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  1. Today
  2. Looks like good news for CSIQ's bi-facial modules - staying duty-free.
  3. That guidance doesn't cut it, they'll end up in the red without one-timers / adjustments: Q2 projection: Rev: $655M GM: 19.5% GP: $127.7M OPEX: $115M INT: $17M EBT: -$4M NI: $-3M EPS: -$0.05 Did somebody order toast?
  4. COVID-19: the race to find a vaccine How biopharma is working to bring an end to the pandemic COVID-19 has sparked an unprecedented shift in R&D. In the weeks after the novel coronavirus was identified and sequenced, businesses and academic groups around the world scrambled to identify drugs and vaccines against the pathogen, using existing molecules and novel platforms to truncate development. The question now is which pieces of the multi-front assault will work, and when. As a novel coronavirus, SARS-CoV-2 poses some challenges to rapid-response R&D programmes. When H1N1 threatened the world, GlaxoSmithKline based a vaccine on an existing mock-up to win approval within three months of the World Health Organization (WHO) declaring a pandemic. Such shortcuts are unavailable to teams targeting SARS-CoV-2. In the absence of an almost off-the-shelf solution, researchers are digging into the development toolkit in search of near- to longterm fixes, scouring libraries of existing molecules for ways to kill the virus and manage the symptoms while starting from scratch on products that could deliver the final blow to the pandemic. The first wave The most advanced programmes feature drugs that have already been tested in humans and in some cases came to market prior to the pandemic. In repositioning such drugs for use against COVID-19, organisations skipped the preclinical stage to quickly enter the clinic. This group of drugs, which represent the best near-term chance of improving outcomes, can be split into several subcategories, notably antivirals, immunomodulators and supportive care. The antiviral subcategory is a key focal point, with drugs such as Gilead Sciences’ remdesivir being tested in tens of trials and attracting the attention of the general public and world leaders. Remdesivir, a failed Ebola drug, is closing in on read-outs from trials, although the cessation of studies in China due to enrolment issues has extended the wait for data. The importance of the drug to a world paralysed by COVID-19 is such that a leaked report of an encouraging, incomplete snapshot of data from a remdesivir trial sent the Dow Jones Industrial Average up by 3%. A subsequent leak about the apparent failure of remdesivir in a Chinese trial then dampened expectations again. Other antivirals including hydroxychloroquine – a drug championed by President Donald Trump – and favipiravir are also in clinical development, raising hopes that researchers will find a drug with some level of efficacy in the pre-pandemic library of molecules. Yet, it is unlikely that any of the drugs will be a panacea, with Jefferies analysts saying remdesivir “might be modestly helpful”. In the absence of a knockout antiviral, researchers are trying to mitigate harmful effects of the virus. Roche, for example, is running a phase 3 trial to test whether Actemra improves outcomes by dampening hyperinflammation. The interleukin-6 receptor antagonist is approved for use in indications including the management of cytokine release syndrome in CAR-T patients. A third set of studies is assessing supportive care drugs. Nitric oxide is being tested in a handful of trials on the grounds that it may counter oxygen deficiency. With regulators keen to move quickly, positive data from trials of antivirals, immunomodulators and supportive care drugs could support approvals this year. A bigger blow The availability of molecules that have already undergone clinical testing in other indications gives the world a shot at improving outcomes today. However, new molecules, notably virusneutralising antibodies, may ultimately prove to be more effective. Neutralising antibodies are key to the natural immune response against all viruses. Antibodies bind to viruses to stop them entering host cells, leading physicians to use serum from previously infected patients in infectious disease treatments from more than 100 years ago. Scientists have since industrialised the concept, leading to the development of antibodies against Ebola and respiratory syncytial virus. The same approach may work against SARSCoV-2. Regeneron Pharmaceuticals, leveraging a platform that spawned an Ebola treatment, is leading efforts to show that antibodies can neutralise SARS-CoV-2. A clinical trial of Regeneron’s drug is scheduled to start in June. A pack of other antibody programmes involving companies including Amgen, AstraZeneca, Eli Lilly and GlaxoSmithKline is following closely behind, with multiple