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PromiCell is a clinical-stage cellular immunotherapy company uniquely positioned to advance potentially curative cell therapies for cancer patients. Building on our experience in rapidly translating promising academic research into clinical applications, we strive to move innovative therapies towards the clinic.
Our next-generation chimeric antigen receptor CAR T cell therapies are designed to address key mechanisms of tumor escape, disease relapse, and immune evasion. CARs are engineered proteins that modify T cells to recognize and eliminate cancer cells. We believe current therapies face limitations, including a lack of durability, safety concerns, and unreliable supply.
Our therapies are optimized for superior in vivo functionality, generating a ‘3-dimensional’ anti-tumor response to improve the depth, durability, and breadth of their impact. This expands their utility across both solid and hematologic tumors. Our scientists are pioneers in CAR T-cell therapy, united in a mission to outsmart cancer and deliver more cures for patients.
Description: Our lead program, PRO CAR-201A, is an unarmored, autologous STEAP 1-directed CAR T therapy, being studied in metastatic castration-resistant prostate cancer (mCRPC) exclusively licensed from the Fred Hutchinson Cancer Center (Fred Hutch).
Target: STEAP 1 is a cell surface protein broadly expressed in prostate cancer (~87%) and other epithelial cancers, with minimal expression in normal tissues.
Clinical Progress:
• Received “Safe to Proceed” on the IND from the FDA in April 2024.
• Phase 1 trial underway, supported by the National Cancer Institute’s Experimental Therapeutics Program (NeXT).
• Preclinical data demonstrated complete tumor response within 5 weeks in prostate cancer models.
Market Potential: In the U.S., metastatic castration-resistant prostate cancer affects ~43,000 people annually and results in ~34,000 deaths.
Description: PRO CAR-201B uses the same construct as PRO CAR-201A: our unarmored, autologous STEAP 1 CAR T. It is currently in pre-clinical testing at Fred Hutch for Ewing Sarcoma, a rare, aggressive bone and soft tissue cancer that usually affects children and young adults.
Target: STEAP 1 is present on most Ewing Sarcoma and highly expressed in >50% (Grunewald TGP, et al. Ann Oncol, 2012.), making this an ideal indication for a STEAP 1 CAR T therapy.
Clinical Progress:
Market Potential: Ewing Sarcoma is a rare disease, with an incidence of 200 patients per year in the US; however, there is no approved therapy for relapsed or refractory disease. The five-year survival rate from the initial diagnosis is ~60%, especially troubling given the young age of Ewing Sarcoma patients. Treatment for this disease has the potential to be designated as an orphan drug by FDA and other regulatory agencies.
Description: PRO CAR-202, exclusively licensed from Fred Hutch, builds on the technology of the PRO CAR-201 program. This platform incorporates the highly potent immunological cytokine IL-18 to enhance immune responses, targeting both antigen-positive and antigen-negative tumor cells. IL-18 contains a fully humanized scFv with high affinity for STEAP 1 on the outside of tumor cells. IL-18 armored STEAP 1 CAR T cells enhance antitumor efficacy in a disseminated Ewing Sarcoma model. It has also shown extension of survival in a highly aggressive, disseminated, syngeneic prostate cancer model.
Target: We believe that armoring with IL-18 should enhance the potency of the treatment by creating a pro-inflammatory immune microenvironment to kill both target-antigen positive and target-antigen negative tumor cells. Based on promising data in the Ewing Sarcoma model, as well as other data showing positive effects of IL-18 on CAR T cell efficacy, we plan to study PRO CAR-202 as a treatment for patients with mCRPC
Clinical Progress:
• Preclinical studies underway, with an IND application expected by late 2025.
• Patient enrollment anticipated in early 2026.
Market Potential: See PRO CAR-201A and PRO CAR 201-B
Description: PRO TCR-401 is an allogeneic HA-1 TCR T therapy for leukemia relapse following bone marrow transplantation (BMT), exclusively licensed from Fred Hutch. HA-1 is a protein found in the immune system of up to 25% of patients and restricted to individuals that have an HLA-A*02:01 allele. In people who express HA-1, the protein is exclusively found on the surface of blood cells.
