Palm Beach, FL – November 7, 2019 – Researchers in nanomedicine are making some big-time advances according to reports in various industry journals. Nanomedicine, a relatively new but rapidly developing branch of nanotechnology (the study, development and application of materials between 1 and 100 nanometers in size) which is devoted to the diagnosis and treatment of various diseases. To put this into perspective, a nanometer is exactly one-billionth of a meter. A meter is 3.28 feet, or 39.37 inches, so a nanometer is 0.0000003937 of an inch. That means there are 25,400,000 nanometers in an inch… a sheet of paper is about 100,000 nanometers thick and a typical human hair is roughly 80,000 nanometers wide. A strand of human DNA, conversely, is around 2.5 nanometers in diameter. It’s in these small places that researchers hope to take big steps in targeting various diseases. One researcher stated: “Technology, in the broadest sense, has evolved to the point where we can look at things closer and closer and effectively work with smaller and smaller amounts of stuff,” said Hall, an assistant professor of biomedical engineering at Wake Forest School of Medicine, which is part of Wake Forest Baptist Medical Center. Ultimately, for cancer and other diseases that we worry about, the root causes are molecules. People may talk about malfunctioning cells, but what happens inside those cells to make them dangerous happens at the molecular level. That’s at the nanoscale, and that’s why we’re working there.” Active biotech and big pharma stocks in the market today include: Constellation Pharmaceuticals, Inc. (NASDAQ: CNST), NanoViricides, Inc. (NYSE: NNVC), Agenus Inc. (NASDAQ: AGEN), GlaxoSmithKline plc (NYSE: GSK), Celgene Corporation (NASDAQ: CELG).
According to Grand View Research, the global nanomedicine market is anticipated to reach USD 350.8 billion by 2025. The report continued: “Development of novel nanotechnology-based drugs and therapies is driven by the need to develop therapies that have fewer side effects and that are more cost-effective than traditional therapies… Application of nanotechnology-based contrast reagents for diagnosis and monitoring of the effects of drugs on an unprecedented short timescale is also attributive driven growth in the coming years.”
One of the more active companies in the industry includes NanoViricides, Inc. (NYSE American: NNVC). NanoViricides, a global leader in nanomedicines against viruses, announced this week that it has completed the process of licensing the VZV (shingles and chickenpox virus) field for drug development and commercialization from TheraCour Pharma, Inc. (“TheraCour”). The Company executed a license agreement for VZV with TheraCour Pharma, Inc. on November 3rd, 2019 (the “Agreement”).
Under this Agreement, NanoViricides has obtained a world-wide, exclusive, sub-licensable, license to use, promote, offer for sale, import, export, sell and distribute drugs that treat Varicella Zoster Virus infections, using TheraCour’s proprietary as well as patented technology and intellectual property. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed.
NanoViricides will not pay any upfront licensing fee under the Agreement. The Company will pay a first milestone payment to TheraCour upon the grant of approval of an Investigational New Drug application (IND), of 75,000 shares of the Company’s Series A Preferred Stock. A second milestone payment will be due upon completion of Phase I human clinical trials in the cash amount of $1.5 million. A third milestone payment will be payable to TheraCour upon completion of Phase II human clinical trials in the cash amount of $2.5 million, and a fourth milestone payment will be due upon completion of Phase III human clinical trials in the cash amount of $5 million. However, NanoViricides shall have no obligation to continue clinical trials beyond Phase I.
Upon commercialization, NanoViricides will pay royalties of 15% of Net Sales to TheraCour, as defined in the Agreement. The Agreement contemplates that the parties will enter into a separate Manufacturing and Supply Agreement for the commercial manufacture and supply of the drug products if and when NanoViricides intends to engage into commercialization of the drugs. The Agreement provides that the Manufacturing and Supply agreement would be on customary and reasonable terms, on a cost-plus basis, using a market rate based on then-current industry standards, and include customary backup manufacturing rights.
“We have been working diligently on completing this license agreement and have taken the time to document the licensing arrangement in a professional and deliberative process, considering the related party nature of this transaction,” said Mr. Stanley Glick, Chairman of the Audit Committee, adding, “We believe that this license agreement is fair to the shareholders of NanoViricides, Inc.” Read the full press release here.
In other biotech news in the markets this week:
Constellation Pharmaceuticals, Inc. (NASDAQ: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, recently announced its third-quarter and nine-month 2019 financial results.
“Our clinical programs continued to advance during the third quarter,” said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. “We are particularly pleased with new MANIFEST data on CPI-0610 in myelofibrosis published today in abstracts by the American Society of Hematology (ASH). The data in the abstracts show signs of encouraging clinical activity in both JAK-inhibitor-naïve patients and ruxolitinib-refractory or -intolerant patients. Based on this activity, we have expanded the MANIFEST trial in first-line patients and in second-line transfusion-dependent patients to look more closely at these signals of activity. We plan to provide a further update on CPI-0610 in oral and poster presentations and at an investor event at the ASH meeting on December 9. Additionally, we have begun planning for a randomized Phase 3 clinical trial for CPI-0610 in JAK-inhibitor-naïve patients that we expect to begin in 2020.”
Agenus Inc. (NASDAQ: AGEN) an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1, and cancer vaccines provided a corporate update and reported financial results for the third quarter of 2019.
“We have made solid progress this year,” said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. “We expect clinical readouts from six separate antibody programs in 2020 as our robust pace continues. We expect to commence combo trials of our NexGen CTLA-4 with our own PD-1 this month. 2020 is expected to be an important year of data generation, substantial milestone payments and prudent collaborations for Agenus. We look forward to discussing these developments in more detail during our call and at our R&D day on November 15th.”
GlaxoSmithKline plc (NYSE: GSK) recently announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: A deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.
Patient selection is based on an FDA-approved companion diagnostic for Zejula.
This represents the first time a PARP inhibitor has been approved for use in patients beyond those with a BRCA-positive (BRCA+) mutation as monotherapy in the late-line treatment setting. Now women with late-line, HRD-positive (HRD+) disease are eligible to be treated with a PARP inhibitor.
Celgene Corporation (NASDAQ: CELG) recently announced data from nearly 70 Company-sponsored, global alliance and investigator-initiated clinical studies evaluating Celgene’s investigational and approved therapies will be presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, in Orlando, Fla.
“Celgene has a deep and ongoing commitment to innovative research and development in treatments for serious blood disorders, with the potential to transform patient outcomes,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “We look forward to ASH as an opportunity to highlight our commitment and leadership in the research and development of novel therapies for the treatment of blood cancers through new insights in both CD19 and BCMA targeted cell therapies and important progress in our myeloid pipeline.”
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