Category Archives: Stell Cell Research

Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients – The New York Times

At least one outside expert said the approach could present safety risks. Paul Knoepfler, a stem cell researcher at the University of California, Davis, said that patients with coronavirus can develop severe reactions where their immune systems go too far in attacking cells in their lungs, causing damaging inflammation. Other cell therapies tested in China are designed to dampen the immune response. He said one risk with the natural killer cells is they could go in the other direction, exacerbating respiratory problems by massive killing of the patients respiratory cells.

Despite the scant evidence, Mr. Giuliani has become an early booster, interviewing Dr. Hariri on a podcast published on his website Saturday, and praising the treatment on Twitter, saying, this therapy has real potential. In a tweet on Saturday, he added, Lets hope F.D.A. can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.

Around the same time, Twitter deleted a post by Mr. Giuliani that it said violated its rules. The tweet, from March 27, made unfounded claims about the malaria drug hydroxychloroquine, one of the treatments that Mr. Trump has supported.

Dr. Hariri said that he has known Mr. Giuliani for years and that the appearance on his podcast was a friendly chat between people who know each other and who share a common interest in this particular response to this disease.

He said that he has no business relationship with Mr. Giuliani, and that Mr. Giuliani is not representing him in any way, either paid or unpaid. I dont have anything to do with what the mayor tweets or whatnot, and I dont agree or disagree with anything, he said.

Dr. Hariri said the company would follow the established process for testing whether a drug works. We have waited for the F.D.A. to complete their review, which they did in a heroic and quick fashion, he said.

On Wednesday evening the same day the F.D.A. approved his trial Dr. Hariri praised the appearance by the agencys commissioner, Dr. Stephen Hahn, on the conservative Fox News talk show The Ingraham Angle.

We are fortunate to have Dr. Hahn at the helm, he tweeted.

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Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients - The New York Times

Stem Cell Therapy for Colon Cancer – Yahoo Finance

WASHINGTON, April 2, 2020 /PRNewswire/ -- An article published in Experimental Biology and Medicine (Volume 245, Issue 6, March 2020) (https://journals.sagepub.com/doi/pdf/10.1177/1535370220910690) examines the safety of stem cell therapy for the treatment of colon cancer.The study, led by Dr. J. Liu in the State Key Laboratory of Bioreactor Engineering and Shanghai Key Laboratory of New Drug Design at the East China University of Science and Technology in Shanghai (China), reports that mesenchymal stem cells from a variety of sources promote the growth and metastasis of colon cancer cells in an animal model.

Mesenchymal stem (MSCs), a category of adult stem cells, are being evaluated as therapy for numerous cancers.MSCs are excellent carriers for tumor treatment because they migrate to tumor tissues, can be genetically modified to secrete anticancer molecules and do not elicit immune responses.Clinical trials have shown that MSCs carrying modified genes can be used to treat colon cancer as well as ulcerative colitis. However, some studies have demonstrated MSCs can differentiate into cancer-associated fibroblasts and promote tumor growth.Therefore, additional studies are needed to evaluate the safety of MSCs for targeted treatment of colon cancer.

In the current study, Dr. Liu and colleagues examined the effects of mesenchymal stem cells (MSCs) from three sources (bone marrow, adipose and placenta) on colon cancer cells.MSCs from all three sources promoted tumor growth and metastasis in vivo. In vitro studies demonstrated that MSCs promote colon cancer cell stemness and epithelial to mesenchymal transition, which would enhance tumor growth and metastasis respectively.Finally, the detrimental effects of MSCs could be reversed by blocking IL-8 signaling pathways. Dr. Ma, co-author on the study, said that "Mesenchymal stem cells have a dual role: promoting and/or suppressing cancer. Which effect is dominant depends on the type of tumor cell, the tissue source of the MSC and the interaction between the MSC and the cancer cell. This is the major issue in the clinical application research of MSCs, and additional preclinical experimental data will be needed to evaluate the safety of MSCs for colon cancer treatment."

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology & Medicine, said: "Lui and colleagues have performed elegant studies on the impact of mesenchymal stem cells (MSCs), from various sources, upon the proliferation, stemness and metastasis of colon cancer stem cells (CSCs) in vitro and in vivo. They further demonstrate that IL-8 stimulates the interaction between colon CSCs and MSCs, and activates the MAPK signaling pathway in colon CSCs.This provides a basis for the further study of MSCs as a biologic therapy for colon cancer."

