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NED Biosystems Announces Leading Infectious Disease Research Scientist Michael Mansour, MD, PhD To Serve as Medical Advisor

By Press

CAMBRIDGE, Mass., Oct. 6, 2020 (SEND2PRESS NEWSWIRE) — NED Biosystems, an innovative clinical-stage biotech company developing therapies for cancer and the novel coronavirus, is pleased to announce that Michael Mansour, MD, PhD, will serve as the Company’s Medical Advisor of Infectious Disease. Dr. Mansour brings a wealth of expertise in infectious disease research where he leads an independent laboratory at the Massachusetts General Hospital (MGH). He is a leading authority guiding investigative studies on COVID-19 treatments and biomarkers which includes serving as Principal Investigator for Phase 3 COVID-19 studies.

Michael Mansour, MD, PhD - NED BiosystemsAs Medical Advisor, Dr. Mansour will direct NED’s clinical trial initiative for NED-260 to establish the treatment’s safety and efficacy for COVID-19 patients. NED-260 is a rationally designed, combination treatment that has the potential to address COVID-19 viral replication and entry based on its multiple mechanisms of action. Through its multifaceted approach to address major processes integral to COVID-19’s progression and how it infects the cell, NED-260 may fulfill a critically important niche in the treatment and prevention of mild-to-moderate illness in the majority of people who are at risk for COVID-19 infection. NED is planning to conduct a Phase 2, randomized, placebo-controlled study of NED-260 in mild-to-moderate COVID-19 patients.*

“This study offers a chance to look at an oral treatment for COVID-19,” said Dr. Mansour. “Taken directly after diagnosis, the combination is aimed at interrupting disease progression – and potentially speeding up a patient’s recovery time. The trial will also explore the use of NED-260 as a potential prophylaxis, to prevent infection.”

“The contribution of Dr. Mansour’s expertise and considerable insight will be invaluable as we establish the safety and efficacy of NED-260 as a COVID-19 treatment,” stated Rebecca Lambert, Founder and Executive Chair of NED Biosystems. “We are eager to commence the NED-260 clinical trials with Dr. Mansour’s seasoned guidance. The time is now to develop an early treatment solution and preventative of infection.”

“Dr. Mansour is an outstanding addition to our team of accomplished medical advisors at NED Biosystems,” stated Dr. Geoffrey Ling, Office of the CEO, Scientific Advisory Board, Board of Directors, NED Biosystems and advisor to the U.S. Government’s COVID-19 Task Force. “His prominence in the field of infectious disease research and deep expertise will help propel our efforts to bring our uniquely comprehensive treatments to the broader patient community. We are delighted to welcome him to the team.”

Dr. Mansour leads a team of medical research scientists at the Mansour Laboratory that focuses on developing novel cellular diagnostics and therapies for invasive fungal infections. He is also a practicing physician specialized in infectious disease at MGH. Dr. Mansour obtained an MD and PhD from Boston University and completed his residency and served as a fellow at the MGH.

 

About NED Biosystems™

Based in Cambridge, Massachusetts, NED Biosystems is a clinical-stage biotech company developing innovative treatments to provide multifaceted approaches to affect multiple key disease processes. Beginning with a focus on patients and their families, NED seeks to dramatically improve patient outcomes with combination treatments comprised of agents with well-established safety and tolerability profiles. NED’s treatment approach is to afford patients high quality of life. Due to ease of oral dosing and cost-effectiveness of the treatments, the company aims to provide revolutionary, efficacious treatment solutions to patients not only in the U.S. and other developed nations, but also in economically challenged regions globally.

For more information, visit https://nedbiosystems.com/.

For additional information regarding this press release, please contact Creative Director, Brett Macias at bmacias@nedbiosystems.com.

*NED-260 is pending approval by the FDA post clinical trials.

PHOTO link for media: https://www.Send2Press.com/300dpi/20-1006s2p-ned-michael-mansour-300dpi.jpg

Caption: Michael Mansour, MD, PhD, NED Biosystems’ New Medical Advisor of Infectious Disease.

