Pipeline

Our Trimer-Tag™ technology platform enables us to drive innovation in vaccines and therapeutics to empower humanity with a healthier future through transformative science.

Our Pipeline

  • Vaccines
  • Oncology
  • Product Candidate

  • Target

  • Indication

  • Discovery

  • Preclinical

  • IND/CTA

  • Phase I

  • Phase II

  • Phase III

  • BLA

  • SCB-2019 (CpG 1018/Alum)(1)
  • SARS-CoV-2 S-Trimer™ (Prototype Strain)
  • COVID-19 Primary Vaccination

    COVID-19 Universal Booster

  • SCB-2020S (CAS-1)(2)
  • SARS-CoV-2 S-Trimer™
    (B.1.351 variant chimera)
  • COVID-19
  • Bivalent COVID-19 Vaccine(3)
    (SCB-2019 + SCB-2022B)
  • SARS-CoV-2 S-Trimers™
    (Original + Omicron)
  • COVID-19
  • Rabies Vaccine(3)
  • RABV G-Trimer
  • Rabies
  • RSV Vaccine(3)
  • RSV F-Trimer
  • RSV
  • Influenza Vaccine(3)
  • HA-Trimers
  • Quadrivalent Seasonal Flu
    Pandemic Flu

(1) COVID-19 vaccine candidate. Announced on September 2021 SPECTRA met the primary and secondary efficacy endpoints. We expect to obtain conditional approvals in 2022 and commence product launch soon after.
(2) SCB-2020S antigen is a chimeric SARS-CoV-2 spike protein based on the RBD of Beta variant and the NTD of the original strain. This candidate will be evaluated with CAS-1, an in-house developed oil-in-water emulsion-based adjuvant.
(3) Other vaccine candidates in early-stage development.
*All milestones are based on currently available information.

  • Product Candidate

  • Target

  • Indication

  • Discovery

  • Preclinical

  • IND/CTA

  • Phase I

  • Phase II

  • Phase III

  • BLA

  • Malignant Ascites
  • TRAIL-Trimer
  • Malignant Pleural Effusion
  • SCB-313(4)
  • Peritoneal Carcinomatosis
  • + APG-1387 (Ascentage)
    IAP Antagonist Combo (5)
  • Peritoneal Carcinomatosis
  • SCB-219M
  • TPO Mimetic Bispecific-Fc
  • Chemotherapy-Induced Thrombocytopenia (CIT)
  • Undisclosed(6)
  • 4-1BB x Undisclosed Bispecific Trimer
  • Immuno-Oncology

(4) Our oncology product candidate for the treatment of malignant ascites (MA), malignant pleural effusions (MPE), and peritoneal carcinomatosis (PC) to address global unmet medical need of intracavitary malignancies. Currently, continued internal development has been paused and pending further assessment of development strategy and resource allocation.
(5) On December 9th 2021, we entered a partnership with Ascentage to jointly conduct Phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and efficacy of SCB-313 in combination with APG-1387 for the treatment of patients with primary or secondary peritoneal carcinomatosis.
(6) This oncology product candidate is in early-stage development, and we are still assessing the target indication(s) for this product.
*All milestones are based on currently available information.

  • Product Candidate

  • Target

  • Indication

  • Discovery

  • Preclinical

  • IND/CTA

  • Phase I

  • Phase II

  • Phase III

  • BLA

  • SCB-808 (Etanercept Prefilled Syringe)(8)
  • TNFRII-Fc
  • Ankylosing Spondylitis (AS)
  • SCB-420 (Aflibercept)(9)
  • VEGFR1R2-Fc
  • Wet Age-related Macular Degeneration (wAMD)

(8) Our Fc-Fusion product candidate is a biosimilar to Enbrel. In China, Enbrel was approved by the NMPA in February 2010 to treat RA and AS. We received the IND approval from NMPA in November 2017 and completed a Phase 1 clinical trial in January 2019. We are conducting a Phase 3 clinical trial with data expected in 2024+. Todate, the NMPA did not raise any objections or material concerns with respect to the development of SCB-808.
(9) Our Fc-Fusion product candidates is a biosimilar to Eylea. We will commence bioequivalence study in 1H2022.
*All milestones are based on currently available information.

Trimer-Tag™ Subunit Vaccine Candidates

SCB-2019 (CpG 1018/Alum)

SCB-2019 (CpG 1018/Alum), our COVID-19 vaccine candidate, consists of two key components, an antigen and an adjuvant. Employing the Trimer-Tag™ technology platform, we developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein (S-Trimer™) based on the original strain of the SARS-CoV-2 virus. We created our COVID-19 vaccine candidate by combining SCB-2019 with Dynavax’s CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

In September 2021, we announced SPECTRA, our global pivotal Phase 2/3 clinical trial for SCB-2019 (CpG 1018/Alum), met the primary and secondary efficacy endpoints. Based on the SPECTRA results, we plan to submit conditional regulatory approval applications to the Chinese National Medical Products Administration (NMPA), the European Medicines Agency (EMA), and the World Health Organization (WHO).

