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Finally! A sign of life (at least publicly) from Therabiologics (GenVec's partner) about success with their glioma program! Hopefully the next release will give details of commencement of the clinical trial for TBX-02, which was scheduled to begin late this year. Here's the link: http://clincancerres.aacrjournals.org/content/early/2016/12/15/1078-0432.CCR-16-1518
Correction to previous post: The Phacilitate conference is slated for early next year, not this year.
Dr. Brough will be one of the presenters at the Phacilitate Cell & Gene Conference to be held this year in Miami. Here's the link: http://www.bioleaders-forum.com
As far as I can tell, everything works exactly as intended, but I'm no analyst, either. More of an eternal optimist, seems like.
Progress report on GENVEC's HATH1 patent:
From freepatentsonline.com:
Title: ADENOVIRAL VECTOR ENCODING HUMAN ATONAL HOMOLOG-1 (HATH1)
Document Type and Number: United States Patent Application 0160102320
Kind Code: A1
Abstract: The invention is directed to a replication-deficient adenoviral vector comprising a nucleic acid sequence encoding a human atonal homolog-1 (Hath1) protein operably linked to a human glial fibrillary acidic protein (GFAP) promoter. The invention also is directed to a composition and method utilizing the adenoviral vector to generate sensory cells in the inner ear of a human.
Inventors: Brough, Douglas E. (Gaithersburg, MD, US)
Ettyreddy, Damodar R. (Clarksburg, MD, US)
Application Number: 14/879318
Publication Date: 4/14/2016
Filing Date: 10/09/2015
----
From The Business of Patents:
The publication of a patent application marks the date at which it is publicly available and therefore at which it forms full prior art for other patent applications worldwide.
It should be understood that a publication is still an application - and cannot be enforced as an issued patent in terms of infringement.
There are some potential monetary advantages to this. In exchange for publication of a patent application, patentees may be able to obtain a reasonable royalty during the period beginning on the date of publication of the application.
Please disregard my last posting. It has been brought to my attention that this is an article from 2004.
Genvec And Nih Expand Hiv Vaccine Manufacturing Contract
Posted on February 7, 2016 by dragon
The Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has expanded its multi-year subcontract with GenVec, Inc. This latest expansion of the subcontract increases the total potential funding from approximately $16 million to approximately $28 million.
GenVec will manufacture a HIV vaccine candidate, based on its proprietary adenovector technology, to support late-stage clinical development using optimized and scaleable processes for vaccine production.
Robert S. Tenerowicz, GenVec’s Vice President Process Development and Clinical Supplies commented, “Expansion of the subcontract will allow us to leverage the resources of our Charlestown site and establish the manufacturing and quality infrastructure to support all of GenVec’s product programs.”The subcontract expansion includes the use of GenVec’s advanced scaleable production process and comprehensive panel of characterization methods designed to support product commercialization, and therefore, has the potential to positively impact the planned production activities for TNFerade, GenVec’s lead oncology product candidate.GenVec focuses on the development and commercialization of novel therapies that improve patient care in the areas of cancer, vision loss, and cardiac disease.