Experimental Biology and Medicine is a global journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. The journal was first established in 1903. Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership, visit http://www.sebm.org. For anyone interested in publishing in the journal, please visit http://ebm.sagepub.com.

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Stem Cell Therapy for Colon Cancer - Yahoo Finance

Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa – BioSpace

HAMBURG, Germany and TORONTO, April 2, 2020 /CNW/ - Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the innovative biotechnology company panCELLa Inc. announced today that the companies have entered into a licensing and investment agreement.

Under the terms of the agreement, Evotec will receive a non-exclusive licence to access panCELLa's proprietary iPS cell lines "iACT Stealth Cells", which are genetically modified to prevent immune rejection of derived cell therapy products ("cloaking"). Furthermore, Evotec will also have access to a new-generation cloaking technology known as hypoimmunogenic cells. In addition, the "FailSafe" mechanism effectively addresses a key challenge in iPSC-based cell therapy, potential tumour formation by residual undifferentiated cells.

Using the cell lines, Evotec will be able to develop iPSC-based, off-the-shelf cell therapies with long-lasting efficacy that can be safely administered to a broad population of patients without the use of medication to supress the patients' immune system. With a growing portfolio of iPSC-based cell therapy projects at Evotec, access to research as well as GMP-grade iPSC lines modified with one or both of the panCELLa technologies significantly accelerates Evotec's cell therapy discovery and development efforts. Modified iPSC lines will be available for the development of cell therapy approaches across a broad range of indications by Evotec and potential partners. Furthermore, Evotec has made an investment to take a minority stake in panCELLa and has nominated Dr Andreas Scheel to join panCELLa's supervisory board.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Cell therapies hold enormous potential as truly regenerative or curative approaches for a broad range of different diseases with significant medical need. Integrating panCELLa's technology and cell lines into our ongoing proprietary research and development efforts strengthens Evotec's position in cell therapy. It is our goal to provide safe highly-effective cell therapy products to as many patients as possible. In addition to small molecules and biologics, cell therapy will become yet another major pillar of Evotec's multimodality discovery and development platform."

Mahendra Rao, MD, PhD, CEO at panCELLa, added: "We welcome the partnership with Evotec. Evotec's widely recognised expertise and existing portfolio of iPSC-related technology platforms will allow panCELLa to rapidly advance its own therapeutic interests in NK cell therapy, pancreatic islet production and iPSC-derived MSC platform, in addition to enabling panCELLa to make its platform technologies widely available. I believe that the investment by Evotec in our company is a strong validation of the leading role of panCELLa in the field of regenerative medicine and in the utility of its platform technologies. We welcome Dr Andreas Scheel to our Board."

No financial details of the agreement were disclosed.

About Evotec and iPSCInduced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka's lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon "for the discovery that mature cells can be reprogrammed to become pluripotent". Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec's iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company's proprietary EVOcells platform.

About cell therapy and panCELLa's FailSafe iPSC technologyCell therapy, one of the most promising regenerative medicine approaches, replaces a patient's missing or broken cells with functioning cells from a range of different sources, either from a donor, from the patient's own material, or from stem cells. The advent of induced pluripotent stem cells ("iPSC") has opened up stem cells as an almost unlimited source of consistent-quality material for such cell therapies. At the same time, differentiating cell therapies from a single validated source circumvents critical risks of contamination associated with administering both donor and patient cell material.

However, the patient's immune system will treat such iPSC-based transplant as "foreign" and use the body's immune system to counteract the therapy, thus undermining its long-term efficacy. While organ transplants require an often lifelong regimen of immunosuppressants, iPSC-derived cells used for cell therapies can be cloaked to make them undetectable by the patient's immune system, thus avoiding rejection and enabling effective long-term relief of the patient's symptoms.

To increase the safety of such iPSC-derived cell products, panCELLa's proprietary FailSafe technology is able to inactivate any iPSC-derived proliferating cell before and after transplantation through the use of a readily available anti-infective medication. FailSafe is the only quantifiable "safety switch" on the market which is expected to be critical for regulators, clinicians and patients to make informed decisions when evaluating treatment options.

