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P403 Intratumoral administration of a multigene construct by electroporation can effectively modulate anti-tumor response in a murine B16.F10 model Shawna Shirley1, Anandaroop Mukhopadhyay1, Christoph Burkart1, Jocelyn Wright1, Robert Pierce2, Jean Campbell2, David Canton1 1Oncosec Medical Incorporated, San Diego, CA, USA 2Fred Hutchinson Cancer Research Center, Seattle, WA, USA Background Immunomodulatory cytokines, such as interleukin-12 (IL-12) are attractive candidates for cancer immunotherapy. IL-12 is a pro-inflammatory cytokine with potent anti-tumor effects; however, systemic administration of IL-12 shows limited clinical efficacy and dose-associated toxicity. In preclinical and clinical studies, intratumoral (IT) delivery of IL-12 plasmid DNA by electroporation (EP) can provide a safe and effective alternative for efficacious dosing. To augment the effects of IL-12, we developed a DNA plasmid platform that allows for delivery of agents that modulate multiple immune pathways as well as tumor- or patient-specific neoantigens. Polycistronic IL-12 Immune Modulator plasmid (PIIM) is a single plasmid encoding IL-12, and a fusion of Flt3L to an antigen. Flt3L is a ligand that stimulates dendritic cell (DC) maturation and enhances antigen processing and presentation. The encoded antigen can be a viral or shared antigen, or a patient-specific neoantigen, which enables customization to patient populations, as well as providing an aid to monitoring antigen-specific immune response(s) that can be correlated to patient outcomes. Here we demonstrate the first functional characterization of PIIM. Methods Two PIIM constructs were created for functional characterization: PIIM-OVA (IL12~Flt3L-OVA) for mouse experiments, and PIIM-NYESO1 (IL12~Flt3L-NYESO1) for testing in human cells. The expression and functional activity of PIIM components were determined. Treated tumors and spleens were assessed for transcriptional changes by NanoString® and phenotypic changes by flow cytometry. Systemic effects of PIIM were assessed using a syngeneic two-tumor model of B16.F10 in which only one tumor received IT-PIIM-EP while the other contralateral lesion remained untreated. Results PIIM-OVA and PIIM-NYESO1 secrete functional IL-12p70, Flt3L-OVA and Flt3L-NYESO1 fusion proteins as assessed by ELISA, flow and cell-based assays. PIIM promotes DC maturation and antigen-specific T cell proliferation both ex vivo and in vivo. Hydrodynamic-based gene delivery of PIIM-OVA lead to splenomegaly and significantly increased splenic CD11c+ DCs. Furthermore, IT-PIIM-EP lead to generation of splenic OVA-specific CD8s and increased APM gene expression. When introduced intratumorally in a mouse two-tumor model, IT-PIIM-EP delays B16.F10 tumor growth in both treated and contralateral tumors compared to untreated controls resulting in increased overall survival. Conclusions PIIM represents a novel approach to cancer immunotherapy. A combination of functional immune modulators can be expressed locally in the tumor microenvironment that increase inflammatory infiltrate, enhances antigen presentation and produces a systemic T cell response specific to the antigen encoded on the plasmid. This customizable approach has the potential to improve therapeutic outcome by enhancing adaptive-immunity and addressing patient-specific neoantigens needs. mouse experiments, and PIIM-NYESO1 (IL12~Flt3L-NYESO1) for testing in human cells. The expression and functional activity of PIIM components were determined. Treated tumors and spleens were assessed for transcriptional changes by NanoString® and phenotypic changes by flow cytometry. Systemic effects of PIIM were assessed using a syngeneic two-tumor model of B16.F10 in which only one tumor received IT-PIIM-EP while the other contralateral lesion remained untreated. Results PIIM-OVA and PIIM-NYESO1 secrete functional IL-12p70, Flt3L-OVA and Flt3L-NYESO1 fusion proteins as assessed by ELISA, flow and cell-based assays. PIIM promotes DC maturation and antigen-specific T cell proliferation both ex vivo and in vivo. Hydrodynamic-based gene delivery of PIIM-OVA lead to splenomegaly and significantly increased splenic CD11c+ DCs. Furthermore, IT-PIIM-EP lead to generation of splenic OVA-specific CD8s and increased APM gene expression. When introduced intratumorally in a mouse two-tumor model, IT-PIIM-EP delays B16.F10 tumor growth in both treated and contralateral tumors compared to untreated controls resulting in increased overall survival. Conclusions PIIM represents a novel approach to cancer immunotherapy. A combination of functional immune modulators can be expressed locally in the tumor microenvironment that increase inflammatory infiltrate, enhances antigen presentation and produces a systemic T cell response specific to the antigen encoded on the plasmid. This customizable approach has the potential to improve therapeutic outcome by enhancing adaptive-immunity and addressing patient-specific neoantigens needs.
