COVID-19 S-Trimer Vaccine + CpG 1018 / University of Queensland, Dynavax - LARVOL DELTA

SCB-2019 as COVID-19 Vaccine (clinicaltrials.gov) - P1; N=150; Active, not recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2021 ➔ May 2021; Trial primary completion date: Oct 2021 ➔ Oct 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SCB-2019 as COVID-19 Vaccine (clinicaltrials.gov) - P1; N=150; Recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Trial completion date: Mar 2021 ➔ Dec 2021; Trial primary completion date: Oct 2020 ➔ Oct 2021

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

COVID-19 S-Trimer vaccine candidates show promise in early trials (European Pharmaceutical Review) - P1, N=150; NCT04405908; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; "Clover Biopharmaceuticals has announced that its protein-based COVID-19 S-Trimer vaccine...induced strong immune responses and had favourable safety and tolerability profiles in 150 adult and elderly Phase I trial participants....Clover and its partners expect to initiate a global Phase II/III efficacy study of the S-Trimer vaccine candidate in combination with GSK’s pandemic adjuvant system in December 2020. The company also intends to initiate a separate clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021....Preliminary results from their stability studies show that S-Trimer is stable at two to eight degrees Celsius for at least six months, or at room temperature and 40o C for at least one month."

New P2/3 trial • New trial • P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease

Development of CpG-adjuvanted stable prefusion SARS-CoV-2 spike antigen as a subunit vaccine against COVID-19. (PubMed, Sci Rep) - "No vaccine-related serious adverse effects were found in the dose-ranging study in rats administered single- or two-dose regimens of S-2P combined with CpG 1018 alone or CpG 1018 with alum. These data support continued development of CHO-derived S-2P formulated with CpG 1018 and alum as a candidate vaccine to prevent COVID-19 disease."

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

"$DVAX with Adjuvant #CpG1018 incredibly powerful... Why are biotechs left out? $GSK Adjuvant is inferior" (@GuyHedge)

Clinical

Heplisav-B: A Hepatitis B Vaccine With a Novel Adjuvant. (PubMed, Ann Pharmacother) - "Literature searches were performed using PubMed and Scopus with the search terms hepatitis B vaccine, HepB-CpG, CpG 1018, 1018-ISS, HBsAg-1018, HBV-ISS, and Heplisav. Additional data are needed regarding the vaccine's safety in the general population and the persistence of its antibody response. HepB-CpG has been shown to be as immunogenic as Engerix-B; however, long-term safety and persistence of immune memory has yet to be established."

Clinical • Journal • Cardiovascular • Hepatitis B • Hepatology • Herpes Zoster • Infectious Disease • Myocardial Infarction • Varicella Zoster

Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. (PubMed, Vaccine) - P3 | "Two-dose HBsAg/CpG 1018 provides a higher level of seroprotection against HBV than does a 3-dose vaccine (HBsAg/alum) with a similar safety profile in patients aged 60-70 years with type 2 diabetes mellitus. Study identifier: NCT02117934."

Clinical • Journal • Diabetes • Hepatitis B • Hepatology • Infectious Disease • Metabolic Disorders • Type 2 Diabetes Mellitus

Dynavax Announces Second Quarter 2020 Financial Results (GlobeNewswire) - "Preliminary safety and immunogenicity results from Phase 1 COVID-19 studies with Clover Biopharmaceuticals and Medicago expected by September and October, respectively."

