Stem cell therapy, a way to replace damaged tissues through regenerative medicine, holds hope for patients everywhere. However, aside from very few applications, cell therapy has not made the leap from laboratory to market. One of the major hurdles have been a cost effective way of achieving purified stem cells. A big challenge in cell therapy has been separating mature donor cells, which can cause severe damage to the patient, from the donor’s stem cells which heal through regenerative medicine. Cellect Biotechnology Ltd. (NASDAQ:APOP), developer of a novel stem cell collection technique, has an effective and elegant technology for harvesting stem cells.
A key component of Cellect’s platform technology, ApoGraft, is the ApoTainer which uses cell suicide inducing proteins to kill older cells through apoptosis, or programmed cell death. Cellect has discovered that in an apoptotic environment, mature cells die, while stem cells survive and thrive. The cell selection process is quick, just hours, and the result is a rich, non-toxic batch of stem cells ready to be implanted.
In its first indication, Cellect is evaluating its technology in allogenic (donor) bone marrow transplant (BMT) where up to 50% of patients suffer graft-versus-host disease (GvHD) under current methods, often leading to sickness and death. With the right stem cell procedure, GvHD can be reduced and potentially eliminated.
BMT, a procedure fraught with the chance for GvHD because of its mix of old cells that trigger rejection of tissue implants, is Cellect’s initial indication. Cellect demonstrated success in its first stem cell transplant in March using ApoGraft in BMT in its Phase I/II trial, leading to the independent Data and Safety Monitoring Boards (DSMB) approval to continue patient enrollment. A total of 12 patients suffering from blood cancer will be treated, with an eye on efficacy and safety in preventing GvHD.
75,000 BMTs are performed in the US annually at an average cost of $800,000 per transplant, resulting a $60 billion market that is growing due to an aging population and is mainly limited by the GvHD.
Currently, stem cells are either sourced from the patient (autologous) prior to undergoing high-dose chemo or radiation therapy, or they are harvested from donor (allogeneic) stem cells. Chances for perfect donor match for blood cancer patients undergoing BMT are only 25%, not good odds. Allogenic donors are subject to an intensive and long procedure including rigorous physical exams, blood samples taken in up to four separate appointments, time commitment of 30 hours spread over four to six weeks, and travel expense.
Both autologous and allogeneic methods can be hazardous because of the combined mix of old cells and vital stem cells that have a better chance to avoid GvHD. This is standard medicine, and not an optimal solution. Cellect’s technology eliminate the non-matched immune response carrying cells . Time and money can be saved.
Operating under a well-thought out business model, Cellect plans to out-license its ApoGraft platform to pharma, biotech, research centers and hospitals, furnishing them with an unprecedented tool. Non-exclusive licensing gives Cellect a broad array of potential partners.
Cellect’s robust intellectual property protection includes patents that cover all aspects of selecting only the cells needed for the transplantation, with the promise of avoiding GvHD. Yet Cellect’s platform is not only for blood cancers. Other future applications can be directed to autoimmune disease such as Juvenile diabetes, all significant markets.
Cellect has drawn leaders in key areas important to further regenerative medicine into mainstream treatment options. Scientific and medical advisors include researchers and practitioners from Dana Farber, Harvard, King’s College London, Pfizer Inc. (PFE:NYSE), the FDA, and Stanford. All have a deep interest in making stem cell therapy a reality. All will be critical to advising the company on current and future regulatory pathways. All strongly believe in Cellect’s technology.
At the end of the first quarter of 2017, Cellect had cash of approximately $7 million. With the stock trading at about $8.50, the market cap is $45 million.
If the Phase I/II study proves successful, Cellect will be well positioned to partner with pharma and biotech firms who will use the ApoGraft platform in whichever applications they wish, giving Cellect an opportunity for ongoing revenue from licensing and royalties. This could boost its cash levels, stock price and market cap.
Cellect leads the world in providing a pioneering method to harvest stem cells that seek to cure many diseases, starting with proof in BMT, without adverse side effects. Its goal is to make ApoGraft available for clinics to use easily and effectively, much like any modern-day medical tool. Its technology is both simple and revolutionary, making stem cell medicine a nearer-term reality than ever before.
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