Moderna Completes Enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)

Health

Moderna Completes Enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)

Published

4 years ago

July 8, 2020

Harry Miller

Cohorts of younger adults (n=300) and older adults (n=300) in Phase 2 study fully enrolled

Cohorts of older adults (ages 56-70, n=30) and elderlyadults (ages 71 and above, n=30) in NIH-led Phase 1 study completed enrollment; results expected to be published once available

Pivotal Phase 3 study expected to begin in July; manufacture of vaccine required to start Phase 3 study completed

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 that it has completed enrollment for both cohorts of the Phase 2 study of its vaccine candidate (mRNA-1273) against COVID-19. mRNA-1273 is Moderna’s second mRNA vaccine for an infectious disease to complete enrollment of a Phase 2 study, following the Company’s CMV Phase 2 study, which was fully enrolled on March 3, 2020.

On June 11, 13 days after the first participant was dosed, the Company announced that the cohort of healthy younger adults ages 18-55 (n=300) and the sentinel group of older adults ages 55 years and above (n=50) in the Phase 2 study of mRNA-1273 was complete. After reviewing the safety data from the sentinel cohort of older adults, on June 25, the Data and Safety Monitoring Committee of the study recommended Moderna to proceed with enrollment for the remainder of the Phase 2 study. The cohort of older adults (n=300) has now been fully enrolled. This Phase 2 placebo-controlled, dose-confirmation study is evaluating the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each participant is receiving placebo, a 50 µg or a 100 µg dose at both vaccinations.

The Company also announced that the cohorts of older adults (ages 56-70, n=30) and elderly adults (ages 71 and above, n=30) in NIH-led Phase 1 study have completed enrollment. Results are expected to be published once available.

“I would like to thank the healthy volunteer participants, our partners at clinical trial sites and the dedicated Moderna team for their support in completing enrollment of the Phase 2 study of mRNA-1273, our vaccine candidate against COVID-19,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “We are committed to helping address this ongoing public health emergency and continue to focus on our Phase 3 study, which remains on track to start in July, less than seven months from the sequencing of the virus.”

Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). 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. and is expected to be conducted in collaboration with NIAID, subject to regulatory approval. Moderna has completed manufacture of vaccine required to start the Phase 3 study. With the Phase 3 dose at 100 µg, 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.

About mRNA-1273

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.

About Moderna’s Prophylactic Vaccines Modality

Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,600 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.

Moderna currently has nine development candidates in its prophylactic vaccines modality, including:

Vaccines against respiratory infections

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)

Vaccines against infections transmitted from mother to baby

Cytomegalovirus (CMV) vaccine (mRNA-1647)
Zika vaccine (mRNA-1893 with BARDA)

Vaccines against highly prevalent viral infections

Epstein-Barr virus (EBV) vaccine (mRNA-1189)

To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). 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.

About Moderna

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.

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.

Forward Looking Statements

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 Phase 2 and planned Phase 3 studies of mRNA-1273, and the Company’s potential manufacturing capabilities and projected vaccine dose production. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at 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.

Source: – Stockhouse

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New technology to advance women’s cancer care at Southlake

Published

9 hours ago

April 24, 2024

Harry Miller

NEWS RELEASE
SOUTHLAKE REGIONAL HEALTH CENTRE
**************************
This Cancer Awareness Month, Southlake is adding advanced technologies to detect and treat breast cancer and other women’s cancers thanks to generous community donor support, most recently through the HERE is Where Cancer Meets its Match campaign. New cancer care technology, including new mammography machines, the MyoSure System and the MOLLI 2® System will make a measurable impact in diagnosing and treating women’s cancers in the communities Southlake serves.

Southlake is installing three new mammography machines to expand its breast cancer screening program to 1,500 more women each year. Two of these machines have new biopsy capabilities that will reduce the number of cancelled exams due to equipment failure, ensuring timely care for women. Women ages 40 to 49 years old will be able to self-refer for publicly funded mammograms through the Ontario Breast Screening Program starting this fall.

“Early detection is critical when treating breast cancer and other women’s cancers,” said Lorrie Reynolds, Director, Regional Cancer Program at Southlake. “We treat more than 1,700 breast cancer patients at Southlake every year. By adding advanced technology, like the new mammography machines, we’re ensuring women have the best experience at Southlake.”

Southlake is also introducing the MyoSure System, an innovative technology that can help detect female reproductive cancers. Damaged tissue in a woman’s uterus such as fibroids and polyps can now be removed in a precise, minimally invasive procedure that leaves the rest of the uterus intact. This will improve the overall patient experience by supporting faster recovery, reducing the risk of infection and giving more women the option to have children. An estimated 200 women per year will benefit from the MyoSure System.

The new mammography machines and the MyoSure System build on Southlake’s recent investment in the MOLLI 2® System, a made-in-Canada wire-free breast localization technology. This technology is considerably less invasive and more accurate when compared to wire-guided localization, resulting in a better patient experience and improved cosmetic outcomes. More than 200 women each year will benefit from this innovative medical device as they are treated for breast cancer at Southlake.

