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The FDA granted approval of Orencia to Bristol Myers Squibb.
Today, the U.S. Food and Drug Administration approved Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD)
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-prevent-graft-versus-host-disease
Nuvation Bio Receives FDA Fast Track Designation for NUV-422 for the Treatment of High-Grade Gliomas, Including Glioblastoma Multiforme
https://www.prnewswire.com/news-releases/nuvation-bio-receives-fda-fast-track-designation-for-nuv-422-for-the-treatment-of-high-grade-gliomas-including-glioblastoma-multiforme-301444794.html
CDMO IN WAY OVERSOLD TERRITORY NOW .... https://finance.yahoo.com/news/avid-bioservices-cdmo-loses-24-150003841.html
Vir Biotechnology (VIR) – Vir Biotechnology is rallying 4.3% in the premarket, putting it in position to rise for a fifth straight day. The drugmaker announced further data showing that its Covid-19 antibody therapy – developed in partnership with GlaxoSmithKline (GSK) – was effective against the omicron variant.
Eli Lilly (LLY) – The drugmaker raised its 2022 profit and revenue forecast ahead of today’s meeting with the investment community, noting that it is on track to meet its goal of delivering 20 new treatments in the 10-year period through 2023
On IPIX BRILICIDIN …
In collaboration with William DeGrado, a researcher at the University of California San Francisco and fellow recipient of the John Scott Award, is the discovery and development of Brilacidin, a synthetic molecule with antimicrobial properties. The drug recently completed a phase II clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19.
“Brilacidin is now among our BEST OPTIONS to fight antimicrobial resistant strains of bacterial infections, one of the scariest global threats,” explained Vincenzo Carnevale, professor of research at CST’s Institute for Computational Molecular Science (ICMS). He noted that the last truly novel class of antimicrobial molecules — NOT an optimization of preexisting molecules—was approved by the U.S. Food and Drug Administration in 1987.
“It is very humbling, even more so when one realizes who has been honored with this award in the past,” said Klein, who joined CST as Laura H. Carnell Professor of Science and ICMS director in 2009. “It’s especially pleasing to be recognized by the city of Philadelphia, a place where my research group has used the tools of high-performance computing to produce exciting predictions about the behavior of assemblies of all kinds of molecules under different conditions, such as gases, liquids, solids and glasses.”
“This recognition owes an enormous debt to the many dedicated members of my research group over the past 50 years or so,” said Klein, who, prior to his appointment as CST dean in 2013, spent 22 years on the faculty at the University of Pennsylvania, serving as director of the National Science Foundation-sponsored Laboratory for Research on the Structure of Matter from 1993 to 2009.
“I have been blessed to have had many very talented scientists as collaborators, and as a bonus, count them among my friends.”
Lancet study showing vaccines damage natural immunity ...
The point IS about vaccines destroying peoples natural immunity with every jab they take.
It’s thousands and hundreds of thousands of cases that are NOT covered in the media or aggregated somewhere because everyone is afraid to lose their jobs etc
https://americasfrontlinedoctors.org/news/post/vaccine-acquired-immune-deficiency-syndrome-vaids-we-should-anticipate-seeing-this-immune-erosion-more-widely/
https://goodsciencing.com/covid/71-athletes-suffer-cardiac-arrest-26-die-after-covid-shot/
It’s horrible that profits are placed above the health of the people!! BUT IT HAS ALWAYS BEEN THAT WAY!!
WHO says omicron variant could change the course of the Covid pandemic https://www.cnbc.com/2021/12/08/who-says-omicron-covid-variant-could-change-the-course-of-the-pandemic.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
The weaker the variants get the more likely they will eventually die out!!
Jasper Therapeutic JSPR .. is a clinical-stage researcher working on hematopoietic stem cell (HSC) therapies. These are the stem cells that give rise to mature human blood cells. Transplants of these stem cells are used to treat both immune system disorders and various cancers.
Jasper has one lead product, JSP191, a novel compound designed to assist and facilitate HSC transplant treatments. The drug candidate is a ‘targeted, humanized monoclonal antibody,’ under development as a clearing and conditioning agent for use prior to HSC transplant. JSP191 causes cell death in immature HSCs, leaving an open space in the bone marrow where transplanted stem cells can engraft and grow. JSP191 is designed to overcome limitations in current conditioning therapy, by acting as a non-toxic clearing agent, and removing one need for more dangerous chemotherapy.