Leading Experts in Cancer Research Nabeel El-Bardeesy and Razelle Kurzrock Join NED Biosystems’ Scientific Advisory Board

By News

CAMBRIDGE, Mass., Sept. 2, 2020 (SEND2PRESS NEWSWIRE) — NED Biosystems, an innovative clinical-stage biotech company developing oral therapies for cancer and novel coronavirus, is pleased to announce that Nabeel El-Bardeesy, PhD and Razelle Kurzrock, MD have joined the Company’s Scientific Advisory Board. Both Dr. El-Bardeesy and Dr. Kurzrock bring a wealth of expertise as scientific and clinical leaders in cancer research and treatments.

Dr. El-Bardeesy is Associate Professor of Medicine at the Harvard Medical School and a leading authority on the causes of cancer. Dr. El-Bardeesy also serves as the Cholangiocarcinoma Foundation Scientific and Medical Advisory Board Co-Chair. Dr. El-Bardeesy additionally is Assistant Professor at Massachusetts General Hospital Cancer Center and is an instructor at the Dana-Farber Cancer Institute. Dr. El-Bardeesy is widely published on the molecular and cellular mechanisms that drive certain types of cancer.

Dr. Kurzrock is Professor of Medicine and Associate Director for Clinical Sciences at the University of San Diego Moore Cancer Center. She leads the Center’s clinical trial programs and heads its recently established Center for Personalized Cancer Therapy. Dr. Kurzrock’s distinguished track record includes leading one of the largest phase one clinical trial programs at the University of Texas MD Anderson Cancer Center, where she spearheaded an innovative approach that utilized advanced molecular technologies to match patients with targeted cancer treatment that optimized the possibility for response.

“The addition of Dr. El-Bardeesy and Dr. Kurzrock to the Scientific Advisory Board further strengthens the resolve of NED’s mission to innovate safe, effective and transformative treatments for cancer and other life-threatening diseases such as Covid-19,” stated Rebecca Lambert, Founder and Executive Chair of NED Biosystems’ Board. “As we advance NED-170 clinical trials for cholangiocarcinoma, ovarian and triple negative breast cancer to establish the product’s safety and efficacy, we will rely heavily on the Scientific Advisory Board’s expert guidance and direction. They will also play an instrumental role in our efforts to launch clinical trials for NED-260, a potential treatment and prophylaxis for COVID-19.*”

NED-170 is a patented investigational cancer therapy that the Company believes is the first to address and affect four key processes that advance all late-stage cancers (Stages II-IV). The same four processes that drive advanced cancers are integral to the pathology of Covid-19.

“The implementation of comprehensive clinical trials is a vitally important step in determining the safety and effectiveness of the treatments for life threatening illnesses that we are innovating at NED Biosystems,” stated Geoffrey Ling, COL(ret) MD, PhD, Office of the CEO, and member of the Scientific Advisory Board and Board of Directors, NED Biosystems and member of the U.S. Government’s Covid-19 Task Force. “The deep expertise of our Scientific Advisory Board provides us with the confidence that we are following the proper methods and techniques to generate a valid set of trial results.”

“Dr. Kurzrock and Dr. El-Bardeesy will provide invaluable guidance on the clinical design and execution for our upcoming NED-170 trials, as well as input into the analysis of the results,” stated Brian Leyland-Jones, BS, MBBS, PhD, FRACP, FRACPC, NED Biosystems Chair of the Scientific Advisory Board. “We are excited to welcome them to the Scientific Advisory Board and look forward to their support of our clinical trial initiatives.”

About NED Biosystems™

Based in Cambridge, Massachusetts, NED Biosystems is a clinical-stage biotech company developing innovative treatments unlike most available today. Beginning with a focus on patients and their families, NED seeks to dramatically improve patients’ outcomes with therapies that lack the toxicity and side effects of today’s treatments, allowing patients to retain a high quality of life. Due to ease of oral dosing and cost-effectiveness of the treatments, the company aims to provide revolutionary, efficacious treatment solutions to patients not only in the U.S. and other developed nations but also in economically challenged global regions.

For more information, visit https://nedbiosystems.com/.

For additional information regarding this press release, please contact Creative Director, Brett Macias at bmacias@nedbiosystems.com.

