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REGENERON’S CASIRIVIMAB AND IMDEVIMAB ANTIBODY COCKTAIL FOR COVID-19 IS FIRST COMBINATION THERAPY TO RECEIVE FDA EMERGENCY USE AUTHORIZATION
https://investor.regeneron.com/news-releases/news-release-details/regenerons-regen-cov2-first-antibody-cocktail-covid-19-receive/
Do you think it’s time IPIX pivots away from Covid? Hurry Leo.
Oxford-AstraZeneca Covid vaccine shows an average 70% effectiveness in preventing the virus.
https://www.cnbc.com/2020/11/23/oxford-astrazeneca-covid-vaccine-is-70percent-effective-trial-shows-.html?__source=iosappshare%7Ccom.apple.UIKit.activity.Message
Do we still need Brilacidin for a Covid trial?
Hahahah.
It doesn’t matter if the vaccine will kill you. You will never make it out alive anyways. Baaahahahahahaha.
LMMFAO!!!! I am here for these posts. Love it.
Go IPIX.
The first #covid19 vaccine is headed to FDA for review, from Pfizer & BioNTech. Moderna expected to follow. Potential advisory committee meetings Dec 8, 9, 10 - with possible EUA soon after.
— Meg Tirrell (@megtirrell) November 20, 2020
Your vaccines could be traveling w your holiday gifts this Dec (PFE using FedEx, UPS) https://t.co/jXQLXzByQb
“#COVID19 UPDATE: We will submit a request today to the @US_FDA for Emergency Use Authorization (EUA) of our mRNA vaccine candidate with @BioNTech_Group.”
Pfizer
Breaking News
“The first #covid19 vaccine is headed to FDA for review, from Pfizer & BioNTech. Moderna expected to follow. Potential advisory committee meetings Dec 8, 9, 10 - with possible EUA soon after.
Your vaccines could be traveling w your holiday gifts this Dec (PFE using FedEx, UPS)”
Meg Tirrell twitter.
Hurry Leo. The vaccines are coming.
B-ABSSI.
Oxford-AstraZeneca Covid vaccine shows robust immune response among older adults
CNBC.
The vaccines just keep coming.
When will the IPIX B-Covid trial start?
Dr Menon has been terminated.
What is next!??
I wonder what Aspire is thinking right now.
“Pfizer & BioNTech final results on #covid19 vaccine phase 3: *95% effective*
170 cases in trial
-162 among placebo group
-8 on vaccine
10 severe cases
-9 on placebo
-1 on vaccine
94% efficacy for those 65+
Fatigue, headache after 2nd shot
Plan to submit to FDA within days”
Meg Tirrell twitter
I wish management would give a comprehensive shareholder update for IPIX.
.17’s almost here. Fill the gap
FORM 4 released today.
Good post. Eom.
IPIX $ .1807 down -6.1299%
1,569,710 Volume
Next PR—> Happy Thanksgiving
The pivot of the company strategy is coming....wait on it. We will soon learn of a Kevetrin refocus.
Brutal. When this hits 400 million it will be closer to another shareholder meeting and vote.
Dilution is concerning.
Common Stock Class A, 355,957,332
Innovation Pharmaceuticals Announces Overseas Regulatory Filing Submitted For COVID-19 Clinical Study
New in vitro data also demonstrates Brilacidin’s anti-SARS-CoV-2 potency is unlikely to be impacted by mutations in different strains of the virus
WAKEFIELD, MA – November 16, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today that an overseas Clinical Trial Application (CTA) has been submitted to the governing health agency, with a U.S. Investigational New Drug (IND) application also to be submitted this week to the FDA. Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.
The randomized, double-blind, placebo-controlled, multi-center study is anticipated to enroll 120 hospitalized patients with COVID-19. Sufficient Brilacidin intravenous (IV) drug product has been manufactured to complete this trial, and potentially future COVID-19 trials, providing the Company with added flexibility as it develops Brilacidin for the treatment of COVID-19.
