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NED Biosystems Gains Patent for Unique Combination Therapy

By News, Press

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

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:

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

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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Tara DiMilia