Preclinical studies showed safe use of JSP191 in animal transplant models. The drug candidate is currently in two early stage human clinical trials. A Phase 1b trial for SCID (Severe combined immunodeficiency) is evaluating JSP191 as a sole conditioning agent. SCID is usually only treatable through HSC transplantation. A second trial, also at Phase 1b, is testing JSP191 in a combined therapy with another clearing agent, for use in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Jasper recently reported that the AML/MSD study is enrolling patients in expansion cohorts, and top-line interim data is expected in the first quarter of next year. And this week, the company announced that data on JSP191, showing its long-term benefits as a monotreatment clearing agent in the SCID study, will be presented at the 2021 American Society of Hematology (ASH) Annual Meeting, on December 12.
This is another company that has jumped on the SPAC bandwagon. Jasper merged with Amplitude Healthcare Acquisition Corporation, completing the transaction on September 24 of this year. The combination brought $100 million in gross proceeds to the biopharma, giving the company sufficient capital to operate through the middle of 2023.
Ken Griffin must really like this newly public stock. His firm bought 3,005,035 shares, taking a stake that’s now worth $24.3 million.
WOW HUGE NEWS ON BREAKTHROUGH CONTRACTIONS AND TRANSMISSIONS!!!!
https://www.sciencedirect.com/science/article/pii/S2666776221002581
Avid Bioservices Reports Financial Results for Second Quarter Ended October 31, 2021 and Recent Developments /// Dec. 07, 2021 4:05 PM ET
Avid Bioservices, Inc. (CDMO), CDMOP -- Recorded Second Quarter Revenue of $26.1 Million --
-- Initiated Strategic Expansion into Viral Vector Development and Manufacturing Services
for Cell and Gene Therapy --
-- Signed $36 Million in New Business Orders and Ended the Quarter with a Backlog of $120 Million --
-- Initiated Construction for Myford South Facility --
TUSTIN, Calif., Dec. 07, 2021 (GLOBE NEWSWIRE) -- Avid Bioservices (CDMO), Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced financial results for the second quarter of fiscal 2022, ended October 31, 2021.
Highlights Since July 31, 2021
“The second quarter was highly productive and a transformative time for Avid. The company’s financial status is increasingly strong, supported by year-over-year revenue growth, continued new business wins and a substantial backlog. Our business development team continues to perform, signing $36 million in new business during the quarter, and ending the period with a backlog of $120 million,” stated Nicholas Green, president and chief executive officer of Avid Bioservices.
“Leveraging the company’s strengths in quality manufacturing, regulatory compliance and customer engagement, we announced during the quarter our expansion into viral vector development and manufacturing for the cell and gene therapy market. We believe we are uniquely qualified to establish an industry-leading viral vector CDMO business, and we are actively building the team and facilities required to drive our success and expand our revenue generating capacity. Regarding mammalian cell operations, we have successfully
completed our annual maintenance shutdown, completed the build-out of our second downstream processing suite in our Myford North facility, and initiated construction for the new Myford South facility. Each of these steps is an essential part of Avid’s strategy to meet the growing demand of our expanding customer base, and we continue to execute this expansion on time and on budget.
“Also during the quarter, we were pleased to have our progress, as measured in the value created for shareholders, recognized as the company’s stock was named for the first time to the S&P SmallCap 600 Index. We are honored to join this index and believe that it speaks to the collective effort of everyone at Avid, while building greater visibility for the company with investors and the industry alike. We are pleased with our recent achievements, and believe that each of the accomplishments during the quarter will facilitate growth and move us toward our overarching goal of establishing Avid as a best-in-class CDMO focused on biologics.”
Financial Highlights and Guidance
The company is confirming revenue guidance for the full fiscal year 2022 of $115 million to $117 million.
Revenues for the second quarter of fiscal 2022 were $26.1 million, representing a 24% increase compared to $21.1 million recorded in the prior year period. The increase in revenues can primarily be attributed to fees received from a customer during the current-year period for unutilized reserved capacity combined with an increase in process development revenues primarily associated with services provided to new customers. For the first six months of fiscal 2022, revenues were $56.9 million, a 22% increase compared to $46.5 million in the prior year period. The increase in revenues for the first six months of fiscal 2022 can primarily be attributed to an increase in fees received from customers for unutilized reserved capacity combined with an increase in process development revenues primarily associated with services provided to new customers.
As of October 31, 2021, revenue backlog was $120 million, an increase of 79% compared to $67 million at the end of the same quarter last year. The company expects to recognize the majority of this backlog over the next twelve months.
