Stem Cell Clinic

The global cell and gene therapy market by revenue is expected to grow at a CAGR of over 30.90% during the period 20192025 – GlobeNewswire

August 04, 2020 09:13 ET | Source: ReportLinker

New York, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell & Gene Therapy Market - Global Outlook and Forecast 2020-2025" - https://www.reportlinker.com/p05827567/?utm_source=GNW 90% during the period 20192025.

The global cell and gene therapy market is one of the fastest-growing segments in the regenerative medicine market. The market is expected to grow at a faster pace during the forecast period. The demand can be attributed to the growing prevalence of several chronic diseases such as cancer, cartilage related problems, wounds, diabetic foot ulcer, genetic disorders, and other rare diseases across the globe. The prevalence of cancer and diabetes is increasing in the global population, which is influencing the growth of the market. There is a large unmet need in the treatment available, which is filled by cell and gene therapies. The market is growing due to the increased availability of funding from various public and private institutions. Besides, there is increased support from regulatory bodies for product approval. Several governments are creating awareness of cell and gene therapies in the population.

The following factors are likely to contribute to the growth of the cell and gene therapy market during the forecast period: Increase in Strategic Acquisition Activities Increased Funding for Cell & Gene Therapy Products Expanding Applications of Cell and Gene Therapies Increased in the Patient Pool

The study considers the present scenario of the cell and gene therapy market and its market dynamics for the period 2019?2025. It covers a detailed overview of several market growth enablers, restraints, and trends. The report offers both the demand and supply aspects of the market. It profiles and examines leading companies and other prominent ones operating in the market. Cell And Gene Therapy Market Segmentation The global cell and gene therapy market research report includes a detailed segmentation by product, disease, end-user, and geography. In 2019, the cell therapy segment accounted for a market share of over 53% in the global cell and gene therapy market. The segment is expected to grow at a steady rate during the forecast period due to the increase in the target population and the rise in the number of countries preferring cell therapies in their patients. Increased therapeutic benefits are attracting several countries to invest in this technology and conduct a high number of clinical trials. However, the lack of advanced infrastructure in developing countries is hindering the growth of the segment.

In 2019, the oncology segment accounted for a share of over 40% in the global cell and gene therapy market. Oncology has been one of the targets of intense research for the gene therapy procedures & approach. More than 60% of on-going gene therapy clinical trials are targeting cancer. The segment is expected to grow at a promising rate on account of the high prevalence of cancer diseases, especially in low and middle-come countries. The market is growing at a double-digit CAGR, which is expected to help the segment as many cell and gene therapy for cancer are commercially available.

The dermatology application segment in the cell and gene therapy includes wound care management among patients. Vendors are focusing on the development and commercialization of advanced wound care products for the treatment of chronic and acute wounds, thereby increasing the growth of the wound care market. The increased pervasiveness of diabetics is increasing acute and chronic wounds, including surgical wounds, pressure ulcers, diabetic foot ulcers, and other wounds.

In 2019, the oncology segment accounted for a share of over 40% in the global cell and gene therapy market. Oncology has been one of the targets of intense research for the gene therapy procedures & approach. More than 60% of on-going gene therapy clinical trials are targeting cancer. The segment is expected to grow at a promising rate on account of the high prevalence of cancer diseases, especially in low and middle-come countries. The market is growing at a double-digit CAGR, which is expected to help the segment as many cell and gene therapy for cancer are commercially available.

The dermatology application segment in the cell and gene therapy includes wound care management among patients. Vendors are focusing on the development and commercialization of advanced wound care products for the treatment of chronic and acute wounds, thereby increasing the growth of the wound care market. The increased pervasiveness of diabetics is increasing acute and chronic wounds, including surgical wounds, pressure ulcers, diabetic foot ulcers, and other wounds.

Segmentation by Product Cell Therapy Gene Therapy Segmentation by Disease Dermatology Musculoskeletal Oncology Genetic Disorders Others Segmentation by End-user Hospitality Cancer Care Centers Wound Care Centers Ambulatory Surgical Centers Others

INSIGHTS BY GEOGRAPHY In 2019, North America accounted for a share of over 60% of the global cell and gene therapy market. There are more than 530 regenerative medicine companies, including cell and gene therapy manufacturing developers. The number of products approved in North America grew significantly in 2019, with developers filed for marketing authorization for 10+ regenerative medicines, many of which we expect to be approved in 2020. Within the next 12 years, the number of approved gene therapies is expected to double. The US and Canada are the major contributors to the cell and gene therapy market in North America. Regulatory bodies are supporting several investigational products, fast track approvals, RMAT designation for the faster approval of the product into the market. The alliance for regenerative medicine and Medicare and Medicaid is working together to bring the structured reimbursement channels for cell and gene therapies.

