Report scope. This 2026 Drug Asset Due Diligence Report evaluates Luminespib as a potential licensing, partnership, acquisition, or option asset. The review separates verified evidence from open diligence questions across clinical development, intellectual property, market positioning, and transaction precedent.
Executive recommendation: HOLD / OPTION
Luminespib is a Small molecule drug associated with HSP90 and a global highest development stage of Phase 2. The lead disclosed indication is Head and Neck Neoplasms. The current evidence supports a HOLD / OPTION posture, subject to confirmation of study-level data, ownership, patent coverage, manufacturing readiness, and regional rights.
Decision memo
- Asset: Luminespib
- Target: HSP90
- Lead indication: Head and Neck Neoplasms
- Highest phase: Phase 2
- Matched trials: 0
- Matched result records: 27
- Matched asset deals: 0
Use PatSnap Life Sciences MCP servers to validate the Luminespib diligence evidence.
1. Asset identity and development status
The first diligence task is entity resolution. Teams should reconcile development codes, nonproprietary names, salts, formulations, combinations, sponsors, and predecessor owners before relying on portfolio counts. For Luminespib, the MCP profile identifies HSP90 as the primary target context and Head and Neck Neoplasms as the lead indication. Global phase labels are useful orientation points, but investment decisions require country- and indication-level status verification.
Confirm the exact molecule, formulation, route, dose, biomarker definition, and current sponsor. Review discontinuations separately from active development so that an historical high phase is not mistaken for a live program.
Use PatSnap Life Sciences MCP servers to validate the Luminespib diligence evidence.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| No asset-specific registered study was returned by the MCP query. Confirm sponsor records and registry synonyms before a licensing decision. | ||||
The clinical program should be audited for randomization, comparator relevance, dose selection, endpoint hierarchy, multiplicity, analysis population, geographic mix, and readout timing. Early-stage programs require attention to pharmacokinetics, pharmacodynamics, adverse events, dose-limiting toxicities, and the rationale for the expansion dose.
Use PatSnap Life Sciences MCP servers to validate the Luminespib diligence evidence.
3. Clinical readouts: what is known
A Phase I/II Trial of Hsp 90 Inhibitor AUY-922 in Patients With Lung Adenocarcinoma With "Acquired Resistance" to EGFR Tyrosine Kinase Inhibitors
Study: NCT01259089 (CTgov). Phase: Phase 1/2. Enrollment: 38. Published: 2018-11-21.
Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922 = 4 Pts
Activity of the Hsp90 inhibitor luminespib among non-small-cell lung cancers harboring EGFR exon 20 insertions.
Study: NCT01854034 (Pubmed | Ann Oncol). Phase: Phase 2. Enrollment: 29. Published: 2018-10-01.
ORR(objective response rate) = 17 %
39 - A Phase Ib Trial of the HSP90 Inhibitor AUY922 in Combination with Pemetrexed in Metastatic Non-Squamous, Non-Small Cell Lung Cancer Patients
Study: WCLC2018. Phase: Not Applicable. Enrollment: 13. Published: 2018-09-25.
Adverse Event: ocular toxicity = Tolerability of AUY922 with pemetrexed is limited by ocular toxicity
Phase II Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR
Study: NCT01854034 (CTgov). Phase: Phase 2. Enrollment: 29. Published: 2018-04-10.
ORR = 5 Pts
Phase 2 Study of the HSP-90 Inhibitor AUY922 in Previously Treated and Molecularly Defined Patients with Advanced Non-Small Cell Lung Cancer.
Study: NCT01124864 (Pubmed | J Thorac Oncol). Phase: Phase 2. Enrollment: 153. Published: 2018-04-01.
Adverse Event: night blindness = 35 patients (22.9%) reported night blindness
A Phase II Open-Label Trial of AUY922, an HSP90 Inhibitor, in Patients With ALK-Rearranged Advanced Non-Small Cell Lung Cancer and Acquired Resistance to Prior ALK Tyrosine Kinase Inhibition
Study: NCT01752400 (CTgov). Phase: Phase 2. Enrollment: 6. Published: 2018-03-29.
ORR = 0 Pts
OA 12.02 - Final Results of a Phase 2 Study of the hsp90 Inhibitor Luminespib (AUY922) in NSCLC Patients Harboring EGFR Exon 20 Insertions
Study: NCT01854034 (WCLC2017). Phase: Phase 2. Enrollment: 29. Published: 2017-10-18.
ORR = 17 %
A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment
Study: NCT01646125 (CTgov). Phase: Phase 2. Enrollment: 59. Published: 2017-03-13.