Gross margin for the second quarter of fiscal 2022 was 35%, compared to a gross margin of 30% for the second quarter of fiscal 2021. Gross margin for the first six months of fiscal 2022 was 36% compared to 32% for the prior year period. The increases in gross margin for the quarter and the first six months were primarily from higher manufacturing and process development revenues during the periods.
Selling, general and administrative expenses (“SG&A”) for the second quarter of fiscal 2022 were $5 million, an increase of 21% compared to $4.2 million recorded for the second quarter of fiscal 2021. For the first six months of fiscal 2022, SG&A expenses were $9.5 million as compared to $8 million for the prior year period. The increase in SG&A during the quarter and six months was primarily due to increases in stock-based compensation, facility and related expenses and advertising costs, partially offset by a decrease in payroll and benefit related expenses.
For the second quarter of fiscal 2022, we recorded net income attributable to common stockholders of approximately $3.5 million or $0.06 per basic and diluted share, as compared to net income attributable to common stockholders of $0.8 million or $0.01 per basic and diluted share, for the second quarter of fiscal 2021. For the first six months of fiscal 2022, the company recorded a consolidated net income attributable to common stockholders of $9.8 million or $0.16 and $0.15 per basic and diluted share, respectively, compared to a consolidated net income attributable to common stockholders of $4.5 million or $0.08 per basic and diluted share, for the fiscal 2021 period.
Avid reported $163.7 million in cash and cash equivalents as of October 31, 2021 compared to $169.9 million as of the prior fiscal year ended April 30, 2021.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.
Recent Corporate Developments
The company announced the expansion of its CDMO service offerings into the rapidly growing cell and gene therapy market. This decision was driven by continued strong growth in this market combined with the CDMO industry’s overall lack of proven, high-quality CGMP manufacturing expertise and capacity for viral vectors. The company believes that the addition of viral vector services is a natural extension of its existing traditional biologics offering and provides another attractive avenue for growth.
The company appointed Matthew Kwietniak as chief commercial officer with responsibility for continuing the current growth trajectory of Avid’s CDMO business through the ongoing expansion of the company’s commercial and clinical client base. Mr. Kwietniak most recently served as head of drug product sales for the Americas within the pharma services group at Thermo Fisher Scientific. In this role, he led the North America team of sales leaders and business development executives for the company’s pharmaceutical development and commercial manufacturing business.
The company appointed Drew Brennan, an experienced CDMO business development executive, as general manager of viral vector technologies to lead the company’s expansion into the cell and gene therapy market. Mr. Brennan will be responsible for overseeing all business activities related to Avid’s expansion into this market. He most recently spent more than a decade in senior sales and operations positions at Novasep, a leading provider of viral vector development and manufacturing services to the cell and gene therapy market, as well as a provider of equipment and services in the fields of both small molecule production and purification for the life science and chemical industries.
The company appointed Elie G. Hanania, Ph.D., as vice president, process development, viral vector technologies. Dr. Hanania is a seasoned life science industry executive with more than 30 years of experience in the field of cell and gene therapy. Prior to joining Avid, Dr. Hanania most recently served as director, upstream process development for Fujifilm Diosynth Biotechnologies, where he led the process development team in charge of upstream production of all viral vectors and therapeutic proteins.
The company’s business development team signed multiple new orders during the second quarter, totaling approximately $36 million. These projects span all areas of the business, from process development to commercial manufacturing.
The two-part expansion of the Myford facility continues to progress according to plan. The first phase of the expansion, which was initiated during the second quarter of fiscal 2021, is mechanically complete, adding a second downstream processing suite to the company’s existing Myford North facility. The company expects to have this equipment validated and operational in the coming months. The second phase, which was initiated during the fourth quarter of fiscal 2021, is designed to further expand capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites within Myford South. During the second quarter of fiscal 2022, the new construction phase of this expansion was initiated.
Combined, the company estimates that the first and second phases of this expansion will result in a total revenue generating capacity of up to approximately $270 million for the mammalian cell business annually. It is anticipated that total annual revenue generating capacity will increase to approximately $350 million with the addition of the viral vector business. While the company believes that these expansions are critical to its ability to service the future needs of its customers, Avid presently has adequate capacity to accommodate current demand.
The company’s stock (NASDAQ:CDMO), was named to the S&P SmallCap 600 Index, effective, October 29, 2021.
