Monthly Archives: October 2022

Dr. Derrick Rossi Named Interim CEO

NEW YORK, Sept. 9, 2022 /PRNewswire/ -- The New York Stem Cell Foundation (NYSCF) today announced the death of its Chief Executive Officer and Co-Founder, Susan L. Solomon, on September 8th, shortly after she had stepped down as CEO, after a long battle with ovarian cancer. Dr. Derrick Rossi, a member of the NYSCF Board of Directors and co-founder of Moderna Therapeutics, has been named Interim CEO of NYSCF.

The New York Stem Cell Foundation today announced the death of its CEO and Co-Founder, Susan L. Solomon

NYSCF is a New York-based non-profit organization that supports stem cell scientists around the world and operates the NYSCF Research Institute, the largest independent stem cell laboratory in the United States. As CEO, Ms. Solomon raised over $400M for stem cell research, helping to catalyze the field and transform the future of medical research.

"This is the end of an incredible era for NYSCF," said Dr. Roy Geronemus, Chairman of the NYSCF Board of Directors. "Susan founded this organization in 2005, and guided it for over 17 years. She imagined the impossible and made it happen. I speak on behalf of the entire Board when I say that we will forever be grateful for all she did for NYSCF and for the field of stem cell research to advance better treatments and cures for patients everywhere. We are confident that Dr. Rossi as Interim CEO, and the rest of the NYSCF team, will continue the trajectory that Susan led us on to move NYSCF's mission forward.The Board has begun a search for a permanent CEO."

A lawyer by training and a longtime entrepreneur and business executive, Ms. Solomon began her role as a health-care advocate in 1992 when one of her sons was diagnosed with type 1 diabetes. After conversations with clinicians and scientists, she identified stem cells as the most promising way to address unmet patient needs and felt an independent organization was needed to help translate cutting-edge stem cell research into clinical breakthroughs and cures for patients. She co-founded NYSCF in 2005. Since then, advances from NYSCF research have twice been named Time magazine's #1 scientific breakthrough of the year, and NYSCF-supported research has led to over 20 major clinical breakthroughs that are already or very soon bringing clinical treatments for devastating diseases. During her time as CEO, Ms. Solomon served on many Boards, including the College Diabetes Network and the Regional Plan Association, and received numerous awards, including the New York State Women of Excellence Award from the Governor of New York, the Triumph Award from the Brooke Ellison Foundation, and recognition as a Living Landmark from the New York Landmarks Conservancy.

During a meeting earlier in the week with NYSCF staff to announce the CEO transition, Ms. Solomon relayed the following message:

"Building NYSCF has been the privilege of a lifetime and I am incredibly proud of the contributions we have made to the field of stem cell research and developing new and more effective treatments and cures to improving the lives of patients. I am confident that our outstanding and dedicated leadership and staff will continue to move our programs forward under Derrick's leadership and that of our longtime COO/CFO Jeff Wallerstein while the Board conducts a search for my successor."

"It has been a great privilege to serve on the NYSCF Board of Directors and I am honored to now serve as Interim CEO," said Dr. Rossi. "Since I first met Susan in 2010 and became a member of the NYSCF community, I have been in awe. Susan was a force of nature, a fierce and effective advocate for science and patients, and a true visionary. She was also a dear friend. Without question, Susan's and NYSCF's impact on science has been enormous and, quite frankly, unmatched.Though I wish that Susan could have continued her incredible and effective leadership of NYSCF for the next hundred years, I am nonetheless honored and ready to lead NYSCF over the coming months as we search for a permanent leader."

Dr. Rossi, a biotechnology entrepreneur and stem cell scientist, is the co-founder of Moderna Therapeutics, and co-founder of Intellia Therapeutics, Magenta Therapeutics, and Stelexis Therapeutics. Until his retirement from academia, he was an Associate Professor at Harvard Medical School and Harvard University, and an investigator at Boston Children's Hospital where he led an academic team working on stem cell biology and regenerative medicine. In 2010, Derrick was named a NYSCF Robertson Stem Cell Investigator and he joined the Board of Directors in 2020. His efforts in the development of cutting-edge technologies and new therapeutic strategies are at the forefront of regenerative medicine and biotechnology. Time magazine named Dr. Rossi as one of the 100 Most Influential People in the world (Time 100) in 2011. Dr. Rossi earned his B.Sc. and M.Sc. from University of Toronto, and his PhD from the University of Helsinki.

