Moderna, Inc. reports developments in mRNA medicines, including commercial vaccines, investigational respiratory vaccines, oncology programs and rare-disease candidates. News commonly covers regulatory authorizations and agency interactions for products such as Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, as well as clinical data for seasonal influenza, pandemic influenza and cancer immunotherapy programs including intismeran autogene and mRNA-4359.
Company updates also include quarterly financial results, revenue mix, expense actions, strategic partnerships, scientific meeting presentations and intellectual-property matters tied to Moderna's infectious disease portfolio and broader mRNA technology platform.
BenevolentAI, a clinical-stage AI-enabled drug discovery company, has appointed Marcello Damiani to its Board of Directors, with confirmation pending at the Annual General Meeting scheduled for 4 May 2023. Damiani, a former executive at Moderna (NASDAQ: MRNA), brings over 25 years of experience in technology and biotech. His leadership is expected to enhance the board's diversity and support BenevolentAI's growth strategy. The company continues to focus on leveraging AI for drug development, collaborating with major institutions to advance its innovative platforms.
Moderna, Inc. (NASDAQ:MRNA) announced the acceptance of two abstracts concerning the investigational mRNA personalized cancer vaccine, mRNA-4157/V940, for presentation at the 2023 AACR Annual Meeting from April 14-19 in Orlando, FL. The first abstract, presented by Dr. Jeffrey S. Weber, addresses the efficacy and safety of mRNA-4157 combined with pembrolizumab for high-risk melanoma. The second, by Dr. Ryan J. Sullivan, evaluates minimal residual disease as a biomarker in treated patients. Moderna and Merck plan to initiate a Phase 3 study in 2023, expanding to other tumor types like non-small cell lung cancer.
Moderna (NASDAQ:MRNA) is expanding its U.S. presence with new offices in South San Francisco and Seattle, complementing existing locations in the U.S. and a global presence in 17 countries.
In 2023, the company plans to hire approximately 2,000 new employees as it invests in technology solutions and aims to embed AI in its operations. Key developments in its pipeline include the personalized cancer vaccine candidate and the RSV vaccine, both receiving Breakthrough Therapy Designation from the FDA.
Moderna currently has 48 mRNA programs under development, with 38 in active clinical trials, reinforcing its commitment to mRNA therapeutics.
Moderna, Inc. (NASDAQ:MRNA) will participate in a fireside chat at Cowen's 43rd Annual Health Care Conference on March 6, 2023, at 9:10 a.m. ET. A live webcast will be available in the Investors section of Moderna's website, with a replay accessible for at least 30 days post-event.
Since its inception over a decade ago, Moderna has advanced mRNA therapeutics and vaccines, notably developing effective COVID vaccines. The company has expanded its clinical portfolio across multiple disease areas, underpinned by strategic alliances and robust manufacturing capabilities. Moderna has been recognized as a leading biopharmaceutical employer by Science for eight consecutive years.
Moderna reported fourth quarter 2022 revenues of $5.1 billion and full-year revenues of $19.3 billion. The company achieved a GAAP net income of $1.5 billion for Q4, with a corresponding diluted EPS of $3.61, marking a year-over-year decline. Among its notable developments, Moderna expects approximately $5 billion in contracted COVID-19 sales for 2023, alongside advancements in its mRNA-1345 RSV vaccine, which received FDA Breakthrough Therapy Designation. The company plans to elevate R&D investments to $4.5 billion in 2023 while announcing corporate leadership changes.
Moderna and Merck have received Breakthrough Therapy Designation from the FDA for their investigational personalized mRNA cancer vaccine mRNA-4157/V940. This designation is based on promising results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, showcasing efficacy in combination with Merck's KEYTRUDA for treating high-risk melanoma post-surgery. The designation expedites development for serious conditions with significant unmet needs. The companies plan to launch a Phase 3 study in adjuvant melanoma in 2023, with the potential to broaden to other cancers, including non-small cell lung cancer.
Moderna has entered a strategic collaboration with Life Edit Therapeutics to develop innovative in vivo gene editing therapies using mRNA technology. This alliance aims to tackle challenging genetic diseases by combining Life Edit's advanced gene editing capabilities, including base editing, with Moderna's mRNA platform. Life Edit will receive an upfront cash payment, ongoing funding for research, and potential milestone payments, along with tiered royalties on global product sales. This partnership exemplifies a commitment to pioneering new therapeutic approaches and broadening the landscape of gene editing.
Health Canada has authorized Moderna's bivalent Omicron-targeting COVID-19 vaccine, mRNA-1273.214, for use in children and adolescents aged 6 to 17. This authorization includes a 25 µg dose for ages 6 to 11 and a 50 µg dose for those aged 12 to 17. Clinical trials demonstrated that both bivalent vaccines (mRNA-1273.214 and mRNA-1273.222) induced superior antibody responses compared to the original vaccine. CEO Stéphane Bancel emphasized the importance of this authorization for broader protection against emerging variants. The decision follows successful Phase 2/3 trials, reinforcing Moderna's commitment to combat COVID-19.
Moderna announced interim results from its Phase 3 trial of mRNA-1010, a seasonal influenza vaccine candidate. The trial showed superiority in seroconversion rates for A/H3N2 and A/H1N1 strains and non-inferiority for A/H1N1 geometric mean titer ratios. However, non-inferiority was not met for the influenza B strains. The vaccine was well-tolerated, with a reported 70% of recipients experiencing minor adverse reactions. The ongoing efficacy study has recorded over 200 PCR-confirmed cases, primarily of influenza A. An interim analysis is expected by the end of Q1 2023. mRNA-1010 is one of five influenza candidates being evaluated by Moderna.
Personalis, Inc. (PSNL) and Moderna, Inc. (MRNA) have signed a new agreement to utilize the Personalis NeXT Platform for clinical studies involving the investigational personalized cancer vaccine, mRNA-4157/V940. This platform previously supported the Phase 2b clinical study, sequencing genomic data from patient tumor samples to identify mutations that may prompt tailored antitumor responses. Chris Hall from Personalis expressed excitement about continuing their collaboration with Moderna, emphasizing the aim to advance individualized cancer treatments.