On August 30, 2017, the US Food and Drug Administration approved the very first Chimeric Antigen Receptor T-cell therapy (CAR T-cell), tisagenlecleucel (KymriahTM), for treatment of pediatric and young adult Acute Lymphoblastic Leukemia. Eight years subsequently, we have witnessed tremendous advancements of immunotherapy in basic research and their breakthrough into clinical trials.
This is evident from the observation that seven CAR T-cell based cancer therapies were approved in the US in 2024 alone. Furthermore, there are over 1,000 clinical trials ongoing worldwide, in various stages, exploring this exciting technology for the treatment of diverse tumor types.
Mary McGann, PharmD, BCOP – a clinical pharmacy specialist in bone marrow transplant and cellular therapy – told Pharmacy Practice News, it’s “Definitely an exciting time. I feel like every year we almost double the number of CAR-T patients that we have.”
With the FDA having approved an additional six CAR T-cell treatments for use in qualified patients to date, the global market for CAR T-cell therapies is expected to reach at least $27 billion by 2033.
Amongst the companies participating in clinical trials right now, Cytomed Therapeutics (NASDAQ: GDTC) is exploring the use of its products as an “off-the-shelf” allogeneic cellular immunotherapy to be used for a broad spectrum of cancers.
Unlike most CAR T-cell therapies, CytoMed’s products aim to use healthy donor cells, rather than cells from compromised patients, to engineer the therapy by developing a single allogeneic product for the treatment of a wide array of cancers.
The company has an ongoing clinical trial currently in Singapore, with and an upcoming trial in India.
Cytomed Therapeutics’ Chairman, Peter Choo, said of the global increase in clinical trials and FDA approvals, “The science behind CAR T-cell therapies has shown to be a real-life saver. It is exciting to see the US FDA finally taking notice of its promise.
“While we are currently involved in two separate trials, we do believe this year, 2025, could very well prove to be the year where we, and the industry as a whole, are proven to not only be viable, but essential in the global fight against cancer.
“Further, our products, as a differentiator, look to treat a multitude of tumors, both solid and liquid, via commercial production, and to do so at a much lower cost than current therapies.
“By achieving this, we believe we could open up treatment for far more patients, with hopes of saving far more lives.”
With the large number of CAR T-cell therapies currently in clinical trials, the outlook for 2025 is very bright. However, the average cost per patient for CAR T-cell therapy in the United States often exceeds $400,000.
The key to real success, outside of patient remission, will be, as Mr. Choo believes, bringing the cost of CAR T-cell therapies down significantly, which is CytoMed’s core approach with its technology.
Read more about CytoMed Therapeutics’ pipeline, HERE
It’s been about 18 years since a four year girl diagnosed with neuroblastoma (a solid tumor cancer) received her first CAR T-cell therapy in clinical trial. Now in her 20’s, she’s been cancer-free for nearly two decades, one of the longest reported remissions following this breakthrough therapy.
However, while tens of thousands of patients have been treated to date with CAR T-cell therapies worldwide, many with great success, this particular case stands as a testament to science, and most importantly, where it is headed.
You see, the vast majority of CAR T-cell recipients are treated for hematological or blood cancers, as solid tumors like neuroblastoma have been, thus far, difficult to effectively target. Unfortunately for most of the patients in the trial cited above, the results were mixed.
Of the 19 children treated with CAR T-cell therapy (all diagnosed with neuroblastoma), 12 unfortunately died within seven years of treatment, and five were disease free after 10-15 years, with one patient (the young lady mentioned above) still in remission.
But a new clinical trial is soon taking place in India, with the ultimate objective to make cell therapy accessible to more patients.
CytoMed Therapeutics (NASDAQ: GDTC) in collaboration with SunAct Cancer Institute, has entered a Phase 1/Phase 2 clinical trial using CytoMed’s proprietary allogeneic gamma delta T cells for treating various cancers, including solid tumors.
Peter Choo, Chairman of CytoMed Therapeutics said, “CytoMed’s collaboration with SunAct is timely and complements our core focus of harnessing CytoMed’s proprietary off-the-shelf technologies to develop novel donor-derived cell-based allogeneic immunotherapies for the treatment of various cancers at affordable cost.
“We are aligned with the foresight of our partner SunAct to provide affordable no-option cancer therapeutics that could improve patients’ quality of life.”
Ultimately, should the trial prove successful, the company hopes to increase remission rates for solid tumor patients, while creating a CAR T-cell therapy that is far more affordable, wide ranging and accessible.
