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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) has advanced its cancer vaccine candidate CVGBM to Part B of a Phase 1 study for patients with resected glioblastoma. The first patient has been administered in this dose-confirmation phase, which is expected to include up to 20 patients. Part B aims to generate extended data on safety, tolerability, and immunogenicity of CVGBM.
CVGBM is CureVac's first investigational cancer vaccine based on its second-generation mRNA backbone. It encodes a single fusion protein with eight epitopes showing immunogenicity in glioblastoma. The study's Part A, involving 16 patients and testing doses from 12 to 100 μg, has been completed with no dose-limiting toxicities reported. A 100 μg dose was recommended for Part B.
Initial data from Part A will be presented at the ESMO Congress on September 13, 2024.
CureVac N.V. (Nasdaq: CVAC) has appointed Dr. Mehdi Shahidi, a clinical oncologist and drug development expert, as an independent director to its Supervisory Board. Dr. Shahidi replaces Ralf Clemens, who served from March 2016 through September 2023. The appointment is effective at the CureVac SE level from September 2024, with consideration for CureVac N.V. at the next Annual General Meeting in June 2025.
Dr. Shahidi brings extensive experience in executive leadership and drug development, particularly in clinical oncology. He is currently the CEO of Petalion Therapeutics and a Venture Partner at Medicxi. His previous role as Senior Vice President, Global Head of Medicine and Chief Medical Officer at Boehringer Ingelheim International saw him oversee five drug approvals and advance over 30 candidates into clinical trials.
CureVac has announced updates on its ongoing patent litigation against Pfizer/BioNTech across the U.S., UK, and Germany. A U.S. trial date has been set for March 3, 2025, following a settlement with Acuitas Therapeutics that led to the withdrawal of three disputed patents. In Europe, the European Patent Office will decide on the validity of EP 3 708 668 B1 on March 25, 2025. German litigation sees a hearing scheduled in Düsseldorf on September 10, 2024. Meanwhile, a UK trial began on July 10, 2024, with a judgement expected later this year. These litigations involve patents related to split poly-A tail technology and COVID-19 vaccine design.
Agomab Therapeutics NV has appointed Pierre Kemula as its new Chief Financial Officer, effective November 1, 2024. Mr. Kemula joins from CureVac N.V. (Nasdaq: CVAC), where he led significant financial achievements, including a successful Nasdaq listing and raising over $1.6 billion in equity. He will replace Tolga Hassan, who recently departed to explore new opportunities. During the transition, Paul van der Horst has been serving as interim CFO. Agomab CEO Tim Knotnerus expressed confidence in Kemula’s expertise to drive the company’s growth. Kemula brings over 15 years of experience in biotech financial leadership, with previous roles at Pixium Vision, Ipsen, and major consulting firms.
CureVac has announced a strategic restructuring to focus on high-value mRNA pipeline opportunities, particularly in oncology and other critical diseases. This includes a 30% workforce reduction to create a leaner organization, emphasizing research and development. The company aims to deliver two clinical candidates by the end of 2025 and initiate two new Phase 1 studies by the end of 2026. A recent licensing agreement with GSK, worth up to €1.45 billion plus royalties, will extend CureVac's cash runway into 2028. Operational expenses are expected to decrease by over 30% from 2025, with one-time restructuring charges of approximately €15 million anticipated in Q4 2024.
GSK and CureVac have restructured their existing collaboration into a new licensing agreement. GSK will acquire full rights to develop, manufacture, and commercialize mRNA candidate vaccines for influenza and COVID-19 globally. CureVac will receive an upfront payment of €400 million, and up to an additional €1.05 billion in milestone payments, along with tiered royalties. This new agreement supersedes any previous financial terms from their prior collaboration. The candidate vaccines are in various stages of clinical development and utilize CureVac's second-generation mRNA technology. GSK aims to leverage its capabilities to advance these vaccines, while CureVac retains rights to develop other mRNA vaccines independently. The agreement is subject to antitrust and regulatory approvals.
CureVac N.V. (NASDAQ:CVAC), a clinical-stage biopharmaceutical company specializing in mRNA-based medicines, announced the voting results of its annual general meeting held on June 24, 2024. Shareholders approved all proposed motions, including the appointment of Thaminda Ramanayake and the reappointment of Malte Greune to the Management Board. Additionally, Jean Stéphenne and Mathias Hothum were reappointed to the Supervisory Board, while Birgit Hofmann was appointed as a new Supervisory Board member. KPMG Accountants N.V. was reappointed as the external auditors for the financial year 2024. Detailed vote tabulations will be released soon.
CureVac has commenced dosing of the first participant in a Phase 2 study for its multivalent seasonal influenza vaccine candidate, developed in collaboration with GSK. This follows interim data from a Phase 2 part of a combined Phase 1/2 study, which showed the vaccine candidate elicited stronger immune responses against influenza A strains but weaker responses against influenza B strains compared to licensed vaccines. The Phase 2 study's design has been updated to match the three flu strains recommended by the WHO, excluding the B/Yamagata lineage. The study will evaluate the safety, reactogenicity, and immunogenicity of the vaccine in 500 healthy adults, split between younger (18-64) and older (65-85) participants.
CureVac (Nasdaq: CVAC) has announced its Q1 2024 financial results and business updates.
The company is in the process of an organizational redesign, reducing 150 positions by year-end to trim pandemic infrastructure and increase efficiency.
CureVac's pre-pandemic H5N1 vaccine, co-developed with GSK, received FDA Fast Track designation and is in Phase 1 development.
Settlements with Acuitas Therapeutics recognized CureVac’s patent claims, while ongoing litigation with Pfizer/BioNTech continues under seven U.S. patents, with a trial set for Q2 2025.
In Q1 2024, CureVac reported €300.2 million in cash, €12.4 million in revenue (up 74% YoY), and an operating loss of €73.3 million.
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