Stem Cell Clinic

FDA Grants Orphan Drug Designation to Temferon for Treatment of … – BioSpace

MILAN and NEW YORK, March 02, 2023 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Temferon for the treatment of glioblastoma multiforme (GBM).

"We expect that the FDAs decision to grant Orphan Drug Designation to Temferon will enhance the development of our cell therapy, which we believe has the potential to address the unmet medical need of patients and strengthen our clinical program," said Pierluigi Paracchi, Chief Executive Officer of Genenta. "The Orphan Drug Designation program highlights the significant need for an efficacious therapy for patients suffering from glioblastoma multiforme."

Temferon is a proprietary cell therapy designed to reprogram the tumor microenvironment by delivering immunomodulatory molecules directly to tumors. Genenta is testing Temferon in an ongoing Phase 1/2a clinical trial in newly diagnosed patients with GBM who have an unmethylated MGMT gene promoter (uMGMT-GBM).

GBM is the most common malignant primary brain tumor and the most aggressive diffuse glioma, with unmethylated MGMT promoter status identified in approximately 60% of the GBM population.

The ODD program supports the development of treatments that address diseases affecting fewer than 200,000 people in the United States (which equates to approximately 6 cases per 10,000 population). Incentives that come with the designation include eligibility for federal grants, tax credits for qualified clinical trials, prescription drug user fee exemptions, and a seven-year marketing exclusivity period upon FDA approval.

About Genenta Science Genenta (www.genenta.com) is a clinical-stage biotechnology company engaged in the development of a proprietary hematopoietic stem cell gene therapy for the treatment of a variety of solid tumor cancers. Temferon is based on ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon, which is under investigation in a phase 1/2a clinical trial in newly diagnosed Glioblastoma Multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM), is designed to reach solid tumors, induce a durable immune response not restricted to pre-selected tumor antigens nor type, and avoid systemic toxicity, which are some of the main unresolved challenges in immuno-oncology.

Forward-Looking StatementsStatements in this press release contain forward-looking statements, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as anticipate, believe, contemplate, could, estimate, expect, intend, seek, may, might, plan, potential, predict, project, suggest, target, aim, should, "will, would, or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genentas current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion and timing of the phase 1/2a clinical trial or any studies relating to the treatment of glioblastoma multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM). Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled Risk Factors in the Annual Report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Genenta Science S.p.A. undertakes no duty to update such information except as required under applicable law.

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Replay, MD Anderson Partner on Cell Therapy Venture – San Diego Business Journal

Replays hub-and-spoke business model has spun out another company this time in partnership with The University of Texas MD Anderson Cancer Center.

On Feb. 14, the San Diego- and London-based Replay and Houston-based MD Anderson announced the launch of Syena, a new oncology-focused product company pioneering T-cell receptor natural killer cell therapies (TCR-NKs).

The new company will utilize intellectual property and technology from both MD Anderson to create a next generation of cell therapy that combines the safety, potency and scalability of natural killer (NK) cells with T-cell receptors (TCRs) ability to target intracellular tumor antigens.

This first-in-class TCR-NK technology provides an opportunity for Replay to disrupt the existing cell therapy paradigm and positions Syena to become a leader in this space, said Adrian Woolfson, executive chairman, president and co-founder of Replay.

The new companys TCR-NK cell platform is based upon the scientific discoveries of Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson.

Rezvanis work has explored the role of NK cells in utilizing the bodys innate defense systems against human malignancies, as well as strategies to enhance their killing function. She was the first investigator to conduct a clinical trial with chimeric antigen receptor-natural killer (CAR-NK) cells derived from umbilical cord blood and has successfully advanced 11 cell therapies into the clinic through MD Andersons institutional support.

Syenas TCR-NK cell therapy platform will combine the advantages of engineered TCR cancer therapy with those of NK cells, offering the possibility of improved safety and efficacy through a multi-armored approach incorporating natural and artificial mechanisms. Unlike chimeric antigen receptor (CAR)-based therapies, which recognize specific surface proteins, TCR therapies are engineered to recognize proteins normally found inside the cell. The use of a TCR allows the NK cell to recognize externalized protein fragments presented by the cells surface immune proteins.