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Gary, here's the link you requested:
http://www.audiology-worldnews.com/news/1517-gene-therapy-to-restore-hearing
"Scientists say they have a new cure for hearing loss"
New article with embedded radio interview with Dr. Lawrence Lustig:
Source - PRI
Science Friday
November 28, 2015 · 9:30 AM EST
Writer Elizabeth Shockman
Here's a link to GenVec's most recent Corporate Overview dated November, 2015
http://content.equisolve.net/genvec/media/da5bcb3c7ebb7442b38b5e79217d667f.pdf
GenVec to present at the Phacilitate Cell and Gene Conference in Barcelona this September - Here's an excerpt from the program:
Big Pharma players in Europe:
How are the large multinationals approaching the challenge of developing and manufacturing commercial ATMP products in Europe? What are the key differences with the US from pharma’s point of view? Includes companies focused on:
o Stem cell platforms, including iPS cell therapies and eSCs
o CARTs and other cellular immunotherapies
o Gene therapy
Panellists:
Jan Thirkettle, Vice President, Cell & Gene Therapy Platform, Biopharm R&D, GlaxoSmithKline
Dr Gregory MacMichael, Global Head of Advanced Therapies- Technology Research & Development,Novartis
Dr Sicco Popma, Scientific Director, Gene Modified Cell Therapies Janssen
Dr Joern-Peter Halle, Senior Vice President, Global Head of External Innovation, Merck Serono
Dr Carlos Plata, Chief Scientific Officer, Chief Medical Officer & Head of R&D, Esteve
Then:
Biotech showcase
4 leading ATMP biotech innovators reveal their latest data and progress in the development of their platform technologies
10.50 Genvec - Dr Bryan Butman, Senior Vice President Development, GenVec
11.00 Showcase 2
11.10 Showcase 3
11.20 Showcase 4
Thank you, zoos7. I believe that this can only be seen as yet another indication of GenVec's ongoing success!
Possible new information:
[52] Gorilla Adenovirus Vectors for Molecular Therapeutics and Vaccines
Douglas E. Brough. GenVec Inc, Gaithersburg, MD
Adenovirus vectors built from gorilla adenovirus are showing superior performance characteristics for molecular vaccines. These new adenovectors (GC Ads) are built from virus isolated from gorilla, and have been cloned and engineered to be replication-defective. GC Ads grow efficiently to high titer on cell lines GenVec has characterized, banked and filed with regulatory agencies for scalable manufacturing. They can be deleted of multiple regions (e.g., E1, E3, and E4) to provide space for multiple transgene cassettes, provide multiple blocks to eliminate replication competent virus and to ensure safer transgene delivery. These new adenovectors have been shown to not be recognized by human sera from either the United States or from Africa. A single intramuscular injection of these GC Ads can induce durable immune responses to encoded antigen. For example, intramuscular injection of GC Ads expressing RSV fusion (F0) glycoprotein induced neutralizing antibody titers that were durable > 24weeks, and protected the lung and nose against RSV challenge at even low doses of immunization in cotton rats. A single intramuscular administration of GC Ads expressing the malaria antigen CSP generated CD8 T cell and antibody responses to CSP that were greater than those generated with Ad5 in mice. In a mouse malaria challenge model the GC Ad regimen was more protective than Ad5. A single intramuscular administration of GC Ads expressing two HSV antigens, UL19 and UL47, resulted in high level cellular responses that were protective against intravaginal HSV2 challenge in mice and the CD8 T cell responses were shown to be durable, 26 weeks. Moreover, repeat administration of the same GC Ad resulted in a boost of antigen-specific immune response. Unlike other adenoviral vectors, homologous prime boost regimens with these GC Ads resulted in a boost of the CD8 T cell responses at all doses and intervals tested. These new GC Ads based on gorilla adenoviruses show generation of strong, durable T cell and neutralizing antibody responses to multiple antigens from a single administration that can be further enhanced by repeat administration. Based on these data, the platform shows great promise for development of a broad array of immunotherapeutic and molecular vaccine product candidates.
Keywords: Adenovirus Vectors; Vaccines; Vector Characterization/Biology
Session: Simultaneous Oral Abstract Sessions: Recent Advances and Applications in Adenovirus Vectors (3:15 PM-5:15 PM)
Date/Time: Wednesday, May 13, 2015 - 5:00 pm
Room: Celestin F
The treatment is working! This is a direct quote (taken from Facebook) from one of the first dosed patients: "I could here myself when I am humming in the right ear it's not clear but it something new for me and I never could hear myself in the right ear before even though its not much. I know it takes a while for the haircells to grow but I am just to excited and hope it just keeps getting better."