Segmentation by Geography North America o US o Canada Europe o UK o Germany o France o Spain o Italy APAC o China o Japan o South Korea o Australia o India Latin America o Brazil o Mexico Middle East & Africa o Saudi Arabia o Turkey o South Africa o UAE

INSIGHTS BY VENDORS The global cell and gene therapy market is highly dynamic and characterized by the presence of several global, regional, and local vendors offering a wide range of therapies. Dendreon, Gilead Sciences, Novartis, Organogenesis, Osiris Therapeutics, Vericel, Amgen, and Spark Therapeutics are the leading players in the market with significant shares. Vendors such as NuVasive, APAC Biotech, Nipro, Orthocell, bluebird bio, J-TEC, and Terumo are the other prominent players in the market with a presence, especially in the cell therapy market. Most leading players are focusing on implementing strategies such as product launches and approvals, marketing and promotional activities, acquisitions, increased R&D investments, and strengthening their distribution networks to enhance their share and presence in the market.

Prominent Vendors Gilead Sciences Spark Therapeutics Novartis Organogenesis Amgen Osiris Therapeutics Dendreon Vericel

Other Prominent Vendors Anterogen Tego Sciences Japan Tissue Engineering JCR Pharmaceuticals Medipost MolMed AVITA Medical CollPlant Biosolution Stempeutics Research Kolon Tissue Gene Orchard Therapeutics Sibiono GeneTech NuVasive Corestem Pharmicell Shanghai Sunway Biotech RMS Regenerative Medical System Takeda Pharmaceutical Company CHIESI Farmaceutici CO.DON AnGes GC Pharma Human Stem Cells Institute JW CreaGene APAC Biotech Nipro Terumo Orthocell bluebird bio

Key Questions Answered 1. What is the cell and gene therapy market size and growth rate during the forecast period? 2. What are the factors impacting the growth of the cell and gene therapy market share? 3. How is the growth of the healthcare segment affecting the growth of the cell and gene therapy market? 4. Who are the leading vendors in the cell and gene therapy market, and what are their market shares? 5. Which product type/ end-user type/region is generating the largest revenue in the Asia Pacific region? Read the full report: https://www.reportlinker.com/p05827567/?utm_source=GNW

About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The global cell and gene therapy market by revenue is expected to grow at a CAGR of over 30.90% during the period 20192025 - GlobeNewswire

ReViral Announces FDA Fast Track Designation Granted to Sisunatovir For The Treatment of Serious Respiratory Syncytial Virus Infection – Business Wire

LONDON & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--ReViral Ltd., a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics that target respiratory syncytial virus (RSV), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sisunatovir for the treatment of patients with serious RSV infection. Sisunatovir is the companys most advanced product candidate, with two international multicentre Phase 2 clinical studies recently initiated in pediatric and high-risk adult patient populations.

We are very pleased that sisunatovir has received Fast Track designation for the treatment of serious RSV, a significant global health concern, said Alex Sapir, CEO, ReViral. RSV affects approximately 64 million people and causes approximately 160,000 deaths each year. We look forward to working closely with the FDA throughout the clinical development of this program with the goal of bringing a potentially life-saving treatment to patients as quickly as possible.

Fast Track is a process intended to facilitate the development and expedite the review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review, and potential approval.

Notes to Editors

About Sisunatovir

Sisunatovir is an orally administered fusion inhibitor designed to block RSV replication by inhibiting RSV F-mediated fusion of RSV with the host cell. Preclinical tests showed sisunatovir to have an excellent toxicity profile with an attractive therapeutic index. In Phase 1 clinical studies, sisunatovir showed excellent exposure with no serious adverse events being reported. In 2018, results from a Phase 2a challenge study in healthy adult volunteers were reported in which sisunatovir produced statistically significant reductions in viral load and clinical symptoms. ReViral has recently initiated two international multicentre Phase 2 clinical studies of sisunatovir in pediatric and adult high-risk patient populations.