NK cells play a pivotal role in anticancer immunity and, following the successes of CAR T-cell therapy, and the potential for CAR-NK therapies, TCR-NK cells are positioned to be a next-generation agent for cancer therapy, Rezvani said. We believe that the TCR-NK cell approach will allow targeting of a broad range of tumor antigens, including cancer-specific neoantigens, and could pave the way for potentially safe and efficacious off-the-shelf cell therapies for hematological malignancies and solid tumors.

Woolfson said Rezvanis research into arming NK cells with TCRs could potentially bring the kind of clinical successes engineered cell therapies have in cancers that begin in blood-forming tissue like the bone marrow to solid tumors.

Replay CEO and co-founder Lachlan MacKinnon described Rezvanis clinical data as compelling and that her expertise with engineered NK cells will prove invaluable for the new company.

We are delighted to have Dr. Rezvani, a world-leading expert in NK-based cell therapy and pioneer of CAR-NK cell therapy, as the scientific founder of Syena. We believe Syena has the potential to redefine this emerging area of medicine and to provide compelling new cell therapy options for patients in need, he said.

Syena marks Replays latest endeavor in its business model, since the company came out of stealth last year with a business model that creates spoke companies which utilize Replys Big DNA toolkit.

This latest spoke company will combine the contributions of Replay and MD Anderson to build a pipeline of engineered cell therapies using Syenas novel TCR-NK cell platform, licensed exclusively from MD Anderson. The pipline of therapies will target a selection of validated cancer neoantigens proteins that form on cancer cells when certain mutations occur in tumor DNA. One such therapy is anticipated to enter the clinic in Q2 2023. Syena will also receive licenses to various Replay cell and genome engineering platform technologies.

MD Anderson and Dr. Rezvani have advanced outstanding science in this space, and we look forward to working with them to accelerate the development of these novel cell therapies, said Kugan Sathiyanandarajah, managing director at KKR and a board director at Replay. KKR led Replays $55 million seed round in July of last year. Coupled with Replays platform technologies and oncology drug development experience, Syena has the potential to have a significant impact on this important life science sector and to make a meaningful contribution to human health.

Replay

Founded: 2020CEO: Lachlan MacKinnonHeadquarters: San Diego and LondonBusiness: Genomics medicine platform technologiesEmployees: 40Website: replay.bioNotable: Replay co-founder Adrian Woolfson previously held executive roles at Pfizer and Bristol Meyers Squibb.

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BioRestorative Therapies Receives Notice of Allowance by the … – GlobeNewswire

--Notice of allowance will be the third US patent to issue from this ThermoStem family targeting obesity and metabolic disorders, including type 2 diabetes--

MELVILLE, N.Y., March 02, 2023 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (BioRestorative, BRTX or the Company) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the United States Patent and Trademark Office has issued a notice of allowance for a patent application related to the Companys metabolic ThermoStem program. The notice of allowance was issued on February 24, 2023.

This will be the third patent granted under this particular family of intellectual property, claims granted under the new patent cover implantable three-dimensional scaffolds and brown adipocytes that have been derived from human brown adipose-derived stem cells. Therapeutic benefits of using brown adipose have been demonstrated in various models and may provide a valuable therapeutic tool for treating a range of metabolic disorders. In addition, BioRestorative is evaluating the use of this technology to target indications outside of metabolic disorders.

This is the second notice of allowance we have received regarding our ThermoStem program within 2023. This notice of allowance is very meaningful as it provides the Company with further protection and strengthens our technology as we develop and expand into the clinic. Additionally, it enhances our ability to engage with the strategic community on collaborative and partnering opportunities said Lance Alstodt, the Companys CEO.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate,BRTX-100,is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. TheBRTX-100production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure,BRTX-100is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial usingBRTX-100to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email:ir@biorestorative.com

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Revolutionizing Stem Cell Therapy: How AI Can Optimize Treatment for Patients – BBN Times

Stem cell therapy has shown promise in treating a wide range of diseases and injuries, from cancer to spinal cord injuries.

