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Moderna CEO: I am aligned with shareholders even though I am selling stock – Yahoo Finance

Moderna CEO Stéphane Bancel joins Yahoo Finance’s Alexis Christoforous, Brian Sozzi, and Anjalee Khemlani to discuss the company’s entry into the Phase 3 trial of its COVID-19 vaccine, and what to expect.

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Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19 – Yahoo Finance

Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late stage clinical development including the expanded Phase 3 study of the Company’s mRNA vaccine candidate (mRNA-1273) against COVID-19.

An earlier award from BARDA for up to $483 million was entered into to support the scale up of mRNA-1273 and clinical development, originally with a smaller anticipated number of participants in the Phase 3 clinical trial. Following discussions with the U.S. Food and Drug Administration (FDA) and consultations with Operation Warp Speed over the past several months, the Company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification. Under the terms of the revised contract, BARDA is expanding their support of the Company’s late stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. The total value of the award is now approximately $955 million.

“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19.” said Stéphane Bancel, Moderna’s Chief Executive Officer. “Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”

ClinicalTrials.gov identifier is NCT04470427.” data-reactid=”27″ type=”text”>The Phase 3 COVE study is being conducted in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and is expected to begin tomorrow, July 27. The Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration (FDA) and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2. The ClinicalTrials.gov identifier is NCT04470427.

Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network (CoVPN), to conduct the Phase 3 COVE study. Working together with collaborators like NIH, the Company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society.

strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the Company’s most recent public equity offering in May 2020.” data-reactid=”29″ type=”text”>The Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s internal U.S. manufacturing site and strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the Company’s most recent public equity offering in May 2020.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00034.

prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. Both cohorts, healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), in the Company’s Phase 2 study of mRNA-1273 are fully enrolled. A summary of the company’s work to date on COVID-19 can be found here.” data-reactid=”32″ type=”text”>mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. Both cohorts, healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), in the Company’s Phase 2 study of mRNA-1273 are fully enrolled. A summary of the company’s work to date on COVID-19 can be found here.

Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,900 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.

The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.

nine development candidates in its prophylactic vaccines modality, including:” data-reactid=”40″ type=”text”>Moderna currently has nine development candidates in its prophylactic vaccines modality, including:

  • Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
  • RSV vaccine for young children (mRNA-1345)
  • Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
  • COVID-19 vaccine (mRNA-1273)
  • Influenza H7N9 (mRNA-1851)
  • Cytomegalovirus (CMV) vaccine (mRNA-1647)
  • Zika vaccine (mRNA-1893 with BARDA)
  • Epstein-Barr virus (EBV) vaccine (mRNA-1189)
  • To date, Moderna has demonstrated positive Phase 1 data readouts for eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV, Zika and COVID-19). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

    www.modernatx.com.” data-reactid=”58″ type=”text”>Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.

    www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.” data-reactid=”60″ type=”text”>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine against the novel coronavirus, the parameters and timing of the P

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    Moderna Downgraded to Neutral by J.P. Morgan on Valuation Concerns – TheStreet

    Drugmaker Moderna  (MRNA) – Get Report, one of the front-runners to producing a viable coronavirus vaccine, fell on Monday after Oxford University and AstraZeneca  (AZN) – Get Report published promising data from an early stage trial of a key coronavirus vaccine study and the stock received a downgrade from J.P. Morgan.

    In a study published on Monday, Oxford and AstraZeneca’s coronavirus vaccine trial showed “potent” cellular and humoral immunogenicity in all 1,077 participants in a Phase 1/Phase II study.

    That, combined with an unrelated downgrade from J.P. Morgan analyst Cory Kasimov to neutral from overweight, pushed shares of Moderna lower. The stock was down 10.12% at $85.25 in trading on Monday. 

    Moderna stock has surged in recent months as various studies of its coronavirus vaccine candidate,  mRNA-1273, have shown promising results in various clinical trials. 

    Moderna’s vaccine has shown to produce coronavirus antibodies in trials, federal researchers said last week, something National Institute of Allergy and Infectious Diseases’ head Dr. Anthony Fauci has called “really quite promising.”

    At the same time, Moderna is one of hundreds of companies seeking an effective vaccine, with no resolute proof that it has the recipe for success. More than 20 vaccine hopefuls are in human testing, and another 130 are in earlier phases of development, according to the World Health Organization.

    Moderna, which is applying similar technology as Pfizer  (PFE) – Get Report and BioNTech  (BNTX) – Get Report to develop a vaccine, received fast-track approval from the Food and Drug Administration for its Covid-19 vaccine candidate in May.

    For its part, Moderna will begin a Phase 3 trial on July 27 that is expected to include some 30,000 participants. The participants will help compare its vaccine with placebo injections of the vaccine and determine whether it continues to show a buildup of antibodies needed to fend off the coronavirus.