About panCELLa Inc. Incorporated in August 2015, panCELLa (www.pancella.com) was founded by Dr Andras Nagy and Dr Armand Keating based on Dr Nagy's ground-breaking work in the area of stem cell research. Through panCELLa, Drs Keating and Nagy are seeking to create an effective cell therapy derived from stem cells, which are modified to provide a sufficient and very high level of safety before and after the cells are introduced to the patient. panCELLa serves those companies developing products from stem cells. panCELLa seeks to create universal "off the shelf" FailSafe Cells and to assist pharmaceutical and biotechnology sectors to achieve such with their own cell lines. Targeted medical applications include deadly, debilitating, or aggressive diseases requiring immediate treatment where there is no time to cultivate a customized stem cell treatment from the patient (i.e. cancer, cardiac infarct, diabetes, stroke and spinal cord injury).

About Evotec SEEvotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,000 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to http://www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTSInformation set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

SOURCE panCELLa Inc.

Company Codes: Frankfurt:EVT, OTC-PINK:EVTCY

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Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa - BioSpace

Fluidigm CyTOF Technology Used to Evaluate Stem Cell Therapy as a Potential Treatment for COVID-19 Pneumonia – Yahoo Finance

SOUTH SAN FRANCISCO, Calif., April 02, 2020 (GLOBE NEWSWIRE) -- Fluidigm Corporation(FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that Fluidigm CyTOF technology was used in a clinical study producing preliminary evidence that mesenchymal stem cell (MSC) therapy improves outcomes in patients with COVID-19 pneumonia, providing key information about potential mechanisms of action of the treatment strategy.

Results of the study, conducted by researchers in China, have been published in Aging and Disease.1

We used a 36-marker CyTOF panel to generate a broad immune profile of each patients peripheral blood before and after transplantation, said Wenjing Wang, PhD, Associate Professor at Beijing Hepatology Research Institute, Youan Hospital. Mass cytometry allowed us to look at all immune populations of interest in a single tube of peripheral blood mononuclear cells, enabling us to use less sample and to simplify our workflow and analysis.

The study, which evaluated clinical outcomes as well as changes in inflammatory and immune function for 14 days in seven patients with COVID-19 pneumonia, indicated that intravenous transplantation of MSCs was a safe and effective treatment for patients with COVID-19 pneumonia, including for those in severe condition.

Pulmonary function and symptoms of these seven patients were significantly improved within two days of MSC transplantation. Three of the patients, including one classified as severe, recovered and were discharged 10 days after treatment.

CyTOF analysis found that MSC treatment of severe cases led to disappearance in three to six days of overactivated cytokine-secreting immune cells and increases in regulatory T and dendritic cells. Importantly, there was a dramatic increase in a population of CD14+CD11c+CD11bmidregulatory dendritic cells, which may have helped to tamp down the cytokine storm associated with COVID-19 respiratory disease. Separate analysis of patient serum found significant reduction in levels of TNF-, a potent inflammatory cytokine, while IL-10, an anti-inflammatory cytokine, increased in the MSC treatment group compared to the placebo control group.

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This level of new and valuable treatment research based on broad-based immune profiling is an important front in the COVID-19 fight, said Chris Linthwaite, President and CEO of Fluidigm. Fluidigm is actively engaged with many researchers in government and medical institutions who are addressing the COVID-19 pandemic from the perspectives of both immune profiling and virus detection and testing, and this study underscores the critical role that our technologies are playing in the global response to the outbreak.

In addition to our instruments, our assays and analysis software are increasingly the focus of customers in the global research community exploring immune profiling of COVID-19 infected populations. Our Maxpar Direct Immune Profiling Assay and Maxpar Pathsetter analysis software are a solution for labs seeking an easily deployed, fixed panel that can incorporate novel exploratory markers as well as standard markers, Linthwaite said.

We are inspired by this opportunity to provide meaningful tools in efforts to develop innovative solutions to this rapidly evolving pandemic.

About FluidigmFluidigm(FLDM) focuses on the most pressing needs in translational and clinical research, including cancer, immunology, and immunotherapy. Using proprietary CyTOF and microfluidics technologies, we develop, manufacture, and market multi-omic solutions to drive meaningful insights in health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies. Our customers are leading academic, government, pharmaceutical, biotechnology, and plant and animal research laboratories worldwide. Together with them, we strive to increase the quality of life for all. For more information, visitfluidigm.com.

Fluidigm, theFluidigmlogo, CyTOF, Direct, Immune Profiling Assay, Maxpar, and Pathsetter are trademarks and/or registered trademarks ofFluidigm Corporationinthe United Statesand/or other countries. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.

