Beijing Clover Biopharma (HK: 1297) completed a $260 million IPO in Hong Kong. The company will use the proceeds to continue development of Trimer-Tag™ vaccines, Trimer-Tag™ oncology candidates and Fc-fusion candidates. Its most advanced product is a S-Trimer-Tag COVID-19 vaccine that was 67% effective against all COVID-19 variants and 79% against the Delta variant. The company plans to file for emergency use approval of the vaccine in China, the EU and with WHO in Q4 of 2021. It expects conditional approvals by the middle of 2022. Clover expects to supply up to 414 million doses of its COVID-19 vaccine through COVAX.

The company's shares fell 3% from the offering price during the first day of trading, dropping from HK$13.38 to HK$12.98.

“We are excited at what the future holds as we submit conditional regulatory approval applications for and potentially commercialize S-Trimer in the near term,” Joshua Liang, CEO and executive director at Clover, said in a statement.

Clover's pipeline consists of six Trimer-Tag™ subunit vaccine candidates, two Trimer-Tag™ oncology candidates and three Fc-fusion candidates. The eleven products will be tested for 13 indications, with 11 clinical trials already underway.

From the company's website, the following is an overview of its clinical and pre-clinical development projects:

Trimer-Tag™ Subunit Vaccine Candidates 

• SCB-2019 (CpG 1018/Alum) -- Clover expects its COVID-19 vaccine candidate will be one of the first protein-based COVID-19 vaccines commercialized globally through the COVAX Facility. It consists of two key components -- an antigen and an adjuvant. Employing its Trimer-Tag™ technology platform, Clover developed a SCB-2019 antigen, a stabilized trimeric form of the S-protein (S-Trimer™) based on the original strain of the SARS-CoV-2 virus. It combined SCB-2019 with Dynavax’s CpG 1018 advanced adjuvant and aluminum hydroxide (alum).
• Second-generation COVID-19 vaccine candidates -- Multiple variants of the SARS-CoV-2 virus have emerged, and Clover plans to develop second-generation COVID-19 vaccine candidates to address these variants. It has produced vaccine antigens against three variants of concern and selected a candidate for second-gen COVID-19 vaccine
• Rabies vaccine candidate -- Cover's rabies vaccine candidate (RABV G-Trimer) is in early-stage development.
• RSV vaccine candidate. The company's RSV vaccine candidate (Fusion F Antigen-Trimer) induced a strong neutralizing antibody response in a rat immunization model.
• Influenza vaccine candidate -- a Hemagglutinin (HA)-Trimer) candidate demonstrated proof-of-concept immunogenicity and viral-challenge results in vivo in mice for pandemic and seasonal flu.
• HIV/AIDS vaccine candidate -- The HIV/AIDS vaccine candidate (gp120-Trimer) demonstrated strong binding affinity to broadly-neutralizing antibodies (bNAbs), suggesting preservation of important antigenic epitopes. 

Trimer-Tag™ Oncology Product Candidates 

• SCB-313 -- Using its Trimer-Tag™ technology platform, Cover designed and developed SCB-313 as a covalently-linked trimeric fusion protein that is structurally and functionally differentiated from the dimeric antibody-based structures and other native ligand-based candidates targeting this pathway. It is being developed to treat intracavitary malignancies, including Malignant Ascites (MA), Malignant Pleural effusions (MPE), and Peritoneal carcinomatosis (PC). Clover is conducting five Phase 1 clinical trials for SCB-313 in China and Australia to treat intracavitary malignancies.
• 4-1BB Agonist Candidate -- A trimeric fusion protein candidates targeting the 4-1BB pathway, a member of the TNFSF, is in discovery mode. Activation of the 4-1BB receptor requires trimerization and is an attractive candidate for applications in cancer immunotherapy. 

Fc-fusion Product Candidates 

• SCB-808 -- A biosimilar to Enbrel (etanercept), a TNF-alpha inhibitor marketed by Amgen, Pfizer, and Takeda Pharmaceuticals with global sales of US$6.3 billion in 2020. SCB-808 is expected to primarily compete with the reference drug Enbrel and other etanercept biosimilars that have been launched or currently under late-stage development in China. The company started a Phase III clinical trial in December 2019 to evaluate SCB-808’s efficacy, safety, and pharmacokinetics for the treatment of AS.
• Selected Pre-clinical Fc-Fusion Product Candidates -- SCB-420 is an aflibercept biosimilar currently in pre-clinical development for ophthalmologic diseases such as wAMD. 

See our other articles on Clover. 

Disclosure: none.