P 586 of PDF of abstracts. Results Progression free survival (PFS) rates for this treatment were 62% at 6 months and 57% at 18 months (median PFS not reached at 24 months) with a 48% BORR. DOR was not assessable as no responders have progressed and no safety signals were observed with only 2/22 grade 3 treatment-emergent adverse events. In responding patients, significant post-treatment increases were observed in both the Th1-associated gene expression of STAT4 and IL-12RB in biopsies, and frequencies of CD8+PD-1+TIGIT+ and proliferating CD8+PD-1+ peripherally. Additionally, responding patients had a significant increase of TCR clonality in the tumors compared to PBMCs with a reversed relationship in non-responding patients. Spatial analysis by mIHC revealed a significant increase of both PD-L1+ and FoxP3+ cells <15um from CD8+ T cells in non-responders. Exploratory analysis with Nanostring’s IO360 Beta Version panels highlighted underexpression of WNT2B and overexpression of MICB in the pretreatment responder biopsies. Conclusions Durable responses and favorable PFS rates in likely PD-1 non responders continues to suggest that combination IT-TAVO-EP with pembrolizumab is an effective therapeutic modality with an excellent safety profile. Associated biomarker data highlights connected immunological mechanisms, whereby intratumoral Th1-polarization, associated TCR clonality and limited suppressive cell types can drive robust anti-tumor responses (intratumoral and systemic) that positively impact this difficult to treat patient population.
40 page Corporate Presentation.
https://ir.oncosec.com/events-presentations
AH form D
ARLZ plus 30%. Nice
Another 13g coming? Alot of volume again.
ARLZ.
$ARLZ Chart - making a bullish move today - a close above the middle Bollinger Band at1.65 would be bullish - pic.twitter.com/iMRrtgCXl9
— Ospreyeye (@MyChartCoachcom) November 2, 2017
On watch. XGTI and ONCS.
TEAR.
TearLab Corporation to Release Third Quarter 2017 Financial Results on November 13, 2017
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Tearlab Corp. (MM) (NASDAQ:TEAR)
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TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”) will announce its third quarter 2017 financial results after market close on Monday, November 13, 2017.
TearLab’s Chief Executive Officer, Seph Jensen and Chief Financial Officer, Wes Brazell, will host a conference call at 4:30 p.m. ET to review the financial results and discuss business developments in the period.
Third Quarter 2017 Results Conference Call Details:
Date: Monday, November 13, 2017
Time: 4:30 p.m. ET
Live Call: 877-303-1593 (Pass Code: 1089456)
Replay: 855-859-2056 (Pass Code: 1089456)
The call will also be broadcast live and archived on the Company's website at www.tearlab.com under the "Webcasts" tab in the Investor's section.
That would be nice.
ONCS. Another 13g. https://ih.advfn.com/p.php?pid=nmona&article=75993297&symbol=ONCS
XGTI trying to break out.
XGTI. Trying to break out.
CATB. October 26, 2017 08:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced that CAT-5571, which restores host defense by activating autophagy, will be presented in a poster at the 31st Annual North American Cystic Fibrosis Conference (NACFC). NACFC is being held November 2 – November 4, 2017, in Indianapolis, IN, at the Indiana Convention Center.
A poster titled “CAT-5571 Improves the Clearance of Intracellular Burkholderia Cenocepacia from Primary Cystic Fibrosis Macrophages,” resulting from a collaboration between Catabasis and Dr. Amal Amer at Ohio State University, will be presented during Poster Session 1 on Thursday, November 2, 2017, from 11:15am – 1:45pm local time.
Anyone know why the news alert is no longer showing up beside the ticker?
RGBP.Regen BioPharma, Inc. Announces Former Eli Lilly Executive and Current CVS Board Member will Lead Newly Formed Business Advisory Board (BAB)
https://finance.yahoo.com/news/regen-biopharma-inc-announces-former-120000477.html?.tsrc=rss
Maybe this is going to finally do something? Seams like some big players for this tiny company.
Mateon Therapeutics Announces Updated Data from Fifth Cohort of Phase 1b Study of OXi4503 in Acute Myeloid Leukemia
New Data Continue to Show OXi4503 has Significant Potential as New Treatment for AML
OXi4503 Recently Prioritized as Lead Drug Development Program at Mateon
SOUTH SAN FRANCISCO, Calif. , Oct. 30, 2017 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc . (OTCQX:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, today announced updated data from the fifth dose cohort of OX1222, a phase 1b dose-ranging study of OXi4503 in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).
