawing upon the 450-year-old legacy of Jesuit education, we provide students with a world-class learning experience focused on educating the whole person through exposure to different faiths, cultures and beliefs.

About Dartmouth College
Founded in 1769, Dartmouth is a member of the Ivy League and consistently ranks among the world's greatest academic institutions. Dartmouth has forged a singular identity for combining its deep commitment to outstanding undergraduate liberal arts and graduate education with distinguished research and scholarship in the Arts and Sciences and its four leading graduate schools—the Geisel School of Medicine, the Guarini School of Graduate and Advanced Studies, Thayer School of Engineering, and the Tuck School of Business.

Contact:
Celdara Medical
16 Cavendish Court, Suite 240
Lebanon, NH 03766
info@celdaramedical.com
617-320-8521
www.celdaramedical.com

For more information on this press release visit: http://www.releasewire.com/press-releases/celdara-medical-receives-23m-grant-to-advance-a-novel-treatment-for-acute-kidney-injury-1229300.htm