What Renaissance Pharma does

Renaissance Pharma Ltd is a clinical-stage pharmaceutical company developing Daretabart (hu14.18K322A), a humanised anti-GD2 monoclonal antibody immunotherapy for the treatment of high-risk neuroblastoma (HRNB), a rare paediatric cancer with only a 50% five-year survival rate under current multimodal standard of care. Founded in 2023 in Manchester, UK by Executive Chairman Lee Morley and CEO Simon Ball, the company in-licensed Daretabart exclusively from St. Jude Children's Research Hospital in August 2023, securing development, manufacturing and commercialisation rights across the US, Canada, Europe, China, Japan and Turkey.

The technical core is a humanised anti-GD2 antibody engineered with three differentiating features: 98% human composition, a specialised cell line producing lower antibody glycosylation, and a K322A mutation designed to limit complement activation and improve tolerability versus earlier-generation anti-GD2 antibodies. Phase II clinical data demonstrated an 86.0% overall survival rate at three years and a 73.7% event-free survival rate in newly diagnosed HRNB patients, with 96.8% achieving partial response or better at the end of induction. In April 2026, the FDA granted Fast Track Designation and IND clearance, enabling initiation of the SHINE Phase II/III trial, and the first commercial-scale GMP batch was successfully manufactured.

Renaissance Pharma is pre-revenue; the disclosed revenue model is pharmaceutical product sales of Daretabart upon regulatory approval. The company was acquired in March 2024 by Essential Pharma, an international specialty pharma group focused on niche, clinically differentiated products, and now operates as a wholly owned subsidiary. Leadership comprises CEO Simon Ball (also Interim CEO of Essential Pharma), Executive Chairman Lee Morley, CMO Dr. Jonathan Morgan and CTO Debra Nevin, with engagement of FDA, EMA and other regulators to configure the optimal submission and commercialisation path.

Name

Renaissance Pharma

Legal name

Renaissance Pharma Ltd

Website

https://renaissancepharma.co.uk

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

1–10 employees

Short description

Renaissance Pharma is a clinical-stage pharmaceutical company developing Daretabart, a humanised anti-GD2 monoclonal antibody immunotherapy for high-risk neuroblastoma in paediatric patients, operating as a wholly owned subsidiary of Essential Pharma.

Ownership category

akta.pro rank

Product category

Pediatric Oncology Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN)

akta.pro secondary industries

Specialty Care Pharmaceuticals (HLAIAAAB), Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA), Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)

Keywords

• Pediatric oncology therapeutics
• Monoclonal antibody immunotherapy
• Rare disease drug development
• Anti-GD2 antibody treatment
• Neuroblastoma clinical development

Headquarters

HQ city

Manchester

HQ country

United Kingdom

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Pharmaceutical product sales: Pre-revenue development stage company. Revenue will be generated through commercialization of Daretabart (hu14.18K322A) upon regulatory approval for the treatment of high-risk neuroblastoma.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Renaissance Pharma is a clinical-stage pharmaceutical company developing Daretabart (hu14.18K322A), a humanized anti-GD2 monoclonal antibody immunotherapy for the treatment of high-risk neuroblastoma in pediatric patients. The investigational compound is being evaluated in the SHINE Phase II/III trial and has received FDA Fast Track Designation and IND clearance. The asset was in-licensed from St. Jude Children's Research Hospital.

Product overview

Renaissance Pharma Limited is a single-product pharmaceutical company focused on rare pediatric diseases, specifically high-risk neuroblastoma. The company's sole offering is Daretabart (hu14.18K322A), a humanized anti-GD2 antibody immunotherapy. This investigational compound is the company's lead and only product candidate, currently in clinical development with Phase II data showing 86% overall survival rate at three years. The company operates as a subsidiary of Essential Pharma following acquisition in April 2024.

