Acquisition to support accelerated commercialization of Koligos KYSLECEL,a personalized islet cell therapy available in the U.S. for chronic and recurrent acute pancreatitis
Goal to rapidly advance KT-PC-301, an autologous cell therapy under investigationfor the treatment of COVID-19-related Acute Respiratory Disease Syndrome (ARDS)
Orgenesis to leverage Koligos 3D-V bioprinting technology across its POCare Platform
GERMANTOWN, Md., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (Orgenesis or the Company), a global biotech company working to unlock the full potential of cell and gene therapies, and Koligo Therapeutics, Inc. (Koligo), a regenerative medicine company, today announced that the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion before year-end (Transaction).
Koligo is a leader in developing personalized cell therapies utilizing the patients own (autologous) cells. Koligo has successfully launched its first commercial product, KYSLECEL, and plans to commence a phase 2 trial of KT-PC-301 for COVID-19-related ARDS. Koligos development stage technology utilizes 3D bioprinting and vascularization with autologous cells (3D-V technology) to create biodegradable and shelf-stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for diabetes and pancreatitis, with longer term applications for neural, liver, and other cell/tissue transplants.
Following closing of the Transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the United States and, subject to regulatory and logistical considerations, in international markets as well. After closing of the Transaction, and subject to FDA review and clearance of the Companys Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Orgenesis also plans to leverage Koligos 3D-V bioprinting technology across its POCare platform.
Under the terms of the merger agreement, Orgenesis will acquire all of the outstanding stock of Koligo from its shareholders (the founders and staff of Koligo and a subsidiary of Bergen Special Opportunity Fund, LP, an institutional investor managed by Bergen Asset Management, LLC). The agreed consideration terms are an aggregate of $15 million in shares of Orgenesis common stock valued at $7.00 per share which shall be issued to Koligos accredited investors (with certain non-accredited investors to be paid solely in cash) and an assumption of $1.3 million in Koligos liabilities, estimated to be substantially all of Koligos liabilities. Additional details of the Transaction will be available in the Companys Form 8-K, which will be filed with the Securities and Exchange Commission, and will be available at http://www.sec.gov.
KYSLECELKoligos KYSLECEL is commercially available in the United States for chronic and recurrent acute pancreatitis in a surgical procedure commonly called Total Pancreatectomy with Islet Autologous-Transplant (TPIAT). TPIAT has been proven to provide significant pain relief, improved quality of life, and a reduction in the need for pain medication for patients suffering from chronic or recurrent acute pancreatitis. KYSLECEL infusion after a total pancreatectomy helps preserve insulin secretory capacity and reduce the risk of diabetic complications. KYSLECEL is made from a patients own pancreatic islets the cells that make insulin to regulate blood sugar.
Koligo has commenced its commercial pilot program for KYSLECEL at six U.S. hospitals, treating 40 patients to date. The KYSLECEL pilot program has generated approximately $2 million in sales revenue. KYSLECEL has also been shown to result in significant savings to payors over traditional chronic pancreatitis management. Following the closing of the Transaction, Orgenesis plans to make KYSLECEL available to an increasing number of hospitals throughout the United States through its POCare Network.
KT-PC-301Koligos lead clinical development program is for KT-PC-301, an autologous cell therapy under investigation for the treatment of COVID-19-related Acute Respiratory Disease Syndrome (ARDS). KT-PC-301 is comprised of autologous stromal and vascular fraction cells (SVF) derived from each patients adipose (fat) tissue. KT-PC-301 contains a population of mesenchymal stem cells, vascular endothelial cells, and immune cells which migrate to the patients lungs and other peripheral sites of inflammation. Nonclinical and clinical evidence demonstrate that KT-PC-301 may: (1) stabilize microcirculation to improve oxygenation; (2) maintain T and B lymphocytes to support antibody production; and (3) induce an anti-inflammatory effect.
Koligo has completed a pre-IND (Investigational New Drug) consultation with the U.S. Food and Drug Administration to start clinical trials of KT-PC-301 in COVID-19-related ARDS. Following the closing of the Transaction, and subject to FDA review and clearance of the Companys Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. As currently planned, the phase 2 trial is expected to enroll 75 patients and evaluate the safety and efficacy of KT-PC-301. Mohamed Saad, MD, Chief of Division of Pulmonary, Critical Care, and Sleep Disorders Medicine at the University of Louisville, will be the lead clinical investigator on the trial.
3D-V Technology Koligos 3D-V bioprinting technology is designed to support development of a number of product candidates for the treatment of diabetes, cancer, neurodegenerative disease, and other serious diseases. The 3D-V technology platform is able to print three-dimensional cell and tissue constructs with a vascular network. Key benefits of the 3D-V approach include: faster revascularization/inosculation of cell/tissue transplant to improve engraftment; host tolerance of the graft while minimizing need for immune suppressive drugs; better site of transplant administration of such products; and scaffolding to keep cell/tissue in place in vivo. These solutions are ideally suited for islet transplant and other cell/tissue transplant applications.
