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Aircraft Wastewater Surveillance for Detection of SARS-CoV-2 Variants
As SARS-CoV-2 testing declines worldwide, surveillance of international travelers for SARS-CoV-2 enables detection of emerging variants and fills gaps in global genomic surveillance (1). Because SARS-CoV-2 can be detected in feces and urine of some infected persons (2), wastewater surveillance in airports and on aircraft has been proposed by the global public health community† as a low-cost mechanism to monitor SARS-CoV-2 variants entering the United States. Sampling wastewater directly from aircraft can be used to link SARS-CoV-2 lineage data with flight origin countries without active engagement of travelers (3).
During August 1–September 9, 2022, the biotech company Ginkgo Bioworks, in collaboration with CDC, evaluated the feasibility of SARS-CoV-2 variant detection in aircraft wastewater from incoming international flights. Aircraft wastewater samples were collected from selected flights from the United Kingdom, Netherlands, and France arriving at John F. Kennedy International Airport in New York City. Wastewater (approximately 0.25 gal [1 L]) was collected from each plane during normal maintenance using a device that attaches to the lavatory service panel port and the lavatory service truck hose.
After concentration with affinity-capture magnetic nanoparticles (4), wastewater samples were tested for SARS-CoV-2 by reverse transcription–polymerase chain reaction (RT-PCR).§ Samples with cycle thresholds <40 underwent whole genome sequencing using ARTIC (version 4.1; ARTIC Network) primers.¶ Multiple lineages within samples were identified using Freyja, a tool for deconvolution of complex samples.** Sequences meeting quality control criteria (e.g., >70% genome coverage)†† were assigned to sublineages using Pangolin (version 4.1.3)§§ and reported to the airline, public SARS-CoV-2 genomic data repositories, and the CDC National Wastewater Surveillance System. This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy.¶¶
During August 1–September 9, 2022, one sample was collected from each of 88 flights (Figure). Sample collection added approximately 3 minutes to normal aircraft maintenance times. Eighty samples were tested for SARS-CoV-2.*** Overall, 65 samples (81%) were positive; the percentage that were positive was similar among the three flight origin countries sampled (Netherlands: 81% [22 of 27]; France: 81% [22 of 27]; and United Kingdom: 81% [21 of 26]). Twenty-seven SARS-CoV-2 genomes were detected in 25 wastewater samples; sequencing quality control criteria were not met for the remaining 40 positive samples. All identified genomes were Omicron sublineages (United Kingdom: 12 BA.5 and one BA.4.6; France: eight BA.5; and Netherlands: five BA.5 and one BA.2.75). In each of 23 samples, single SARS-CoV-2 genomes were identified and assigned to the BA.5 (21), BA.4.6 (one), and BA.2.75 (one) sublineages. In each of two additional samples, two distinct SARS-CoV-2 genomes were identified and assigned to different BA.5 sublineages (Figure). The SARS-CoV-2 genomes identified in aircraft lavatory wastewater were consistent with Western European sequences uploaded to the Global Initiative on Sharing Avian Influenza Data (GISAID) at the time (approximately 90% BA.5).†††
This investigation demonstrated the feasibility of aircraft wastewater surveillance as a low-resource approach compared with individual testing to monitor SARS-CoV-2 variants without direct traveler involvement or disruption to airport operations. Limitations include dependence on lavatory use during the flight, which correlates with flight duration (5); inability to distinguish travelers with connecting flight itineraries, which lessens precision when ascertaining variant origin; and potential carryover of residual SARS-CoV-2 RNA between flights yielding viral detections unrelated to travelers on the flight. Stringent genome coverage thresholds might reduce the likelihood of carryover variant identification on subsequent flights.
