ACP-319 Drug Asset Due Diligence Report 2026

This ACP-319 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: 16 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 ACP-319 can convert its Small molecule drug profile and PI3Kδ biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	ACP-319 (query alias: ACP-319)
Modality / target	Small molecule drug; PI3Kδ; PI3Kδ inhibitors
Highest global status	Phase 2
Originator	Acerta Pharma BV
Active developers	Acerta Pharma BV

The MCP disease footprint includes Chronic Lymphocytic Leukemia, Multiple Myeloma, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma. 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
NCT02328014	Phase 1/2	Completed	40	Primary endpoint not disclosed in English source
NCT02157324	Phase 1	Active, not recruiting	12	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 1/2 Proof-of-Concept Study of the Combination of ACP-196 and ACP-319 in Subjects With B-cell Malignancies

Phase 1/2; n=40; evaluation: Not stated in English source. Reported fields: CR = 33.3 % (95%CI, 4.30 - 77.7); CR = 0 % (95%CI, 0 - 45.9)

Acalabrutinib combined with PI3Kδ inhibitor ACP-319 in patients (pts) with relapsed/refractory (R/R) B-cell malignancies.

Phase 1/2; n=25; evaluation: Positive. Reported fields: DLT = One pt had a DLT in the ACP-319 50-mg group (maculopapular rash [MR]); 2 had DLTs in the 100-mg group (MR; febrile neutropenia, diarrhea & pneumonitis) ; DLT = One pt had a DLT in the ACP-319 50-mg group (maculopapular rash [MR]); 2 had DLTs in the 100-mg group (MR; febrile neutropenia, diarrhea & pneumonitis)

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

ACP-319 addresses Chronic Lymphocytic Leukemia, Multiple Myeloma, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma. Commercial attractiveness rests on addressable patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The MCP screen returned 28 matched transaction record(s) under the scope “target-level comparable: PI3Kδ.” Partner activity is a market-validation signal, but it does not establish net present value.

5. Transaction precedent and economics

Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: PI3Kδ records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
2026-03-24	OrphanPacific entered an agreement to commercialize Pharming 's Joenja for activated phosphoinositide 3-kinase delta syndrome (APDS) in adult and pediatric patients ages four years and older in Japan	Approved	Financial terms not disclosed
2023-04-06	Adlai Nortye entered into an option agreement with Nippon Kayaku to further advance the commercialization of AN2025 in Japan.	Preclinical	Financial terms not disclosed
2022-07-14	Convalife acquires global rights to PI3K β/δ inhibitor from Karus	Phase 1	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 “Methods of cancer treatment using a combination of BTK inhibitors and PI3 kinase inhibitors”. The milestone feed surfaced a patent-application signal described as “Combined therapy for treating cancer”. The milestone feed surfaced a patent-application signal described as “Combination therapy for treating PIK3ca-mutated cancer”.

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

Therapeutic index and off-target toxicity
Resistance biology and biomarker-defined patient selection
Differentiation from established and emerging standards

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