USPTO Issues New Patents for Cell Source's Veto Cell Technology

NEW YORK, March 19, 2021 /PRNewswire/ -- Cell Source, Inc. (OTC: CLCS) ("Cell Source" or the "Company"), the world leader in Veto Cell based innovative immunotherapy technologies that safely facilitate mismatched donor stem cell transplants, e.g. bone marrow transplants (BMT) and organ transplants. In addition, Veto Cells can durably treat malignant and non-malignant blood diseases through active immune response management. Today, Cell Source announced that it has received USPTO issuance notices for two patents covering its Veto Cell technology. The first patent, "Veto Cells Generated from Memory T Cells", describes Veto Cells that safely elicit patient acceptance of transplanted cells, such as stem cells, by overcoming the barriers of graft rejection and graft versus host disease (GvHD). Veto Cells are also capable of fighting potential viral and bacterial infections and can treat unresponsive cancers or cancers where limited treatment options exist. The second patent, "Methods of Transplantation and Disease Treatment", describes an invention in which Veto Cells act as unique, powerful companion cells that allow cellular therapies such as CAR-T and NK to be safely tolerated by the patient without transplant rejection or graft vs. host disease (GvHD) – while increasing overall combined treatment impact.

"These issued patents reiterate the versatility of Veto Cells as a powerful, multi-faceted immunotherapy platform technology," said Dennis Brown, Chairman of Cell Source. "They can act as enablers that improve the duration and efficacy of important cellular therapy treatment methodologies such as the use of CAR-T or NK cells, are capable of fighting bacterial and viral infections that often occur with stem cell transplants, and can be employed in a direct, stand-alone, cancer-fighting capacity. We believe Veto Cells have the potential to play a crucial role in the future for a broad range of adoptive cell therapies, as a stand-alone cell therapy, and in combination with other treatments."

The patents describe Veto Cell inventions in which Veto Cells work in conjunction with existing stem cell transplant therapies to protect the patient from transplant-related complications while increasing overall treatment efficacy, as well as inventions in which Veto Cells have been exposed to third-party antigens, thereby enabling Veto Cells to work on their own to effectively target cancers that have not responded to genetically modified T-cell therapies or where these therapies do not currently exist.

US Patent No. 10,961,504 (to be issued March 30, 2021)
VETO CELLS GENERATED FROM MEMORY T CELLS
The patent describes Veto Cells that have been exposed to disease-related antigens, thereby creating a "memory" function that allows the Veto Cells to efficiently recognize and attack specific targets, including viruses, bacteria, and cancer. This "memory" capability adds functionality to Veto Cells beyond their ability to induce immune system tolerance in the patient. As the Veto Cells are generated from T cells with "memory" (i.e., prior exposure to the antigen), these Veto Cells are especially beneficial in a mismatched (i.e., allogeneic) setting, being tolerated by the patient's immune system and overcoming common stem cell transplant-related issues such as infections, transplant rejection, and GvHD. 

One application of this invention is currently being utilized in Cell Source's Phase 1/2 clinical trial treatment protocol, in which Veto Cells both induce patient tolerance to transplanted allogeneic donor stem cells as well as prevent viral infections, as the Veto Cells exhibit "memory" that enables them to attack specific viral peptides (e.g., Cytomegalovirus, Epstein-Barr Virus). In cancer treatment applications, this approach involves utilizing Veto Cells imbued with a target memory function that enables them to attack specific tumor types – without the need for stem cell transplants or genetic modifications. This direct "anti-cancer" Veto Cell application could have the potential to be particularly efficacious against tumors where genetically modified adoptive T-cell therapy (e.g. CAR-T cells) do not exist or have not been shown to be effective. Rather than relying on patient or donor cells, in this methodology, Veto Cells can be imbued with memory from third party sources, making this a truly stand-alone approach.