In addition to routinely monitoring variants entering the United States, this modality can be surged based on global public health needs (e.g., outbreaks or mass gatherings in settings with limited SARS-CoV-2 variant surveillance). In combination with traveler-based surveillance (1), aircraft wastewater monitoring can provide a complementary early warning system for the detection of SARS-CoV-2 variants and other pathogens of public health concern.
https://www.investorvillage.com/smbd.asp?mb=20048&mn=22&pt=msg&mid=23927866
Ginkgo snags DARPA contract
DARPA RPM Aims to Speed-Up Production of On-Demand Protein-Based Therapeutics
Agency names performers for Reimagining Protein Manufacturing program
OUTREACH@DARPA.MIL
2/15/2023
Reimaging Protein Manufacturing (RPM)
Department of Defense (DoD) access to critical protein-based therapeutics is limited by the slow pace and substantial costs associated with current protein production methods. The goal of the DARPA Reimaging Protein Manufacturing (RPM) program is to develop tools for distributed, on-demand manufacturing of protein-based drugs, such as antibodies or vaccines, or the proteins required to make them. DARPA has selected performer teams that aim to demonstrate immediate production -- initiated within 24 hours -- of protein products with yields in excess of 500 units per week with correct protein modifications.
“The current process for producing protein-based therapeutics requires more than a year to establish, while still requiring purification and significant infrastructure,” noted RPM program manager, Dr. Michael Feasel. “RPM aims to initiate protein production within 24 hours, eliminating this long lead time. Fast, on-demand distributed manufacturing could make key proteins on a DoD-relevant timeline in operational environments.”
The 50-month RPM program will address two technical areas. Technical Area 1, Production Yield and Time, focuses on protein synthesis technologies for near-immediate manufacture of proteins at high yields. Technical Area 2, Post-Translational Modifications, seeks novel approaches to make necessary modifications to proteins after production, in a controlled manner to ensure that the final product is bioactive and of high quality.
DARPA selected the following research teams, which are pursuing a variety of approaches to meet the challenges of RPM: Ginkgo Bioworks, Inc., Leidos Inc., and Northwestern University.
“In biology, cellular protein production follows a central dogma: DNA makes RNA and RNA makes protein. Cells do this efficiently, but when you engineer cells to make a protein of your choice, the protein production process is much more time consuming,” Feasel said. “RPM aims to remove the cells from the process using cell-free protein synthesis technologies to decrease time to production, increase yield of production, and perform the correct protein modifications.”
DARPA will utilize independent validation and verification partners throughout the program to assess the function, stability, and composition of the proteins produced through a series of field-recognized analytical techniques.
https://www.darpa.mil/news-events/2023-02-15
Institutions added in 4th quarter
https://www.investorvillage.com/smbd.asp?mb=20048&mn=17&pt=msg&mid=23906518
National Security Commission on Emerging Biotechnology
Lawmakers round out membership of new emerging biotech commission
By Briana Reilly / December 30, 2022 at 4:05 PM
Legislative defense leaders today announced the full slate of members tapped to serve on a recently established commission tasked with making recommendations on the use of emerging biotechnology and biomanufacturing in the military.
Though the congressional defense committee’s top Democrats and Republicans had previously announced their joint selection of eight appointees back in March, it wasn’t until nine months later that the final four commissioner slots -- and the panel’s chair and vice chair -- were unveiled.
The 12-member body was created in the Fiscal Year 2022 National Defense Authorization Act, which called on the panel to review advances in emerging biotech, biomanufacturing and related areas while keeping in mind “the methods, means, and investments necessary to advance and secure” development of those technologies.
Helming the so-called National Security Commission on Emerging Biotechnology is Jason Kelly, the co-founder and CEO of synthetic biology company Ginkgo Bioworks, while Michelle Rozo will take the No. 2 role, according to a press release from the House and Senate Armed Services committees. Rozo, whose membership was first announced today, most recently served as the National Security Council’s director for technology and national security.
Under the FY-22 NDAA, eight of the commission’s members were to be selected by the heads of the armed services committees, while the remaining four positions were to be filled by the House speaker and minority leader, as well as the Senate majority and minority leaders. The four members newly announced today, including Rozo, are: Eric Schmidt, the former Google CEO and first chairman of the Defense Innovation Board; Angela Belcher, who helms MIT’s Department of Biological Engineering; and Dawn Meyerriecks, who most recently served as the deputy director of the CIA for science and technology.