    Moderna has been focused on testing a vaccine that will not only prevent infection from SARS-CoV-2, the virus that causes Covid-19, but also prevent severe cases of the disease that require hospitalization.

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    Is Moderna Close to Winning the Coronavirus Vaccine Race? – Motley Fool

    Moderna’s phase 1 data looks positive, but the company’s investigational coronavirus vaccine has a lot more to prove in late-stage trials.

    Moderna (NASDAQ:MRNA) has taken another step closer to making its dream of commercializing a coronavirus vaccine a reality. The company just released more detailed interim results from its phase 1 trial — and they are enough for Moderna and investors to cheer about.

    What’s so encouraging about the results? And do they really bring Moderna close to victory? Let’s take a look.

    A researcher draws a dose of vaccine from a vial.

    Image source: Getty Images.

    Moderna’s trial included 45 healthy volunteers ranging from 18 to 55 years old. Each participant was given two doses of mRNA-1273 28 days apart in one of three dosage levels. Based on the results, Moderna chose to pursue the 100-microgram dose — the mid-range dose — in late-stage trials.

    Neutralizing antibody levels

    The key positive in the phase 1 data has to do with neutralizing antibodies. These are the antibodies that actually block infection, so the ability of a vaccine to stimulate their production is crucial. Moderna, in a publication in The New England Journal of Medicine, reported that all evaluated trial participants showed neutralizing antibody production. And in the 100-microgram dosage group, levels were four times higher than those seen in recovered COVID-19 patients.

    Initial data released in May only showed neutralizing antibody data for eight trial participants. While the neutralizing antibody levels came in at or above those of patients who had suffered from COVID-19, the sample wasn’t big enough to demonstrate a clear trend. This latest report of neutralizing antibody production in all participants is a big step forward. Results also showed T-cell responses following the second dose in the lower-dosage group and in the 100-microgram dose. T cells are another important piece of the puzzle as they are an immune system tool to detect and fight infection.

    Moderna will aim to replicate that positive data in as many as 30,000 people when the company begins phase 3 studies on July 27.

    A step closer to the finish line

    All of this is good news for Moderna. The biotech company has taken a step closer to the finish line. But others have been catching up. Moderna isn’t as far ahead as it was several weeks ago.

    AstraZeneca (NYSE:AZN) is conducting a phase 2/3 trial now. The U.S. Food and Drug Administration recently granted the Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) team Fast Track designation for two vaccine candidates. Pfizer and BioNTech, like Moderna, are developing a vaccine using messenger RNA. They aim to begin a phase 2b/phase 3 trial in 30,000 participants later this month. Moderna, AstraZeneca, and the Pfizer and BioNTech team are among a handful of drugmakers closest to the finish line right now. 

    Inovio Pharmaceuticals (NASDAQ:INO) and Novavax (NASDAQ:NVAX) are close behind. Inovio plans to begin a phase 2/3 study this summer, and Novavax expects to release phase 1/2 interim data at the end of this month and then begin the phase 2 part of the study shortly thereafter.

    Of course, that list of “who is ahead” is all from a timeline perspective. What, ultimately, is most important — and will determine the winner or winners — is the safety and efficacy of the vaccine candidate. Though Moderna’s results are encouraging, we still should rein in excitement.

    Here’s why: First there’s the question of neutralizing antibodies. It’s still not clear how long neutralizing antibodies will remain in the body and what level of antibodies is needed to prevent infection. Another question is the vaccine’s performance in the elderly, a group heavily hit by COVID-19. A successful vaccine must be safe and effective in this population. Moderna is testing the vaccine in older and elderly volunteers in phase 2 and will also include these groups in phase 3.

    What does this mean for investors?

    Moderna shares have climbed 315% since the start of the year. The company doesn’t yet have products on the market. Besides the COVID-19 vaccine, Moderna’s most advanced candidate is in phase 2 studies. That means if Moderna’s vaccine fails, the company is still years away from commercializing a product.

    In the near term, with any good news, this biotech stock likely has more to gain. And if Moderna’s vaccine is successful, the shares may skyrocket. But if the company loses this race or produces a vaccine that isn’t as strong as a rival’s, the result may be devastating for the shares. That’s why, for now, long-term investors may want to watch Moderna’s final sprint to the finish from the sidelines.


    Adria Cimino has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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    Moderna Vaccine Results Spark Stock Rally – MSN Money

    © (Maddie Meyer/Getty Images)
    CAMBRIDGE, MASSACHUSETTS – MAY 08: A view of Moderna headquarters on May 08, 2020 in Cambridge, Massachusetts. Moderna was given FDA approval to continue to phase 2 of…
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    Moderna COVID-19 vaccine enters final stage trial this month – Yahoo! Voices

    Washington (AFP) – US biotech firm Moderna said Tuesday it would enter the final stage of human trials for its COVID-19 vaccine on July 27, to test how well it protects people in the real world.