“As a clinician caring for women with cancer in our community, I’m incredibly proud of the work Southlake is doing to advance women’s health and improve patient experiences,” said Sara Temple, MD, Surgical Oncologist and Chief of Surgery at Southlake. “Women who visit Southlake can be confident that they are receiving leading edge care, close to home when they need it most.”

The World Health Organization anticipates a 77 per cent increase in cancer diagnoses by 2050. Southlake serves some of the fastest growing communities in Canada and anticipates that the number of patients requiring cancer care will grow. By investing in new technology, Southlake is ensuring that women in the communities it serves have access to leading edge cancer care. All of these investments were funded with support from community donors who generously gave to Southlake to support investments into women’s health at the hospital.

“The generosity of our donor community and the impact they have made for women receiving cancer diagnosis and treatment at Southlake is something we can all take great pride in,” said Jennifer Ritter, President and CEO of Southlake Foundation. “From our Women’s Health Initiative donors supporting new mammography machines, to the Ladies in Philanthropy for Southlake funding the MOLLI 2 System, to our long-standing partners The Edge Benefits and Pheasant Run Golf Club enabling the introduction of MyoSure System through their joint annual charity golf tournament, we are incredibly lucky to share a vision of access to exceptional care for everyone who depends on Southlake when they need us most. Thank you, to every donor who contributed to these important upgrades to care for women.”

Southlake Foundation’s HERE is Where Cancer Meets its Match campaign supports the Stronach Regional Cancer Centre at Southlake. For more information or to make a donation, visit: southlake.ca/HERE.

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Pasteurized milk includes remnants of H5N1 bird flu, U.S. officials say

Published

10 hours ago

April 24, 2024

Harry Miller

The U.S. Food and Drug Administration says that samples of pasteurized milk have tested positive for remnants of the bird flu virus that has infected dairy cows.

The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.

“To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the FDA said in a statement on Tuesday.

The announcement comes nearly a month after an avian influenza virus that has sickened millions of wild and commercial birds in recent years was detected in dairy cows in at least eight states. The Agriculture Department (USDA) says 33 herds have been affected to date.

FDA officials didn’t indicate how many samples they tested or where they were obtained. The agency has been evaluating milk during processing and from grocery stores, officials said. Results of additional tests are expected in “the next few days to weeks.”

WATCH | Bird flu spread in U.S. cows:

Bird flu is spreading in cows. Are humans at risk? | About That

15 days ago

Duration 8:54

For the first time ever, avian influenza, or H5N1 bird flu, was detected in roughly a dozen dairy cow herds across the U.S. About That producer Lauren Bird explores why scientists and public health officials are concerned about the cross-species transmission and whether humans are now at higher risk.

The polymerase chain reaction (PCR) lab test the FDA used would have detected viral genetic material even after live virus was killed by pasteurization, or heat treatment, said Lee-Ann Jaykus, an emeritus food microbiologist and virologist at North Carolina State University

“There is no evidence to date that this is infectious virus, and the FDA is following up on that,” Jaykus said.

Officials with the FDA and the USDA had previously said milk from affected cattle did not enter the commercial supply. Milk from sick animals is supposed to be diverted and destroyed. Federal regulations require milk that enters interstate commerce to be pasteurized.

Tests for viable virus underway, agency says

Because the detection of the bird flu virus known as Type A H5N1 in dairy cattle is new and the situation is evolving, no studies on the effects of pasteurization on the virus have been completed, FDA officials said. But past research shows that pasteurization is “very likely” to inactivate heat-sensitive viruses like H5N1, the agency added.

The agency said it has been evaluating milk from affected animals, in the processing system and on the shelves. It said it is completing a large, representative national sample to understand the extent of the findings.

The FDA said it is further assessing any positive findings through egg inoculation tests, which it described as a gold standard for determining viable virus.

Matt Herrick, a spokesperson for the International Dairy Foods Association, said that time and temperature regulations for pasteurization ensure that the commercial U.S. milk supply is safe. Remnants of the virus “have zero impact on human health,” he wrote in an email.

Scientists confirmed the H5N1 virus in dairy cows in March after weeks of reports that cows in Texas were suffering from a mysterious malady. The cows were lethargic and saw a dramatic reduction in milk production. Although the H5N1 virus is lethal to commercial poultry, most infected cattle seem to recover within two weeks, experts said.

To date, two people in the U.S. have been infected with bird flu. A Texas dairy worker who was in close contact with an infected cow recently developed a mild eye infection and has recovered. In 2022, a prison inmate in a work program caught it while killing infected birds at a Colorado poultry farm. His only symptom was fatigue, and he recovered.

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Remnants of bird flu virus found in pasteurized milk, FDA says

Published

11 hours ago

April 24, 2024

Harry Miller

The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows.