SCB 2019
Alternative Names: 2019-nCoV S-Trimer vaccine - Clover Biopharmaceuticals; CpG-1018/Alum; Protein-based COVID-19 S-trimer vaccine - Clover Biopharmaceuticals; recombinant 2019-nCoV S protein subunit-trimer vaccine - Clover Biopharmaceuticals; Recombinant S subunit trimer vaccine - Clover Biopharmaceuticals; Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine - Clover Biopharmaceuticals; S-trimer COVID-19 vaccine; S-Trimer vaccine - Clover Biopharmaceuticals; SCB 2019 (CpG 1018/Alum); SCB-2019Latest Information Update: 14 Jul 2023
At a glance
- Originator Clover Biopharmaceuticals
- Class Adjuvants; COVID-19 vaccines; Recombinant proteins; Subunit vaccines; Viral vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase III COVID 2019 infections
Most Recent Events
- 23 Apr 2023 Clover Biopharmaceuticals completes the phase II/III SPECTRA trial in COVID-2019 infections (Prevention) in Belgium, Germany, Brazil, Colombia, Philippines, and South Africa (IM) (NCT04672395)
- 15 Dec 2022 Clover Biopharmaceuticals withdraws a phase II/III trial in COVID-2019 infections (Prevention, In infants, In neonates, In adolescents, In children) in Colombia (IM), during the EC submission process prior to the enrolment (NCT05193279)
- 20 Sep 2022 Clover Biopharmaceuticals announces intention to submit NDA and MAA to WHO, NMPA and EMA for COVID-2019 infections in the second half of 2022
Development Overview
Introduction
SCB 2019 is a recombinant S-trimer subunit vaccine being developed by Clover Biopharmaceuticals for prevention of COVID-2019 infections. The company is utilising its patented Trimer-Tag© technology to construct a recombinant protein subunit-trimer vaccine (S-Trimer) and produces the vaccine via a rapid mammalian cell-culture based expression system. Coronaviruses are positive single-stranded RNA (ssRNA) viruses with a trimeric spike (S) protein on its viral envelope. The trimeric S protein of 2019-nCoV is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry. SCB 2019 is a stabilised trimeric antigen of the S-protein (S-Trimer) based on the original strain of SARS-CoV-2 virus, in combination with adjuvants, CpG 1018 from Dynavax and aluminum hydroxide (alum). Clinical development is underway in Africa, Australia, Europe and Latin America.
Timer-Tag is a drug development platform which produces covalently-trimerized fusion proteins targeting trimerization-dependent pathways. The platform takes advantage of the C-prodomains of collagen proteins which are capable of efficient self-trimerization. It allows any secreted protein (cytokines, soluble receptors, Fab of mAbs) to be made as covalently linked homo-trimers with greatly increased avidity to their disease-causing targets.
Company Agreements
In January 2021, Clover Biopharmaceuticals and GlaxoSmithKline (now GSK) decided to discontinue the partnership to evaluate the S-Trimer COVID-19 vaccine candidate with GSK's pandemic adjuvant system. Earlier, in February 2020, Clover Biopharmaceuticals entered into a research collaboration with GlaxoSmithKline for its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer). GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies. Having one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China, Clover could potentially rapidly scale-up and produce large-quantities of the coronavirus vaccine. [1] [2] [3]
In June 2021, Clover Biopharmaceuticals entered into an advance purchase agreement (APA) with Gavi the Vaccine Alliance, to provide up to 414 million doses of its protein-based COVID-19 vaccine candidate SCB 2019. Under this, Clover will make an initial 64 million doses available for procurement in 2021. Gavi also retains options to procure up to an additional 350 million doses to be delivered in 2022. The agreement also contains the opportunity to access Clover variant-adapted COVID-19 vaccine candidates. Under the terms of the agreement, Clover will receive a significant upfront payment, a payment upon positive phase II/III data, and additional advance payments upon Gavi's exercise of options for doses to be delivered in 2022. Gavi will allocate Clover's COVID-19 vaccine doses to the AMC (Advanced Market Commitment)-eligible and self-financing participants under a tiered pricing schedule. Clover will further receive additional payments upon the delivery of the doses of its COVID-19 vaccine at all pricing tiers, including doses being delivered to the AMC-eligible participants. In December 2021, Clover received a milestone payment of US$64 million from GAVI upon achieving certain milestones. The total funding received to-date from GAVI under the APA to US$224 million. [4] [5]
In December 2021, Clover Biopharmaceuticals enters into a long-term agreement (LTA) with UNICEF, to supply its COVID-19 vaccine candidate SCB 2019, to the COVAX Facility. The LTA will operationalise the Advance Purchase Agreement (APA) with GAVI, the Vaccine Alliance, and will allow participating countries of the COVAX Facility to access SCB 2019, through UNICEF, once the vaccine candidate receives an Emergency Use Listing by the WHO.
