APOP stock exploded higher in pre-market trading on January 7, 2020, after the company announced pending patent awards.
Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of innovative technology which enables the functional selection of stem cells, received official communication from two jurisdictions, the European Patent Office (EPO) and the Israeli Intellectual Property Office, regarding their intention to grant European Patent Application No. 14851547.1 and Israeli Patent Application No. 244982, respectively. These patent applications include a cell-based product and a method of manufacturing a stem and progenitor cell population with enhanced activity by short incubation with an apoptotic ligand.
“Continued recognition from global jurisdictions validates the breadth of Cellect’s technology. These latest acknowledgments are significant as they cover the ability to activate stem cells, therefore improving stem cell products and manufacturing processes,” commented Dr. Shai Yarkoni, Chief Executive Officer of Cellect. “Our collaboration efforts with companies in Germany, Korea and Israel have each reported similar data using our process in various tissue sources (including fat derived cells). These added protections continue to create barriers to entry and allows us to advance our business development strategies to monetize our innovation.”
The Company has previously published third-party data demonstrating improved “stemness” of stem cells. Specifically, it significantly improves both proliferation and functional capabilities of hematopoietic (HSC) and mesenchymal (MSC) stem cells originating from bone marrow, peripheral blood, umbilical cord and adipose tissue.
“We believe the combination of strong IP protection and validated business collaborations support our business model and will enable us to attract external resources to strengthen and expand our opportunities,” concluded Dr. Yarkoni.
The patents applications cover an ex vivo method for obtaining an improved population of stem and progenitor cells (SPC) with enhanced engraftment characteristics by activation of TNF family receptors. The Company’s previous patents covered the negative selection exerted by the ApoGraft process and product translated into clinical safety superiority. The latest patent applications describe and protect the positive effect that the same molecules have on stem cells and translates to the efficacy of the transplanted cells and the yields of the manufacturing processes for clinical use).
Including this latest notification, the Company has 65 patent applications worldwide of which 33 are issued/allowed patents.
On December 23, 2019, Cellect Biotechnology Ltd. (NASDAQ: APOP) received approval to initiate a trial in the U.S. to evaluate the safety and tolerability of the ApoGraft technology for haploidentical bone marrow transplantations. The company is collaborating with Washington University School of Medicine in St. Louis on the trial. A total of 18 patients are planned for this initial phase, with enrollment expected to begin in the first half of 2020. The company has received the approval of the protocol by Washington University’s Institutional Review Board, which is required before the trial can begin, follows other successful milestones, such as the IND approval from the U.S. Food and Drug Administration (FDA) in November 2019, positive feedback from the institutional independent scientific committee and a complete technology transfer during 2019.
“With the succession of executed milestones, we are getting closer to achieving our primary objective of commencing our first clinical trial in the U.S.,” commented Dr. Shai Yarkoni, Chief Executive Officer. “Our team, together with Washington University, is focused on this goal in the first half of 2020, aiming to achieve a level of success similar to our ongoing Phase 1/2 clinical trial being performed in Israel that shows initial promising results.”
The Principal Investigator for the U.S. clinical trial is Zhifu Xiang, M.D, Ph.D., of Washington University School of Medicine. Dr. Xiang is an Associate Professor in the Division of Oncology’s Bone Marrow Transplantation & Leukemia Section in the Department of Medicine. In addition, John Dipersio M.D, Ph.D., will act as co-Principal Investigator for the study. He is the chief of the Division of Oncology in the Department of Medicine at Washington University.
In 2017, the FDA granted orphan drug designation for ApoGraft™, and the Company is planning to request for ApoGraft™ be designated a Regenerative Medicine Advanced Therapy (RMAT) under the 21st Century Cures Act. The RMAT designation is intended to facilitate expedited development, review and approval for important new regenerative medicine therapies for which preliminary clinical evidence indicates the potential to address a serious or life-threatening disease or condition. In addition to providing an avenue for increased and earlier interactions with the FDA, RMAT-designated products may be eligible for priority review and accelerated approval – thus dramatically shortening time to market and commercial value.