U.S. FDA clears lung cancer IND for CVHNLC, a proprietary off-the-shelf candidate targeting squamous non-small cell lung cancer (sqNCLC), with clinical study expected to begin H2 2025; Clinical Trial Application filed in Europe with decision expected in Q2 2025 Glioblastoma study fully enrolled with Part B of Phase 1 CVGBM trial completing enrolment in Q1 2025; go/no-go decision on moving to Phase 2 planned for H2 2025 First... Read More

European Patent Office largely dismisses opposition filed by BioNTech SE, Pfizer Inc., and others in December 2023 challenging validity of EP 4 023 755 B1 and maintains the patent subject to amendments to specific patent claims A hearing on infringement of EP 4 023 755 B1 which will also include EP 3 708 668 B1, the validity of which was confirmed in amended form in March 2025, is scheduled for July 1, 2025, before the... Read More

Strategic Milestone Achievement and Increased Financial Discipline Underscore Year of Corporate Transformation Completed enrollment of Part B of Phase 1 glioblastoma study with investigational precision immunotherapy CVGBM; Part B first data readout anticipated in H2 2025 Filed IND and CTA submissions for Phase 1 study with proprietary off-the-shelf program in squamous non-small cell lung cancer (sqNSCLC) Received FDA... Read More

TÜBINGEN, DE / ACCESS Newswire / April 8, 2025 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biotech company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), will report financial results, and provide business updates for the fourth quarter and full-year 2024 on Thursday, April 10, 2025. The company will host a conference call and webcast on the same day at 3 p.m. CET / 9... Read More

Significant Regulatory Milestone: U.S. FDA cleared IND application for CVHNLC, CureVac's investigational therapy targeting squamous non-small cell lung cancer Proprietary Epitopes: CVHNLC encodes novel tumor epitopes identified through proprietary whole genome-based discovery platform Enhanced Combination Therapy: CVHNLC to be tested in combination with pembrolizumab, aiming to amplify targeted anti-tumor immune responses... Read More

European Patent Office largely dismisses opposition filed by BioNTech SE in April 2023 challenging validity of EP 3 708 668 B1 and maintains the patent in amended form A hearing on infringement of EP 3 708 668 B1 is scheduled for July 1, 2025, before the Regional Court Düsseldorf Confirming validity of patent in its amended form marks major milestone in broader patent litigation in Germany, recognizing CureVac's pioneering... Read More

CureVac among global top 100 most fast-paced innovators for third consecutive year in acknowledgment of its innovative strength and extensive intellectual property portfolio The company holds one of the broadest intellectual property portfolios in mRNA technology TÜBINGEN, GERMANY AND BOSTON, MA / ACCESS Newswire / February 18, 2025 / CureVac N.V. (Nasdaq:CVAC), a global biopharmaceutical company developing a new class of... Read More

Strengthened Cash, Strategic Refocus and Pipeline Progress Define Transformative Quarter €400 million upfront payment from restructured GSK collaboration reflected in financials, cash position increased to €551 million; expected cash runway re-affirmed into 2028 CVGBM Phase 1 glioblastoma study showed 77% of patients with antigen-specific T-cell responses; data presented at ESMO, SITC and SNO New off-the-shelf program for... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / November 7, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), will report financial results, and provide business updates for the third quarter and first nine months 2024 on Tuesday, November 12, 2024. The company will host a conference call and... Read More

Experienced CFO and investment banker with 30-year track record will help drive CureVac's transformation TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / November 4, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the appointment of Axel Sven Malkomes as Chief Financial Officer,... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / November 4, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that new and updated data will be shared in two oral presentations and four posters at the 12 th International mRNA Health Conference, taking place in Boston, Massachusetts,... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / October 28, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced poster presentations at the Society for Immunotherapy of Cancer (SITC) 39 th Annual Meeting, taking place November 8-10 in Houston, USA. CureVac will present, among other... Read More

Preliminary immunogenicity results demonstrate induction of cancer antigen-specific T-cell responses in 77% of evaluable patients following CVGBM monotherapy 84% of immune responses were de novo, observed in patients without pre-existing T-cell activity against encoded cancer antigens CVGBM was generally well tolerated up to the highest tested dose level of 100 µg with no dose-limiting toxicities Most common adverse events... Read More