The other members, all of whom were previously named, include four lawmakers: Reps. Stephanie Bice (R-OK) and Ro Khanna (D-CA), as well as Sens. Alex Padilla (D-CA) and Todd Young (R-IN). Also serving on the panel are Paul Arcangeli, an 18-year veteran House Armed Services Committee staffer who retired in spring 2022; Dov Zakheim, a former Defense Department chief financial officer and under secretary of defense; and Alexander Titus, a product strategy and operations lead at Google Research who previously served as the office of the under secretary of defense for research and development’s assistant director for biotechnology.
The law’s text directs the commission to consider a number of things while conducting that review, ranging from ways to grow the nation’s bioeconomy and commercial industry through the development of biotech-enabled capabilities to avenues to establish international standards for biotech, biomanufacturing and digital biosecurity.
Members are expected to submit their initial findings to the congressional defense committees within a year of the commission’s establishment, with a final report due within a two-year timeframe, per the language.
Will large government contracts ensue? Which additional countries?
CDC figuring out 'logistical and legal' aspects of testing airplane wastewater for coronavirus variants, source says
Posted: Jan 26, 2023 2:14 PM CST
(CNN) -- The US Centers for Disease Control and Prevention is ironing out the "logistical and legal" aspects of testing wastewater from airplanes for coronavirus variants as it continues to explore such an infectious disease monitoring program.
The agency is still "figuring out how to operationalize this program," a person close to CDC discussions said, adding that there are "logistical and legal" hurdles that need to be sorted out before the program "would be operational."
Some of the agency's partners tell CNN that they are poised to help roll out this potential next frontier in the nation's Covid-19 surveillance effort.
Monitoring sewage for traces of coronavirus variants is a "validated" scientific process -- no longer in its pilot phase -- and airplanes are a logical next step, said Matt McKnight, general manager at Boston-based synthetic biology company Ginkgo Bioworks. Its Concentric by Ginkgo biosecurity and public health unit has been chosen to partner in the CDC's traveler-based genomic surveillance program to detect Covid-19 and flu variants among international travelers.
For now, the use of testing services to collect and analyze airplane wastewater for variants "is an active conversation between CDC, the White House and the airlines," McKnight said.
But the process of testing airplane wastewater itself is "validated methodology, and it is a program that can be run actively," he added. "The system is ready to go."
How wastewater monitoring works
Testing aircraft wastewater involves collecting sewage from individual passenger-carrying commercial airplanes.
"You can pull it off the airplane in under two minutes, quickly put it into a lab network, which we manage all of that," McKnight said.
Once those wastewater samples arrive at a diagnostic lab for testing, scientists scan them for traces of known or unknown viruses, such as emerging variants of SARS-CoV-2, the coronavirus that causes Covid-19. When samples test positive for the virus, scientists conduct genome sequencing to identify exactly which variant that virus is.
"Usually, sequencing takes about five to seven days," said Casandra Philipson, a researcher and program lead for Ginkgo Bioworks. Then, scientists may analyze their results and submit their findings to the CDC.
"We can do analysis really quickly," Philipson said, such as in a few days. "And then return results immediately."
Both McKnight and Philipson said that airplane wastewater surveillance not only can help with detecting emerging coronavirus and influenza variants -- serving as a "radar system" -- it can alert vaccine makers to which variants our Covid-19 shots might need to target each year.
Advisers to the US Food and Drug Administration are scheduled to meet this week to discuss Covid-19 vaccines becoming annual immunizations, similar to the seasonal flu vaccine.
That process could include streamlining the vaccine composition, immunization schedules and periodic updates of vaccines, according to meeting documents posted Monday. The FDA has said it expects to assess circulating strains of the coronavirus at least annually and decide in June which strains to select for the fall season, similar to the process of updating annual flu vaccines.
"If you give Moderna or Pfizer information early enough, they can make a vaccine really quickly, which we couldn't do at the beginning of the pandemic," McKnight said. "The big lesson learned is that you can think about all of these variants of viruses circulating around the world, and it's kind of like anything else we would have a radar system for, to detect what is out there so you can get an early warning."