A Phase 1/2 clinical trial is currently in progress testing the safety and efficacy of Cell Source's Veto Cells in patients with hematological cancers or with non-malignant hematological diseases. Information regarding the clinical trial may be located here: https://www.clinicaltrials.gov/ct2/show/NCT03622788

US Patent No. 10,933,124 (Issued March 2, 2021)
METHODS OF TRANSPLANTATION AND DISEASE TREATMENT
The patent describes an invention in which Veto Cells act as a critical enabler allowing transplanted mismatched-donor cells, including treatment cells (e.g., CAR-T or NK cells), to achieve "safe passage" through the patient's immune system while avoiding transplant-related issues such as GvHD. The Veto Cells accompany transplanted treatments to ensure that the patient's immune system fully accepts and integrates the treatment cells, enabling the cell therapy to reach its target and persist in the patient's body.

In this methodology, a therapeutic amount of Tcm (central memory T-lymphocyte phenotype) anti-third party Veto Cells are administered to the patient as "passport" or "bodyguard" cells for the purpose of inducing immune tolerance, thereby enabling adoptive cell therapy in the absence of graft rejection and/or graft versus host disease (GvHD). Accordingly, the anti-third party Tcm Veto Cells can be used as an adjuvant therapy in situations in which adoptive cell therapy is warranted, including in cancer therapy, in cases of organ dysfunction or failure, in tissue injury, and in the treatment of infectious diseases.

About Cell Source
Cell Source, Inc. (OTC: CLCS) is the worldwide, exclusive innovator of Veto Cell based cellular therapy and immunotherapy platform technologies designed to provide safer and more accessible bone marrow transplantation (BMT) and improve the treatment of malignant blood cancers such as multiple myeloma and leukemia. In addition, Veto Cells can be exploited for the correction of nonmalignant genetic blood disorders like sickle cell disease and to durably treat auto immune diseases such as type 1 diabetes. The Company is developing and evaluating its Veto Cell CAR-T platform, which could potentially enable CAR-T vectors to be used in donor-derived (allogeneic) settings with increased safety, efficacy, and persistence. Cell Source's Veto Cell technologies are also being developed to facilitate improved safety in mismatched organ transplants (e.g., kidney and liver) by eliminating the need for life-long immune system suppression.

The Company is focused on transitioning its globally exclusive allogeneic Veto Cell platform technologies into broader human studies in order to develop safe and curative BMT from mismatched donors as well as "off-the-shelf," safe, durable, and efficacious immunotherapy and immuno-oncology products.

Cell Source Investor Resource Center
Cell Source maintains a comprehensive Investor Resource Center including share information, SEC filings, investor relations contacts, and more, located here: https://cell-source.com/investor-center

Cell Source General Information

For general information regarding Cell Source, please visit the Company's website at https://cell-source.com

A PDF presentation introducing Cell Source and its technologies is available here:

https://cell-source.com/wp-content/uploads/2020/12/CLCS-Introduction-Q1-2021.pdf

For details regarding Cell Source's Veto Cell Technology Platform and other immunotherapy innovations, please visit https://cell-source.com/veto-cells

Background information on Professor Yair Reisner, Ph.D, the award-winning Chairman of Cell Source's Scientific Advisory Board, is available here: https://cell-source.com/professor-yair-reisner-ph-d

Dr. Reisner's other published works and additional background information are available via ORCID, here: http://orcid.org/0000-0002-3354-6945

To learn about Cell Source's world-class collaborative partnerships, please visit http://cell-source.com/collaborative-partnerships.

For information regarding Cell Source's Scientific Advisory Board, please visit https://cell-source.com/scientific-advisory-board

Company Contact
Itamar Shimrat, CEO
646.612.7554
[email protected]

Investor Contact
Michael Briola
Alternative Advisory Group
917.455.0820
[email protected]

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. The actual future results of Cell Source, Inc. could differ significantly from those statements. Factors that could cause actual results to differ materially include risks and uncertainties such as the inability to finance the company's operations, inability to hire and retain qualified personnel, and changes in the general economic climate, as well as the risk factors disclosed in Cell Source, Inc.'s Form 10-K filed on March 30, 2020. Cell Source, Inc. may, in some cases, use terms such as "anticipates," "continue," "estimates," "predicts," "believes," "potential," "proposed," "expects," "plans," "intends," "may," "could," "should," "might," "will," or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by Cell Source, Inc. or any other person, that such forward-looking statements will be achieved. Cell Source, Inc. undertakes no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements. This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity.

SOURCE Cell Source, Inc.

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