Biotech Stocks Snapshot: Fighting Deadly Bacteria and Coronavirus - (NASDAQ: CTXR) (NASDAQ: INO) (NASDAQ: NVAX), (NYSE: NNVC) (NASDAQ: MRNA)
Point Roberts, WA and Delta, BC - January 27, 2020 (Investorideas.com Newswire) a leading investor news resource covering pharmaceutical and biotechnology stocks releases a special report on the opportunity within the specialty drug segment of the sector to address viral outbreaks and bacterial resistance, featuring Citius Pharmaceuticals, Inc. (NASDAQ: CTXR).
Certain social and technological advancements as well as new and deadlier viral (coronavirus) and bacterial outbreaks are forcing innovative business approaches for this competitive sub-sector and specialty companies are answering the call!
Looking at the current headline attention of the coronavirus, Infectioncontroltoday.com also addressed the current crisis of antimicrobial resistance. "Now that the planet's attention is turned toward infectious disease thanks to the spotting of coronavirus in the United States, the World Health Organization (WHO) took the opportunity to point to another problem: the growing shortage of antibiotics available to fight all pathogens."
A WHO press release reported, "Tedros Adhanom Ghebreyesus, PhD, the director-general of WHO, said in the press release that "never has the threat of antimicrobial resistance been more immediate and the need for solutions more urgent. Numerous initiatives are underway to reduce resistance, but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines."
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products is in the midst of bringing their products to market having recently announced a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks.
The analysis was conducted by the Mino-Lok trial Data Monitoring Committee ("DMC"), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the pre-specified 40% enrollment required for the interim futility analysis in late September and, based on the analysis of the data and recommendations of the DMC, will proceed with the current trial as planned. Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020. The market potential for an effective antibiotic lock therapy is estimated at $750 million per year in the US and approximately $1.5 billion per year worldwide.
"We are extremely happy and proud that the first independent expert review of the patient data in our Mino-Lok trial concludes that our study is on track. Enrollment has continued since finalizing the 40% level futility report, and we have now reached the midpoint of our study. The DMC will evaluate clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus standard-of-care antibiotic locks," said Myron Holubiak, Chief Executive Officer of Citius. "We would also like to thank all of the patients, study investigators, and support personnel at the 32 clinical sites that are participating in our trial. Lastly, we also want to acknowledge the research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer Center in advancing this novel therapy."
Citius Pharmaceuticals, Inc. "Saving Lives of Hospital Patients with Catheters Infected by Deadly Bacteria" :
Citius was recently featured in a recent edition of BiotechStock Review, which discussed the Citius "Mino-Lok" treatment - "created to kill infected catheters, Mino-Lok was developed clinicians and technologists at the M.D. Anderson Cancer Center. The Mini-Lok technology while complex is easy for investors to understand. Their market is huge, estimated at $500 million to $1 billion annually and fairly-easy for investors to identify. The need for Mino-Lok is rather obvious as we will later explain. Also, studies to date have proven it to be much safer, more effective and less expensive than the alternatives and once again, easy for investors to grasp. Finally, the time (they're in Phase III), path and cost to approval are modest in comparison to biotech companies creating drugs from scratch. A ‘five-fecta' so to speak."
Continued: "Part of the Citius business strategy is to build a successful company by developing and commercializing cost-effective products that address unmet medical needs. It seeks to leverage the FDA's 505(b)(2) pathway for new drug approvals and bring products to market faster and with lower cost than other FDA new drug approval pathways (meaning creating drugs from scratch)."
Continued "The Mino-Lok solution was created to kill bacteria that cannot be eradicated using current methods, resulting in the catheter needing to be removed and replaced. A dangerous and complicated procedure, Mino-Lok is the first - and only - therapy under investigation that can be used to sterilize and save the infected catheter."
Continued "Mino-Lok is a patented solution that combines Minocycline, an antibiotic from the Tetracycline family with two other well-known ingredients. Minocycline was patented around the time we were born, as in 60 years ago - and prescribed 2 million times last year. It's now a generic costing about $12 a dose. The list of use includes things like Anthrax and even the Bubonic Plague. So were guessing the FDA will recognize both its usefulness and safety profile."