clinical trials scheduled to start over the summer. If successful, the programmes could fill two gaps in the armamentarium. Firstly, an effective antibody could improve outcomes in patients infected with SARS-CoV-2, preventing deaths and helping people to recover faster or avoid mechanical ventilation. Secondly, the antibody could be used prophylactically, protecting healthcare workers and other key groups against SARS-CoV-2. The significance of those use cases in the global effort to get a handle on COVID-19 has led to calls to bring an anti-SARS-CoV-2 antibody to market by the autumn. Doing so would make it easier for countries to lift economies out of self-induced comas without overwhelming healthcare systems or causing another spike in deaths. Pandemic endgame SARS-CoV-2 will remain a threat until a significant proportion of people are immune. Global lockdowns mean natural exposure to the virus is unlikely to result in herd immunity any time soon, making vaccines the best hope of achieving population-scale protection against SARS-CoV-2. The race to get a vaccine to market is advancing on multiple fronts. Moderna was the first group to test a vaccine in humans, using its mRNA platform to enter the clinic in record time. BioNTech, CureVac and Translate Bio are also working on mRNA vaccines, while Pfizer and Sanofi are involved in those programmes through partnerships with BioNTech and Translate Bio, respectively. Moderna thinks its vaccine could be available to healthcare professionals as early as the autumn, but the accepted timeline for widespread use runs into 2021 and beyond. The fact that many people have fairly mild symptoms means there may be reticence to use a vaccine in low-risk groups until the safety record is proven. There is also a risk that mRNA vaccines will be ineffective. The idea of inducing immunity by delivering genetic material that encodes for viral proteins is largely untested. No mRNA vaccines are approved but with the WHO reporting that nine are in development for use against COVID-19, that could change as a result of the pandemic. The pandemic could also serve as a proving ground for DNA plasmid vaccines. Inovio Pharmaceuticals began testing its plasmid candidate in humans in April, putting it at the head of a pack of six groups that have DNA vaccines in development. No DNA vaccines are approved. Other groups are applying marginally more established technologies to SARS-CoV-2. China’s CanSino Biological is running phase 1 and 2 clinical trials of an adenovirus type 5 vector vaccine candidate. The same platform underpins CanSino’s Ebola vaccine that won approval in China in 2017. Multiple groups are advancing vaccines based on similar technology. University of Oxford researchers are enrolling volunteers in a trial of its adenovirus vaccine, while Johnson & Johnson and the US government have a $1 billion adenovirus vector vaccine collaboration. Around half the vaccines tracked by the WHO use one of the aforementioned approaches. Vaccines based on established approaches, such as the delivery of protein sub-units, are in development but are less advanced than the nucleic acid candidates. If the novel approaches confer limited immunity, there may be a role for vaccines based on established technologies in neutralising the SARS-CoV-2 threat. Upcoming approvals Many of the drugs now in the clinic may present underwhelming results, and the vaccines that could end the pandemic are likely to be at least a year away from widespread use and are based on unproven technology. Sceptical voices such as SVB Leerink analyst Geoffrey Porges think a 2-3 year wait is more realistic. However, the breadth of the R&D response to COVID-19, coupled with the willingness of regulators to fast-track programmes, creates the chance that the back half of 2020 will be punctuated by a string of approvals of drugs that improve outcomes in patients infected with SARSCoV-2. Pharmacological responses to COVID-19 are coming, but it may be some time before the pharmacological fix arrives. Nick Taylor is a journalist specialising in the life sciences industry 27th May 2020 http://www.pmlive.com/pharma_intelligence/COVID-19_the_race_to_find_a_vaccine_1340763
  5. Earnings out. Great EPS. Q2 guidance looks very strong compared to Q1 for volume shipments. Gross margins are nice and strong. http://investors.canadiansolar.com/news-releases/news-release-details/canadian-solar-reports-first-quarter-2020-results For the second quarter of 2020, the Company expects total module shipments to be in the range of 2.5 GW to 2.7 GW, including approximately 200 MW of module shipments to the Company's own projects that may not be immediately recognized as revenues. Total revenues are expected to be in the range of $630 million to $680 million, with gross margin expected to be between 18.5% and 20.5%.
