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Your 'friend' needs a new broker.DKSC has a green light thru TDAmeritrade & Fidelity.
Idiotic post. "Liars" not "lyers".
Filings imminent.Newest tweet from Whitechapel Holdings:
@whitechapelusa
"Year end was updated on OTCMarkets. Now we can upload the financials.
Once uploaded we can (finally) get the lawyer do DD for the letter.
The patience we learned during years of training in a Buddhist monastery is coming in handy :)
1:19 PM · Feb 5, 2019 · Twitter Web Client"
Year end was updated on OTCMarkets. Now we can upload the financials.
— whitechapelusa (@whitechapelusa) February 5, 2019
Once uploaded we can (finally) get the lawyer do DD for the letter.
The patience we learned during years of training in a Buddhist monastery is coming in handy :)
Buy DKSC, Jamcracker. You'll be glad you did.
Load up DKSC, JamCracker. You might be able to afford to move out of your parent's basement.
Whitechapel Holdings (DKSC)
@whitechapelusa
"We are all eagerly awaiting the status update:
OTCMarkets explained Friday: uploaded info is reviewed. Can take 2 days to reflect. Soon as all info is updated online the attorney can do his final due diligence & issue letter.
It is a process but we are on it like white on rice!"
6:20 AM · Feb 4, 2019 · Twitter Web Client
We are all eagerly awaiting the status update:
— whitechapelusa (@whitechapelusa) February 4, 2019
OTCMarkets explained Friday: uploaded info is reviewed. Can take 2 days to reflect. Soon as all info is updated online the attorney can do his final due diligence & issue letter.
It is a process but we are on it like white on rice!
Rumored DKSC uplisting to NASDAQ in 2020.
"Rumors, Murmurs & Buzz
@StockTweetsHQ
Cut Through All The Red Tape_DAKSHIDIN CORP $DKSC Executives To Tour The Nasdaq On Wednesday As 2020 Uplisting Preparations Move Forward"
https://mobile.twitter.com/StockTweetsHQ/status/1091847440339066880
01/23/19 Dakshidin Corporation (DKSC), Corporate Update https://on.mktw.net/2WaPHeM
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PRESS RELEASE
Dakshidin Corporation (DKSC), Corporate Update
By
Published: Jan 23, 2019 3:13 p.m. ET
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LAS VEGAS, Jan 23, 2019 (GLOBE NEWSWIRE via COMTEX) -- LAS VEGAS, Jan. 23, 2019 (GLOBE NEWSWIRE) -- Dakshidin Corporation (DKSC) is working on distribution for the current CBD lineup of products and there will be a new product (salve) added this quarter. The pending licensing agreement for our "Superfruit" we hope to release in Q2 will be a worldwide exclusive. As with everything to do with our health and wellness products, we have a significant amount of research that we will publish to underscore the level of R&D that went into our formulas/products.
There seems to be a mixture of confusion and concern over the status of the ownership of the farm that has been mentioned in our press releases. The status is as follows: Runnymede Farms has committed to the purchase of the farm and currently has $500K of financing in place to complete the purchase. The owner of the property has agreed to join the company as Master Cultivator and is currently working on the plans for the next planting (outdoor plants). The actual purchase of the property is one step in the development of the completed project. There are the purchase and installation of the Greenhouses, the Solar system, and the Wind Turbine Generator, the combined cost of the above is as much as the property. We (Management) are raising the necessary funds to complete the project, which as previously disclosed will not result in dilution of DKSC stock, but rather be done on a revenue share basis.
The Company also submitted all documents requested by OTCMarkets this morning and as soon as the application is approved, we will be able to start updating all filings. A follow up call with the attorney for the final letter to be filed is scheduled for tomorrow.
*Note: The company will use its newly created Twitter account to inform interested parties as to the steps being completed, as well as corporate updates in between news releases.
https://twitter.com/whitechapelusa
About Dakshidin Corporation (DKSC)
DKSC has positioned itself as an innovator in the emerging CBD and cannabis derived products and services industry. The company is driven by three pillars of thought that guide the development of its business:
Cannabis prohibition is approaching its inevitable end,
Cannabis & CBD are conventional products used by a broad spectrum of consumers,
Trusted brands will be the future of the cannabis industry.
Dakshidin Corporation (DKSC), Appoints Senior Management, New CFO https://on.mktw.net/2S7Ysax
Trulance scripts (wk of 1/11/19) are very strong.
