Full Press Release Details
CureVac Presents Preliminary Data from Phase
of Oncology Candidate CV8102
T BINGEN, Germany/ Boston, USA -
November 11, 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 data from the Phase 1 expansion study of CV8102, the company's
non-coding RNA candidate in oncology. Preliminary results from the completed Phase 1 expansion study in patients with PD-1 refractory
melanoma confirm a robust safety profile of CV8102 as a single agent and in combination with anti-PD-1 antibodies. Preliminary efficacy
was observed in a cohort of 30 patients treated in combination with anti-PD-1 antibodies, 40% of whom were pretreated with anti-CTLA-4
antibodies. As of June 15, 2022, in the anti-PD-1 combination cohort, five out of 30 patients (17%) experienced a partial response according
to RECIST 1.1. Responses appeared durable for up to one year from the start of treatment. No objective responses were observed in the
10 patients of the single-agent cohort, 50% of whom were pretreated with anti-CTLA-4 antibodies. The data will be presented today at the
37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held in Boston, Massachusetts.
Extensive analysis of
immune cell activation was performed to better understand CV8102's mobilization of the immune system against injected tumors as
well as non-injected tumors. The data confirm that single agent or combination treatment, after the first dose, activated systemic pathways
of immune response. Preliminary analysis of the tumor microenvironment in a subgroup of patients showed the positive outcome of increased
infiltration of T cells, following intra-tumoral injection in 4 out of 8 (single agent cohort) and 10 out of 18 (anti- PD1 combination
cohort) analyzed paired biopsy samples.
"The data we collected in the heavily pretreated
patients of our Phase 1 expansion study further confirm the safety and immuno-modulatory activity of CV8102" said Ulrike Gnad-Vogt,
interim Chief Development Officer at CureVac. "As a non-coding RNA, CV8102 is designed to mimic a viral infection of the tumor and
to induce an adaptive immune response against a broad panel of tumor antigens. The preliminary efficacy we see in the small group of pretreated
patients further validates this technology. Given our strategic focus on developing a meaningful portfolio of mRNA-based therapeutic cancer
vaccines, we will seek to assess CV8102's potential as a complementary technology."
Final results are expected
in H1 2023 and will be submitted for publication in a peer reviewed journal.
CV8102 is being tested in a fully recruited dose-escalation
and expansion Phase 1 study to confirm its safety, tolerability and efficacy as a single agent and in combination with licensed anti-PD-1
antibodies. Preliminary results from the completed dose-escalation part of the study in a range of solid tumors, were previously reported
at the European Society for Medical Oncology (ESMO) conference in September 2021.
CV8102 is a single-stranded non-coding RNA optimized
to maximize activation of cellular receptors that normally detect viral pathogens entering the cells, such as toll-like receptors 7 and
8 (TLR7/8), and retinoic acid inducible gene I (RIG-I), mimicking a viral infection of the tumor. CV8102 is designed to recruit and activate
antigen-presenting cells at the site of injection to present tumor antigens released from tumor cells to T cells in the draining lymph
node. This potentially leads to activation of tumor-specific T cells, which can kill tumor cells at the injected site, but also at distant
non-injected tumor lesions or metastases. The Phase 1, open-label, dose escalation and expansion study of CV8102 aims to assess safety,
tolerability and efficacy of CV8102 as a single agent and in combination with licensed PD1-antibodies. Preliminary results from the completed
dose-escalation part in patients with advanced melanoma, cutaneous squamous cell carcinoma, squamous cell carcinoma of head and neck or
adenoid cystic carcinoma were reported at the European Society for Medical Oncology (ESMO) conference in September 2021. The expansion
part of the study focuses on patients with PD-1 refractory melanoma treated with a recommended dose of 600 g.
CureVac (Nasdaq: CVAC) is a
global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing,
optimizing, and manufacturing this versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology
is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range
of diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious
diseases based on CureVac's second-generation mRNA technology. This collaboration was later extended to the development of second-generation
COVID-19 vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac has built a deep clinical
pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac
SE has its headquarters in T bingen, Germany, and has more than 1,000 employees across its sites in Germany, the Netherlands, Belgium,
Switzerland and the U.S. Further information can be found at www.curevac.com.
CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
CureVac Media Contact
Bettina J dicke-Braas, Manager Communications
CureVac, T bingen, Germany
T: 49 7071 9883-1087
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