Aleta Biotherapeutics
Aleta Biotherapeutics is a clinical-stage immuno-oncology company developing multi-antigen CAR T Engager (CTE) biologics that retarget circulating CAR T-cells against relapsed/refractory B-cell malignancies, AML, myeloma, and solid tumors, with lead asset ALETA-001 in Phase I/II trials.
- Company typePrivate
- Founded2016
- HeadquartersNatick, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Aleta Biotherapeutics does
Aleta Biotherapeutics is a privately held, clinical-stage immuno-oncology company headquartered in Natick, Massachusetts that is developing a portfolio of multi-antigen CAR T Engager (CTE) biologics designed to overcome tumor antigen loss, insufficient antigen density, and tumor heterogeneity — the principal causes of relapse in patients previously treated with CAR T-cell therapies. The company's core technology is a platform of engineered proteins that bind to cancer cell surface antigens and "transform" tumor cells by displaying antigens recognized by approved CAR T-cell receptors, thereby enhancing the efficacy of CAR T-cells already circulating in the patient. The lead candidate, ALETA-001, is a three-domain biologic containing a CD19 extracellular domain linked to an anti-CD20 antibody domain that is currently in a 72-patient Phase I/II trial (NCT06045910) for patients with relapsed/refractory B-cell malignancies following CD19 CAR T-cell therapy, with first-patient-dosed in February 2024 and interim data announced in December 2025 demonstrating a highly tolerable safety profile and durable complete metabolic remissions in some patients.
The pipeline extends the same CD19-bridging concept into additional indications: ALETA-004 (preclinical) targets acute myeloid leukemia, ALETA-005 (discovery) targets multiple myeloma via BCMA, and ALETA-002/003 target solid tumors. The company is also developing a second-generation COSTIM-TCE platform incorporating CD58 and B7-2 costimulatory domains to create immune-synapse-like structures that enhance T-cell activation.
Aleta operates a non-commercial, clinical-stage business model with no current product revenue; the stated revenue model is future one-time licensing of biologics to pharmaceutical partners. Development is substantially de-risked through a landmark 2021 collaboration with Cancer Research UK, in which CRUK's Centre for Drug Development funds, sponsors, and conducts the Phase I/II ALETA-001 trial at University Hospital Birmingham and The Christie NHS Foundation Trust, with Aleta retaining commercialization rights in exchange for milestone and royalty payments. Regulatory positioning includes FDA Orphan Drug Designation for Mantle Cell Lymphoma (2024), MHRA Innovation Passport under ILAP (2022), and MHRA Clinical Trial Authorization (2023). The company has raised over $13.7 million in disclosed funding (2021 SEC Form D), is backed by Advent Life Sciences, and is led by CEO Alan Walts (joined June 2025, ex-Genzyme), CSO Paul Rennert, and CMO Marco Schupp (ex-Kite Pharma, lead on axi-cel).
Aleta Biotherapeutics firmographics
Firmographics- Name
- Aleta Biotherapeutics
- Legal name
- Aleta Biotherapeutics, Inc.
- Website
- https://aletabio.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Aleta Biotherapeutics is a clinical-stage immuno-oncology company developing multi-antigen CAR T Engager (CTE) biologics that retarget circulating CAR T-cells against relapsed/refractory B-cell malignancies, AML, myeloma, and solid tumors, with lead asset ALETA-001 in Phase I/II trials.
- Ownership category
- akta.pro rank
Aleta Biotherapeutics industry classification
Industry- Product category
- Immuno-oncology biologics (CAR T Engagers)
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- CAR-T & TCR-T Therapies (HLAAABAC)
- akta.pro secondary industry
- Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies) (HLAAANAK)
Keywords
Where Aleta Biotherapeutics is headquartered
LocationHeadquarters
- HQ city
- Natick
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Aleta Biotherapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
Revenue model
- Biopharmaceutical Development and Commercialization: Pre-revenue clinical stage company. Revenue potential from commercialization of CAR T Engager biologics for oncology indications upon regulatory approval. Model based on proprietary therapeutic candidates developed through clinical trials and licensed to pharmaceutical partners.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels4 records
Aleta Biotherapeutics product offering
Product offeringCore offering
Aleta Biotherapeutics develops and commercializes a portfolio of proprietary CAR T Engager (CTE) biologics — multi-antigen binding proteins designed to enhance the effectiveness of existing CAR T-cell cancer therapies. These off-the-shelf, point-of-care biologic drugs transform cancer cell surface antigen expression to match circulating CAR T-cell receptors, addressing tumor antigen loss, low antigen density, and tumor heterogeneity. The lead product, ALETA-001, is in a Phase I/II clinical trial for B-cell lymphoma patients who have relapsed after CD19 CAR-T therapy.