$SGYP Full Stats for the week ending 1/11/19. Special thanks for Jose for providing Bloomberg screen shots. pic.twitter.com/tF8iAuUSOq
— ABBA (@thegunnerab) January 18, 2019
CBIS Patent for "Composition for the treatment of neurobehavioral disorders" http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=2&f=G&l=50&co1=AND&d=PTXT&s1=%22Cannabis+Science%22&OS=%22Cannabis+Science%22&RS=%22Cannabis+Science%22
United States Patent 9,763,991
Bray , et al. September 19, 2017
Composition for the treatment of neurobehavioral disorders
Abstract
The invention relates to a composition for use in the treatment of neurobehavioral disorders, a Cannabis plant extract comprising Cannabinol preferably with other constituents of this plant for such use and a method for the extraction of plants. The plants or plant parts may for instance be derived from Cannabis sativa and/or Cannabis indica and/or Cannabis ruderalis and/or citrus fruits, and mixtures thereof. The plant extracts derived showed particularly beneficial effects against sleeping disorders, in particular insomnia, and anxiety disorders including ADHD.
Inventors:Bray; Dorothy Helen (Buckinghamshire, GB), Lap; Mario (Amsterdam, NL), Dupetit; Alfredo Carlos (Neunkirchen-Richelbach, DE)
Applicant:
Name City State Country Type
Cannabis Science International Holding B.V.
Haarlem
Assignee: CANNABIS SCIENCE INTERNATIONAL HOLDING B.V. (Haarlem, NL)
Family ID: 51177113
Appl. No.: 14/898,251
Filed: June 13, 2014
PCT Filed: June 13, 2014
PCT No.: PCT/NL2014/050391
371(c)(1),(2),(4) Date: December 14, 2015
PCT Pub. No.: WO2014/200350
PCT Pub. Date: December 18, 2014
New DKSC CEO Chris Haigh is a huge win for company.
https://finance.yahoo.com/news/dakshidin-corporation-dksc-appoints-chris-210000407.html
"Christopher Haigh is a recognized leader in the growth sector of electronic transactions and services. Chris brings international leadership expertise in sales, marketing and technology innovation to Dakshidin. As the President and CEO of Kingsmead Group, a consulting services company that specialises in financial services Chris was initially introduced to the cannabis industry about four years ago as a result of the intrinsic finance and banking issues the industry is still plagued with due to ongoing Federal prohibition. He recognized an early stage opportunity to provide a wide range of ancillary skills and services that formerly no one would attach their reputations to because of the stigma involved. After gaining additional understanding and further exposure to the industry he then recognized a potentially huge underserved market for organic health and wellness CBD products that would cater to the senior demographic.
Mr. Haigh commented: “As soon as the company is current* with all of it’s filings, which will result in the removal of the stop sign, we will apply for a name change. I am truly excited for the additional opportunities that a public parent company provides and we will work extremely hard to reward our current and new shareholders alike.”"
Cannabis Science (CBIS) Confirms Receipt of Issued US Patent Number 9,763,991 For Compositions of Cannabinol (CBN) for Treatment of Various Neurobehavioral Disorders, Sleep Deprivation (Insomnia), Anxiety Disorders (ADHD), and (PTSD)
https://finance.yahoo.com/news/cannabis-science-confirms-receipt-issued-130130538.html
Price currently at 52-wk low.
Smokefree Innotec $SFIO To Announce New Revenue Sharing Agreement With Fortune 500 Company, Announcement Pending https://rumormurmursbuzz.blogspot.com/2019/01/every-rose-has-its-thornsmokefree.html?m=1
Could hit 0.02+ today!
SFIO mentioned in 5 RJR patents in 2017-2018. http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=Smokefree+Innotec&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PTXT
"Results of Search in US Patent Collection db for:
"Smokefree Innotec": 5 patents.
Hits 1 through 5 out of 5
PAT. NO. Title
1 10,172,392 Full-Text Humidity sensing for an aerosol delivery device
2 10,090,143 Full-Text Real time measurement techniques combining light sources and mass spectrometer
3 9,927,452 Full-Text Pipetting system
4 9,918,495 Full-Text Atomizer for an aerosol delivery device and related input, aerosol production assembly, cartridge, and method
5 9,833,019 Full-Text Method for assembling a cartridge for a smoking article"
0.01!!!!
Almost at 0.01!
New patent RJR Tobacco with SFIO mentioned... http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=%22Smokefree+Innotec%22&OS=%22Smokefree+Innotec%22&RS=%22Smokefree+Innotec%22
"United States Patent 10,172,392
Sur , et al. January 8, 2019
Humidity sensing for an aerosol delivery device"
"Abstract
An aerosol delivery device is provided. The aerosol delivery device comprises a control component and a humidity sensor. The humidity sensor is configured to measure a property thereof that is variable with relative humidity in an environment of the aerosol delivery device to which the humidity sensor is exposed. The humidity sensor is also configured to generate a corresponding signal that indicates a value of the property from which the relative humidity is calculable. The control component, or the humidity sensor, is configured to calculate the relative humidity from the value indicated by the corresponding signal, and control operation of at least one functional element of the aerosol delivery device based on the relative humidity so calculated, including output of the relative humidity for presentation by a display."