[6]
In November 2020, Coalition for Epidemic Preparedness Innovations expanded its agreement with Clover Biopharmaceuticals to fund through a global pivotal phase II/III trial and to licensure in China and globally, if the vaccine is proven to be safe and effective. The total investment of CEPI will be upto $US328 million, including earlier commitment of $US69.5 million. It will also fund additional clinical studies in special populations, such as people with autoimmune conditions, immunocompromised individuals, pregnant women and children. Earlier in July 2020, the Coalition for Epidemic Preparedness Innovations expanded its agreement with Clover Biopharmaceuticals to rapidly advance the development and manufacture of COVID-19 S-Trimer vaccine candidate. According to the expanded agreement, CEPI will make an additional investment of $US66m upfront in S-Trimer which will immediately fund preclinical studies, the execution of phase I clinical trials, and preparation of sites globally for an efficacy trial. The investment will support scale up of manufacturing capacity to potentially allow the production of hundreds of millions of doses per year. Further upon the success of the clinical trials CEPI will provide significant additional investment which will fully fund the S-Trimer vaccine candidate through to licensure in China and globally. The agreement was initiated in April 2020, for the development of a COVID-19 vaccine. As per the agreement, CEPI will provide initial US$3.5m to Clover Biopharmaceuticals to support preparation and initiation of a phase I trial of Clover’s protein-based COVID-2019 S-Trimer vaccine in Australia. In April, 2021, CEPI expanded its agreement with the company to provide funding to manufacture CpG 1018 for its COVID-19 vaccine grantees, increasing total funding under the loan agreement from $US99 million to $US176 million. In November 2021, CEPI funded additional $US36.9 million for the development of SCB 2019 bringing CEPI’s total potential funding up to $US397.4 million. [7] [8] [9] [10] [11]
In July 2021, Clover Biopharmaceuticals entered into a commercial supply agreement with Dynavax Technologies for Dynavax's CpG 1018TM advanced adjuvant, for use in Clover's protein-based COVID-19 vaccine candidate, SCB 2019 (CpG 1018/Alum). The commercial supply agreement extends to the end of 2022. The agreement includes doses for delivery in 2021, manufactured under the previously announced funding agreement between Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. Earlier, in March 2020, Clover Biopharmaceuticals and Dynavax Technologies Corporation entered into a research and development agreement to develop a vaccine for COVID-2019 infections. Under the terms of agreement, Dynavax will provide technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018. Financial details of the agreement were not disclosed. [12] [13]
In November 2020, Clover Biopharmaceuticals entered into a manufacturing agreement with Cytiva to scale up the output of its protein-based S-Trimer subunit vaccine SCB 2019. Under the agreement, Cytiva will help Clover add two more 2000L bioreactors for a total of 4 x 2000L manufacturing capacity through the Cytiva FlexFactory, which will provide a total solution including process equipment, services, and consumables to ensure safety, efficiency, scaled-up capacity for vaccine development. Other financial details of the agreement were not disclosed. [14]
Clover Biopharmaceuticals received exclusive worldwide rights from GenHunter Corporation to utilise Trimer-Tag© technology for the development of drug candidates (Clover Biopharmaceuticals website, December 2017).
Key Development Milestones
In February 2022, Clover Biopharmaceuticals announced timelines for the regulatory submissions and reported that the submissions will include booster data. The submissions are expected to be completed in mid-2022 for Chinese NMPA and in Q3 2022 for WHO and EMA [5] . Earlier, in January 2022, Clover Biopharmaceuticals had reported that the process of submitting conditional regulatory applications to NMPA, EMA and the WHO for approval of SCB 2019 was underway, and announced the plans to commence product launch post conditional approval [15] .
In September 2021, Clover Biopharmaceuticals announced that Zhejiang Clover Biopharmaceutical (its wholly owned subsidiary) received a Pharmaceutical Manufacturing Permit from the Zhejiang Medical Products Administration for production of SCB 2019 in Zhejiang province, China [16] .
As of June 2021, Clover Biopharmaceuticals had a pending Emergency Use Listing (EUL), from the World Health Organization (WHO) [4] .
