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Yes. This vaccine produces from the first dose, high levels of dimeric immunoglobulins A (with two dimers) in the nasal and lung mucosa that are up to 15 times more effective and neutralize COVID-19 by preventing the virus from entering the epithelial cells of the respiratory system. It also produces blood immune response T cells, B cells, blood immunoglobulins A, etc.
https://stm.sciencemag.org/content/13/577/eabf1555.full
Dimeric RBD IgA are the most effective neutralizing antibodies in the respiratory mucosa that prevent against covid 19 infection in addition to IgA against S and N proteins and it is what is expected from this vaccine, Phase 2/3 will give valuable information on serum immunity and prophylaxis.
ADXS-HOT , "with immune response data anticipated in early 2020".
Never disappoints, always lie after lie.
Brivaness Safety Data versus Approved Therapies
FDA Briefing Document
Cardiovascular and Renal Drugs
Advisory Committee (CRDAC)
Meeting
December 10, 2019
Data for ibutilide PCV and ECV, two currently
available treatments for the rapid conversion of atrial fibrillation.
Ibutilide labeling (Corvert®),
FDA’s Adverse Events Reporting System (FAERS), and the medical literature were reviewed Postmarketing Data
FDA Adverse Event Reporting System Data
The FDA Adverse Event Reporting System (FAERS) database was searched through September5, 2019 for all reports of ibutilide and outcome of death 16 reports identified, two reports were excluded based on unlikely casual association of death related to ibutilide. Davarashvili et al.42 in 2018 from a retrospective observational study, reported 9 deaths.
Electrical Cardioversion Literature Review 33,177 total ECV procedures in 58 publications noted above, an additional 32deaths. Guédon-Moreau et al.56 in 2007, reported
among 684 ECV procedures that there were 3 deaths.
Hellman et al.60 in 2018, reported from 4,356 ECV procedures that there were 4 deaths. In a 2015 study of 1,017 ECV procedures,
Steinberg et al.81 reported 14 deaths
Gallagher et al.51 in 2008, reported that among 2,522 ECV procedures, there were 9 unexpected deaths
Vernakalant IV (Brinavess®) Of the 2,015 patients screened
and enrolled, No fatal events were reported in SPECTRUM.
Conversion ratios are higher for Brivaness and shorter hospitalization hours.
I see feasible the approval of Brinavess® by the 24th.
December 12, 2007
https://www.medscape.com/viewarticle/789813
I hope will shortly be approved by the FDA, despite ADCOMM vote,
https://www.aerjournal.com/articles/introducing-vernakalant
17142000 cashless warrants in August today $ 13 million.
ii) the conversion of shares of Series A convertible preferred stock into shares of common stock that will occur following stockholder approval of a reverse stock split the company expects to conduct, but before giving effect to such reverse stock split, there are expected to be 415,786,654 total shares of common stock outstanding and warrants to purchase 444,088,071 total shares of common stock outstanding.
75+303+30(7'5%Gilead)=408million shares + 312(warrants A) +103(Warrants B) +30(warrants Gilead) =850million shares fully diluted. R/S 100/1
Nailed it.
Thanks
No cash, no deal, pump and dump.
My hopes were dashed.
COMPOSITIONS AND METHODS FOR EVALUATING POTENCY OF LISTERIA-BASED IMMUNOTHERAPEUTICS
We claim
1. A method of assessing potency of a Listeria- based immunotherapeutic, comprising:
(a) infecting antigen presenting cells (APCs) with the recombinant Listeria- based immunotherapeutic to provide infected APCs, wherein the recombinant Listeria- based immunotherapeutic expresses a disease-associated antigenic peptide;
(b) co-culturing the infected APCs with a population of T cells enriched for T cells having reactivity to the disease-associated antigenic peptide; and
(c) determining a cytokine production profile of the T cells, wherein an increase in the cytokine production indicates expression of the disease-associated antigenic peptide in the infected APCs.