About Respiratory Syncytial Virus (RSV)

RSV is a respiratory pathogen that can lead to severe and life-threatening lower respiratory tract infections, or LRTIs, in high-risk populations, such as infants, immunocompromised patients, and the elderly. RSV constitutes a substantial disease burden. The US-based National Institute of Health (NIH) estimates that, globally, RSV affects approximately 64 million people and causes approximately 160,000 deaths each year. Globally, there are an estimated 33 million cases of RSV LRTI each year in children younger than five years of age, with about 3 million of them being hospitalized and approximately 60,000 dying each year from complications associated with the infection. Currently, there are no effective therapeutic treatment options for patients who develop RSV infection.

About ReViral

ReViral is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics, with an initial focus on the treatment of respiratory syncytial virus (RSV). The companys lead product candidate, sisunatovir, is an orally administered fusion inhibitor currently being evaluated in two global Phase 2 clinical studies: one in a pediatric patient population and the other in an adult stem-cell transplant patient population. In addition, the company has an N-protein inhibitor program in late preclinical development. Both programs were discovered in-house and the company has retained worldwide development and commercialization rights.

For more information, please visit http://www.reviral.com

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ReViral Announces FDA Fast Track Designation Granted to Sisunatovir For The Treatment of Serious Respiratory Syncytial Virus Infection - Business Wire

Janssen Announces Health Canada Approval of DARZALEX* SC, a New Subcutaneous Formulation for the Treatment of Patients with Multiple Myeloma – Canada…

DARZALEX SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions compared to intravenous DARZALEX (daratumumab)

TORONTO, Aug. 4, 2020 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved DARZALEX SC (daratumumab), a new subcutaneous formulation of daratumumab.1 DARZALEX SC is approved in four regimens across five indications in patients with multiple myeloma, most notably newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, DARZALEX SC can be administered over approximately three to five minutes, significantly less time than intravenous (IV) DARZALEX, which is administered over hours.2 DARZALEX SC is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma.

In the Phase 3 COLUMBA study published in The Lancet, DARZALEX SC demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with IV DARZALEXin patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for DARZALEX SC compared to IV DARZALEX(13 per cent vs. 34 per cent, respectively).3

"DARZALEX has become a backbone therapy in the treatment of multiple myeloma, supported by a robust body of evidence in both the frontline and relapsed and refractory settings," says Dr. Darrell White, Hematologist, Queen Elizabeth II Health Sciences Centre, Halifax. "With this new subcutaneous formulation, not only is treatment much more convenient for patients, but it will also play a very important role in reducing wait times and the burden on our busy healthcare system, especially during this time."

The approval is based on data from the Phase 3 COLUMBA and Phase 2 PLEIADES studies.4,5In the COLUMBA study, the ORR was non-inferior for patients taking DARZALEX SC as monotherapy compared to those taking IV DARZALEXas monotherapy (41 per cent vs. 37 per cent, respectively).6 Additionally, in the Phase 2 PLEIADES study evaluating the efficacy and safety of DARZALEXSC in combination therapies, objective responses were demonstrated in combination with bortezomib, melphalan and prednisone (D-VMP) in newly diagnosed transplant ineligible patients. In addition, objective responses were demonstrated in combination with lenalidomide and dexamethasone (D-Rd) in relapsed or refractory patients who received one prior line of therapy.7In a pooled safety population of 490 patients who received DARZALEXSC as monotherapy or in combination, the ARR rate was 11 per cent.8

DARZALEX SC is approved in all current IV indicationsincluding (1) in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, (2) in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, (3) in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, and (4) as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.9

Active discussions are ongoing with public insurers to determine how DARZALEX SC can be made accessible for both relapsed or refractory patients as well as newly diagnosed, transplant ineligible patients.

"This approval exemplifies Janssen's mission and commitment to bringing together passion, science and ingenuity to advance novel solutions for patients," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC.

