Mavrilimumab Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Mavrilimumab 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: 15 July 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.
Discontinued
Highest phase
12
Registered trials
23
Result records
4
Matched deals
Executive recommendation: HOLD / OPTION
Decision memo
Preserve optionality until clinical differentiation, transaction economics, and freedom-to-operate are sufficiently de-risked.
The central underwriting question is whether Mavrilimumab can convert its Monoclonal antibody profile and CD116 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Mavrilimumab (query alias: mavrilimumab) |
|---|---|
| Modality / target | Monoclonal antibody; CD116; CD116 inhibitors |
| Highest global status | Discontinued |
| Originator | CSL Ltd. |
| Active developers | Not disclosed |
The MCP disease footprint includes no disclosed indication. 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 |
|---|---|---|---|---|
| NCT04447469 | Phase 2/3 | Completed | 814 | Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 |
| NCT04399980 | Phase 2 | Completed | 40 | Subjects Alive and Off of Oxygen at Day 14 |
| NCT04463004 | Phase 2 | Completed | 2 | Proportion of Subjects Alive and Off of Oxygen at Day 14 |
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
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation
Phase 2; n=1; evaluation: not stated. Reported fields: Proportion of Subjects Alive and Off Oxygen at 14 Days = 0 Participants ; -; -
A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis
Phase 2; n=70; evaluation: not stated. Reported fields: Time to Flare by Week 26(Median) = 25.1 weeks (95% Confidence Interval, 16.0 - NA); Time to Flare by Week 26(Median): Hazard Ratio (HR) = 0.38(95% CI, 0.15 - 0.92), P-Value = 0.0263; Time to Flare by Week 26(Median): Hazard Ratio (HR) = 0.38(95% CI, 0.15 - 0.92), P-Value = 0.0263
Efficacy and safety of mavrilimumab in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial
Phase 2; n=70; evaluation: Positive. Reported fields: Unclear or overly complex description of the primary endpoint indicators = 25.1 Week ; Unclear or overly complex description of the primary endpoint indicators = NR
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
Mavrilimumab addresses its disclosed development indications. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Monoclonal antibody—must demonstrate a benefit large enough to offset class-specific safety and operational costs.
The strongest market-validation signal in this screen is partner behavior: 4 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.
5. Transaction precedent and economics
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| 2025-02-25 | Kiniksa exercised its right to terminate its exclusive license agreement for mavrilimumab with MedImmune. | Phase 2 | US$8.0M upfront; US$157.5M milestones |
| 2022-02-21 | Hangzhou Zhongmei will collaborate with Kiniksa to develop and market Arcalyst and mavrilimumab in the Asia Pacific Region, which encompasses Greater China, South Korea, Australia, and 18 other countries (excluding Japan). | Approved | US$22.0M upfront; US$640.0M milestones; US$662.0M stated total |
| 2019-12-11 | Kite And Kiniksa Pharmaceuticals Announce Clinical Collaboration Evaluating Investigational Combination Of Yescarta® And Mavrilimumab In Relapsed Or Refractory Large B-Cell Lymphoma | Approved | 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
No asset-specific patent-application milestone appeared in the returned milestone slice. That absence is not a freedom-to-operate conclusion; a dedicated family, claim, ownership, expiry, and legal-status search remains mandatory before signing.
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. Confirm that licensed patents, data and know-how track every granted territory and field.
7. Principal risks and diligence gates
- Class crowding and differentiation versus other PD-(L)1/VEGF agents
- Immune and anti-angiogenic safety, including bleeding and cardiovascular risk
- Biomarker strategy, indication selection, and head-to-head endpoint execution
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
HOLD / OPTION
Preserve optionality until clinical differentiation, transaction economics, and freedom-to-operate are sufficiently de-risked.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 15 July 2026. Counts and status fields may change as source records update.