Prior to founding NYSCF, Ms. Solomon had a diverse career spanning many decades. After graduating from New York University, she received her JD from Rutgers University School of Law while raising her eldest son as a single mother and serving as an editor of the Law Review. She began her career as an attorney at Debevoise & Plimpton. The work she was most passionate about was her pro bono work, including the representation of a woman suing the NYC Fire Department for sexual discrimination based on the firefighting qualification testing that was biased toward male applicants.

She later continued her law career as counsel for Warner Amex Satellite Entertainment Corporation, a joint venture in the then-new industry of cable television to develop television networks, including MTV, Nickelodeon, and Showtime.

After jobs at United Satellite Entertainment and CBS Productions, a film arm of CBS, Ms. Solomon joined MacAndrews & Forbes to help in the area of media acquisitions, and later APAX, formerly MMG Patricof and Company, another financial firm.

Ms. Solomon subsequently joined Sony Corporation to establish and serve as President of a new radio network, Sony Worldwide Networks, which was the first to do internet radio broadcasting. She then moved on to her last media job as the founding CEO of Sothebys.com, where she helped to develop the first online auction platform.

Prior to founding NYSCF in 2005, she started her own strategic management consulting firm, Solomon Partners LLC, through which she worked with a range of non-profit and media companies.

Ms. Solomon is survived by her husband Paul Goldberger and three sons and daughters-in-law, Adam and Delphine Hirsh, Ben Goldberger and Melissa Rothberg, and Alex Goldberger and Carolyna De Laurentiis, and six grandchildren Thibeaux and Josephine Hirsh, Julian and Gabriel Goldberger, and Arlo and Celeste Goldberger.

About The New York Stem Cell Foundation Research Institute

The New York Stem Cell Foundation (NYSCF) Research Institute is an independent non-profit organization accelerating cures and better treatments for patients through stem cell research. The NYSCF global community includes over 200 researchers at leading institutions worldwide, including the NYSCF Druckenmiller Fellows, the NYSCF Robertson Investigators, the NYSCF Robertson Stem Cell Prize Recipients, and NYSCF Research Institute scientists and engineers. The NYSCF Research Institute is an acknowledged world leader in stem cell research and in the development of pioneering stem cell technologies, including the NYSCF Global Stem Cell Array, which is used to create cell lines for laboratories around the globe. NYSCF focuses on translational research in an accelerator model designed to overcome barriers that slow discovery and replace silos with collaboration.

David McKeon212-365-7440[emailprotected]

SOURCE The New York Stem Cell Foundation

Excerpt from:
The New York Stem Cell Foundation Mourns the Loss of CEO Susan L. Solomon

With two recently approved chimeric antigen receptor T therapies targeting B-cell maturation antigen, this novel platform has altered the treatment paradigm for heavily-pretreated patients with multiple myeloma.

Ever since high-dose melphalan with autologous stem cell transplantation (ASCT) became standard-of-care for multiple myeloma (MM), many have sought a replacement. Part of the reason is the historical toxicity of ASCT; however, advances in supportive measures have significantly improved transplant-related morbidity and mortality, thereby allowing it to expand to wider populations and to be performed in the ambulatory setting.1-3 Perhaps, in part, the desire to find an alternative to ASCT stems from the perceived lack of refinement of the continued use of myeloablative chemotherapy for a disease in which clinicians have many highly effective novel agents and cellular/immunotherapies.

Nowhere is this circumstance more apparent than at the imminent collision of ASCT with chimeric antigen receptor (CAR) T-cell therapy. With two recently approved CAR T therapies targeting B-cell maturation antigen (BCMA), this novel platform has altered the treatment paradigm for heavily-pretreated patients with MM. The logical progression is to investigate if CAR T-cell therapy can challenge and supplant ASCT (with or without maintenance therapy) as a principal component of frontline MM therapy.

At the 10th Annual Meeting of the Society of Hematologic Oncology (SOHO 2022), Amrita Krishnan, MD, Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research, professor, Department of Hematology & Hematopoietic Cell Transplantation, and chief, Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope Cancer Center will debate this topic with Saad Z. Usmani, MD, MBA, FACP, chief, myeloma service, Memorial Sloan Kettering Cancer Center, New York, New York.

