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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

NED Biosystems Raises $2 Million in Series B Financing Round and Appoints New CEO

By | News

Company Announces New Members to Scientific Advisory Board Including Nobel Laureate Dudley Herschbach, Ph.D.

Cambridge, MA, August 1, 2018 – NED Biosystems, a clinical-stage biotech company developing a unique oral oncologic combination treatment that simultaneously attacks 5 cancer-driving processes, today announced it has raised over $2 million toward its Series B round of financing which includes funding from new and existing company investors. Significant investors in this round include Benjamin Griswold IV, Chairman of Brown Advisory, an independent Baltimore-based investment firm. The funds raised to date will allow the company to initiate a Phase 2 clinical trial by early 2019 of NED-170, an investigational, oral combination therapy dosed daily, for both rare and common cancers.
“NED-170’s multi-pathway, chronic treatment strategy represents an innovative approach to treating many cancers,” said Marsha A. Moses, Ph.D., the Julia Dyckman Andrus Professor at Harvard Medical School. “Based on the company’s provocative early data, NED-170 merits evaluation in the rigorous clinical program the company is initiating.”

The funding brings NED Biosystems closer to achieving key development, clinical, regulatory, and early commercialization milestones. The company is actively seeking to raise the additional funds necessary to close out the Series B round to help fulfill its mission of longer survival with high quality of life for late-stage cancer patients. “There’s a great need for therapies that not only extend life but also improve the quality of a patient’s life,” said Robert S. Kerbel, Ph.D., Professor and Senior Scientist at the University of Toronto Sunnybrook Health Sciences Centre and member of NED’s Scientific Advisory Board. “NED’s focus on patient quality of life as well as extended survival is a critical aspect of their enabling technology for treating cancer.”

Separately, NED Biosystems has announced that the Company appointed Marc Blaustein as Chief Executive Officer and has expanded its Scientific Advisory Board. Members of the Board include Nobel Laureate Dudley Herschbach, Ph.D.; Marsha Moses, Ph.D., the Julia Dyckman Andrus Professor at Harvard Medical School; Robert S. Kerbel, Ph.D., a leader in translational research of metronomic chemotherapy, immunotherapy and antiangiogenic therapy; Judith Karp, M.D., an expert in experimental therapeutics for acute leukemias; Geoffrey Ling, M.D., Ph.D., Col. (Ret), founding Director of DARPA Biotechnologies Office; and NED’s Chief Medical Officer Edward Garmey, M.D., an expert in oncology drug development.

“Our ability to attract these talented and accomplished professionals speaks to the potential clinical and commercial value of NED-170,” said Rebecca Lambert, Founder and Chairman of the Board of NED Biosystems. “Marc, who has already made significant contributions to our company since his appointment, and our expanding Scientific Advisory Board are tremendous assets to support the company’s continued growth and the development of NED-170, our lead combination therapy.”

Mr. Blaustein, CFA, has been serving as CEO of NED Biosystems since November 2017. Prior to joining the Company, he was co-founder and CEO of Akashi Therapeutics, where he led the company through construction of a multi-product portfolio, generation of clinical data, and establishment of a strategic pharmaceutical partnership, and previously held leadership roles at Dyax Corp. (now Shire), Alkermes, Inc. and at the genomics business unit at Genetics Institute (now Pfizer).

Mr. Blaustein has more than 20 years of biopharma executive leadership experience and received a B.A. in Biology from the University of Pennsylvania and a Master’s Degree in Public Policy and Management from Harvard University.

NED-170 is a 7-component regimen of oral compounds to target five 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 outcomes and patient quality of life. The 28 new solid tumor oncology drugs in the past 5 years have provided an average survival advantage of only 5.4 months¹, often with serious side effects.

Because NED-170 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 patients. Given the extensive history of the individual NED-170 components and the research and data on the combination therapy generated by NED Biosystems, the FDA has agreed to an abbreviated regulatory approval path known as 505(b)2 for NED-170.

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 attacks 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, effective treatment solutions to patients not only here in the US, but also in the developing world. Visit nedbiosystems.com.

# # #

Contact:

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

 

¹U.S. Food & Drug Administration. 2017 New Drug Therapy Approvals: Advancing Health Through Innovation. January 2018.