Makana Therapeutics

What Makana Therapeutics does

Makana Therapeutics is a preclinical biotechnology company developing genetically modified pigs to serve as a source of donor organs for human xenotransplantation. Founded in 2009 (originally as Xenobridge, LLC) by transplant surgeon Dr. Joe Tector, the company is headquartered in Miami, Florida, and operates with 11-50 employees. Makana is targeting the transplantable organ shortage crisis, with kidney transplantation as the lead indication and additional programs spanning heart, liver, lung, pancreatic islet cells, and blood products. The patient population served is end-stage organ failure patients, particularly the more than 100,000 individuals on the US kidney transplant waiting list, where 12 people die daily awaiting a transplant.

The company's core technology platform is the Triple Knockout (TKO) Pig, carrying three xenoantigen gene knockouts (GGTA1-KO, B4GALNT2-KO, CMAH-KO) that camouflage pig tissues from the human immune system and eliminate hyperacute and acute rejection. In September 2024, Makana extended the platform with a fourth gene knockout (SLA DR) to address early rejection in clinical applications, advancing the asset to a quadruple knockout configuration. Supporting technology includes proprietary crossmatch assays for patient compatibility testing, somatic cell nuclear transfer (SCNT) cloning, and clinical-grade designated-pathogen-free animal husbandry. The TKO genetics have been granted patents in Europe (January 2023) and South Korea (May 2024), and have become the field's baseline standard for xenotransplantation research.

Makana is pre-revenue with no current product sales. The planned business model centers on direct distribution of transplantable pig organs to transplant centers and healthcare institutions following FDA approval, beginning with a first-in-human clinical trial in kidney xenotransplantation planned for early 2026 at the University of Miami's Miami Transplant Institute. Strategic investors include Novartis and Baxter, and the company established a collaboration with Tonix Pharmaceuticals in April 2025 to evaluate anti-CD40L antibody TNX-1500 in combination with Makana's engineered organs across kidney, heart, and islet cell programs to support an IND filing. Pricing of organs is not publicly disclosed, and no commercial revenue is expected prior to regulatory approval.

Name

Makana Therapeutics

Legal name

Makana Therapeutics Holdings, Inc.

Website

https://makanatherapeutics.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Makana Therapeutics is a preclinical biotechnology company developing genetically modified Triple Knockout (TKO) pigs as a source of transplantable organs for human xenotransplantation, with kidney as the lead indication and a first-in-human clinical trial planned for early 2026.

Ownership category

akta.pro rank

Product category

Xenotransplantation

NAICS

Hog and Pig Farming (11221), Hog and Pig Farming (112210)

SIC

Biological Products, (No Disgnostic Substances) (2836), In Vitro & In Vivo Diagnostic Substances (2835), Agricultural Prod-Livestock & Animal Specialties (200)

akta.pro primary industry

High-Health/Biosecure Hog Production (SPF/Pedigree Nucleus) (AFAEAEAL)

akta.pro secondary industries

Veterinary Pharmacy, Vaccine & Biologics Services (AFAEANAK), Veterinary Vaccines (Biologics) (HLAMAEAL)

Keywords

• Xenotransplantation technology
• Genetically engineered pigs
• Organ transplantation
• Biopharmaceutical research
• Preclinical biotechnology

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales

Revenue model

1. Xenotransplantation Products: Pre-revenue biotechnology company developing genetically modified pig organs for human transplantation. Revenue will be generated through the sale of transplantable organs (kidney, heart, liver, lung, pancreatic islets, blood products) once clinical trials are successful and regulatory approvals are obtained.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Makana Therapeutics develops genetically modified pigs with reduced xenoantigen expression (Triple Knockout / TKO pigs) to enable pig-to-human transplantation of cells, tissues, and organs. The company's pipeline spans kidney, heart, liver, lung, pancreatic islet, and blood xenotransplantation applications, supported by proprietary crossmatch assays for patient-recipient compatibility and advanced cloning and animal husbandry capabilities for clinical-grade production.

Product overview

Makana Therapeutics is a xenotransplantation company singularly focused on solving the transplantable organ shortage crisis by developing genetically modified pigs as an abundant source of donor organs. The company's core product portfolio centers on the Triple Knockout (TKO) Pig, a genetically engineered pig with three xenoantigen knockouts (GGTA1-KO, B4GALNT2-KO, CMAH-KO) that camouflage pig organs from human immune response. The company has evolved to the TKO + SLA DR KO Pig (Quadruple Knockout) with a fourth genetic modification. These genetically engineered pigs are applied across multiple organ transplantation applications including kidney, heart, liver, lung, pancreatic islets, and blood. The company also offers proprietary crossmatch assays for patient compatibility testing. Makana's focus on simplified genetics (knockout-only approach without transgenes), optimized pig cloning techniques, and careful patient selection through its crossmatch assay is designed to streamline product development and deliver safer, more efficacious xenotransplantation products.

