What Fortis Therapeutics does

Fortis Therapeutics is a privately held, clinical-stage immuno-oncology biotech founded in 2016 and headquartered in La Jolla, California (operating within COI Pharmaceuticals, Avalon's Community of Innovation in San Diego). The company is developing FOR46, a first-in-class antibody-drug conjugate (ADC) that targets CD46, a transmembrane complement inhibitory receptor that is highly expressed in tumor cells and forms part of the tumor's immune defense shield. FOR46 binds a tumor-specific conformational epitope of CD46, enabling targeted tumor cell killing while sparing normal tissues, with preclinical data demonstrating tumor elimination and long-term survival in rodent models of human prostate cancer.

The company's lead clinical programs target two late-stage oncology indications: metastatic castration-resistant prostate cancer (mCRPC), particularly in patients resistant to abiraterone or enzalutamide, and relapsed or refractory multiple myeloma, especially in patients with chromosome 1q21 amplification where CD46 expression is markedly elevated. The FDA cleared two IND applications for FOR46 in November 2018, and the company is currently conducting Phase 1 dose-escalation and expansion trials in both indications (NCT03575819 for mCRPC, NCT03650491 for multiple myeloma).

Fortis is pre-revenue and operates a traditional pharmaceutical go-to-market model, generating future revenue through drug commercialization upon regulatory approval (targeting oncologists, hematologists, and cancer treatment centers) or through potential out-licensing transactions. The company has raised $58 million across two Series A rounds ($18M in September 2016 led by Avalon Ventures, and $40M in March 2021 with existing investors plus new investors Myeloma Investment Fund and Fulcrum 2020, LLC). Its IP base is founded on technology exclusively licensed from UCSF (Bin Liu, Ph.D. laboratory), and its leadership team includes executives with track records of multiple FDA-approved oncology drug development programs at BioMarin, Lilly, Isis, Novartis, and the National Cancer Institute.

Name

Fortis Therapeutics

Legal name

Fortis Therapeutics, Inc.

Website

https://fortistx.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Fortis Therapeutics is a clinical-stage immuno-oncology biotech developing FOR46, a first-in-class antibody-drug conjugate targeting CD46 for relapsed/refractory multiple myeloma and metastatic castration-resistant prostate cancer.

Ownership category

akta.pro rank

Product category

Immuno-Oncology Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE)

Keywords

• Antibody drug conjugates
• Immuno-oncology therapeutics
• CD46 targeted therapy
• Multiple myeloma treatment
• Prostate cancer therapeutics

Headquarters

HQ city

La Jolla

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Drug Development and Commercialization: Pre-revenue clinical-stage biotech company focused on developing FOR46 antibody-drug conjugate for treatment of late-stage multiple myeloma and metastatic castration-resistant prostate cancer. Revenue will be generated through pharmaceutical product sales upon regulatory approval.

Go-to-market motion1 record

Marketing channels1 record

Core offering

Fortis Therapeutics is developing FOR46, a first-in-class antibody-drug conjugate (ADC) that targets a tumor-specific conformational epitope of CD46, a complement inhibitory receptor highly expressed in tumor cells. The product is being advanced as a treatment for relapsed/refractory multiple myeloma and metastatic castration-resistant prostate cancer (mCRPC), with two Phase 1 clinical trials ongoing (NCT03650491 and NCT03575819). The ADC uses a fully human antibody conjugated to a potent cytotoxic payload via a proven linker-chemistry platform, designed to spare normal tissues while killing tumor cells.

Product overview

Fortis Therapeutics is developing a single lead product, FOR46, a novel antibody-drug conjugate (ADC) targeting CD46. The company is an immuno-oncology biotech focused on advancing this first-in-class therapeutic for the treatment of late-stage multiple myeloma and metastatic castration-resistant prostate cancer (mCRPC). The ADC uses a fully human antibody conjugated to a potent payload using a proven chemistry platform, designed to direct precision therapies to CD46 proteins while sparing normal tissues.

Differentiator

Problem solved

Functional benefit

Products and services

• FOR46 FOR46 is a first-in-class, fully human antibody-drug conjugate (ADC) targeting a tumor-specific conformational epitope of CD46, a complement inhibitory receptor highly expressed in tumor cells. It is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and relapsed/refractory multiple myeloma. The antibody is conjugated to a potent cytotoxic payload using a proven linker-chemistry platform, designed to spare normal tissues while killing CD46-expressing tumor cells. FOR46 is being evaluated in two Phase 1 clinical trials: NCT03575819 (mCRPC) and NCT03650491 (relapsed/refractory multiple myeloma).

Quantifiable outcome

• Phase 1 trial ongoing for mCRPC (NCT03575819) with dose escalation completed up to 3.0 mg/kg
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

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.

• UCSF (University of California, San Francisco)coreTechnology or Integration · 1 January 2016Fortis was founded based on technology exclusively licensed from UCSF, developed in the laboratory of Bin Liu, Ph.D. in the Department of Anesthesia. The company exclusively licensed rights to the FOR46 antibody in 2016 and maintains a strong intellectual property position.
• COI PharmaceuticalscoreOthersFortis Therapeutics is located in COI Pharmaceuticals, Avalon's Community of Innovation, in San Diego. This provides shared infrastructure and operational support.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• ADC Therapeutics: Clinical and commercial-stage ADC company developing targeted antibody-drug conjugates for hematologic and solid tumors. Closely comparable to Fortis as a focused ADC developer in oncology, though more advanced (multiple products in/approaching commercialization).
• Mersana Therapeutics: Clinical-stage biotech developing novel ADCs (e.g., XMT-1660, XMT-2056) for cancer. Directly comparable technology platform (ADC), similar development stage, and similar indication strategy in oncology.
• Pyxis Oncology: Clinical-stage oncology biotech developing ADCs and immunotherapies against novel tumor antigens. Comparable as a small-cap ADC developer using differentiated antibody engineering against emerging targets.
• Janux Therapeutics: Clinical-stage immuno-oncology company developing T-cell engager therapeutics. Closely tied to the Avalon Ventures / COI incubator that produced Fortis, sharing investors, infrastructure, and the same biotech-creation model in oncology.
• Bolt Biotherapeutics: Clinical-stage immuno-oncology company developing antibody-drug conjugates with immune-stimulating payloads (ISACs). Comparable as a clinical-stage ADC company with platform technology targeting solid tumors.

Emerging players

• Sutro Biopharma: Clinical-stage company developing ADCs and other biologics using cell-free protein synthesis platform. Comparable technology category (ADCs) and similar clinical-stage oncology focus, though more advanced pipeline.
• Heidelberg Pharma: German clinical-stage biotech developing ADCs using the proprietary amanitin payload (different mechanism from Fort46's payload). Comparable clinical-stage ADC developer with a distinct payload/chemistry angle.
• Molecular Partners: Clinical-stage biotech developing DARPin-based therapeutics for oncology, including immune-engaging candidates. Comparable as a clinical-stage, venture-backed oncology company with a differentiated targeting platform.

Broad incumbents

• ImmunoGen (AbbVie): Pioneer in ADC technology and developer of Elahere (mirvetuximab) for ovarian cancer; acquired by AbbVie. Sets the bar as the established leader in the same ADC category Fortis operates in.
• Seagen (Pfizer): Market-leading ADC company (Adcetris, Padcev, Tukysa, Enhertu partnership with Daiichi Sankyo). The dominant commercial incumbent in the ADC space and a likely strategic acquirer or partner for clinical-stage ADC developers.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds2 records

Investors7 records

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M&A

Investments

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

Frequently asked questions about Fortis Therapeutics