"Additional manufacturers,designers,and/or assignees of components and related technologies that may be employed in the aerosol delivery device of the present disclosure include...Smokefree Innotec of Las Vegas, Nev...."
Thanks for heads up. Just placed order thru Fidelity. Couldn't earlier today.
Huge! RJR Tobacco has 4 patents in 2017-2018 with SFIO mentioned as one of the manufacturers/designers/assignees of components/tech that may be employed for each patented device: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=Smokefree+Innotec&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PTXT http://patft.uspto.gov/netacgi/nph-Parser?
Example 1: Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=4&f=G&l=50&co1=AND&d=PTXT&s1=%22Smokefree+Innotec%22&OS=%22Smokefree+Innotec%22&RS=%22Smokefree+Innotec%22
"Additional manufacturers, designers, and/or assignees of components and related technologies that may be employed in aerosol delivery device include ....Smokefree Innotec of Las Vegas, Nev...."
SFIO- Maybe a cannabis product(s) in the works?
TD Ameritrade is a go. Fidelity is still a no-go. Run, SFIO, run!
SGYP Trulance estimated $133M Rev's in '18. twitter.com/thegunnerab/sta...
TD Ameritrade allowed me to place order.
Fidelity did not. Anyone else?
Great news! Trying to find a link to post on other sites.
Almost fell over when I saw that the SFIO lock has been lifted. Thought my 2.5M shares were dead. You never know.
SGYP Jan.1,'19.Trulance now on Express Scripts Formulary.This is big. businesswire.com/news/home/...
Thanks!
Bausch's $200M for SGYP is a "Stalking Horse Bid", not a final/accepted bid. More bids will come. https://www.investopedia.com/terms/s/stalkinghorsebid.asp
"What is a Stalking-Horse Bid?
A stalking-horse bid is an initial bid on the assets of a bankrupt company. The bankrupt company will choose an entity from a pool of bidders who will make the first bid on the firm's remaining assets. The stalking horse sets the low-end bidding bar so that other bidders can not underbid the purchase price. The term "stalking horse" originates from a hunter trying to conceal himself behind either a real or fake horse."
Bausch's $200M for SGYP is a "Stalking Horse Bid", not a final/accepted bid. More bids will come. https://www.investopedia.com/terms/s/stalkinghorsebid.asp
"What is a Stalking-Horse Bid
A stalking-horse bid is an initial bid on the assets of a bankrupt company. The bankrupt company will choose an entity from a pool of bidders who will make the first bid on the firm's remaining assets. The stalking horse sets the low-end bidding bar so that other bidders can not underbid the purchase price. The term "stalking horse" originates from a hunter trying to conceal himself behind either a real or fake horse."
$SGYP Regardless of NASDAQ listing, bids are what matter. Current bid is $200M by Bausch. Trulance/Dolcanatide are worth way more. Expect at least 1-2 more bids before February 9,'19.
Cofactor Genomics to Provide Solid Tumor Immune Profiling for GNCA Genocea Biosciences
09:00 EST 4 Dec 2018 | Businesswire
-- Pilot study to evaluate use of Cofactor assay in Genocea’s neoantigen vaccine clinical trial --
Cofactor Genomics, a clinical RNA sequencing and translational assay developer, today announced a pilot study to evaluate use of Cofactor’s ImmunoPrismTM assay in Genocea Biosciences’ Phase 1/2a clinical trial testing the safety and efficacy of its lead personalized cancer vaccine candidate, GEN-009, in adult cancer patients with a variety of solid tumors.
The pilot study is designed to enable Genocea to comprehensively characterize the immune responses that patients enrolled in the clinical trial generate in response to vaccination. The RNA-based assay developed by Cofactor should enable Genocea to compare the immune cell composition for 8 major immune types within and between patients, including expression reporting for key immune escape genes.
“We are working to develop truly effective personalized neoantigen vaccines with which to treat cancer patients. Through exploration of advanced technologies like Cofactor’s ImmunoPrism assay, we aim to better understand the intratumoral immune responses we are eliciting in response to our vaccine,” said Jessica Baker Flechtner, Ph.D., Chief Scientific Officer at Genocea.
“Pilot studies such as this one, where our technology is implemented in the field to empower drug developers to find the most robust markers of therapeutic success, are extremely important in validating our cutting-edge technology,” noted David Messina, Chief Operating Officer at Cofactor Genomics. “Demonstrating the utility of a new approach to immune profiling is best accomplished with partners like Genocea, who are eager to gain access to the most innovative and advanced assays.”
