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.
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Moderna, Inc. (Nasdaq:MRNA) will conduct a live conference call and webcast on May 4, 2023, at 8:00 a.m. ET to discuss its first quarter 2023 financial results and provide a corporate update.
The call will be accessible via the Moderna Investors website, with an archived version available two hours post-call for one year.
Founded over a decade ago, Moderna has evolved from a research-stage company into a leader in mRNA therapeutics and vaccines, successfully producing COVID-19 vaccines and developing a wide range of therapeutics. The company is recognized for its innovative mRNA technology and robust manufacturing capabilities, maintaining collaborative relationships to advance scientific and therapeutic breakthroughs.
Moderna (Nasdaq:MRNA) has entered into a partnership with IBM (NYSE:IBM) to leverage quantum computing and artificial intelligence for advancing mRNA medicine development. This collaboration includes investments in generative AI to enhance product design.
Moderna aims to build a workforce skilled in quantum technologies and will participate in IBM's Quantum Accelerator program. The goal is to apply quantum computing to complex scientific challenges, enhancing mRNA therapeutics.
Additionally, the companies will utilize the MoLFormer AI model to optimize lipid nanoparticles and mRNA, targeting improved safety and performance in new mRNA medicines. This investment underscores Moderna's commitment to pioneering technology in biotechnology.
Moderna and Merck announced positive results from the Phase 2b KEYNOTE-942 trial involving mRNA-4157 (V940) in combination with KEYTRUDA for treating high-risk stage III/IV melanoma. The combination therapy reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone. The trial included 157 patients with a median follow-up of 23-24 months. In the combination group, 83.4% of patients were recurrence-free at 12 months, compared to 77.1% in the control group. The U.S. FDA granted Breakthrough Therapy Designation for this therapy. A Phase 3 study will start in 2023.
Moderna, Inc. (NASDAQ: MRNA) has made significant advancements in its clinical pipeline, including the dosing of the first participant in the Phase 3 trial for its next-generation COVID-19 vaccine, mRNA-1283. The company is also preparing to file for approval of another vaccine candidate, mRNA-1345, targeting RSV, within this quarter. However, the first influenza vaccine candidate, mRNA-1010, faced challenges as it did not achieve sufficient cases in an interim efficacy analysis, leading to continued follow-up recommendations from the independent DSMB. Positive preliminary results indicate strong immunogenicity against certain influenza strains. Moderna has introduced new vaccine candidates for Lyme disease and norovirus. The company established a financial framework projecting sales in its respiratory franchise to reach between $8 billion to $15 billion by 2027.
Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) announced that their investigational personalized mRNA cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, has received PRIME scheme designation from the European Medicines Agency (EMA). This designation follows positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial for treating high-risk stage III/IV melanoma after complete surgical resection. The first detailed results will be presented at the American Association for Cancer Research (AACR) from April 14-19. With a high unmet need for melanoma therapies, this designation aims to accelerate access to effective treatments for patients. Further, the FDA has granted Breakthrough Therapy Designation for the same combination, alongside plans for a Phase 3 study in 2023.
Moderna and the Government of Kenya have finalized an agreement to build an mRNA manufacturing facility in Kenya, marking the company's first such facility in Africa. The new facility aims to produce up to 500 million doses of vaccines annually, enhancing health security for Kenya and the broader African continent. This investment aligns with Moderna's global public health strategy to address unmet health needs, including infectious diseases like HIV and Ebola. The facility will operate under a Special Economic Zone status to facilitate economic growth and attract foreign investment.
Gandeeva Therapeutics has announced a research collaboration with Moderna Inc. (NASDAQ: MRNA) to explore applications of its cryogenic electron microscopy (cryo-EM) technology. The collaboration aims to validate Gandeeva's unique platform for a specific Moderna target, details of which remain undisclosed. The partnership reflects Gandeeva's drive to develop innovative therapeutics by integrating AI and structural biology to target challenging protein interactions. Research payments will be made by Moderna as part of the agreement, facilitating the advancement of Gandeeva's preclinical oncology pipeline.
Moderna, Inc. (NASDAQ:MRNA) will host its Vaccines Day for analysts and investors on April 11, 2023, at 8:00 a.m. ET. The event aims to showcase presentations on its mRNA vaccines and essential vaccine development insights from management and key opinion leaders. The presentation will be available via a live webcast and can be accessed later on Moderna's website. Over the past decade, Moderna has evolved from a research-stage entity to a leading biotechnology company, recognized for its groundbreaking mRNA therapeutics and vaccines, including significant contributions to COVID-19 vaccination efforts.
Moderna (Nasdaq:MRNA) has announced a strategic collaboration with Generation Bio to develop novel nucleic acid therapeutics. This partnership will leverage Generation Bio's proprietary stealth cell-targeted lipid nanoparticle (ctLNP) delivery system and closed-ended DNA (ceDNA) technology for two immune cell and two liver programs, with an option for a third program. Moderna will provide a $40 million upfront cash payment, a $36 million equity investment, and will fund all research and development activities. The collaboration aims to expand the therapeutic pipeline, targeting immune cells and the liver for gene therapies, potentially benefiting numerous patients.