As of June 2022, Clover Biopharmaceuticals terminated a phase III trial due to the inability to enroll the required study population (NCT05012787; CLO-SCB2019-005). The trial evaluated the safety and immunogenicity of the investigational CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 trimeric spike (S)-protein subunit vaccine (SCB-2019) in adult patients with stable chronic inflammatory immune-mediated diseases (IMDs), compared to control vaccine. The double-blind, multicentre, parallel, prospective, randomized trial was initiated in November 2021 and enrolled 1 patient in Ukraine [17]
In April 2023, Clover Biopharmaceuticals completed the phase II/III SPECTRA (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine) trial that evaluated the safety and efficacy of SCB 2019 vaccine adjuvanted with CpG 1018 plus alum, for COVID-2019 infection (CLO-SCB-2019-003; NCT04672395; EudraCT2020-004272-17). The a double-blind, randomised, controlled study was initiated in March 2021, that enrolled 31,454 adult and elderly participants in Belgium, Germany, Brazil, Colombia, Philippines and South Africa [18] . In January 2022, Clover amended the trial to evaluate the immunogenicity and safety of SCB 2019 for primary vaccination in adolescent (12-18 years) subgroup in an expanded 1,200 adolescent population [5] . The trial is funded by the Coalition for Epidemic Preparedness Innovations (CEPI). In September 2021, the company released the efficacy and safety data form the trial [19] [20] [21] [22] [23] . In October 2021, Dynavax Technologies announced that the pivotal SPECTRA met its primary and secondary efficacy endpoints. In January 2022, the company released final efficacy data from this trial [15] . As of March 2022, additional data from a phase II clinical trial in Brazil evaluating SCB 2019 as a booster in individuals who previously received two doses of Coronavac (inactivated COVID-19 vaccine) is expected by Q2-2022 [24] . In March 2022, the company announced that SCB 2019 maintained 100% efficacy against severe COVID-19 and demonstrated 95% efficacy against hospitalization at five months after the second dose in the primary vaccination setting against any SARS-CoV-2 strain. There was also no evidence that clinical efficacy against COVID-19 declined over a five-month period in individuals with prior SARS-CoV-2 infection who were subsequently boosted with SCB 2019. No safety concerns were observed in individuals dosed with SCB 2019 in this follow-up period. In August 2022, the company released updated efficacy and safety data from the trial [25] . In September 2022, company released efficacy data from the trial [26] .
In December 2022, Clover Biopharmaceuticals withdrew a phase II/III study during the EC submission process prior to the enrolment, which was designed to evaluate the safety, reactogenicity and immunogenicity of SCB 2019 in children <18 years of age (NCT05193279; CLO-SCB-2019-007). The randomised, controlled, dose-finding, observer-blind trial was planned to be initiated in October 2022, and intended to recruit approximately 3 820 patients in Colombia [27] .
In March 2022, the company also announced preliminary data from ongoing clinical trials that demonstrated a SCB 2019 booster dose in both homologous and heterologous booster settings induced strong immune responses and broad neutralization against all variants of concern, including Omicron [28] .
In December 2021, Clover Biopharmaceuticals completed a phase I trial that evaluated the safety and immunogenicity of SCB 2019 (NCT04932824; CLO-SCB-2019-002). This non-randomised, long-term follow up trial was initiated in January 2021, and recruited approximately 137 healthy volunteers in Australia [29] .
In December 2021, Clover Biopharmaceuticals completed a phase I trial that evaluated the safety, reactogenicity, and immunogenicity of SCB 2019 at multiple dose levels, with and without adjuvant (AS03 and CpG 1018 plus alum adjuvant) in healthy volunteers for COVID-2019 infection (NCT04405908; CLO-SCB-2019-001). The trial was initiated in June 2020 and the first healthy volunteer was dosed in the same month. The randomised, double-blind, placebo-controlled trial completed enrollment of 150 volunteers in Australia. In November 2020, Clover Biopharmaceuticals announced that the trial included 280 additional volunteers for dose expansion study [14] [30] [31] [32] [33] . In December 2020, results from the trial were released by the Clover Biopharamceuticals [34] . In January 2021, Clover Biopharmaceuticals released updated results from the trial [23] .
In May 2021, Clover Biopharmaceuticals released preclinical data of SCB 2019 followed by a booster dose [35] .
In September 2020, positive preclinical data from non human primate models were released by Clover Biopharmaceuticals [30]
As at January 2020, early research and development is ongoing for the subunit trimer vaccine for the prevention of COVID-2019 infections [36] .
Financing information
In February 2021, Clover Biopharmaceuticals completed an oversubscribed $US230 million Series C financing. The proceeds will be used to support the continued development and expansion of Clover's pipeline of protein-based vaccines and biologic cancer therapies utilising its innovative and proprietary Trimer-Tag© technology platform [37] .
In November 2021, CEPI committed up to an additional US$36.9 million (for a total investment of up to US$397.4 million) to support the development of SCB 2019 (CpG 1018/Alum) through licensure for use as a primary vaccination for all age groups (including paediatric, adolescent, adult, and elderly) and as a potential booster candidate [5] . In January 2021, Clover Biopharmaceuticals announced that the Coalition for Epidemic Preparedness Innovations (CEPI) has committed to fund SCB 2019 through licensure with a total investment of up to US$328 million, a portion of which will support the global phase II/III study. Earlier, the CEPI had commited $US69.9 million funding, which was used forpreclinical studies and phase I clinical trials, preparations for the global pivotal phase II/III efficacy study, and initial manufacturing scale-up activities. The phase I clinical trial for SCB 2019 that initiated in June 2020 is being supported by the funding and collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) [23] [9] .
