FOR-46 Drug Asset Due Diligence Report 2026

This FOR-46 Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 18 September 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Phase 2

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: CONDITIONAL GO

Decision memo

Advance with milestone-based economics while efficacy durability, safety differentiation, patent scope, and market positioning are validated.

The central underwriting question is whether FOR-46 can convert its Antibody drug conjugate (ADC) profile and CD46 x Tubulin biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	FOR-46 (query alias: FOR-46)
Modality / target	Antibody drug conjugate (ADC); CD46 x Tubulin; CD46 inhibitors, Tubulin inhibitors
Highest global status	Phase 2
Originator	University of California San Diego
Active developers	University of California San Diego, Kyntra Bio, Inc., Fortis Therapeutics, Inc.

The MCP disease footprint includes Metastatic castration-resistant prostate cancer, Prostatic Cancer. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT06842498	Phase 2	Recruiting	75	Primary endpoint not disclosed in English source
NCT05011188	Phase 1/2	Active, not recruiting	44	Primary endpoint not disclosed in English source
NCT03650491	Phase 1	Completed	31	Primary endpoint not disclosed in English source

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

A phase 1b/2 study of FOR46 in combination with enzalutamide (enza) in patients with metastatic castration resistant prostate cancer (mCRPC).

Phase 1/2; n=44; evaluation: Positive. Reported fields: Composite response rate = 21.0 %

Phase I, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients With Metastatic Castration-Resistant Prostate Cancer

Phase 1; n=56; evaluation: Positive. Reported fields: MTD = 2.7 mg/kg mg/kg ; MTD = 2.7 mg/kg mg/kg

A phase 1b dose escalation study of FOR46, a novel antibody-drug conjugate targeting a tumor-specific epitope of CD46, in combination with enzalutamide (Enza) in patients with metastatic castration resistant prostate cancer (mCRPC).

Phase 1; n=17; evaluation: Positive. Reported fields: MTD = 2.1 mg/kg

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

FOR-46 addresses Metastatic castration-resistant prostate cancer, Prostatic Cancer. Commercial attractiveness rests on addressable patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Antibody drug conjugate (ADC)—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The MCP screen returned 1 matched transaction record(s) under the scope “asset-specific.” Partner activity is a market-validation signal, but it does not establish net present value.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2023-05-08	FibroGen Enters into Exclusive License for FOR46 with Fortis Therapeutics	Phase 1/2	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Method for increasing concentration of macromolecular drug in tumor tissue”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights.

7. Principal risks and diligence gates

Clinical differentiation versus current standards and pipeline competitors
Safety, dose optimization, and long-term tolerability
Patent scope, territorial rights, manufacturing, and commercial positioning

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

CONDITIONAL GO