Koligo ManagementFollowing the closing of the Transaction, Koligos management team will be joining Orgenesis to continue commercial and development activities. Koligos CEO, Matthew Lehman, is an accomplished executive in the biotech and regenerative medicine fields. Prior to co-founding Koligo, he was CEO of Prima Biomed Ltd (now Immutep Ltd, a Nasdaq (IMMP) and ASX (IMM) listed biotech company). Stuart Williams, PhD, Chief Technology Officer, is a bioengineer and thought leader in regenerative medicine, with over 300 publications and 20 issued patents in the field. Dr. Williams has co-founded three other biotech companies and is an experienced academic-industry collaborator. Michael Hughes, MD, Chief Medical Officer, is a transplant surgeon who started the islet transplant program at University of Louisville which was the genesis of Koligos KYSLECEL program. He has successfully treated nearly 50 chronic pancreatitis patients with islet autologous transplant after pancreatectomy. Balamurugan Appakalai, PhD, has more than 20 years of islet isolation experience, having processed more than 800 human pancreases. He is a leader in the field of islet transplant with 100+ publications.
Vered Caplan, Chief Executive Officer of Orgenesis, stated, We are pleased to announce this transformative acquisition, which we expect will add broad capabilities to our therapeutic and technology platform, and will further our leadership in the cell and gene therapy field. Based on several phase 1 studies, Koligos KT-PC-301, using a patients own cells, has demonstrated safety and tolerability, and has shown signs of efficacy to support continued development in COVID-19-related ARDS. If successful for the treatment of COVID-19-related ARDS, KT-PC-301 is likely to have applications in other acute and chronic respiratory indications, areas that represent significant unmet medical need. In addition, we see significant potential in KYSLECEL, a commercial stage asset for the treatment of chronic and acute recurrent pancreatitis, which we plan to introduce through our global network of hospitals. Finally, Koligos 3D-V bioprinting technology is highly complementary to our POCare Platform, as we implement new technologies to improve efficacy and lower the costs of cell and gene therapies. I would like to personally welcome Matthew and the rest of the Koligo team to the Orgenesis organization when the Transaction closes. We believe that their skills and experience will be an important addition as we execute on our strategy to unlock the power of cell and gene therapies and make them accessible to all.
Matthew Lehman, Chief Executive Officer of Koligo Therapeutics, stated, The merger with Orgenesis marks a major milestone for our company and builds on our recent progress, including the Pre-IND package submitted to the U.S. FDA for KT-PC-301 and our pilot commercial program for KYSLECEL. The Orgenesis team brings extensive clinical, regulatory, and manufacturing expertise well suited to supporting Koligos goals. Orgenesis intellectual property is highly complementary to Koligos technology and the combined companies will work to advance a robust commercial and development product portfolio. Orgenesis POCare technologies are also ideally suited for low-cost and efficient production of autologous cell therapies at the point of care, which we believe will considerably enhance the delivery of these therapies to patients. Additionally, we believe Orgenesis global network of leading hospitals and healthcare institutions will enable us to accelerate the commercial rollout of KYSLECEL. We are quite encouraged by the outlook for the business and look forward to leveraging Orgenesis POCare Platform in order to accelerate the timeline to bringing our innovative cell therapies to market. Through this merger, we believe we can maximize value for all shareholders and we are grateful to Orgenesis for this opportunity.
Pearl Cohen Zedek Latzer Baratz LLP and KPMG advised Orgenesis on the Transaction. Maxim Group LLC acted as a finder and Nelson Mullins Riley & Scarborough, LLP advised Koligo on the Transaction.
About Koligo Therapeutics Koligo Therapeutics, Inc. is a US regenerative medicine company. Koligos first commercial product is KYSLECEL (autologous pancreatic islets) for chronic and acute recurrent pancreatitis. Koligos 3D-V technology platform incorporates the use of advanced 3D bioprinting techniques and vascular endothelial cells to support development of transformational cell and tissue products for serious diseases. More information is available at http://www.koligo.net.
About OrgenesisOrgenesis is a global biotech company working to unlock the full potential of celland gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCarePlatform is comprised of three enabling components: a pipeline of licensedPOCare Therapeuticsthat are processed and produced in closed, automatedPOCare Technologysystems across a collaborativePOCare Network. Orgenesisidentifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. Learn more about the work Orgenesis is doing atwww.orgenesis.com.
Notice Regarding Forward-Looking Statements The information in this release is as of September 29, 2020. Orgenesis assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments. This release contains forward looking statements about Orgenesis, Koligo, Koligos technology, and potential development and business opportunities of Koligo and Orgenesis following the closing of the Transaction, each of which involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of the Companys products; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any such regulatory authorities may approved the Companys development products, and, if approved, whether such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of the Companys products; uncertainties regarding the impact of COVID-19 on the Companys business, operations and financial results and competitive developments.
