Dynavax

5 replies [Last post]
By JudyH on Sat, 11-01-03, 23:41

Does anyone know anything about the immunotherapy Dynavax ([url]http://www.dynavax.com[/url]) is developing?

I contacted them just recently. I was told they are looking for participants to give blood for their study. However, they are located in Northern California and need the blood to get to them within two hours. I am in Southern California, too far to get the blood there in time. Anyone of you up in No. Ca. may want to look into this.

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By Nutternomore on Sun, 11-02-03, 06:26

JudyH,

Thanks for raising attention to the work of this company.

I hadn't heard about it, but reviewed their site for some info.

Some interesting info gleaned from the site:

[i]Background on the technology[/i]: Our principal product development efforts are based on a technology that uses short synthetic DNA molecules known as ISS that stimulate a Th1 immune response while suppressing Th2 immune responses. ISS contain specialized sequences that activate the innate immune system. ISS are recognized by a specialized subset of dendritic cells containing a unique receptor called Toll-Like Receptor 9, or TLR-9. The interaction of TLR-9 with ISS triggers the biological events that lead to the suppression of the Th2 immune response and the enhancement of the Th1 immune response.

We believe ISS have the following benefits:

ISS work by reprogramming the immune responses that cause disease rather than just treating the symptoms of disease.

ISS influence helper T cell responses in a targeted and highly specific way by reprogramming only those T cells involved in the disease pathway. As a result, ISS do not alter the ability of the immune system to mount an appropriate response to infecting pathogens. In addition, because TLR-9 is found only in a specialized subset of dendritic cells, ISS do not cause a generalized activation of the immune system, which might otherwise give rise to an autoimmune response.

ISS, in conjunction with an allergen or antigen, establish populations of memory Th1 cells, allowing the immune system to respond appropriately to each future encounter with a specific pathogen or allergen, leading to long-lasting therapeutic effects.
We have developed a number of proprietary ISS compositions and formulations that make use of the different ways in which the innate immune system responds to ISS. Depending on the indication for which ISS is being explored as a therapy, we use ISS in different ways.

[i]Description of Peanut Allergy efforts[/i]:

Peanut Allergy
Commercial Opportunity
Peanut allergy accounts for the majority of severe food-related allergic reactions. Approximately 1.5 million people in the U.S. have a potentially life-threatening allergy to peanuts, with an estimated 50 to 100 deaths occurring in the U.S. each year.

Current Peanut Allergy Treatments and Their Limitations
There are currently no products available that prevent peanut allergy. People allergic to peanuts must carefully monitor their exposure to peanuts and peanut byproducts. Emergency treatment following peanut exposure and the onset of allergic symptoms primarily consists of the administration of epinephrine to treat anaphylaxis. A clinical trial conducted by an academic research institution that attempted to desensitize patients with peanut allergy through conventional immunotherapy was halted due to the occurrence of a serious adverse event.

Our Approach to the Treatment of Peanut Allergy and its Benefits
We believe that ISS linked with the principal peanut allergen, Ara h 2, may be able to suppress the Th2 response and reduce or eliminate the allergic reaction without inducing anaphylaxis during the course of immunotherapy. Our primary advantage in this area is the potentially increased safety that may be achieved by linking ISS to the allergen. By using ISS to block recognition of the allergen by IgE and therefore prevent subsequent histamine release, we may be able to administer enough of the ISS-linked allergen to safely reprogram the immune response without inducing a dangerous allergic reaction. We believe the resulting creation of Th1 memory cells may provide long-term protection against an allergic response due to accidental exposure to peanuts.