PFS(Median) = 1.5 Month (90%CI, 1.2 - 5.6) | PFS(Median) = 2.3 Month (90%CI, 1.2 - 4.0)
A Phase II Study of the HSP90 Inhibitor AUY922 in Patients With Relapsed and Refractory Lymphoma
Study: NCT01485536 (CTgov). Phase: Phase 2. Enrollment: 21. Published: 2017-01-23.
DLBCL (N=14) = 1 Pts
A Phase II Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor
Study: NCT01404650 (CTgov). Phase: Phase 2. Enrollment: 25. Published: 2016-10-04.
PFS(Median) = 3.9 Month (95%CI, 2.5 - 5.3)
A Phase 2 Study of the Hsp90 Inhibitor AUY922 as Treatment for Patients with Refractory Gastrointestinal Stromal Tumors
Study: NCT01404650 (Pubmed | Cancer Invest). Phase: Phase 2. Enrollment: 25. Published: 2016-07-02.
mPFS = 3.9 Month (95%CI, 2.5 - 5.3)
Phase 1B/2 study of the HSP90 inhibitor AUY922 plus trastuzumab in metastatic HER2-positive breast cancer patients who have progressed on trastuzumab-based regimen
Study: NCT01271920 (Pubmed | Oncotarget). Phase: Phase 1/2. Enrollment: 45. Published: 2016-06-21.
RP2D = the RP2D was weekly AUY922 70 mg/m2 plus trastuzumab | RP2D = the RP2D was weekly AUY922 70 mg/m2 plus trastuzumab
A Phase II Study of the HSP90 Inhibitor, AUY922, in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
Study: NCT01668173 (CTgov). Phase: Phase 2. Enrollment: 7. Published: 2016-05-23.
ORR = 1 participant with Stable Disease
Results of Phase II trial of AUY922, a novel heat shock protein inhibitor in patients with metastatic gastrointestinal stromal tumor (GIST) and imatinib and sunitinib therapy.
Study: NCT01389583 (ASCO_GI2016). Phase: Phase 2. Enrollment: 25. Published: 2016-02-01.
DCR = 20 %
023 - A Phase II Trial of AUY922, a Heat Shock Protein 90 (HSP90) Inhibitor, in ALK-Positive Lung Cancer Patients Previously Treated with ALK Inhibitors
Study: WCLC2015. Phase: Not Applicable. Enrollment: 6. Published: 2015-09-09.
mPFS(median progression-free survival) = 1.43 Month (95%CI, 1.3 - 2.8)
Activity of AUY922 in NSCLC Patients With EGFR Exon 20 Insertions
Study: WCLC2015. Phase: Not Applicable. Enrollment: 21. Published: 2015-09-09.
ORR = 24 %
Phase 1/1B trial of the heat shock protein 90 inhibitor NVP-AUY922 as monotherapy or in combination with bortezomib in patients with relapsed or refractory multiple myeloma
Study: NCT00708292 (Pubmed | Cancer). Phase: Phase 1. Enrollment: 29. Published: 2015-07-01.
MTD = no MTD was reached. | MTD = no MTD was reached.
Activity of AUY922 in NSCLC patients with EGFR exon 20 insertions.
Study: NCT01854034 (ASCO2015). Phase: Phase 2. Enrollment: 10. Published: 2015-05-20.
ORR(objective response rate) = 1 %
Phase I/II Study of HSP90 Inhibitor AUY922 and Erlotinib for EGFR-Mutant Lung Cancer With Acquired Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors
Study: NCT01259089 (Pubmed | J Urol | J Clin Oncol). Phase: Phase 1/2. Enrollment: 37. Published: 2015-05-20.
DLT = six patients， dose-limiting toxicity (ie, junctional cardiac rhythm)
A Phase I Study of the Hsp90 Inhibitor AUY922 plus Capecitabine for the Treatment of Patients with Advanced Solid Tumors
Study: NCT01226732 (Pubmed | Cancer Invest). Phase: Phase 1. Enrollment: 23. Published: 2015-01-01.
MTD = 70 mg/m^2
Phase I study of the HSP90 inhibitor AUY922 in combination with capecitabine as treatment for patients with advanced solid tumors.
Study: NCT01226732 (ASCO2013). Phase: Phase 1. Enrollment: 23. Published: 2013-05-20.
AE(adverse events) = 43 % (grade 1/2, grade 3/4, 17)
A phase II study of HSP90 inhibitor AUY922 and erlotinib (E) for patients (pts) with EGFR-mutant lung cancer and acquired resistance (AR) to EGFR tyrosine kinase inhibitors (EGFR TKIs).
Study: NCT01259089 (ASCO2013). Phase: Phase 2. Enrollment: 16. Published: 2013-05-20.