A further description of risks and uncertainties can be found in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov.
Contact for Orgenesis:Crescendo Communications, LLCTel: 212-671-1021ORGS@crescendo-ir.com
Visit link:
- Signal of Benefit for Stem Cell Therapy in Progressive MS - Medscape - March 7th, 2024
- The Controversies Surrounding Stem Cell Therapy for Autism - The Portugal News - February 24th, 2024
- Benefits of Stem Cell Therapy - News Channel 5 Nashville - February 7th, 2024
- What is Stem Cell Therapy & How It Helps Others - Publicist Paper - January 31st, 2024
- A guide to stem cell therapy in Thailand - Thaiger - January 4th, 2024
- Half of pediatric patients with aHUS benefit from Soliris after... - AHUS News - December 21st, 2023
- Real world analysis on the determinants of survival in primary ... - Nature.com - December 5th, 2023
- The Best Beauty Gifts According To People Who Really Know Skin Care - HuffPost - December 5th, 2023
- The Eyepopping Factory Construction Boom in the US - WOLF STREET - December 3rd, 2023
- Benefit of Neoadjuvant Therapy Illustrated During ESMO Congress ... - Targeted Oncology - December 1st, 2023
- Benefits Outweigh Risks as FDA Inspects CAR-T Cell Therapy ... - Curetoday.com - December 1st, 2023
- Review What Real Cavityn Customers Say About Benefits and Side ... - Seattle Weekly - December 1st, 2023
- 'There is a Scientific Fraud Epidemic' - Slashdot - Slashdot - December 1st, 2023
- 15 Best Hydrating Serums to Soothe Any Skin Type 2023 - Town & Country - December 1st, 2023
- Innovations in Cosmetic Dermatology: A Glimpse into the Future - APN News - December 1st, 2023
- FDA Probes New Cases of Cancer That May Stem From Cancer Cell ... - MedCity News - November 29th, 2023
- Use of plant stem cells in topical formulations on the rise - CosmeticsDesign.com USA - November 29th, 2023
- Stem cell-based treatment controls blood sugar in people with Type ... - EurekAlert - November 29th, 2023
- Biologics Market is projected to grow at a CAGR of 8.5% by 2034: Visiongain - Yahoo Finance - November 29th, 2023
- Scientists devise new technique that can pinpoint the causes and ... - EurekAlert - November 29th, 2023
- Global Advanced Therapy Medicinal Products Market is on the brink ... - PharmiWeb.com - November 29th, 2023
- Introducing Orgavalue - The 2023 EIT InnoStars Awards winner - EU-Startups - November 29th, 2023
- Episode 160: Euan Ashley discusses precision medicine and the ... - IHMC - November 29th, 2023
- Is Phenq Right For You? Review The Facts Before Making a ... - Vashon-Maury Island Beachcomber - November 27th, 2023
- Cavityn Reviews - Does It Work? Cheap Scam or Effective ... - The Daily World - November 25th, 2023
- Trend Hunting With Beautystreams At Cosmoprof Asia 2023 - BeautyMatter - November 25th, 2023
- FDA Considers First CRISPR Gene Editing Treatment That May ... - Slashdot - November 25th, 2023
- How Do Plants Determine Where the Light Is Coming From? - Lab Manager Magazine - November 25th, 2023
- Deaths From Coal Pollution Have Dropped, But Emissions May be ... - Slashdot - November 25th, 2023
- Stem cell-based therapies for stroke in newborns - Cochrane - November 23rd, 2023
- Dr Leslie on Outpatient CAR T-Cell Therapy Programs for ... - OncLive - November 23rd, 2023
- Human Milk-Based Therapy May Be Beneficial in Blood Cancers - Curetoday.com - November 23rd, 2023
- Oncological Horizons: The Synergy of Medical and Surgical ... - Cureus - November 23rd, 2023
- Human and environmental safety of carbon nanotubes across their ... - Nature.com - November 23rd, 2023
- Immix Biopharma to Host KOL Event to Discuss its BCMA-Targeted ... - BioSpace - November 23rd, 2023
- #HearTheMarsdenKids call on NHS London to reconsider cancer ... - Metro.co.uk - November 23rd, 2023
- Diagnosis and Management of Cardiovascular Risk in Patients with ... - Dove Medical Press - November 23rd, 2023
- BioLineRx Reports Third Quarter 2023 Financial Results and ... - PR Newswire - November 21st, 2023
- Why our Award Winners Beauty Box is the ultimate beauty gift (for ... - Yahoo Singapore News - November 21st, 2023
- SightCare Reviews - Is Official Website for Sight Care Legit to Try or ... - Vashon-Maury Island Beachcomber - November 21st, 2023
- Legend Biotech Reports Third Quarter 2023 Results and Recent ... - StreetInsider.com - November 21st, 2023