To read more about the CytoMed/SunAct collaboration, visit HERE
Or, to read more about the young lady who is nearing the two decade mark in remission, visit HERE
Chimeric Antigen Receptor T-Cell therapy, or CAR T-cell therapy, has revolutionized cancer treatment. First approved by the US Food and Drug administration in 2017, over 34,000 cancer patients have been treated to date.
However, while CAR T-cell therapies have proven to be highly effective against certain cancers, the costs associated with the development and administration of CAR T-cells are unacceptably high. In the US alone, estimates show that treatment of a single patient can cost between $300,000 and $600,000.
Clearly, while the science (and results) behind CAR T-cell treatments is exciting, the sky-high price tag associated with treatment must come down. Thankfully, there are ways to approach this issue.
BioInformant, the world’s largest stem cell industry blog says, “The high cost makes it (CAR-T cell therapy) inaccessible for many patients and poses a challenge for healthcare systems worldwide.”
In its coverage on the industry, the publication includes five ways to help reduce the costs of this life-saving treatment.
They are:
1: Producing the therapy in countries with lower manufacturing costs
2: Implementing point of care manufacturing
3: Developing off-the-shelf (allogeneic) CAR T-cell therapies
4: Engineering CAR-T cells inside the body (in Vivo)
5: Expanding CAR-T to other indications
Of the high costs of CAR T-cell therapies, Peter Choo, Chairman of CytoMed Therapeutics (NASDAQ: GDTC) said, “Our goal, and I believe the goal of the entire industry, is to greatly reduce the costs of CAR-T cell therapy…
“Currently, while the technology has proven to be very beneficial, its cost is a very high barrier for the vast majority of those in need. BioInformant makes very good points in its coverage.
“I would add that our mission at CytoMed is to create a CAR-T cell therapy that incorporates most of BioInformant’s cost-cutting points, especially points 1,2, 3 and 5. Producing the therapy in a lower cost manufacturing region, and on-site in Asia. Developing an off-the-shelf, allogeneic therapy and expanding our therapies to treat a multitude of cancers, both solid tumors and blood.”
By manufacturing an allogeneic, off-the-shelf CAR T-cell therapy that targets a wide range of cancers, CytoMed Therapeutics, with manufacturing facilities in Malaysia, could help to not only reduce the high cost of CAR-T cell therapies, but bring the costs down enough to treat a much larger pool of qualified patients.
To learn more about CytoMed Therapeutic’s technology, visit HERE
Or, to read the BioInformant coverage, visit HERE
New research from SNS Insider shows the Regenerative Medicine Market is projected to be valued at $235.98 billion by 2032. Notably, the firm says the market, valued at $32.50 billion in 2023, is experiencing significant growth due to new, innovative therapies for chronic disease and advances in stem cell technology.
These new and innovative therapies look to target chronic disease, cancer, genetic disorders and degenerative conditions.
“In 2023, cell therapy held the dominant share of the regenerative medicine market, accounting for 35% of the total market share. This segment is experiencing robust growth due to its broad applicability in various therapeutic areas such as oncology, musculoskeletal disorders, and neurological diseases.
“The introduction of innovative treatments like CAR-T cell therapy has dramatically advanced the efficacy of cancer therapies, particularly in treating blood cancers such as leukemia and lymphoma,” an excerpt from the report shows.
Of the new research, Peter Choo, Chairman of CytoMed Therapeutics (NASDAQ: GDTC) said, “The prevalence of both chronic, degenerative disease and cancer is, unfortunately on the rise due to an aging world. I agree with SNS’s assessment of the 2032 market value for therapeutics targeting these conditions.
“I would add, however, CytoMed is right now working on CAR T-cell therapies that that target solid cancers. Not only blood cancers like leukemia and lymphoma as the report notes, but an entire host of solid tumors as well.
“For this reason, and of course to assist patients of cancer and degenerative diseases, CytoMed Therapeutics has not only concentrated its efforts on its advanced, off-the-shelf allogenic CAR T-cell cancer therapies, but has acquired the valued assets of cord blood bank CellSafe International.
“This acquisition gives us direct access to rare precious cord blood. Naïve cord blood offers a wide range of opportunities in the fields of regenerative medicine and aging diseases, including auto-immune diseases.
“Further, we were able to acquire CellSafe’s assets at a very reasonable cost. These resources, combined with our scientific expertise, may allow the company to introduce advanced cell technology products into the fast-growing regenerative medicine market,” he said.
For more information on CytoMed Therapeutics and its acquisition of Cord Blood Bank, CellSafe International, visit HERE
Or, to access to the SRS report on Regenerative Medicine, visit HERE