*NED-170 and NED-260 are pending approval by the FDA post clinical trials.

NED Biosystems Unveils First Peer-Reviewed Presentation at ASCO Breakthrough Summit

By News

Promising outcomes for advanced cancers associated with novel investigational cancer therapeutic

 

Cambridge, Mass., October 13, 2019 – NED Biosystems, Inc., a clinical-stage biotech company investigating solutions for a broad range of cancers, recently presented its first peer-reviewed data demonstrating that NED-170 may potentially provide advanced-stage cancer patients with a safe, effective, and lower cost alternative to standard chemotherapy. The presentation, a poster on lead therapeutic NED-170, was presented at the American Society of Clinical Oncology, Inc. (ASCO) Breakthrough Summit on October 12, 2019 a premier international cancer meeting taking place in Bangkok, Thailand.

“The results in patients to date with NED-170 offer great hope that a low-toxicity oral treatment may offer a valuable therapeutic alternative for late-stage cancer patients,” said lead author Edward Garmey, MD, scientific advisory board member, NED Biosystems, who also serves as adjunct instructor at Harvard Medical School’s Therapeutics Graduate Program and a member of the Board of Overseers at the Beth Israel Deaconess Medical Center. “It is fitting to me that NED’s first published data were presented at this ASCO Breakthrough Summit, a first-of-its-kind event designed to highlight innovative breakthroughs in cancer care.”

The data presented at the ASCO Breakthrough Summit demonstrated statistically significant tumor growth inhibition in an in-vivo preclinical study comparing NED-170 to standard of care cancer therapy. Clinical case reports of quality of life improvements for patients receiving NED-170 were also presented in the poster.  The two NED-170 case studies further demonstrated notable tumor reduction with patient reported improvements in their quality of life. Based on the data presented, NED Biosystems is planning a multinational phase 1/2 clinical trial.

“The NED-170 therapy shows promise and presenting this data as part of the ASCO Breakthrough Summit gave us the opportunity to describe the prospective observational data and patient responses to some of the world’s leading oncologists,” said author Bridget Martell, MA, MD, and scientific advisor to NED Biosystems. “Working on NED-170, a unique and easily-administered combination therapy for late stage patients, is addressing a large unmet medical need among oncology patients – including for those requiring care in developing countries. I look forward to my continued collaboration with the NED team and ultimately bringing this therapy to patients.”

ASCO is the world’s leading oncology organization, representing nearly 45,000 oncology professionals who care for people living with cancer. This year’s inaugural ASCO Breakthrough Summit was the world’s first global summit for oncology innovators.

 

About NED-170

NED-170 is an oral regimen designed to target five of the essential physiological processes that drive all late stage (stages II-IV) cancer. The regimen consists of 7 components: three FDA-approved drugs and four naturally-occurring compounds combined in particular doses and specific timing, which as a whole have been recognized by the FDA as a unique therapeutic combination and has been granted a composition of matter patent by the U.S. Patent and Trademark Office.

About NED Biosystems™

Based in Cambridge, Massachusetts, NED Biosystems is a clinical-stage biotech company developing innovative approaches to cancer  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. Ease of oral dosing, favorable storage conditions and cost-effectiveness of the treatment supports the company’s mission  to provide revolutionary, efficacious treatment solutions to patients not only in the U.S. and other developed nations but also in the developing world. Visit NEDbiosystems.com.

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Contact:

Tara DiMilia
908-369-7168
Tara.dimilia@tmstrat.com

World-Renowned Cancer Leader Brian Leyland-Jones Named Chairman of NED Biosystems’ Scientific Advisory Board

By News

Cambridge, Mass., October 17, 2019 – NED Biosystems, a clinical-stage biotech company investigating solutions for a broad range of cancers, is pleased to announce Brian Leyland-Jones, BS, MBBS, PhD, FRACP, FRCPC, has been named Chairman of the Scientific Advisory Board. Dr. Leyland-Jones is a pre-eminent expert in cancer therapy, clinical trials and drug development. He will take on this role immediately.

“As we prepare for our lead therapeutic, NED-170, to enter into clinical trials in 2020, Brian’s extensive experience as a world cancer leader will help provide us with valuable strategic guidance that can take our capabilities to the next level,” said Dr. Geoffrey Ling, CEO, NED Biosystems.

