Industry

Healthcare

Company Type

Pharmaceuticals

Size

$3.5 Million

Investment Type

Equity

For important risk and disclaimer information, Click Here.


Overview


Goal to dramatically improve survival and quality of life in adults and children with brain cancer


Programs for newly diagnosed glioblastoma (GBM) and pediatric
medulloblastoma (MB)


Very experienced team, including co-founder Santosh Kesari, MD, PhD, a Harvard-trained brain cancer physician and researcher


100% owned intellectual property rights

Opportunity

Recipient of prestigious CPRIT $7.6M award


36-month timeline to clinical data in adults and pediatrics


Seeking up to $3.5M to complete a $5M Series A preferred equity offering


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


Pharmacodynamic/Efficacy Measures

  • 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.
Scientific Co-Founder

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.

Curtana Pharmaceuticals

Learn More About Curtana Pharmaceuticals
Thank you for your interest in Curtana Pharmaceuticals.Please fill out your information and we will contact you shortly with more information on this opportunity.

0 Comments

Leave a reply

Your email address will not be published. Required fields are marked *

*

CONTACT US

Hi. We're not around right now. But you can send us an email and we'll get back to you, asap.

Thanks, Ken

Ken Margolis | Managing Partner Castle Placement, LLC
1460 Broadway Street, Rte 400
New York, New York 10036
(212) 418-1188 | C: (516) 712-7784
kmargolis@castleplacement.com

Sending