BreakBio

What BreakBio does

BreakBio Corp. is a clinical-stage biotechnology company developing AI-enabled personalized cancer immunotherapies for patients with solid tumors. The company's platform combines patient-specific multi-omic profiling — comprehensive DNA and RNA sequencing paired with advanced mass spectrometry — with a proprietary AI engine called BreakBioAI that ranks more than 40 mutated and non-mutated targets per patient to identify optimal immunotherapy candidates. Based on those targets, BreakBio manufactures a customized peptide immunotherapy designed to stimulate T-cells against the patient's specific tumor, with a stated 45-day window from biopsy to treatment delivery.

The company is currently enrolling patients for a Phase 1/2 clinical trial targeting Triple Negative Breast Cancer (TNBC), beginning in 2026, under an FDA-approved Investigational New Drug application, and is pursuing FDA Breakthrough Therapy Designation. Its stated platform is indication-agnostic, designed to extend to any solid cancer, and is positioned to work synergistically with standard-of-care therapies such as checkpoint inhibitors. The company was founded by Roy de Souza, the entrepreneur behind ad-tech firm ZEDO, after his wife Aisha de Sequeira was diagnosed with metastatic colon cancer in 2017; both were honored by the American Cancer Society in 2023 for contributions to personalized cancer treatment.

BreakBio is pre-revenue and privately held, with no disclosed funding rounds or institutional investors identified in the available source material. The company operates with 1–10 employees from its headquarters in Miami, Florida, and has not yet established commercial pricing, distribution channels, or partnership economics. Revenue is expected to follow successful clinical trials and regulatory approval.

Name

BreakBio

Legal name

BreakBio Corp.

Website

https://breakbio.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

BreakBio is a clinical-stage biotech developing AI-enabled personalized peptide immunotherapies for solid tumors, using multi-omic profiling and a proprietary target-ranking engine to deliver customized treatments within 45 days of biopsy.

Ownership category

akta.pro rank

Product category

Personalized Cancer Immunotherapy

NAICS

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

SIC

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

akta.pro industry

PRIMARYHLAAANAK

Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies)

Healthcare & Life Sciences/Biotechnology & Biologics/Precision Medicine Solutions

Keywords

• Personalized cancer immunotherapy
• AI drug discovery
• Multi-omic profiling
• Peptide cancer vaccines
• Oncology therapeutics

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Others

Revenue model

1. Personalized Cancer Immunotherapy: BreakBio is a clinical-stage company that has not yet generated revenue. The company is developing personalized peptide immunotherapies for cancer treatment and expects to commercialize its platform following successful clinical trials and regulatory approval.

Go-to-market motion1 record

Core offering

BreakBio develops personalized peptide cancer immunotherapies by combining AI-driven multi-omic profiling (DNA/RNA sequencing plus mass spectrometry) with proprietary peptide manufacturing to deliver individualized cancer treatments within 45 days from biopsy. The company is currently running a Phase 1/2 clinical trial in Triple Negative Breast Cancer (TNBC) under FDA IND approval, with an indication-agnostic platform designed to address any solid cancer.

Product overview

BreakBio offers a unified personalized cancer immunotherapy platform consisting of three integrated components: (1) Multi-Omic Profiling Service, which analyzes each patient's cancer cells through comprehensive DNA/RNA sequencing and mass spectrometry; (2) BreakBioAI Platform, which processes this multi-omic data to rank 40+ potential targets and identify optimal immunotherapy targets; and (3) Personalized Peptide Immunotherapy, which is manufactured based on BreakBioAI's recommendations to stimulate patient T-cells against their specific tumor targets. The entire process from biopsy to treatment delivery is completed in 45 days.

Differentiator

Problem solved

Functional benefit

Brands

• BreakBioAI: Proprietary AI platform that ranks 40+ mutated and non-mutated unique targets from each patient's tumor cells for personalized cancer treatment.

Products and services

• BreakBioAI Platform

Quantifiable outcome

• 45-day turnaround from biopsy to personalized treatment delivery

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature3 records

Scale indicators5 records

Recent moves5 records

Expansion highlights4 records

Emerging players

• Caris Life Sciences: Provider of multi-omic profiling services (DNA/RNA + proteomics via mass spectrometry-based platforms like ADAPT) used to inform personalized oncology programs. Comparable on the multi-omic profiling layer of BreakBio's workflow.
• Personalis: AI-driven genomics and multi-omic tumor profiling company whose neoantigen identification capabilities and tumor molecular profiling sit upstream of personalized cancer vaccine development. Comparable on multi-omic target ranking technology.
• Marker Therapeutics: Clinical-stage immuno-oncology company developing T-cell based personalized therapies for solid tumors. Comparable on individualized manufacturing for solid-tumor immunotherapy.
• Nouscom: Clinical-stage biotech developing personalized neoantigen cancer vaccines and immunotherapies. Comparable as a fellow emerging personalized-vaccine player targeting solid tumors with individualized manufacturing.
• Anixa Biosciences: Clinical-stage immuno-oncology company developing personalized cancer vaccine and CAR-T programs. Comparable as a fellow small-cap, founder-influenced personalized cancer immunotherapy developer.

Direct peers

• Gritstone bio: Developer of personalized neoantigen vaccine programs (GRANITE) and off-the-shelf tumor vaccine programs using multi-omic target identification. Directly comparable in personalized solid-tumor immunotherapy strategy and multi-omic sequencing approach.
• BioNTech: Pioneer in individualized mRNA-based neoantigen cancer vaccines (e.g., BNT122 in colorectal and other solid tumors). Directly comparable to BreakBio in target patient population, indication-agnostic ambition, and personalized immunotherapy modality.
• Moderna: Through its mRNA-4157 program with Merck, Moderna is the most advanced personalized mRNA cancer vaccine player (Phase 3 in adjuvant melanoma). Directly overlaps BreakBio on AI-driven neoantigen selection and combination-with-checkpoint-inhibitor positioning.

Broad incumbents

• Genentech (Roche): Major oncology developer with leading checkpoint inhibitor franchises (Tecentriq) and deep presence in personalized/individualized oncology R&D. Comparable as a strategic combination partner and benchmark for commercialization scale in immuno-oncology.
• Tempus AI: Large AI-driven precision medicine and multi-omic profiling platform serving oncology drug development. Comparable in the AI/multi-omic + oncology positioning, though broader and not focused on therapeutic peptide manufacturing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/breakbio

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 BreakBio