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Showing posts with label MRNA. Show all posts
Showing posts with label MRNA. Show all posts

Thursday, December 14, 2023

===Moderna (MRNA), Merck (MRK) vaccine with Keytruda cuts risk of deadly skin cancer returning in half

 


Moderna and Merck (MRK) announce mRNA-4157 in combination with Keytruda demonstrated continued improvement in recurrence-free survival and distant metastasis-free survival in patients with high-risk stage III/IV melanoma following complete resection versus Keytruda at three years 
  • Co announced follow-up data from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection. In this planned analysis occurring with a median follow-up of approximately three years, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA continued to demonstrate a clinically meaningful improvement in recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.288-0.906]; one-sided nominal p=0.0095) compared with KEYTRUDA alone. mRNA-4157 (V940) in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), compared with KEYTRUDA alone, reducing the risk of developing distant metastasis or death by 62% (HR=0.384 [95% CI, 0.172-0.858]; one-sided nominal p= 0.0077).
  • Adverse events observed with mRNA-4157 (V940) in KEYNOTE-942 remain consistent with those previously reported. At a median planned follow-up of approximately three years, the number of patients reporting treatment-related Grade = 3 adverse events were similar between the arms (25% for mRNA-4157 (V940) in combination with KEYTRUDA vs 20% for KEYTRUDA alone). The most common adverse events of any grade attributed to mRNA-4157 (V940) were fatigue (60.6%), injection site pain (56.7%), and chills (49%).
  • Based on data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, the U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma. The companies previously presented data on the study's primary analysis with a median planned follow-up of approximately two years. The study's primary endpoint, RFS, was presented in April 2023 at the American Association for Cancer Research (AACR) Annual Meeting, and the study's secondary endpoint, DMFS, data was presented in June 2023 at the American Society of Clinical Oncology (ASCO) Annual Meeting. Data from the primary analysis has been submitted for publication in a peer-reviewed journal.

Thursday, August 20, 2020

CureVac (CVAC) and EU in advanced talks for 225 million Covid-19 vaccine doses

  • CureVac has said its Covid-19 vaccine could be ready for the public by mid-2021

Shares of CureVac NV soared Thursday after the German biotech firm said it was in advanced talks for the supply of at least 225 million doses of a potential Covid-19 vaccine to EU member states.

CureVac said talks with the EC, the European Union’s executive arm, include an option to supply an additional 180 million doses, once the mRNA-based vaccine has proven to be safe and effective against Covid-19, bringing the total to up to 405 million doses.

The EC is also in talks with Johnson & Johnson (JNJ) and France’s Sanofi (SNY) for their vaccines under development. It also reached an agreement last week with AstraZeneca (AZN) to buy at least 300 million doses of its potential Covid-19 vaccine which it is developing with Oxford University.

CureVac (CVAC) is specializing in the messenger RNA technology that is the basis of many of the leading Covid-19 vaccine programs, including Moderna Inc. (MRNA) and BioNTech S.E. (BNTX).

“In the current pandemic, we are very pleased to further strengthen the European Commission’s endeavor to provide rapid access to a safe and effective vaccine against the Covid-19 virus across Europe and beyond,” Franz-Werner Haas, chief executive of CureVac said.

“Assuming positive results from our ongoing clinical trials and approval from the regulatory authorities, we are fully committed to ensure broad access to our vaccine,” he added.

Backed by Microsoft founder and billionaire Bill Gates, CureVac listed on the Nasdaq Stock Market on Aug. 14, raising $213 million.

In July, GlaxoSmithKline PLC (GSK) said it was taking a stake in CureVac, the latest move by a major drugmaker to boost capabilities to fight pandemics. FTSE 100-listed Glaxo said CureVac’s mRNA technology would complement its own capabilities as it inked a deal worth up to £866 million ($1.09 billion).