A fellow of the American College of Physicians and a recipient of numerous research grants, Dr. Leyland-Jones has served as principal, co-principal and co-investigator on more than 100 clinical studies and was instrumental in the development of numerous cancer treatments, including Herceptin (trastuzumab) and Taxol (paclitaxel). He has authored and co-authored more than 210 peer-reviewed articles and book contributions, 25 books and book chapters, 425 abstracts and 35 patents.

Dr. Leyland-Jones has served as an instrumental leader of three cancer centers and held positions as Founding Chair of Oncology and Director of the McGill University Comprehensive Cancer Centre; Director of the Winship Cancer Centre and Associate Vice-President of Health Sciences at Emory University; Vice President of the Molecular and Experimental Medicine Genomics Medicine Program at the Avera Cancer Institute. Additionally, he founded three companies including AKESOgen, Inc., Xanthus Pharmaceuticals Ltd., and Viviphi Ltd.

“NED-170 has serious potential to provide longer and higher quality of life to cancer patients,” said Rebecca Lambert, founder and executive chair of NED Biosystems’ Board. “Brian will be instrumental in leading the continued development of NED-170 as we aim to serve a significant unmet need.”

Dr. Leyland-Jones currently holds roles on several national and international boards including Chief Medical Officer and Scientific Advisory Board Member for the National Foundation for Cancer Research (NFCR); Chief Medical Officer of OTraces and the N OF 1 Mission; Asian Foundation for Cancer Research (AFCR); Non-Pareil; Ratio and the WIN Consortium. He holds biochemistry, medical, and doctoral degrees from the University of London. Dr. Leyland-Jones completed residency training at London hospitals including Hammersmith, Brompton, and St. Bartholomew’s, as well as a clinical pharmacology fellowship at Cornell University and a medical oncology fellowship at Memorial Sloan-Kettering Cancer Center.

“I have examined NED-170’s system biology approach and am impressed by its potential to benefit cancer patients worldwide, including those in developing parts of the world,” said Dr. Leyland-Jones. “Cancer affects so many and I am passionate about finding and delivering solutions to those suffering.”

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 in the U.S. and other developed nations but also in the developing world. Visit nedbiosystems.com.

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Contact:

Tara DiMilia
908-369-7168
Tara.dimilia@tmstrat.com

Founding Director of DARPA Biological Technologies Office, Geoffrey Ling, Appointed CEO of NED Biosystems

By News

Ling brings significant medical insight, strategic vision and dynamic implementation to guide NED Biosystems’ development of unique cancer treatment combination

Cambridge, Mass., July 10, 2019 – NED Biosystems, a clinical-stage biotech company investigating solutions for a broad range of cancers, is pleased to announce Geoffrey Ling, MD, PhD, Col. (Ret.), has been named CEO. He is both a physician and pharmacologist. A former U.S. government leader of innovation, Dr. Ling is well-known for his ability to identify, advise and direct solutions to overcome global medical challenges. He will take on the role immediately.

“As a visionary and energetic champion of novel approaches to solve unmet medical needs, Geoff will provide an unprecedented level of guidance for our company and will be an incredible asset as we continue the development of our lead therapeutic, NED-170,” said Rebecca Lambert, founder and executive chair of NED Biosystems’ Board. “In moving from Board member to CEO, Geoff brings the strategic leadership and the hands-on innovation management expertise our cancer combination merits.”

“NED-170 represents a major breakthrough in cancer that will potentially benefit all cancer patients – even those in the developing world,” said Dr. Ling. “I am passionate about NED’s mission and believe NED-170’s system biology approach is what has long been missing in the cancer treatment armament. Cancer patients want to effectively treat and manage their disease while enjoying full quality of life. This is NED-170’s promise. I look forward to working with NED’s remarkable team to bring our therapy to market.”