Halozyme Therapeutics, Inc. (NASDAQ:HALO) ... Number of Hedge Fund Holders: 23
Halozyme Therapeutics, Inc. (NASDAQ:HALO) is a biopharma technology platform firm. The company has registered a 145% increase in royalties between June and September this year as the sales of Darzalex, an FDA-approved second-line therapy for multiple myeloma, skyrocket. The company is also on the top of a list of high growth stocks for 2022 released by Goldman Sachs, with consensus 3-year profit margin of 63% and consensus 3-year sales growth rate of 30%.
On December 2, investment advisory Canaccord maintained a Buy rating on Halozyme Therapeutics, Inc. (NASDAQ:HALO) stock and raised the price target to $48 from $27, noting that the firm had achieved “sustainable positive free cash flow from operations”.
At the end of the third quarter of 2021, 23 hedge funds in the database of Insider Monkey held stakes worth $179 million in Halozyme Therapeutics, Inc. (NASDAQ:HALO), up from 20 the preceding quarter worth $194 million.
In its Q4 2020 investor letter, Artisan Partners Limited Partnership, an asset management firm, highlighted a few stocks and Halozyme Therapeutics, Inc. (NASDAQ:HALO) was one of them. Here is what the fund said:
“Among our top Q4 individual contributors was Halozyme. Halozyme is a biotechnology firm that licenses to pharmaceuticals companies the use of its proprietary enzyme—its ENHANZE® platform—which aids delivery of biologics subcutaneously, as opposed to intravenously. The benefit is improved absorption and convenience to patients and physicians. The company has established partnerships with leading biopharmaceuticals companies—Roche, Johnson & Johnson (JNJ), Bristol-Myers Squibb and Argenx—and ENHANZE® is already used in four approved products. Halozyme’s partnership with JNJ/Genmab has recently borne fruit (higher royalty revenues) as Darzalex Faspro—a multiple myeloma drug which utilizes ENHANZE®—has experienced rapid uptake since receiving FDA approval earlier in 2020. Given additional runway for Faspro adoption and a solid pipeline of clinical trials either underway or set to commence over the near term, we remain confident in the profit cycle ahead.”
Avid Bioservices, Inc. (NASDAQ:CDMO) .... Number of Hedge Fund Holders: 21
Avid Bioservices, Inc. (NASDAQ:CDMO) is a biotech firm based in California. Goldman Sachs had predicted that the firm will grow sales at a rate of 32% in the next three years and expand profit margins by up to 24% during the period.
Avid Bioservices, Inc. (NASDAQ:CDMO) had announced back in October that it would be expanding the manufacturing and contract development service into the cell and gene therapy market through a new facility being built in Costa Mesa. The facility will cost the firm around $75 million and be operational within eighteen months.
At the end of the third quarter of 2021, 99 hedge funds in the database of Insider Monkey held stakes worth $195 million in Avid Bioservices, Inc. (NASDAQ:CDMO), the same as in the previous quarter worth $190 million.
Unlike expensive names like Apple Inc. (NASDAQ:AAPL), Amazon.com, Inc. (NASDAQ:AMZN), Microsoft Corporation (NASDAQ:MSFT), and Alphabet Inc. (NASDAQ:GOOG), Avid Bioservices is an affordable growth stock with long-term potential.
In its Q2 2021 investor letter, Laughing Water Capital LP, an asset management firm, highlighted a few stocks and Avid Bioservices, Inc. (NASDAQ:CDMO) was one of them. Here is what the fund said:
“Long-term holding CDMO, our large molecule contract drug manufacturing business, is continuing with its expansion plans in a recession proof industry where supply struggles to keep up with demand. The biggest risk here continues to be an explosion of supply, but CDMO’s long-term regulatory track record acts as a significant competitive advantage. Simply stated, upstarts can’t fake a history of successful operations, and customers want to see a history of successful operations when choosing their manufacturing partner. The balance sheet has been strengthened, the backlog has nearly doubled YoY, and management has indicated they are considering additional opportunities within the core business, as well as in adjacent businesses which would broaden the range of services that Avid provides. In sum, everything is going as planned as management executes, and future opportunity remains abundant.”
WAIT!!! WHAT????
https://www.facebook.com/kyle.cardinal.9216/videos/1056193241881297
Humanigen Announces Conference Call and Webcast to Discuss Lancet Respiratory Medicine Publications and Provide a Corporate Update …. December 01 2021 - 06:45PM
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced that it will host a conference call and webcast to discuss The Lancet Respiratory Medicine publications and provide a corporate update at 8am EST on December 2, 2021.
