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At PromiCell, we are at the forefront of biotechnology, harnessing the power of CAR T and TCR platforms to outsmart cancer. Our therapies are designed to address the limitations of current treatments—enhancing precision, durability, and safety while expanding the fight against both solid and hematologic cancers.
PromiCell’s CAR T cells are engineered with IL-18 cytokine armoring, a groundbreaking advancement that enhances the immune system’s ability to combat cancer. By creating a pro-inflammatory microenvironment, this innovation enables our therapies to target and destroy both antigen-positive and antigen-negative tumor cells. This dual action addresses tumor resistance, expanding the effectiveness of our therapies to tackle some of the most challenging cancer cases.
Our state-of-the-art manufacturing process uses hypoxic (low-oxygen) environments to mimic the natural conditions of solid tumor micro-environments. This approach produces more durable and functional immune cells with enhanced tumor-killing abilities. By leveraging Xcellbio’s GMP-compliant technology, PromiCell ensures that every therapy we produce is optimized for superior efficacy, even in the most aggressive cancers.
PromiCell’s robust pipeline includes a range of therapies designed to address both solid and hematologic malignancies, offering multiple pathways for clinical success. From our flagship PRO CAR-201 therapy targeting metastatic prostate cancer to cutting-edge TCR therapies for leukemia, our innovative platforms provide hope to patients with limited treatment options. Each therapy is backed by extensive preclinical and clinical research, ensuring we meet the highest standards of safety and efficacy.
At PromiCell, patients are at the heart of everything we do. Our therapies are meticulously designed to prioritize safety, enhance durability, and improve long-term outcomes in adults and paediatric patients. By focusing on the unique needs of cancer patients, we are developing solutions that go beyond treating the disease to transforming lives. Our goal is to deliver treatments that are not only effective but also provide new hope for a brighter future.
Exclusively Licensed from Fred Hutchinson Cancer Center, targeting metastatic castration-resistant prostate cancer (mCRPC)
Demonstrated robust tumor response in preclinical studies
Phase 1 trial enrolling patients at Fred Hutchinson Cancer Center, and supported by NExT (NCI Experimental Therapeutics Program)
Exclusively Licensed from Fred Hutchinson Cancer Center, targeting relapsed/refractory Ewing Sarcoma
Demonstrated complete tumor eradication in preclinical studies
IND application expected by late 2025, with clinical trial opening expected in 2026
Exclusively Licensed from Fred Hutchinson Cancer Center, targeting metastatic castration-resistant prostate cancer (mCRPC)
Combines STEAP1 targeting with IL-18 cytokine to generate a pro-inflammatory immune environment to deliver deeper and more reliable tumor control
IND application expected by late 2025, with clinical trial opening expected in 2026
Exclusively Licensed from Fred Hutchinson Cancer Center, targeting leukemia relapse after allogeneic bone marrow transplantation
First-in-human studies showed safety and signal of response in 4 out of 9 patients (NCT03326921)
Phase 1 trial completion expected in 2025 with plan to transfer to phase 2 with updated manufacturing and clinical protocol, addressing a large patient population across different leukemia types
Exclusively Licensed from Memorial Sloan Kettering Cancer Center (MSK), targeting relapsed/refractory acute myeloid leukemia
Demonstrated markedly superior potency over current clinically validated best-in-class CD33-specific CAR T therapies in preclinical models
IND-enabling studies are ongoing with IND filing and clinical trial opening expected in Q4 2025/Q1 2026
CAR T stands for Chimeric Antigen Receptor T cell. It is a new class of immunotherapy where T cells are genetically engineered to target cancer cells and destroy them. The CAR is designed to target antigens on the outside of tumor cells and activate the killing power of the T cells when bound to this antigen. CAR T cells are grown in the laboratory and then infused back into the patient, where they home to cancer cells expressing the target antigen and kill them.
TCR stands for T Cell Receptor. Like CAR T, it is a new class of immunotherapy involving genetically engineered T cells which target cancer cells and destroy them. T cells are genetically engineered to express naturally occurring TCRs which allow them to detect tumor cells in a very natural way - by detecting pieces of tumor-associated proteins on the surface of cancer cells.
CAR T cells detect proteins exclusively located on the surface of tumor cells, while TCRs allow for detection of proteins (both internal and external) expressed by cancer cells that are loaded into naturally occurring antigen presenting machinery.
• PRO CAR – 201A
o Target: STEAP 1 directed CAR T
o Indication: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
o Current Stage: Phase 1
• PRO CAR - 202
o Target: IL-18 STEAP 1 directed CAR T
o Indication: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
o Current Stage: IND Enabling Phase
• PRO CAR – 201B
o Target: STEAP 1 directed CAR T
o Indication: Ewing Sarcoma
o Current Stage: IND Enabling Phase
• PRO CAR - 301
o Target: CD-33 directed CAR T
o Indication: Acute Myeloid Leukemia (AML)
o Current Stage: IND Enabling Phase
• PRO TCR - 401
o Target: HA-1 Engineered TCR T
o Indication: Transplant Relapsed Acute Myeloid Leukemia (AML)
o Current Stage: Phase 1
● PRO CAR-201A: Initial readouts of safety and efficacy could be available in mid-2025.
● PRO CAR-201B: We expect an IND application for PRO CAR-201B to be submitted to the FDA in mid-2025, followed by patient enrolment within the second half of 2025.
● PRO CAR-202: We hope to submit an IND application to the FDA by late 2025, followed by patient enrolment in early 2026.
● PRO CAR-301: Pre-IND preclinical studies are ongoing at MSK, and we anticipate filing an IND by the end of 2025.
● PRO TCR-401: The PRO TCR-401 trial is planned to open in the first half of 2025.
An IND (Investigational New Drug) application is permission from the FDA to start testing a new drug in humans after lab and animal studies show it might be safe.
● Phase 1 tests the drug in a small group (20-100 people) to check if it’s safe and find the right dose.
● Phase 2 involves more people (100-300) to see if the drug works for a specific disease and to monitor side effects.
● Phase 3 tests in a larger group (300-3,000) to confirm effectiveness, compare it to existing treatments, and check for rare side effects before approval.
Due to the promising therapeutic effect of cell therapies, we expect increasing competition from new and existing companies across four major fronts, which include, among others:
● Autologous T cell therapy: Adaptimmune Therapeutics plc, Autolus Therapeutics plc, bluebird, Bristol-Myers Squibb Company, Gracell Biotechnologies Inc., Kite, a Gilead Company, Novartis International AG, Poseida, TCR2 Therapeutics Inc., and Vor Biopharma Inc
● Allogeneic T cell therapy: Allogene, Arsenal Biosciences, Atara Biotherapeutics, Inc., Cellectis, Celyad Oncology SA, CRISPR Therapeutics, Fate Therapeutics, Inc., Gracell, Kite, Legend Biotech Corporation, Poseida, Precision Bio, Sana Biotechnology, Inc., and Vor
● Allogeneic NK therapy: Artiva Biotherapeutics, Inc., Celularity Inc., Editas, Fate, Fortress Biotech, Inc., Immunity Bio, Inc., Nkarta,Inc., NKGen Biotech, Inc., and Takeda Pharmaceutical Company Limited
● Other cell therapies: Other companies are developing CAR-expressing immune cell therapies derived from natural killer T cells, or NKT cells, including Kuur Therapeutics; from macrophages, including Carisma Therapeutics; and from gamma-delta T cells, including Adicet Bio, Gamma Delta Therapeutics, Cytomed Therapeutics, TC Biopharm, Hebei Senlang Biotechnology, and Beijing Doing Biomedical Technology Co., Ltd.; and
● Other oncology therapeutics: Multiple biotechnology and pharmaceutical companies developing other directly competitive technologies, such as small molecule, antibody, bi-specific antibody, and antibody-drug conjugates.
T cells produced from the patient’s own cells, is known as an “autologous” T cell. When a patient receives a T cell that started with another donor’s T cell, it is known as an “allogeneic” T cell.
We believe that our novel and proprietary technologies are complementary and have broad potential applicability across multiple human cancers. Furthermore, we believe that our CAR T cell therapy product candidates have the potential to offer a superior treatment option to patients due to the incorporation of innovative technologies and rigorous and extensive preclinical validation by world-leading academic centers.
We have not generated any revenue to date, and do not expect to generate revenue unless or until we successfully commercialize our products. We anticipate that we will continue to incur losses in the foreseeable future, as we do not expect to generate revenue until 2030 at the earliest, which is when we expect to launch our first product.
Thus far, seven CAR T cell therapies and one TCR cell therapy have been approved by the FDA, owned by six Companies (Kite/Gilead, Novartis, Bristol Myers Squibb, Autolus, JNJ/Legend Biotech, Adaptimmune).
Adding to the above, in question 7, there is a non-exhaustive list of companies developing therapies using similar technologies.
We have entered into two exclusive license agreements with the Fred Hutchinson Cancer Institute (Fred Hutch) and into one exclusive license agreement with Memorial Sloan-Kettering Institute for Cancer Research (MSK):
● The first Fred Hutch agreement, entered into on January 19, 2023, grants Promicell an exclusive license to utilize certain patents held by Fred Hutch, and non-exclusive license of certain know-how.
● The second Fred Hutch agreement, entered into on September 22, 2023, grants to Promicell a license, subject to retained rights by the Leukemia and Lymphoma Society and another party to utilize certain patents and know-how held by Fred Hutch for multiple patent filings done in the US and abroad.
● We entered the MSK agreement on October 5, 2024, granting Promicell exclusive license to utilize certain patents and know-how developed by MSK.
In a broader definition, an exclusive license agreement is a legal contract where the owner of a product, technology, or intellectual property (IP) grants exclusive rights to another party (the licensee) to use, sell, or develop that IP—meaning no one else, including the owner, can use it during the agreement period.
Despite the success of the eight approved T cell products above, there is still a tremendous unmet need in cancer. In fact, approved T cell therapies are appropriate for only a small minority of cancer patients.
Traditional treatments for cancer include surgery, radiation and chemotherapy. A fourth treatment category, known as “Precision Medicine”, enabled by late-20th century advances in biology and antibody drug development, allows for targeted therapy of cancer without some of the more widespread side effects and toxicities of chemotherapy and radiation. Beginning in the early 21st century, treatments harnessing the power of the body’s immune system have been employed as a fifth treatment category to fight cancer. This is known as “immunotherapy” and includes both CAR T and TCR technology.
There is still a tremendous unmet need for cancer. New CAR T cell therapies and TCR cell therapies in development aim to increase efficacy, decrease adverse effects, and expand treatment into non-hematological malignancies. More specifically, we believe the limitations of approved cellular therapies include limited depth of response (only a fraction of tumor is killed), short durability of effect (tumor killing is short-lived), and lack of diversity of therapeutic effect (cancer cells that do not express the targeted tumor protein can escape being killed). We aim to develop therapies with improved Depth, Durability and Diversity anti-tumor response, to expand their utility across solid and hematological tumors.
PromiCell has exclusively licensed technology from, and closely collaborates with, both Fred Hutchinson Cancer Research Center (Fred Hutch) and Memorial Sloan Kettering Cancer Center (MSK) to take preclinically vetted and validated cutting-edge cell-based immunotherapies to the clinic.
Our partners have world-class expertise in manufacturing and caring for patients being treated with CAR T and TCR therapies. We plan to leverage these to support our Phase 1 trials. This creates a risk-mitigated and cost-efficient business model.
Under License Agreement One, Promicell is required to pay certain development milestone payments related to clinical trials and granting of certain regulatory approvals ranging from $500,000 to $3,000,000. Additionally, the Company is required to pay certain commercial milestones based on the attainment of certain sales thresholds, with milestone payments ranging from $750,000 to $25,000,000.
Under License Agreement Two, the Company is required to pay certain development milestone payments related to clinical trials and granting of certain regulatory approvals ranging from $500,000 to $3,000,000. Additionally, the Company is required to pay certain commercial milestones based on the attainment of certain sales thresholds, with milestone payments ranging from $5,000,000 to $30,000,000.