Cofactor Genomics recently announced the release of their ImmunoPrism Immune Profiling Kit, which enables access to their proprietary molecular and machine-learning informatics for RNA analysis of the tumor microenvironment. The ImmunoPrism kit offers laboratories the ability to validate the assay, as Cofactor has done through their CAP-accredited laboratory.
Cofactor will present the results of this clinical validation work during an upcoming webinar titled, “Clinical Validation of a Multidimensional Pan-Cancer Immune Assay” on Thursday, December 13 at 11 AM EST: http://www.clinicalinformaticsnews.com/cofactor-genomics/clinical-validation/
About Cofactor Genomics, Inc.
Cofactor Genomics uses RNA to help researchers and clinicians understand, diagnose, and predict drug response for the 95% of disease that can’t be assessed by DNA alone. Founded by three former Human Genome Project scientists, Cofactor has built a database of multidimensional gene expression models, and a proprietary platform capable of overcoming the chemical and computational challenges of performing complex characterization of clinical-grade human samples. Cofactor has contracts to provide RNA sequencing and analysis services to the research arms of eight of the world’s largest pharma and biotech companies and is in the process of commercializing a suite of clinical diagnostic assays. Find out more about Cofactor Genomics at cofactorgenomics.com.
About Genocea Biosciences, Inc.
Genocea's mission is to help conquer cancer by designing and delivering targeted cancer vaccines and immunotherapies. While traditional immunotherapy discovery methods have largely used predictive methods to propose T cell targets, or antigens, Genocea has developed ATLAS™, its proprietary technology platform, to identify clinically relevant antigens of T cells based on actual human immune responses. Genocea is currently studying the safety, immunogenicity, and efficacy of its lead neoantigen cancer vaccine, GEN-009, in a Phase 1/2a clinical trial. For more information, please visit www.genocea.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181204005385/en/
GNCA KOL Event Webcast Monday, Nov. 26, 12:00 PM EST, registration link: lifesci.rampard.com/2018112...
GENOCEA UNVEILS POSSIBLE MECHANISM FOR TUMOR RESISTANCE TO IMMUNOTHERAPY AT SOCIETY FOR IMMUNOTHERAPY OF CANCER’S (SITC) 33RD ANNUAL MEETING
November 6, 2018 at 8:00 AM EST
https://ir.genocea.com/news-releases/news-release-details/genocea-unveils-possible-mechanism-tumor-resistance
ATLAS™-identified “inhibitory” neoantigens promote tumor growth in mouse model
ATLAS platform continues to differentiate versus in silico methods for true neoantigen identification
CAMBRIDGE, Mass., Nov. 06, 2018 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, today highlighted data from poster presentations at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) taking place November 7 to 11, 2018 at the Walter E. Washington Convention Center in Washington, D.C.
Jessica B. Flechtner, Ph.D., Genocea’s chief scientific officer, provided context: “We are pleased to share new data suggesting the potential deleterious effect of what we term “inhibitory” neoantigens because of their association with inhibition of T cell responses to tumors. Our new data in a mouse model present early evidence that these neoantigen-specific inhibitory responses, which we frequently identify in human subjects, may be tumor-promoting. Even as we continue to explore the mechanism of such responses, we are confident that their identification will play an important role in creating best-in-class cancer immunotherapies and in a better understanding of cancer treatment resistance. We believe our posters offer a comprehensive snapshot of how our ATLAS platform differentiates Genocea from our peers, the majority of whom use in silico methods to predict neoantigens and who consequently have no means of identifying inhibitory neoantigens.”
Kwok-Kin Wong, M.D., Ph.D, Chief of Hematology and Medical Oncology, New York University Langone Health Center, also commented on the data: “Personalizing a vaccine by selecting neoantigens that are recognized by the patient’s own immune system certainly avoids any limitations from in silico selection. However, the novel discovery in ATLAS that many mutations may have a patient-specific immune suppressive effect raises provocative questions as to the importance of identifying and excluding these sequences from immunotherapies.”
The following posters will be located in Poster Hall E and presented on Saturday, November 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m. ET.
Summary of Poster #P166 – Ex vivo ATLAS-identified inhibitory neoantigens promote mouse melanoma tumor progression
• ATLAS performed on splenocytes from untreated tumor-bearing mice identified that, of the >1,600 mutations identified in the B16F10 melanoma, 4% elicited stimulatory and 3% elicited inhibitory T cell responses, defined as a statistical increase or decrease in beneficial cytokine secretion, respectively, relative to baseline controls.
• MHC-binding prediction algorithms failed to identify the majority of ATLAS-identified neoantigens (<10% PPV); in addition, approximately half of the neoantigens accurately predicted by algorithms were shown by ATLAS to be inhibitory, which could not have been predicted.
