€1.45 Billion Deal: GSK and CureVac Restructure mRNA Collaboration, Focusing on Influenza/COVID-19 Vaccines and Oncology Pipeline

Jul 03, 2024 15:46 CST Updated 15:46

GSK

Pharmaceutical R&D Manufacturer

CureVac

mRNA Drug Developer

丨Organized by the Drug Hunter Club Research Team

On July 3, GlaxoSmithKline (GSK) and CureVac N.V. announced that the two companies had restructured their existing collaboration into a new licensing agreement, allowing both parties to prioritize investment and focus on their respective mRNA development activities.

According to the new agreement, GSK has obtained the rights to develop globally.Development, Production and CommercializationInfluenzaAndCOVID-19 mRNA Candidate Vaccines (Including Combination VaccinesMiao) all rights,CureVac will receive400 million eurosThe prepayment and up toEUR 1.05 billionAdditional development, regulatory and sales milestone payments, as well as tiered royalties; The new agreement replaces all financial terms in the previous collaboration agreement between GlaxoSmithKline and CureVac.

On the same day, CureVac announced the launch of a "strategic restructuring" to focus resources on high-value mRNA pipeline opportunities:

IncludingLayoffs of approximately 30%, and refocus on research, development, and innovation to create a leaner, more agile organization;
Focus onOncologyAnd other specific diseasesThe high-value approach applies proprietary mRNA technology to develop new therapeutic methods;
The company expects toBy the end of 2025, there will be two or more clinical candidate drugs., and plan toInitiate at least two new Phase 1 trials by the end of 2026；
By signing a new licensing agreement with GSK, operational costs were reduced and financial discipline was improved.Cash Runway Extended to 2028

GSK Chief Scientific Officer Tony Wood said: "We are excited about our flu/COVID-19 program and the opportunity to develop a first-class mRNA vaccine to transform the standard of care. Through this new agreement, we will apply GSK's capabilities, partnerships, and intellectual property to CureVac's technology to deliver these promising vaccines on time."

CureVac Chief Executive Alexander Zehnder said, "The cooperation with GSK helps to leverage our proprietary mRNA platform to develop promising late-stage clinical vaccine candidates. This new licensing agreement puts us in a strong financial position, enabling us to focus on building a robust R&D pipeline."

CureVac: Fallen from Grace, When Will It Rise Again?

As the "three giants of mRNA",At the onset of the COVID-19 pandemic in 2020, CureVac was one of the key players in the early race for vaccine development and was highly regarded by all parties.In June 2020, the German government acquired 23% of CureVac's shares for 300 million euros. In July of the same year, GSK invested 143 million euros to purchase 10% of CureVac's shares to jointly develop vaccines.

In August 2020, CureVac rode this momentum to launch its IPO on the Nasdaq, with its stock price surging 250% on the first day of trading and raising $213 million in its initial public offering.CureVac's stock price continued to rise subsequently, reaching a peak of $150.8 per share on December 31, 2020.

However, with the clinical failure of CureVac's COVID-19 vaccine program, CureVac's stock also began to head towards Waterloo.On June 16, 2021, CureVac announced the latest data from the Phase 2b/3 clinical trial of its COVID-19 mRNA vaccine. The efficacy rate of CVnCoV was only 47%, failing to meet the predefined statistical success criteria. Following this news, CureVac's after-hours stock price plummeted by half, and its market value dropped below $9 billion.

CureVac's consecutive failures in the development of its COVID-19 vaccine have caused this highly talked-about mRNA company to miss its chance for takeoff.In contrast, the other two "giants," Moderna and BioNTech, quickly obtained emergency authorization for their COVID-19 mRNA vaccines, rapidly transforming from small biotech companies into pharmaceutical enterprises worth tens of billions.

However, the current downturn may be temporary. CureVac, which ranks among the top globally in terms of the number of mRNA patents, may see new opportunities as it changes course.

On April 24, 2024, CureVac released its long-delayed 2023 financial report, announcing a major restructuring plan, including layoffs of 150 employees, and business updates.As of December 31, 2023, cash and cash equivalents amounted to €402.5 million, extending the company’s cash runway into the fourth quarter of 2025 following the corporate restructuring.

Since the beginning of this year, CureVac has continuously welcomed catalysts, successively announcing the joint development of a novel mRNA cancer vaccine with the MD Anderson Cancer Center at the University of Texas, as well as the disclosure of interim Phase II data for the seasonal influenza vaccine development program in collaboration with GSK.

The company expects to release Phase 1 trial data for its cancer candidate vaccine CVGBM targeting glioblastoma in the second half of 2024. By the end of 2025, CureVac anticipates having two clinical candidates for "shared antigen" cancer vaccines for solid tumors and blood cancers, including one developed in collaboration with researchers at MD Anderson, and plans to initiate two additional Phase 1 trials before the end of 2026.

Following this restructuring, CureVac expects its operating costs to decrease by more than 30% starting from 2025. This includes a reduction of approximately 250,000 euros in personnel costs. The company anticipates incurring around 150,000 euros in one-time restructuring costs, including employee severance pay, benefits, and related expenses. These costs are expected to be recorded in the fourth quarter of 2024.

Based on this, the €400 million upfront payment and up to €1.005 billion in additional payments, along with tiered royalties from this year's GSK licensing agreement, will extend the company's cash runway to 2028 through these cost savings.

CureVac Plans to Provide Further Financial and Strategic Updates in the Third Quarter Report of 2024.

GSK: The King of Infectious Disease Vaccines Is Accelerating Its mRNA Technology Layout

The global infectious disease market is worth up to £105 billion, and as a world leader in this market, GSK has as many as 67 vaccine products in its pipeline. mRNA is naturally also an important tool for GSK to expand its vaccine portfolio.

mRNA, as a highly adaptable vaccine technology, has been widely used in emerging and evolving viral pathogens due to its ability to support rapid strain changes. Since 2020, GSK and CureVac have been collaborating on the development of mRNA vaccines for the treatment of infectious diseases, and currently haveSeasonal InfluenzaAndCOVID-19 Candidate Vaccine（In Phase II Clinical Development），Avian Influenza Candidate Vaccine（In Phase I Clinical Development). All candidate vaccines are based on CureVac's proprietary second-generation mRNA technology. To date, the data obtained from these candidate vaccines show promising prospects, demonstrating their potential to become first-class novel vaccines.

In addition, GSK continues to develop and optimize its mRNA capabilities through investment and collaboration, including AI/ML-based sequence optimization, nanoparticle design, and manufacturing.

Source:

[1] Biopharmaceutical Editor: The Fallen mRNA Giant

[2] Company Official Website

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