NEW YORK, NY – Immunotherapy is undoubtedly one of the most talked about and promising areas in biotechnology today. As the library of research continues to grow, combination therapies are emerging to hopefully deliver more clinically meaningful outcomes. This is exemplified by the recent pact between Kite Pharma (NASDAQ: KITE) and Roche’s (OTCQX: RHHBY) Genentech to collaborate on using Kite’s experimental CAR-T (chimeric antigen-receptor T cell) treatment, KTE-C19, in combination with Roche’s PD-L1 (programmed death ligand-1) immunotherapy, atezolizumab, in patients suffering from refractory, aggressive non-Hodgkin lymphoma (NHL).
In immuno-oncology, one of the biggest buzzwords is CAR-T. T cells are the building blocks in adaptive cell transfer. The cells are collected from a patient’s blood and genetically engineered to produce specific CARs on their surface (proteins that recognize antigens on tumor cells). In the case of KTE-C19, the antigen of focus is CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. Produced into the billions, the killer CAR-T cells are then infused back into the patient where they go on their mission to home in on the antigen to seek and destroy cancer cells, no matter how hard they are trying to hide.
Coupling KTE-C19 with the monoclonal antibody atezolizumab, which binds with the T cell inhibitor PD-L1, is hoped to improve and extend activity of KTE-C19.
There are still many challenges facing immunotherapy. One issue is the autologous nature of immunotherapies, meaning that products are generated using cells derived from the patient. While potent, the logistics can be difficult, not to mention drive costs upward. An allogeneic (donor supplied) “off the shelf” product is needed. When it comes to bone marrow transplants (BMT), a common procedure in treating blood cancers, bone marrow failure diseases like aplastic anemia and immune disorders, Graft versus Host Disease (GvHD) and associated high mortality rates still represent significant risks that approved therapies have failed to overcome.
In most BMT cases, a matched family donor is not available, so mismatched donors are used as a last resort for about 30,000 patients each year. A poignant fact is that approximately 35-40% of all unrelated donor transplant patients die within a year of transplantation. The majority of the time it is not the cancer that is the cause of death, it’s something else, with GvHD the most common culprit.
Fortunately, some companies are making progress on these fronts as well.
Itamar Shimrat, CEO of Cell Source, Inc. (OTCQB: CLCS), an upstart with a blue chip leadership team working on a unique approach in coupling immunotherapy with regenerative medicine for difficult to treat diseases, recognizes the tremendous advancements that have been made in recent years that have helped paved the way for his company. Shimrat attributes pioneering work of scientists like Christian Itin and Yair Reisner and others in helping move the needle towards bringing immunotherapies mainstream, especially as it pertains to oncology and bone marrow transplants.
“It was groundbreaking work stemming from the discovery of certain adoptive T-cell therapies in Israel that now has scientists thinking in more innovative ways than ever before and making breakthroughs on a steady basis that will one day reshape how we treat deadly diseases,” Shimrat said is a phone conversation. “There is still much research to be done, but we are understanding how to engineer cells and combine treatments to harness the powers of the immune system to selectively hunt down and kill harmful cells while protecting healthy ones,” he added.
Dr. Itin and his team at Micromet were frontrunners in the field of T cell engaging antibodies, more precisely a bispecific T cell engager, or BiTE. Simply, BiTE technology uses an antibody to redirect killer T cells to destroy tumor cells. Previously listed on the Nasdaq exchange, Micromet was acquired by Amgen (NASDAQ: AMGN) in 2012 for $1.16 billion in cash, giving Amgen the technology and Micromet’s lead drug, blinatumomab, which was at that time in mid-stage trials for acute lymphoblastic leukemia (ALL). Blinatumomab earned a Breakthrough Therapy designation from the FDA and was later approved under the accelerated pathway. Dr. Itin recently assumed the position of chief executive at London-based biotech Autolus Limited.
