Goal to dramatically improve survival and quality of life in adults and children with brain cancer
Programs for newly diagnosed glioblastoma (GBM) and pediatric
Very experienced team, including co-founder Santosh Kesari, MD, PhD, a Harvard-trained brain cancer physician and researcher
100% owned intellectual property rights
Lead Program Highlights
Target: OLIG2, a brain-specific transcription factor found in all gliomas
Clinical Candidate: CT-179, a potent oral OLIG2 inhibitor
- Efficacy/Safety: Survival benefit in multiple preclinical animal models/No significant toxicities identified at therapeutic doses
- Mechanism: Direct binding to OLIG2 protein leading to cancer cell death
- Regulatory: FDA orphan-drug designation for the treatment of malignant glioma. FDA rare pediatric disease designation for the treatment of medulloblastoma. FDA fast track designation for the treatment of glioblastoma
- Clinical: Active IND for Phase 1 trial in newly diagnosed GBM patients treated with CT-179 in combination with radiation therapy (RT)
- Development Plan: Three clinical trials in adults and pediatrics within less than 24 months
$3 Billion Market Opportunity In 7 Major Markets (US, EU-5, and Japan)
Addressable Market Opportunity
*EU-5 are France, Germany, Italy, Spain, and the UK
- GBM and MB opportunity estimated to be over $3 billion
- US represents nearly two-thirds of the opportunity
- China and rest of Asia also major markets
Scientifically Rational Combination Therapy Is The Future Of GBM Treatment
- GBM is characterized by 4 cellular states with high levels of cell state plasticity
- OLIG2 is localized to the OPC-like and NPC-like cellular states
- EGFR is localized to the AC-like state
- In theory, targeting two or more cellular states should be better than targeting either alone
Phase 1b Clinical Development Strategy
Arm 1 Objective: Determine MTD of CT-179 in patients with recurrent GBM
- MRI to determine growth rate trajectory changes
- FDOPA-PET to demonstrate decreased proliferation
Arm 2 Objective: Determine MTD/RP2D of CT-179 when combined with radiation therapy in patients with IDH-WT, MGMT-unmethylated, newly diagnosed GBM
Outcome Measures: PFS-12 and OS-12
Plan to include biomarker discovery program
Curtana: Developing A Breakthrough Treatment For Brain Cancer
- A once daily oral medication will dramatically change the way the most severe forms of brain cancer in adults and children are treated
- Compelling preclinical data in multiple animal models of adult glioblastoma (GBM) and pediatric medulloblastoma (MB) demonstrate the effectiveness of this highly targeted novel medication known as CT-179
- Market approval for the treatment of pediatric medulloblastoma is possible with 4 -5 years
- Multiple FDA designations including Orphan Drug Designation for Gliomas, Rare Pediatric Disease Designation for Medulloblastoma, and Fast Track Designation for CT-179 will accelerate the development timeline, reduce costs, and reduce risks
- Ready to initiate the first clinical trial in patients with recurrent and newly diagnosed GBM. Importantly, everything is ready to go – drug in bottles, clinical sites and investigators identified, and the team in place
Complete Phase 1 trial and have two other trials fully enrolled within 36 months
Curtana Team With Significant Preclinical and Clinical Development Experience
Gregory Stein, M.D., M.B.A.
Chief Executive Officer
30+ years in clinical medicine and life science company formation and operations.
Santosh Kesari, M.D., Ph.D.
25+ years in brain cancer research, clinical trials and clinical care.
David Weiner, M.D.
Chief Medical Officer
25+ years of leading numerous clinical development programs.
Daniel Pertschuk, M.D. VP, Clinical Development
30+ years of leading numerous clinical development programs, particularly for glioblastoma.
Michelle Rose, Ph.D. VP, Regulatory Affairs
20+ years of experience as a regulatory and clinical development advisor
Lawrence Trost, Ph.D., VP, Preclinical Development
20+ years of experience managing ADME, PK, and GLP toxicology studies and nonclinical development strategy
Mark Sorenson, Ph.D.
Head of CMC Department
25+ years providing CMC support associated with the development of small chemical entities.
Frank Del Greco, M.B.A
Head of Clinical Operations
15+ years experience in program management, clinical operations development.