Dr. Ling has extensive experience in leading innovative global projects as well as managing challenging medical situations. He currently serves as co-leader of The Brain Health Project, an ambitious initiative that aims to double human brain health in the next 10 years. He also serves as a professor of neurology, and is an attending neurocritical care physician at Johns Hopkins University and Hospital. He previously served as the founding director of the Biological Technologies Office at the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, responsible for the development of emerging technologies for use by the military, and as assistant director for Medical Innovation of the Science Division in President Obama’s White House Office of Science and Technology Policy (OSTP). A retired U.S. Army colonel, Dr. Ling proudly served for 27 years during which time he was deployed to Iraq and Afghanistan.

With a medical degree from Georgetown University and a doctorate in Pharmacology from Cornell University, Dr. Ling completed a neuropharmacology fellowship at Memorial Sloan-Kettering Cancer Center. He has board certifications in both Neurology and Neuro Critical Care and has published more than 200 peer-reviewed articles, book chapters and reviews. He is a member of the honor societies of Alpha Omega Alpha, Sigma Xi and Military Medical Order of Merit. Dr. Ling is a fellow of the American Neurological Association, American Academy of Neurology and Neurocritical Care Society. He is a member of the Society for Critical Care Medicine, American Society of Pharmacology and Experimental Therapeutics and The Society of Federal Health Professionals (AMSUS).

Additionally, Peter D’Errico, currently CFO of NED Biosystems, will add the role of COO to his title.

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 in the U.S. and other developed nations but also in the developing world. Visit nedbiosystems.com.

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Contact:

Tara DiMilia
908-369-7168
Tara.dimilia@tmstrat.com

NED Biosystems Gains Patent for Unique Combination Therapy

By News, Press

Hennessy’s Highlights – The Latest Oncology News from Mike Hennessy, Jr., President – OncLive.com

April 2019

Biotechnology company NED Biosystems is developing a novel therapeutic that integrates 7 compounds into a single orally administered treatment regimen for patients with late-stage cancer. The company, based in Cambridge, Massachusetts, has landed a patent from the US Patent and Trademark Office that it believes is the first issued to protect the composition of matter for a formulation containing this number of components.

The therapeutic, NED-170, consists of the FDA-approved chemotherapy drugs cyclophosphamide, metformin, and naltrexone combined with the naturally occurring compounds curcumin, melatonin, α-lipoic acid, and genistein. Investigators for NED Biosystems hypothesize that these 7 components, when combined in a regimen involving particular doses and timing, offer a new treatment option for patients with advanced cancers that progressed through standard therapy.

The patent, which will remain in force until at least 2034, includes claims to the unique combination of NED-170 components, providing protection to any NED-170 drug product or kit, as well as claims for its use in late-stage ovarian cancer. Specifically, the patent details an ovarian cancer regimen consisting of least 1 dose per day of metformin (range, 500-1000 mg), cyclophosphamide (50 mg), naltrexone (range, 1.5-4.5 mg), α-lipoic acid (1200 mg), curcumin (range, 750-4500 mg), genistein (500 mg), and melatonin (10 mg).

The combination regimen simultaneously targets essential physiological processes driving all latestage cancers, including angiogenesis, reduced apoptosis, differential cancer cell metabolism, and evasion of immune response, according to NED Biosystems.

“Patients who have exhausted standards of care have limited treatment options. They can go into phase I clinical trials, they can recycle chemotherapy drugs, or they can opt for the palliative care pathway,” Edward Garmey, MD, chief medical officer and chairman of the scientific advisory board at NED Biosystems, said in an interview. “NED170 has been created with the view that there needs to be another pathway available for these patients that is predicated on tumor control combined with quality-of-life preservation.

“It’s a big goal, and it certainly represents a paradigm shift for what’s currently offered to [patients with] late-stage cancer, but we feel it’s an achievable goal,” Garmey added.

Garmey said the company is finalizing the protocol for a phase I/IIA clinical trial to investigate the safety and efficacy of NED-170 in 10 patients with treatment-refractory triple-negative breast cancer and 10 with refractory cholangiocarcinoma. The FDA allowed the company to bypass the typical dose escalation required in phase I studies because the drugs involved have been demonstrated to be safe and effective in clinical trials. NED Biosystems expects to begin enrollment in the second half of 2019.

The company eventually plans to investigate the combination in other types of cancers, including breast, head and neck, and leiomyosarcoma.