In May 2020, Dynavax Technologies announced its intention to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. It expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the common stock being offered in the offering. The company intends to use the net proceeds to fund activities, associated with the ongoing commercialisation of adjuvanted Hepatitis B vaccine (recombinant) [see Adis Insight Drug Profile800020941], to advance its CpG 1018 vaccine platform, including any scale up efforts in support of a potential COVID-19 vaccine by Dynavax and its collaborators, and for general corporate purposes, including working capital [38] .
Patent Information
Clover Biopharmaceuticals has patent protection for Trimer-Tag technology platform in the US, Europe, Japan and China (Clover Biopharmaceuticals website, January 2020)
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation unspecified
- Class Adjuvants, COVID-19 vaccines, Recombinant proteins, Subunit vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E9 (All other viral vaccines)
Biomarkers Sourced From Trials
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| SCB 2019 | ACE2 | Outcome Measure |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure | |
| vitronectin | Brief Title, Official Title, Outcome Measure |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Phase III | Ukraine | IM / unspecified | Clover Biopharmaceuticals | 12 Nov 2021 |
| COVID 2019 infections | - | Prevention | Phase II/III | Belgium, Brazil, Colombia, Germany, Philippines, South Africa | IM / unspecified | Clover Biopharmaceuticals | 24 Mar 2021 |
| COVID 2019 infections | - | Prevention | Phase I | Australia | IM / unspecified | Clover Biopharmaceuticals | 19 Jun 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Clover Biopharmaceuticals | Originator | China |
| Clover Biopharmaceuticals | Owner | China |
| GenHunter Corporation | Technology Provider | USA |
| Coalition for Epidemic Preparedness Innovations | Funder | Norway |
| Dynavax Technologies | Collaborator | USA |
Scientific Summary
Adverse Events
In a pivotal phase II/III SPECTRA trial against COVID-2019 infection, SCB 2019 vaccine adjuvanted with CpG 1018 plus alum showed that adverse events were mostly mild and transient, were balanced between vaccine and placebo (saline) groups, and comparable to results observed in the adult population [25] . Final data of the double-blind, randomized, pivotal phase II/III SPECTRA trial against COVID-2019 infection, SCB 2019 vaccine adjuvanted with CpG 1018 plus alum showed a favorable safety profile with no significant differences observed in systemic adverse events or severe adverse events, when compared with placebo [15] . Interim results showed that SCB 2019 demonstrated a favorable safety profile. Severe and serious adverse events (AEs) were infrequent and balanced between vaccine and placebo groups. Solicited local AEs were mostly mild and transient cases of pain at the injection site and decreased in frequency after the second dose. There were no significant differences observed between vaccine and placebo groups for the solicited systemic AEs monitored (fatigue, headache, muscle pain, joint pain, loss of appetite, nausea, chills, fever). The study evaluated 22000 patients [20] [18] .
Results from phase I trial in healthy volunteers demonstrated that administration of SCB 2019 was well tolerated with no serious adverse events reported. The majority of adverse events were mild and transient [23] [34] [33] .
Pharmacodynamics
Summary
Preclinical data from non human primate animal models demonstrated that SCB 2019 in combination with adjuvants from either GSK or Dynavax’s advanced adjuvant CpG 1018 plus alum induced a strong immune response and protection against SARS-CoV-2 in animal models. No measurable viral load or other clinical measures were observed in the lung tissues in non-human primates challenged with SARS-CoV-2 [30]
Immunogenicity
Summary
Results from phase I trial in healthy volunteers demonstrated that administration of SCB 2019 with adjuvants demonstrated strong immune response including neutralising antibodies and cell mediated immunity. SCB 2019 at selected dose of 9 µg with GSK's pandemic adjuvant system induced neutralising antibody titers in 100% of participants at in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800. Moreover, SCB 2019 at selected dose of 30 µg with Dyanvax's adjuvant, CpG 1018 induced neutralizing antibodies in 100% of adult participants dose with GMT of greater than 1:1,000 with seroconversion of 88%. Administration of the vaccine with either of adjuvant induced Th1 cell mediated immune response [23] [34] [33] .
Mice immunisation with two doses of SCB 2019 and the addition of a third B.1.351 S-Trimer booster dose on day 35 of either SCB 2019 or B.1.351 S-trimer vaccine [see Adis profile 800062558] was able to increase cross-reactive neutralising antibodies against B.1.351 [35] .