Forward-Looking Statements for FluidigmThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding the implementation of Fluidigm microfluidics technology and products by third parties and the anticipated benefits of, and applications and demand for, such products. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to risks relating to the potential adverse effects of the coronavirus pandemic on our business and operating results during 2020; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks relating to company research and development and distribution plans and capabilities; interruptions or delays in the supply of components or materials for, or manufacturing of, Fluidigm products; potential product performance and quality issues; intellectual property risks; and competition. Information on these and additional risks and uncertainties and other information affectingFluidigmbusiness and operating results is contained in Fluidigms Annual Report on Form 10-K for the year endedDecember 31, 2019, and in its other filings with theSecurities and Exchange Commission. These forward-looking statements speak only as of the date hereof.Fluidigmdisclaims any obligation to update these forward-looking statements except as may be required by law.

1 Leng, Z., Zhu, R., Hou, W. et al. Transplantation of ACE2 mesenchymal stem cells improves the outcome of patients with COVID-19 pneumonia. Aging and Disease 11 (2020): 216228.

Contacts:

Media:Mark SpearmanSenior Director, Corporate Communications650 243 6621mark.spearman@fluidigm.com

Investors:Agnes LeeVice President, Investor Relations650 416 7423agnes.lee@fluidigm.com

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Fluidigm CyTOF Technology Used to Evaluate Stem Cell Therapy as a Potential Treatment for COVID-19 Pneumonia - Yahoo Finance

Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19…

CRANFORD, N.J., April 1, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome (ARDS) from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.

Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.

"ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven COVID-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS. We believe Novellus is at the forefront of creating allogeneic, iPSC-derived MSCs. These cells have the potential to overcome the limitations of MSCs derived from adult donors, which are telomere shortened and introduce variability into the manufacturing process," said Citius Chief Executive Officer Myron Holubiak.

Novellus Chief Science Officer Matt Angel, PhD, stated, "Using our mRNA-based cell-reprogramming technology, Novellus can provide a near-unlimited supply of MSCs for treating patients with ARDS, including those critically ill from COVID-19. These will be allogeneic ('off-the-shelf') cells that in vitro have demonstrated much greater expansion potential and much higher immunomodulatory protein expression than donor-derived MSCs. We are excited to employ our technology to such an urgent medical crisis and believe that our MSCs represent an ideal source of cells to be used in this extremely important development effort."

Holubiak added, "No effective pharmacotherapy for ARDS exists, and ARDS-related morbidity and mortality are high. MSCs have been studied in the treatment of lung injury, and we aim to build upon this work with Novellus's iPSC-derived MSCs to improve the immunomodulatory response in humans. We have assembled a team of experts who are dedicated to advancing this project to an Investigational New Drug (IND) application as quickly as possible."

About ARDSAcute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain, particularly while inhaling, and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Novellus, Inc.Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellus-inc.com.

Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and our Phase III trial for Mino-Lok; risks relating to the results of research and development activities; risks associated with developing our product candidates, including any licensed from Novellus, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close, and integrate product candidates and companies successfully and on a timely basis; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677ascott@citiuspharma.com

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SOURCE Citius Pharmaceuticals, Inc.

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Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19...

Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results – Yahoo Finance

Achieved Primary Investigational New Drug (IND) Approval in the U.S.; Positioned to Commence Patient Enrollment

Maintained Clinical Progress in Israel and Nearing Completion of Phase 1/2 Trial

Strategic Commercial Agreement with Canndoc Anticipated to Generate Significant Revenue; Closing of Merger Transaction Progressing as Planned

TEL AVIV, Israel, April 3, 2020 /PRNewswire/ -- Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of a novel stem cell production technology, today announced operating and financial results for the fourth quarter and full year ended December 31, 2019.

"We achieved a number of strategic priorities in 2019, including the IND approval to commence our first-ever trial in the U.S.," commented Dr. Shai Yarkoni, Chief Executive Officer."We plan to begin enrolling patients for this trial and completing the trial in Israel when the COVID-19 pandemic is mitigated. While these near-term events are value-enhancers, I believe that our recently announced prospective partnership with Canndoc could be a game-changer for Cellect and change our growth trajectory. It has the potential to significantly enhance our short and long term business prospects and shareholder value. As a player in the fast-growing pain management market, we would anticipate significant revenue opportunities already this year."

Recent Strategic Development

As previously announced, on March 4, 2020, the Company entered into a commercial binding Letter Of Intent (LOI) with Canndoc Ltd, a leading pharma grade medical cannabis pioneer and a wholly owned subsidiary of publicly-traded Intercure Ltd. (TASE: INCR),to acquire from Canndoc all rights to the use and sell Canndoc products for the reduction of opioid usage, including accumulated data, as well as on-going and pipeline of clinical trials. This commercial arrangement is subject to negotiation and approval by each company's board of directors and definitive agreements.