- Lorenzo's Oil: Can It Really Treat ALD? - Verywell Health - November 19th, 2023
- Doctor Says Living To 120 By End Of Decade Is Possible What's the Secret? - Benzinga - November 19th, 2023
- The week in pharma: action, reaction and insight week to ... - The Pharma Letter - November 19th, 2023
- Race Cannot Be Used To Predict Heart Disease, Scientists Say ... - Slashdot - November 19th, 2023
- SpaceX's Starship Reaches Outer Space Before Intentional ... - Slashdot - November 19th, 2023
- Mesenchymal Stem Cells Market is projected to reach USD 3,319 million by 2030 according to a new research r... - WhaTech Technology and Markets News - November 17th, 2023
- LMRUK: Protecting the next generation through cord blood - Charity Today News - November 17th, 2023
- Anti-aging molecule discovered that extends lifespan - Earth.com - November 17th, 2023
- Montana State researcher envisions living building materials that ... - Montana State University - November 17th, 2023
- OxyHelp Explores the Benefits of Hyperbaric Oxygen Therapy for ... - StreetInsider.com - November 15th, 2023
- Health benefits of bone marrow - Pakistan Observer - November 15th, 2023
- Evolving the standard of care: What is next for functional ... - NeuroNews International - November 15th, 2023
- Affimed Reports Third Quarter 2023 Financial Results and ... - BioSpace - November 15th, 2023
- Meet the World's First Whole-Eye Transplant Recipient - TIME - November 15th, 2023
- Calidi Biotherapeutics Reports Third Quarter 2023 Operating and ... - Business Wire - November 15th, 2023
- 10 Asia-Pacific biotech companies leading innovation in the region - Labiotech.eu - November 15th, 2023
- Fitspresso Reviews (November Update) Natural Ingredients That ... - Bainbridge Island Review - November 15th, 2023
- 2seventy bio Reports Third Quarter Financial Results and Recent ... - Business Wire - November 15th, 2023
- Japan To Create $6.6 Billion Fund To Develop Outer Space Industry ... - Slashdot - November 15th, 2023
- Be The Match, Healthcare Marketing Impact Awards 2023 - Ad Age - November 13th, 2023
- Medicare coverage saves lives. Enrolling shouldn't be this ... - Kevin MD - November 13th, 2023
- Future Ocean Foods: 36 Global Alt-Seafood Startups Form Association To Tackle Overfishing, Microplastics & More - Green Queen Media - November 13th, 2023
- Orchard Therapeutics Reports Third Quarter 2023 Financial Results ... - StreetInsider.com - November 13th, 2023
- Celebrity doctor reveals Hollywoods hidden trend of stem cell antiaging therapies - Longevity.Technology - November 11th, 2023
- Amazon Expands Healthcare Push With One Medical Benefits For ... - Slashdot - November 11th, 2023
- Bene Meat Technologies becomes the first to receive EU approval ... - Pet Food Processing - November 11th, 2023
- FDA Grants Orphan Drug Designation to MAIA Biotechnology for THIO as a Treatment for Glioblastoma - Yahoo Finance - November 11th, 2023
- MaaT Pharma Provides Third Quarter 2023 Business Update and ... - Business Wire - November 11th, 2023
- IN8bio Reports Third Quarter 2023 Financial Results and Provides ... - GlobeNewswire - November 11th, 2023
- Fast Lean Pro Reviews - Overpriced or Optimal Ingredients That ... - Journal of the San Juan Islands - November 11th, 2023
- Fate Therapeutics Reports Third Quarter 2023 Financial Results and ... - GlobeNewswire - November 11th, 2023
- Worlds first whole-eye and partial face transplant gives Arkansas man new hope - CNN - November 9th, 2023
- Glowing Fingertips And Green Eyes: First-of-Its-Kind Monkey ... - ScienceAlert - November 9th, 2023
- 10 Natural Body Scrubs That Exfoliate And Invigorate My Skin - PINKVILLA - November 9th, 2023
- CRISPR Therapeutics Provides Business Update and Reports Third ... - StreetInsider.com - November 9th, 2023
- Fate Therapeutics Reports Third Quarter 2023 Financial Results and ... - StreetInsider.com - November 9th, 2023
- Sight Care Reviews - Overpriced or Worth the Hype? SightCare Pills ... - Journal of the San Juan Islands - November 9th, 2023
- 6 Amazing Health Benefits Of Giloy (Tinospora cordifolia) - WION - November 9th, 2023
- The Global Market for Bispecific Antibody Therapeutics Contract Manufacturing 2023-2030: Driven by Demand for Innovative Therapies and Promising... - November 7th, 2023
Recent Comments