BioWorld: NED Biosystems assembles 7-pronged attack on cancer

By News, Press

See full story here: http://www.bioworld.com/report/BWT02082019NED.pdf

By Michael Fitzhugh, News Editor, BioWorld Volume 30, No. 27

February 8, 2019

NED Biosystems Inc., a Cambridge, Mass.-based venture developing a seven-agent combination therapy for cancer, has secured a U.S. patent for the treatment, called NED-170. The oral regimen, which comes in a daily seven-pill pack, targets both angiogenic and immune response pathways for the potential treatment of several types of cancers. If successful, it could potentially help not only extend lives, but also drive down the costs of cancer care in certain cases.

The company’s name is pronounced letter-by-letter as an acronym for “no evidence of disease.” It was founded in 2013 by Rebecca Lambert, whose younger sister was diagnosed with stage IV leiomyosarcoma and told that she had less than a year to live, a prognosis made especially heartbreaking since she had a young son. Lambert, who was working on Wall Street at the time, quit her job to help her sister, eventually connecting in that mission with Harvard University’s Judah Folkman, a late scientist known for his research on tumor angiogenesis. With his help, Lambert built a team that put together a regimen of drugs that helped her sister live for nine years, a refinement of which now forms the heart of NED-170.

Lambert, now chairman of NED’s board, told BioWorld that “my goal for my sister’s therapy in 2001 is identical to ours at NED today, to chronically control cancer’s growth and spread, permit patients to significantly extend life and live life with the full quality we associate with health each day.”

To support that work, the company has raised more than $3 million out of an anticipated $10 million series B it expects to close before the end of the second quarter. An earlier series A round provided the company with $1.5 million in 2015.

As patented, NED-170 contains a mix of three generic drugs, cyclophosphamide, metformin and naltrexone, and four GMP-grade natural products, alpha-lipoic acid, curcumin, genistein and melatonin. “The seven compounds are all selected so that they have very specific biological activity because we want multiple driver processes of cancer,” CEO Marc Blaustein told BioWorld. Each is given at a dose that’s known to be well-tolerated and has been selected to avoid drug-drug interactions, he said. Taken together, the medicines act to target two fuel supplies of growing tumors — angiogenesis and metabolism — while simultaneously aiming to boost immune response and apoptosis.

To test expectations for the combination, the company is gearing up for a small phase I/II trial which its team hopes to begin around the middle of this year. The open-label study is designed to enroll 10 patients in each of two arms, one focused on the rare cancer cholangiocarcinoma and the second testing the regimen in triple-negative breast cancer. Blaustein said he expects the trial to take about 18 months to run. In addition to safety data, investigators will also be looking for additional tumor response using RECIST criteria, progression-free and overall survival.

If successful, the company will decide whether to seek a partner to proceed with its work, raise additional capital or potentially go public, Blaustein said. Initial plans also include running a registration-directed cholangiocarcinoma trial to support a 505(b)2 new drug application while also looking ahead to phase III studies in other indications or potentially a basket trial.

The company announced Thursday that the U.S. Patent and Trademark Office has awarded it U.S. Patent No. 10,195,219 for NED-170, a protection that expires no earlier than 2034. Blaustein said his team is also pursuing intellectual property protections in other major markets.

As a Delaware Public Benefit Corporation, the company is also aiming to make a positive impact on the world by providing an at-home, low-toxicity therapy. “That goes with our quality-of-life focus,” he said. “But it also means that the costs that you typically associate with cancer care, including managing intense side effects and special delivery at infusion centers, you should be able to avoid with NED-170, meaning it could be very effective for overall cancer treatment.”

Another part of the company’s long-term vision, Lambert said, is to provide cancer treatments to under- and unserved patients in the developing world. “Requiring neither sophisticated clinical infrastructure nor cold chain management, NED-170 is uniquely suited to make cancer treatment possible in the developing world where today most patients lack any treatment,” she said.

First-of-its-kind Composition Patent Awarded to NED Biosystems for 7-Agent Combination Cancer Therapeutic

By News

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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Contact:

Tara DiMilia
908-369-7168
Tara.dimilia@tmstrat.com