A 'valuable component'
A report released last week by the National Academies of Sciences, Engineering and Medicine describes wastewater surveillance as a "valuable component" of infectious disease management and notes that wastewater surveillance at major US airports and ports of entry could help identify initial cases for pathogens from other regions among international travelers. The report was produced at the request of the CDC.
https://www.investorvillage.com/uploads/87669/files/Wastewater-testing.pdf
Two largest Ginkgo shareholders further up their holdings
https://www.investorvillage.com/smbd.asp?mb=20048&mn=10&pt=msg&mid=23856055
Jason Kelly at World Economic Forum
https://www.onenewspage.com/video/20230120/15350947/Jason-Kelly-CEO-of-Ginkgo-Bioworks.htm
In on LEAPS today
Mostly Jan '25 but some on Jan. '24. Wish the founders would quit selling.
WORLD ECONOMIC FORUM ANNUAL MEETING
Biotech (R)evolution
January 18, 2023 16:15–17:00CET
As the biotech revolution continues to unfold, there is a landscape of potential for these technologies in medicine, food and materials.
What are the most investable technologies for industry deployment in the next decade?
Public Speakers
Magdalena Skipper
Editor-in-Chief, Nature
Jason Kelly
Chief Executive Officer, Ginkgo Bioworks
Joanna Shields
Chief Executive Officer, BenevolentAI
Mads Krogsgaard Thomsen
Chief Executive Officer, Novo Nordisk Foundation
K T Rama Rao
Minister of Information Technology, Industries, Municipal Administration and Urban Development, Government of Telangana
I'm guessing close to 49 days before meeting
"Im guessing once they call the meeting it will probably be within 30 days or so?"
https://www.investorvillage.com/smbd.asp?mb=2294&mn=9118&pt=msg&mid=23826697
Notice of Allowance received from USPTO
What is a Notice of Allowance?
A Notice of Allowance is a document sent to a patent applicant from the United States Patent and Trademark Office (USPTO) after a patent examiner has decided to issue the requested patent. The Notice of Allowance comes after the inventor has turned in a patent application and provided all information about the invention. This information includes the patent's description, design, drawings, or blueprints.
Since the Notice of Allowance shows the application is complete and meets all requirements, it is the final step in the long and complex patent application process. Your patent application has been fully reviewed and your invention has been given the green light for patenting. All that's left is to pay remaining fees and send any drawing corrections.
When a USPTO examiner feels an invention qualifies for a patent, he or she prepares a Notice of Allowance. When mailed to the inventor, the notice's mailing date is electronically recorded. If it will be published, the application requires both a publication and issue fee. Any fee requirements are listed in the Notice of Allowance. Applicants are also reminded to send an extra copy of the "Notice of Allowance and Fees Due" form when paying fees.
Once the issue fee has been paid, you'll be sent an Issue Notification letting you know your patent number and its anticipated issue date. Any extra patent applications based on the original "parent" application will need to be filed before the parent patent issue.
Eighteen months or more after the patent application's earliest filing date, the USPTO will publish the patent and it will be on public file.
https://www.investorvillage.com/uploads/87669/files/bioxcel-notice-USPTO.pdf
Igalmi now available!
https://www.igalmihcp.com/
EMA Paediatric Investigation Plan modification approved this week
That should grease skids for EMA marketing authorization application for Igalmi in adults.