Dr. Reisner is a Professor of Immunology and has served as Head of both the Immunology Department and the Center for Transplantation Biology Research at the Weizmann Institute of Science, Israel’s leading academic research institution and among the top research institutions in the world. He also serves as Chief Scientific Consultant at Cell Source. Overall, Cell Source’s leadership team reads a veritable “who’s who” in immunology, transplantation, oncology and more.
In addition to Dr. Reisner, the team includes Dr. Dennis Brown as Chairman of the Board. Dr. Brown has an extensive list of successes in drug discovery and development, including founding ChemGenex Therapeutics. In a matter of only a few years, the company merged with an Australian company to become Nasdaq-listed ChemGenex Pharmaceuticals, which was then bought by Cephalon, which subsequently was then acquired by Teva Pharmaceuticals (NYSE: TEVA) in 2011 for $6.8 billion.
Shimrat says he sees the potential for combining immunotherapy with other therapies, including CAR-T cell therapy to one day not just result in stabilization or remission for cancer patients, but total eradication of disease. In this quest, Cell Source is developing “Veto” Anti 3rd Party Central Memory T cell (Tcm), a next generation cell therapy treatment targeting specific patient immune system characteristics. The technology was developed by Dr. Reisner and his team at the Weizmann Institute of Science in Rehovot, Israel and is exclusively licensed to Cell Source
The company’s Veto Cell platform utilizes veto cells, white blood cells that are taken from either the patient or a healthy donor. The cells are then processed with a proprietary mix of cytokines to activate their “veto” or “attacker blocking” capability and re-infused into the patient to deliver a variety of benefits, such as selective attenuation of immune response, with minimal side effects.
Shimrat explained that the Veto Cell approach of his company is very unique because it leverages the inherent specificity of the human immune system. The body produces millions of T cell clones for every threat, with each directed to only attack the specific target while ignoring any other threat. The Veto Cell technology is designed to actively regulate an immune response, meaning that an individual stream of T cell clones could be “switched off” without affecting any other stream of T cell clones launched by the immune system to destroy other threats. This makes it ideal for many uses, including bone marrow transplants to allow for partially matched donors to improve outcomes, reduce rejection rates and cases of GvHD and greatly reduce the need to aggressive use of immunosuppressant drugs.
In preclinical studies, Cell Source discovered that Veto Cells can facilitate partially mismatched bone marrow transplantations without the need for “supralethal” myoeblation, or ultra high levels of immune suppression
“If proven in human trials, this could be a real game changer,” said Shimrat. “It not only would greatly reduce risk in bone marrow transplants for hematological cancers, but is expandable into mismatched vital organ transplants and treatment of certain non-malignant diseases, where there is dire need because of a dearth of matched donors and high mortality rates associated with both supralethal myoeblation and GvHD.”
Cell Source has completed pre-clinical research and is planning on commencing clinical trials late 2016/early 2017. Given the uniqueness of the therapies and area of unmet medical need, expedited FDA pathways (i.e. Fast Track, Breakthrough Therapy, etc.) will be pursued and, if all goes well, Shimrat sees commercialization as a possibility in less than five years.
Furthermore, Cell Source has announced that it has recently filed provisional patent applications based on recent preclinical data showing that Veto Cells can be successfully combined with genetically modified T cells in a manner that allows them to overcome rejection in the absence of GvHD. Cell Source believes that combing Veto Cells with CAR-T cell therapy, for example, would allow this very promising cancer treatment to graduate from a “personalized therapy” niche of autologous treatment to a “drug like” off the shelf treatment. By increasing the persistence of CAR-T cells, a combined treatment could unlock the potential to treat large numbers of patients who suffer from both blood cancers and solid tumor cancers in a logistically and economically feasible manner.
As Cell Source explores collaborations with CAR-T cell companies, it may be moving towards the ultimate combination therapy – a universally allogeneic cell therapy to set to eradicate the most common forms of cancer.
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Company Name: Cell Source Inc
Contact Person: Itamar Shimrat – CEO
Address:57 West 57th St. Suite 400
Country: United States