Additionally, the two companies signed a non-binding LOI for a full merger. Under preliminary details, Cellect will acquire from Intercure all of Canndoc outstanding shares, in exchange for additional Cellect ADRs to be in total ~95% (~93% on a fully diluted basis) of the merged company. The proposed merger is subject to independent valuation of both companies, fairness opinion by a third party, negotiation of a definitive agreement, approval of the agreement by the Company's Board of Directors and shareholders, internal approvals by Canndoc and Intercure, and customary closing conditions, including the approval of the IMCA (Israeli Medical Cannabis Agency). Upon the closing of the merger, Cellect and Canndoc will aim to fulfill all of the requirements to ensure the Company's ADRs and warrants continue trading on the Nasdaq Stock Market (Nasdaq) and, for this purpose, Intercure would commit to invest a cash sum of at least $3.0 million in any public offering that is undertaken by the Company, at a price of not less than $4.50 per ADR.

Based on the progress to date, the Company continues to expect the commercial and merger transactions will close in the second quarter of 2020.

Additional Operating Highlights:

Clinical Progress Update:

Due to the ongoing COVID-19 pandemic, the Company is experiencing clinical disruption such as:

The Company continues to take all the necessary precautions advised by global health officials to ensure the health and safety of its employees and partners. The Company is unaware of any impact on employees from pandemic related exposure or illness and is continuing to perform in-house research, including in the opioid/pain management area.

Fourth Quarter and Full Year 2019 Financial Results:

Balance Sheet Highlights:

For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2019 (U.S. $1 = NIS 3.456).

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

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Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's intent regarding the future potential of Cellect's technology. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Cellect Biotechnology Ltd

Consolidated Statement of Operation

Convenience

translation

Twelve months

ended

Twelve months ended

Three months ended

December 31,

December 31,

December 31,

2019

2019

2018

2019

2018

Unaudited

Audited

Audited

Unaudited

Unaudited

U.S. dollars

NIS

(In thousands, except share and pershare data)

Research and development expenses

3,508

12,122

13,513

2,571

4,040

General and administrative expenses

2,954

10,210

15,734

2,378

4,733

Operating loss

6,462

22,332

29,247

4,949

8,773

Financial expenses (income) due towarrants exercisable into ADS

(2,032)

(7,022)

(7,719)

998

(4,784)

Other financial expenses (income), net

433

1,498

(1,415)

129

(238)

Total comprehensive loss

4,863

16,808

20,113

6,076

3,751

Loss per share:

Basic and diluted loss per share

0.023

0.079

0.155

0.027

0.029

Weighted average number of sharesoutstanding used to compute basic anddiluted loss per share

212,642,505

212,6432,505

129,426,091

224,087,799

130,274,953

Cellect Biotechnology Ltd

Consolidated Balance Sheet Data

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Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results - Yahoo Finance

Fate inks $100M J&J pact for ‘off-the-shelf’ cancer cell therapies – BioPharma Dive

Dive Brief:

First-generation autologous CAR-T therapies involve genetically edited immune cells taken directly from patients in a lengthy, logistically challenging and costly procedure. Fate is one of a group of companies advancing an "off-the-shelf" cell therapy approach, which utilizes cells taken from healthy donors.

It's an emerging field of research that's still in its early stages. Only slivers of human data have been published thus far. These companies have yet to prove off-the-shelf approaches can match, or surpass, what has been seen with CAR-T without triggering serious or potentially deadly immune reactions.

But pharma has made notable investments in the work, which could lead to treatments that are quicker and less costly to produce than their autologous counterparts. Among them: Pfizer's wide-ranging deal with Allogene Therapeutics in 2018 as well as Bayer's buyout of BlueRock Therapeutics and investment in Century Therapeutics last year.

Entering this year, the allogeneic field looked set to take some steps forward. As analyst firm Jefferies noted in March, Precision,AllogeneTherapeutics and CRISPRTherapeutics, which each use different off-the-shelf approaches, could all produce notable human data this year.

The coronavirus pandemic, however, has threatened clinical research timelines across the industry, disrupting study enrollment and treatment.

Fate is in the mix, too, though it acknowledged COVID-19 could impact its plans. In announcing the J&J deal, Fate also warned of coronavirus-related "delays or disruptions in patient enrollment and site initiation" that will affect the timing of its clinical trials. It didn't provide specific details.