https://www.investorvillage.com/uploads/87669/files/agenda-pdco-agenda-May-2022-meeting.pdf
Conference call transcript - pricing info
https://www.investorvillage.com/uploads/87669/files/BioXcel-CC-transcript-5-9-22.pdf
New journal publication
https://pubmed.ncbi.nlm.nih.gov/35477628/
Abstract
Episodes of acute agitation associated with psychiatric disorders are often managed in emergency and inpatient settings. These trials evaluated the efficacy, safety, and tolerability of dexmedetomidine orally dissolving film (ODF), an investigational treatment for acute agitation associated with schizophrenia (SERENITY I) or bipolar disorder (SERENITY II). Dexmedetomidine ODF is a highly selective agonist of alpha 2 adrenergic receptors that modulate norepinephrine release from the locus coeruleus. Two randomized, double-blind, placebo-controlled Phase 3 trials in 15 U.S. sites included participants aged 18 to 75 with acute agitation and a DSM-5 diagnosis of schizophrenia or schizoaffective disorder (Serenity I) or bipolar disorder I or II (Serenity II). Agitation was defined as ³14 on the Positive and Negative Syndrome Scale-Excited Component (PEC) at screening and baseline, and ³4 on at least 1 of the 5 PEC items (poor impulse control, tension, hostility, uncooperativeness, and excitement) at baseline. Randomization was 1:1:1 to dexmedetomidine ODF 120 or 180 mcg or matching placebo. All participants self-administered study drugs. For persistent or recurrent agitation after 2 hours, investigators could redose a half-dose. The primary endpoint was changed from baseline in PEC total at 2 hours. The secondary endpoint was the earliest time at which a statistically significant separation from placebo occurred.A total of 380 patients were randomized in each trial (N = 760). All doses of dexmedetomidine ODF met the primary endpoint of change from baseline in PEC at 2 hours vs placebo (P < .001). Statistically significant improvement in PEC occurred as early as 20 minutes with the 180 mcg dose in both trials. A second (half-strength) dose was given to 10 (4.0%) participants in the 180 mcg groups, 34 (13.3%) in the 120 mcg groups, and 58 (23.0%) in the placebo groups in Serenity 1 and Serenity 2. There were no drug-related serious or severe TEAEs in either trial. No participant was unarousable by the Agitation and Calmness Evaluation Scale. For dexmedetomidine 180 mcg, 120 mcg, and placebo, the incidence of TEAEs was 37.3%, 39.5%, and 15.1% in Serenity 1 and 35.7%, 34.9%, and 17.5% in Serenity 2. Somnolence was the most common TEAE in both trials (22% Serenity I; 21% Serenity 2). Of 110 somnolence reports, 75% were mild and 25% moderate. In 2 Phase 3 trials, the investigational treatment, dexmedetomidine ODF, effectively treated acute agitation associated with schizophrenia or bipolar disorder, with onset of action as early as 20 minutes at the 180 mcg dose. Both doses of dexmedetomidine ODF produced a calming effect without unarousable sedation. Mild or moderate somnolence was the most common AE. Dexmedetomidine ODF is a selective alpha-2 adrenergic receptor agonist that allows self-administration, making it a potential addition to noninvasive treatments for acute agitation associated with schizophrenia or bipolar disorder.
EMA meeting this week for Igalmi PIP.
Discussions on Modification of an Agreed Paediatric Investigation Plan
https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-agenda-19-22-april-2022-meeting_en.pdf
OnkosXcel Therapeutics subsidiary gives BioXcel more options
1) Sell OnkosXcel to suitor interested in cancer treatment franchise
2) Sell Igalmi franchise to suitor interested in schizophrenia/bi-polar/Alzheimer treatment
3) Sell OnkosXcel and Igalmi to different suitors
4) License Igalmi to Europe/Asian partners and focus on domestic market for both BXCL501 and BXCL701
-------------------------------------------------------------
From today's SEC filing
Notwithstanding the foregoing, the Credit Agreement permits OnkosXcel Therapeutics LLC (“OnkosXcel”), the Company’s subsidiary formed to develop BXCL701 and related assets (together with OnkosXcel Employee Holdings LLC and their respective subsidiaries, the “BXCL701 Subsidiaries”) to receive third-party investment or transfer all or substantially all of their assets to an unaffiliated third party, in each case subject to terms and conditions set forth in the Credit Agreement,
Psychiatrist. trashes the non-Igalmi anti-agitation pharmaceutical options
https://www.psychiatrictimes.com/view/treating-agitation-a-new-fda-approval
Dr Krystal is the Robert L. McNeil, Jr. professor of translational research; professor of psychiatry, neuroscience, and of psychology; and codirector at the Yale Center for Clinical Investigation. He also serves as chair and chief of psychiatry at Yale-New Haven Hospital. He is also the director of the NIAAA Center for the Translational Neuroscience of Alcoholism, and director of the clinical neuroscience division at the VA National Center for PTSD.