Preclinical Status
We are developing a peanut allergy product candidate that consists of ISS linked to the major peanut allergen, Ara h 2. We have demonstrated in mice that peanut allergen linked to ISS induces much higher levels of Th1-induced IgG antibodies and much lower levels of IgE than natural peanut allergen. ISS-linked Ara h 2 also induces much higher levels of interferon-gamma and much lower levels of IL-5 than unmodified Ara h 2 in mice. Immunization with our product candidate has also been shown to protect peanut-allergic animals from anaphylaxis and death following exposure to peanuts. In addition, we have demonstrated that ISS-linked Ara h 2 has significantly reduced allergic response as measured by in vitro histamine release assays using blood cells from peanut-allergic patients.

I also noted that they are positioning themselves for an IPO, and have a few other things "in the pipeline" that are at the last stages of clinical trial.

Would be great if they can keep the $$'s flowing in to be able to move forward with trials in the peanut allergy arena and avoid the mistakes made by Tanox (who can't pursue TNX-901 w/o agreement from their partners).

Surely something to keep an eye on [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

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By Nutternomore on Mon, 02-23-04, 07:37

Saw a small blurb in the Business section of my newspaper last Thursday...

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Dynavax Technologies Corp. (DVAX), a company that develops therapies for allergies, infectious diseases and inflammatory diseases, raised $45 million in an initial public offering Wednesday.

Dynavax sold 6 million shares at $7.50 each, less than the $12 to $14 per share range indicated in its filing with the Securities and Exchange Commission. Bear Stearns Cos. managed the offering and shared fees of as much as $3.2 million with Deutche Bank Securities Inc. and Piper Jaffray Cos., which also helped to arrange the sale.

The company, based in Berkeley, intends to use proceeds to conduct clinical trials for its drugs.

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By Heather2 on Wed, 08-18-04, 21:12

I think what this company is developing can actually be considered a "vaccine" where what Tanox is developing is considered a "treatment". Someone correct me if I'm wrong. With Tanox's treatment, our children will have to get a maintenance shot. With Dynavax's vaccine they will get a one time shot.

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By Nutternomore on Mon, 11-29-04, 20:21

Very interesting! Go Dynavax!
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[url="http://www.pharmalive.com/News/index.cfm?articleid=190376&categoryid=15"]http://www.pharmalive.com/News/index.cfm?articleid=190376&categoryid=15[/url]
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[b]Dynavax Peanut Immunotherapy Inhibits Allergic Response in Preclinical Studies[/b]

BERKELEY, Calif., November 15, 2004 /PRNewswire-FirstCall/ -- Dynavax Technologies (NASDAQ [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]VAX) presented data from preclinical models showing that the company's immunostimulatory sequence (ISS)-based peanut immunotherapy demonstrated potent inhibition of harmful allergic responses and induction of therapeutic immune responses to peanut allergen. The data suggest that Dynavax' peanut allergy product candidate, which consists of ISS linked to the peanut allergen, Ara h 2, has the potential to be a safe and attractive candidate for therapy in peanut allergic subjects. There are currently no products available that prevent peanut allergy. In vivo testing of peanut immunotherapy products poses the risk of anaphylaxis, and most research has been done in animal models or in vitro. Approximately 3 million Americans have peanut or tree nut allergies.
The data showed that ISS linked to Ara h 2 administered to non-sensitized mice resulted in inhibition of immunoglobulin G1 (IgG1) and interleukin-5 (IL-5), mediators associated with the harmful Th2 pathway that causes allergic response, and induction of IgG2a and Interferon gamma (IFNg), mediators associated with the protective Th1 immune response pathway. In vitro data showed that linking Ara h 2 to ISS reduced histamine release from blood cells from peanut allergic subjects and inhibited binding to IgE, findings that correlate with inhibition of allergic response. These results are consistent with the mechanism of action of ISS in reprogramming the immune system via the stimulation of the Th1 pathway and suppression of the Th2 pathway, and suggest that ISS linked to Ara h 2 has potential utility as a peanut allergy therapeutic.