Krishnan is in favor of ASCT followed by maintenance therapy, but Usmani believes that CAR T-cell therapy will replace it. The hurdles that CAR T-cell therapy must overcome to replace ASCT are substantial, not only because of the proven efficacy of ASCT compared with other therapies but also because of ASCTs toxicity profile, the known effectiveness of subsequent therapies, and the favorable financial burden in comparison with CAR T-cell therapy. The debate will be September 29, 2022, at 1:58 pm during the meetings Multiple Myeloma session.

Evidence Supports Autologous Stem Cell Transplantation as the Current Standard for Frontline Consolidation

In the era predating novel MM therapies, the MRC Myeloma VII trial (NCT00002599) and an Intergroupe Francophone du Mylome (IFM; IFM2009) trial demonstrated an overall survival (OS) benefit of ASCT-based frontline therapy compared with prolonged nonmyeloablative conventional chemotherapy.4,5 The subsequent introduction of highly effective novel therapies led to similar studies comparing transplant and nontransplant frontline strategies (Table 16,7,8). The IFM 2009 study examined lenalidomide-bortezomib-dexamethasone (RVD) induction followed by ASCT vs RVD for 8 cycles without ASCT, with both arms receiving 1 year of lenalidomide maintenance.6,7 Although the primary end point of progression-free survival (PFS) was superior in the transplant arm, OS has remained statistically comparable. It results in part from the increased utilization of ASCT at first relapse among the nontransplant cohort (76.7%), but also the expansion of novel and immunotherapies available as salvage options. This study established that ASCT could be performed in the front line or at first relapse without sacrifice.

More recently, the phase 3 DETERMINATION study (NCT01208662) compared similar cohorts with those of IFM2009, with both arms receiving maintenance lenalidomide until progression or intolerance.8 Overall, the findings were similar to IFM2009 with superior PFS and comparable OS between cohorts. Notably, however, among patients with high-risk cytogenetics, ASCT yielded a particularly superior median PFS (55.5 months vs 17.1 months) and 5-year OS (63.4% vs 54.3%). To date, only a minority of patients at first relapse have received a subsequent ASCT (28%), although this proportion is expected to increase with longer follow-up.

Current State of CAR T as a Standard Therapy for Advanced Myeloma

CAR T therapy has revolutionized the treatment of advanced, relapsed/refractory MM, with the addition of 2 approved agents, idecabtagene vicleucel (ide-cel; Abecma) and ciltacabtagene autoleucel (cilta-cel; Carvykti); others are in clinical development.9 Ide-cel, in the pivotal phase II KarMMa trial (NCT03361748), yielded a median PFS of 8.6 months in a heavily pretreated patient population.10,11 At a median follow-up of 28 months in a similarly refractory cohort from CARTITUDE-1 (NCT03548207), the median PFS of cilta-cel had not yet been reached at the last analysis, with a 2-year PFS of 60.5% (Table 2).12,13 Responses with these cellular therapies are deep, especially with cilta-cel, for which recent highlights reported 55% sustained minimal residual disease (MRD) negativity (10-5) for 12 months or more, correlating with a 79% 2-year PFS.

Although ide-cel and cilta-cel are now established as a standard therapy option for eligible patients with triple-class refractory MM, data on earlier use are immature. CARTITUDE 2 (NCT04133636), a multiarm exploratory phase 2 trial, has reported early results from deploying cilta-cel in patients with 1 to 3 prior lines of therapy (cohort A) and patients with early relapse after 1 line of therapy (cohort B), both with complete response (CR) rates exceeding 80% and 6-month PFS rates exceeding 90%.14,15 However, the most provocative arm is exploring substitution of cilta-cel for ASCT as consolidation (Cohort E), which has yet to report findings. KarMMa-4 is similarly examining ide-cel for frontline consolidation in high-risk populations in lieu of ASCT.16 Although results of these studies will yield some insight into the feasibility of CAR T replacing ASCT, they are not powered to answer that question. The upcoming international phase III CARTITUDE-6/EMN trial (NCT05257083), however, will directly compare ASCT with cilta-cel, both following daratumumab plus RVD induction, in a study powered to assess coprimary end points of PFS and sustained MRD-negative CR (10-5 for 12 months).