The success of stem cell therapy depends on a number of factors, including the type of stem cells used, the delivery method, and the ability of the stem cells to differentiate into the desired cell types. Artificial intelligence (AI) has the potential to revolutionize stem cell therapy by providing insights into these factors and helping clinicians optimize the therapy for individual patients. In this article, we will explore how AI can be used to augment stem cell therapy in hospitals.

One of the challenges of stem cell therapy is identifying the most effective type of stem cells for a particular disease or injury. There are many different types of stem cells, each with its own unique properties and potential applications. AI can help clinicians identify the most promising types of stem cells by analyzing large datasets of stem cell research and identifying patterns and correlations that might be missed by human researchers.

Another key factor in the success of stem cell therapy is the delivery method. Stem cells can be delivered to the body in a variety of ways, including injection, infusion, and transplantation. The optimal delivery method depends on a variety of factors, including the type of stem cells being used and the location of the injury or disease. AI can help clinicians optimize the delivery method by analyzing patient data, such as medical imaging scans, to determine the best way to deliver the stem cells.

The success of stem cell therapy also depends on the ability of the stem cells to differentiate into the desired cell types. AI can help clinicians monitor stem cell differentiation by analyzing medical imaging scans and other data to track the progress of the therapy. This can help clinicians adjust the therapy as needed to ensure that the stem cells are differentiating as expected.

One of the most exciting applications of AI in stem cell therapy is the potential to personalize the therapy for individual patients. By analyzing patient data, including genetic information and medical history, AI can help clinicians identify the most effective type of stem cells, the optimal delivery method, and the best way to monitor stem cell differentiation for each patient. This personalized approach could significantly improve the success rate of stem cell therapy and reduce the risk of side effects.

AI has the potential to revolutionize stem cell therapy by providing insights into the most effective type of stem cells, optimizing the delivery method, monitoring stem cell differentiation, and personalizing the therapy for individual patients. While there are still many challenges to overcome, such as the need for large amounts of high-quality data and the development of sophisticated AI algorithms, the potential benefits of AI-augmented stem cell therapy are too significant to ignore.

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Revolutionizing Stem Cell Therapy: How AI Can Optimize Treatment for Patients - BBN Times

Cellular Cancer Immunotherapy Development and Manufacturing in … – Cancer Discovery

As the seven FDA approved CAR T cell products continue to prove therapeutically and commercially viable, the development and scalability of CAR manufacturing platforms within academic cell production facilities will be critical to keeping pace with industry partners and ensuring academic workflows can be transferred to commercial production. CAR manufacturing must be further streamlined, standardized, and economized. To this end, closed and automated manufacturing systems offer a means of reducing labor costs, alleviating GMP manufacturing environmental requirements, and minimizing the risk associated with contamination or product variability. The CliniMACs Prodigy, a combination of a cell washer, magnetic cell separation system, and cell cultivation device is likely the most feasible means of achieving this goal, as it is one of the systems available that can enrich cell products within a closed environment (53). The Prodigy has already demonstrated the ability to select and expand T cells from preselected populations or whole apheresis, enabling the scalable production of CAR T cells in a controlled, GMP-compliant manner with no advanced manufacturing training necessary (8183). Closed-system continuous perfusion bioreactors offer varying degrees of automatic T-cell selection, expansion, vector transfection or transduction, cell washing, concentration, harvesting, cell product formulation, and in-process control testing. A number of manufacturing studies conducted at academic institutions have demonstrated that closed-system bioreactors, including the Prodigy, limit microbial contamination and are capable of generating CAR T cells with tumor-specificity, functionality, and phenotypic expression similar to immunotherapies generated by other methods (28, 8486). Although cell products did meet release criteria for expansion, cytotoxicity, and sterility, issues did arise with variability in cell growth, vector copy number, and myc overexpression (86). Transduction efficiency and cell yield are sufficient for clinical application in the manufacturing of CAR T-cell and DC therapies (85, 87, 88). Importantly, the use of an automated, closed-loop manufacturing system has already proven successful in the treatment of relapsed and refractory B-cell malignancies in trials conducted at academic medical centers (82, 89).

Refining transduction techniques beyond -retroviral and lentiviral vectors will also give academic manufacturing programs more flexibility in developing future CAR T-cell therapies. The use of SB, CRISPR Cas9, and mRNA gene transfer systems would circumvent the need for costly release testing and viral vector production. Concerns related to transduction efficacy, cell viability, duration of culture, and the duration of expression in the case of mRNA can only be dispelled through expanded clinical trials. Likewise, production variability in relation to treatment outcomes must be closely monitored before these modalities can be more widely adopted in academic manufacturing protocols.

The CAR transgene itself can also be updated through continued exploration of costimulatory molecules, suicide genes, and expanded CAR T-cell targets. CD20, CD22, CD30, CD33, CD138, CD171, CEA, EGFR, EFGRvIII, ErbB, FAP, GD2, Glypican 3, Her 2, Mesothelin, and NKG2D are all tumor associated proteins currently being targeted by academic programs designing CAR T cells (90). Targeting novel surface receptors is proving to be a key component of successful CAR T-cell products for the treatment of solid neoplasms. Tumor heterogeneity and antigen loss as a means of therapeutic escape reinforce that creating CAR T-cell therapies that target multiple surface markers through a pooled product may further improve clinical responses and prevent disease relapse.

Given the commercial success of multiple CAR T-cell products, collaboration with industry partners will further improve these manufacturing tools. When leveraged with the resources and finances available to the biopharma industry, the extensive experience academic programs have in the CAR T-cell arena can facilitate needed technological advancement, accelerate workflow development, and promote the expansion of CAR T-cell therapies to a greater patient population. The T-Charge platform, developed by Novartis, could be a particularly apt example of the benefit collaboration could pose for academic manufacturing centers; although only abstract data are currently available, the platform has demonstrated the ability to retain T-cell stemness and rapidly produce CAR T-cell products in less than 2 days.

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Cellular Cancer Immunotherapy Development and Manufacturing in ... - Cancer Discovery

VetStem Shares the Success Story of Sherlock who was Treated with VetStem Cell Therapy for Arthritis and Knee – EIN News

Sherlock, a large mixed-breed dog, was successfully treated with VetStem Cell Therapy for arthritis and cruciate ligament injuries.

Sherlock's Owner

Sherlocks veterinarian recommended surgical repair in addition to VetStem Cell Therapy. To begin the VetStem process, Sherlocks veterinarian collected fat from his abdomen while he was anesthetized for his cruciate ligament surgery. The fat was aseptically packaged and shipped to the VetStem processing laboratory in Poway, California. Lab technicians processed the fat to extract and concentrate the stem and regenerative cells contained therein. Four injectable doses of Sherlocks cells were shipped to his veterinarian for treatment and all the remaining cells were put into cryostorage for potential future treatment. Approximately 48 hours after the initial fat collection procedure, Sherlock received one injection of his own stem cells into each knee and each elbow.

Sherlocks owner reported that he responded well to his initial stem cell treatment but that shortly after, he injured the cruciate ligament in his left knee. This time, his veterinarian was able to request doses from his stored stem cells, which she administered during the surgery on his left knee. Sherlock once again received an injection of his own stem cells into each knee and each elbow.

After treatment, his owner said that his recovery went from six weeks to three-and-a-half weeks. She stated, He healed so quickly that it surprised everyone. He was 12 years old by this time and a full recovery seemed almost too hopeful to wish for, but instead we not only got a full recovery but a faster recovery than before. She went on to state, Sherlock is now 13 years old and we do not run and chase balls anymore, but we enjoy walks on the beach and lots of snuggles and I am so grateful that he is still here feeling good and enjoying life with me. Stem cell therapy made an immense difference in his ability to live a high quality life in his older years.