A heterologous booster dose of SCB 2019 (CpG 1018/Alum) in individuals previously receiving two doses of AstraZeneca’s COVID-19 vaccine induced approximately 2-fold higher levels of neutralizing antibodies against the omicron variant when compared to individuals receiving three doses of AstraZeneca’s vaccine [24] .
A single dose of SCB 2019 in individuals previously infected with SARS-CoV-2 induced approximately 4-fold higher levels of neutralizing antibodies against the Omicron variant when compared to individuals receiving three doses of AstraZeneca’s COVID-19 vaccine (non-head-to-head trial) [24] .
A homologous booster dose of SCB-2019 (CpG 1018/Alum) in individuals previously infected with SARS-CoV-2 induced multi-fold higher levels of neutralizing antibodies against the Omicron variant when compared to individuals receiving three doses of AstraZeneca’s COVID-19 vaccine (non-head-to-head trial). Additionally, a homologous booster dose appeared to induce a robust and rapid immune response against prototype strain and Omicron variant that exceed levels after the primary immunization series [24] .
Therapeutic Trials
Updated results from the trial showed that SCB 2019 elicited a 17-fold increase in neutralizing antibodies against the original strain, with geometric mean titers (GMT) of antibodies increasing from 44 at baseline (pre-booster) to 733 (14 days post-booster). This response was 12-fold higher than the response to the inactivated vaccine, which elicited a 2-fold increase (GMTs: 33 [baseline], 61 [post-booster]) in neutralizing antibodies against the original strain. In the same population, SCB-2019 elicited a 6-fold increase (GMTs: 33 [baseline], 193 [post-booster]) in neutralizing antibodies against Omicron BA.1 and an 8-fold increase (GMTs: 51 [baseline], 410 [post-booster]) in neutralizing antibodies against Omicron BA.2. This response was 5 and 6-fold higher, respectively, than the response to the inactivated vaccine, which elicited a 1-fold increase (GMTs: 30 [baseline], 42 [post-booster]) against Omicron BA.1 and a 1-fold increase (GMTs: 47 [baseline], 67 [post-booster]) against Omicron BA.2 [26] . Previously updated positive data from a phase II/III SPECTRA trial evaluating SCB 2019 (CpG 1018/Alum), in adolescents (aged 12 to 17 years) showed that the trial met the primary endpoint and demonstrated that vaccination with SCB 2019 (CpG 1018/Alum) elicited approximately 2-fold higher neutralizing antibody titers in adolescents compared to young adults (aged 18 to 25 years), a population where SCB 2019 (CpG 1018/Alum) had previously been demonstrated to be highly protective against COVID-19 [25] .Final efficacy data of the double-blind, randomized, pivotal phase II/III SPECTRA trial against COVID-2019 infection, showed that SCB 2019 vaccine adjuvanted with CpG 1018 plus alum achieved the primary efficacy endpoint and secondary efficacy endpoints. The vaccine demonstrated 100% efficacy against severe COVID-19 and hospitalization caused by any strain of SARS-CoV-2, in the trial [15] . Interim results showed that SCB 2019 achieved its primary and secondary endpoints in treating COVID-19 patients. No severe cases were observed, resulting in 100% efficacy (95% CI: 42.7,100) against hospitalization due to COVID-19 and 100% efficacy (97.86% CI: 25.3,100) against severe COVID-19. The efficacy was 83.7% (97.86% CI: 55.9,95.4) against any strain and 81.7% (95% CI: 35.9,96.6) against the delta strain in moderate to severe COVID-19 disease. The overall efficacy against any strain was observed to be 67.2% (95.72% CI: 54.3,76.8); 91.8% (95% CI: 44.9,99.8) against Gamma, 78.7% (95% CI: 57.3,90.4) against Delta and 58.6% (95% CI: 13.3,81.5) against Mu. The study evaluated a total 22000 patients [20] [18] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2022 | Regulatory Status | Clover Biopharmaceuticals announces intention to launch SCB 2019, by end of 2022 [5] | 16 Feb 2022 |
| 31 Dec 2022 | Regulatory Status | Clover Biopharmaceuticals announces intention to submit to NDA to the NMPA for COVID-2019 infections in the second half of 2022 (9349512) [40] | 21 Sep 2022 |
| 31 Dec 2022 | Regulatory Status | Clover Biopharmaceuticals announces intention to submit NDA and MAA to WHO, NMPA and EMA for COVID-2019 infections in the second half of 2022 (9349512) [39] | 22 Sep 2022 |
