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Dynavax Technologies Corporation (DVAX)
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Valneva starting with mass production ... Emergency use authorization highly probable
Biological E and Serum Institute are private firms. Our two other Covid vaccine partners, Medigen Vaccine Biologics and Valneva are listed firms and their share prices have witnessed a 300% to 400% surge in the past 12 months
The reason that Medicago and Clover Biopharmaceuticals both favored GSK's adjuvant to Dynavax's is Most probably the side benefits of collaborating with an industry leader. Sinovac didn't use any adjuvant except Alum in its vaccine and ended up with an effectiveness of just over 50%. It is now selling the vaccine very cheap but they would not be able to sell any of it later on when more effective vaccines hit the market in plenty
All of our four Covid vaccine partners may apply and receive emergency use approval. Medigen has stated that would apply for it at the end of Q2 2021. Biologica E is in advanced clinical trials and may approach the drug controller for emergency use approval according to the Indian health ministry
Indian Bharat Biotech's Covid vaccine (the so-called Covaxin) finished phase 1 and 2 with promising results in India. Out of nowhere the American microcap Ocugen jumps in on a partnership with them for phase 3 and receives vaccine's US rights. I think Dynavax can do the same. Biological E and Medigen both have other US collaborators besides Dynavax which can be of use in doing so (Baylor college and NIH respectively)
Building off of Joel's positive comments about the Dynavax "H. C. Wainwright BioConnect 2021 Conference" presentation from the other day, I just watched it and there are big things coming up! I loved the messaging of Heplisav and the 2 doses in one month compared to the current three doses in six months of competitors - with the low overall completion rate of the three dose in six month regimens. It's all over the slides and mentioned often. Bravo on that! Quick takeaways - Valneva contract alone will bring in $130Mill with the first batch of 60 million doses for the UK, with upwards of $230Mill if they supply all 100 million doses in 2021. Based on my math, that equates to $2.30 per dose of CpG 1018...very reasonable number I think we would all agree with. These numbers only represent the work with Valneva, so there is huge potential into this year and beyond 2021 even if one only considers Valneva, yet we know there are many other partnerships Dynavax is involved in with other covid vaccines in progress (Medigen, Clover, BioE, Serum Institute of India etc).
European plan will begin with Germany, and Spencer mentioned working with an established distributor.
Dynavax also mentions a goal for 2021 to out license Heplisav-B in China. First I heard of that, and I imagine China has some use for Heplisav with just around 1.4 billion people running around.
They also go through the operation losses of $13.8mill in Q3 2020 compared to $30mill operation loss in Q3 2019. This was promised last year, and they have definitely delivered on that....SD-101 etc.
Term loan was mentioned and at $180Mill...it was amended again to include CpG 1018 and is now due Dec 2023. If this thing gets paid off in 2021/2022, I am not even sure if I can comprehend what that does for the share price.
The slide show is on the Dynavax site, and I will link to it in a reply below (if it allows me to post). There is much more to discuss, but for now just wanted to get something up. The current dvax market cap at $550Mill seems incredibly low based on all of these numbers.
**the news about J&J single dose vaccine was announced at 5pm EST today and may, or may not, challenge other covid vaccine company share prices...if it does, I would think it opens another opportunity to buy dvax at a lower price. If it doesn't go lower, then investors may now be aware of Dynavax, Heplisav, and their CpG 1018 "broad vaccine adjuvant platform" mentioned in the presentation.
News from 6 am presentation. Heplisav B highest quarterly sales since launch, rapid growth in IDN market, but most important, CDC Advisory Committee on Immunization Practices may consider universal Hep B vaccination. Also, multiple collaborations for CPG 1018 in progress. Covid 19, producing revenue, and TDAP and universal flu vaccine. Revenue from Hep B, Valneva coming in 2021. Standard of care for a universal vaccine would be impressive going forward.
Today, the European Commission concluded exploratory talks with the pharmaceutical company Valneva with a view to purchasing its potential vaccine against COVID-19. The envisaged contract with Valneva would provide for the possibility for all EU Member States to purchase together 30 million doses, and they could further purchase up to 30 million more doses.
Market closed Monday for MLK....you'll hafta wait until Tuesday to load-up on DVAX shares.
I rate DVAX one of the best buys in the market, right now.....another is FIS, as their merger fell apart.
Today the 50 day moving average is crossing the 100 day moving average....which historically is the start of a big run fir DVAX.
Some Covid vaccines in development:
1. Further strengthening its fight against COVID-19, Serum Institute of India (SIIPL), the world's largest vaccine manufacturer by volume, has partnered with Dynavax Technologies Corporation (Nasdaq: DVAX) a biopharmaceutical company focused on developing and commercializing novel vaccines, and today jointly announced that the first participants have been dosed in the Phase 1 part of the Phase 1/2 clinical trial evaluating SIIPL's vaccine candidate adjuvanted with CpG 1018 to prevent COVID-19.
2. Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that MVC has obtained a Taiwan government subsidy for successfully initiating a Phase 1 clinical trial in Taiwan. The first participant in MVC's Phase 1 clinical trial was dosed with MVC's COVID-19 vaccine combined with Dynavax's CpG 1018 adjuvant at National Taiwan University Hospital in early October. The subsidy will be released at agreed upon milestones in the total amount of up to NT$ 472 million (US$ 16.4 million). The grant received by MVC was earmarked by the Taiwan government for purposes of research and development of a locally produced COVID-19 vaccine.
3. Herblain (France), Emeryville (U.S.), April 22, 2020 – Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced their collaboration to initiate a vaccine program for the current coronavirus, COVID-19.
4. Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, announced today that the first participants have been dosed in the Phase 1 clinical trial to evaluate Clover Biopharmaceuticals’ vaccine candidate to prevent COVID-19 that contains the Company’s CpG 1018 adjuvant.
In this previously announced collaboration, Clover is advancing its COVID-19 S-Trimer vaccine (SCB-2019), which is based on Clover’s proprietary Trimer-Tag© vaccine technology platform, while Dynavax is providing the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018.
* NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and the Icahn School of Medicine at Mount Sinai (“Mount Sinai”) today announced they have entered into a collaboration to develop a universal influenza (flu) vaccine. Mount Sinai’s current work in this area is funded under a contract award from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), as part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program established by NIAID. The Mount Sinai CIVICs team will evaluate a novel approach they have developed called chimeric hemagglutinin (cHA) designed to protect against all strains of influenza in combination with Dynavax’s CpG 1018TM adjuvant
NEWS ! HERES YOUR DATA!
EMERYVILLE, Calif. , Jan. 7, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced final immunogenicity and interim safety results of the ongoing clinical trial evaluating HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis.
Final immunogenicity data in 119 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) undergoing hemodialysis, demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintain protection in patients undergoing hemodialysis. Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed. Full safety data are expected by the end of 2021.
"We are pleased with these positive results from the ongoing hemodialysis trial which reinforce the existing clinical data regarding the safety and ability of HEPLISAV-B to provide high rates of protection," commented Robert Janssen , MD, Chief Medical Officer at Dynavax . "We believe the 4-dose regimen of HEPLISAV-B, we are evaluating in this study, can provide an important hepatitis B vaccination alternative for patients undergoing hemodialysis by delivering high levels of protection with fewer doses compared to the current standard of care which requires up to 8 injections to complete the regimen."
After Britain, EU is also seeking purchase contract with Valneva
Multiple “shots on goal” for CpG 1018 in adjuvanted vaccine product candidates
Collaborator Indication Development
Preliminary safety and immunogenicity results expected early Q1;
Phase 2 clinical trial expected to start mid Q1
Clover Bio Phase 1
complete Pivotal Phase 2/3 clinical trial expected to start 1H21
Biological E. Limited Phase 1/2
ongoing Phase 1/2 initiated November 2020; results expected February 2021
Serum Institute of India Phase 1/2
ongoing Phase 1/2 initiated December 2020
Valneva SE Phase 1/2
Commercial supply agreement announced under which Dynavax will
provide CpG 1018 to produce up to 190 million doses over a four-year
period to support Valneva's contract with the U.K. government;
Phase 1/2 initiated December 2020; results expected early Q2 21
Serum Institute of India TdaP Preclinical Completion of Phase 1-enabling animal studies and toxicology
Mount Sinai Universal and
Seasonal Flu Preclinical Phase 1 clinical trial expected to begin in 202
U.S. FDA approved, 2-dose adult hepatitis B vaccine
Positioned to become the standard of care for adults in U.S.
Addresses potential $600 million market opportunity in U.S.
CHMP positive opinion on HEPLISAV-B European MAA
― Final approval expected Q1 2021
Advanced adjuvant contained in FDA approved HEPLISAV-B
Utilized in multiple vaccine approaches across varied
indications, including COVID-19, pertussis and universal flu
Valneva COVID-19 commercial supply agreement expected to
provide $130-$230 million in revenue to Dynavax in 2021
I've just seen DVAX's video-presentation (
) and I must say I was rather pleased with the CEO and CFO's confidence for 2021.
This stock has all the conditions to make a 400% ride to the $20s.
I cannot imagine being a DVAX sales rep calling of Dr. offices that do huge amounts of work with GSK and you are trying to get your foot in the door. Uphill battle all the way. But shame on the doctors who continue to prescribe a vaccine that requires 3 shots, over 6 months, that has a huge built in failure rate because the third shot does not get taken. This is criminal.