P1 data • Infectious Disease • Novel Coronavirus Disease

"When will #CpG1018 be WARP-SPEED'ed?" (@GuyHedge)

"Should do adjuvanted vaccine with #CpG1018" (@GuyHedge)

Clinical

CEPI Expands Partnership with Clover Biopharmaceuticals to Rapidly Advance Development and Manufacture of COVID-19 Vaccine Candidate (Businesswire) - "CEPI, the Coalition for Epidemic Preparedness Innovations, today announced the expansion of its partnership with Sichuan Clover Biopharmaceuticals, Inc (China) ('Clover') to rapidly advance the development and manufacture of Clover’s protein-based COVID-19 S-Trimer vaccine candidate....CEPI will make an additional investment of $66m upfront in S-Trimer which will immediately fund preclinical studies, the execution of Phase 1 clinical trials....The results of these clinical trials and initial manufacturing scale-up activities will inform planning for efficacy trials and full manufacture of the vaccine."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

4000 people sign up for WA COVID-19 vaccine trial, doses begin (Business News Australia) - "More than 4,000 people have registered for a Phase 1 COVID-19 vaccine trial in Perth, where Linear Clinical Research has already dosed 10 participants with expectations a further 140 will take part in the coming months. The clinical trial involves the COVID-19 S-Trimer vaccine developed by Chinese company Clover Biopharmaceutical....Funding for the trial is coming from the Coalition for Epidemic Preparedness Innovations (CEPI), which is involved in trials including with the CSIRO, the University of Queensland (UQ) and CSL....Preliminary safety and immunogenicity results are expected starting from August."

Enrollment status • Infectious Disease • Novel Coronavirus Disease

SCB-2019 as COVID-19 Vaccine (clinicaltrials.gov) - P1; N=150; Recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Clover Biopharmaceuticals Initiates Phase 1 Clinical Trial for COVID-19 Vaccine Candidate (Businesswire) - "Clover Biopharmaceuticals today announced that the first participants have been dosed in the Phase 1 first-in-human study evaluating the company’s COVID-19 S-Trimer subunit vaccine candidate....Preliminary safety and immunogenicity results for this Phase 1 study are expected in August 2020. In parallel, the planning for a global Phase 2b/3 vaccine efficacy trial has begun, with initiation targeted by year-end 2020. The Phase I study will evaluate two adjuvant systems – GSK’s...pandemic adjuvant system as well as Dynavax’s...CpG 1018 adjuvant combined with alum."

New P2/3 trial • P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

SCB-2019 as COVID-19 Vaccine (clinicaltrials.gov) - P1; N=150; Not yet recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

"What is the main difference between CpG1018 and CpG7079? Number of base pairs? Or something else?" (@Hall8Jack)

Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults (clinicaltrials.gov) - P1; N=105; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Active, not recruiting ➔ Recruiting

Clinical • Enrollment open

Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults (clinicaltrials.gov) - P1; N=105; Active, not recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Dynavax and CEPI announce collaboration to support global effort to develop a vaccine for coronavirus (COVID-19) (GlobeNewswire, Dynavax Technologies Corporation) - “Dynavax Technologies Corporation…and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a collaboration supporting the global effort to develop a vaccine to prevent the coronavirus (COVID-19). Dynavax will make the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018TM, available for the development of effective vaccines against COVID-19….CEPI and Dynavax will work together to identify and coordinate engagements with entities around the world working on COVID-19 vaccines. The focus of this collaboration is to identify programs that could benefit from combination with CPG 1018 to provide a more rapid or robust immune response.”

Licensing / partnership

Dynavax announces fourth quarter and full year 2019 financial results (GlobeNewswire) - “Advancing efforts to leverage Dynavax’s vaccine adjuvant CpG 1018 in product candidates for pertussis and coronavirus (COVID-19).”

Clinical • Trial status

Dynavax and Clover Biopharmaceuticals announce research collaboration to evaluate coronavirus (COVID-19) vaccine candidate with CpG 1018 adjuvant (GlobeNewswire) - “Dynavax Technologies Corporation…and Clover Biopharmaceuticals…announced that they have entered into a research collaboration to develop a vaccine candidate to prevent COVID-19. Clover is advancing evaluation of its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) in preclinical studies. Dynavax is providing technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support this initiative…Utilizing its patented Trimer-Tag© technology, Clover has produced a COVID-19 S-Trimer subunit vaccine candidate that resembles the native trimeric viral spike via a rapid mammalian cell-culture based expression system….Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.”

Licensing / partnership