•Immunization with inhibitory neoantigens led to hyperprogression in some mice. Hyperprogression has been observed in some human subjects treated with checkpoint blockade drugs. These data suggest inhibitory responses to neoantigens may play an important role in the observation.
• Stimulatory peptide antigens combined with adjuvant were immunogenic and promoted anti-tumor response. These may ultimately be enhanced when combined with checkpoint blockade therapy.
Summary of Poster #P154 – Empiric profiling of neoantigen-specific T cell responses in NSCLC patients with ATLAS™ reveals unexpected neoantigen and inhibitory antigen profiles
• More than 1,000 putative neoantigens were screened using autologous antigen-presenting cells and T cells from 9 individuals with small cell or non-small cell lung cancer.
• ATLAS empirically identified which somatic mutations from each patient's tumor were neoantigens, independently of HLA type and without predictions, including which were stimulatory and which were inhibitory.
Overall, approximately equal proportions of inhibitory and stimulatory antigens were identified.
Most of the antigens were not predicted by algorithms or enriched by other classifiers such as expression level, mutation type, or predicted mutant to wild-type peptide binding affinity ratios.
There is little overlap between CD4+ and CD8+ T cell antigens; less than 2% of neoantigens were shared between T cell subsets in the study.
• Patients who failed to respond to checkpoint blockade therapy often had a greater proportion of inhibitory to stimulatory neoantigens.
Summary of Poster #P174 – A phase 1/2a study to evaluate the safety, tolerability, immunogenicity, and anti-tumor activity of GEN-009 adjuvanted neoantigen vaccine in adult patients with selected solid tumors
• Study design of GEN-009-101 – trial initiated in August 2018 with initial immunogenicity data expected in the first half of 2019.
• First trial to use ATLAS-identified, stimulatory neoantigens as part of a personalized vaccine:
Part A: monotherapy in patients with no evidence of disease, high risk of relapse (n=6-9)
- NSCLC, urothelial, melanoma, HNSCC
- Readouts: safety and immunogenicity
Part B: combination therapy with nivolumab. Patients with stable disease or PR (n=15 per cohort)
- NSCLC, urothelial, melanoma, HNSCC, RCC
- Readouts: safety, immunogenicity, efficacy
Part C: monotherapy in patients with relapsed/refractory disease (n≤40 patients)
- Same indications as Part B
- Readouts: safety, immunogenicity, efficacy
• Immunogenicity readouts will include: ex vivo dual fluorospot IFN-gamma/Granzyme B to detect CD4+ and CD8+ T cell responses to each SLP, cultured fluorospot, CD4+ and CD8+ polyfunctional responses by intracellular cytokine staining, immunophenotyping PBMC, and tumor biopsy assessments using RNAseq and immunofluorescence
•Efficacy readouts will include:
Part A: disease-free survival
Part B: response improvement rate, duration of response, progression-free survival
Part C: objective response rate, duration of response, progression-free survival
About Genocea Biosciences, Inc.
Genocea's mission is to help conquer cancer by designing and delivering targeted vaccines and immunotherapies. While traditional immunotherapy discovery methods have largely used predictive methods to propose T cell targets, or antigens, Genocea has developed ATLAS™, its proprietary technology platform, to identify clinically relevant antigens of T cells based on actual human immune responses. Genocea is using ATLAS to develop cancer vaccines and immunotherapies. Genocea is currently studying the safety, immunogenicity, and efficacy of its lead neoantigen cancer vaccine, GEN-009, in a Phase 1/2a clinical trial. For more information, please visit www.genocea.com.
Contact:
Jennifer LaVin
617-715-6687
jennifer.lavin@genocea.com
Source: Genocea Biosciences, Inc.
GENOCEA UNVEILS POSSIBLE MECHANISM FOR TUMOR RESISTANCE TO IMMUNOTHERAPY AT SOCIETY FOR IMMUNOTHERAPY OF CANCER’S (SITC) 33RD ANNUAL MEETING
November 6, 2018 at 8:00 AM EST
ATLAS™-identified “inhibitory” neoantigens promote tumor growth in mouse model
ATLAS platform continues to differentiate versus in silico methods for true neoantigen identification
CAMBRIDGE, Mass., Nov. 06, 2018 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, today highlighted data from poster presentations at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) taking place November 7 to 11, 2018 at the Walter E. Washington Convention Center in Washington, D.C.
Jessica B. Flechtner, Ph.D., Genocea’s chief scientific officer, provided context: “We are pleased to share new data suggesting the potential deleterious effect of what we term “inhibitory” neoantigens because of their association with inhibition of T cell responses to tumors. Our new data in a mouse model present early evidence that these neoantigen-specific inhibitory responses, which we frequently identify in human subjects, may be tumor-promoting. Even as we continue to explore the mechanism of such responses, we are confident that their identification will play an important role in creating best-in-class cancer immunotherapies and in a better understanding of cancer treatment resistance. We believe our posters offer a comprehensive snapshot of how our ATLAS platform differentiates Genocea from our peers, the majority of whom use in silico methods to predict neoantigens and who consequently have no means of identifying inhibitory neoantigens.”
