Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of a novel stem cell production technology, announced that it has entered into a strategic manufacturing and supply agreement with Swiss Biotech Center (SBC) to secure production of FasL protein – Cellect’s main active ingredient in ApoGraft™ and the line of Apotainer™.
According to the agreement, SBC grants to Cellect exclusivity to the FasL protein developed by SBC for a period of five years. The agreement further provides for the production of clinical batches of the FasL protein for Cellect’s planned US clinical trials. Cellect and SBC contemplate expanding production capacity to meet future needs including marketing and collaborations with licensors of Cellect technology.
The FasL protein is a key active ingredient in Cellect’s product line and technology for cell separation and functional selection of stem cells. As Cellect advances in its product development, it becomes essential to secure a consistent and reliable supply of pharma-grade FasL. Production of large quantities of clinical grade material is currently the gating item for initiating US-based clinical trials.
Dr. Shai Yarkoni, Cellect CEO comments: “We are getting ready to support many clinical trials and collaborations using the Apograft containing FasL. This agreement supports Cellect’s mission statement of enabling a multi-billion global market over the next 5 years while positioning Cellect towards potentially meeting commercial demand for millions of patients worldwide in need of stem cell therapy, as well as providing raw materials for stem cells research centers and the biobanking industry.”
Cellect Biotechnology also signed a collaboration and material transfer agreement with the denovoMATRIX group of the Technische Universität Dresden (TU Dresden). TU Dresden and its Center for Regenerative Therapies Dresden (CRTD), one of the leading centers for stem cell research in Germany. According to the agreement, the team of denovoMATRIX employed by TU Dresden will conduct examinations into the tentative synergy between Cellect’s ApoGraft™ and the denovoMAtrix technology for the purpose of evaluating the collaborative development of products for regenerative medicine.
About Swiss Biotech Center (SBC)
Swiss Biotech Center (SBC) offers services and a dedicated environment for the development and manufacturing of innovative drugs such as biologics or Advanced Therapy Medicinal Products (ATMP) by gathering all the competencies, internally or externally, infrastructures and technologies. Positioned as a solutions provider aiming at delivering high-quality drugs for saving lives, SBC is highly oriented towards boosting value creation by accelerating the path to clinical development.
About Regenerative Medicine and Cell Therapy
Regenerative medicine is a novel approach using cells and tissues to replace or regenerate human cells, tissues or organs in a wide variety of medical indications. This could be achieved by either stimulating the body to use its own repair mechanisms to heal tissues or organs or by growing tissues and organs in the laboratory and transplanting them into the patient.
Stem cells play a major role in the achievement of the extraordinary potential results in regenerative medicine. In cell therapies, they can be injected to reconstitute the entire blood system in bone marrow transplantations. Alternatively, their injection can supply the necessary biologically active molecules to induce the patients’ own cells to regain normal function, as used in immunomodulation therapy. In tissue engineering, where entire organs like the retina, bone, cartilage or the skin may be replaced, stem cells are the starting material for the growth of such tissues in the laboratory. Moreover, in tissue engineering, an artificial system might be created by inducing cells to perform certain biochemical functions lost due to disease (e.g., artificial pancreas or liver).
Regenerative medicine using cellular therapy in combination with new technologies like tissue engineering and gene transfer can be used in a virtually unlimited number of indications. The most frequently used cells are hematopoietic stem cells (HSC) due to their capability to reproduce the entire blood system in blood cancer and hematological disorders. Mesenchymal stem cells, which have the capability to differentiate to a large number of tissue types like bone, cartilage, fat, heart muscle and more, are of growing importance. Potential applications of cell therapies include treating cancers, autoimmune disease, urinary problems and infectious disease, rebuilding damaged cartilage in joints, repairing spinal cord injuries, improving a weakened immune system, and helping patients with neurological disorders.
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 research, hospitals 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.