"We believe that our ISS-based peanut allergy immunotherapeutic addresses the major challenge in treating this deadly allergy, namely, the ability to mask presentation of the allergen and promote a Th1 response, thus effectively transforming the allergen into a drug," said Dino Dina, MD, president and chief executive officer of Dynavax. "As these preclinical data suggest, by using ISS to block recognition of the Ara h 2 allergen by IgE and prevent subsequent histamine release, it may be possible to reprogram the immune response without inducing an allergic reaction. In addition, we believe the resulting creation of Th1 memory cells may provide long-term protection against an allergic response due to accidental exposure to peanuts. Our hope is to advance this promising program toward initiating a clinical study in the near future."

The data were presented at the annual meeting of the American College of Allergy, Asthma and Immunology, in a poster entitled, "Immunogenicity and Allergenicity of Ara h 2 Linked to Immunostimulatory DNA."

Study Results

In this study, ISS was linked to the Ara h 2 protein in two ratios: peanut ISS conjugate (PIC) consists of an average of two ISS linkages, and heavy peanut ISS conjugate (HPIC) consists of an average of four ISS linkages. Immunogenicity, or the ability to induce an immune response, was tested by administering PIC, HPIC or Ara h 2 to non-sensitized mice (two immunizations of 5 micrograms). Animals immunized with PIC showed significantly enhanced IgG2a responses and strong IFNg responses, indicative of Th1-type responses, while mice immunized with Ara h 2 elicited predominantly IgG1 and IL-5 responses, indicative of a Th2-type response. HPIC immunized mice elicited little antibody response, possibly due to B-cell epitope blockage, but did induce IFNg responses.

Allergenicity, or the ability to induce an allergic response, was also tested in a histamine release assay using blood cells from peanut allergic donors. In cells treated with low levels of Ara h 2 (0.01 nanograms per milliliter), histamine release was detected. A 10-fold higher concentration of PIC (0.1 nanograms per milliliter) was required to detect histamine release. At HPIC concentrations up to 1000-fold higher (10 nanograms per milliliter), histamine release was undetectable. A similar trend was shown in an IgE binding competition assay. The results suggest that antigen-ISS vaccines may be safe and attractive candidates for therapy in allergic subjects.

About ISS

ISS are short synthetic DNA molecules that stimulate a Th1 immune response while suppressing Th2 immune responses. ISS contain particular sequences that activate the innate immune system. ISS are recognized by a specialized subset of dendritic cells containing a unique receptor called Toll-Like Receptor 9, or TLR-9. The interaction of TLR-9 with ISS triggers the biological events that lead to the suppression of the Th2 immune response and the enhancement of the Th1 immune response. ISS influence helper T cell responses in a targeted and highly specific way by redirecting the response of only those T cells involved in a given disease. ISS, in conjunction with an allergen or antigen, establish populations of memory Th1 cells, allowing the immune system to respond appropriately to each future encounter with a specific pathogen or allergen, leading to long-lasting therapeutic effects.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. ISS are being developed in three initial indications: ragweed allergy immunotherapeutic, currently in a Phase 2/3 clinical trial; a Hepatitis B vaccine that has completed a Phase 2 clinical trial; and an asthma immunotherapeutic that has completed a Phase 2 exploratory trial.

Under the terms of an agreement established in 2004 with UCB Farchim, S.A., a subsidiary of UCB, S.A., a publicly traded multi-national company based in Brussels, Belgium, UCB has an option to license Dynavax' peanut allergy program.

Dynavax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to plans to advance its peanut allergy program toward clinical trials, to advance its clinical programs in ragweed allergy, hepatitis B and asthma, and to demonstrate the potential of its ISS technology. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward- looking statements should not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Dynavax's business including, without limitation, risks relating to: the progress and timing of advancing its peanut allergy program into clinical testing; the progress and timing of its clinical trials in ragweed allergy, hepatitis B and asthma; difficulties or delays in developing, testing, obtaining regulatory approval of, producing and marketing its products; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to maintain effective financial planning and internal controls; and other risks detailed in the "Risk Factors" section of Dynavax's Annual Report on Form 10-K filed on June 30, 2004, and in the section titled "Additional Factors That May Affect Future Results" within Dynavax's quarterly report on Form 10-Q filed on November 8, 2004. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Dynavax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

