SP0254 / Sanofi - LARVOL DELTA

Nonclinical safety assessment of an mRNA Covid-19 vaccine candidate following repeated administrations and biodistribution. (PubMed, J Appl Toxicol) - "The biodistribution data demonstrated that the mRNA and Lipid-1 components of the vaccine formulations were mainly detected at the injection site and in the draining lymph nodes. These results support the use of MRT5500 and its deployment into clinical trials."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

VAW00001: Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=182 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Nov 2022 ➔ Jun 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Nov 2022 ➔ Jun 2022; Sponsor's decision not to pursue further development of this product given the wide availability of authorized/approved mRNA COVID-19 vaccines

Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Pan-SARS neutralizing responses after third boost vaccination in non-human primate immunogenicity model. (PubMed, Vaccine) - "The breadth of the neutralizing response was independent of vaccine sequence or modality, as we further showed either MRT5500 or recombinant subunit Spike protein (with adjuvant) can serve as boosters to induce broadly neutralizing antibodies in the NHPs primed with MRT5500. The data support the notion that a third vaccination is key to boosting existing titers and improving the breadth of antibodies to address variants of concern, including those with an E484K mutation in the Receptor Binding Domain (RBD) (Beta, Gamma)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

VAW00001: Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older (clinicaltrials.gov) - P1/2; N=182; Active, not recruiting; Sponsor: Sanofi Pasteur, a Sanofi Company; Recruiting ➔ Active, not recruiting; N=333 ➔ 182

Clinical • Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and efficacy of mRNA COVID-19 vaccine MRT5500 in preclinical animal models. (PubMed, NPJ Vaccines) - "In addition, MRT5500 elicited T1-biased responses in both mouse and non-human primate (NHP), thus alleviating a hypothetical concern of potential vaccine-associated enhanced respiratory diseases known associated with T2-biased responses. These data position MRT5500 as a viable vaccine candidate for entering clinical development."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

VAW00001: Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older (clinicaltrials.gov) - P1/2; N=415; Recruiting; Sponsor: Sanofi Pasteur, a Sanofi Company; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

VAW00001: Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older (clinicaltrials.gov) - P1/2; N=415; Not yet recruiting; Sponsor: Sanofi Pasteur, a Sanofi Company

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Sanofi and Translate Bio Initiate Phase 1/2 Clinical Trial of mRNA COVID-19 Vaccine Candidate (GlobeNewswire) - "Sanofi Pasteur...and Translate Bio...announced the start of the Phase 1/2 clinical trial for MRT5500...Translate Bio will receive a $25 million payment based on achievement of this milestone. The Companies expect interim results from this trial in the third quarter of 2021....Preclinical studies are ongoing and...will induce neutralizing antibodies against the emerging SARS-CoV-2 variants...The joint development team is working on improving the temperature stability of the mRNA vaccine candidate..."

Commercial • P1/2 data • Preclinical • Trial status • Infectious Disease • Novel Coronavirus Disease

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly (GlobeNewswire) - P1/2; N=440; NCT04537208; Sponsor: Sanofi Pasteur, a Sanofi Company; "Phase 1/2 interim results showed an immune response comparable to patients...aged 18 to 49 years; Insufficient response in older adults demonstrates the need to refine the concentration of antigen...Study in non-human primates performed with an improved antigen formulation demonstrated that the vaccine candidate could protect against lung pathology and lead to rapid viral clearance...The Companies plan a Phase 2b study expected to start in February 2021...Global Phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021....Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio...Sanofi expects the Phase 1/2 study to start in Q1 2021, with earliest potential approval in the second half of 2021."

New P1/2 trial • New P2b trial • New P3 trial • P1/2 data • Preclinical • Infectious Disease • Novel Coronavirus Disease

Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine (GlobeNewswire) - "Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines. Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine....Through the COVAX Facility’s efforts, vaccines will be distributed in participating countries..."

Commercial • Infectious Disease • Novel Coronavirus Disease

Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine (GlobeNewswire) - "Sanofi and GSK have today signed agreements with the Government of Canada for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021....Both companies have vaccine manufacturing sites in Canada that are contributing to overall global COVID-19 vaccine development, and these plus their global industrial network will play a pivotal role to the production of the COVID-19 vaccine doses for Canada....In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant respectively with the target of producing up to one billion doses in total per year, globally....Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio....Sanofi expects the Phase 1/2 study to start in November, with earliest potential approval in the second half of 2021."

Licensing / partnership • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Sanofi’s virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patients (GlobeNewswire) - "Sanofi transforms R&D to drive productivity....This includes an integrated development organization...resulted in rapid initiation of clinical trials such as the studies evaluating Kevzara® (sarilumab) as a potential COVID-19 therapeutic....A recombinant protein-based​ vaccine approach (baculovirus), in collaboration with GSK....Sanofi expects a Phase 1/2 study to start in September and at the earliest, full approval by the first half of 2021....A messenger RNA (mRNA) candidate in collaboration with Translate Bio....Sanofi expects a Phase 1 study to start by the end of the year, and, if data is positive, an approval at the earliest in the second half of 2021​."

New P1 trial • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

"@Sanofi is a great innovator! #COVID19 @macromoltek" (@raminderpal_)

"#COVID19: Ministerul #Sănătăţii a primit de la @Sanofi #România 18.000 de cutii de Hidroxiclorochină, medicament folosit în tratamentul pacienţilor infectaţi cu virusul SARS-CoV-2. Cele 1.080.000 de doze vor ajunge la peste 45.000 de pacienţi din România." (@RRInternational)

"Dear Mr @raoult_didier #NobelPrize for you sir #USA #usaCoronavirus #Italycorona case are stared to decrease! #HydroxychloroquineAndAzithromycin @saglikbakanligi @Sandoz_Global @sanofi @realDonaldTrump @SteveFDA @US_FDA @aktaserdogan" (@hakan65415760)

Clinical

"Oui ils testent sur des malades du #Covid_19 . le médecin De sanofi a expliqué ce cas a la radio." (@serge_vtc)