Product overview
Aleta Biotherapeutics is a clinical-stage immuno-oncology company pioneering a portfolio of multi-antigen CAR T Engagers (CTEs). The company's core platform consists of biologic therapies that transform cancer cell antigen expression to match circulating CAR T-cell therapies, addressing critical issues of tumor antigen loss, density, and heterogeneity. The lead product ALETA-001 (Phase I/II) is a CD19/CD20-targeting CTE for B-cell malignancies in patients who have relapsed after CD19 CAR T-cell therapy. The pipeline includes ALETA-004 (preclinical, AML), ALETA-005 (discovery, multiple myeloma), and ALETA-002/003 (solid tumor programs). All CTEs work by binding to existing tumor antigens and changing antigen expression to match specific CAR T receptors, enabling enhanced cancer cell killing.
Differentiator
Problem solved
Functional benefit
Products and services
- ALETA-001 ALETA-001 is a CAR T-cell Engager (CTE) biologic in Phase I/II clinical trials. It contains the CD19 target protein recognized by approved anti-CD19 CAR T therapeutics, linked to an anti-CD20 antibody domain. It is designed to improve the effectiveness of CD19-directed CAR T therapies by increasing CD19 antigen density and restoring lost CD19 expression on cancer cells, allowing CD19+/CD20+ cancer cells to be recognized and killed by previously administered CD19-directed CAR T-cells circulating in the patient. GMP-manufactured, vialed, and released as a simple off-the-shelf biologic for B-cell lymphoma/leukemia patients relapsed after CD19 CAR-T therapy.
- ALETA-004 ALETA-004 is a preclinical multi-antigen binding CTE designed to extend the cancer killing activity of CD19 CAR T cells to patients with advanced acute myeloid leukemia (AML). It binds two well-known AML antigens and links them to CD19 CAR T cells using the same CD19 target protein recognized by approved anti-CD19 CAR T therapeutics.
- ALETA-005 ALETA-005 is a discovery-stage CTE that contains the BCMA target protein recognized by approved CAR T cell therapeutics, linked to multiple myeloma antigen-binding domains. Designed to be given alongside BCMA CAR T therapy for treatment of advanced multiple myeloma patients, presenting multiple binding sites for BCMA CAR T cells to optimally stimulate cancer cell killing.
- ALETA-002 and ALETA-003 ALETA-002 and ALETA-003 are CAR T Engagers designed to treat solid tumor cancers. They use CD19-protein based CTEs directed to well-validated solid cancer cell antigens and are designed to be incorporated into CD19-based CAR T therapy to connect non-B cell cancers to CD19 CAR T cells for cancer cell killing.
- CAR T Engager (CTE) Platform The CAR T Engager (CTE) Platform is a proprietary technology platform consisting of multi-antigen CAR T Engagers — simple, potent biologic therapies designed to transform the expression of cancer tumor cells to match CAR T-cell therapies circulating in patient blood. CTEs work by binding to cancer cells to enhance the efficacy of CAR T cell therapies, increasing cancer target density, preventing resistance and escape from therapy, and increasing the speed and effectiveness with which CAR T cells can kill cancer cells.
Quantifiable outcome
- ALETA-001 expected to improve durable response rates to more than 60% of CAR-T treated patients versus 45% with CAR T therapy alone
- +2 more outcomes
Companies that use Aleta Biotherapeutics
Customer profileNamed customers1 record
Segments1 record
Ideal customer profiles1 record
Aleta Biotherapeutics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Aleta Biotherapeutics partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and supporting.
- UK Medicines and Healthcare products Regulatory Agency (MHRA)coreMHRA granted Innovation Passport under ILAP for ALETA-001, triggering collaboration with partner agencies including NICE and SMC to chart regulatory roadmap for faster patient access.
- Cancer Research UKcoreLandmark collaboration where Cancer Research UK's Centre for Drug Development funds, sponsors, and conducts the Phase I/2a clinical trial of ALETA-001. Trial led by investigators at University Hospital Birmingham and The Christie NHS Foundation Trust. Aleta retains rights to further develop and commercialize ALETA-001 with licensing of clinical trial results in return for milestone and royalty payments.
- University Hospital Birmingham NHS Foundation TrustcoreClinical trial site for ALETA-001 Phase I/II clinical trial. Dr. Sridhar Chaganti serves as Chief Investigator leading the trial.
- The Christie NHS Foundation TrustsupportingClinical trial site in Manchester, UK. Dr. Amit Patel's Cellular and CAR-T therapies team initially leading the trial.
