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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 N.V. (NASDAQ: CVAC) announced its strategic shift towards developing a second-generation mRNA COVID-19 vaccine, CV2CoV, in collaboration with GSK, following the withdrawal of its first-generation candidate, CVnCoV, from regulatory review. The company reported a cash position of €1.06 billion as of September 30, 2021, despite a substantial increase in operating losses, which reached €143.1 million for Q3 2021. Promising preclinical results published in Nature show CV2CoV's immune response is comparable to an approved mRNA vaccine, enhancing CureVac's position in the mRNA vaccine space.
CureVac (NASDAQ:CVAC) has published new preclinical data for its second-generation COVID-19 vaccine candidate, CV2CoV, developed with GSK, in Nature. The study shows antibody levels after vaccination with 12μg of CV2CoV are comparable to those following a 30μg dose of Comirnaty® (Pfizer/BioNTech). CV2CoV demonstrated enhanced immune responses, with better neutralizing capacity against variants like Delta. This research underscores the potential of non-chemically modified mRNA technology in vaccine development.
CureVac recently reported promising outcomes from the Phase 1 clinical trial of its oncology candidate CV8102, indicating a systemic immune response in both injected and non-injected tumors. The completed dose-escalation study demonstrated significant stimulation of the immune system, with increased T cell infiltration observed in biopsy samples. The expansion phase, fully recruited by October 2021, includes 40 patients and aims to confirm CV8102's safety and efficacy. Results from this study are anticipated in the second half of 2022.
CureVac N.V. (CVAC) has announced a strategic pivot in its COVID-19 vaccine efforts, prioritizing the development of second-generation mRNA vaccine candidates in partnership with GSK. The company will withdraw its first-generation vaccine candidate, CVnCoV, from regulatory review due to potential overlaps with approval timelines for newer candidates. CureVac expects the second-generation program to enter clinical development soon and aims for market readiness in 2022, with reported pre-clinical data indicating up to 10x higher immunogenicity than CVnCoV.
CureVac has announced a strategic adjustment to its European manufacturing network in response to decreased demand for its COVID-19 vaccine candidate, CVnCoV, currently under review by the EMA. The company is terminating contracts with WACKER and Celonic while maintaining agreements with Rentschler Biopharma and Novartis. This move aims to align manufacturing capacity with actual demand. Vaccine production for the second-generation COVID-19 candidate, CV2CoV, developed with GSK, remains unaffected and is expected to enter clinical trials in Q4 2021.
CureVac (Nasdaq:CVAC) announced groundbreaking findings demonstrating the efficacy of HNF4A mRNA therapeutics in treating liver fibrosis and cirrhosis, published in the Journal of Hepatology. The preclinical study showed that treatment in mouse models significantly restored HNF4A levels, reducing liver injury. This research is a crucial step towards developing effective therapies for a condition that causes millions of deaths annually. Ongoing research will focus on optimizing these mRNA candidates for future clinical applications.
CureVac N.V. reported financial results for Q2 and H1 2021, showing a cash position of €1.36 billion as of June 30. Vaccine candidate CVnCoV has demonstrated 48% efficacy across all age groups, particularly 53% in ages 18-60. A second-generation vaccine, CV2CoV, showed improved immune responses in preclinical studies and is set to enter Phase 1 trials in Q4 2021. However, total revenues decreased by 35% and 14% year-over-year due to a one-time revenue effect in 2020. Operating losses increased to €147.8 million in Q2.
CureVac has announced results from its pivotal Phase 2b/3 HERALD study of COVID-19 vaccine candidate CVnCoV, demonstrating overall vaccine efficacy of 48% against COVID-19 of any severity. The study included 40,000 participants across 10 countries and showed significant efficacy of 53% in participants aged 18 to 60. Notably, CVnCoV provided full protection against hospitalization or death in this age group. CureVac is in ongoing discussions with the European Medicines Agency (EMA) regarding regulatory submission.
CureVac N.V. (NASDAQ:CVAC) announced the appointment of Dr. Malte Greune as Chief Operating Officer effective July 1, 2021. Dr. Greune, with extensive pharmaceutical experience, will lead CureVac's clinical and commercial manufacturing initiatives. Concurrently, Dr. Florian von der Mülbe resigns from the Management Board to focus on The RNA Printer project, enhancing CureVac's mobile RNA vaccine manufacturing capabilities. Dr. Greune's leadership aims to transition CureVac from a science-driven to a commercial pharmaceutical entity, boosting its RNA-based product development.
CureVac N.V. (NASDAQ:CVAC) announced the results of its annual general meeting where shareholders approved most proposals, notably the appointments of Antony Blanc and Klaus Edvardsen as managing directors, and the re-appointment of Pierre Kemula. However, they rejected the authorization for the management board to acquire shares. The company emphasizes its focus on mRNA technology, leveraging over 20 years of expertise to develop innovative therapies across various domains.
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