LAS VEGAS, NV / ACCESSWIRE / April 4, 2016 / The granting of a patent is one of the most essential steps any growing biotech must achieve, as without a patent the work is largely not defendable from infringement. Given biotech’s capital-intensive nature, patents function as a key part of ensuring potential returns for investors. Hence why patent news is received extremely favorably by investors and usually sparks major price appreciation.
That is why we believe it is imperative investors look closely at Endonovo Therapeutics, Inc. (OTCQB:ENDV). Endonovo, an innovative biotechnology company developing bioelectronics-based products and therapies for regenerative medicine, received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application entitled "Biological Molecules Produced by Electromagnetically Stimulating Living Mammalian Cells."
Why is this news so important? When the USPTO intends to issue a patent, it sends the applicant a Notice of Allowance, which ENDV just received. The final steps before patent issuance are essentially a formality (the applicant pays issue fees and submits any final drawings). So, essentially, ENDV has received patent approval. This is a MAJOR milestone adding another exploratory avenue for the Company as it continues pursuing potential revenue producing applications of its portfolio of intellectual property.
The current patent application covers the production of biological molecules, including growth factors and cytokines in adult stem cells using the Company's proprietary technologies.
The Company stated in its press release that some of the technology's applications include the production of fully human proteins for research purposes or the potential production of next-generation biologics. Conventional methods used to produce therapeutic proteins such as biological drugs include recombinant techniques used with bacteria, eukaryotic or Chinese Hamster Ovary (CHO) cells.
Proteins are the most complex molecules in nature. Therefore, biologics are the most difficult drugs to produce. Biologically active proteins, such as biological drugs, can have additional modifications, such as glycosylation - where sugar molecules are attached at various points. Other complexities include the folding of the proteins' amino acid chains into highly organized structures.
While the use of bacteria, eukaryotic or non-human cell lines are favored for their ability to produce large quantities of recombinant proteins, there are key differences in the glycosylation machinery of lower organisms, non-human eukaryotic or mammalian cells, and human cells. Native human proteins feature correct glycosylation, which is important in their activity, stability and half-life. Cytokines are glycoproteins of the immune system that act as cellular signaling molecules. Cytokines are widely used in research, diagnostics and therapeutics, and there exists an increasing demand for high quality and reasonably priced human cytokines for stem cell and clinical research.
According to Thomson Reuters, the biologics sector is set for an unprecedented level of activity as U.S. companies have rapidly increased biologics development during the past five years. The market for next-generation biologics is estimated to reach a value of $30 billion by 2024, according to Visiongain. These next-generation biologics will seek to address shortcomings in current therapies, including inconvenient dosing and potential side-effects.
ENDV's bioelectronic devices are based on the Time-Varying Electromagnetic Field (TVEMF) technology originally developed at NASA.
Their bioelectronics technology uses electromagnetic pulses to deliver electrical stimulation to the nervous system and cells in order to produce a biological effect. ENDV is currently developing two platforms based on bioelectronics, Cytotronics and Immunotronics.
ENDV's Cytotronics™ platform uses bioelectronics to expand and enhance the biological properties of cells for the creation of next-generation cell therapies and biologics. This platform covers a range of products from the production of biomolecules to the expansion of cord blood stem cells. The company is currently developing a cell therapy for the treatment of Graft-Versus-Host Disease (GvHD) and has recently retained Holland & Knight to file for Orphan Drug Designation.
ENDV's Immunotronics™ platform is a non-invasive, non-implantable bioelectronic device for preventing and treating vital organ failure through the reduction of inflammation and cell death, and the promotion of regeneration. It has been identified in pre-clinical studies to be an innovative approach for treating acute inflammation.
Genocea Biosciences, Inc. (GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, just announced positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial. This news has created major interest in the stock as it began to climb Thursday on the heels of this news.
Global Blood Therapeutics, Inc. (GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, recently reported business progress and financial results for the fourth quarter and year ended December 31, 2015. The company has been on a bit of a run since announcing the results earlier this week.
Zafgen, Inc. (ZFGN), a biopharmaceutical company creating treatments for patients affected by obesity and complex metabolic disorders, announced that new scientific data from the bestPWS ZAF-311 study, a pivotal, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of beloranib, a MetAP2 inhibitor, in patients with Prader-Willi syndrome (PWS) during a six-month randomized treatment period, they will be presenting at ENDO 2016 beginning Friday, the Endocrine Society's 98th Annual Meeting & Expo taking place in Boston from April 1-4.
Raptor Pharmaceutical Corp. (RPTP) announced last week that Health Canada has accepted for review its New Drug Submission (NDS) for PROCYSBI® (cysteamine bitartrate) delayed-release capsules for the treatment of nephropathic cystinosis (NC), with Priority Review status. Priority Review provides for a shortened review process of 180 days compared to a standard 300 days. Raptor estimates, based on information provided by physicians, that there are approximately 100 individuals affected by nephropathic cystinosis in Canada. PROCYSBI, a cystine depleting agent, is approved in the U.S. for the treatment of NC in adults and children ages two years and older and in all patients with NC in Europe. The stock has appreciated in price quite a bit since the announcement, however, is now stuck in a trading channel which could breakout higher. Investors should monitor this closely.
Array BioPharma Inc. (NASDAQ:ARRY) and Asahi Kasei Pharma Corporation announced a strategic collaboration to develop and commercialize select Tropomyosin receptor kinase A (TrkA) inhibitors, including Array-invented ARRY-954, for pain, inflammation and other non-cancer indications. Array retains the right for all compounds for all indications outside of Asia. Within Asia, Array retains the right to cancer indications for all compounds, excluding those compounds being developed by Asahi Kasei Pharma, including ARRY-954. Array will receive $12 million in up-front payment and up to $64 million in additional development and commercialization milestones, including up to double-digit royalties on future sales. This is another positive update for a company that has seen investor interest spike recently.
Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. ACR Communication, LLC. which owns Microcapspeculators.com, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. ACR Communication, LLC., which owns Microcapspeculators.com, may from time to time have a position in the securities mentioned herein and may increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice. ACR Communication LLC., which owns Microcapspeculators.com, may be compensated for its services in the form of cash-based compensation or in equity in the companies it writes about, or a combination of the two. ACR Communication, LLC has been compensated a total of $24,000 cash by a non-affiliate third party of ENDV.
SOURCE: ACR Communication, LLC