- University of PennsylvaniasupportingDr. Marco Ruella, Associate Professor of Medicine and Scientific Director of the Lymphoma Program, serves as advisor to Aleta and provided commentary on ALETA-001 clinical data.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
Aleta Biotherapeutics competitors and assessment
Company assessmentDirect peers
- Precision BioSciences: Clinical-stage CAR-T developer using ARCUS gene-editing platform for B-cell lymphoma and other hematologic malignancies. Comparable size, stage, and oncology CAR-T focus to Aleta.
- Allogene Therapeutics: Clinical-stage allogeneic CAR-T developer with multiple oncology programs (including CD19/BCMA). Directly comparable as a small-cap clinical-stage CAR-T platform company targeting similar hematologic malignancy indications.
- Caribou Biosciences: Allogeneic CAR-T developer (CB-010 for B-cell malignancies). Comparable clinical-stage CAR-T platform company pursuing next-gen oncology cell therapies with similar regulatory and capital profiles.
- Arcellx: Clinical-stage CAR-T company focused on BCMA-targeting therapy (anito-cel) for multiple myeloma. Directly comparable to Aleta's ALETA-005 program, which is designed to be used alongside BCMA CAR-Ts.
- Adicet Bio: Clinical-stage gamma delta CAR-T developer with oncology programs including CD19 CAR-T for B-cell malignancies. Comparable clinical-stage CAR-T company at similar scale and stage.
- Vor Biopharma: Clinical-stage cell therapy company developing engineered hematopoietic stem cell transplants and CAR-T programs for AML — directly comparable to Aleta's ALETA-004 AML program.
- Lyell Immunopharma: Clinical-stage CAR-T company focused on solid tumor indications. Comparable to Aleta's solid tumor programs (ALETA-002/003) and similarly reliant on next-gen T-cell technologies to address tumor microenvironments.
- Fate Therapeutics: Clinical-stage iPSC-derived NK and T-cell therapy company with multiple oncology programs. Comparable clinical-stage cell therapy platform with similar partnership-driven model.
Broad incumbents
- 2seventy bio: Commercial-stage CAR-T company (Abecma, BCMA-directed) that is a natural potential strategic partner or competitor for Aleta's ALETA-005 program. Comparable BCMA CAR-T franchise in multiple myeloma.
- Bristol Myers Squibb (Cell Therapy): Owns Breyanzi (CD19 CAR-T) and Abecma (BCMA CAR-T), both of which are the existing CAR-T products that ALETA-001 and ALETA-005 are designed to complement. A natural acquirer or partner for Aleta's CTE platform.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks6 records
Key highlights6 records
Customer concentration
Aleta Biotherapeutics social profiles
Digital presenceAleta Biotherapeutics compliance and trust
Trust signalCompliance2 records
Aleta Biotherapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Aleta Biotherapeutics leadership team
Management profileNumber of profiles
Profiles13 records
Aleta Biotherapeutics funding detail
Funding detailFunding overview
Funding rounds2 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Aleta Biotherapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Aleta Biotherapeutics
What does Aleta Biotherapeutics do?
Aleta Biotherapeutics develops and commercializes a portfolio of proprietary CAR T Engager (CTE) biologics — multi-antigen binding proteins designed to enhance the effectiveness of existing CAR T-cell cancer therapies. These off-the-shelf, point-of-care biologic drugs transform cancer cell surface antigen expression to match circulating CAR T-cell receptors, addressing tumor antigen loss, low antigen density, and tumor heterogeneity. The lead product, ALETA-001, is in a Phase I/II clinical trial for B-cell lymphoma patients who have relapsed after CD19 CAR-T therapy.
Is Aleta Biotherapeutics a public or private company?
Aleta Biotherapeutics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Aleta Biotherapeutics founded?
Aleta Biotherapeutics was founded in 2016. It employs 1 to 10 people.
Where is Aleta Biotherapeutics based?
Aleta Biotherapeutics is headquartered in Natick, United States, in the North America region.
How does Aleta Biotherapeutics make money?
One revenue line is on record: biopharmaceutical Development and Commercialization.
Who are Aleta Biotherapeutics's main competitors?
Direct peers on record are Precision BioSciences, Allogene Therapeutics, Caribou Biosciences, Arcellx, Adicet Bio, Vor Biopharma, Lyell Immunopharma and Fate Therapeutics. Broad incumbents are 2seventy bio and Bristol Myers Squibb (Cell Therapy).
Does Aleta Biotherapeutics have an API?
No public API is recorded for Aleta Biotherapeutics.
What industry is Aleta Biotherapeutics in?
Aleta Biotherapeutics's product category is Immuno-oncology biologics (CAR T Engagers). Its primary akta.pro industry code is HLAAABAC, CAR-T & TCR-T Therapies, with a secondary code of HLAAANAK, Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies). Its NAICS code is 325414 and its SIC code is 2836.