Paves Way for NED-170 Clinical Trials and FDA Submission
Cambridge, MA, February 7, 2019 – NED Biosystems, a clinical-stage biotech company investigating solutions for a range of cancers, today announced that the U.S. Patent and Trademark Office has awarded the company patent number 10,195,219 for its lead investigational therapeutic, NED-170. It is believed to be the first-ever composition patent to protect composition of matter for a combination therapeutic containing this many components. NED-170 is an oral combination therapy being explored in several types of cancers for its ability to simultaneously attack 4 cancer-driving processes. The patent expires no earlier than 2034 and provides commercial protection for NED-170 for all uses.
“While the individual NED-170 components each have merit as anti-cancer agents, we believe they will have even greater impact together,” said Marc Blaustein, CEO, NED Biosystems. “This patent decision affirms the novelty of the NED-170 composition and our belief that this combination of agents offers unique qualities that may benefit patients with cancer.”
NED-170 is a 7-component regimen of oral compounds targeting four essential physiological processes that drive all late stage (stages II-IV) cancer. There remains a significant need for an alternative approach to cancer treatment with improved therapeutic outcomes and patient quality of life. The 27 new solid tumor oncology drugs approved by FDA during the most recent 5 calendar years have provided an average survival advantage of only 5.8 months¹, often with serious side effects.
Rebecca Lambert, chairman of the board and founder, NED Biosystems noted, “Granting of this patent is recognition of the innovation of NED-170 and represents an important milestone in NED’s achieving its mission to provide longer survival with high quality of life for late-stage cancer patients.”
The patent includes claims to the unique combination of NED-170 components, providing composition of matter protection to any NED-170 drug product or kit. The patent also includes claims for NED-170’s use in late-stage ovarian cancer.
With NED-170, the company seeks to avoid the customary toxicity and side effects of today’s typical cancer treatments; it offers the potential for longer survival with high quality of life for late-stage cancer patients. NED Biosystems will rely in part on research and data previously generated regarding the individual NED-170 components to support the safety and efficacy of the treatment in a 505(b)2 new drug application.
The company plans to initiate a Phase 2 clinical trial in the first half of this year to investigate the safety and efficacy of NED-170 in patients with triple negative breast cancer or cholangiocarcinoma, and anticipates expanding research to other types of cancer, both rare and common, including ovarian cancer.
“Because of the challenges treating advanced solid tumor cancers, there is a particularly great need for a treatment that offers less side effects and improved efficacy over current standards of care,” stated Geoffrey Ling, M.D., an NED director, expert in medical innovation and member of NED’s Scientific Advisory Board. “The collective mechanism of NED-170 represents a much-needed innovative approach to treating cancer.”
About NED Biosystems™
Based in Cambridge, Massachusetts, NED Biosystems is a clinical-stage biotech company developing an innovative oral cancer combination treatment. NED Biosystems was founded by Rebecca Lambert, who assembled a team of leading cancer researchers from across the country to develop a drug that simultaneously affects the key processes that drive cancer survival and growth. Due to ease of oral dosing and cost-effectiveness of the treatment, the company aims to provide revolutionary, efficacious treatment solutions to patients not only here in the US, but also in the developing world. Visit nedbiosystems.com.
1During the period 2014-2018, of the 27 NMEs approved by FDA for solid tumor indications where survival was reported, the average survival improvement over standard of care comparator was 5.8 months.
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