The peer-reviewed paper in The Lancet Respiratory Medicine is available via the follow link: https://doi.org/10.1016/S2213-2600(21)00494-X
The associated comment in The Lancet Respiratory Medicine is available via the following link: https://doi.org/10.1016/S2213-2600(21)00539-7
Details about how to access the conference call and webcast are provided below:
Webcast Link: https://event.on24.com/wcc/r/3546628/89B026371EFD46CB1F47B869C82E1992
The webcast will be available for up to one year under the Events & Presentations section of Humanigen’s Investor Relations website at https://ir.humanigen.com/English/events-and-presentations/
Dial by Phone:
United States (Toll Free): (844)-200-6205
All other locations: +1 (929)-526-1599 ... Access code: 259894
About Humanigen, Inc.
Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ?cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent cytokine storm in hospitalized patients with COVID-19. Humanigen has submitted lenzilumab to Medicines and Health Regulatory Agency in the United Kingdom for a rolling review towards potential Conditional Marketing Authorization. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.
Humanigen Resumes Clinical Trials for Antibody Treatment Targeting Cytokine Storm
https://www.benzinga.com/general/biotech/21/11/24323400/these-biotech-companies-are-attempting-to-use-improved-antibody-technology-in-the-fight-to-eradic#/.YaUWzGg4a9I.twitter
One of the major risk factors in COVID-19 patients is the threat of cytokine storm, an inflammatory condition that occurs when an overworked immune system starts attacking its own body as it tries to fight the virus.
Humanigen Inc. HGEN -1.64% has been working hard to develop an antibody treatment that could prevent cytokine storms from happening or minimize the damage when they do. It does this by targeting the cytokines themselves.
While the FDA rejected Humanigen’s request for emergency use authorization last month, it invited the company to apply again when it had more clinical data available. Despite the setback, ongoing trials continue to study the potential benefits of the antibody treatment, and the company is working to get authorization in the United Kingdom and elsewhere.
Interview: A MEDICAL DOCTOR BLOWS THE ROOF OFF OF EVERYTHING! Gregory Mannarino and Dr. Harding: A MOST HIGHLY ACCREDITED MD, PHD EXPLAINS THE CV19 SITUATION ....
New study: Brilacidin works against malaria. Out of 951 compounds tested in vitro and in vivo against malaria Brilacidin was ranked among the top 5 compounds.
PDF: Glideosomal GAP50 binders that inhibit invasion and restrict malaria parasite in vitro and in vivo
It also showed strong synergy with existing malaria drugs
The plant-based antiviral agent thapsigargin (TG), derived from a group of poisonous plants known as 'deadly carrots', appears to be effective against all variants of SARS-CoV-2 in the lab – and that includes the quick-spreading Delta variant.
Fruit of Thapsia villosa – deadly carrot plant.
A previous study published in February demonstrated that TG can be effective against a host of viruses. Now, this latest work by the same research team confirms that the antiviral also isn't being outflanked as SARS-CoV-2 evolves. With the emergence of new variants an ongoing possibility, it's intriguing to observe the continuous efficacy of TG.
In tests on cell cultures in the lab, doses of TG delivered either before infection or during active infection were shown to block and inhibit SARS-CoV-2 variants, triggering a broad and powerful protective response.
"A single pre-infection priming dose of TG effectively blocked all single-variant infections and EVERY combination (AB, AD, BD variants) of co-infection at greater than 95 percent relative to controls," write the researchers in their published paper.
As a host-centric antiviral, TG seems to break some of the mechanisms that viruses like SARS-CoV-2 hijack in host cells to replicate themselves and spread throughout the body.
"All available data (generated by us and others) as exemplified in influenza virus, respiratory syncytial virus, and coronaviruses, including SARS-CoV-2, indicate that TG does not prevent viral entry but rather triggers intracellular pathways to inhibit virus replication," the team writes.
The cell culture study also confirmed the higher replication rate and cell-to-cell transmission rate of the Delta variant: it was found to spread at four times the rate of the Alpha variant of coronavirus and at nine times the rate of the Beta variant.
What's more, Delta can accelerate the multiplication of other variants when co-infections occur. If someone succumbs to two variants of SARS-CoV-2 at the same time, then Delta acts as an extra boost for whatever other variant it's partnering up with.
"Our new study has given us better insights into the dominance of the Delta variant," says Kin-Chow Chang, a professor of Veterinary Molecular Medicine at the University of Nottingham in the UK.
"Even though we have shown that this variant is clearly the most infectious and promotes production of other variants in co-infections, we are pleased to have shown that TG is just as effective against all of them."
While vaccinations massively reduce the risk of getting infected with SARS-CoV-2, they don't reduce the risk entirely – and of course, there are substantial numbers of people who can't or won't agree to get a jab to protect themselves against the virus.