  6. Horrible you guys: Trump’s Push to Kill Solar Loophole Blocked by Trade CourtRead more at: https://www.bloombergquint.com/business/trump-s-push-to-kill-solar-loophole-blocked-again-by-trade-court-kaplppm3Copyright © BloombergQuint
  7. Yesterday
  8. Last week
  9. Let's summarize the day. Moderna (MRNA) has safety concerns; executives of the company are caught in the scandal to spin results as positive to sell shares potentially. Over $400M has been given to Moderna for what appears to be a bunch of vomit and headache symptoms. The highest dose has been stopped as everyone was getting sick. No data has been published, but an opinion that was excellent from the same crowd, which was busy selling stock. Next, Astra Zeneca (AZN) has been given over $1.2B to produce a vaccine in cooperation with Oxford University. Nobody at the university believes it will work, so they give it a 50% chance. Merck (MRK) has joined the COVID-19 race grasping straws by buying a variety of companies at the pre-clinical level. The condition says they got nothing today, and they are looking to find something by acquiring laboratory coats. Finally, Novavax (NVAX) announced the start of the previously announced phase I. It had been mentioned that Novavax had a coronavirus candidate for MERS sometime in 2014. Still, it has no referral to it in the current pipeline. The CEO of the company was quoted to say Novavax has experience with vaccines against the common flu, so I think there is a bit of exploration rather than confirmation in the trial. There is a difference between the flu virus and coronavirus. Inovio announced a webinar on June 1. The exciting part is about providing updates on INO-4800, its DNA vaccine in Phase 1 clinical development for COVID-19, and INO-5401, its DNA immunotherapy designed to treat glioblastoma multiforme (GBM), the most common and aggressive type of brain cancer. Inovio is linking pre-clinical results, and they are calling for an update. I imagine the first 20 participants who received a single dose have been assessed already. Investors will be updated potentially on the safety profile and some immunology, however, this is speculation on my part. The post before has the webinar news
  10. - Leading Researchers and Scientists Detail INOVIO's Proprietary DNA Medicines Technology; Provide Updates on INO-4800 COVID-19 DNA Vaccine and INO-5401 GBM DNA Immunotherapy - Webinar and Q&A 10 a.m. to Noon EDT on June 1; Registration Information Included PLYMOUTH MEETING, Pa., May 26, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to protect and treat people from infectious diseases, cancer, and diseases associated with HPV, today announced it will hold a webinar event on June 1 from 10 AM to noon EDT to detail its proprietary DNA medicines technology and provide updates on INO-4800, its DNA vaccine in Phase 1 clinical development for COVID-19, and INO-5401, its DNA immunotherapy designed to treat glioblastoma multiforme (GBM), the most common and aggressive type of brain cancer. Preclinical data on INO-4800 demonstrating robust neutralizing antibody and T cell immune responses was published in the peer-reviewed journal Nature Communications on May 20, 2020. Data demonstrating 85% of newly diagnosed glioblastoma patients were alive 12 months following treatment with INO-5401, in combination with INO-9012 and PD-1 inhibitor Libtayo® (cemiplimab), will be featured at an oral poster presentation at the ASCO 2020 Virtual Scientific Program, May 29-31, 2020. Participating in the webinar event will be INOVIO leadership and world-renowned scientists, including: J. Joseph Kim, Ph.D., INOVIO President, CEO and Director David B. Weiner, Ph.D., Executive Vice President and Director, Vaccine Center, The Wistar Institute; INOVIO Director and Scientific Advisory Board Member Stanley A. Plotkin, M.D., Emeritus Professor, The Wistar Institute and the University of Pennsylvania; INOVIO Scientific Advisory Board Member Kate E. Broderick, Ph.D., INOVIO Senior Vice President, Research and Development, Team Lead for COVID-19 Vaccine Development Jeffrey Skolnik, M.D., INOVIO Vice President, Clinical Development, Oncology David Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute; Coordinating Principal Investigator of GBM-001/INO-5401 Phase 1/2 Investigator The event will be held virtually and include a Q&A. To register, please go to INOVIO's website at http://ir.inovio.com/events-and-presentations/default.aspx. An archived version of the presentation will be made available through the INOVIO Investor Relations events page following the event. About INOVIO's DNA Medicines Platform INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI). DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body. INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured, the stability of the products which do not require freezing in storage and transport, and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials. With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 6,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates to meet urgent global health needs.