In other important news, the Company has been informed by researchers at George Mason University’s Regional Biocontainment Laboratory that new in vitro testing showed Brilacidin exerted similarly potent inhibition against two strains of SARS-CoV-2, the novel coronavirus responsible for COVID-19. These data suggest Brilacidin would likely not be susceptible to resistance developing due to SARS-CoV-2 mutations, unlike many other vaccines and antivirals currently in use and in development.
“Due to the rapid worldwide spread of the COVID-19 pandemic, the need for novel therapeutics to help control this disease has only increased,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “While we all hope for the expedient arrival of safe and effective COVID-19 vaccines, which is one part of the solution, the need for better therapeutics to treat this disease, including its different strains, also remains essential. Vaccines and therapeutics both will play integral roles in addressing the current COVID-19 pandemic and possible future viral pandemics. We are excited by Brilacidin’s potential to treat SARS-CoV-2 and look forward to the start of our upcoming clinical trial, as we continue to advance Brilacidin in the global fight against COVID-19.”
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2. In a human lung cell line, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded on bioRxiv.org at the link below.
Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website (http://www.ipharminc.com), and at the following link:
https://ipixcovid19tracker.com/
Moderna vaccine 94.5% effective
Will IPIX pivot back to B-Acne?
Moderna Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001)
Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months
Where is the IPIX Phase 2 trial..?
IPIX hurry.
Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
November 16, 2020 at 6:56 AM EST
PDF Version
First interim analysis included 95 participants with confirmed cases of COVID-19
Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001)
Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 16, 2020-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).
A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).
The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived. These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis.
Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.
As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. They are an inspiration to us all. I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine. We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). Moderna also plans to submit applications for authorizations to global regulatory agencies.
Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations. By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021. On November 10, the American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code to report vaccination with mRNA-1273 (code: 91301). Moderna recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.
To learn more about Moderna’s work on mRNA-1273, visit www.modernatx.com/COVID19.
About the Phase 3 COVE Study
The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution of the COVE study.
The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at risk of severe COVID-19 disease and completed enrollment of 30,000 participants ages 18 and older in the U.S. on October 22, including those at high risk of the severe complications of COVID-19 disease. The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study. The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19. The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.
Some might get the vaccine before Brilacidin ever makes it into a Phase 2 trial for Covid-19.
10-Q where are you
Welcome back, I hope you have some inside info!! IPIX.
“Diffusion currently intends to participate in two virtual, biopharmaceutical and biotechnology industry conferences in mid-January 2021 – Biotech Showcase and the H.C. Wainwright 2021 Bioconnect Conference – and to provide its next update regarding its development program for TSC at that time.”
Due ..Monday November 16th
Happy Thanksgiving
It doesn’t feel like many investors here are concerned with dilution.
...the 10-Q is almost due.....
He had an idea of the timing of the release of the results but I don’t think he knew if the results were good or bad or in between. He bet on good.
*predetermined planned sale" from August.. bizarre but not nefarious.
Jim Cramer twitter
I would worry about IPIX stock price. Prizer is doing well.
45k @ .19 Bid
IPIX start the trial.
BREAKING: Eli Lilly’s Covid-19 antibody therapy gets emergency FDA clearance, widening access to a treatment that early data show can keep some patients out of hospital. The drug is called bamlanivimab.
"Lilly has a cocktail antibody that looks like the closest thing we have to a cure to this virus," says @ScottGottliebMD on #COVID19 vaccines. "Albeit it is the early data but it looked very effective. They're not going to have a lot of supply this year." pic.twitter.com/lHIp636AtB
— Squawk Box (@SquawkCNBC) November 10, 2020
"Lilly has a cocktail antibody that looks like the closest thing we have to a cure to this virus," says @ScottGottliebMD on #COVID19 vaccines. "Albeit it is the early data but it looked very effective. They're not going to have a lot of supply this year."
Squawk Box twitter.
IPIX is moving to slow
“"Last night we received emergency use authorization for the first drug ever to be designed for beating back COVID-19," says $LLY CEO David Ricks. "This will help reduce hospitalizations."”
Squawk Box CNBC twitter
Hurry IPIX.
Volume 4,148,301 shares traded
price down - 7.8341%
10-Q due a week from today....