About the COLUMBA Study The randomised, open-label, multicenter Phase 3 COLUMBA study included 522 patients (median age of 67 years) with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both a PI and an ImiD. In the arm that received DARZALEX SC (n=263), patients received a fixed dose of DARZALEX SC 1,800 milligrams (mg), co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) 2,000 Units per milliliter (U/mL), subcutaneously weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. In the IV DARZALEXarm (n=259), patients received DARZALEXfor IV infusion 16 milligrams per kilogram (mg/kg) weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. Each cycle was 28 days. In the arm that received DARZALEX SC, it was given in a fixed volume of 15 mL over three to five minutes; the median injection time was five minutes. In the arm that received the IV administration, the median durations of the first, second and subsequent IV DARZALEXinfusions were 7.0, 4.3 and 3.4 hours, respectively. Patients in both arms continued treatment until disease progression or unacceptable toxicity.10,11

About the PLEIADES Study The non-randomised, open-label, parallel assignment Phase 2 PLEIADES study included adults with multiple myeloma, including 67 patients with newly diagnosed multiple myeloma who were treated with 1,800 mg of DARZALEX SC in combination with bortezomib, melphalan, and prednisone (D-VMP) and 65 patients with relapsed or refractory disease who were treated with 1,800 mg of DARZALEX SC plus lenalidomide and dexamethasone (D-Rd). The primary endpoint for the D-VMP and D- Rd cohorts was overall response rate.12

About DARZALEXand DARZALEX SCDARZALEX is the first CD38-directed monoclonal antibody (mAb) approved to treat multiple myeloma and in 2020, DARZALEX SC (daratumumab) follows as the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma.13It binds to CD38,a surface protein highly expressed across multiple myeloma cells.14 DARZALEX induces tumor cell death through cell lysis via multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).15DARZALEX has also demonstrated immunomodulatory effects such as increasing CD4+ and CD8+ T-cells counts, which may contribute to clinical response.16

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize DARZALEX. Janssen Inc. commercializes DARZALEX and DARZALEX SC in Canada. For full Prescribing Information and more information about DARZALEX and DARZALEX SC, please visit http://www.janssen.com/canada.

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.17 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that 3,400 Canadians will be diagnosed with multiple myeloma and there will be 1,600 deaths associated with the disease.18 While some patients with multiple myeloma have no symptoms in the early stages, patients are diagnosed due to symptoms that can include bone disease or pain, anemia, calcium elevation, and kidney problems.19

About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at http://www.janssen.com/canada. Follow us at @JanssenCanada. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson.

*All trademark rights used under license. **Dr. White was not compensated for any media work. He has been compensated as a consultant.

Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding DARZALEX SC. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References:

1

[DARZALEX SC Product Monograph, Janssen Inc., July 29, 2020]

2

[DARZALEX SC Product Monograph, Janssen Inc., July 29, 2020]

3

Mateos MV, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial [published online ahead of print March 23, 2020]. Lancet Haematol doi.org/10.1016/S2352-3026(20)30070-3.

4

Mateos M-V et al. Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (pts) With Relapsed or Refractory Multiple Myeloma (RRMM): COLUMBA. 2019 American Society of Clinical Oncology Annual Meeting. June 2019.

5

Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565.

6

Mateos MV, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial [published online ahead of print March 23, 2020]. Lancet Haematol doi.org/10.1016/S2352-3026(20)30070-3.

7

Chari A, M. J., McCarthy H, et al Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy: PLEIADES study update. Poster presented at: 61st American Society of Hematology (ASH) Annual Meeting. Orlando, FL.

8

[DARZALEX SC Product Monograph, Janssen Inc., July 29, 2020]

9

[DARZALEX SC Product Monograph, Janssen Inc.,July 29, 2020]

10

[DARZALEX SC Product Monograph, Janssen Inc., July 29, 2020]

11

Mateos MV, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial [published online ahead of print March 23, 2020]. Lancet Haematol doi.org/10.1016/S2352-3026(20)30070-3.

12

Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565.

13

Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565.

14

[DARZALEX SC Product Monograph, Janssen Inc., July 29, 2020]

15

[DARZALEX SC Product Monograph, Janssen Inc., July 29, 2020]

16

[DARZALEX SC Product Monograph, Janssen Inc., July 29, 2020]

17

Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapywith IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57.

18

Canadian Cancer Society. "Signs and Symptoms of Multiple Myeloma." Available at: https://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/statistics/?region=on.Accessed June 2020.

19

Canadian Cancer Society. "Signs and Symptoms of Multiple Myeloma." Available at: http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/signs-and-symptoms/?region=on.Accessed June 2020.

SOURCE Janssen Inc.