  11. Longi lowering wafer prices again. Horrible for First: http://guangfu.bjx.com.cn/news/20200526/1075494.shtml
  12. Inovio mentioned along Pfizer https://businessmirror.com.ph/2020/05/26/challenges-in-the-race-for-a-coronavirus-vaccine/
  13. Those who are interested in sharing views please join, it is free. To register just email address and id, no spam is guaranteed.
  14. The real contenders in phase I trials, having potential to move to phase 2 trials based on positive results of phase 1. BioNTech and Pfizer Type: mRNA vaccine Stage: Phase 1/2 clinical trial Name: BNT162 program Background: Pfizer Inc. PFE, +0.64% announced March 17 it would help develop and distribute BioNTech SE’s BNTX, -1.67% COVID-19 vaccine candidate, though the deal excludes China. The 360 patients in the U.S. trial had started to receive the first doses of the four vaccine candidates included in the study as of May 5. Dosing in 200 participants in the German trial began April 23. As part of the deal, Pfizer will pay $185 million upfront, with additional possible future milestone payments of up to $563 million. Mikael Dolsten, Pfizer’s chief scientific officer, said during an April 28 earnings call that the companies expect the first round of trial data in May or June, with the vaccine candidate moving into “expanded trials that could allow emergency use or accelerated approval coming in the fall, possibly October.” BioNTech is also testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China. Moderna Type: RNA-based vaccine Stage: Phase 1 clinical trial Name: mRNA-1273 Background: Moderna Inc. MRNA, +2.90% received funding from CEPI in January to develop an mRNA vaccine against COVID-19. On Feb. 24, it said it had shipped the first batch of mRNA-1273 to the NIAID for a Phase 1 clinical trial in the U.S. Clinical trials: The first patient in the Phase 1 trial received a dose of the vaccine candidate on March 16. The study is expected to enroll 45 healthy adult patients, between the ages of 18 and 55 years old, in an open-label Phase I clinical trial to test mRNA-1273 as a vaccine for COVID-19. Participants will be followed for one year. The trial, which is expected to conclude June 1, 2021, will be conducted at Kaiser Permanente Washington Health Research Institute in Seattle. CEPI funded the manufacturing of the investigational vaccine for the first phase of the trial, which is evaluating different doses for safety and immune response. A Phase 2 trial is expected to begin in the second quarter. In mid-April, Moderna said it will receive up to $483 million in BARDA funding to support its vaccine development program. “We believe that we would be able to supply millions of doses a month in 2020 and with further investments, tens of millions a month in 2021, if the vaccine candidate is successful in the clinic,” Moderna CEO Stéphane Bancel said at the time. Novavax Type: Vaccine Stage: Phase 1 clinical trial Name: NVX-CoV2373 Background: Novavax Inc. NVAX, -7.90%, a preclinical biotechnology company, announced Feb. 26 that it had several vaccine candidates in preclinical animal studies. By April 8, the company said it had identified a COVID-19 vaccine candidate, and it plans to initiate a Phase I clinical study in mid-May. The first phase of the placebo-controlled study will enroll 130 healthy adults; the first round of data from that study is expected in July. In March the company said it had received $4 million from CEPI to develop a COVID-19 vaccine and that Emergent BioSolutions Inc. would support contract development and manufacturing for the experimental vaccine. The University of Oxford and AstraZeneca Plc have begun recruiting more than 10,000 subjects for advanced human studies of one of the world’s fastest-moving experimental Covid-19 vaccines. The University of Oxford and AstraZeneca Plc have begun recruiting more than 10,000 subjects for advanced human studies of one of the world’s fastest-moving experimental Covid-19 vaccines. AstraZeneca received a boost in its efforts to get the immunization tested and ready for use when the U.S. pledged as much as $1.2 billion toward development on Thursday, May 21st. Adult subjects in the studies will be randomly chosen to receive one or two doses of the Oxford candidate or an already licensed vaccine against meningococcus for comparison. The volunteers will be recruited across the U.K. and will record their reactions in an e-diary and attend some follow-up visits. Some will be given swabs for taking samples at home. The proposed Covid-19 vaccine is made from a weakened version of a common cold virus that’s genetically changed to make it unable to grow in humans. More than 1,000 people have already received it in an early-stage trial that began in April. Astra plans to make as many as 30 million doses available in Britain as early as September. Under its agreement with Astra, the U.S. could begin receiving supplies as early as October. Inovio Pharmaceuticals Inc. Type: DNA-based vaccine Timeline: Phase 1 clinical trial Name: INO-4800 Background: Another CEPI grantee (with roughly $17 million in total awards), Inovio Pharmaceuticals Inc. INO, -1.12% is testing its vaccine candidate in a Phase 1 clinical trial at two sites in the U.S.: the Perelman School of Medicine at the University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City, Mo. Inovio develops immunotherapies and vaccines but hasn’t yet had a product approved for treatment. For INO-4800, preclinical testing was performed between Jan. 23 and Feb. 29. The company began clinical trials in the U.S. with up to 40 participants in April, dosing the first patient on April 6. Inovio said it expects to have the first results from the trial in the fall and to have 1 million doses of the vaccine ready for additional clinical trials or emergency use by the end of the year. Inovio on March 12 announced a $5 million grant from the Bill & Melinda Gates Foundation to test a delivery device for its vaccine candidate. In late March, Inovio said that Ology Bioservices Inc., a contract development and manufacturing organization, had received a $11.9 million contract from the Department of Defense to support future potential manufacturing of Inovio’s vaccine candidate for military personnel.