Unfortunately, cruciate ligament rupture is one of the most common reasons for hind limb lameness, pain, and subsequent knee arthritis in dogs. Additionally, according to the American College of Veterinary Surgeons, 40-60% of dogs who injure one cruciate ligament will go on to injure the other cruciate ligament in the future. Because of this, many veterinarians choose to treat both knees with stem cells, even when there is only one injured knee. While there are multiple treatment options available, both surgical and non-surgical, treatment with stem cells may accelerate and improve healing within the joint. Stem cells are regenerative cells that can differentiate into many tissue types, reduce pain and inflammation, help to restore range of motion, and stimulate regeneration of tendon, ligament, and joint tissues. According to surveys answered by owners and veterinarians, greater than 80% of dogs showed an improved quality of life after receiving VetStem Cell Therapy for orthopedic conditions.

About VetStem, Inc. VetStem is a veterinarian-led Company that was formed in 2002 to bring regenerative medicine to the profession. This privately held biopharmaceutical enterprise, based near San Diego, California, currently offers veterinarians an autologous stem cell processing service (from patients own fat tissue) among other regenerative modalities. With a unique expertise acquired over the past 15 years and thousands of treatments by veterinarians for joint, tendon and ligament issues, VetStem has made regenerative medicine applications a therapeutic reality. The VetStem team is focused on developing new clinically practical and affordable veterinary solutions that leverage the natural restorative abilities present in all living creatures. In addition to its own portfolio of patents, VetStem holds exclusive global veterinary licenses to a large portfolio of issued patents in the field of regenerative medicine.

Kristi Hauta, Director of Commercial OperationsVetStem, Inc.+1 858-748-2004email us here

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VetStem Shares the Success Story of Sherlock who was Treated with VetStem Cell Therapy for Arthritis and Knee - EIN News

SARS-CoV-2-reactive antibody waning, booster effect and … – Nature.com

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SARS-CoV-2-reactive antibody waning, booster effect and ... - Nature.com

Targeted Therapies and Immunotherapy Play Greater Role in … – Targeted Oncology

Neeta Somaiah, MD, an associate professor and deputy department chair in the department of sarcoma medical oncology, division of cancer medicine at The University of Texas MD Anderson Cancer Center, discusses new and upcoming targeted therapies for sarcomas at the Inaugural Miami Cancer Institute Precision Medicine Oncology Symposium.

Due to the variety of sarcomas, different targets are under investigation. According to Somaiah, liposarcomas and desmoid sarcomas are subtypes where targeted therapies have shown efficacy, including CDK4 inhibitors and MDM2 inhibitors. Gamma secretase inhibitors have been employed in Kaposi sarcoma. Additionally, FGFR and IDH mutations have shown potential as targets in some soft tissue sarcomas and bone sarcomas.

Somaiah says that immunotherapy is an important area of investigation for her, though there is a challenge in finding the right subtype that will respond to immunotherapy. Combination immunotherapies are under investigation in patients with soft tissue and bone sarcoma, but the same combinations used in other cancers may not be effective in sarcomas. Currently the only sarcoma with an approved immunotherapy is alveolar soft part sarcoma, where pembrolizumab (Keytruda) alone or in combination with axitinib (Inlyta) are preferred regimens.

TRANSCRIPTION:

0:08 | We have targets within the liposarcoma space, we have CDK4 inhibitors, MDM2 inhibitors that are of interest. In the desmoid space, there are newer gamma secretase inhibitors that are being looked at, similarly there are specific mutations in FGFR or IDH, etc, that are being targeted across certain soft tissue sarcomas and bone sarcomas.

I personally am very interested in advancing immunotherapy in the sarcoma space. The challenge there is finding the right subtypes that will respond and also finding the right type of immunotherapy combinations that will be helpful for these [patients with sarcoma] that are different than some of the carcinomas that we see. I think there are some combination trials that we'll be seeing in the future that we hope can bring the immunotherapy into the soft tissue and bone sarcoma spaces as well. Right now, [immunotherapy] is only approved for a small subtype called alveolar soft part sarcomas.