The Imminent Collision between CAR T-cell Therapy and ASCT

CARTITUDE-6, and others pitting CAR T-cell therapy against ASCT as consolidation, will be required to answer questions beyond comparative efficacy. Whereas the cellular component of ASCT is solely for hematopoietic rescue, to date, the impact of intensive induction therapy on CAR T-cell therapy production, expansion, and function remains unclear, both from the standpoint of potential T-cell impairment and reduced in vivo antigenic stimulation.17

The toxicity profile of consolidative ASCT is well established and generally confined to the acute setting. Among 15,999 patients reported to the Center for International Blood and Marrow Transplant Research who received high-dose melphalan with ASCT between 2013 and 2017, 100-day nonrelapse mortality was 0% in those younger than 70 years and 1% among those 70 years or older.1 Among published studies, BCMA CAR T therapy has led to acute, life-threatening toxicities as well as delayed or prolonged adverse events such as cognitive and motor neurotoxicity, second primary malignancies, and delayed hematopoietic recovery.10,12 Although mitigation efforts have reduced immune-related toxicities, and fewer prior therapies will theoretically result in more resilient immune and hematopoietic systems, this residual robustness of the autologous CAR T-cell therapy cells could potentially raise the risk of immune-related toxicity in a relatively treatment-nave population.

Although ASCT with maintenance has long been the standard, substantial evidence exists demonstrating the efficacy of subsequent therapies after relapse.6 Frontline CAR T studies must also demonstrate that early use of CAR T-cell therapy does not impair therapies deployed after relapse, including stem cell collection and ASCT; therefore, PFS2 (time to second objective disease progression) and OS are imperative secondary end points.

High-dose melphalan with ASCT does have a transient negative impact on quality of life (QOL) metrics.18 Pivotal BCMA CAR T-cell therapy studies reported improvements in QOL, although many patients had advanced, symptomatic disease and the studies lacked control groups.19 Whether CAR T-cell therapy can meaningfully improve QOL among patients with controlled disease relative to standard of care remains to be seen.

Beyond PFS, all of the abovementioned end points (toxicity, QOL, OS, PFS2) are needed to gauge the relative efficacy and cost-effectiveness of these 2 modalities.20 With an established median PFS exceeding 5 years, a survival benefit among those with high-risk cytogenetics, manageable and predictable toxicity, and total treatment cost representing a fraction of that of CAR T-cell therapy, ASCT with maintenance is unlikely to be overtaken as frontline consolidation. Unless CAR T can effectively cure a substantial proportion of patients with MM, it would best serve patients as a complement to ASCT after relapse or potentially for those with suboptimal response to ASCT.

See more here:
In Multiple Myeloma, Will ASCT Survive Collision With CAR T-Cell Therapy? - Targeted Oncology

New York, Sept. 28, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Live Cell Imaging Market - Global Outlook & Forecast Market 2022-2027" - https://www.reportlinker.com/p06323431/?utm_source=GNW In 2021, North America accounted for the highest share of the global live cell imaging market.

Live cell imaging has revolutionized studying cells, processes, and molecular interactions. Imaging techniques for living cells allow scientists to study cell structures and processes in real-time and over time. Such factors have significantly impacted the growth of the market. A few of the most widespread applications include examining the structural components of a cell, the dynamic studying processes, and the localization of molecules.

MARKET TRENDS & DRIVERS

Rising Target Patient Population

Live cell imaging is a vital tool in the study of cancer biology. Although high-resolution imaging is indispensable for studying genetic and cell signaling changes in underlying cancer, live cell imaging is essential for a deeper understanding of the function and disease mechanisms. Around 400,000 children develop cancer every year. Developed and emerging countries are facing the burden of communicable diseases. Most developing countries get exposed due to several factors that include demographic, socio-economic, and geographic conditions. Hence, the growing number of deaths and chronic conditions drive the live cell imaging market.

Deep Learning & Artificial Intelligence

The role of Artificial intelligence (AI) in life science is rapidly expanding and holds great potential for microscopy. In the past, the power of microscopy for supporting or disproving scientific hypotheses got limited by scale, and the time associated with quantifying, capturing, and analyzing large numbers of images was often prohibitive. Recently, AI has made fast inroads into many scientific fields and the world of microscopy. AI-based self-learning microscopy shows the potential to produce high throughput image analysis that is more effortless and less time-consuming. Newer AI technology allows better visualization of unlabeled live cells over a prolonged period.