| 30 Jun 2022 | Trial Update | Clover in collaboration with the EMA Pediatric Committee, for its Pediatric Investigation Plan (PIP), plans to initiate clinical trials (In children) in the first half of 2022 [5] | 16 Feb 2022 |
| 31 Mar 2022 | Trial Update | Clover Biopharmaceuticals plans a phase III trial for COVID-2019 infections (Prevention) in March 2022 (IM) (NCT05188677) | 27 Jun 2022 |
| 01 Dec 2021 | Trial Update | D'Or Institute for Research and Education plans a phase II trial for COVID-19 infections (Prevention) in Brazil in December 2021 (IM) (NCT05087368) | 16 Jun 2022 |
| 01 Aug 2021 | Trial Update | Clover Biopharmaceuticals plans a phase II trial for COVID-2019 infections (Prevention) in China (IM) (NCT04954131) in August 2021 | 08 Mar 2022 |
| 30 Jun 2021 | Trial Update | Clover Biopharmaceuticals plans a phase II/III pivotal trial for COVID-2019 infections in first half of 2021 [34] | 26 Mar 2021 |
| 31 Dec 2020 | Trial Update | Clover Biopharmaceuticals plans a phase II/III in COVID-2019 infections at the end of 2020 (700323683) [30] | 20 Jan 2022 |
| 20 Jun 2020 | Trial Update | Clover Biopharmaceuticals plans a phase I trial for COVID-2019 infections (Prevention) (IM) in June 2020 (NCT04405908) (700321277) | 24 Jun 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 23 Apr 2023 | Trial Update | Clover Biopharmaceuticals completes the phase II/III SPECTRA trial in COVID-2019 infections (Prevention) in Belgium, Germany, Brazil, Colombia, Philippines, and South Africa (IM) (NCT04672395) Updated 14 Jul 2023 |
| 15 Dec 2022 | Trial Update | Clover Biopharmaceuticals withdraws a phase II/III trial in COVID-2019 infections (Prevention, In infants, In neonates, In adolescents, In children) in Colombia (IM), during the EC submission process prior to the enrolment (NCT05193279) Updated 06 Apr 2023 |
| 20 Sep 2022 | Regulatory Status | Clover Biopharmaceuticals announces intention to submit NDA and MAA to WHO, NMPA and EMA for COVID-2019 infections in the second half of 2022 [5] [39] Updated 22 Sep 2022 |
| 07 Sep 2022 | Scientific Update | Efficacy data from a phase II/III trial in COVID-2019 infections released by Clover Biopharmaceuticals [26] Updated 07 Sep 2022 |
| 25 Aug 2022 | Scientific Update | Updated efficacy and adverse events data from the phase II/III SPECTRA trial in COVID-2019 infections released by Clover Biopharmaceuticals [25] Updated 01 Sep 2022 |
| 27 Jun 2022 | Regulatory Status | Clover Biopharmaceuticals announces intention to submit to NDA to the NMPA for COVID-2019 infections in the second half of 2022 [5] [40] Updated 21 Sep 2022 |
| 01 Jun 2022 | Trial Update | Clover Biopharmaceuticals terminated a phase III trial in COVID-2019 infections (Prevention) in Ukraine (IM) due to the inability to enroll the required study population (NCT05012787) Updated 01 Jun 2022 |
| 31 May 2022 | Regulatory Status | Clover Biopharmaceuticals plans to launch SCB 2019 for COVID-2019 infections in China and globally [25] Updated 02 Jun 2022 |
| 26 Apr 2022 | Active Status Review | No update - 9355284, booster dose study not covered Updated 26 Apr 2022 |
| 18 Mar 2022 | Scientific Update | Immunogenicity data from a trial in COVID-2019 infections released by Clover Biopharmaceuticals [24] Updated 22 Mar 2022 |
| 14 Feb 2022 | Regulatory Status | Clover Biopharmaceuticals announces intention to launch SCB 2019, by end of 2022 [5] Updated 16 Feb 2022 |
| 14 Feb 2022 | Trial Update | Clover in collaboration with the EMA Pediatric Committee, for its Pediatric Investigation Plan (PIP), plans to initiate clinical trials (In children) in the first half of 2022 [5] Updated 16 Feb 2022 |
| 21 Jan 2022 | Scientific Update | Final efficacy and adverse events data from the phase II/III SPECTRA trial in COVID-2019 infections released by Clover Biopharmaceuticals [15] Updated 25 Jan 2022 |
| 12 Jan 2022 | Trial Update | Clover Biopharmaceuticals plans a phase III trial for COVID-2019 infections (Prevention) in March 2022 (IM) (NCT05188677) Updated 27 Jun 2022 |
| 16 Dec 2021 | Trial Update | Clover Biopharmaceuticals completes a phase I trial for COVID-2019 infections (Prevention, In volunteers) in Australia (IM) (NCT04932824) Updated 21 Feb 2022 |
| 08 Dec 2021 | Trial Update | Clover Biopharmaceuticals completes a phase I trial for COVID-2019 infections (Prevention, In volunteers) in Australia (IM) (NCT04405908) Updated 28 Feb 2022 |
| 12 Nov 2021 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in Ukraine (IM) (NCT05012787) Updated 01 Jun 2022 |