  15. https://www.zonebourse.com/DAQO-NEW-ENERGY-CORP-12249683/agenda/
  16. From the Moderna news release, below. It is worth noting that 250 µg was mentioned during 2020 Global Healthcare Conference by the exec Kate E. Broderick, Ph.D. Senior Vice President, Inovio on May 19th. It was apparently stopped due to grade 3 events mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. The sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.
  17. https://www.fiercebiotech.com/research/harvard-animal-studies-suggest-covid-19-protection-can-come-from-previous-infection-or-dna
  18. Publication in Nature Communications demonstrates generation of robust neutralizing antibodies and T cell responses against SARS-CoV-2 - Preliminary safety and immune responses data from Phase 1 clinical trial expected in June - Multiple animal challenge study data expected in coming weeks - Phase 2/3 efficacy trial planned to start in July/August pending regulatory approval PLYMOUTH MEETING, Pa., May 20, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO) today announced the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The study was published in the peer-reviewed journal Nature Communications titled, "Immunogenicity of a DNA vaccine candidate for COVID-19" by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine. Dr. Kate Broderick, INOVIO's Senior Vice President of R&D and the Team Lead for COVID-19 vaccine development, said, "These positive preclinical results from our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our DNA medicines platform, but also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700. The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials." INO-4800 targets the major surface antigen Spike protein of SARS-CoV-2 virus, which causes COVID-19 disease. The studies demonstrated that vaccination with INO-4800 generated robust binding and neutralizing antibody as well as T cell responses in mice and guinea pigs. Importantly, the authors demonstrated virus neutralizing activity using three separate neutralization assays testing the vaccine's ability to generate antibodies which can block virus infection by: 1) an assay using live SARS-CoV-2 viruses; 2) an assay using a pseudo-virus assay, where another virus displays the SARS-CoV-2 Spike protein; and, 3) a novel high-throughput surrogate neutralization assay measuring the ability of INO-4800-induced antibodies to block SARS-CoV-2 Spike binding to the host ACE2 receptor. Study authors also detected these antibodies in the lungs of the vaccinated animals which could be important in providing protection from SARS-CoV-2. In addition, high levels of Spike-specific T cell responses were observed with INO-4800 vaccination, which could be important in mediating protection from the virus infection. Collectively, this preclinical dataset demonstrates that INO-4800 is a promising COVID-19 vaccine candidate against this emerging disease threat. Dr. J. Joseph Kim, INOVIO's President & CEO, said, "INOVIO and our collaborators are working diligently to advance INO-4800 to help fight the current pandemic. We are planning to utilize these positive preclinical results along with our upcoming animal challenge data and safety and immune responses data from our Phase 1 studies to support rapidly advancing this summer to a large, randomized Phase 2/3 clinical trial." INOVIO's swift progress in COVID-19 vaccine development is based on the ideal suitability of its DNA medicine platform to rapidly develop vaccines against emerging viruses with pandemic potential. INOVIO was the first to advance its DNA vaccine INO-4700 against MERS-CoV, a related coronavirus, into evaluation in humans in a collaboration with GeneOne Life Science and the Walter Reed Army Institute of Research. INO-4700 is the only MERS-CoV vaccine with positive data from a Phase 1/2a clinical trial, and INOVIO is currently preparing to initiate a larger Phase 2 vaccine trial for INO-4700 in the Middle East where most MERS viral outbreaks have occurred. These efforts are supported by CEPI funding. About INO-4800 INO-4800 is INOVIO's DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was designed using INOVIO's proprietary DNA medicine platform rapidly after the publication of the genetic sequence of the coronavirus that causes COVID-19. INOVIO has deep experience working with coronaviruses and is the only company with a Phase 2a vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS). About INOVIO's Global Coalition Advancing INO-4800 INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and the Laval University. INOVIO has partnered with Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including VGXI, Inc., Richter-Helm BioLogics, and Ology Biosciences to produce INO-4800 and seeking additional external funding and partnerships to