Universal COVID-19 Booster Vaccine Development

Clover and investigators are conducting multiple clinical trials exploring SCB-2019 (CpG 1018/Alum) as a heterologous booster, which is the administration of a different COVID-19 vaccine technology from the primary vaccination, and as a homologous booster following primary vaccination with SCB-2019 (CpG 1018/Alum).

SCB-2020S (CAS-1) and Bivalent COVID-19 Vaccine Candidates

Multiple variants of the SARS-CoV-2 virus have emerged and are circulating globally. Given the error-prone nature of RNA virus replication, more variants will inevitably emerge as the virus is transmitted.

We are leveraging the proprietary Trimer-Tag™ technology platform to develop candidates that have the potential to expand the breadth of vaccine-induced neutralizing antibodies to address the existing and potential new variant strains of the SARS-CoV-2 virus.

We have advanced SCB-2020s (CAS-1), a second-generation, potentially broadly protective COVID-19 vaccine candidate based on the chimeric Beta variant and the prototype trimeric SARS-CoV-2 S-protein, into a Phase 1 clinical trial. We also continue to develop our bivalent COVID-19 vaccine candidate, which combines the trimeric spike antigen from the original SARS-CoV-2 strain and the Omicron variant.

Rabies Vaccine Candidate

Our rabies vaccine candidate (RABV G-Trimer) is currently in early-stage development. Currently approved rabies vaccines have limitations in their production capacities, required administration schedules, storage requirements, and cost. There continues to be a need for better rabies vaccines in certain countries, such as China, where animal immunization programs have been unsuccessful.

RSV Vaccine Candidate

Our RSV vaccine candidate (Fusion F Antigen-Trimer) induced a strong neutralizing antibody response in a rat immunization model. This candidate demonstrated high binding affinity (sub-picomolar) to palivizumab.

Influenza Vaccine Candidate

Our influenza vaccine candidate (Hemagglutinin (HA)-Trimer) demonstrated proof-of-concept immunogenicity and viral-challenge results in vivo in mice (pandemic and seasonal). An adjuvanted protein-based seasonal flu vaccine may also be attractive to achieving stronger immune responses in elderly populations which traditionally have observed lower responses to traditional flu vaccines. A flu vaccine candidate could also potentially be developed to be used in a pandemic situation or as a universal (HA-stem) flu vaccine.

Trimer-Tag™ Oncology Product Candidates

SCB-313

Utilizing the Trimer-Tag™ technology platform, we have successfully designed and developed SCB-313 as a covalently-linked, native-like trimeric fusion protein which is structurally and functionally differentiated from the dimeric antibody-based structures and other native ligand-based candidates targeting this pathway.

We believe SCB-313 has the potential to address the unmet global need for the treatment of intracavitary malignancies, including Malignant Ascites (MA), Malignant Pleural effusions (MPE), and Peritoneal carcinomatosis (PC), as well as additional cancer indications. Clover continues to explore other targets in the tumor necrosis factor super family (TNFSF) for immuno-oncology and immunology indications and is conducting discovery programs evaluating trimeric fusion protein candidates targeting the 4-1BB pathway, a member of the TNFSF.

In December 2021, we entered a partnership with Ascentage Pharma to jointly conduct a Phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and efficacy of SCB-313 in combination with APG-1387 for the treatment of patients with primary or secondary peritoneal carcinomatosis.

SCB-219M

We are exploring SCB-219M, an innovative human thrombopoietin receptor agonist (TPO-RA), for the treatment of chemotherapy-induced thrombocytopenia (CIT). CIT is a serious, chemotherapy-associated complication observed in a wide range of cancer patients that can have detrimental impacts on treatment outcomes and can result in chemotherapy dose delay or dose reduction, and potentially fatal bleeding events. We initiated a Phase 1 trial in June 2022.

Discovery- Stage Immuno-Oncology Product Candidate

We are conducting discovery programs evaluating trimeric fusion protein candidates targeting the 4-1BB pathway, a member of the TNFSF. Activation of the 4-1BB receptor requires trimerization and is an attractive candidate for applications in cancer Immunotherapy. In multiple pre-clinical studies we demonstrated potent cytotoxic immune cell activation and antitumor responses. Building on experience utilizing the Trimer-Tag™ technology platform and deep understanding of protein trimerization, we believe we will be able to design a native-like trimeric fusion protein to target the 4-1BB pathway. This oncology product candidate is in early-stage development, and we are still assessing the target indication(s) for this product.