Kwok-Kin Wong, M.D., Ph.D, Chief of Hematology and Medical Oncology, New York University Langone Health Center, also commented on the data: “Personalizing a vaccine by selecting neoantigens that are recognized by the patient’s own immune system certainly avoids any limitations from in silico selection. However, the novel discovery in ATLAS that many mutations may have a patient-specific immune suppressive effect raises provocative questions as to the importance of identifying and excluding these sequences from immunotherapies.”
The following posters will be located in Poster Hall E and presented on Saturday, November 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m. ET.
Summary of Poster #P166 – Ex vivo ATLAS-identified inhibitory neoantigens promote mouse melanoma tumor progression
• ATLAS performed on splenocytes from untreated tumor-bearing mice identified that, of the >1,600 mutations identified in the B16F10 melanoma, 4% elicited stimulatory and 3% elicited inhibitory T cell responses, defined as a statistical increase or decrease in beneficial cytokine secretion, respectively, relative to baseline controls.
• MHC-binding prediction algorithms failed to identify the majority of ATLAS-identified neoantigens (<10% PPV); in addition, approximately half of the neoantigens accurately predicted by algorithms were shown by ATLAS to be inhibitory, which could not have been predicted.
•Immunization with inhibitory neoantigens led to hyperprogression in some mice. Hyperprogression has been observed in some human subjects treated with checkpoint blockade drugs. These data suggest inhibitory responses to neoantigens may play an important role in the observation.
• Stimulatory peptide antigens combined with adjuvant were immunogenic and promoted anti-tumor response. These may ultimately be enhanced when combined with checkpoint blockade therapy.
Summary of Poster #P154 – Empiric profiling of neoantigen-specific T cell responses in NSCLC patients with ATLAS™ reveals unexpected neoantigen and inhibitory antigen profiles
• More than 1,000 putative neoantigens were screened using autologous antigen-presenting cells and T cells from 9 individuals with small cell or non-small cell lung cancer.
• ATLAS empirically identified which somatic mutations from each patient's tumor were neoantigens, independently of HLA type and without predictions, including which were stimulatory and which were inhibitory.
Overall, approximately equal proportions of inhibitory and stimulatory antigens were identified.
Most of the antigens were not predicted by algorithms or enriched by other classifiers such as expression level, mutation type, or predicted mutant to wild-type peptide binding affinity ratios.
There is little overlap between CD4+ and CD8+ T cell antigens; less than 2% of neoantigens were shared between T cell subsets in the study.
• Patients who failed to respond to checkpoint blockade therapy often had a greater proportion of inhibitory to stimulatory neoantigens.
Summary of Poster #P174 – A phase 1/2a study to evaluate the safety, tolerability, immunogenicity, and anti-tumor activity of GEN-009 adjuvanted neoantigen vaccine in adult patients with selected solid tumors
• Study design of GEN-009-101 – trial initiated in August 2018 with initial immunogenicity data expected in the first half of 2019.
• First trial to use ATLAS-identified, stimulatory neoantigens as part of a personalized vaccine:
Part A: monotherapy in patients with no evidence of disease, high risk of relapse (n=6-9)
- NSCLC, urothelial, melanoma, HNSCC
- Readouts: safety and immunogenicity
Part B: combination therapy with nivolumab. Patients with stable disease or PR (n=15 per cohort)
- NSCLC, urothelial, melanoma, HNSCC, RCC
- Readouts: safety, immunogenicity, efficacy
Part C: monotherapy in patients with relapsed/refractory disease (n≤40 patients)
- Same indications as Part B
- Readouts: safety, immunogenicity, efficacy
• Immunogenicity readouts will include: ex vivo dual fluorospot IFN-gamma/Granzyme B to detect CD4+ and CD8+ T cell responses to each SLP, cultured fluorospot, CD4+ and CD8+ polyfunctional responses by intracellular cytokine staining, immunophenotyping PBMC, and tumor biopsy assessments using RNAseq and immunofluorescence
•Efficacy readouts will include:
Part A: disease-free survival
Part B: response improvement rate, duration of response, progression-free survival
Part C: objective response rate, duration of response, progression-free survival
About Genocea Biosciences, Inc.