The J&J partnership does give Fate some breathing room. The San Diego biotech is getting $100 million to produce up to four new therapies that J&J will have the option to license, while J&J covers the associated R&D costs. Fate could receive another $3 billion in various conditional payments tied to regulatory and sales milestones if all goes to plan, though those payments may never materialize.

"From speaking to management, we think this is exactly the type of deal [Fate] was looking for," wrote Cantor Fitzgerald analyst Alethia Young, referring to a back-loaded agreement that gives the company the chance to keep some rights to the programs in the alliance.

Young wrote the deal is also "a strong validation" of Fate's approach, which draws from stem cell and CAR-T technologies.Fate turns cells from donors into induced pluripotent stem cells, which in turn can be re-engineered into a variety of different cells. In their partnership, for instance, Fate and J&J aim to create certain types of immune cells natural killer, or NK cells, and T cells that can hunt down tumors.

The partnership doesn't include any of the other treatments currently in Fate's pipeline. Shares climbed about 20%, to around $25 apiece, in pre-market trading Friday.

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Fate inks $100M J&J pact for 'off-the-shelf' cancer cell therapies - BioPharma Dive

Using Microparticles to Repair and Detox Cardiac Muscle – News-Medical.net

Heart disease is one of the most common pathological conditions in the human body. Cardiac tissue can be damaged through any number of means, including genetic predispositions, lifestyle choices, and infection. Research into new and novel applications to provide therapeutic and regenerative benefits has been ongoing for many years now. One approach recently has been the use of microparticles.

Image Credits: Choksawatdikorn / Shutterstock.com

Microparticles are small in size, in the range of 1-1000 m. They are commonly found in nature, occurring as pollen, dust, sand, flour, as well as in biological cells where they play roles in biologically important functions including being involved in apoptosis, cell activation, cell signaling, and autoimmune responses. Synthetic microparticles have been developed to perform a number of functions.

Microparticles have useful physical and chemical properties that make them suitable for a variety of applications. Their small volume compared to their surface area is especially desirable. They can also be engineered to give them specific properties that are tailored to the task they are needed to perform.

This can include resistance or susceptibility to low or high temperatures, insolubility or solubility in organic solvents dependant on cross-linking in the chemical structure, specific porosity of the surface membrane, high monodispersity and uniformity of shape, and many more properties besides.

Within the biomedical sciences, the ability to engineer microparticles based on synthetic or natural materials is pushing the science to the forefront of the field and is finding new cutting-edge solutions for drug delivery, gene therapy, and a myriad of therapies.

Cardiovascular disease is the leading cause of death worldwide. According to the World Health Organization, around 18 million people die each year, an estimated 31% of all deaths globally. Four out of five instances of cardiovascular fatalities are from heart attacks and strokes, and about one-third of them occur in people under 70 years of age.

Those who suffer from raised blood pressure and obesity, and people who make unhealthy lifestyle choices including smoking, are at particular risk, but congenital heart defects can cause early death as well.

Pathologies resulting in atherosclerosis and coronary artery disease lead to myocardial cell death following myocardial infarction. Furthermore, after cell death, the cardiac muscle tissue does not regenerate overall and is replaced by connective tissue, which is non-contractile. This causes weakening of the heart muscle, which is then unable to fully contract and thus heart failure usually follows.

Traditionally, the main approach to treating cardiovascular disease has been the use of pacemakers and heart transplants. However, these approaches are not without their problems: pacemakers have to be replaced and maintained, which can prove costly and may require repeat visits to the hospital; and heart transplants can be difficult to source and can be rejected by the patient. New approaches are therefore clearly needed.

For over 50 years, scientists and physicians have been carrying out research into ways to repair cardiac muscle following a heart attack. There have been several medications and procedures developed that have significantly improved heart function, but none have had the ability to actively regenerate damaged cardiac muscle. Current, widely used therapies do not give patients the desired degree of pre-heart attack activity levels. The use of micro- and nanoscale particles has recently been explored.

MicroRNA has been explored as one possibility. This is due to the role microRNAs play in the regulation of gene expression as well as their involvement in modifications at the post-transcriptional level. Microparticles can aid in the delivery of microRNA, leading to the proliferation of cardiomyocytes, which are cells that make up cardiac muscle, leading to tissue regeneration. The most potent microRNAs found include human miR-1825 and miR-99a-5p.