Phase 2 data demonstrated positive immune responses to A and B strains, with acceptable safety and reactogenicity profile, meeting all pre-defined study endpoints Vaccine candidate based on CureVac's proprietary second-generation mRNA backbone GSK confirmed data support advancing program to Phase 3; dosing of first Phase 3 participant is associated with a significant milestone payment for CureVac In July 2024, GSK assumed... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / September 9, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the first clinical data from CureVac's ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be presented at the European Society for... Read More

Closed new licensing agreement with GSK worth up to €1.45 billion, including €400 million upfront; provides strong validation of CureVac's mRNA platform Initiated strategic workforce reduction of ~30% by end of 2024, optimizing business to focus on high-value opportunities in oncology, infectious diseases and other areas Invoiced €10 million milestone payment after Phase 2 transition of pre-pandemic avian influenza (H5N1)... Read More

First patient administered in dose-confirmation Part B of Phase 1 study with mRNA-based, multiepitope cancer vaccine candidate CVGBM Part B expected to include up to 20 patients to generate extended data on safety, tolerability, and immunogenicity of CVGBM TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / August 15, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / August 15, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today named clinical oncologist Mehdi Shahidi, M.D., as an independent director to the company's Supervisory Board. Dr. Shahidi replaces Ralf Clemens, who served on the Supervisory Board... Read More

New trial date for U.S. patent litigation set for March 3, 2025, following settlement with Acuitas Therapeutics First instance decision on validity of EP 3 708 668 B1 (split poly-A tail technology) scheduled for March 25, 2025, by European Patent Office in the context of the German patent litigation UK trial on validity of intellectual property rights EP 3 708 668 B1 and EP 4 023 755 B1 (split poly-A tail technology) began... Read More

GSK acquires full rights to develop, manufacture and commercialize globally mRNA candidate vaccines for influenza and COVID-19, including combinations CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced LONDON, UK, TÜBINGEN, GERMANY... Read More

Strategic restructuring includes a workforce reduction of approximately 30%, re-focusing on research, development, and innovation to create leaner and more agile organization Prioritization of high-value opportunities in oncology and other selected diseases, leveraging proprietary mRNA technology to develop novel treatment approaches Company expects to deliver two or more clinical candidates by the end of 2025 and plans to... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / June 24, 2024 / CureVac N.V. (NASDAQ:CVAC), a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the voting results of the Company's annual general meeting. The shareholders of the Company voted in favor of all proposals. These proposals included the appointment of... Read More

Phase 2 study to assess updated formulations for improved immune responses of multivalent vaccine candidate against influenza B strain Study initiated following previously reported interim data from Phase 2 Part of combined Phase 1/2 study in seasonal influenza Composition of vaccine candidate changed to match all three WHO-recommended flu strains, following recommendation to exclude B/Yamagata lineage TÜBINGEN, GERMANY AND... Read More

Organizational redesign on track, trimming residual pandemic infrastructure and reducing 150 positions by year end U.S. FDA Fast Track designation granted for pre-pandemic avian influenza (H5N1) vaccine currently in Phase 1 development; candidate jointly developed with GSK Settlement with Acuitas Therapeutics includes acknowledgment of CureVac's ownership of certain patent claims and Acuitas's licenses to selected patents... Read More

Organizational redesign and rightsizing initiated across company to streamline structures, increase efficiency and reduce operating costs Together with GSK, ended Pandemic Preparedness Agreement (PPA) with Federal Republic of Germany, after consultation with the German Federal Ministry of Health Cash and cash equivalents position of €402.5 million as of December 31, 2023; cash runway extended into Q4 2025 with organizational... Read More

Mr. Ramanayake brings more than fifteen years of experience in biopharma company development and deal-making Strong track record of successful clinical collaborations, M&A, asset in-licensing and strategic financing initiatives across multiple therapeutic areas TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / April 24, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of... Read More

Phase 1 part of combined Phase 1/2 study initiated as part of pandemic preparedness against highly pathogenic avian influenza (H5N1) virus, considered to be potential future pandemic threat Study will assess monovalent vaccine candidate, encoding an influenza A H5-antigen using proprietary second-generation mRNA backbone Avian influenza is latest program progressing to clinical trials under broad infectious disease... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / April 18, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), will report financial results, and provide business updates for the fourth quarter and full-year 2023 on Wednesday, April 24, 2024. The company will host a conference call and webcast on the... Read More

