Global Roundup: Clover’s COVID-19 Vaccine Booster Reaches Phase III

Clover dosed the first participants in a Phase III study of its COVID-19 booster shot, while Global Access Diagnostics, Orbit Discovery, Proximie and more provide business and pipeline updates.

COVID-19 continues to be a pressing concern across the globe, including in China, where the global pandemic originated. Clover Biopharmaceuticals is pushing forward with its experimental vaccine as a potential booster for currently-available vaccines, such as Pfizer and BioNTech’s Comirnaty, AstraZeneca’s Vaxzevria, or Sinovac’s CoronaVac.

Based in Shanghai, Clover dosed the first participants in a Phase III study of SCB-2019. Data from a previous study announced in April showed that a heterologous booster dose of SCB-2019 administered to individuals who previously received two doses of AstraZeneca’s COVID-19 vaccine produced a more rapid response and higher levels of neutralizing antibodies against the virus and variants of concern, such as Omicron, compared to individuals receiving three doses of AstraZeneca’s COVID-19 vaccine. When available, the company plans to include these universal COVID-19 booster data in its regulatory submissions. This new Phase III study will add to the growing body of evidence regarding SCB-2019 as a potential universal COVID-19 booster candidate.

“Building on the strength of our promising booster results to date demonstrating that SCB-2019 (CpG 1018/Alum) can significantly boost broad neutralization against Omicron and other variants, we are delighted to initiate this Phase 3 study to advance the development of SCB-2019 as a potential universal COVID-19 booster candidate,” Nicholas Jackson, president of global research and development of Clover said in a statement. “As Omicron and new subvariants continue to challenge existing vaccine immunity necessitating booster vaccines that can elicit potent and broad protection, we believe that SCB-2019 could play an important role in supporting the increased demand for a universal COVID-19 booster vaccine.”

Elsewhere around the globe:

Global Access Diagnostics: The first portfolio company from U.K.-based Global Access Health, Global Access Diagnostics was formed to address gaps in the global provision of diagnostics with a focus on expanding affordable access to quality tests. The new company uses rapid diagnostics developed by Mologic Ltd., which was acquired by GAH last year. Through decentralized research, development, and manufacturing in and for the Global South, GADx aims to “address gaps in the provision of global diagnostics, in regions that profit-focused business has failed to address.”

Orbit Discovery: Also based in the U.K., privately-held Orbit Discovery Ltd. was awarded a £472,000 Smart Grant from Innovate U.K., the U.K.’s innovation agency. The grant will support the development of droplet-based microfluidics for cell-based functional screening. The funds will also be used to significantly expand the capabilities and throughput of Orbit’s peptide display platform. The project aims to advance the discovery of peptide therapeutic candidates, including the most challenging drug targets, by improving overall process efficiency whilst reducing the risk and associated costs.

Monument Therapeutics: Another U.K.-based company, Monument Therapeutics, announced the beginning of its Phase I study of MT1980, a novel formulation of an on-market anti-inflammatory compound developed as a novel therapy for poorly-treated conditions associated with neuroinflammation, such as Alzheimer’s disease, stroke, traumatic brain injury, schizophrenia, depression, post-operative cognitive decline and long COVID.

Proximie: Based in London, Proximie raised $80 million in a Series C financing round. Proceeds will be used to accelerate the development of key products and services, build out Proximie’s marketplace ecosystem and scale their Operating System of the OR, a centralized platform delivering connected surgical care. The funding round was led by Advent Life Sciences, with participation from new investors Emerson Collective, SoftBank Vision Fund 2, British Patient Capital, Mubadala Investment Company, and the Minderoo Foundation. Existing investors, F-Prime Capital, Eight Roads, Questa Capital, Global Ventures, and Maverick Ventures also participated in the round.

Sirona Biochem: Based in Vancouver, Sirona has begun a strategic review of every facet of the company, including management, organizational structure, project pipeline, financial position and the exchanges on which the Sirona shares are listed. The company noted that organizational changes and management expansion would occur in its headquarters in Vancouver, Canada, as well as its research facility in Rouen, France. External resources will be engaged to assist, and there will be updates communicated throughout the remainder of 2022.

In addition to its strategic review, Sirona also announced a licensing agreement with Allergan Aesthetics, a division of AbbVie. Under terms of the deal, Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona’s patents for TFC-1067 and related compounds. Under the license agreement, Sirona will receive an upfront payment, milestones, and potential royalties on product sales.

Aeterna Zentaris: On the other side of Canada, in Toronto, Aeterna Zentaris announced its Autoimmunity Modifying (AIM) Biologicals program has achieved pre-clinical proof-of-concept for the potential treatment of neuromyelitis optica spectrum disorder (NIMOSD). Also known as Devic disease, NIMOSD is a chronic autoimmune disorder of the brain and spinal cord dominated by inflammation of the optic nerve and spinal cord. It is typically fatal in approximately 30% of patients within five years of diagnosis.

Centogene N.V.: Based in Germany, Centogene expanded its partnership with Agios Pharmaceuticals. Centogene will provide lab support Agios’ two global, pivotal Phase III trials, ACTIVATE-kids and ACTIVATE-kidsT, both of which are being conducted to evaluate the efficacy and safety of Pyrukynd (mitapivat) in children with P.K. deficiency between the ages of 1 to 17. Centogene and Agios have been partners since 2015.

Olink Holding AB: Sweden’s Olink announced that FinnGen, a research collaboration in Finland, will use Olink technology to provide detailed proteomics data to improve understanding of human health. FinnGen is one of the first personalized medicine projects that collects and analyzes genomic and health data from 500,000 Finnish biobank participants. Olink has been chosen by FinnGen to provide comprehensive proteomics profiling of up to 2,500 individuals as part of the study. These findings can serve as the basis for further functional studies in combination with high quality proteomics, providing the potential for new insights into disease mechanisms.

Pierre Fabre: France’s Pierre Fabre and Lonza have entered into a manufacturing agreement that will support W0180, an innovative monoclonal antibody discovered by Pierre Fabre targeting the VISTA checkpoint. W0180 is being investigated as a single agent and in combination with Merck’s Keytruda (pembrolizumab) in a Phase I clinical trial in various solid tumors.