AAVCOVID / Novartis, Massachusetts Eye and Ear, Massachusetts General Hospital - LARVOL DELTA

Single-Dose Optimized AAV-Based COVID-19 Vaccine Elicits Durable and Protective Immunity Against Variants of Concern in Nonhuman Primates (ASGCT 2022) - "Additionally, we developed optimized AAVCOVID vaccine candidates for higher potency and protection against variants of concern (VOC)...We also show unique antibody durability in NHP models, with up to 1.5 years peak antibody levels. These observations together with the single, low dose requirement, high yield manufacturability, and 1-month stability for storage at room-temperature may make this technology well-suited to support effective immunization campaigns for emerging pathogens on a global scale."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity of an AAV-Based COVID-19 Vaccine in Murine Models of Obesity and Aging. (PubMed, Viruses) - "Here, we investigated the effectiveness of the AAVCOVID vaccine candidates in murine models of obesity and aging...In aged mice, vaccine immunogenicity was impaired. These results suggest that AAV-based vaccines may have limitations in older populations and may be equally applicable in obese and non-obese populations."

Journal • Preclinical • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Obesity • Respiratory Diseases

AAVCOVID: A SINGLE-DOSE, THERMOSTABLE COVID-19 VACCINE WITH DURABLE IMMUNOGENICITY (CROI 2022) - "This work shows the adaptability and versatility of AAVCOVID vaccine platform to improve potency and protect against VOC. These observations together with the single, low dose requirement, high yield manufacturability, and 1-month stability for storage at room-temperature may make this technology well-suited to support effective immunization campaigns for emerging pathogens on a global scale."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] An AAVbased, roomtemperature stable, single dose COVID19 vaccine (ESGCT 2021) - "In conclusion, AAVCOVID presented the desired features to potentially become a competitive vaccine candidate. Ongoing optimizations to the expression cassette show a 10fold increase in potency and adaptability to variants of concern."

Gene Therapies • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

[VIRTUAL] AAVCOVID, a single dose AAVbased vaccine, elicits potent and broad SARSCoV2 neutralizing response (ESGCT 2021) - "In summary, AAVCOVID in mouse and nonhuman primates demonstrated singledose protection from SARSCoV2 challenge and durable neutralizing titers against currently predominant VOCs. We are currently assessing if better expression cassette and different antigen types can induce a better crossreactive response against VOCs."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] AAVCOVID: An AAV-based single dose vaccine, room-temperature stable COVID-19 with durable immunogenicity (ESGCT 2021) - No abstract available

Infectious Disease • Novel Coronavirus Disease

An AAV-based, room-temperature-stable, single-dose COVID-19 vaccine provides durable immunogenicity and protection in non-human primates. (PubMed, Cell Host Microbe) - "Here, AAVCOVID-1, an adeno-associated viral (AAV), spike-gene-based vaccine candidate demonstrates potent immunogenicity in mouse and non-human primates following a single injection and confers complete protection from SARS-CoV-2 challenge in macaques...Vector genome persistence and expression wanes following injection. The single low-dose requirement, high-yield manufacturability, and 1-month stability for storage at room temperature may make this technology well suited to support effective immunization campaigns for emerging pathogens on a global scale."

Journal • Gene Therapies • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] Candidate Selection in BALB/c Mice towards a Single Dose AAV-Based COVID19 Prophylactic Vaccine (ASGCT 2021) - "Remarkably, T cell responses in the low dose group mice were equivalent to modestly higher than those in high dose group.Taken together, these results indicate that the AAVCOVID platform induces high level neutralizing responses that are complemented with robust T-cell immunogenicity. Based on these data and other strategic parameters, AAVCOVID-1 (membrane anchored pre-fusion stable S) and AAVCOVID-3 (secreted S1) progressed to further studies toward consideration of one candidate for clinical development."

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

[VIRTUAL] Immunogenicity of Two AAV-Based COVID-19 Vaccine Candidates in Mouse Models of Aging and Obesity (ASGCT 2021) - "However, AC3 at low dose induced significantly lower binding antibody responses in obese mice compared to lean controls and failed to elicit neutralizing antibodies. This data suggests that AAVCOVID should be further evaluated in the clinical setting, especially in obese and aged populations; those that are most at risk during this pandemic."

Preclinical • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Obesity • Respiratory Diseases

[VIRTUAL] Immunogenicity of An AAV-Based, Room-Temperature Stable, Single Dose COVID-19 Vaccine in Mouse and NHP (ASGCT 2021) - "We have designed two clinically relevant vaccine candidates that consist of AAVrh32.33 carrying the stabilized full-length SARS-CoV-2 Spike (S) or the secreted S1 subunit, named AAVCOVID19-1 (AC1) and AAVCOVID19-3 (AC3), respectively...In conclusion, AC1 and AC3 vaccines elicit high antibody responses in various preclinical models and showed quantitative and kinetic differences. Ongoing challenge studies will reveal if lower doses protect NHP from SARS-CoV-2 infection."

Preclinical • Gene Therapies • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4