Agreement creates strong synergies between CureVac's unique end-to-end mRNA capabilities and MD Anderson's translational and clinical research expertise Collaboration aims to develop novel, off-the-shelf, mRNA-based cancer vaccines in selected hematological and solid cancers with high unmet medical need MD Anderson responsible for leading initial Phase 1/2 studies; CureVac retains worldwide exclusive rights to late-stage... Read More

Seasonal flu vaccine candidate boosted antibody titers at all dose levels and for all encoded seasonal influenza strains across younger and older adults Potentially differentiated, multivalent candidate encodes antigens matched to all four WHO-recommended flu strains For influenza A strains, geometric mean titers numerically exceeded those elicited by the licensed comparator vaccines consistently across all tested dose... Read More

Head-to-head comparison with licensed bivalent mRNA-based comparator vaccine confirms competitive immune responses at lower doses and favorable tolerability profile Monovalent mRNA vaccine candidate, CV0601, encoding Omicron BA.4-5 variant and bivalent candidate, CV0701, encoding Omicron BA.4-5 variant as well as the original SARS-CoV-2 virus, successfully boosted antibody titers and were generally well tolerated across all... Read More

Validity of CureVac patent EP 1 857 122 B1 denied by German Federal Patent Court after nullity action filed by BioNTech SE Decision does not affect ongoing litigation in Germany regarding seven other intellectual property rights, covering strong foundational as well as COVID-19-specific mRNA innovation CureVac to appeal before the German Federal Court of Justice, while remaining confident in the strength of its broad... Read More

Enrollment completed for Phase 2 COVID-19 study with mono- and bivalent vaccine candidates; study on track for data read-out in early 2024 First participant dosed in seasonal flu Phase 2 study with potentially differentiated multivalent candidate; €15 million milestone payment by GSK triggered Phase 1 study in glioblastoma well on track with opening of third dose level for CVGBM, CureVac's multiepitope cancer vaccine... Read More

COVID-19 Phase 2 clinical trial fully enrolled Study compares mono- and bivalent vaccine candidates against licensed comparator COVID-19 vaccine First participant dosed in seasonal flu Phase 2 part of combined Phase 1/2 study Study compares a potentially differentiated, multivalent vaccine candidate with broad antigen coverage against licensed comparator vaccine TÜBINGEN, GERMAN and BOSTON, MA / ACCESSWIRE / November 1, 2023... Read More

Initiated Phase 2 study in COVID-19 with monovalent and bivalent, modified mRNA vaccine candidates; continued execution on infectious disease development program in collaboration with GSK Initiated Phase 1 study of cancer vaccine candidate, CVGBM, for surgically resected glioblastoma; recruitment of second dose cohort well on track Broadened position in patent litigations by expanding the scope and asserting new intellectual... Read More

Phase 2 study initiated at clinical sites in Australia with monovalent and bivalent mRNA COVID-19 vaccine candidates Vaccine candidates developed in collaboration with GSK within COVID-19 vaccine development program TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / August 1, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / July 14, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that Dr. Igor Splawski, CureVac's Chief Scientific Officer, will step down effective July 14, 2023 to return to early-stage research in the United States. During the search for... Read More

Cases in Germany and the U.S. broadened by asserting additional, new intellectual property rights Three new intellectual property rights added to infringement lawsuit against Pfizer/BioNTech in Germany, increasing number of asserted intellectual property rights to eight Tenth patent added to CureVac's counterclaim against Pfizer/BioNTech in the U.S., covering innovations in mRNA purification methods highly relevant to the... Read More

Cancer vaccine candidate CVGBM utilizes single mRNA, encoding eight epitopes of tumor-associated antigens with demonstrated relevance in glioblastoma Study designed to evaluate safety and immunogenicity in patients with glioblastoma after surgical resection and radiotherapy First study to apply CureVac's second-generation mRNA backbone in oncology TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / June 20, 2023 / CureVac N.V.... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / June 20, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the appointment of Michael Brosnan as an independent director to the company's Supervisory Board. Mr. Brosnan replaces Hans Christoph Tanner, who has been a member of CureVac's... Read More