For further information: Media Contact: Janssen Inc., Jennifer McCormack, Office: (416) 382-5121; Investor Contact: Jennifer McIntyre, Office: (732) 524-3922

http://www.janssen.ca/

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Janssen Announces Health Canada Approval of DARZALEX* SC, a New Subcutaneous Formulation for the Treatment of Patients with Multiple Myeloma - Canada...

Sernova Enters into Exclusive Worldwide License Agreement with University of Miami for Therapeutic Cell Immune Protection Technologies -…

Sernova expands its intellectual property portfolio and capabilities to develop first-in-class cell therapy solutions for type 1 diabetes and other chronic diseases that eliminate the need for life-long immunosuppression drugs

LONDON, ONTARIO - August 4, 2020 - Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE:PSH), a clinical-stage regenerative medicine company developing a 'functional cure' for type 1 diabetes and other chronic diseases, announced today it has entered into an exclusive, worldwide license with the University of Miami at Coral Gables, Florida, for the commercial rights to novel conformal coating immune protection technologies. The technologies were developed by Dr. Alice Tomei, Dr. Jeffrey Hubbell, and Aaron Stock (Graduate Student). Dr. Tomei is a leading international expert in immunoprotection and diabetes immunoengineering, of the renowned Diabetes Research Institute (DRI), a designated Center of Excellence at the University of Miami Miller School of Medicine. Dr. Hubbell is the Eugene Bell Professor of Tissue Engineering at the University of Chicago and leading international researcher in immunoengineering.

This exclusive worldwide license agreement is important to Sernova because it broadens the technology scope of Sernova's immune protection conformal coating technologies and related intellectual property. Furthermore, it adds to a series of recent strategic acquisitions and collaborations for the Company and builds on our goal of protecting Sernova's therapeutic cells or tissues transplanted into Sernova's Cell Pouch(TM) from a detrimental auto-immune system response while eliminating the need for immunosuppressive drugs in treated patients.

"Sernova is further advancing development of its novel Cell Pouch System(TM) as a therapeutic platform to provide cell therapy solutions to patients with chronic diseases, such as type 1 diabetes, without the current need for life-long immunosuppressive drugs. We believe, with the addition of local immune protection, our breakthrough technologies will have the potential to significantly expand access to and the availability of therapeutic solutions to millions of people as a 'functional cure' for the chronic diseases from which they are suffering," said Dr. Philip Toleikis, President and CEO of Sernova Corp.

Dr. Toleikis continued, "As we continue to advance our first-in-class technologies, we have diligently selected complementary technologies developed by recognized experts in the field such as those by Dr. Tomei and colleagues to add to our Cell Pouch(TM) platform. With the continued expansion of our regenerative medicine therapeutics platform, we are positioning the Company at the forefront in the development of safe, functional regenerative medicine therapeutics."

Dr. Alice Tomei, the Director of the Islet Immunoengineering Laboratory at DRI stated, "Following my postdoctoral training in Dr. Hubbell's laboratory at Ecole Polytechnique Federale de Lausanne, Switzerland, I joined the University of Miami where I have focussed my academic career in the pursuit and development of novel cellular immune protection technologies to advance the field of cell therapy. With Sernova's goal of a 'functional cure' for diabetes, supported by its positive preclinical and more recent, emerging clinical safety and efficacy data from the University Chicago clinical trial, I am excited to contribute to the addition of local immune protection technologies provided by conformal coatings as the next important step towards this ultimate goal."

ABOUT SERNOVA CORP.

Sernova Corp is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch(TM)) and immune protected therapeutic cells/tissues (i.e., human donor cells, corrected human cells and stem cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular production of proteins or hormones missing or in short supply within the body. For more information, please visit http://www.sernova.com.

ABOUT SERNOVA'S CELL POUCH(TM) SYSTEM

The Cell Pouch(TM), as part of the Cell Pouch(TM) System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease. The Cell Pouch(TM), along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase I/II study at the University of Chicago.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Dominic Gray

Sernova Corp.

Tel: (519) 858-5126

dominic.gray@sernova.com

http://www.sernova.com

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute "forward-looking statements" that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the Company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management's beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova's actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the Company's ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the Company's Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the Company's quarterly and annual filings available on http://www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Sernova Enters into Exclusive Worldwide License Agreement with University of Miami for Therapeutic Cell Immune Protection Technologies -...