# Aleta Biotherapeutics

> Aleta Biotherapeutics is a Natick, Massachusetts immuno-oncology company building CAR T Engagers (CTEs) - simple biologic proteins that make existing CAR-T cell therapies work better. Its lead drug, ALETA-001, bridges a patient's CD19-targeted CAR T-cells to CD20 on cancer cells, aiming to rescue patients who relapse after standard CAR-T treatment for B-cell cancers. Founded in 2015 by Paul Rennert and Roy Lobb, the company is running a Phase 1/2 trial in the UK with Cancer Research UK and reported encouraging early data in December 2025.

- **Founded:** 2015
- **Headquarters:** Natick, Massachusetts, United States
- **Founders:** Paul Rennert (Co-Founder, President & Chief Scientific Officer), Roy Lobb (Co-Founder)
- **Team size:** ~7 employees
- **Products:** ALETA-001, CAR T Engager (CTE) platform, ALETA-002 / ALETA-003, ALETA-004, ALETA-005
- **Notable:** ALETA-001 received FDA Orphan Drug Designation, ALETA-001 granted UK MHRA Innovation Passport (November 7, 2022), First patient dosed in ALETA-001 Phase 1/2 trial (February 2024)

## Products & services

- **ALETA-001** — Lead first-in-class biologic CAR T-Cell Engager. Bridges a patient's circulating CD19-targeted CAR T-cells to CD20-expressing cancer cells, aiming to rescue patients with relapsed/refractory B-cell malignancies after CD19 CAR-T therapy. In Phase 1/2 (NCT06045910).
- **CAR T Engager (CTE) platform** — Multi-antigen biologics that increase cancer target density, prevent antigen escape and resistance, and improve the speed and effectiveness of CAR-T cell killing - without re-engineering the cells.
- **ALETA-002 / ALETA-003** — Discovery-stage CAR T Engager candidates directed at solid tumors.
- **ALETA-004** — Preclinical CAR T Engager program targeting acute myeloid leukemia (AML).
- **ALETA-005** — Preclinical CAR T Engager program designed for multiple myeloma.

## Achievements

- ALETA-001 received FDA Orphan Drug Designation
- ALETA-001 granted UK MHRA Innovation Passport (November 7, 2022)
- First patient dosed in ALETA-001 Phase 1/2 trial (February 2024)
- Announced promising Phase 1/2 data with Cancer Research UK (December 8, 2025), with a tolerable safety profile across all doses and encouraging efficacy
- Built a multi-antigen CAR T Engager pipeline spanning blood cancers and solid tumors

## Latest updates

- **2025-12** — Aleta and Cancer Research UK announced promising Phase 1/2 data for ALETA-001: a highly tolerable profile at all doses tested and encouraging efficacy in relapsed/refractory B-cell malignancy patients previously treated with CD19 CAR-T.
- **2025-06** — Alan Walts, PhD joined as Executive Chairman.
- **2024-02** — First patient dosed in the ALETA-001 Phase 1/2 clinical trial (NCT06045910) for relapsed/refractory B-cell malignancies.
- **2024-01** — Satish Jindal, PhD appointed CEO.
- **2022-11** — ALETA-001 received the UK MHRA Innovation Passport designation.

## Links

- Website: https://aletabio.com
- LinkedIn: https://www.linkedin.com/company/aletabio
- Twitter/X: https://twitter.com/BioAleta

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Profile page: https://yespress.io/aleta-biotherapeutics
Published by YesPress — https://yespress.io
Last updated: 2026-06-10
