Navigation Links
eFFECTOR Therapeutics' Lead Product Candidate, eFT508, Receives Orphan Designation from FDA for Treatment of Diffuse Large B-Cell Lymphoma
Date:3/9/2017

SAN DIEGO, March 9, 2017 /PRNewswire/ -- eFFECTOR Therapeutics today announced that its lead product candidate, eFT508, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma. eFT508 is a potent, highly selective inhibitor of MNK1 and MNK2, two enzymes that are critical for the growth and survival of tumors. eFFECTOR also announced that it has dosed the first subject in a Phase 1/2 clinical trial of eFT508 in patients with B-cell hematological malignancies.

"Diffuse large B-cell lymphoma is an aggressive disease for which patients badly need additional treatment options," said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. "We hope that eFT508, a selective translation regulator that blocks multiple oncogenic growth and proliferation pathways, as well as activates anti-tumor immunity, will prove effective in treating patients afflicted with this devastating disease."

The recently initiated trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics and antitumor activity of eFT508. The primary goals will be to establish a maximum tolerated dose and recommended dose for further evaluation and to assess preliminary efficacy of the compound. eFFECTOR is also conducting a Phase 1/2 dose escalation trial of eFT508 in patients with solid tumors.

Orphan designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the United States. The orphan designation of eFT508 for DLBCL provides increased access to FDA reviewers to discuss clinical trial designs, the ability to qualify for tax credits for certain clinical research costs, the ability to apply for annual grant funding, and a waiver of Prescription Drug User Fee Act filing fees, as well as the potential for seven years of U.S. marketing exclusivity if the product candidate is approved.

About eFT508
eFT508 is a potent, highly selective and orally bioavailable inhibitor of MNK1 and MNK2 being studied in patients with solid tumors and lymphoma. MNK1 and 2 are kinases acting as signal integrators at the convergence of multiple oncogenic pathways to regulate production of disease-driving proteins, including checkpoint proteins.

About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma is an aggressive form of non-Hodgkin lymphoma (NHL) that can begin in lymph nodes and areas of the body outside of the lymphatic system. DLBCL is the most common form of NHL, making up 30 percent of newly-diagnosed NHL cases each year, according to the Lymphoma Research Foundation. Due to the fast-acting and aggressive nature of the disease, DLBCL requires immediate treatment upon diagnosis.

About eFFECTOR Therapeutics
eFFECTOR Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of selective translation regulators as a new class of small molecule therapeutics for cancer. The company's investigational compounds are designed to restore translational control to halt underlying disease mechanisms while preserving healthy physiological processes. eFFECTOR's most advanced program focuses on the development of eFT508. The company has additional selective translation regulator programs currently in discovery and development. For more information visit www.effector.com.

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/effector-therapeutics-lead-product-candidate-eft508-receives-orphan-designation-from-fda-for-treatment-of-diffuse-large-b-cell-lymphoma-300420884.html


'/>"/>
SOURCE eFFECTOR Therapeutics
Copyright©2017 PR Newswire.
All rights reserved


Related biology technology :

1. eFFECTOR Therapeutics Appoints Alana McNulty Chief Financial Officer
2. Peer-Reviewed Study in Cell Validates eFFECTOR Therapeutics Novel Small-Molecule Approach to Cancer Treatment
3. First patent issues on TAL effector technology
4. Audentes Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
5. Orexigen Therapeutics to Provide Business Update and Discuss Fourth Quarter and Year End 2016 Financial Results on March 28, 2017
6. UNIAPAC Foundation Think Tank in Paris selects Renova Therapeutics CEO and Co-founder as keynote speaker for annual meeting
7. Envisia Therapeutics To Present At American Glaucoma Society 2017 Annual Meeting
8. Stealth BioTherapeutics Initiates Observational Study of Patients With Mitochondrial Myopathy
9. Sangamo Therapeutics Announces Presentation At The Cowen And Company 37th Annual Health Care Conference
10. Nektar Therapeutics Reports Fourth Quarter and Year-End 2016 Financial Results
11. Sangamo Therapeutics Reports Fourth Quarter And Full Year 2016 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2017)... Springs, FL (PRWEB) , ... ... ... Chief Strategic Analyst, Kenny Soulstring, today announced that the stock market news ... specializing in risk assessment diagnostic testing that screens and identifies exposure, progression ...
(Date:7/20/2017)... BC, Canada (PRWEB) , ... July 20, 2017 , ... ... today announced the winning recipients of the 2017 IAC Awards at the 22nd World ... awards, the committee also named four faculty to receive the Distinguished Fellowship Awards. , ...
(Date:7/20/2017)... , ... July 20, 2017 , ... ... seminar on digital pathology and artificial intelligence Tuesday, July 25, during the Association ... Baras from Johns Hopkins Medicine. , Baras, Associate Director of Pathology Informatics, ...
(Date:7/20/2017)... (PRWEB) , ... July 20, 2017 , ... ... solution to make clinical trial sites and study participants truly unified. TrialKit, a ... compliant (FDA 21 CFR Part 11) research studies entirely on mobile devices. With ...
Breaking Biology Technology:
(Date:4/24/2017)... , April 24, 2017 ... and partner with  Identity Strategy Partners, LLP (IdSP) ... "With or without President Trump,s March 6, 2017 ... Terrorist Entry , refugee vetting can be instilled with ... resettlement. (Right now, all refugee applications are suspended ...
(Date:4/13/2017)... 2017 UBM,s Advanced Design and Manufacturing event ... emerging and evolving technology through its 3D Printing and ... alongside the expo portion of the event and feature ... focused on trending topics within 3D printing and smart ... event will take place June 13-15, 2017 at the Jacob ...
(Date:4/11/2017)... 2017 No two people are believed ... New York University Tandon School of Engineering and ... that partial similarities between prints are common enough ... phones and other electronic devices can be more ... lies in the fact that fingerprint-based authentication systems ...
Breaking Biology News(10 mins):