Navigation Links
NewGen Therapeutics Presents Data on NT-113, A Novel Pan-ErbB Inhibitor, at American Association of Cancer Research

MENLO PARK, Calif., April 8, 2013 /PRNewswire/ -- Preclinical data showing high potency, excellent pharmacokinetics and single-agent anti-cancer activity of NT-113, a novel irreversible Pan-ErbB Tyrosine Kinase Inhibitor under development by NewGen Therapeutics, was presented in a poster session today at the American Association of Cancer Research Meeting in Washington, D.C. 


Data showed that NT-113 is a very potent inhibitor of ErbB subtypes, including EGFR, HER2 and ErbB4, in a panel of over 100 tyrosine kinases and is highly active against erlotinib (Tarceva®) and gefitinib (Iressa®) resistant cancer cells with EGFR mutations including T790M, L858R, and d-746-750.  Potent anti-cancer activity was demonstrated in T790M mutant non-small cell lung (NSCLC) cancer and HER2 positive gastric cancer xenograft models. Pharmacokinetic data showed excellent oral bioavailability, a long half-life and the ability to penetrate the blood barrier at therapeutic concentrations.

In collaboration with C. David James , Ph.D., University of California, San Francisco (UCSF), NT-113 was studied for both in vitro and in vivo for activity in glioblastoma (GBM).  NT-113 showed a broad spectrum of in vitro activity across multiple human GBM cell lines. In addition, data showed statistically significant anti-cancer activity and increase in survival relative to a control group in an intracranial GBM39 mouse xenograft model. GBM39 is a human GBM cell line that carries the disease driving EGFRvIII mutation.

Key differentiating features of NT-113 include:

  • Equipotency across EGFR, HER2 and ErbB4
  • Excellent distribution of NT-113 into the brain at therapeutic doses (4:1 brain/plasma concentrations)
  • Excellent oral bioavailability and pharmacokinetics
  • Potency against the distinct EGFR mutations found in both GBM and other solid tumors including extra-cranial malignancies such as NSCLC, breast cancer and melanoma
  • Demonstrated potent anti-cancer activity in an HER2 positive gastric cancer, T790M mutant NSCLC and GBM39 intracranial mouse xenograft studies

"These unique differentiating attributes have the potential to make NT-113 the preferred treatment for patients with malignancies that over-express members of the ErbB family, including GBM, NSCLC, breast cancer, gastric cancer, colon cancer, head and neck cancer, and melanoma," commented Harry D. Pedersen , President and Chief Executive Officer. "Over 90% of solid tumors over-express at least one ErbB receptor. Agents targeting single receptors in the family, including Iressa®, Herceptin®, Erbitux® and Tarceva®, have made a significant impact on survival in a number of cancers and account for billions of dollars in annual sales.  A single agent that targets all receptors in the family should result in better overall clinical outcomes."

"Moreover, NT-113's remarkable ability to cross the blood brain barrier suggests it could be particularly beneficial to patients with GBM or brain metastases from susceptible primary cancer types. While current agents that target individual ErbB receptors have high clinical response rates and significant increases in survival, patients frequently progress with brain metastases.  Since no other currently approved ErbB inhibitors cross the blood brain barrier, NT-113 has the potential to be a major advancement in the treatment of cancers that over-express one of the ErbB receptors and tend to metastasis to the brain.  Our plan is to initially focus on GBM, where EGFR is a validated target and we have a chance for an accelerated approval within five years, and to eventually expand into other solid tumors that over-express EGFR and tend to metastasize to the brain."

Mr. Pedersen noted that NT-113 and additional analogs are currently in preclinical development, and that NewGen expects to file an Investigational New Drug (IND) application to begin clinical trials with NT-113 in 2014.