| 21 Oct 2021 | Trial Update | D'Or Institute for Research and Education plans a phase II trial for COVID-19 infections (Prevention) in Brazil in December 2021 (IM) (NCT05087368) Updated 16 Jun 2022 |
| 22 Sep 2021 | Scientific Update | Efficacy and safety data from the phase II/III SPECTRA trial in COVID-2019 infections released by Clover Biopharmaceuticals [20] Updated 18 Oct 2021 |
| 10 Sep 2021 | Biomarker Update | Biomarkers information updated Updated 02 Oct 2021 |
| 08 Jul 2021 | Trial Update | Clover Biopharmaceuticals plans a phase II trial for COVID-2019 infections (Prevention) in China (IM) (NCT04954131) in August 2021 Updated 08 Mar 2022 |
| 05 Jul 2021 | Trial Update | Clover Biopharmaceuticals completes enrolment in the phase II/III SPECTRA trial for COVID-2019 infections (Prevention) in Belgium, Germany, Brazil, Colombia, Philippines, South Africa (IM) (NCT04672395) [21] Updated 09 Jul 2021 |
| 01 Jul 2021 | Licensing Status | Clover Biopharmaceuticals enters into a commercial supply agreement with Dynavax Technologies for Dynavax's CpG 1018 advanced adjuvant, to use in SCB 2019 (CpG 1018/Alum) [13] Updated 07 Jul 2021 |
| 30 Jun 2021 | Regulatory Status | Clover Biopharmaceuticals has pending an Emergency Use Listing (EUL) from the WHO, for COVID-2019 infections [4] Updated 08 Jul 2021 |
| 17 May 2021 | Scientific Update | Immunogenicity data from a preclinical study in COVID-2019 infections released by Clover Biopharmaceuticals [35] Updated 13 Jun 2021 |
| 30 Apr 2021 | Licensing Status | Coalition for Epidemic Preparedness Innovations expands partnership with Clover Biopharmaceuticals to provide funding to manufacture CpG 1018 for its COVID-19 vaccine grantees [10] Updated 12 May 2021 |
| 01 Mar 2021 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Belgium, Germany, Brazil, Colombia, Philippines, and South Africa (IM) (NCT04672395) [22] [13] Updated 07 Jul 2021 |
| 31 Jan 2021 | Licensing Status | GlaxoSmithKline and Clover Biopharmaceuticals discontinue their partnership to evaluate Recombinant S subunit trimer vaccine for COVID-2019-infections [2] Updated 02 Feb 2021 |
| 31 Jan 2021 | Scientific Update | Updated adverse event and immunogenicity data from a phase I trial in COVID-2019 infections released by Clover Biopharmaceuticals [23] Updated 02 Feb 2021 |
| 19 Jan 2021 | Trial Update | Clover Biopharmaceuticals initiates enrolment in a phase I trial for COVID-2019 infections (Prevention, In volunteers) in Australia (IM) (NCT04932824) Updated 25 Jun 2021 |
| 04 Dec 2020 | Trial Update | Clover Biopharmaceuticals plans a phase II/III pivotal trial for COVID-2019 infections in first half of 2021 [34] Updated 26 Mar 2021 |
| 04 Dec 2020 | Scientific Update | Adverse event and immunogenicity data from a phase I trial in COVID-2019 infections released by Clover Biopharmaceuticals [34] Updated 08 Dec 2020 |
| 03 Nov 2020 | Company Involvement | Coalition for Epidemic Preparedness Innovations expands partnership with Clover Biopharmaceuticals for the development of SCB 2019 for COVID-2019 infections [9] Updated 05 Nov 2020 |
| 03 Nov 2020 | Trial Update | Clover Pharmaceuticals plans additional clinical trials in COVID-2019 infections (Prevention) [9] Updated 05 Nov 2020 |
| 25 Sep 2020 | Trial Update | Clover Biopharmaceuticals plans a phase II/III in COVID-2019 infections at the end of 2020 [30] Updated 20 Jan 2022 |
| 25 Sep 2020 | Scientific Update | Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Clover Biopharmaceuticals [30] Updated 28 Sep 2020 |
| 25 Sep 2020 | Trial Update | Clover Biopharmaceuticals completes enrolment in phase I trial for COVID-2019 infections (Prevention, In volunteers) in Australia (IM) (NCT04405908) [30] Updated 28 Sep 2020 |
| 08 Jul 2020 | Licensing Status | Coalition for Epidemic Preparedness Innovations expands agreement with Clover Biopharmaceuticals for the development of SCB 2019 for COVID-19 infections [8] Updated 14 Jul 2020 |
| 19 Jun 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Prevention) in Australia (IM) [32] Updated 24 Jun 2020 |
| 19 Jun 2020 | Trial Update | Clover Biopharmaceuticals initiates enrolment in phase I trial for SCB 2019 (Prevention, In volunteers) for COVID-2019 infections in Australia (NCT04405908) Updated 24 Jun 2020 |
| 28 May 2020 | Trial Update | Clover Biopharmaceuticals plans a phase I trial for COVID-2019 infections (Prevention) (IM) in June 2020 (NCT04405908) Updated 24 Jun 2020 |