Fusionscienceacademy.com reports, "According to the Centers for Disease Control and Prevention (CDC), the leading federal agency focused on public health in the United States, over two million infections are caused by the antibiotic-resistant bacterial pathogens per year in the country, resulting in around 23,000 deaths."
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) has seen opportunity in a viral disaster, having recently announced the Coalition for Epidemic Preparedness Innovations (CEPI) has awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (2019-nCoV). This initial CEPI funding will support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine matched to the outbreak strain. CEPI previously awarded Inovio a grant of up to $56 million for the development of vaccines against Lassa fever and Middle East Respiratory Syndrome (MERS), also caused by a coronavirus.
Inovio's participation in this developing effort is based on the ideal suitability of its DNA medicine platform to rapidly develop a vaccine against an emerging virus with pandemic potential, proven vaccine development capabilities and a strong track record of rapidly generating promising countermeasures against previous pandemic threats. Inovio was the first to advance its vaccine (INO-4700) against MERS-CoV, a related coronavirus, into evaluation in humans. Inovio is currently preparing to initiate a Phase 2 vaccine trial for INO-4700 in the Middle East where most MERS viral outbreaks have occurred.
In a recently published paper in Lancet Infectious Diseases, Inovio's Phase 1 study of its MERS-CoV vaccine demonstrated it was well tolerated and furthermore induced high levels of antibody responses in roughly 95% of subjects, while also generating broad-based T cell responses in nearly 90% of study participants. Durable antibody responses to INO-4700 were also maintained through 60 weeks following dosing.
Richard Hatchett, CEPI's CEO said, "Given the rapid global spread of the 2019-nCoV virus the world needs to act quickly and in unity to tackle this disease. Our intention with this work is to leverage our work with Inovio on the MERS coronavirus and rapid response platform to speed up vaccine development."
Dr. J. Joseph Kim, Inovio's President and CEO said, "We're extremely honored to expand our partnership with CEPI to tackle this new threat to global public health. Our DNA medicine platform represents the best modern day approach to combatting emerging pandemics. We have already demonstrated positive clinical outcomes with our vaccine against MERS-CoV, another coronavirus. Importantly, following the Zika viral infection outbreak, Inovio and our partners developed a vaccine that went from bench to human testing in just seven months - the fastest vaccine development on record in recent decades. We believe we can further improve upon this accelerated timeline to meet the current challenge of the emerging coronavirus 2019-nCoV."
Talking about stocks moving on potential vaccines for the Coronavirus, Zacks Research reported "Obviously, shares of vaccine manufacturers have gained sharply on concerns over the new virus. Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company, saw its shares soar 72% on Jan 21. The company is primarily manufacturing two late-stage vaccines for the flu and various other infectious diseases. Another nano-biopharmaceutical company, NanoViricides, Inc. NNVC (NYSE: NNVC) witnessed its shares climb more than 100%. After all, the company is known for developing nano-medicines for viral diseases like swine and bird influenza."
Another specialty biotech company, Moderna, Inc. (NASDAQ: MRNA) is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Moderna just announced a new collaboration to develop an mRNA vaccine against the novel coronavirus (2019-nCoV).
From the news: Under the terms of the agreement, Moderna will manufacture an mRNA vaccine against 2019-nCoV, which will be funded by CEPI. The Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, collaborated with Moderna to design the vaccine. NIAID will conduct IND-enabling studies and a Phase 1 clinical study in the US.
From the news: Over the past four years Moderna has had six positive Phase 1 clinical readouts in its prophylactic vaccines modality and moved two additional programs into development. Moderna's technology platform, fully integrated manufacturing site and development experience, combined with a multi-year relationship with the NIH, including exploring ways to respond to public health threats, allows for the rapid identification and advancement of a vaccine candidate against 2019-nCoV.
With antibiotic-resistant bacteria on the rise and new strains of viruses surfacing, opportunity abounds for the smaller specialty drug maker that can provide solutions.
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