Mateon previously reported that two of four patients in this cohort of the study had morphological complete remissions following one cycle of treatment with OXi4503. A morphological complete remission occurs when an AML patient has fewer than 5% AML blasts in the bone marrow count following treatment and has no significant hematologic abnormalities or other evidence of disease.
One of the patients showing disease remission discontinued the study due to an unrelated adverse event. The other patient continued to receive treatment with an additional two cycles of OXi4503 and remains in complete remission with a cytogenetic complete response. A cytogenetic complete response occurs when testing shows eradication of chromosomal abnormalities following treatment.
"We continue to see encouraging signs of safety and efficacy for OXi4503 in Study OX1222, including complete remissions at very low doses and evidence of a dose-response as we progressively increase the dose of OXi4503 in the trial," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "OXi4503 represents a completely new way to treat AML - by both killing tumor cells directly and by destroying their protective environment in the bone marrow. Based on the results seen to date, we are excited about the enormous potential for this compound in relapsed/refractory AML, especially in older patients unable to tolerate the high levels of chemotherapy typically needed to see a response. There is a huge unmet medical need in these patients and they specifically appear to benefit from treatment with OXi4503."
Summarized initial efficacy data generated to date from OX1222 in relapsed/refractory AML or MDS are as follows:
Cohort (Dose) n CR% PR% ORR%
Cohort 1 (3.75 mg/m2) 6 17% 0% 17%
Cohort 2 (4.68 mg/m2) 4 25% 0% 25%
Cohort 3 (6.25 mg/m2) 4 25% 25% 50%
Cohort 4 (7.81 mg/m2) 3 0% 33% 33%
Cohort 5 (9.76 mg/m2) 4 50% 0% 50%
n: number of patients
CR: complete remission
PR: partial remission
ORR: overall response rate (sum of partial and complete)
OXi4503 continues to have a favorable safety profile. The most common adverse events (AEs) of any grade across all cohorts include neutropenia, fever, nausea, anemia and diarrhea. Grade 3 or above AEs which were related to treatment include anemia (32%), decreased platelet count (27%), decreased neutrophil count (23%) and decreased white blood cell count (18%).
Mateon is in the process of expanding the size of future, higher-dose cohorts to 10 patients to increase the utility of the data generated. The company is also continuing discussions to secure a partner or otherwise obtain additional capital prior to initiating treatment in the sixth cohort of Study OX1222.
Maxim Group Reaffirms “Buy” Rating for OncoSec Medical Incorporated (ONCS).
https://www.dispatchtribunal.com/2017/10/29/maxim-group-reaffirms-buy-rating-for-oncosec-medical-incorporated-oncs.html
Why wouldn't he want it public? He knows he has a following and the price will go up. Now how long he holds is another story.
Just got another email alert from Fidelity. Zach's dropped coverage already. What the heck?
I just got an email alert from Fidelity. Zack's resumes coverage on ONCS with a buy rating.
I just got an email alert from Fidelity. Zack's resumes coverage on ONCS with a buy rating.
I just got an email alert from Fidelity. Zack's resumes coverage on ONCS with a buy rating.
They must really like ONCS's IL 12. Point 72 is Steve Cohen.
ONCS. Point 72 brought shares. https://whalewisdom.com/schedule13d/view/point72-asset-management-lp-sc-13g-2017-10-26-oncs
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October 26, 2017 - 7:00 AM EDT
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APRI 1.70 0.02
Today 5d 1m 3m 1y 5y 10y
Apricus Biosciences Announces Corporate Update and Third Quarter 2017 Financial Results Conference Call
SAN DIEGO, Oct. 26, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that Apricus’ third quarter 2017 financial results will be released on Thursday, November 2, 2017 at 4:01 p.m. Eastern Time. Company management will host a conference call on Thursday, November 2, 2017, at 4:30 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.
To participate by telephone, please dial (855) 780-7196 (Domestic) or (631) 485-4867 (International). The conference ID number is 8498419. The live audio webcast can be accessed via the Investor Relations’ section of Apricus’ website at www.apricusbio.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for 30 days following the live call.
MILIPOL
Industry: Public Safety/Law Enforcement/Defense
Nov. 21-24, 2017
Paris, France
Event website
XGTI. MILIPOL
Industry: Public Safety/Law Enforcement/Defense
Nov. 21-24, 2017
Paris, France
Event website