Another promising approach has been the use of biodegradable microparticles to deliver neuregulin, a growth factor that aids in inducing cell differentiation and growth into infarcted cardiac tissue. The microparticles used are formed from polylactic glycolic acid and polyethylene glycol, and they slowly degrade over a period of 12 weeks, releasing the neuregulin in a slow and controlled manner.

Another useful element of these microparticles is that they are resistant to immune cells, providing advantages for targeted delivery. Delivering the particles via a spray method as a biodegradable glue has been explored.

Other possibilities have been explored in the field of stem cell research and delivering/transplanting them into infarcted cardiac tissue so that new muscle cells can be formed and proliferate. Microparticles clearly can play a role in controlled and targeted delivery to these cells.

Further research has been carried out into the detoxification of defective heart muscle. In research published online in 2020, a team led by Zhenhua Li described the use of artificial platelet microparticles to deliver IL-1 blockers in a targeted way. IL-1 (Interleukin-1) is involved in the bodys inflammatory response to an acute myocardial infarction.

Conventional blockers lack the specificity of targeting, which can lead to serious detrimental side-effects. The team hopes that by delivering the blockers in this way they can bind to the injured heart and provide an efficient detoxification method for injured cardiac muscle.

Heparin microparticles used to deliver bone morphogenetic protein - Image Credits: Marian Hettiaratchi / EurekAlert.com

Heart disease is a public health problem that affects millions of people worldwide, leading to reduced quality of life and untimely death for many.

Targeted therapies that aim to repair cardiac muscle and provide efficient levels of detoxification are currently in development, though researchers admit that they have much work to do to understand the mechanisms of heart repair and the potential of these therapies in a practical manner that can aid in the development of the next generation of cardiovascular medicine. Microparticles may provide a unique approach to these issues and provide cutting-edge treatment options.

Topic Overview: Cardiovascular Diseases World Health Organisation https://www.who.int/health-topics/cardiovascular-diseases/#tab=tab_1

Duelen, R and Sampaolesi, M (2017) Stem Cell Technology in Cardiac Regeneration: A Pluripotent Stem Cell Promise EBioMedicine Vol. 16 Pgs. 30-40 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5474503/

Kochegarov, A and Lemanski, L.F. (2016) New Trends in Heart Regeneration: A Review J Stem Cells Regen Med Vol. 12 Issue 2 Pgs. 61-68 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5227105/

Li. Z et al. (2020) Targeted antiIL-1 platelet microparticles for cardiac detoxing and repair Science Advances Vol. 6 No. 6 https://advances.sciencemag.org/content/6/6/eaay0589

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Using Microparticles to Repair and Detox Cardiac Muscle - News-Medical.net

ReNeuron assessing potential of emerging cell technology in the coronavirus fight – Proactive Investors UK

It has developed a line of the human exosomes that can deliver a medically relevant payload; viral vaccines, for example

() has said it is assessing the potential of an emerging celltechnology to help in the fight against the coronavirus (COVID-19).

It has developed a line of the human exosomes that can deliver a medically relevant payload; viral vaccines, for example.

Previously presented, unpublished data show that ReNeuron's exosomes can be loaded with biologically active cargo and delivered preferentially to certain specific sites in the body, the company said in a statement.

This research is in its initial stages, the goal being to establish whether an increase in the potency of SARS-CoV-2 coronavirus vaccines in development can be enhanced in this way, utilising ReNeuron's established expertise in exosome isolation, modification and manufacture at scale.

The insight was provided alongside a wider update on progress in the face of the COVID-19 outbreak, which has led to wholesale lockdowns on both sides of the Atlantic.

The stem cell specialist said the disruption will inevitably lead to delays in the recruitment of patients to trials of its treatments for people with stroke disability and a degenerative eye condition called retinitis pigmentosa.

It said it will update on how this will affect the release of top-line data from the two studies once it knows the full impact of the restrictions.

ReNeurons priority internal research, meanwhile, is progressing to current timelines. The firm said it is adhering to safety guidelines in the labs with a rota system and, where possible, work is being done from home.

The safety of employees, suppliers, clinical trial participants and all other people with whom the company interacts is of over-riding importance to the company, investors were told.

Finally, ReNeuron's exclusive licensing partner in China, Shanghai Fosun, has recently filed to open clinical sites to take part in the ongoing PISCES III clinical trial in stroke disability.