CONTACT: Jane M. Green, Ph.D., Vice President, Corporate Communicationsof Dynavax Technologies Corporation, +1-510-665-4630, or [email]jgreen@dvax.com[/email]

Web site: [url="http://www.dynavax.com/"]http://www.dynavax.com/[/url]

Ticker Symbol: (NASDAQ [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]VAX)

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By synthia on Mon, 11-29-04, 21:11

[url="http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20041129005042&newsLang=en"]http://home.businesswire.com/portal/site...042&newsLang=en[/url]

Dyax Corp. Grants Use of its Antibody Phage Display Libraries to Tanox, Inc. for Therapeutic Antibody Development

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 29, 2004--Dyax Corp. (Nasdaq: DYAX) announced today that it has granted a non-exclusive license to its proprietary antibody phage display libraries to Tanox, Inc. Tanox, which specializes in the development of biotherapeutics for asthma, allergy, oncology, inflammation and infectious disease, intends to utilize the Dyax libraries to identify fully human monoclonal antibodies that bind with high specificity and affinity to a number of its undisclosed targets. Under the terms of the agreement, Dyax will receive an up front license fee, annual technology license fees, clinical milestone payments, and royalties upon successful commercialization by Tanox of products based on antibodies identified from the Dyax libraries.

"We are very pleased to provide Tanox with a license to our high quality antibody libraries, which we expect will yield promising leads. The agreement contributes to Dyax's objective of leveraging our core technology to generate revenue, and is the seventh antibody collaboration that Dyax has entered into this year," stated Henry E. Blair, Chairman, President and CEO of Dyax Corp.

About Dyax

Dyax Corp. is a biopharmaceutical discovery and development company focused on advancing novel therapeutics for unmet medical needs, with an emphasis on cancer and inflammatory indications. Dyax integrates the discovery and clinical development of its antibody, small protein and peptide compounds, with a goal of product commercialization.

DX-88 and DX-890 are recombinant small proteins discovered at Dyax that are currently in Phase II clinical development for their therapeutic potential in three separate indications: hereditary angioedema (HAE), cystic fibrosis (CF) and open heart surgery, specifically on-pump coronary artery bypass grafting (CABG) procedures. Both compounds have orphan drug designation in the US and EU, and DX-88 has Fast Track designation in the US for the treatment of HAE.

Both DX-88 and DX-890 were identified using Dyax's patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. This powerful discovery engine is being used to build a pipeline of drug candidates that may be advanced into clinical development by Dyax and/or in partnership with other companies. Dyax leverages its technology broadly with over 75 revenue-generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents.

Dyax is headquartered in Cambridge, Massachusetts, and has antibody discovery facilities in Liege, Belgium. For online information about Dyax Corp., please visit [url="http://www.dyax.com."]www.dyax.com.[/url]

Dyax Disclaimer

This press release contains forward-looking statements, including statements regarding the expected benefits of Dyax's license to Tanox, Inc. Statements that are not historical facts are based on Dyax's current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the expected benefits of Dyax's license to Tanox include the risks that: Dyax's future benefits from its non-exclusive licensing program depend on the efforts and priorities of its licensees, such as Tanox, which may be subject to changes in the licensee's business direction or priorities; others may develop technologies or products superior to Dyax's phage display technologies; Dyax may not be able to obtain and maintain intellectual property protection for technologies; and other risk factors described or referred to in Dyax's most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law. Dyax specifically disclaims responsibility for information describing Tanox and its business other than the license with Dyax. Dyax and the Dyax logo are the registered trademarks of Dyax Corp.

Contacts

Dyax Corp.
Sondra Henrichon, (617)250-5839
Director Investor Relations and Corporate Communications
[email]shenrichon@dyax.com[/email]

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