Genocea's mission is to help conquer cancer by designing and delivering targeted vaccines and immunotherapies. While traditional immunotherapy discovery methods have largely used predictive methods to propose T cell targets, or antigens, Genocea has developed ATLAS™, its proprietary technology platform, to identify clinically relevant antigens of T cells based on actual human immune responses. Genocea is using ATLAS to develop cancer vaccines and immunotherapies. Genocea is currently studying the safety, immunogenicity, and efficacy of its lead neoantigen cancer vaccine, GEN-009, in a Phase 1/2a clinical trial. For more information, please visit www.genocea.com.
Contact:
Jennifer LaVin
617-715-6687
jennifer.lavin@genocea.com
Source: Genocea Biosciences, Inc.
GNCA: A ‘Hint of Good News’ for Genital Herpes Vaccine
GEN-003 a therapeutic bivalent vaccine candidate for genital herpes simplex virus type 2 (HSV-2)
Reviewed by:
Robert Carlson, MD
November 2nd, 2018
Article by:
Don Ward Hackett
https://www.google.com/amp/s/www.precisionvaccinations.com/gen-003-therapeutic-bivalent-vaccine-candidate-genital-herpes-simplex-virus-type-2-hsv-2%3famp
On October 31, 2018, Genocea Biosciences, Inc. reported its financial results for the third quarter ended September 30, 2018.
Which were very impressive!
But, the most important information to millions of genital herpes sufferers shared during this wall-street analyst call was a ‘hint’ of some potentially good news regarding the GEN-003 herpes vaccine candidate.
Genocea’s management said ‘Genocea is engaged in discussions with potential partners to continue the development of GEN-003 following multiple, successful Phase 2 trials.’
‘Management is still optimistic that they'll be able to find a good home for the vaccine.’
GEN-003 is therapeutic bivalent vaccine candidate for genital herpes simplex virus type 2 (HSV-2).
During July 2018, clinical research reported GEN-003 was clinically effective at doses of 60 µg/50 µg and 60 µg /75 µg for reducing viral shedding for up to 1 year in adults with symptomatic genital herpes simplex virus 2 (HSV-2) infection.
Additionally, these investigators saw a reduction in lesion rates following administration of GEN-003, at varying doses.
For this study, the investigators compared each dose in regard to the participants’ associated rates of viral shedding at baseline and following the 3-dose treatment regimen.
At baseline, the viral shedding rates were 22.2 percent for placebo, and between 13.6 percent and 27.1 percent for the active doses.
“GEN-003 reduced viral shedding for up to 12 months following completion of a 3-dose series, with the 60/50 and 60/75 doses representing the most promising combinations for further evaluation based on viral shedding and overall safety assessment,” reported these researchers.
According to the Centers for Disease Control and Prevention (CDC), genital herpes is widespread throughout the USA.
Genital herpes is a common sexually transmitted disease (STD) that any sexually active person can get. Most people with the virus don’t have symptoms. Even without signs of the disease, herpes can still be spread to sex partners.
Genital herpes is caused by two types of viruses. The viruses are called herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2).
Oral herpes is usually caused by HSV-1 and can result in cold sores or fever blisters on or around the mouth. Most people with oral herpes were infected during childhood or young adulthood from non-sexual contact with saliva.
But, they are still at risk of acquiring herpes simplex virus type 2.
HSV-2 infection is almost exclusively sexually transmitted and is lifelong and incurable.
Genital herpes caused by HSV-2 is a global issue, and an estimated 417 million people worldwide were living with the infection in 2012, says the World Health Organization (WHO).
Prevalence of HSV-2 infection in the Americas is high, at 14.4 percent.
Over 24 million people in the United States are infected with HSV-2 and there are 776,000 new infections each year, says the CDC.
More women (267m) are infected with HSV-2 than men (150m) in 2012. This is because sexual transmission of HSV is more efficient from men to women than from women to men, says the WHO.
If a woman is pregnant and has genital herpes, it is very important to tell a doctor. There is some research that suggests that genital herpes infection may lead to miscarriage, or could lead to an early delivery.
Herpes infection can be passed from you to your unborn child before birth, but is more commonly passed during delivery, says the CDC.
Antivirals, such as acyclovir, famciclovir, and valacyclovir are the most effective medications available for people infected with HSV.
These medications can help reduce the severity and frequency of symptoms.
But, these antivirals cannot cure the HSV-2 infection.
Genocea Biosciences, Inc., is a biopharmaceutical company, engages in developing T cell-directed vaccines and immunotherapies to treat infectious diseases and cancer.
GNCA: A ‘Hint of Good News’ for Genital Herpes Vaccine
GEN-003 a therapeutic bivalent vaccine candidate for genital herpes simplex virus type 2 (HSV-2)
Reviewed by:
Robert Carlson, MD
November 2nd, 2018
Article by:
Don Ward Hackett
https://www.google.com/amp/s/www.precisionvaccinations.com/gen-003-therapeutic-bivalent-vaccine-candidate-genital-herpes-simplex-virus-type-2-hsv-2%3famp
On October 31, 2018, Genocea Biosciences, Inc. reported its financial results for the third quarter ended September 30, 2018.
