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KDDF-201408-09 Clinical phase 1 Study of CWP291 in Relapsed Patients with Multiple Myeloma(Oncology, Chemical) [2019-08-29]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

To receive fast-track FDA approval for CWP291, a potent β-catenin inhibitor that has shown excellent antitumor activity in multiple myeloma models, as a therapeutic agent and conduct multinational clinical trial research in patients suffering from relapsed and refractory multiple myeloma in Korea and the US.

Future commercialization through licensing and developmental collaboration with a multinational pharmaceutical company.

Unmet Medical Need & Target Patients

Target patients: Relapsed or refractory multiple myeloma patients who have failed standard therapies.
 
Unmet Medical Needs
① Poor prognosis for many multiple myeloma patients, with high rates of relapse after receiving standard of care.
② Targeted therapies with lowered toxicity are needed, particularly because the majority of multiple myeloma patients are seniors.
③ Novel approaches that can synergize with standard therapies are needed to increase the therapeutic options available to physicians.

Status

Preclinical studies have revealed that CWP291 demonstrates outstanding in vitro, and in vivo anti-tumor effects through the inhibition of β-catenin, a major factor implicated in relapsed and refractory multiple myeloma cases. CWP291 also demonstrated synergism when treated in combination with standard therapies.
 

In order to increase translational relevance, we conducted and confirmed CWP291’s antitumor activity in additional preclinical models including mesenchymal stem cell co-culture system,  patient-derived (PD) xenografts and standard treatment resistant cells.
 

A phase 1 study to assess the safety, tolerability, pharmacokinetics and efficacy of CWP291 in subjects with relapsed or refractory myeloma patients has been filed and received FDA IND approval in July 2014. MFDS IND approval in Feb 2015. Patient enrollment is ongoing.

 

Intellectual Property

CWP291 compound-patents are granted in major markets valid until 2028.

Competitive Advantages

- First-in-class drug with potent β-catenin inhibitory effects at an early development stage in comparison to competing candidates
- Exhibits outstanding in vitro/in vivo anti-cancer effects in resistant multiple myeloma models and demonstrates synergism in co-administration with standard therapy
- Lower toxicity profile when compared to standard therapy and existing cytotoxic drugs
- Indications may be expanded to various solid tumor types that display drug tolerance due to β-catenin overexpression
- Strong patent position and guaranteed monopoly period

Contact & Company Overview

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