A little information about Synagis: It isn't technically a vaccine. It is an immunoglobulin that must be administered in 5 separate injections usually into the thigh muscle at the whopping cost of $1300-2600 per injection. It is important to note that Synagis does not prevent RSV infection and only potentially reduces the severity of illness should RSV be contracted. With that in mind, I would think that ABT would have a huge interest in adding to its arsenal where this disease is concerned. Red, you make my head hurt with your questions sometimes, but I gotta give you credit for your invaluable insights.
Here is the link to GenVec's presentation on their RSV research from the 9th International Respiratory Syncytial Virus Symposium (posted to GenVec's website within the last 24 hours):
http://content.stockpr.com/genvec/media/e3ecf118d345e00b8e68f5308d96a1b5.pdf
Looks like AARP is on-board:
http://blog.aarp.org/2015/02/04/a-cure-for-hearing-loss/
Gary, you raise some very good questions, and thank you for asking. Perhaps someone here more knowledgeable than myself can provide you with some relevant answers. As for me, I'd prefer to stay within my comfort zone and continue to try to help out by bringing new information to the board as it is uncovered.
Therapeutic potential of adenovirus-mediated delivery of ß-defensin 2 for experimental otitis media
http://ini.sagepub.com/content/21/2/215
Wishing you all the best. Nice going, Gary! So glad to hear of your continued progress.
From the JP Morgan Conference yesterday:
http://www.novartis.com/downloads/investors/event-calendar/2015/jan-12-novartis-jpm-presentation.pdf
(Please see page twelve if this link doesn't take you directly to it).
Good one, Red! You finally got me to laugh (inside) :o)
Colorado TV station news story (for anyone not on FaceBook):
http://www.9news.com/story/news/health/2014/11/29/hearing-loss-gene-therapy/19669727/
New Novartis piece mentioning GenVec (I'm posting this for anyone that might not be on FaceBook):
http://www.novartis.com/stories/discovery/2014-11-hearing-loss.shtml
Thanks, Reds. I'm not so much concerned about the patient's previous medical history. There's no reason to doubt that the physicians in charge have carefully considered all possible angles that might potentially effect the results. I, for one, feel fully confident that this is the case.
Here's the link to the Fox News report: http://fox4kc.com/2014/11/13/first-gene-therapy-to-restore-hearing-tested-in-kansas-city/
GenVec has redesigned their website. Also, please check out their FaceBook page. There is a link to a segment that Fox News just broadcast. We've hit the big time, you guys! GLTA!
Thank you, Gary. Your words of wisdom are always greatly appreciated.
Novartis news on CGF166 from the Philippine Daily Inquirer. http://business.inquirer.net/180879/innovative-treatments-for-diseases-that-commonly-affect-older-people
GenVec climbs on “excellent news” for investors, says H.C. Wainwright
Thursday, October 30, 2014 12:19
(Before It's News)
GenVec (NASDAQ:GNVC) advanced Thursday after H.C. Wainwright analyst Reni Benjamin reiterated his buy rating on the company and 12-month price target of $9.
Shares were currently up 2.3 percent at $1.82 in New York.
On Wednesday, the company announced that the first patient has been treated in a phase 1/2 trial of its lead gene therapy program for hearing loss, partnered with Novartis (NYSE:NVS).
“We believe this announcement should be viewed as excellent news for investors. In our opinion, dosing of the first patient confirms to us that Novartis’ commitment to GenVec and the CGF166 program remains firm,” wrote Benjamin in his note released earlier Thursday.
“While the initiation of the study brings us one step closer to data release, investors should also be aware that event triggers a $3 MM milestone payment to GenVec.
“With the lead program in the capable hands of a conservative and diligent large Pharma partner, multiple milestone payments tied to the advancement of the clinical program, a low annual burn rate, and $15.8 MM in cash (pro forma), we believe GenVec represents an undervalued innovator in the new arena of gene therapy addressing indications with no therapeutic options.”