2. The method of claim 1, wherein the APCs are THP-l cells.
3. The method of any preceding claim, wherein step (a) comprises infecting the APCs with the recombinant Listeria- based immunotherapeutic at a multiplicity of infection (MOI) of 1-200.
4. The method of claim 3, wherein the APCs are infected with the recombinant Listeria- based immunotherapeutic at an MOI of about 1, about 2, about 5, about 10, about 20, about 100, or about 200.
5. The method of any preceding claim, wherein infecting the APCs comprises incubating the APCs with the recombinant Listeria- based immunotherapeutic for 0.5-24 hours.
6. The method of claim 5, wherein infecting the APCs comprises incubating the APCs with the recombinant Listeria- based immunotherapeutic for about 1 hour, about 2 hours, about 5 hours, or about 24 hours.
7. The method of any preceding claim, wherein the APCs are washed and cultured for 18-24 hours prior to co-culture with the T cells.
8. The method of any preceding claim, wherein the ratio of APCs to T cells in step (b) is 1 :1 to 4:1.
9. The method of any preceding claim, wherein the number of APCs in step (b) is about 5000 to about 40,000.
10. The method of any preceding claim, wherein the APCs are co-cultured with the T cells for about 18-24 hours.
11. The method of any preceding claim, wherein the APCs are co-cultured with the T cells in the presence of a protein secretion inhibitor, optionally wherein the protein secretion inhibitor is brefeldin A.
12. The method of any preceding claim, wherein determining a cytokine expression profile of the T cells comprises measuring the level of interferon gamma (IFNy) produced by the T cells.
13. The method of claim 12, wherein determining a cytokine expression profile of the T cells comprises measuring the level of IFNy produced by the T cells and secreted into a culture media.
14. The method of claim 12 or 13, wherein IFNy is detected by enzyme-linked immunosorbent assay (ELISA).
15. The method of any preceding claim, wherein the disease-associated antigenic peptide is a tumor-associated antigen.
16. The method of any preceding claim, wherein the recombinant Listeria-based immunotherapeutic is a Listeria monocytogenes strain.
17. The method of claim 16, wherein the Listeria monocytogenes comprises a nucleic acid comprising a first open reading frame encoding a fusion
polypeptide, wherein the fusion polypeptide comprises a PEST-containing peptide fused to the disease-associated antigenic peptide.
18. The method of claim 17, wherein the PEST-containing peptide is listeriolysin O (LLO) or a fragment thereof, and the disease- associated antigenic peptide is a human papillomavirus (HPV) protein E7 or a fragment thereof.
19. The method of claim 17 or 18, wherein the recombinant Listeria- based immunotherapeutic is an attenuated Listeria monocytogenes strain comprising a deletion of or inactivating mutation in prfA, wherein the nucleic acid is in an episomal plasmid and comprises a second open reading frame encoding a D133V PrfA mutant protein.
20. The method of claim 17, wherein the recombinant Listeria- based immunotherapeutic is an attenuated Listeria monocytogenes strain comprising a deletion of or inactivating mutation in actA, dal, and dal, wherein the nucleic acid is in an episomal plasmid and comprises a second open reading frame encoding an alanine racemase enzyme or a D-amino acid aminotransferase enzyme, and wherein the PEST-containing peptide is an N-terminal fragment of listeriolysin O (LLO).
21. The method of claim 16 wherein the Listeria monocytogenes strain is ADXS11-001, and the T cell is an HPV-reactive T cell or an HPV-E7-reactive T cell.