About NewGen
NewGen Therapeutics is a privately held pharmaceutical company developing patient-targeted cancer drugs that are designed to overcome limitations of currently available therapies. The company's pipeline includes multiple programs with novel small molecule drug leads against clinically important targets, each addressed to significant medical needs. NT-113, a potent irreversible pan-ErbB inhibitor, is the company's most advanced program and has demonstrated anti-cancer activity in several cancer xenograft studies, including GBM, gastric cancer and NSCLC.  NT-113 will enter Phase 1 clinical trials in 2014.  In addition, NewGen's pipeline includes NT-004, a reversible pan-ErbB inhibitor and NT-125, a PARP inhibitor, both in late preclinical development

NewGen's strategy is to identify and in-license promising programs, add value through further development and then partner with pharmaceutical companies for clinical development and commercialization. For more information, please visit our website at:

SOURCE NewGen Therapeutics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics, Inc. (CTI) to Report First Quarter Financial Results on April 20
2. Faruqi & Faruqi, LLP Encourages Investors Who Suffered Substantial Losses Investing in Chelsea Therapeutics International, Ltd. to Contact the Firm
3. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
4. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
5. Zacks Industry Outlook Highlights: Eli Lilly, Forest Labs, ViroPharma, Novartis and United Therapeutics
6. Oxford BioTherapeutics Appoints Senior Industry Leader to Head its New Clinical Development Operations in Basel, Switzerland
7. Nektar Therapeutics Reports Financial Results for the First Quarter of 2012
8. Cara Therapeutics Licenses Novel Kappa Opioid Agonist, CR845, to Chong Kun Dang Pharmaceutical Corporation For South Korean Market
9. Frost & Sullivan: High Uptake of New Drug Therapies and Aging Population Expansion Keep the U.S. Retinal Therapeutics Market Buoyant
10. Zenobia Therapeutics, Inc. And BioBlocks, Inc. Announce Sale Of A Joint Fragment Library Ideal For Screening By All Popular Methods
11. New Forecast Shows Global Protein Therapeutics Market to Reach $143.4 Billion by 2015
Post Your Comments:
(Date:12/1/2015)... 1, 2015 During the recent 2015 ... San Francisco, CA , Medinol Ltd. continued ... marketplace. During a satellite symposium, "The BioNIR eDES: ... Minimize Restenosis", a renowned physician panel discussed the ... CoCr Coronary Stent System and the Medinol eDES ...
(Date:12/1/2015)... 2015 ... of the "2016 Europe Enteric ... Coli, Enterovirus, Rhinovirus, Rotavirus, Salmonella, Shigella, ... offering. --> ) ... "2016 Europe Enteric Disease Testing ...
(Date:12/1/2015)... ALBANY, New York , December 1, ... (Oral Contraceptive Pills, Contraceptive Injectables, Topical Contraceptives, ... Contraceptive Implants, Contraceptive Vaginal Rings, Contraceptive Diaphragms, ... Global Industry Analysis, Size, Share, Growth, Trends ... been released by Transparency Market Research (TMR).The ...
Breaking Medicine Technology:
(Date:12/1/2015)... Libertyville, IL (PRWEB) , ... December 01, 2015 ... ... catheters, keeping their independence is everything. That is why Hollister Incorporated has launched ... excited to offer this next product in the VaPro touch free catheter portfolio,” ...
(Date:12/1/2015)... Spokane, WA (PRWEB) , ... December 01, 2015 ... ... announced today that it has been selected as a finalist in this year’s ... FierceHealthcare, and FierceMobileHealthcare. Next IT Healthcare was recognized as a finalist in the ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... ... clinical solutions for the care management and population health arenas, is pleased to ... clinical and cost containment services, has successfully implemented the ACUITY Complete Care™ Management ...
(Date:12/1/2015)... ... December 01, 2015 , ... PartnerTech , a leader ... leadership since 2008. Gary Bruce, President of PartnerTech North America, currently serves as ... significant amount of time in Sweden since joining PartnerTech based in Malmo, Sweden. ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... Magazine as a Modern Man for 2015. , Angeleno Magazine is a ... United States. Established in 1994, Modern Luxury includes more than 50 magazine titles ...
Breaking Medicine News(10 mins):