scale up the manufacturing capacities to satisfy the urgent global demand for a safe and effective vaccine. To date, the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the US Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800. About INOVIO's DNA Medicines Platform INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI). DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body. INOVIO's DNA medicines deliver optimized plasmids directly into cells intradermally or intramuscularly using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured, the stability of the products which do not require freezing in storage and transport, and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials. With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 6,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs. About INOVIO INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to protect and treat people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com. CONTACTS: Media: Jeff Richardson, 267-440-4211, jrichardson@inovio.com Investors: Ben Matone, 484-362-0076, ben.matone@inovio.com
  19. Below is the news release from April 28th, The important parts is a relationships to IN-4800, highlighted. INO-4700 (GLS-5300) DNA vaccine demonstrates 100% binding and 92% neutralizing antibody responses against MERS-CoV - INO-4800 DNA vaccine for COVID-19 currently in Phase 1 trial utilizes identical strategy targeting Spike protein and CELLECTRA intradermal delivery PLYMOUTH MEETING, Pa. and SEOUL, South Korea, April 28, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO) and GeneOne Life Science (KSE:011000) today announced interim data through week 16 from a Phase 1/2a trial of DNA vaccine INO-4700 (also called GLS-5300) for MERS coronavirus (MERS-CoV). Vaccine recipients demonstrated strong antibody and T cell immune responses after 2 or 3 doses with 0.6 mg of INO-4700, a DNA vaccine that targets the MERS-CoV Spike (S) glycoprotein, delivered with intradermal CELLECTRA® device. The vaccination regimen was well-tolerated with no vaccine-associated severe adverse events (SAEs). The researchers at the Wistar Institute, Seoul National University Hospital, and the International Vaccine Institute (IVI) collaborated on this study with funding from IVI. These results were selected for an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Conference to be held virtually from May 12-15, 2020. Dr. J. Joseph Kim, INOVIO's President & CEO, said, "The INO-4700 Phase 1/2a clinical trial data demonstrates that our MERS DNA vaccine is able to generate robust immune responses using INOVIO's intradermal CELLECTRA delivery system. This exciting data provides a great foundation for the ongoing COVID-19 vaccine advancement as it demonstrates the power of INOVIO's delivery system and the strength of our coronavirus experience. As we have designed our COVID-19 vaccine INO-4800 using the same strategy as INO-4700, including the selection of full length Spike protein as the target and the use of intradermal CELLECTRA device, we are hopeful that the ongoing Phase 1 clinical trial with INO-4800 would generate similar clinical immune responses and safety data as we have just reported for INO-4700." Overall, for those receiving 0.6 mg of INO-4700, 88% demonstrated seroconversion after a 2 dose regimen at 0 and 8 weeks, while for those receiving a 3 dose regimen given at 0, 4 and 12 weeks, 84% seroverted after 2 doses and 100% after 3 doses, as measured by a binding antibody assay against the full-length S protein (ELISA). Additionally, 92% of the vaccine recipients in both groups displayed the ability to neutralize the virus using a neutralization assay (EMC2012-Vero neutralization). Robust T cell responses were observed in 60% of vaccine recipients after the 2 dose regimen and 84% of those in the 3 dose group (ELISpot assay). Interestingly, a single dose of 0.6 mg of INO-4700 intradermal vaccination resulted in 74% binding antibody response rate and 48% neutralization antibody response rate. Dr. Jerome Kim, Director General of IVI, said, "IVI is pleased to join partners in reporting these findings as a result of our collaboration in the world's first vaccine candidate against MERS. These and subsequent clinical trials could pave the way for accelerated development of a DNA vaccine against MERS." This is the 2nd study of INO-4700 (GLS-5300) in a clinical trial, the first being a 75-person study (MERS-001) of vaccine administered intramuscularly and followed by electroporation at either 0.67, 2 or 6 mg. Notably in the MERS-001 study, there was no significant difference between dose levels and vaccine induced immune responses were similar to those seen in recovered patients following natural infection (Lancet Infectious Disease, 2019). INO-4700 vaccination has previously been