TÜBINGEN, GERMANY and BOSTON, USA / ACCESSWIRE / June 19, 2023 / CureVac N.V. (Nasdaq:CVAC), a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the voting results of the Company's annual general meeting. The shareholders of the Company voted in favor of all proposals. The proposals voted in favor for included the... Read More

Initiated Phase 1/2 study in seasonal flu with multivalent, modified mRNA vaccine candidates; continued execution on infectious disease development program in collaboration with GSK Filed infringement counterclaim in U.S. patent litigation with Pfizer/BioNTech; case filed under nine CureVac patents; litigation timeline expected to be accelerated by successful court transfer Received positive preliminary opinion of German... Read More

Motion to transfer U.S. litigation to Eastern District of Virginia granted at CureVac's request and expected to significantly accelerate U.S. litigation timeline CureVac is filing counterclaim in U.S. court under nine patents covering foundational mRNA innovations highly relevant to the design, formulation and manufacturing of Comirnaty® German Federal Patent Court issued preliminary opinion in April 2023 supporting validity... Read More

Initial Phase 1 part started with multivalent modified mRNA influenza vaccine candidates Candidates developed in collaboration with GSK within broad infectious disease vaccine program encode for antigens covering four WHO-recommended flu strains TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / May 8, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative... Read More

In 2022, ongoing business transformation driven by COVID-19 and flu clinical develop­ments in collaboration with GSK and successful broadening of oncology footprint Early 2023, strong validation of CureVac's proprietary mRNA technology platform from positive preliminary Phase 1 data in COVID-19 and flu in collaboration with GSK Monovalent modified COVID-19 candidate CV0501 demonstrated efficient booster activity and good... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / April 18, 2023 / CureVac N.V. (Nasdaq:CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), will report financial results, and provide business updates for the fourth quarter and full-year 2022 on Tuesday, April 25, 2023. The company will host a conference call and webcast on the same day at 3 p.m.... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / March 28, 2023 / CureVac N.V. (NASDAQ:CVAC), a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the voting results of the Company's extraordinary general meeting. The shareholders of the Company voted in favor of all proposals. The proposals voted in favor for... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / February 10, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), announced today the closing of its follow-on public offering of 27,027,028 common shares, at a public offering price of $9.25 per common share, for total gross proceeds of approximately... Read More

TÜBINGEN, GERMANY / BOSTON, MA / ACCESSWIRE / February 7, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), announced today that it intends to offer $200 million of its common shares in an underwritten public offering. In addition, CureVac intends to grant the underwriters a 30-day option to... Read More

Dr. Mendila joins CureVac as Chief Development Officer with more than 20 years of global industry experience TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / February 1, 2023 / CureVac N.V. (Nasdaq:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that Myriam Mendila has taken up her role as CureVac's Chief Development... Read More

CureVac recognized as a Top 100 innovator in acknowledgment of the company's innovative strength and extensive intellectual property portfolio The company holds one of broadest intellectual property portfolios in mRNA technology TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / January 31, 2023 / CureVac N.V. (Nasdaq:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger... Read More

Continued technology platform validation with extended preliminary data from older adults in ongoing Phase 1 studies in COVID-19 and flu COVID-19: monovalent modified mRNA construct CV0501 successfully boosted antibody titers against BA.1 and ancestral variants in adults age ≥65 Flu: monovalent modified mRNA construct Flu-SV-mRNA elicited antibodies approximately 2.3 times those of licensed vaccine comparator in adults aged... Read More

Dr. Franz-Werner Haas to complete successful tenure as CEO by March 31, 2023 Dr. Alexander Zehnder to succeed Dr. Haas as new CEO, joining from Sanofi on April 1, 2023 TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / January 9, 2023 / CureVac N.V. (NASDAQ:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that after more... Read More

Promising COVID-19 and flu modified mRNA vaccine candidates identified based on positive preliminary data from ongoing Phase 1 studies All candidates use CureVac's advanced second-generation mRNA backbone optimized to achieve improved mRNA translation and strong immune responses at low doses The preliminary results provide strong evidence of technology for CureVac's mRNA platform; CureVac and partner GSK plan to advance... Read More

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / December 14, 2022 / CureVac N.V. (NASDAQ:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that Chief Executive Officer Franz-Werner Haas, Chief Financial Officer Pierre Kemula and Interim Chief Development Officer Ulrike Gnad-Vogt sold an aggregate of 103,775 CureVac common... Read More