With that in mind, finding new treatments to manage COVID-19 will remain a high priority for controlling the ongoing global pandemic. It's not certain that TG would be as effective against future variants, but the signs are good.
After demonstrating its efficacy in the lab, the next step is actually developing treatments from TG, which would of course take time – as you might expect from an agent developed from a poisonous plant, it's going to take a significant amount of further research to turn it into something safe for humans.
Testing it against cell cultures and getting promising results is by no means even a guarantee that this antiviral would eventually pass a clinical trial, but it's a hugely exciting first step for sure.
"Together, these results point to the antiviral potential of TG as a post-exposure prophylactic and an active therapeutic agent," says Kin-Chow Chang.
The research has been published in Virulence.
Recent study has identified features linked to severe COVID-19.
High amounts of viral RNA (vRNA) in plasma, which has been associated with greater severity and worst outcome
Several cytokines were positively correlated with increased vRNA levels with the highest correlation with GM-CSF and IL-6
https://www.science.org/doi/10.1126/sciadv.abj5629
Belgium confirms case of new, heavily mutated Covid variant https://www.cnbc.com/2021/11/26/belgium-confirms-case-of-new-heavily-mutated-covid-variant.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
New study from Germany confirms higher vax coverage >>> Higher Excess Mortality<<<
The Harvard study showed vaccination makes things worse as far as cases goes. This new study from German shows that the more you vaccinate the more people get killed. Not a surprise to me.
Steve Kirsch
I just got a new study from a friend in Germany (Max Langen).
What this new German study shows is: The higher the vaccination rate, the higher the excess mortality.
I can’t say I’m surprised. These are the deadliest vaccine in human history by a factor of over 800. But it is always nice to get confirmation from multiple sources who have NO Conflicts.
The authors write (translated into English): “The correlation is + .31, is amazingly high and especially in an unexpected direction. Actually, it should be negative, so that one could say: The higher the vaccination rate, the lower the excess mortality. However, the opposite is the case and this urgently needs to be clarified. Excess mortality can be observed in all 16 countries”
In plain English: vaccination makes things worse, NOT better.
I wanted to share this study with you because it might be interesting for you and maybe you want to add it to your vaccine data.
Here is the link to the original study (it will download a word docx in German).
The original German study translated into English is available as a PDF here.
And here is a news report about this study: Bundesländer mit hoher Impfquote haben höchste Übersterblichkeit - reitschuster.de
The physicist Dr. Ute Bergner , who formerly belonged to the FDP parliamentary group in the Thuringian state parliament, has meanwhile switched to the “Citizens for Thuringia” party, held on November 17. A speech in front of the Thuringian state parliament in which she presented an analysis she had commissioned .
She commissioned two statisticians to investigate whether there was a connection between the vaccination rate and excess mortality in the 16 federal states.
Prof. Dr. Rolf Steyer and Dr. Gregor Kappler analyzed the period from week 36 to week 40.
The results are alarming. The summary of the analysis states: Excess mortality can be found in all 16 countries. The number of Covid deaths reported by the RKI in the period under review consistently only represents a relatively small part of the excess mortality and above all cannot explain the critical issue:
The higher the vaccination rate, the higher the Excess Mortality.
The most direct explanation is:
? Complete vaccination increases the likelihood of death.
https://stevekirsch.substack.com/p/new-study-from-germany-confirms-higher
Translational Oncology
Neoplasia Press “S2 Subunit of SARS-nCoV-2 Interacts with Tumor Suppressor Protein p53 and BRCA: an In Silico Study”
My thoughts: An especially interesting and IPIX-pertinent study which may underscore the need for Kevetrin in treating vaccine associated genetic damage to P53. This modeling study shows that the spike protein has a high affinity for the anti cancer proteins P53, BRCA1/2, binding to and inactivating these tumor suppressor genes.