    The announcement came as the results from an earlier trial intended to prove the vaccine was safe and triggered antibody production were published.

    The upcoming Phase 3 trial will recruit 30,000 participants in the US, with half to receive the vaccine at 100 microgram dose levels, and the other half to receive a placebo.

    Researchers will then track them over two years to determine whether they are protected against infection by the virus. Or, if they do get infected, whether the vaccine prevents symptoms from developing.

    If they do get symptoms, the vaccine can still be considered a success if it stops severe cases of COVID-19.

    The study should run until October 27, 2022, but preliminary results should be available long before.

    The announcement came shortly after the New England Journal of Medicine published results from the first stage of Moderna’s vaccine trial, which showed the first 45 participants all developed antibodies to the virus.

    Moderna is considered to be in a leading position in the global race to find a vaccine against the coronavirus, which has infected more than 13.2 million people and killed 570,000.

    But scientists caution that the first vaccines to come to market may not be the most effective or safest.

    – Encouraging results –

    Moderna had previously published “interim results” from the first stages of its trial, called Phase 1 in May.

    The early results were called “encouraging” by Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, which is co-developing the vaccine.

    But some in the scientific community said they would reserve judgment until they saw the full results in peer-reviewed form.

    According to the paper, 45 participants were split into three groups to test doses of 25 micrograms, 100 micrograms and 250 micrograms.

    They were given a second dose of the same amount 28 days later.

    After the first round, antibody levels were found to be higher with higher doses.

    Following the second round, participants had higher levels of antibodies than most patients who have had COVID-19 and gone on to generate their own antibodies.

    More than half the participants experienced mild or moderate side effects, which is considered normal.

    The side effects included fatigue, chills, headache, body ache and pain at the injection site.

    Three participants did not receive their second dose.

    They included one who developed a skin rash on both legs, and two who missed their window because they had COVID-19 symptoms, but their tests later returned negative.

    Amesh Adalja, an infectious diseases specialist at Johns Hopkins University, said it was encouraging that the participants developed high levels of an advanced class of antibodies.

    He added, however: “You have to be very limited in how much you can extrapolate from a phase one clinical trial, because you want to see how this works when a person is exposed to the actual virus.”

    The Moderna vaccine belongs to a new class of vaccine that uses genetic material — in the form of RNA — to encode the information needed to grow the virus’s spike protein inside the human body, in order to trigger an immune response.

    The spike protein is a part of the virus that it uses to invade human cells, but by itself the protein is relatively harmless.

    The advantage of this technology is that it bypasses the need to manufacture viral proteins in the lab, helping to ramp up mass production.

    No vaccines based on this platform have previously received regulatory approval.

    Early work using this technology backfired by making hosts more, not less, susceptible to infection, David Lo, a professor of biomedical sciences at University of California Riverside told AFP.

    “One of the things we certainly want to look out for is whether there is a long term effect where the immune response… potentially develops an immunologic tolerance which would actually be detrimental to protection,” he said.

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    Coronavirus Moderna

    Moderna coronavirus vaccine shows promising results in early clinical trial – POLITICO

    Avolunteer receives a Covid-19 test vaccine injection. | Siphiwe Sibeko/AP Photo

    An experimental coronavirus vaccine developed by Moderna provoked an immune response without major side effects in an early-stage clinical trial, scientists reported Tuesday in the New England Journal of Medicine.

    The Phase I trial, conducted in partnership with the National Institute of Allergy and Infectious Diseases, enrolled 45 people who were given two doses of the vaccine in March and April. More than half of participants developed mild side effects, including chills and body aches, and three did not receive the second vaccine dose.

    The vaccine is the first developed by a U.S. company to publish clinical trial results. Moderna, which has received more than $500 million from the government to develop its shot, released partial results on 8 of the 45 trial participants in a press release in May.

    What it means: Participants received either a low, medium or high dose of the vaccine. Those who in all three groups who received both shots eventually produced “high levels of neutralizing antibody activity” that may keep Covid-19 at bay, the scientists reported. The antibody levels were similar to those seen in people who recovered from coronavirus infections.

    But wait: The development of the antibodies is not direct proof that the vaccine works. Determining that will require a final, Phase III clinical trial.

    What’s next: Researchers began enrolling participants in a Phase II trial in late May to further study the vaccine’s safety and its ability to produce an immune response.

    Moderna plans to start a Phase III trial on July 27 to determine whether the vaccine can prevent coronavirus infection. That trial — conducted with help from NIAID and the federal government’s Operation Warp Speed initiative — will eventually enroll 30,000 people.