GlaxoSmithKline plc / CureVac N.V.

Infectious diseases — self-amplifying mRNA vaccines and monoclonal antibodies (excluding COVID-19, flu, rabies)

58K US cases/yr · $35.0B Global vaccines market 2020 (USD MM, IQVIA) · 80000 Projected global vaccines market 2030 (USD MM)

Disease Overview

The GSK-CureVac strategic collaboration, announced July 2020, targets infectious disease vaccine and antibody applications using CureVac's proprietary self-amplifying mRNA (saRNA) technology. Self-amplifying mRNA encodes both the antigen and a viral replicase machinery (typically derived from alphaviruses such as Venezuelan equine encephalitis virus) enabling intracellular RNA self-replication and dramatically reduced dose requirements (sub-microgram range vs 30-100 mcg for conventional mRNA). The infectious disease addressable space — excluding the COVID-19, flu, and rabies indications already in CureVac's pipeline — encompasses respiratory syncytial virus (RSV, ~14,000 US deaths/year in older adults, ~58,000 hospitalizations in under-5s), cytomegalovirus (CMV, ~30,000 congenital infections/year US), HIV (1.2M Americans living with HIV, CDC 2020), tuberculosis (10M global cases, 1.5M deaths annually pre-pandemic), malaria (229M global cases 2019), Lassa fever, Zika, dengue, Nipah, Marburg, Ebola, and pandemic preparedness X candidates. The global vaccines market in 2020 was approximately $35B (IQVIA) and projected to reach $80B+ by 2030, with mRNA representing the fastest-growing segment. Beyond vaccines, the deal also covered up to five mRNA-based monoclonal antibody therapeutics — a nascent application using mRNA-encoded immunoglobulins as transient passive immunization (Moderna's mRNA-1944 chikungunya antibody Phase 1 was a prototype).

Competitive Landscape

The mRNA infectious disease vaccine and monoclonal antibody competitive landscape circa July 2020 was dense and accelerating. Direct mRNA platform competitors include Moderna (mRNA-1273 COVID-19 Phase 3, mRNA-1647 CMV Phase 2, mRNA-1010 seasonal flu Phase 1, mRNA-1345 RSV Phase 2/3, mRNA-1944 chikungunya antibody Phase 1, plus EBV/HMPV/PIV3/Zika), Pfizer/BioNTech (BNT162b2 COVID-19, BNT161 influenza partnered Aug 2018, BNT164 TB), Sanofi/Translate Bio (parallel July 2020 deal expanding to all infectious diseases, $425M upfront), Arcturus Therapeutics (LUNAR-COV19 Phase 2 — also self-amplifying mRNA, direct mechanism overlap with CureVac saRNA), Imperial College/VacEquity Global Health (saRNA COVID-19 platform), and Providence Therapeutics. CureVac's CVnCoV COVID-19 vaccine (separate from this deal) was advancing into pivotal Phase 2b/3 with conventional unmodified mRNA. Adjacent non-mRNA competitors in infectious disease include AstraZeneca/Oxford ChAdOx1 viral vector, Janssen Ad26 platform, Novavax NVX-CoV2373 (protein subunit + Matrix-M), GSK's own Shingrix/Cervarix/Bexsero recombinant protein vaccines, Sanofi Pasteur's pre-existing Fluzone/Menactra/Pentacel franchises, Merck's Gardasil 9/M-M-R II, and Dynavax CpG 1018 adjuvant. CureVac's saRNA differentiates on dose-sparing and theoretical durability versus conventional mRNA, but the platform had not been clinically validated in humans at deal date — Phase 1 saRNA rabies and yellow fever programs were earlier stage than CureVac's lead conventional mRNA rabies program.