Cell Source Shares Promising Interim Results From Groundbreaking Veto Cell Clinical Trial

Rhea-AI Summary

Cell Source (OTCQB:CLCS) has announced promising interim results from its Phase 1/2 First-in-Human clinical trial of Veto Cell technology at MD Anderson Cancer Center. The trial, involving 15 patients with hematologic diseases, demonstrated successful engraftment without severe graft-versus-host disease (GvHD) using T-cell-depleted, haploidentical stem cell transplants under reduced intensity conditioning. Key findings include consistent engraftment at 42 days post-transplant, no Veto Cell-related toxicity, and an enhanced protocol using mild conditioning with Rituximab. The technology aims to make transformative treatments more accessible for conditions ranging from leukemia to sickle cell disease.

Positive

• Successful interim results showing both safety and efficacy in Phase 1/2 trial
• No patients experienced adverse effects from Veto Cells
• Technology addresses $100+ billion total addressable market
• Potential application expansion to organ transplant procedures

Negative

• Early-stage trial results (Phase 1/2) still require further validation
• Trading on OTCQB market indicates lower tier exchange listing

First-of-Its-Kind Success in Mismatched Donor Stem Cell Transplantation: Engraftment Under Mild Immune Suppression with Minimal Graft-versus-Host Disease

NEW YORK, NY / ACCESSWIRE / November 21, 2024 / Cell Source, Inc. (OTCQB:CLCS) ("Cell Source", or the "Company"), a pioneer in Veto Cell-based immunotherapy, today shared positive interim results from its Phase 1/2 First-in-Human clinical trial conducted at The University of Texas MD Anderson Cancer Center. The trial has treated 15 patients using Cell Source's proprietary Veto Cell technology in stem cell transplants for malignant and non-malignant hematologic diseases. These early results indicate both safety and efficacy, marking a promising advance in stem cell transplant outcomes.

"Our Veto Cell platform aims to overcome two significant challenges in stem cell therapy: preventing severe graft-versus-host disease (GvHD) while reducing treatment toxicity. With this safer, more patient-friendly approach, we are closer to making transformative treatments accessible for individuals with a variety of hematologic conditions, ranging from leukemia and lymphoma to sickle cell disease," said Dr. Dennis Brown, Chairman of Cell Source, Inc.

Breakthrough Results for Safer and Effective Transplants

Previously presented at the American Society for Hematology (ASH) Annual Meeting, the interim study results highlight:

Consistent engraftment without severe GvHD: Achieved at 42 days post- transplant with T-cell-depleted, haploidentical stem cell transplants under reduced intensity conditioning (RIC).

No toxicity linked to Veto Cells: No patients experienced adverse effects directly associated with Veto Cells.

Enhanced protocol: A mild conditioning regimen, combined with Rituximab to prevent antibody-related complications, makes transplants safer and suitable for a broader range of patients.

These findings underscore the potential of Veto Cells to increase access to life-saving allogeneic transplants for cancer patients and individuals with non-malignant blood disorders, supporting the strategic advancement of Cell Source's technology.

Comparable Successes Demonstrate Market Potential

The cell therapy and immunotherapy market has seen robust investor interest, with several start-up companies achieving multibillion-dollar valuations after clinical success. For example, Kite Pharma and Juno Therapeutics were acquired for $12 billion and $9 billion, respectively, following successful clinical outcomes and regulatory approvals in similar areas of cellular therapy. These precedents highlight the significant financial upside for novel treatments that achieve distinctive clinical efficacy and regulatory milestones.

With Cell Source's Veto Cell platform showing early promise in achieving safer and thus more effective stem cell transplants without severe GvHD, the Company is strategically positioned to capitalize on this expanding market. The total addressable market (TAM) for hematological therapeutics, including both cancer and nonmalignant diseases, is estimated to be in excess of $100 billion, underscoring the vast commercial potential for Veto Cells to gain market traction as the platform advances through clinical trials.

Pathway to Market and Competitive Edge

Cell Source's Veto Cell technology offers a unique advantage by combining reduced immune suppression with avoidance to GvHD, making it an attractive alternative to current stem cell transplant methods. The Company's Veto Cell platform is also being developed for organ transplant applications, potentially allowing for partially mismatched donors as well as reducing or possibly even eliminating reliance on lifelong immunosuppression post-transplant.

Expanding the Investor Base and Future Updates

As Cell Source advances its clinical program, the Company invites investors to explore the potential of its Veto Cell technology through our Investor Resource Center, where shareholders and prospective investors can access comprehensive information on financials, SEC filings, and the latest corporate updates. Cell Source anticipates additional milestones in 2024 and looks forward to providing further updates.

About Cell Source, Inc.

Cell Source, Inc. (OTCQB:CLCS) is the worldwide, exclusive innovator of Veto Cell-based cellular therapy and immunotherapy platform technologies designed to provide safer and more accessible stem cell (e.g. bone marrow)transplantation and improve the treatment of blood cancers such as leukemia, lymphoma and multiple myeloma. The company licenses the technology from The Weizmann Institute of Science in Israel and sponsors both research and clinical development at The University of Texas MD Anderson Cancer Center. In addition, its Veto Cell platform is being developed to reverse sickle cell disease and other non-malignant genetic blood disorders and to durably treat autoimmune diseases such as type 1 diabetes. The Company is also developing a Veto Cell CAR-T platform which could potentially enable CAR-T therapy 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 safer, donor mismatched organ transplants (e.g., kidney and liver) and also avoid the current need for life-long daily immune system suppression.

The Company is focused on transitioning this allogeneic Veto Cell platform into additional clinical trials in order to develop safe and curative cell therapy treatments (such as stem cell transplants) from mismatched donors as well as safe, durable, and efficacious "off- the-shelf" immunotherapy and immuno-oncology products.

For more information, visit cell-source.com.

Investor Contact

Brendan Rempel
brendan@alternativeadvisory.com

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 June 6, 2024. 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.

Contact Information

Itamar Shimrat
CEO
info@cell-source.com
6464167896

SOURCE: Cell Source, Inc.

View the original press release on accesswire.com

FAQ

What are the key findings from Cell Source's (CLCS) Phase 1/2 clinical trial?

The trial showed successful engraftment at 42 days post-transplant without severe GvHD, no toxicity related to Veto Cells, and demonstrated effectiveness using a mild conditioning regimen with Rituximab.

How many patients were treated in Cell Source's (CLCS) Veto Cell clinical trial?

The Phase 1/2 First-in-Human clinical trial conducted at MD Anderson Cancer Center treated 15 patients using Cell Source's proprietary Veto Cell technology.

What is the market potential for Cell Source's (CLCS) Veto Cell technology?

The total addressable market for hematological therapeutics, including cancer and nonmalignant diseases, exceeds $100 billion, presenting significant commercial potential for the Veto Cell platform.

What conditions can Cell Source's (CLCS) Veto Cell technology potentially treat?

The technology can potentially treat various hematologic conditions, including leukemia, lymphoma, and sickle cell disease, as well as possible applications in organ transplantation.