Preclinical data from Medigen.
In the current study, we applied our adjuvanted stable prefusion SARS-CoV-2 spike (S-2P)-based vaccine, MVC-COV1901, to hamster models to demonstrate immunogenicity and protection from virus challenge. Golden Syrian hamsters immunized intramuscularly with two injections of 1 μg or 5 μg of S-2P adjuvanted with CpG 1018 and aluminum hydroxide (alum) were challenged intranasally with SARS-CoV-2. Prior to virus challenge, the vaccine induced high levels of neutralizing antibodies with 10,000-fold higher IgG level and an average of 50-fold higher pseudovirus neutralizing titers in either dose groups than vehicle or adjuvant control groups. Six days after infection, vaccinated hamsters did not display any weight loss associated with infection and had significantly reduced lung pathology and most importantly, lung viral load levels were reduced to lower than detection limit compared to unvaccinated animals.
Novavax next in line to offer COVID-19 vaccine alternatives - SVB Leerink
Jan. 05, 2021 12:27 PM ETGlaxoSmithKline plc (GSK)By: Dulan Lokuwithana, SA News Editor1 Comment
Despite a setback to GlaxoSmithKline (NYSE:GSK)/Sanofi (NASDAQ:SNY) in their COVID-19 vaccine development, Novavax (NASDAQ:NVAX), using a similar vaccine platform, will be the first to offer key late-stage data giving an alternative to recently approved vaccines against COVID-19, SVB Leerink predicts. The shares have resumed last year's dream run, rising 4.5% today.
In December, the mRNA-based vaccines from Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) received the FDA’s emergency use authorization. And Sanofi/ GSK partnership, citing an insufficient immune response in older adults, announced a delay in their protein-based COVID-19 vaccine program.
Despite subunit vaccines are considered the ‘lowest risk among the alternatives,’ the setback to GSK/Sanofi ‘has eroded the analysts’ confidence.
However, “further inquiries into the other leading programs in this category (Novavax’s NVX-CoV2373 and Clover’s SCB-2019) have reassured us that they are still viable alternatives to the mRNA programs, with clear operational advantages once they come to market” continues the note.
If Novavax demonstrates 90%+ efficacy as mRNA vaccines, they can be “more confident about all adjuvanted protein vaccines specifically and of course about NVXCoV2373 particularly,” argue the analysts.
In early December, Clover Biopharmaceuticals announced positive early-stage clinical data for its protein-based COVID-19 candidate adjuvanted with either CpG 1018 plus alum from Dynavax (NASDAQ:DVAX) or GSK’s pandemic adjuvant system.
Shorts are going to cover real soon.....5.20 - 5.25 - get ready for the gap-up to the 5,75 level, although that's really not a gap-up by definition, but it'll do for now.
Trying to create my own press release - since Medigen translates to "high end", there is no translation from Chinese that actually uses the word "Medigen". So here ya go - it's been blocked a few times already.
Medigen Approved for Phase 2: Dec 30th, 2020 - translated from the very nice ETToday website.
"Medigen (6547) announced today (30) that the new coronavirus (MVC-COV1901) is under development and has been approved by the Food and Drug Administration (TFDA) of Taiwan’s Ministry of Health, and the second phase of human clinical trials of the new coronary pneumonia vaccine can be implemented. Taiwan's first domestic vaccine approved for Phase II clinical trials.
Medigen said the new coronavirus vaccine development projects switched U.S. National Institutes of Health (the NIH), Construction of S-2P length gene trimer structure presentation modified recombinant spike protein as a vaccine antigen, and screening the candidate vaccine composition, now The pre-clinical drug toxicology test and hamster challenge test have been completed, and the interim analysis report of the first phase human clinical trial has been completed.
Medigen pointed out that on December 15 it submitted an application for the second phase of human clinical trial to the Food and Drug Administration (TFDA). After review and evaluation by the TFDA expert meeting, it officially obtained the second phase of the TFDA clinical trial license, and was developed in response to the emergency use of the vaccine. , And will discuss with the regulatory authorities in the follow-up on the analysis schedule of the second phase of the trial in order to apply for the emergency use authorization of the vaccine.
In Medigen's vaccine plan, the second phase of the new crown vaccine will accept about 3,700 people at the window. It is expected that 600 people over 65 years old and 300 people from 12 to 18 years old will be admitted. The acceptance will be completed as soon as the first quarter of next year and will be completed in 12 After the completion of the medical center and hospital, if the follow-up test is successfully completed, it is expected to obtain Taiwan’s emergency use authorization before the end of June next year to supply Taiwan with 1 million doses of the new crown vaccine."
**Dynavax is providing their Cpg 1018 adjuvant to this project.
Great stock. Everything points to be on the verge of a rally
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