Cellect & Washington University File IND & Prepare for Apograft Bone Marrow Transplantation Clinical Trials

team of surgeons at working in the operating room

Washington University St. Louis and moved closer to the commencement of their first clinical trial to test the safety and tolerability of the Apograft technology for bone marrow transplantations. A successful trial led by Investigators Zhifu Xiang and John Dipersio will introduce transformative stem cell capability and growing sponsor, Cellect Biotechnology share price.

The two organizations, one a venerable midwestern university, the other Israeli based Cellect Biotechnology Ltd. Have formed a dynamic collaboration to bring to market novel technology to support bone marrow transplantations. The two organizations just completed a successful execution of a technology transfer agreement from Cellect to Washington University, St. Louis. 

What follows is a breakdown of this collaboration via question and answer format.

What is Apograft™ Technology?

Developed by Cellect Biotechnology of Israel, it is a novel technology for GvHD prevention. They are developing the technology to turn the production of stem cells into a simple, safe and inexpensive process. It has been developed as part of the wave of innovation around “regenerative medicine.” Regenerative medicine is about replacing the use of drugs and traditional treatments with stem cells as building blocks for creating biopart replacements. All humans have stem cells in their bodies but they are scarce and difficult to isolate from mature cells. Current approaches to mass stem cell harvesting are ways out. Cellect developed Apograft technology to overcome existing barriers to regenerative medicine involving stem cell manufacture. Aporgraft uses natural biological processes to isolate stem cells and help move regenerative medicine forward.

The link offers the range of elements associated with Apograft technology including preclinical data and a description technology platform.

What is GvHD?

Called Graf-versus-host-disease, or (GvHD) is a medical condition following the receipt of transplanted tissue from a genetically different person than the patient. GvHD is commonly associated with stem cell transplantation as those that occur with bone marrow transplants.

White blood cells of the donor’s immune system which remain within the donated tissue (the graft) recognize the recipient (the host) as foreign (non-self). The white blood cells present within the transplanted tissue then attack the recipient’s body cells, which leads to GvHD.

This should not be confused with a transplant rejection, which occurs when the immune system of the transplant recipient rejects the transplanted tissue. Rather GvHD occurs when the donor’s immune system’s white blood cells reject the recipient.

The underlying principle (alloimmunity) is the same, but the details and course may differ. GvHD can also occur after a blood transfusion if the blood products used have not been irradiated or treated with an approved pathogen reduction system

Aprograft Preclinical Research Summary

Cellect published preclinical research findings in the journal Blood. They summarize that GvHD is a threat to the wellbeing and survival of patients following hematopoietic stem cell transplantation (HSCT). In-vivo and ex-vivo T cell depletion are the most effective methods for GvHD prevention, but attendant risks of infection, graft failure, and leukemic recurrence offset the advantages of these manipulations.

The posit that less extensive T cell depletion leaves many patients at risk for the ravages of treatment-resistant GvHD. Alternative approaches to eliminate GvHD -causing cells are needed. Fas and ligand (FasL), a member of the tumor necrosis factor (TNF) family, can selectively induce apoptosis of mature T cells while sparing stem and progenitor cells.

Cellect developed a novel FasL-mediated selection process which eliminates mature T cell subsets in hematopoietic stem cell grafts and effectively prevents GvHD in preclinical models without impairing engraftment and immune system recovery.

Cellect has reported the data from ex-vivo and in-vivo studies supporting the use of FasL-mediated depletion of mature T-cells, a process they have named ApoGraft, as a novel method for GvHD prophylaxis in the context of allogeneic HSCT.

Upcoming U.S. ApoGraft02 Study: Target FPFV First Half 2020

The U.S ApoGraft02 study is planned for the first patient first visit (FPFV) in the first half of 2020. They seek approval of Scientific Advisory Board by mid-quarter 2019. In parallel, they are working on Investigator New Drug Application (IND) with the FDA by the end of Q3 2019. Upon FDA’s acceptance of Cellect and Washington University’s IND application, they will plan for FPFV first half of 2020.

Accelerated Clinical Trial Agreement

In pursuant to the collaborator’s agenda, the two have executed a technology transfer to Washington University’s facility, and results of the in-vivo portion of the toxicology study have evidenced no signs or symptoms of toxicity.

Lead Research/Investigator for the Upcoming ApoGraft02 Study

Zhifu Xiang, MD is an Associate Professor at Washington University’s Division of Oncology’s Bone Marrow Transplantation & Leukemia Section in the Department of Medicine, Principal Investigator

John Dipersio, MD, Ph.D., co-Principal Investigator, chief of the Division of Oncology, Department of Medicine. Dr. Dipersio will head up the collaboration.

Cellect CEO Comment

Dr. Shai Yarkoni, CEO noted “We have had ongoing discussions with the Food and Drug Administration (FDA) and based on its feedback we can bypass further pre-investigational New Drug (IND) interactions and proceed directly to IND filing. Therefore, our immediate next step is to complete our IND application and submit it to the FDA during the first quarter, and our objective remains to commence treatment of U.S. patients during the first half of 2020.”

About Cellect Biotechnology Ltd.

An Israel-based company engaged in regenerative medicine through the development of products facilitating immune stem cell selection. It 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 offer researchers, the clinical community and commercial sponsors 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 firm’s present clinical trial is aimed at bone marrow transplantations in cancer treatment.

Company Financials: A Penny Stock in Hopes of a Bigger Reality

The company represents a thinly capitalized, penny-stock equity. A current share price of around .50 cents pegs it at a market capitalization of $1.59 million. In 2017 it raised $4.3 million from accredited investors in what has been the fuel to keep the research effort going. Over 54% of its stock is controlled by insiders. The firm has very little capital. The company employs between 10 and 30—on the professional network, LinkedIn 23 self-identify with the company. CEO Shai Yarkoni has been with the firm for several years now.