Welcome to our dedicated page for CureVac N.V. Ordinary Shares news (Ticker: CVAC), a resource for investors and traders seeking the latest updates and insights on CureVac N.V. Ordinary Shares stock.
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.
OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company focused on treating neuropathic corneal pain and inflammatory dry eye disease, announces its participation in the 4th Annual Virtual BTIG Ophthalmology Day on December 2nd, 2024. CEO Gary S. Jacob will engage in one-on-one meetings and lead a fireside chat from 2:40-3:15pm.
The event will feature over 20 medical technology and biotechnology companies, discussing latest developments in ophthalmic technologies and therapeutics. OKYO is developing treatments for NCP, which currently lacks FDA-approved therapies, and DED, representing a multi-billion-dollar market opportunity.
CureVac reported a transformative Q3 2024, marked by a €400 million upfront payment from a restructured GSK collaboration, increasing cash position to €551 million with runway extended into 2028. The company's Phase 1 glioblastoma study showed promising results with 77% of patients demonstrating antigen-specific T-cell responses. A new off-the-shelf program for squamous non-small cell lung cancer and a preclinical vaccine program for urinary tract infections were initiated. The company is implementing a 30% workforce reduction for cost savings from 2025. Q3 revenues reached €493.9 million, primarily driven by the GSK agreement. Operating profit was €368.4 million for Q3 2024.
CureVac (Nasdaq: CVAC) has announced it will release its third quarter and first nine months 2024 financial results on November 12, 2024. The company will host a conference call and webcast at 3 p.m. CET / 9 a.m. EST on the same day. The event will include financial results presentation and business updates. Investors can access the webcast through CureVac's website, where presentation slides will be available before the event, and a replay will be provided afterward.
CureVac has appointed Axel Sven Malkomes as Chief Financial Officer, effective November 11, 2024. Malkomes brings over 30 years of senior corporate and investment banking experience in biotech and pharmaceutical industries. He most recently served as CFO at Cardior Pharmaceuticals, where he led significant financing rounds culminating in its acquisition by Novo Nordisk in 2024. Previously, he was CFO and Chief Business Officer at Medigene AG and held senior roles at Barclays, Société Générale, and 3i Group plc. He currently serves on the Board of Directors of Cellectis SA, chairing its audit committee.
CureVac (Nasdaq: CVAC) announced upcoming presentations at the 12th International mRNA Health Conference in Boston, November 12-14, 2024. The company will share two oral presentations and four posters, featuring expanded data from their Phase 1 CVGBM cancer vaccine study in glioblastoma patients. Initial results showed 77% of evaluable patients developed cancer antigen-specific T-cell responses, with 84% of immune responses being vaccine-generated.
The presentations will include detailed safety and immunogenicity data from the dose escalation study, along with CureVac's approach to optimizing LNP delivery. Additional posters will showcase the company's mRNA platform optimization strategies and new development targets in oncology and infectious disease areas.
CureVac has announced its upcoming presentations at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting in Houston from November 8-10, 2024. The company will showcase extended preliminary immunogenicity results from their Phase 1 CVGBM cancer vaccine study in glioblastoma patients.
Building on previous results presented at ESMO Congress, the study demonstrated that CVGBM monotherapy successfully induced cancer antigen-specific T-cell responses in 77% of evaluable patients, with 84% being de novo responses. Three poster presentations are scheduled, covering topics including preliminary immunogenicity results from the CVGBM trial, mRNA vaccination's enhancement of TCRtg T cell therapy efficacy, and T cell receptor identification for TP53 frameshift.
CureVac N.V. (Nasdaq: CVAC) presented promising Phase 1 data for its CVGBM cancer vaccine in glioblastoma patients at the ESMO 2024 Congress. Key findings include:
- 77% of evaluable patients showed cancer antigen-specific T-cell responses after CVGBM monotherapy
- 84% of immune responses were de novo
- 69% of responding patients showed CD8+ responses, 31% had CD4+ responses, and 23% had both
- CVGBM was well-tolerated up to 100 μg with no dose-limiting toxicities
- Most common adverse events were mild to moderate and resolved within 1-2 days
The 100 μg dose was selected for the ongoing dose expansion phase. These results suggest potential for CVGBM in cancer immunotherapy across various tumor types.
CureVac N.V. (Nasdaq: CVAC) announced that its partner GSK reported positive Phase 2 data from their seasonal influenza mRNA vaccine program. The vaccine candidate, based on CureVac's second-generation mRNA backbone, demonstrated positive immune responses against influenza A and B strains compared to current standards, meeting all predefined success criteria in both older and younger adult groups. The data suggests an acceptable safety and reactogenicity profile.
GSK confirmed that the data supports advancing the program to Phase 3, which would trigger a significant milestone payment for CureVac. This development follows the July 2024 agreement where GSK assumed full control of the influenza vaccine program. The Phase 2 study involved 500 participants across two age groups, testing different dose levels against licensed comparator vaccines.
CureVac N.V. (Nasdaq:CVAC) announced the presentation of first clinical data from its Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma at the ESMO Congress 2024. The study evaluates the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-promoter unmethylated glioblastoma or astrocytoma. Key points:
- Oral presentation on September 13 will cover Part A results, including safety, tolerability, and initial immunogenicity data for dose levels of 12-100 μg
- Treatment-emergent adverse events were mostly Grade 1-2 with no dose-limiting toxicities
- CVGBM features a single unmodified mRNA encoding eight epitopes from tumor-associated antigens
- Part B enrollment began earlier this year, expected to include up to 20 additional patients at the recommended 100 μg dose
CureVac N.V. (Nasdaq:CVAC) announced financial results for Q2 and H1 2024, highlighting key developments:
- New licensing agreement with GSK worth up to €1.45 billion, including €400 million upfront
- Strategic workforce reduction of ~30% by end of 2024
- Initiated Phase 1 study Part B in glioblastoma with CVGBM
- Cash position of €202.5 million as of June 30, 2024 (excluding €400 million GSK payment)
- Reaffirmed cash runway into 2028
Financial highlights for H1 2024:
- Revenues: €26.8 million (82% increase YoY)
- Operating loss: €146.9 million
- Pre-tax loss: €141.1 million
The company is focusing on high-value opportunities in oncology and infectious diseases while streamlining operations.
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