Increase in Funding for Cell & Gene Therapy

The demand for regenerative medicine has increased across developed countries, and investments in cell & gene therapy have grown drastically in recent years. The public and private sectors are at the forefront of funding cell and gene therapy developers. Recently, many government organizations and private firms have started funding many biotech start-ups and research institutes that invest in the R&D of cell and gene therapy products. According to the Alliance for Regenerative Medicines, there was a 164% jump in funding for cell & gene therapy in 2019 compared to 2017.

Advancements & Newer Imaging Techniques

Live cell imaging arises from scientific interest coupled with imaging and labeling technology improvements. Putting together various technological advancements with biological interests gives scientists many more ways to use live cell imaging. In particular, exciting progress in probe development has enabled a broad array of nucleic acids, proteins, glycans, lipids, ions, metabolites, and other targets to be labeled. Many recent advancements in microscopic technologies use software that enables a better quantitative image analysis of label-free images.

Also, current microscopy techniques limit the quantity and quality of information available to researchers and clinicians and harm the living cells during long-term studies. Hence new imaging technologies are being developed to overcome various limitations. These advancements will help towards future market growth. For instance, the progress of combining 3D fluorescence imaging and holotomography microscopy has overcome some limitations.

Growing Research-based Activities

In the past two decades, the spending on R&D and the introduction of newer drugs have increased rapidly. In 2019, the pharma industry spent around $83 billion on R&D. From 2010 to 2019, the number of novel drugs were approved, whose sales increased by 60% compared with the previous decade, with a peak of 59 new drugs approved in 2018. The rising amount of R&D expenditure and the number of R&D activities in the pharmaceutical sector has led to the significant growth of the market.

SEGMENTATION ANALYSIS

The global live cell imaging market by product includes sub-segments by equipment, consumables, and software. In 2021, the equipment sector accounted for the highest share in the global live cell imaging market.Under the equipment sector, live-cell imaging microscopes are opening novel and exciting avenues for studying cellular health, viability, colony formation, migration, and cellular responses to external stimuli. The demand for microscopes is at a larger scale, majorly due to the technological advancements in microscopes and increasing studies into cell behavior. Fluorescence microscopy, confocal microscopy, transmitted light microscopy, and other techniques are included in the global live cell imaging market by technique. Fluorescence microscopy held the largest share of 53.68% in the global live cell imaging market in 2021. Live-cell imaging techniques are involved in a wide spectrum of imaging modalities, including widefield fluorescence, confocal, multiphoton, total internal reflection, FRET, lifetime imaging, super-resolution, and transmitted light microscopy. An increasing number of investigations are using live-cell imaging techniques. Owing to these advances, live-cell imaging has become a requisite analytical tool in most cell biology laboratories. Cell biology, drug discovery, developmental biology, and stem cell are the application's primary segments of the live cell imaging market. In 2021, cell biology accounted for the highest share of 38.72% in the global live cell imaging market. The end-user market includes segments by pharma & biotech companies, academic & research institutes, and others. Academic and research institutions identify promising discoveries and seek to initiate their development and commercialization. Most new insights into biology, disease, and new technologies arise in academia, funded by public grants, foundations, and institutional funds. The discovery and development of new therapies have and will likely continue to require contributions from academic institutions and the biopharmaceutical industry.

Segmentation by Product Type Equipment Consumables Software

Segmentation by Technique Fluorescence microscopy Confocal microscopy Transmitted light microscopy Others

Segmentation by Application Cell Biology Drug Discovery Developmental Biology Stem Cells

Segmentation by End-Users Pharma & Biotech Companies Academic & research centers Others

GEOGRAPHIC ANALYSIS

By geography, the report includes North America, Europe, APAC, Latin America, and the Middle East & Africa. In 2021, North America accounted for the highest share of the global live cell imaging market.

Live cell imaging systems are used for diagnostics purposes, drug discovery & development, and precision medicine. The increase in healthcare expenditures and funding for R&D activities for live cells-driven drug discovery, development, and personalized medicine is one of the major driving factors for leading the North American region. Europe holds the second-largest share of the global market, owing to a growing patient population in need of new treatments such as stem cell therapy and gene therapy, an increasing number of drug approvals for precision medicine, government funding for research-based activities, rapid advancements in live cell imaging, and a variety of other factors.

