NED-260: A Multi-pronged Approach for COVID-19

NED Biosystems™ is developing NED 260, an oral investigational combination product, for its potential to simultaneously broadly target at least four overlapping systemic processes found to be integral in both cancer and COVID-19 disease progression.

COVID-19 Attacks the Body Via Four Distinct Processes:

NED-260 is designed to have multiple agents redundantly target integral processes in different ways in order to achieve a synergistic therapeutic effect.

Summarized Rationale

Drugs being used experimentally to treat COVID-19 are narrowly focused and have not been shown to be effective, with few exceptions. Each individual component of NED-260 has been designed to inhibit the virus and/or potentiate antiviral responses in the body. This multi-pronged approach is intended to serve as a treatment and, potentially, as a prophylactic for COVID-19. The proposed therapeutic effect of the combination is greater than that of any of the individual agents alone; it is this synergy of the individual agents that is intended to provide a broad antiviral therapeutic effect against COVID-19.

The main aims of this novel approach are:

  • To prevent the virus from attaching via ACE2 receptor (prophylaxis).
  • To act early in the disease process before damage occurs to minimize/eliminate the advancement to severe disease.
  • To treat multiple processes simultaneously, which allows lower dosages of any one drug to improve tolerability and reduce the likelihood of adverse reactions. COVID-19 will likely not be susceptible to just one medication, but rather will require multiple medications that affect multiple processes, similar to the treatment of TB or HIV.
  • To complement or replace what is currently being used. COVID-19 is currently being treated with antivirals, interleukin antibodies, and IVIG, and these
Three projected scenarios:
1. Virus infects the cell: The activated SARS-CoV-2 S protein binds to the ACE2 receptor on the cell surface, facilitating infection of the cell.

1. Virus infects the cell:

The activated SARS-CoV-2 S protein binds to the ACE2 receptor on the cell surface, facilitating infection of the cell.

2. Virus is blocked:

NED-260 may promote the shedding of ACE2 receptors from the cell surface, which inhibits SARS-CoV-2 cellular entry.

3. Virus is contained:

In cells previously infected, NED-260 may attenuate several aspects of viral replication and promote the clearance of the infectious virus.

NED-260’s Mechanisms of Action Summarized:

  • Inhibit production of an array of interleukins, including IL-6
  • Elicit broad anti-inflammatory, antioxidant, and anti-thrombotic effects to suppress the cytokine storm that leads to ARDS
  • Proactively block viral entry into cells by promoting the shedding of the ACE2 receptor and inhibiting endocytosis
  • Inhibit viral polymerase and protease
  • Inhibit viral capsid formation

NED-170: Transforming Treatment for Cancer

NED Biosystems’ other drug in development, NED-170, is an investigational treatment for cancer. Cancer is a challenging therapeutic target, as cancer cells rapidly mutate, often metastasizing throughout the body. As a result, therapies based on a single target or biological process typically have a limited efficacy window. For example, the twenty-seven (27) solid tumor cancer therapies approved by the FDA in the last five (5) years have a median survival extension of only 5.1 months. And even with today’s “precision medicine” approach,  approximately 50% of all late-stage patients do not have the tumor defects addressed by the targeted “matched” drugs. High toxicity, along with low quality of life and limited survival, is still the experience for many advanced stage cancer patients today.

NED’s Solution: Treatment for “Unmatched” Patients

To date, no multi-target therapy approaches have been designed for “unmatched” patients. NED-170 is designed to fit this large, unmet advanced-stage patient need. NED Biosystems has developed NED-170, our lead therapeutic candidate, to be a first-in-class oral combination treatment. We believe multi-component therapies will transform advanced cancer (stages II-IV) into a chronic, manageable disease. We have observed the potential benefit and tolerability of the treatment in a pre-clinical study, as well as in observational patients. NED-170 holds the promise of not only long-term outcomes in numerous cancers, but to also radically improve the patient experience during treatment.

NED-170’s Biological Processes Multiple-Target Approach

NED selected well-studied pharmacologic agents to achieve broad spectrum coverage against major disease drivers in most cancers, regardless of genetic profile. NED-170 is designed to simultaneously target—and significantly affect— at least five processes characteristic of late-stage solid tumor cancers.

Continuous daily dosing of NED-170 has the potential to shut down cancer’s fuel supplies–angiogenesis (blood) and metabolism (glucose)–while simultaneously boosting the immune system, stimulating cancer cell death (apoptosis), and inhibiting cancer stem cells.

NED-170: Non-Clinical and Clinical Data

NED-170 has been tested in a syngeneic mouse model of metastatic colon cancer at Charles River Labs, a leading contract research laboratory. These studies show that in this model the combination of the NED-170 components together performs better than each individual component or specific subsets.

American Society of Clinical Oncology (ASCO) Breakthrough Therapy peer-reviewed poster

NED-170 has also been used by twenty-seven (27) observational cancer patients. These patients were not part of a controlled clinical trial; however, the observational data from these patients points to the potential use of NED-170 across a range of cancer types and stages of disease. Cancer types represented in these case studies include ovarian cancer, breast cancer, non-small cell lung cancer, leiomyosarcoma, head and neck cancer, gastric squamous, colon cancer, PEComa, prostate, and other cancer types.

Although NED Biosystems has not yet run a controlled clinical trial, to date, NED-170 appears to be well-tolerated. None of the twenty-seven patients reported a drug-related safety or tolerability issue leading to suspension or cessation of therapy. Further, none of these patients required the typical ancillary care (e.g., infusions, ER visits) that is necessary for most cancer patients when treated with chemotherapy or biologics. Given the observed safety, signals of drug activity, and improvements in quality of life, NED Biosystems believes there is an opportunity to make a significant impact on the treatment of cancer, and intends to initiate a controlled clinical trial.