CNS Oncology · Cambridge, MA · Est. 2018
Crimson Biopharm Inc. is advancing CM93, a first-in-class brain-penetrant EGFR inhibitor with over 2,000% brain-to-plasma enrichment — redefining treatment for patients with CNS metastases and glioblastoma.
About
Crimson Biopharm Inc. (CrimsonBio) was incorporated in Delaware in January 2018 by Drs. Jean Zhao and Thomas Roberts — both Professors at Harvard Medical School and Dana-Farber Cancer Institute — with a singular vision: to develop transformative, brain-penetrant therapies for CNS malignancies driven by EGFR alterations.
Our lead program, CM93, was licensed from Dana-Farber in 2018. Through rigorous preclinical development, we identified CM93's extraordinary CNS pharmacokinetics, establishing it as a paradigm-shifting candidate for patients with EGFR-mutant NSCLC who develop brain or leptomeningeal metastases, as well as glioblastoma.
"A paradigm shift in CNS-targeted oncology therapeutics."
Founded by HMS professors. CM93 discovered at Dana-Farber and exclusively licensed in 2018.
FDA-cleared IND for glioblastoma. First-in-human trials active (NCT04933422) within NCI's GTN.
WO2016105525A2 · WO2022271861A1 · US2024/0293405A1 · US2024/0239796A1
Returning to NSCLC targeting EGFRm brain and leptomeningeal metastases.
A novel third-generation, irreversible covalent EGFR tyrosine kinase inhibitor designed to overcome the fundamental limitations of existing therapies — poor CNS penetration and dose-limiting toxicity.
| Property | CM93 — CrimsonBio | Osimertinib (Tagrisso) |
|---|---|---|
| Brain-to-Plasma Enrichment (Kp) | >2,000% | ~100% |
| CNS Penetration vs. Standard | Over 20-fold higher | Reference standard |
| Toxic Metabolites | None detected | AZ5104 (dose-limiting) |
| Maximum Tolerated Dose | 6× higher than osimertinib | Constrained by AZ5104 |
| EGFR Mutation Coverage | Ex19del, L858R, T790M + WT | Ex19del, L858R, T790M |
| Binding Mechanism | Irreversible covalent | Irreversible covalent |
| Active IND | Yes — GBM (NCT04933422) | Approved — NSCLC |
CM93 achieves >2,000% brain-to-plasma enrichment — a pharmacokinetic profile unlike any approved EGFR inhibitor. This extraordinary CNS distribution is driven by a unique combination of active blood–brain barrier transport and favorable passive permeability.
Unlike osimertinib, which forms the toxic metabolite AZ5104 that constrains dose escalation, CM93 produces no analogous toxic metabolites. This substantially widens the therapeutic window, enabling a 6× higher maximum tolerated dose.
CM93's retention of wild-type EGFR activity — combined with its CNS penetration — positions it for both EGFR-mutant NSCLC brain and leptomeningeal metastases and glioblastoma, where EGFR amplification coexists with wild-type kinase domains.
Pipeline
World-class expertise in cancer biology, translational pharmacology, and oncology drug development.
Pioneered research integrating genetics and pharmacology to uncover RTK-PI3K signaling. NIH Outstanding Investigator Award recipient. Professor at HMS and Dana-Farber Cancer Institute.
Over 40 years in cancer biology. Co-discovered the PI3K signaling pathway with Dr. Lewis Cantley. Played a pivotal role in the development of Gleevec — one of the first molecularly targeted cancer therapies.
Over 40 years in pharmaceutical R&D. CEO of Accellient Partners, filing 3–5 INDs/year. Co-chaired FDA expert committee on vascular injury biomarkers. Expert in CMC and nonclinical development.
Director of the Center for Neuro-Oncology at DFCI. Leading the investigator-initiated Phase I trial of CM93 in recurrent glioblastoma (NCT04933422) as part of NCI's Glioblastoma Therapeutics Network.
Neuro-oncologist at NYU co-leading first-in-human CM93 trials for recurrent glioblastoma within NCI's Glioblastoma Therapeutics Network (GTN, U19).
Senior regulatory consultants with direct experience obtaining FDA clearances and approvals for oncology therapeutics in GBM and CNS indications.
Milestones
CrimsonBio incorporated in Delaware by Drs. Zhao and Roberts. CM93 IP (WO2016105525A2) licensed from Dana-Farber. Preclinical development initiated in EGFRm NSCLC.
EQRx partnership initiated then disrupted by COVID-19. CM93's extraordinary brain penetration recognized — company pivots to GBM as lead indication.
FDA clears CM93 IND for EGFR-mutant/amplified glioblastoma. Incorporated into NCI's Glioblastoma Therapeutics Network (GTN, U19) as first-in-class brain-penetrant EGFR inhibitor.
CM93 enters first-in-human trials for recurrent GBM (NCT04933422), led by Dr. Patrick Wen (DFCI) and Dr. McFaline-Figueroa (NYU). Additional IP secured (WO2022271861A1).
Phase II STTR program targets EGFRm brain and leptomeningeal metastases. IP expanded with US2024/0293405A1 and US2024/0239796A1. Three integrated research aims funded.
Planned: STTR completion to support IND expansion into EGFRm NSCLC CNS metastases. Targeting Orphan Drug and Breakthrough Therapy designations. Partnership discussions anticipated.
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