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CureVac N.V. (NASDAQ: CVAC) is a pioneering biopharmaceutical company based in Germany, known for its groundbreaking work in the field of messenger RNA (mRNA) technology. Founded in 2000 as a spin-off from the University of Tübingen, CureVac has developed a unique position as a leader in mRNA research and development. The company's core technology uses mRNA as a data carrier that instructs the human body to produce its own proteins capable of fighting a wide range of diseases, including cancer, infectious diseases, and rare genetic disorders.
CureVac's proprietary mRNA technology has a broad range of applications. In oncology, the company is developing both off-the-shelf and personalized cancer vaccines. Their off-the-shelf cancer vaccines target tumor antigens shared across different cancer types, while the personalized vaccines are tailored to individual patients based on their unique tumor profiles. CureVac has recently entered a collaboration with The University of Texas MD Anderson Cancer Center to further this mission.
In infectious disease, CureVac has partnered with pharmaceutical giant GSK to develop a suite of prophylactic vaccines. This includes second-generation COVID-19 vaccines and a promising seasonal influenza vaccine program. Recent Phase 2 interim data showed that CureVac's influenza vaccine candidates produce higher geometric mean titers against influenza A strains compared to licensed vaccines, though optimizations are ongoing for influenza B strains. Additionally, a new Phase 2 study has been initiated to further enhance the immune response against the relevant influenza B strain.
Financially, CureVac remains robust, with cash and cash equivalents amounting to €402.5 million at the end of 2023. The company's strategic initiatives, such as organizational redesign and partnerships, aim to extend this runway into the fourth quarter of 2025. As of late, CureVac has also achieved significant milestones in its clinical pipeline, which includes a move to Phase 2 studies for its H5N1 avian flu vaccine candidate and ongoing litigation to defend its intellectual property rights.
Overall, CureVac continues to push the boundaries of mRNA technology, with a deep clinical pipeline and strong collaborations to back its innovative discoveries. For more information, visit their official website at www.curevac.com.
CureVac announced the initiation of a rolling submission with the European Medicines Agency (EMA) for its CVnCoV COVID-19 vaccine, currently in late-stage trials. The submission began with pre-clinical data that successfully passed technical validation. This process aims to streamline marketing authorization during the public health emergency. The HERALD trial is assessing CVnCoV in healthy adults across Europe and Latin America. CureVac emphasizes the potential of its mRNA technology in combating COVID-19 and highlights ongoing expansions in manufacturing capacity.
CureVac N.V. (NASDAQ:CVAC) is hosting a conference call on February 5, 2021, at 4:00 p.m. CET / 10:00 a.m. EST to discuss updates regarding its COVID-19 partnership. Interested participants can join via dial-in numbers or through a live webcast available on the CureVac website. The company is recognized for its innovative mRNA technology with over 20 years of expertise, focusing on developing treatments across various medical fields, including vaccines and cancer therapies. The call intends to outline future business strategies and updates on clinical developments.
CureVac N.V. (CVAC) announced a collaboration with the UK Government to develop and manufacture variant vaccines targeting SARS-CoV-2. The aim is to produce 50 million doses, pending regulatory approval, to mitigate current pandemic effects and prepare for future outbreaks. This partnership leverages CureVac's mRNA technology and the UK’s Vaccine Taskforce expertise. The collaboration involves rapid assessment of multiple variants, with a focus on expediting clinical trials in the UK. CureVac is also working with Bayer and GlaxoSmithKline on its existing COVID-19 vaccine, CVnCoV, currently in Phase 3 trials.
CureVac N.V. (NASDAQ:CVAC) has initiated an expansion of its ongoing Phase 1 trial for CV8102, an RNA-based cancer treatment, focusing on advanced melanoma. The selected dose of 600µg aims to confirm the drug's safety, tolerability, and efficacy. Initial results have shown promising immune responses in patients, with the upcoming trial enrolling 30 patients with PD-1 refractory melanoma. The study will provide further insights into CV8102's mechanism and its potential as a new form of cancer therapy.
CureVac (NASDAQ:CVAC) announced that underwriters of its public offering, which closed on February 1, 2021, fully exercised their option to purchase an additional 750,000 common shares at $90.00 per share. This brings the total shares sold to 5,750,000, generating approximately $517.5 million in gross proceeds before expenses. BofA Securities, Jefferies, and Evercore ISI managed the offering, which was registered with the SEC on January 27, 2021. The additional capital enhances CureVac's capabilities in mRNA technology and its clinical pipeline.
CureVac N.V. (Nasdaq: CVAC) has announced a follow-on public offering of 5 million common shares priced at $90.00 each, aiming for gross proceeds of approximately $450 million. The underwriters have an option to purchase an additional 750,000 shares within 30 days. The offering will close on February 1, 2021, pending customary conditions. BofA Securities, Jefferies, and Evercore ISI are the joint book-running managers. This follows a registration declaration by the SEC on January 27, 2021.
CureVac (NASDAQ:CVAC) announced a public offering of 5,000,000 common shares, with a potential additional 750,000 shares from underwriters. The offering aims to raise capital for its mRNA technology development, focusing on vaccines and therapies. Joint book-running managers include BofA Securities, Jefferies, and Evercore ISI. The registration statement is pending approval by the SEC, and all shares will be offered by CureVac. This move reflects the company's ongoing efforts to expand its clinical pipeline.
CureVac N.V. (Nasdaq: CVAC) announced promising preclinical data for its COVID-19 vaccine candidate, CVnCoV, highlighting strong antibody and T cell responses in non-human primates. Animals vaccinated with 8μg of CVnCoV displayed full lung protection against SARS-CoV-2, reinforcing the vaccine's immunogenicity and efficacy at lower doses than those used in ongoing Phase 2b/3 trials. The findings support the continuation of clinical studies and suggest potential for broader immunization against COVID-19.
Bayer has established a collaboration and services agreement with CureVac (NASDAQ:CVAC) to support the development and supply of the COVID-19 vaccine candidate CVnCoV. Bayer will utilize its expertise and infrastructure in critical areas such as clinical operations and regulatory affairs, aiming to facilitate the supply of several hundred million doses globally upon regulatory approval. CureVac will retain Marketing Authorization Holder status, while Bayer will assist with operations in the EU and select markets. This partnership is expected to enhance vaccine accessibility amid the ongoing pandemic.
CureVac N.V. (Nasdaq: CVAC) announced the enrollment of the first participant in its Phase 2b/3 study for its mRNA vaccine candidate, CVnCoV, targeting COVID-19. This pivotal trial, named HERALD, plans to enroll over 35,000 participants across Europe and Latin America, assessing vaccine safety and efficacy at a 12 µg dose. The study aims to prevent confirmed COVID-19 cases and includes a long-term monitoring phase for safety and efficacy. Previous trials showed promising immunogenicity and tolerability for CVnCoV.
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