shown to provide 100% protection against MERS virus disease in a pathogenic monkey challenge model. INOVIO is planning to advance INO-4700 into a Phase 2 clinical trial in the Middle East with a previously announced funding of $56 million by the Coalition for Epidemic Preparedness Innovations (CEPI). About INOVIO's Global Coalition Advancing INO-4800 INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, Université Laval, and the University of Texas. INOVIO has partnered with Beijing Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including VGXI, Inc., Richter-Helm, and Ology Biosciences to produce one million doses of INO-4800 by year-end and seeking additional external funding and partnerships to scale up the manufacturing capacities to satisfy the urgent global demand for a safe and effective vaccine. To date, CEPI, the Bill & Melinda Gates Foundation, and the US Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800. About INO-4800 INO-4800 is INOVIO's DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was designed using INOVIO's proprietary DNA medicine platform rapidly after the publication of the genetic sequence of the coronavirus that causes COVID-19. INOVIO has deep experience working with coronaviruses and is the only company with a Phase 2a vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS). About INOVIO's DNA Medicines Platform INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI). DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body. INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured, the stability of the products which do not require freezing in storage and transport, and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials. With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 6,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates to meet urgent global health needs. About GeneOne Life Science GeneOne Life Science Inc. is an international developer of DNA and RNA vaccines, nucleic acid-based therapeutics, and small molecule therapies. GeneOne sponsored the MERS-001 and MERS-002 clinical trials against MERS-CoV and the ZIKA-001 and ZIKA-002 vaccine studies against the Zika virus. GeneOne's research group has developed DNA vaccines and products to prevent and treat incurable diseases as well as hematologic diseases, metabolic diseases, and cancers. GeneOne is a recognized leader in the fight against Emerging Infectious Diseases (EIDs) with a pipeline to address a number of pathogenic organisms with a role in numerous international advisory committees regarding vaccine development against EIDs. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary, located in Texas, is the leading cGMP DNA plasmid manufacturing facility in the world for the vaccine, cell therapy, and gene therapy industries. VGXI has manufactured numerous DNA vaccines against EIDs including the GLS-5300/INO-4700 and INO-4800 vaccines for MERS-CoV and COVID-19, respectively. For more information, visit www.genels.com and www.vgxii.com. About the International Vaccine Institute (IVI) The International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP). Headquartered in Seoul, South Korea, IVI was the first international organization hosted by Korea. IVI has 35 signatory countries and the World Health Organization (WHO) on its treaty, including Republic of Korea, Sweden and India as state funders. Our mandate is to make vaccines available and accessible for the world's most vulnerable people. We focus on infectious diseases of global health importance such as cholera, typhoid, shigella, salmonella, schistosomiasis, Group A Streptococcus, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int About INOVIO INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to potentially treat and protect people from diseases associated with HPV, cancer, and infectious diseases. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, Plumbline Life Sciences, Regeneron, Richter-Helm, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.
  20. I wonder if we could discuss revenue potential of approved vaccine for COVID-19. Regardless of the company. Hepatitis B is about $2B plus a year but not sure how many people get vaccinated. The total vaccine market is about $35B https://www.cnbc.com/2020/02/21/coronavirus-brings-light-to-the-35-billion-vaccine-market.html I imagine COVID-19 could generate easily that amount, but even at $10B, a company having it would be worth 5 to 10 times of sales. In case of Moderna (MRNA) this would mean only double, but for a company like INO it would be 10 to 20 fold. The numbers also indicate there is room for more than one company or vaccine.
  21. Thank you, appreciate your input. Yes, Inovio's pipeline has a lot more, which is great, just in case.
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