Which were very impressive!
But, the most important information to millions of genital herpes sufferers shared during this wall-street analyst call was a ‘hint’ of some potentially good news regarding the GEN-003 herpes vaccine candidate.
Genocea’s management said ‘Genocea is engaged in discussions with potential partners to continue the development of GEN-003 following multiple, successful Phase 2 trials.’
‘Management is still optimistic that they'll be able to find a good home for the vaccine.’
GEN-003 is therapeutic bivalent vaccine candidate for genital herpes simplex virus type 2 (HSV-2).
During July 2018, clinical research reported GEN-003 was clinically effective at doses of 60 µg/50 µg and 60 µg /75 µg for reducing viral shedding for up to 1 year in adults with symptomatic genital herpes simplex virus 2 (HSV-2) infection.
Additionally, these investigators saw a reduction in lesion rates following administration of GEN-003, at varying doses.
For this study, the investigators compared each dose in regard to the participants’ associated rates of viral shedding at baseline and following the 3-dose treatment regimen.
At baseline, the viral shedding rates were 22.2 percent for placebo, and between 13.6 percent and 27.1 percent for the active doses.
“GEN-003 reduced viral shedding for up to 12 months following completion of a 3-dose series, with the 60/50 and 60/75 doses representing the most promising combinations for further evaluation based on viral shedding and overall safety assessment,” reported these researchers.
According to the Centers for Disease Control and Prevention (CDC), genital herpes is widespread throughout the USA.
Genital herpes is a common sexually transmitted disease (STD) that any sexually active person can get. Most people with the virus don’t have symptoms. Even without signs of the disease, herpes can still be spread to sex partners.
Genital herpes is caused by two types of viruses. The viruses are called herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2).
Oral herpes is usually caused by HSV-1 and can result in cold sores or fever blisters on or around the mouth. Most people with oral herpes were infected during childhood or young adulthood from non-sexual contact with saliva.
But, they are still at risk of acquiring herpes simplex virus type 2.
HSV-2 infection is almost exclusively sexually transmitted and is lifelong and incurable.
Genital herpes caused by HSV-2 is a global issue, and an estimated 417 million people worldwide were living with the infection in 2012, says the World Health Organization (WHO).
Prevalence of HSV-2 infection in the Americas is high, at 14.4 percent.
Over 24 million people in the United States are infected with HSV-2 and there are 776,000 new infections each year, says the CDC.
More women (267m) are infected with HSV-2 than men (150m) in 2012. This is because sexual transmission of HSV is more efficient from men to women than from women to men, says the WHO.
If a woman is pregnant and has genital herpes, it is very important to tell a doctor. There is some research that suggests that genital herpes infection may lead to miscarriage, or could lead to an early delivery.
Herpes infection can be passed from you to your unborn child before birth, but is more commonly passed during delivery, says the CDC.
Antivirals, such as acyclovir, famciclovir, and valacyclovir are the most effective medications available for people infected with HSV.
These medications can help reduce the severity and frequency of symptoms.
But, these antivirals cannot cure the HSV-2 infection.
Genocea Biosciences, Inc., is a biopharmaceutical company, engages in developing T cell-directed vaccines and immunotherapies to treat infectious diseases and cancer.
GENOCEA ANNOUNCES UPCOMING PRESENTATIONS AT SITC 2018
October 9, 2018 at 8:35 AM EDT
Posters showcase ability of ATLAS™ platform to identify neoantigens for inclusion in and exclusion from personalized immunotherapies
CAMBRIDGE, Mass., Oct. 09, 2018 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, today announced the titles and times of its presentations at the upcoming 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC 2018) taking place November 7 to 11, 2018 at the Walter E. Washington Convention Center in Washington, D.C.
The following posters will be located in Poster Hall E. While the Poster Hall will be open on Friday, November 9 from 8 a.m. – 8 p.m. and Saturday, November 10 from 8 a.m. – 8:30 p.m., the three Genocea posters will be presented simultaneously on Saturday, November 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m.
Poster Number: P154
Title:Empiric profiling of neoantigen-specific T cell responses in NSCLC patients with ATLAS™ reveals unexpected neoantigen and inhibitory antigen profiles
Poster Number: P166
Title:Ex vivo ATLAS-identified inhibitory neoantigens promote mouse melanoma tumor progression
Poster Number: P174
Title:A phase 1/2a study to evaluate the safety, tolerability, immunogenicity, and anti-tumor activity of GEN-009 adjuvanted neoantigen vaccine in adult patients with selected solid tumors
Per SITC policy, full abstracts are embargoed until 8 am ET on November 6, 2018.