Differentiator

Problem solved

Functional benefit

Products and services

• Daretabart (hu14.18K322A) Investigational humanized anti-GD2 monoclonal antibody immunotherapy engineered to target and destroy high-risk neuroblastoma (HRNB) cells. Specifications: 98% human composition, specialized cell line production with lower glycosylation, and a K322A mutation limiting complement activation. Phase I and II trials demonstrated tolerability and clinical activity in HRNB. In-licensed from St. Jude Children's Research Hospital.

Quantifiable outcome

• Phase II trial: 86.0% overall survival rate at 3 years, 73.7% event-free survival rate at 3 years
• +2 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Two partnerships are on record, tiered core.

• Essential PharmacoreOthers · 22 March 2024Essential Pharma, an international specialty pharma group focused on ensuring patients have sustainable access to niche pharmaceutical products, completed acquisition of the entire issued share capital of Renaissance Pharma Ltd on March 22, 2024. This acquisition added a clinical development-stage asset to Essential Pharma's rare disease portfolio. Simon Ball, CEO and co-founder of Renaissance Pharma, continues to work with Essential Pharma on Daretabart development.
• St. Jude Children's Research HospitalcoreOEM/ Whitelabel/ Licensing Partner · 1 August 2023Exclusive license agreement signed August 1, 2023 for Daretabart (hu14.18K322A). Renaissance Pharma secured exclusive development, manufacturing and commercialisation rights to US, Canada, Europe, China, Japan and Turkey. The antibody was originally developed by St. Jude and targets GD2 on neuroblastoma cells.

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Emerging players

• Atreca: Atreca is a clinical-stage biotechnology company leveraging its immune repertoire capture technology to develop antibody-based immunotherapies for cancer. Its antibody-discovery focus and oncology pipeline make it an emerging comparable in the antibody therapeutics space.
• Phanes Therapeutics: Phanes Therapeutics is a clinical-stage biopharmaceutical company developing biologics for oncology and eye diseases. Its emerging pipeline of antibody-based oncology therapeutics makes it a comparable emerging player in the biologics development space.
• Eureka Therapeutics: Eureka Therapeutics is a clinical-stage company developing T-cell receptor-based therapies and antibodies for solid tumors including neuroblastoma. Its work on anti-GD2 CAR-T and antibody approaches overlaps with Renaissance's anti-GD2 strategy.

Direct peers

• Day One Biopharmaceuticals: Day One Biopharmaceuticals develops targeted therapies for pediatric oncology and rare diseases of childhood. Its pediatric cancer focus and specialty pharma structure make it a directly comparable peer for Renaissance's pediatric neuroblastoma indication.
• United Therapeutics: United Therapeutics markets Unituxin (dinutuximab), the first FDA-approved anti-GD2 antibody for high-risk neuroblastoma. As the established incumbent in Renaissance's target indication, it represents the primary competitive benchmark for efficacy, safety, and market access.
• Y-mAbs Therapeutics: Y-mAbs developed and commercializes Danyelza (naxitamab), an approved anti-GD2 monoclonal antibody for high-risk neuroblastoma. It is the most directly comparable competitor to Renaissance Pharma, operating in the same indication with the same target and mechanism.

Broad incumbents

• MacroGenics: MacroGenics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based therapeutics for cancer. While not focused on neuroblastoma specifically, its antibody platform and oncology pipeline make it a comparable peer in the anti-GD2/biologics space.
• AstraZeneca: AstraZeneca is a major pharmaceutical company with significant oncology and rare disease franchises. Its broad biopharmaceutical portfolio, including antibody therapeutics, makes it a relevant comparable as a potential acquirer or competitor in the oncology biologics space.
• Roche (Genentech): Roche/Genentech is a global biopharmaceutical leader with extensive oncology and rare disease pipelines, including antibody-based biologics. Its scale and pediatric oncology experience make it a relevant broad incumbent peer.

Regional players

• Innovent Biologics: Innovent Biologics is a Chinese biopharmaceutical company developing monoclonal antibody therapeutics for oncology. Renaissance's exclusive license includes China rights, and Innovent's presence in the Chinese oncology biologics market makes it a regionally relevant peer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/about

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Renaissance Pharma