| 27 Apr 2020 | Licensing Status | Clover Pharmaceuticals signs partnership agreement with Coalition for Epidemic Preparedness Innovations (CEPI) for development of COVID-2019 vaccine [7] Updated 29 Apr 2020 |
| 27 Apr 2020 | Trial Update | Clover Biopharmaceuticals plans a phase I trial for COVID-2019 infections in Australia [7] Updated 29 Apr 2020 |
| 24 Mar 2020 | Licensing Status | Clover Biopharmaceuticals and Dynavax Technologies enter into research and agreement for recombinant S subunit trimer vaccine [12] Updated 27 Mar 2020 |
| 24 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in China (IM) [12] Updated 27 Mar 2020 |
| 25 Feb 2020 | Licensing Status | GlaxoSmithKline and Clover Biopharmaceuticals agree to co-develop Recombinant S subunit trimer vaccine for COVID-2019-infections [1] Updated 27 Feb 2020 |
| 03 Feb 2020 | Patent Information | Clover Biopharmaceuticals has patent protection for Trimer-Tag© technology in USA, Europe, Japan and China (Clover Biopharmaceuticals website, February 2020) Updated 03 Feb 2020 |
| 28 Jan 2020 | Licensing Status | Recombinant subunit trimer vaccine is available for licensing as of 03 Feb 2020 before February 2020 (Clover Biopharmaceuticals, website, February 2020)http://www.cloverbiopharma.com/index.php?m=content&c=index&a=lists&catid=44 Updated 03 Feb 2020 |
| 28 Jan 2020 | Phase Change | Early research in COVID-2019-infections (Prevention) in China (unspecified route) before January 2020 [36] Updated 03 Feb 2020 |
| 28 Dec 2017 | Licensing Status | Clover Biopharmaceuticals in-licenses Trimer-Tag© technology from GenHunter Corporation worldwide (Clover Biopharmaceuticals website, December 2017) Updated 03 Feb 2020 |
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Clover Provides Corporate Update and 2022 Priorities.
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Clover Signs COVID-19 Vaccine Supply Agreement with UNICEF.
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CEPI Expands Partnership with Clover Biopharmaceuticals to Rapidly Advance Development and Manufacture of COVID-19 Vaccine Candidate.
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CEPI Extends Partnership With Clover Biopharmaceuticals to Fund COVID-19 Vaccine Candidate Through Global Phase 2/3 Study to Licensure.
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Dynavax Announces First Quarter 2021 Financial Results.
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Clover and CEPI Expand Partnership for COVID-19 Vaccine Candidate to Include Evaluation as a Booster.
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Dynavax and Clover Biopharmaceuticals Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate with CpG 1018 Adjuvant.
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Clover and Dynavax Announce Commercial Supply Agreement of Dynavax's CpG 1018 Adjuvant for Clover's COVID-19 Vaccine Candidate.
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Cytiva supports Clover Biopharmaceuticals to scale up the output of its vaccine candidate.
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Clovers Final SPECTRA Phase 2/3 Clinical Trial Efficacy Data Is Published in The Lancet.
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Clover Biopharmaceuticals Receives Pharmaceutical Manufacturing Permit from Zhejiang Medical Products Administration to Produce COVID-19 Vaccine.
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COVID-19 Vaccine Developed by Clover Biopharmaceuticals Using Dynavax's CpG 1018 Adjuvant Meets Primary and Secondary Efficacy Endpoints in Global Phase 2/3 Trial.
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Clover's COVID-19 Vaccine Candidate Demonstrates 79% Efficacy Against Delta in Global Phase 2/3 SPECTRA Trial Dominated by Variants of Concern and Interest.
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Clovers COVID-19 Vaccine Candidate Demonstrates Durable High Protection and Immune Responses Against Omicron as a Booster.
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Clovers COVID-19 Vaccine Candidate Demonstrates Superior Booster Responses Compared to Inactivated Vaccine.
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Clover Reports Full Year 2021 Financial Results.
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Clover Biopharmaceuticals Raises $230 Million in Oversubscribed Series C Financing.
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