The APAC region will likely witness the fastest growth in the global live cell imaging market. The significant factors behind this growth can be due to the constant rise in cancers and infectious diseases, growing demand for stem cell research studies, rising R&D expenditures, the increased utility of biomarkers for diagnostic purposes, rising awareness for cell & gene therapies, need for precision medicine, and advances in drug discovery & cell and biology development. However, Latin America and Middle East & Africa accounted for minimal shares in the global market.

Segmentation by Geography

North Americao THE USo Canada Europeo Germanyo Franceo UKo Italyo Spain APACo Japano Chinao Indiao South Koreao Australia Latin Americao Brazilo Mexicoo Argentina Middle East & Africao Turkeyo Saudi Arabiao South Africao UAE

COMPETITIVE LANDSCAPE

The leading players in the market are implementing various strategies such as marketing and promotional activities, mergers & acquisitions, product launches, and approvals. Also, high R&D investments and boosting distribution networks have helped companies enhance their market share and presence.

The global live cell imaging market includes global and regional players. Major players contributing to the market's significant shares include Agilent, Bruker, Carl Zeiss AG, Danaher, Merck KGaA, PerkinElmer, and Thermo Fisher Scientific. Other prominent players in the market include Axion (CytoSMART Technologies), Bio-Rad Laboratories, blue-ray biotech, Etaluma, Grace Bio Labs, ibidi GmbH, KEYENCE, NanoEnTek, Nanolive SA, Nikon, Olympus, and others.

Recent Developments in the Global Market

In 2021, CytoSMART launched CytoSMART Lux3 BR, a new type of bright-field microscope, i.e., a live-cell imaging microscope equipped with a high-quality CMOS camera to assist label-free cell imaging procedures. In 2021, the Zeiss group announced that they would launch Zeiss Visioner 1, a Zeiss live cell imaging system, an innovative digital microscope that facilitates real-time all-in-one focus via a micro-mirror array system. In 2020, CytoSMART Technologies launched CytoSMART Multi Lux, a remote live cell imaging system.

Key Vendors Danaher Agilent Technologies PerkinElmer Merck KGaA ZEISS Thermo Fisher Scientific

Other Prominent Vendors Axion BioSystems BD Bio-Rad Laboratories Blue-Ray Biotech Bruker Eppendorf Etaluma Grace Bio-Labs ibidi GmbH Intelligent Imaging Innovations KEYENCE Logos Biosystems NanoEntek Nanolive SA Nikon Evident ONI Oxford Instruments Phase Focus Phase Holographic Imaging PHI AB Proteintech Group Sartorius AG Sony Biotechnology Tomocube

KEY QUESTIONS ANSWERED1. What is the expected live cell imaging market size by 2027?2. What is the live cell imaging market growth?3. What are the latest trends in the live cell imaging market?4. Who are the market leaders in the global live cell imaging market?5. Which region has the largest live cell imaging market share?Read the full report: https://www.reportlinker.com/p06323431/?utm_source=GNW

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The global live cell imaging market is expected to grow at a CAGR of 8.44% during 2022-2027 - Benzinga

LONDON, Ontario, Sept. 28, 2022 (GLOBE NEWSWIRE) -- Sernova Corp. SVA SEOVF (FSE/XETRA:PSH), a clinical-stage company and leader in regenerative cell therapeutics, today announced it will be presenting at the upcoming Roth Inaugural Healthcare Opportunities Conference being held in-person in New York, NY on October 6, 2022. Company management will also be participating in one-on-one investor meetings at the conference.

Roth Inaugural Healthcare Opportunities Conference

Please contact your Roth representative to schedule one-on-one meetings with the management team during the conference.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative cell therapeutic technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders including hemophilia A. Sernova is currently focused on developing a functional cure' for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release necessary proteins or factors missing from the body to treat chronic diseases. Sernova's Cell Pouch System has already shown it can potentially provide a functional cure' to people with type 1 diabetes in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to cloak the therapeutic cells from the immune system attack with the goal to eliminate the need for chronic immunosuppressives. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also in development of two additional programs that utilize its Cell Pouch System an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

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.

Excerpt from:
Sernova to Participate in the Roth Inaugural Healthcare Opportunities Conference - Sernova (OTC:SEOVF) - Benzinga