Study to determine if the
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7324311/
Spike Protein effects on endothelial cells, I guess there is a lot of literature supporting that spike protein from real virus or from vaccines is highly inflammatory to endothelial cells:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091897/
is one of the first findings, but this article is already cited by many other interesting ones:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091897/citedby/
especially this one talking about spike proteins damaging brain endothelial cells:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8538996/
Bruce Patterson says long-Covid can result from persistent infection or negative effects of spike proteins in nonclassical monocytes, which interact with fractalkine on endothelial cells, and that long Covid is primarily a vasculopathy:
https://www.healthrising.org/blog/2021/07/21/patterson-cracked-long-covid/
https://www.medpagetoday.com/hematologyoncology/lungcancer/94772?th=1&xid=fb-md-cbtm-onc-plor&trw=no&scrf=1&adh=0&fbclid=IwAR3xM3oUgn3i63rh5gn9-xVyeppZAZc9-liSmpJWOlRoI8VTdYamkduSjb4_aem_AYIAi-YDRfTdIbItyxz2WHAB2mh5qcNyfR4_kEG9uy8aNbl41GJAJH2MOZQmpFc95DKL72BQiUj8VVXA-wvmEPHybeK9JxHUBi0Gq5Y0sNFoUw3w72t2xia02CP4KxCrhrk
Immunotherapy Combo Fails to Boost Survival in Limited-Disease SCLC
— No PFS or OS improvement with consolidation nivolumab-ipilimumab after standard treatment
https://nypost.com/2021/11/18/pfizer-us-gov-sign-5b-deal-for-possible-covid-treatment/
Pfizer asked the Food and Drug Administration on Tuesday to authorize emergency use of the experimental pill, which has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections.
The FDA is already reviewing a competing pill from Merck and will hold a public meeting on it later this month.
The price for Pfizer’s potential treatment amounts to about $529 per course. The US has already agreed to pay roughly $700 per course of Merck’s drug for about 3.1 million treatments
Innovation Pharmaceuticals Provides Brilacidin Program Update
WAKEFIELD, MA / November 18, 2021 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provided an update on clinical development plans for Brilacidin, the Company’s defensin-mimetic drug candidate being evaluated in clinical testing for multiple indications.
The Company remains optimistic about Brilacidin even though the Brilacidin Phase 2 COVID-19 clinical trial did not meet its primary endpoint. There is much still to learn from the trial, with full analysis of the data ongoing. Should deeper analysis yield promising data, the plan is to submit Brilacidin for inclusion in government-sponsored COVID-19 clinical trial platforms.
The Company is further encouraged by compassionate use of Brilacidin, which involved the treatment of extremely critically-ill patients who had exhausted all other therapeutic options. Compassionate use cases comprised Brilacidin being administered over a longer duration (up to 10 days) than in the Phase 2 COVID-19 trial (3 and 5 day dosing), with some patients also receiving higher and more frequent dosing (two doses every 24 hours). Patient data is planned to be compiled and evaluated, which may shed additional light on Brilacidin’s treatment potential in COVID-19.
More broadly, evaluation of Brilacidin’s broad-spectrum antiviral properties continues through collaborations with NIH scientists and academic researchers, and may introduce opportunities to study Brilacidin in neglected tropical diseases. The Company plans to announce new findings as they are reported to us.
The Company also has not lost sight of the fact that, while Brilacidin for COVID-19 moved to the forefront due to the global pandemic, the focus pre-COVID was on developing Brilacidin for Ulcerative Colitis and Oral Mucositis, both areas of large unmet need with substantial commercial opportunities.
New Inflammatory Bowel Disease (IBD) treatments are sought after given IBD’s complex pathogenesis and variability in patient response to any one drug. Oral delivery of Brilacidin to the gut is focused on developing an immediate release, multi-particulate capsule formulation in preparation for clinical testing of Brilacidin in Ulcerative Colitis. Research on Brilacidin stability in the GI tract and its interaction with the gut’s microbiome also is underway. Oral Mucositis (OM), a painful side-effect of chemoradiation, similarly represents a tremendous unmet need, as there are no approved drugs for prevention of severe OM. The OM competitive landscape has changed significantly, the result of recent later-stage clinical trial failures by Oragenics, Soligenix and Galera. Development of an optimized Brilacidin oral rinse formulation is in progress, with potential to progress to Phase 3 OM testing in 2022.
The Company believes strongly in Brilacidin’s treatment potential and its commercial prospects as a novel drug candidate proven to have antibiotic, anti-inflammatory and antiviral properties. We remain committed to the advancement of our pipeline on multiple fronts and will provide additional updates on pre-clinical and clinical developments as they occur.
We already knew GM-CSF inhibition was the key to stopping severe Covid and Covid death but it seems GM-CSF inhibition is also the key to preventing Long Covid as well.
Quote: While our data show that a broad range of cytokines remain deregulated
long after infection, IL-1ß, IL-6 and TNF-a represented a triad that was associated with
PASC. Blood profiling and single-cell data from early infection indicated that these
cytokines are induced in COVID-19 lung pro-inflammatory macrophages creating a
feedback loop that may trigger their long-term activation.