ORR = 13 % (95%CI, 2 - 37)
Phase II study of the HSP90 inhibitor AUY922 in patients with previously treated, advanced non-small cell lung cancer (NSCLC).
Study: ASCO2012. Phase: Phase 2. Enrollment: 112. Published: 2012-05-20.
ORR(confirmed (RECIST) objective response rate) = 13 %
Phase IB/II study of the HSP90 inhibitor AUY922, in combination with trastuzumab, in patients with HER2+ advanced breast cancer.
Study: ASCO2012. Phase: Phase 2. Enrollment: 31. Published: 2012-05-20.
ORR(preliminary antitumor activity) = 23 %
Use of biomarkers and imaging to evaluate the treatment effect of AUY922, an HSP90 inhibitor, in patients with HER2+ or ER+ metastatic breast cancer.
Study: ASCO2011. Phase: Phase 2. Enrollment: 10. Published: 2011-05-20.
HSP70 = 1.9 Fold
Pharmacodynamics and pharmacokinetics of AUY922 in a phase I study of solid tumor patients
Study: ASCO2009. Phase: Phase 1/2. Enrollment: 40. Published: 2009-05-20.
HSP70 induction = 1.4 Fold
A phase I dose escalation study of AUY922, a novel HSP90 inhibitor, in patients with advanced solid malignancies
Study: ASCO2009. Phase: Phase 1. Enrollment: 44. Published: 2009-05-20.
Disease stabilization = 16 Week
For every reported endpoint, obtain the protocol, statistical analysis plan, patient disposition, baseline characteristics, subgroup definitions, exposure duration, and full safety tables. Conference abstracts and registry summaries can support screening, but they should not replace source data review in a binding transaction.
Use PatSnap Life Sciences MCP servers to validate the Luminespib diligence evidence.
4. Market and competitive position
The commercial case depends on differentiated efficacy, tolerability, convenience, biomarker reach, treatment setting, and access. A target-level market may be attractive while an individual asset remains undifferentiated. Benchmark Luminespib against approved therapies and clinical competitors in Head and Neck Neoplasms, including likely standards of care at the expected launch date.
Build a scenario model around addressable patients, diagnosis and biomarker rates, line of therapy, duration, net price, uptake, displacement, combination costs, and probability-adjusted timelines. Test slower enrollment, delayed readout, narrower labels, safety restrictions, and competitor launches.
Use PatSnap Life Sciences MCP servers to validate the Luminespib diligence evidence.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| No exact asset-specific transaction was returned. Use target-level precedents only as comparables and do not present them as asset transactions. | ||||
Transaction records should be normalized for territory, asset scope, phase at signing, option mechanics, development obligations, cost sharing, royalties, milestones, and change-of-control terms. Undisclosed economics must not be converted into invented benchmarks.
6. IP and freedom-to-operate screen
Complete a family-level patent review covering composition of matter, sequence or construct claims, polymorph and salt claims, formulation, dosing, combinations, biomarkers, manufacturing, and method of use. Verify priority, ownership, assignments, prosecution status, term adjustments, extensions, oppositions, and regional coverage. Freedom to operate is a separate legal analysis and should include competitor claims and platform dependencies.
The diligence room should reconcile inventorship, employee and contractor assignments, university or platform licenses, sublicensing restrictions, government rights, and obligations triggered by development milestones or commercialization.
Use PatSnap Life Sciences MCP servers to validate the Luminespib diligence evidence.
7. Principal risks and diligence gates
- Identity risk: resolve all aliases, formulations, combinations, and owners.
- Clinical risk: confirm source data, protocol deviations, endpoint definitions, and safety follow-up.
- Regulatory risk: review agency correspondence, meeting minutes, holds, commitments, and indication-specific pathways.
- IP risk: validate enforceable coverage, remaining life, ownership, and freedom to operate.
- CMC risk: assess process control, analytical methods, comparability, scale-up, supply, and cost of goods.
- Commercial risk: pressure-test differentiation, market access, competitive timing, and realistic adoption.
- Transaction risk: map rights, encumbrances, royalties, options, consent requirements, and change-of-control provisions.
8. Final go/no-go memorandum
HOLD / OPTION
Proceed only through staged diligence. Before exclusivity or a binding offer, require a verified asset identity package, complete clinical data room, regulatory correspondence, patent-family schedule, freedom-to-operate opinion, CMC package, ownership chain, regional rights map, and risk-adjusted valuation. Any material mismatch between public records and source documents should pause the process until reconciled.
Method note: This report uses PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP data retrieved on 2026-10-15. It is a screening and diligence framework, not medical, legal, regulatory, or investment advice.