22. A method of assessing potency of a Lisle ria-hased immunotherapeutic, comprising:
(a) infecting THP-l cells with a recombinant Listeria- based immunotherapeutic at an MOI of 1-20 for 2 hours to provide infected THP-l cells, wherein the recombinant Listeria- based immunotherapeutic comprises a live attenuated Listeria monocytogenes strain genetically modified to express a fusion protein of listeriolysin O (LLO) or a fragment thereof and a human papillomavirus (HPV) 16 protein E7 tumor antigen comprising HPV 16 protein E7 or a fragment thereof;
(b) washing the THP- 1 cells and culturing the THP- 1 cells for an additional 18-24 hours in the absence of gentamicin;
(c) co-culturing the infected THP- 1 cells with T cells having reactivity to an HPV16 E7 antigenic peptide for 18-24 hours; and
(d) measuring interferon gamma (IFNy) production, wherein an increase in IFNy production indicates expression of the HPV 16 protein E7 tumor antigen or a fragment therof in the infected THP-l cells.
23. The method of claim 22, wherein the HPV 16 E7 tumor antigen comprises SEQ ID NO: 101.
Considering that the stock market capitalization in December 2018 was $5 million, it can go down to 0.1 fully diluted.
Active Twitter account of Berlin as Pres/CEO of Rosetta. Sorry LOL. @ROSGKen
Berlin tried to shorten the deadlines to 2020 and caused a maintenance of AXAL, with the risk that the data would be invalidated and not be able to use them in a new EMA if it had not been lifted. Petit had to wait to fix the mess of the CMO and CEO.
Hov,
I'd like to hear your assessment of Petit's new CCO. Thank you
Tomorrow August 23rd cashless exchange of 17,100,000 Warrants for shares. This is the letter of a cynical.
Bourbon,
ADXS could buy back stocks taking advantage of low prices. Prices would rise and ADXS would have part of the shares for the prefunded Warrants. What do you think? The inept CFO will never do it, it won't bother the sharks.
"Subject 4 has yet to be
evaluated but has experienced normal performance status over the 3 months of therapy with
ADXS-NEO 1×108 CFU",
Frontiers in Cancer Immunotherapy May 14,2019.
Today, "To date, dosing of ADXS-NEO at 1x10
8 colony forming units (CFU) has been well-tolerated in two patients". Subject 4,MSS CRC,
8 doses, 24 weeks, 5 months(ADXS-NEO Parts A, B, and C : Intravenously (IV) every 3 weeks for up to 48 weeks).
Neon says NEO-PV-01 “is custom-designed and manufactured based on the unique mutational fingerprint of each individual patient. NEO-PV-01, which is designed to include up to 20 neoantigen(ADXS 40 NEOANTIGENS) -targeting peptides selected by Neon’s RECON bioinformatics engine, is intended to generate an anti-tumor immune response directing T-cells to target particular neoantigens in the patient’s tumor.”
https://www.biospace.com/article/neon-therapeutics-cancer-vaccine-effective-in-melanoma-and-lung-and-bladder-cancers/?utm_source=dlvr.it&utm_medium=twitter
Two patients (one treated at 1x109 and one at 1x108 CFU) achieved stable disease per RECIST 1.1 criteria. Another patient has yet to be evaluated but has experienced normal performance status and an active lifestyle over the three months of therapy with ADXS-NEO at 1x108 CFU.
Data from the two MSS colorectal cancer patients dosed with ADXS-NEO at 1x108CFU demonstrated increased CD8+ T cell infiltration in the tumor microenvironment after three doses of ADXS-NEO. Both patients had metastatic colorectal cancer, which is considered to be a “cold” tumor and typically exhibits little CD8+ T cell infiltration and resistance to immunotherapy, yet both successfully transitioned from “cold” tumors into “hot” tumors with ADXS-NEO therapy. An estimated 80-85% of colorectal cancer patients are MSS.
Advaxis (NASDAQ:ADXS) was upgraded by analysts at ValuEngine from a buy rating to a strong-buy rating.
Please don’t take it personally. We are publicly traded and must be very careful not to provide information to individuals that we have not communicated to everyone. We truly appreciate the investment of shareholders and do everything we can to maximize its benefit to patients.
— Robert Petit (@RGPetit2) March 27, 2019
ADXS Zacks Rank: 1 Strong buy