Dynavax Technologies Corp (DVAX)

[Zmill]

Some research for y'all, yes it costs this kind of work takes time and all good things cost money https://msmoneymoves.com/2019/05/25/dvax-restructuring-surprise-was-a-sell-off-the-right-reaction/

[ClayTrader]

* * $DVAX Video Chart 05-24-2019 * *

Link to Video - click here to watch the technical chart video

[ClayTrader]

* * $DVAX Video Chart 05-09-2019 * *

Link to Video - click here to watch the technical chart video

[jondoeuk]

ASCO titles https://meetinglibrary.asco.org/record/177869/abstract https://meetinglibrary.asco.org/record/176209/abstract https://meetinglibrary.asco.org/record/176281/abstract

[lakingsphan0427]

After hours news..This is great

Dynavax Announces European Medicines Agency Accepts Marketing Authorization Application for HEPLISAV-B® for Prevention of He...
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Dynavax Technologies Corp. (NASDAQ:DVAX)
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Today : Thursday 28 March 2019

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Dynavax Technologies Corporation (NASDAQ:DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, today announced that the European Medicines Agency (EMA) has accepted the Company's Marketing Authorization Application (MAA) for review of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
This acceptance follows Dynavax's submission of the MAA on March 11 and marks the beginning of the regulatory review process for HEPLISAV-B in the European Union (EU). The outcome of the MAA review by the EMA is expected next year.

"The acceptance of the HEPLISAV-B application for review by the EMA signifies an important milestone in our journey to help prevent hepatitis B in adults through vaccination," said Robert Janssen, M.D., chief medical officer of Dynavax. "Many at-risk adults remain unprotected against this highly infectious virus. HEPLISAV-B has been shown to provide higher rates of protection with fewer doses than currently available vaccines. We hope to make HEPLISAV-B available beyond the U.S. to help address the global hepatitis B public health problem."

In 2017, the U.S. Food and Drug Administration (FDA) approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B was the first new hepatitis B vaccine in the U.S. in more than 25 years and the only two-dose hepatitis B vaccine for adults.

The MAA for HEPLISAV-B is based upon the successful outcomes from three Phase 3 non-inferiority trials of nearly 10,000 adult participants who received HEPLISAV-B. The pivotal studies compared HEPLISAV-B administered in two doses over one month to Engerix-B administered in three doses over a six-month schedule. Results from the largest Phase 3 trial, which included 6,665 participants, showed that HEPLISAV-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. Across the three clinical trials, the most common local reaction was injection site pain (23% to 39%). The most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

For more information about HEPLISAV-B, visit http://heplisavb.com/.

About Dynavax
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax's lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.

Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding HEPLISAV-B and the potential timing of an EMA review decision. These statements are subject to a number of risks, including whether the EMA will find the submission to be complete or whether it will seek further information, including the conduct of additional clinical trials; whether it will complete its review of the MAA within the anticipated timeframe; and whether the outcome of its review will be an approval, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2018, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

Contact:
Heather Rowe
Vice President, Investor Relations & Corporate Communications
[e-mail]
510-665-7269

___________________________________________________

[Small Time Joe]

Beware this could fill the gap created on May 30, 2017 by going down to $6. At the rate things are going it wouldn't surprise me at all.

[lakingsphan0427]

I couldn't resist I added another 300 shares @ 7.48 to my holdings..

Let see if DVAX can turn around because its been painful to see dropped from its highs..

[jondoeuk]

AACR

Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non small cell lung cancer (NSCLC) https://www.abstractsonline.com/pp8/#!/6812/presentation/10037

Interim results of a Phase I/II trial of intratumoral CpG, local low-dose radiation, and oral ibrutinib in patients with low-grade B-cell lymphoma https://www.abstractsonline.com/pp8/#!/6812/presentation/9851

Tumor abscopal responses induced by the TLR9 agonist, SD-101, are strongly potentiated by a HDAC class I inhibitor, domatinostat https://www.abstractsonline.com/pp8/#!/6812/presentation/2506

[jondoeuk]

I'm guessing we won't hear anything until ASH.

[Amatuer17]

Interesting - the 1st trial NCT03410901 for same combination is still going on - for some reason the - 15 patients are still not enrolled. We need to hear some update on that trial.

I was really excited about the 1st trial start after this initial article

https://www.precisionvaccinations.com/combination-tlr-ligand-and-anti-ox40-antibody-cured-multiple-types-cancer-mice?amp

Hope we see similar dramatic results in the trials.