Quote: Conclusion: We provide evidence for a long-lasting cytokine signature potentially underlying many of the clinical symptoms of PASC that may be driven by macrophage primed during acute infection. This study demonstrates how the combination of digital epidemiology with selective biobanking can rapidly generate hints towards disease mechanisms.
Quote:Gene set analysis covering transcripts of response genes to these cytokines suggested that the pro-inflammatory macrophage not only produced this cytokine triad, but also responded to it
Quote: Mining of this single-cell sequencing dataset for cytokine response pathways revealed that such macrophages may not only be primed in the lung to produce the cytokine triad, but may also respond to it. The nature of response genes involved suggested chronic cytokine exposure. Based on this data, one may speculate that acute pro-inflammatory reprogramming of long-lived lung macrophages or their precursors may result in a vicious circle of IL-1ß, IL-6 and TNF-a production that self maintains this cellular compartment. This hypothesis may be supported by recent evidence showing epigenetic reprogramming of the monocyte/macrophage compartment in COVID-19 that results in pathological inflammasome engagement in these cells.
Quote: IL-1ß, IL-6 and TNF-a are cytokines which are mainly secreted by monocytes and macrophages upon inflammatory stimuli. The myeloid compartment and especially lung macrophages are strongly deregulated in COVID-19 patients as evidenced by previously published single cell analyzes on lung tissue, bronchoalveolar lavage fluid (BALF) and blood from patients with acute COVID-19 (20,25). To explore the potential cellular sources of IL-1ß, IL-6 and TNF-a in acute COVID-19, we analyzed previously published single-cell transcriptomics datasets from lung tissue, peripheral blood and BALF of patients in acute infection20-22. This analysis confirmed that this triad of cytokines was specifically expressed by the myeloid/macrophage compartment in the lungs (Figure 4B), but not or to a lesser extent by the myeloid/monocyte compartment in blood of patients with acute COVID-19 (Supplementary Figure 3). In a next step, we looked in-depth into macrophage subpopulations from bronchoalveolar fluid of patients with acute COVID-19. This analysis showed that the production of IL-1ß, TNF-a and to a lesser extent that of IL-6 was concentrated in the pro-inflammatory subset of lung macrophages.
Quote:
20. Zhao Y, Kilian C, Turner JE, et al. Clonal expansion and activation of tissue-resident memorylike Th17 cells expressing GM-CSF in the lungs of severe COVID-19 patients. Sci Immunol 202
https://www.facebook.com/100005282737366/videos/575068053794234/ ..... FROM ISRAEL, VERY IMPORTANT INFORMATION ...
An in-vitro study from Stockholm, Sweden found that the SARS-CoV-2 spike protein enters the cell nucleus and impairs DNA repair.
“Mechanistically we found that the spike protein localizes in the nucleus & inhibits DNA damage repair by impeding key DNA repair protein BRCA1 & 53BP1 recruitment to the damage site.”
The Covid-19 vaccines use mRNA to deliver an instruction to cells to produce this same spike protein.
If the spike protein enters the nucleus and inhibits DNA repair then this potentially increases the likelihood of cancer later developing.
Although, it's important to note that this is one in-vitro study and this has not been verified in humans, but this goes to show how risky it is to experiment on children with mRNA vaccines that we do not know the long-term safety implications of.
Study:
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8538446/
IMPACT Partnership @impactstemcell
We're thrilled to be working with @humanigen to deliver this trial of #lenzilumab for treating high-risk acute graft versus host disease following allogeneic stem cell transplantation, led by Professor Adrian Bloor of @TheChristieNHS #GvHD #ASCT @AnthonyNolan @NHSBT @LeukUK https://t.co/2R9sbNP7gK
— ASCENT - Accelerated Stem CEll traNsplant Trials (@crctuASCENTteam) November 15, 2021
Looks like IPIX has brought the OM part back in-house if they are ordering brilacidin for a P-III without having announced a licensing agreement. Locust Walk had been working on licensing the OM piece.
Quote: We have ordered Brilacidin API (active pharmaceutical ingredient) for delivery in January 2022, for use in our planned oral mucositis Phase 3 clinical study. There is no assurance the order will be manufactured or received timely. We have encountered prior delays and cost overruns in ordering the production of Brilacidin API.
Here's the IPIX PR from January 2020:
Innovation Pharmaceuticals Further Engages Locust Walk to Lead Out-Licensing Negotiations for Rights to Phase 3-Ready Oral Mucositis Drug Candidate
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