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Targeted Therapies and Immunotherapy Play Greater Role in ... - Targeted Oncology

iTolerance, Inc. Completes Pre-IND Meeting with U.S. FDA for … – AccessWire

MIAMI, FL / ACCESSWIRE / March 1, 2023 / iTolerance, Inc. ("iTolerance" or the "Company"), an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced it has completed a Pre-Investigational New Drug Application ("pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") to discuss the development of the Company's iTOL-100 immunomodulatory technology. A pre-IND meeting provides an opportunity for a drug development company and the FDA to discuss the drug's development plan and to obtain the agency's guidance for clinical studies of the company's new drug candidate.

iTolerance's iTOL-100 immunomodulatory technology is a biotechnology-derived Strepavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. Utilizing its iTOL-100 immunomodulatory technology, the Company is developing iTOL-102 as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. iTOL-100, which acts to generate localized immune tolerance is combined with insulin producing stem cell-derived pancreatic islets to be implanted in the body. These stem cell-derived pancreatic islets are potentially capable of secreting insulin in response to sugar intake, similar to how native pancreatic islet cells behave. Additionally, the use of stem cell-derived pancreatic islets provides a potentially inexhaustible supply of insulin-producing cells.

"It's critical to have open dialogue with regulatory bodies as we continue the development of our lead program, iTOL-102. The meeting and subsequent feedback provided valuable insight and clarity for iTolerance as we advance our iTOL-100 immunomodulatory technology," commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. "We are grateful for the guidance from the FDA and are pleased that it was in line with our team's expectations. Importantly, the Agency's guidance allows the company to maintain its current timeline for the iTOL-102 development program. Moving forward, our focus remains on the advancement of iTOL-102 towards an IND submission."

About iTolerance, Inc.iTolerance is an early-stage privately held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging its proprietary biotechnology-derived Strepavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company's lead program, iTOL-102, leverages significant advancements in stem cells to derive pancreatic islets which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for the treatment of liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company's platform technology. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor ContactJenene ThomasChief Executive OfficerJTC Team, LLCT: 833.475.8247[emailprotected]

Media ContactSusan RobertsT: 202.779.0929[emailprotected]

SOURCE: iTolerance, Inc.

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iTolerance, Inc. Completes Pre-IND Meeting with U.S. FDA for ... - AccessWire

You could be the stem cell donor who saves Murray Foltyn’s life – Jewish News

The Sue Harris Campaign is behind an urgent search for a stem cell donor to save the life of a married father of two.

Murray Foltyn aged 41, formerly of Hampstead, now lives in Sydney, Australia and urgently needs an unrelated stem cell donor to help save his life.

Married to Claudia and with two young children Jamie (3 years old) and Georgia (just 9 months old), Murrays potential lifesaver is likely to share his Ashkenazi background and have Czech or Russian ancestors. Indeed, he can trace his family back to the village of Trnava (today part of Slovakia) or Morava Ostrava (today close to the border of Poland).

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He has a rare blood cancer, for which his only chance of successful treatment is with a stem cell transplant from someone with a matching tissue type. Because Murray is Jewish, a matching donor is far more likely to be Jewish too.

HERE IS HOW YOU CAN HELP:

If you are a young Jewish person aged between 16 and 30 years old, the Sue Harris Campaign is running recruitment drives on the evening of Monday 6th March at Purim events at several sites in London and also at Jewish societies across the country.

Here are the places you can get swabbed this Purim:

Monday 6 March, eveningAish UK Central London Purim EventChabad, Hampstead Garden SuburbNer Yisrael SynagogueSouth Hampstead SynagogueSt Johns Wood SynagogueThe Jewish Learning ExchangeLondon JSoc Purim PartyLeeds JSocOxford JSocNottingham JSoc

Tuesday 7 March, eveningHampstead Garden Suburb Synagogue

Thursday 9 March, eveningMoishe House Camden

If you are unable to attend any of the above, you can still potentially save a life by requesting a swab kit be sent to you by clicking here.

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You could be the stem cell donor who saves Murray Foltyn's life - Jewish News