Target: HA-1 is a minor antigen specific to the patient’s blood cells, for the treatment of patients with relapsed or refractory acute leukemia after donor HCT, while sparing donor cells and other tissues.
Clinical Progress:
Market Potential:
Each year there are approximately 10,000 allogeneic stem cell transplantations in the US. Roughly half of these are likely to be HLA-A*02:01-positive, and about 50% of these are likely to express HA-1, making the patient market size for PRO TCR-401 compelling.
Description: PRO CAR-301 is an autologous CD33-directed CAR T cell that integrates a next-generation armor known as "SAVVY/IL-18". It is an armored CD33-specific CAR T therapy for acute myeloid leukemia (AML), exclusively licensed from Memorial Sloan Kettering Cancer Center (MSK).
Target: CD33, a cell surface protein expressed by mature myeloid cells and hematopoietic stems cells (HSCs), is expressed on over 80% of AML cells and hematopoietic stem cells, making it an effective treatment target.
Clinical Progress:
Preclinical studies are ongoing at MSK demonstrate superior potency compared to standard CD33-specific CAR T therapies. We anticipate IND submission to the FDA by the end of 2025 and commence phase 1 clinical trials in 2026.
Market Potential:
AML causes the highest number of leukemia deaths in the U.S., despite a relatively low incidence of ~20,000 cases annually with 5-year survival rate of approximately 30%.
We are incorporating advanced, automated cell therapy manufacturing technology from Xcellbio in San Francisco. This platform enables GMP-compliant manufacturing in hypoxic (low-oxygen) environments, mimicking the solid tumor microenvironment. Preliminary data indicate:
• Enhanced biological functionality of CAR T cells.
• Longer and improved tumor-killing capabilities.
PromiCell will be among the first clinical partners to adopt Xcellbio’s platform, enhancing the quality, cost-efficiency, and therapeutic potential of cell therapies, particularly for solid tumors.
PromiCell was established in Delaware in October 2022 and commenced operations following its initial funding in April 2023. Since then, we have raised $12 million from four family offices and entered into three exclusive license agreements with world renowned cancer research centers. Our efficient collaboration with the institutions resulted, in that short period of time, in having already commenced a Phase 1 clinical trial and being poised to commence a second Phase1 clinical trial.
We aim to become a fully integrated, leading cancer immunotherapy company by developing novel and cell and gene therapies for cancer. Our strategy to achieve this goal involves close collaboration with premier cancer research centers, a focus on highly differentiated product candidates and advancing clinical trials of our diverse product pipeline.
Focus on highly differentiated product candidates and unmet needs.
Our product candidates represent highly differentiated and novel CAR T and TCR T platforms to be developed across separate solid and hematologic cancers. Each product candidate is supported by robust preclinical data that demonstrates the potential for being a ‘best-in-class’ drug product.
Our pipeline of innovative products currently includes STEAP1 CAR T cells, HA-1 TCR T cells and CD33 CAR T cells, applicable across a number of tumor indications. We plan to advance STEAP 1 CAR T and HA 1 TCR T through their Phase 1 clinical trials and beyond for the treatment of patients with metastatic castration-resistant prostate cancer and recurrent leukemia, respectively. In addition, we plan to leverage our platform technologies to advance the following key programs into clinical development: our STEAP 1 CAR T cell program for Ewing Sarcoma; our IL-18 armored STEAP 1 CAR T cell program for metastatic castration-resistant prostate cancer; and our SAVVY/IL-18 armored CD33 CAR T cell therapy for acute myeloid leukemia.
Promicell has exclusively licensed technology from, and closely collaborates with, both Fred Hutchinson Cancer Research Center (FredHutch) and Memorial Sloan Kettering Cancer Center (MSK) to take pre-clinically vetted and validated cutting-edge cell-based immunotherapies to the clinic.
Our partners have world-class expertise in translational research, clinical trials, and cell processing and manufacturing. We plan to leverage the infrastructure and experience of cancer research center teams to support translational and correlative science, IND-enabling work and Phase 1 product manufacturing. This creates a risk-mitigated and cost-efficient business model.