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Archive - Jul 28, 2020

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Pfizer & BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 & Commence Phase 2/3 Global Study of Up to 30,000 Participants, Starting in US and to Include Approximately 120 Sites Globally; 100 Million Doses Anticipated by End of 2020

On July 27, 2020, Pfizer Inc. (NYSE: PFE) (https://www.pfizer.com/) and BioNTech SE (Nasdaq: BNTX) (https://biontech.de/) announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2. After extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, Pfizer and BioNTech announced that they have chosen to advance their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30 µg dose level in a 2-dose regimen. BNT162b2, which recently received U.S. FDA Fast Track designation, encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies. “Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine. The Phase 2/3 study protocol follows all the U.S. FDA guidance on clinical trial design for COVID-19 vaccine studies,” said Kathrin U. Jansen, PhD, Senior Vice President and Head of Vaccine Research & Development, Pfizer. “The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the program progresses.” “Today, we are starting our late-stage global study, which will include up to 30,000 participants.

Seer, Inc., Announces Publication in Nature Communications Demonstrating Performance, Scalability, and Utility of its Platform Technology for Deep, Unbiased Proteomics

On July 22, 2020, Seer, Inc. (https://seer.bio/) announced the publication in Nature Communications (https://www.nature.com/articles/s41467-020-17033-7) of a study demonstrating the power of its proprietary, engineered nanoparticle technology platform to discover novel proteins and biomarkers through an unprecedented combination of unbiased, deep, rapid, large-scale proteomics. The study brought together an interdisciplinary team of scientists, engineers and physicians from MIT, Harvard Medical School, Seer, and other organizations. The open-access article, entitled “Rapid, Deep and Precise Profiling of the Plasma Proteome with Multi-Nanoparticle Protein Corona,” establishes the novel technology’s ability to interrogate the plasma proteome across many orders of magnitude spanning highly abundant to rare proteins, and reproducibly capture and robustly quantify proteins in a rapid, automated workflow without the need for additional sample-processing steps. Omid Farokhzad, MD, Chief Executive Officer at Seer, commented on the significance of the findings, “Measuring the vast amount of proteomic information across many individuals, many time points, and many diseases has long been a goal of scientific and industry researchers. But, that goal has not been achievable due to the complexity of the proteome and inherent challenges in measuring it. Essentially, researchers have had to sacrifice depth of profiling either for number of proteins or for speed. As the study published today demonstrates, this is the first technology to eliminate that trade-off – and, importantly, offer an unbiased view of the proteome.” The technology described in the Nature Communications paper forms the foundation for Seer’s Proteograph™ suite of products, including reagents, instruments, and software, which the company plans to begin commercializing next year.

Proteomics Company "Seer" Announces $55M Financing Led by Fidelity Management and Research Company

On July 22, 2020, Seer, Inc., a life sciences company focused on empowering exceptional scientific outcomes through the power of rapid, deep, unbiased proteomics information, announced that it has raised $55 million in a new funding round. This latest equity financing was led by Fidelity Management and Research Company, and included a new investor, HBM Healthcare Investments. All existing investors also participated in the round, including funds and accounts advised by T. Rowe Price Associates, Invus, aMoon, and Maverick Ventures. “We’re thrilled by the high caliber of investors we continue to attract who share Seer’s vision to transform proteomics and empower researchers to exponentially advance our understanding of human health and disease,” said Omid Farokhzad, MD, Chief Executive Officer and Founder of Seer. “We are paving the road for researchers to measure hundreds of thousands of distinct protein variants that make up the human proteome at population scale and provide the missing functional context to genomic data sets. This will have a fundamental impact on our understanding of biology and disease, including the selection of more precise biomarkers for early disease detection and the elucidation of novel targets for disease treatment.” Seer will use the proceeds from this financing to expand its research and development activities and to prepare for the planned 2021 commercial launch of its Proteograph™ suite of products, comprising reagents, instruments, and software. The Proteograph suite of products leverage Seer’s proprietary engineered nanoparticles to enable an entirely new way of accessing the proteome.