[jondoeuk]

A new trial (NCT03831295) testing SD-101 and BMS-986178 (anti-OX40 mAb) in patients with advanced or metastatic solid malignancies. It is sponsored by Standford

[Small Time Joe]

Good looking day. Something must be happening.

[jondoeuk]

This could be a mess for the company https://www.prnewswire.co.uk/news-releases/vaxelis-new-fully-liquid-paediatric-hexavalent-vaccine-approved-in-the-european-union-569389291.html

[jondoeuk]

That's debatable and if you have listened to some of the cc's and read the SEC filings, it's clear Heplisav-B isn't paying any of the bills and won't be any time soon. I can't see the two PhIII trials happening next year either.

[Small Time Joe]

The street knows all that stuff from past history. What we need are better than expected Heplisav revenue and a partner with big bucks.

[jondoeuk]

I'm hoping they put the TLR7/8 agonist into the clinic soon. In this preclinical study, they show the combination of both has a synergistic effect https://jitc.biomedcentral.com/articles/10.1186/2051-1426-2-12 Treating extremely large tumours of this size is generally considered futile.

Also, if DV281 pans out adding on an inhaled TLR3 agonist should enhance the efficacy of it https://www.tandfonline.com/doi/full/10.1080/2162402X.2015.1040214

[jondoeuk]

AZD1419 update https://www.fiercebiotech.com/biotech/astrazeneca-s-tlr9-oligonucleotide-misses-goal-asthma-phase-2

[Small Time Joe]

They will need a partner, no doubt about that. Only then can they say how long it might take. I'm not a doctor but the science sounds promising anything that can fight that horrible cancer stuff. Hopefully big money feels the same way.

[jondoeuk]

''How long and how much money will it take to get SD101 approved do you think.''

The company doesn't have enough money to run the two pivotal trials they want. I'm hoping data from the from the 2 mg cohort in the SCCHN trial will bring in a partner.

[jondoeuk]

From this: ''Dr. Torrejon and his colleagues attempted to overcome the mechanisms of these resistances with combination therapy. With intratumoral administration of SD-101, a TLR-9 agonist, the JAK1/2 knockout cell lines overcame local resistance to checkpoint inhibition,even in an abscopal manner.'' https://www.targetedonc.com/conference/sitc-2018/two-rapidfire-abstracts-break-down-biomarkers-of-response-and-resistance

[Small Time Joe]

It's been up 3 days in a row, I keeping my eyes on it.

[lakingsphan0427]

You listened/read the CC Joe and you know it sounded very good..

I think you might have missed to get back in that is dirt cheap..I'ts a month and half away til 2019 so still cheap and make good ROI from these prices..

[lakingsphan0427]

Things are progressing on all front.. Love the company's update.. 2019 looking very bright for DVAX..

[Small Time Joe]

Conference call sounds great for the future.

[Small Time Joe]

Very bad sales IMO. See what this settles out before I put any money back into it. GLTA

[Small Time Joe]

Good stuff. I hope someday a cure is found for cancer. How long and how much money will it take to get SD101 approved do you think.

[jondoeuk]

ASH abstract https://ash.confex.com/ash/2018/webprogram/Paper119931.html

[Small Time Joe]

Glad I didn't get back in. This just keeps breaking down through resistance levels. I will wait.

[Small Time Joe]

Not yet. Wish I got back in at $11.35. Need to see things settle some since the price ran up. Challenges still ahead.

[lakingsphan0427]

A nice 360 from $11.35 to $13.04 atm.. Hope you got back in Joe.. Let's see if there's lots of meat into their upcoming financial report..

[lakingsphan0427]

Sometimes I do that with other stocks.. Gotta stick to what you believe in Joe.. GO DVAX!

[Small Time Joe]

Figures I get out and they get great news. Out at $11.43 see when I can get back in. GLTA.

[jondoeuk]

HNSCC data: The ORR was 30.4% in combo with Pembro in PD-1 naive pts (8 mg was the dose). It was 40% at AACR

[Small Time Joe]

I'm out I don't like the charts. See what happens in the future. GLTA.

[Prodigious]

DVAX Presenting data oct 19-23 in Germany.

BERKELEY, Calif., Oct. 09, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ:DVAX) announced today that data will be presented from its ongoing Phase 1b/2 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada). Data will be presented in three individual sessions with data for advanced melanoma patients who are naïve to anti-PD-1 therapy being presented as a late-breaking abstract poster discussion, at the European Society for Medical Oncology (ESMO) 2018 Congress, being held October 19-23, 2018 in Munich Germany.

[Small Time Joe]

Same here. It filled that gap. I should have waited, got back in too early. Now hopefully it stays above that $10.50 level and moves higher.

