Telaglenastat Drug Asset Due Diligence Report 2026

This Telaglenastat 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 Telaglenastat can convert its Small molecule drug profile and GLS1 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Telaglenastat (query alias: Telaglenastat)
Modality / target	Small molecule drug; GLS1; GLS1 inhibitors
Highest global status	Phase 2
Originator	Calithera Biosciences, Inc.
Active developers	National Cancer Institute, Synhale Therapeutics, University of Coimbra

The MCP disease footprint includes Advanced Cervical Carcinoma, Advanced Malignant Solid Neoplasm, Metastatic Solid Tumor. 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
NCT07223528	Phase 1/2	Not yet recruiting	28	Primary endpoint not disclosed in English source
NCT05521997	Phase 2	Not yet recruiting	42	Primary endpoint not disclosed in English source
NCT04824937	Phase 2	Unknown status	30	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 Trial of MLN0128 (Sapanisertib) and CB-839 HCl (Telaglenastat) in Advanced NSCLC Patients

Phase 1; n=22; evaluation: Not stated in English source. Reported fields: Maximum Tolerated Dose/Recommended Phase II Dose of MLN0128 (Sapanisertib) and CB-839 HCl (Telaglenastat) in Combination (Dose-escalation) = NA mg

A Phase Ib Study of Osimertinib (AZD9291) and Telaglenastat (CB-839) HCl in Patients With EGFR Mutant Non-Small Cell Lung Cancer

Phase 1/2; n=22; evaluation: Not stated in English source. Reported fields: Telaglenastat (CB-839) HCl = 800 mg ; Other (Not Including Serious) Adverse Events = 3 Pts

Phase I/II Study of CB-839 and Capecitabine in Patients With Advanced Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer

Phase 1/2; n=50; evaluation: Not stated in English source. Reported fields: PHASE I: Recommended Dose for Phase II Study = 1,000 mg/m^2 ; PHASE II: Progression-free Survival (PFS) = 0 Pts

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

Telaglenastat addresses Advanced Cervical Carcinoma, Advanced Malignant Solid Neoplasm, Metastatic Solid Tumor. 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 2 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
2025-05-01	Synhale Therapeutics Acquires Telaglenastat, Accelerates Development for Pulmonary Hypertension Treatment	Phase 2	Financial terms not disclosed
2018-10-05	Calithera Biosciences Announces Clinical Trial Collaboration To Evaluate IBRANCE® (palbociclib) And talazoparib In Combination With CB-839	Phase 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 “Pharmaceutical composition containing GLS1 inhibitor and AMPK activator and application thereof”. The milestone feed surfaced a patent-application signal described as “Treatment of cancer with a met kinase inhibitor”. The milestone feed surfaced a patent-application signal described as “Compositions and methods for administering a YAP1/WWRT1 inhibiting composition and a GLS1 inhibiting composition”.

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