Differentiator

Problem solved

Functional benefit

Products and services

• Triple Knockout (TKO) Pig Genetically engineered pig with three xenoantigen gene knockouts (GGTA1-KO, B4GALNT2-KO, CMAH-KO) that effectively camouflage cross-species grafts from the human immune response, enabling successful xenotransplantation of organs and tissues.
• TKO + SLA DR KO Pig (Quadruple Knockout) Next-generation genetically engineered pig with four gene knockouts including the SLA DR knockout, developed to address early rejection seen in clinical xenotransplantation applications.
• Kidney Xenotransplantation Pig-to-human kidney transplantation using genetically engineered donor pigs for treatment of end-stage renal disease patients who cannot find human donors.
• Heart Xenotransplantation Pig-to-human heart transplantation using genetically engineered donor pigs for treatment of end-stage heart failure.
• Liver Xenotransplantation Pig-to-human liver transplantation using genetically engineered donor pigs for treatment of chronic or acute liver failure.
• Lung Xenotransplantation Pig-to-human lung transplantation using genetically engineered donor pigs.
• Pancreatic Islet Xenotransplantation Pig-to-human pancreatic islet cell transplantation for treatment of diabetes.
• Blood Xenotransplantation Pig-to-human blood product transplantation.
• Proprietary Crossmatch Assays Proprietary diagnostic assays to identify patients without pre-existing donor-specific antibodies, reducing likelihood of antibody-mediated rejection in xenotransplantation.

Quantifiable outcome

• 70% of kidney failure patients could benefit from Makana's TKO pig organs (30% with no detectable antibodies + 40% with available pre-transplant treatment)
• +2 more outcomes

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Tonix PharmaceuticalscoreStrategic or Co-development Partner · 9 April 2025Collaborative research agreement to study Tonix's anti-CD40L monoclonal antibody candidate TNX-1500 in combination with Makana's genetically engineered organs for xenotransplantation. The collaboration spans multiple programs including kidney, heart and islet cell transplant. Preclinical studies will support submission of an investigational new drug application (IND) to FDA. TNX-1500 is viewed as critical part of effective immunomodulatory regimen for successful xenotransplantation.
• University of MiamicoreStrategic or Co-development PartnerPrimary research collaborator and site of planned first human clinical trial. Dr. Joe Tector serves as Director of Xenotransplant Research and Surgical Director of Small Bowel and Multivisceral Transplant Program at University of Miami Medical School. The xenotransplant program at Miami Transplant Institute (MTI) is led by Dr. Tector. MTI is a collaboration between Jackson Memorial Hospital and University of Miami Health System.
• University of Minnesota Medical SchoolminorStrategic or Co-development PartnerScientific collaborator in xenotransplantation research. Makana team members previously conducted research at Indiana University before relocating to Miami.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• eGenesis: eGenesis is the most direct competitor, also developing gene-edited pigs (with up to 69 edits) for xenotransplantation. Both companies target pig-to-human organ transplants using CRISPR-edited pigs and are pursuing clinical trials; eGenesis has raised $125M+ and is backed by Bayer.
• eGenesis (Cambridge subsidiary): (Duplicate category for ranking.) The eGenesis program targeting heart and kidney xenotransplantation is the single most directly comparable peer to Makana's platform given overlapping technology (gene-edited pigs), clinical stage, and indication focus.

Broad incumbents

• United Therapeutics (Revivicor): United Therapeutics acquired Revivicor, the company that produced the first 10-gene-edited pigs used in successful pig-to-human heart and kidney transplants at NYU and University of Maryland. It is the most clinically advanced competitor and a publicly traded large-cap biotech with substantial resources.

Emerging players

• Qihan Biotech: Qihan Biotech is a Hangzhou-based biotech using CRISPR to create gene-edited pigs for xenotransplantation. It is an emerging competitor focused primarily on Asia with overlapping technology platform (multiplexed gene knockouts in pigs for human organ transplant).
• Vertex Pharmaceuticals: Vertex has pioneered cell-based therapies for type 1 diabetes (VX-880 islet cell therapy). It addresses the same pancreatic islet/diabetes transplant opportunity that Makana targets via xenotransplant islets, making it a partial-overlap emerging competitor in islet replacement.
• Miromatrix Medical: Miromatrix is developing decellularized pig organ scaffolds (not gene-edited whole organs) for human transplant. It addresses the same organ shortage problem with a different technological approach, making it an emerging adjacent competitor.
• Sangamo Therapeutics: Sangamo is a gene-editing and cell therapy company with applications in transplant immunology. While not focused exclusively on xenotransplantation, its zinc finger nuclease platform has been applied to gene-edited pig organs, creating partial technological overlap with Makana.

Others

• Tonix Pharmaceuticals: Tonix Pharmaceuticals is Makana's 2025 co-development partner developing the TNX-1500 anti-CD40L monoclonal antibody for use in combination with Makana's xenotransplant organs. It is an enabling/adjacent partner rather than a competitor.
• Novartis: Novartis is a strategic investor in Makana and a major transplant immunology pharmaceutical company. While not a direct xenotransplant competitor, Novartis's investment creates strategic alignment and validates the platform; it is an enabling ecosystem participant.
• Harvard Apparatus Regenerative Technology: Harvard Apparatus/ORGANOVO-related regenerative medicine companies supply organ-on-chip and bioengineered tissue technologies that address adjacent organ-replacement and disease-modeling needs. They are ecosystem participants rather than direct competitors but operate in overlapping end markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/MakanaThera
• YouTubeyoutube.com/channel/UCIwiA9c2xbSAWGbf-H0xBBA
• Facebookfacebook.com/MakanaTherapeutics
• LinkedInlinkedin.com/company/makana-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 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 Makana Therapeutics