[lakingsphan0427]

WTF really! I would never of thought it could go back this low

[Kylef]

Would do better above $12, but must stay over $11.07 area

[lakingsphan0427]

Chart or not DVAX is a good investment from here on out.. Been beat up by the street for too long eventually this will comeback with vengeance..Looks like you're looking good with your buys..

[Kylef]

Chart brought me here...looks ready!

[Small Time Joe]

End of the 3rd quarter. Hope sales met expectations.

[jondoeuk]

I'm hoping it will. I know intratumoral injected CDX-301 has been shown to increase a number of DC subsets including pDCs within the TME. This could be used to improve the response rate.

[Small Time Joe]

Sure ain't starting out good.

[Small Time Joe]

Back in at 11.98 see where it goes over the next week. GLTA.

[chmcnfunds]

Back in late yesterday @ $13.05. No longer over-bought and $13.05 has been a good support of recent:



DVAX

[Amatuer17]

It is an interesting approach -

Pd-1 are inhibitors and OX40 are accelerators - theoretically by using PD-1 you remove the brakes and OX40 agonist accelerates. CLR9 like SD-101 helps the process. So this combo really should some good results

[jondoeuk]

It's a shame they aren't injecting the anti-OX40 mAb into the tumour like they did in the preclinical study. If all goes well I hope Dr. Levy gets funding to test the triplet (IT SD-101, anti-CTLA4 and anti-OX40) https://www.jci.org/articles/view/64859

[jondoeuk]

Does anyone know when the data from the PhII of AZD1419 is due?

[lakingsphan0427]

Dynavax Announces Publication of Two Papers in Leading Oncology Journal Highlighting Data From Clinical Studies of Its TLR9 Agonist, SD-101

GlobeNewswire•August 28, 2018


BERKELEY, Calif., Aug. 28, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (DVAX) today announced that two peer-reviewed papers reporting clinical studies of SD-101 have been published by Cancer Discovery, a journal publication from American Association of Cancer Research (AACR). The investigators report clinical activity and broad immune activation in the tumor microenvironment when SD-101 is administered in combination with either low dose radiation in patients with indolent lymphoma or in combination with PD-1 blockade in patients with unresectable or metastatic melanoma. Top-line results from these studies have previously been presented at major oncology conferences.
“Promising data from multiple trials studying intratumoral administration of TLR9 agonists indicate that stimulating the innate immune system through the TLR9 pathway can enhance the adaptive immune response to both injected and non-injected tumors,” said Antoni Ribas, M.D., Ph.D., Director of the Tumor Immunology Program at the Jonsson Comprehensive Cancer Center. “TLR9 agonists are showing potential as an important component of combination immuno-therapy for the treatment of cancer. With further research we hope to realize the full value that this approach can create for immuno-oncology.”
Dr. Ribas is the lead author for the paper titled SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase 1b, Multicenter Study. This trial evaluated 22 patients who received intratumoral SD-101, a synthetic CpG-oligonucleotide that stimulates Toll-like receptor 9 (TLR9), in combination with a PD-1 inhibitor in patients with unresectable or metastatic malignant melanoma. The combination was well tolerated and the most common adverse events related to SD-101 were injection site reactions and transient, mild-to-moderate “flu-like” symptoms. Durable tumor responses were seen in both peripheral and visceral lesions. Among the 9 patients naïve to anti-PD-1 therapy, the overall response rate (ORR) was 78%. The estimated 12 month progression free survival (PFS) rate was 88%, and overall survival (OS) rate was 89%. Among 13 patients having prior anti-PD-1 therapy, the ORR was 15%. These clinical responses were supported by biomarker data indicating the induction of broad immune activation in the tumor microenvironment, including increased NK cells, cytotoxic cells, dendritic cells, B cells and CD8+ T cells and T cell infiltration. Increases in CD4+ and CD8+ T cells generally correlated with tumor responses. The paper can be found online here.
Ronald Levy, M.D., Robert K. and Helen K. Summy Professor in the School of Medicine at Stanford University, is the lead author of the paper titled In situ vaccination with a TLR 9 agonist and local low dose radiation induces systemic responses in untreated indolent lymphoma. It reports on a phase 1/2 multicenter study in which 29 patients received 4 Gy of radiation followed by five weekly intratumoral injections of SD-101 at a single tumor site. The paper can be found online here.
About SD-101
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.
About Dynavax
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], was approved by the United States Food and Drug Administration in November 2017 for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax's lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.

[Small Time Joe]

Good move. I was too chicken. See what happens.