EMA met February regarding BioXcel Paediatric Investigation Plan
https://www.investorvillage.com/uploads/87669/files/agenda-pdco-agenda-22-25-february-2022-meeting_en.pdf
Therapeutic implications of EMA approval of icosapent-ethyl
https://www.investorvillage.com/uploads/87669/files/Icosapent-Europe.pdf
And dexmedetomidine already approved in EU (IV)
https://www.ema.europa.eu/en/medicines/human/EPAR/dexdor
Groundwork laid for IGALMI EMA submission
https://www.investorvillage.com/uploads/87669/files/EMA-decision-pediatric-investigation-plan.pdf
Igalmi world-wide supply contract for ten years inked
ARx has agreed to exclusively manufacture and supply the Company with all of the Company’s worldwide supply of thin film formulation of dexmedetomidine to be used for the commercial supply of IGALMI
https://www.investorvillage.com/uploads/87669/files/Igalmi-supply.pdf
Igalmi label is pretty broad
The Street was expecting it to be only approved for hospital use at best.
https://www.investorvillage.com/uploads/87669/files/Igalmi-label.pdf
But most CEOs/Directors don't decide ..,
... to put 30% of the company's shares (8.5 million shares), that they own personally, on the market.
SEC registration complete
Jeffries starts selling up to 8.5 million shares next week. But at what price?
Updated Cumulative Results Of Treatment With Mavacamten
https://www.acc.org/Latest-in-Cardiology/Articles/2022/04/02/13/22/Sun-945am-Treatment-Mavacamten-acc-2022
Certainly BMY never would've parted with China franchise.
LianBio might be better play for mavacamten
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8977&pt=msg&mid=23095516
I really have no idea.
Shouldn't surprise from investigators who couldn't meet deadline
unable to analyze the data in time ...
... to meet the deadline and have to post-pone release of the findings. We apologize for the delay.
We're praying for you Raf.
Good thing we have this forum
... to come to when we want the most accurate of information. And RT too.
Now I'm curious
Something's rotten in the state of Denmark
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The Danish Medicines Agency has decided that Vazkepa, soft capsules containing icosapentethyl in the strength of 998 mg, should not have a general subsidy or a general conditional subsidy.
We assess that Vazkepa does not meet the criteria for general subsidies, including general conditional subsidies.
General reimbursement
When medicine receives a general reimbursement, it means that all patients receive an automatic reimbursement for the medicine in question when the medicine is bought on prescription at the pharmacy. The subsidy is automatically deducted from the price at the dispatch at the pharmacy. See the limits for medicine reimbursement here: medicine reimbursement limits
General conditional reimbursement
If a medicine has a general conditional reimbursement, this means that only patients who meet certain special conditions can receive a reimbursement for the medicine. It is the attending physician who assesses whether a patient is covered by the special conditions. In these cases, the doctor must write "Supplement" on the prescription. The subsidy is automatically deducted from the price at the dispatch at the pharmacy. See the limits for medicine reimbursement here: medicine reimbursement limits
https://laegemiddelstyrelsen-dk.translate.goog/da/nyheder/2022/vazkepa-faar-ikke-generelt-eller-generelt-klausuleret-tilskud/?_x_tr_sl=da&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=sc
https://www.investorvillage.com/uploads/87669/files/Vazkepa-Danish-decision.pdf
How's yer Deutsch?
Lot's of info here to be perused.
https://www.g-ba.de/downloads/40-268-8269/2022-02-17_AM-RL-XII_Icosapent-Ethyl_D-726_TrG.pdf
Suitable comparator data from Amarin
evaluation
The Institute for Quality and Efficiency in Health Care (IQWiG) last checked in 2022 whether icosapent-ethyl has advantages or disadvantages for people with a high cardiovascular risk compared to standard therapies.
However, the manufacturer did not provide any suitable data to answer this question.
https://www.gesundheitsinformation.de/icosapent-ethyl-vazkepa-bei-hohem-herz-kreislauf-risiko.html
German 'added-benefit' decision
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8916&pt=msg&mid=22952845