The company said yesterday that the first patient was dosed with CGF166, an investigational gene therapy involving ATOH1, which is a protein required for formation and differentiation of sensory hair cells. These cells work to convert sound waves into electrical signals, and are typically destroyed in patients with sensorineural hearing loss.
The trial will test the therapy in patients with severe to profound bilateral hearing loss, and is being conducted at three of Novartis‘ investigative sites, GenVec said. Initial results are expected by the second half of next year.
The study will examine safety, dosing and the efficacy of the therapy, and will be divided into three different parts. Patients will be evaluated at weeks one, two and four, and every month following for six months post-treatment.
The H.C. Wainwright analyst noted that preclinical results in mice have indicated success.
He also highlighted that GenVec’s core technology platform should be leveraged through additional collaboration. The company is continuing to seek partners to develop its technology and preclinical vaccine candidates for RSV and HSV. If successful, Benjamin said the company could secure upfront licensing and milestone payments.
Headline released today by Street Insider - Roth Affirms GenVec (GNVC) at 'Buy'; Novartis Partnership is Entering 'Prime Time'.
All things are possible, Grasshopper. . . Only believe!
I hadn't noticed that, but nice work on your part! Not sure what it might mean, though. I just know that all of this waiting is making my head hurt.
New information on status of trial at the Johns Hopkins location. We're getting closer, friends!
https://sites.google.com/site/vestibularneuroengineering/people/joong-ho-ahn
Your diligence and tenacity in helping to uncover important news is much appreciated. I hope you share my gut feeling that we are on the brink of a breakthrough to the upside in PPS. Keep up the good work and one day very soon we will be richly rewarded for our efforts!
No offense taken. Have a nice day.
ok, that was just weird and uncalled for.
Sorry, Red, but I'm no analyst. I can, however, do my part by assisting the research, when time allows.
More patent information from patft.uspto.gov website.
United States Patent 8,765,146
Bruder , et al. July 1, 2014
Adenoviral vector-based malaria vaccines
Abstract
The invention provides adenoviral vectors comprising an adenoviral genome comprising heterologous antigen-encoding nucleic acid sequences, such as Plasmodium nucleic acid sequences, operably linked to promoters. The invention further provides a method of inducing an immune response against malaria in a mammal comprising administering the adenoviral vectors to the mammal.
Inventors: Bruder; Joseph T. (Ijamsville, MD), Kovesdi; Imre (Rockville, MD), King; C. Richter (New York, NY), McVey; Duncan L. (Derwood, MD), Ettyreddy; Damodar R. (North Potomac, MD), Doolan; Denise Louise (Camp Hill, AU), Carucci; Daniel John (Washington, DC)
Applicant:
Bruder; Joseph T.
Kovesdi; Imre
King; C. Richter
McVey; Duncan L.
Ettyreddy; Damodar R.
Doolan; Denise Louise
Carucci; Daniel John
Assignee: GenVec, Inc. (Gaithersburg, MD)
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (Rockville, MD)
The United States of America, as represented by the Secretary of the Navy
Appl. No.: 12/064,554
Filed: August 31, 2006
PCT Filed: August 31, 2006
PCT No.: PCT/US2006/033982
371(c)(1),(2),(4) Date: October 27, 2008
PCT Pub. No.: WO2007/027860
PCT Pub. Date: March 08, 2007
Government Interests
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT
This invention was made in part with Government support under Cooperative Research and Development Agreement (CRADA) Number NMR-04-1869, and amendments thereto, executed between GenVec, Inc. and the Naval Medical Research Center (NMRC). The Government may have certain rights in this invention.
Great news on GNVC's malaria patent filing:
http://www.4-traders.com/GENVEC-INC-7834075/news/GenVec--US-Navy-GenVec-Henry-M-Jackson-Foundation-for-the-Advancement-of-Military-Medicine-Ass-18673996/