CureVac Presents Preliminary Data from Phase 1 Study Expansion of Oncology Candidate CV8102

• Data confirm CV8102's safety and ability to strongly mobilize the immune system against tumors
• Final data of complete Phase 1 dose-escalation and expansion study expected in H1 2023

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / 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 37 ^th 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."

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