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ReNeuron assessing potential of emerging cell technology in the coronavirus fight - Proactive Investors UK

Seneca Biopharma Announces Executive Appointments and Key Promotion – Herald-Mail Media

GERMANTOWN, Md., April 1, 2020 /PRNewswire/ --Seneca Biopharma, Inc. (Nasdaq: SNCA), a clinical-stage biopharmaceutical company developing novel treatments for diseases of high unmet medical need, announced today the appointment of Matthew W. Kalnik, Ph.D. as President and Chief Operating Officer (COO) and Dane R. Saglio as Chief Financial Officer (CFO). Seneca also promoted Thomas Hazel, Ph.D. to the newly created position of SVP of Research and Development.

"We are thrilled to welcome Matt and Dane to the executive team," said Kenneth C. Carter, Ph.D., Seneca's Executive Chairman. "They are seasoned professionals who bring decades of operational, financial and industry expertise to Seneca, and I look forward to working with them as we transform the company and build Seneca for the future. With Dr. Hazel in his new role as SVP of Research and Development, we are focused on developing promising new medicines that can generate value for our shareholders and provide opportunities for growth as our company matures."

Dr. Kalnik brings over 25 years of industry experience in senior research and development and business development roles to Seneca. He joins Seneca from Antidote Therapeutics, which he founded to develop novel nicotine-blocking therapies for treating diseases caused or worsened by nicotine, and established a multi-year strategic collaboration with the National Cancer Institute. Previously, Dr. Kalnik was Senior Vice President and Officer, Strategic Planning & Business Operations at Nabi Biopharmaceuticals, playing a key role in bringing NicVAX from Phase 2 to Phase 3. Earlier, he served in executive positions at Daiichi Medical Research, Genaissance (now Allergan) and Pfizer. Over his career, he has led efforts to in-license or acquire drug candidates and emerging technologies, as well as establish innovative drug discovery and development partnerships. He holds a Ph.D. in Biochemistry & Molecular Biophysics from Columbia University and conducted his post-doctoral fellowship at the Department of Molecular Biology at The Scripps Research Institute, La Jolla.

Dr. Kalnik, President and COO of Seneca, commented, "I am excited to join Seneca as we expand efforts to build a new pipeline of innovative drugs that address areas of high unmet medical need. Our team is well suited to execute on our acquisition and in-licensing strategy to transform Seneca."

Mr. Saglio brings over three decades of operational and financial experience in private and publicly traded companies to Seneca. Previously, Mr. Saglio served as CFO at RegeneRx Biopharmaceuticals, New Generation Biofuels, and EntreMed, all public companies in the biotechnology and pharmaceutical industry. Prior to joining Seneca as a consultant in August 2019, he served as CFO at Celios Corporation from October 2017 until July 2019 and Helomics Corporation, a personalized medicine company in cancer from October 2014 through July 2017. He began his career at Informatics Corp, now Computer Associates International, and at Bressler & Reiner, a DC-based real estate developer and home builder. Mr. Saglio earned his BS degree in business administration from the University of Maryland and is a licensed CPA in Maryland (inactive).

Dr. Hazel has held senior leadership positions in biotechnology companies for nearly 20 years and has over 25 years of experience in the stem cell field. He joined Seneca (formerly Neuralstem) in 1998 and has served in senior positions within the Company for 17 years, leading development of the company's platform technology, preclinical research efforts, and stem cell manufacturing activities in the US and China. From 2004-2008, Dr. Hazel served in senior leadership positions at Innovative Biosensors, a biotechnology company focused on the development of cell-based assays, where he played a key role in technology development and corporate fund-raising activities. Dr. Hazel received his Ph.D. in Genetics from the University of Illinois at Chicago and did post-doctoral research at the National Institutes of Health.

About Seneca Biopharma, Inc.

Seneca Biopharma, Inc. is a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need. The Company is in the process of transforming the organization through the acquisition or in-licensing of new science and technologies for development under its seasoned management team, with the goal of providing meaningful therapies for patients.

Cautionary Statement Regarding Forward Looking Information:

This news release contains "forward-looking statements" made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as "expect," "anticipate," "intend," "plan," "believe," "seek" or "will." Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements includethe completion of the offering, including the satisfaction of the closing conditions, and the use of anticipated proceeds,risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, market conditions, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time inSeneca'speriodic reports, including its Annual Report on Form 10-K for the year endedDecember 31, 2019, as well as our Quarterly Reports on Form 10-Q, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements, except as required by law.

Contact:

Hibiscus Bioventuresjosh@hibiscusbio.com

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Seneca Biopharma Announces Executive Appointments and Key Promotion - Herald-Mail Media