Pharmaceutical Technology Editors

Metagenomi, a gene editing start-up focused on metagenomics, announced that they have secured $175 million in funding. In addition to past funding, this gives the start-up approximately $300 million to spend toward its gene editing therapeutic programs, the company stated in a Jan. 25, 2021 press release.

Metagenomi uses a metagenomics-powered platform to develop potentially curative therapeutics to accurately edit DNA where current technologies struggle. This recent financing will go towards funding their lead 

“Our expertise in mining the world’s natural environments for novel gene editing systems has resulted in the discovery of a powerful suite of gene editing tools,” said Brian C. Thomas, co-founder and CEO of Metagenomi, in the press release. “We are honored to be supported by an impressive group of investors who understand the enormous potential of our gene editing capabilities. We look forward to the next phase of the [c]ompany’s development as we accelerate our lead gene editing programs and open new treatment options in metabolic, cardiovascular, and CNS diseases as well as in immuno-oncology.”

In November 2021, Metagenomi struck a deal with Moderna to investigate genetic medicines for various unspecified diseases.

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Metagenomi has successfully raised $175 million for use toward its research pipeline.

Gene Editing Startup Metagenomi Raises $175 Million

On Jan. 26, 2022, Moderna announced that they had dosed their first patient in a Phase II study of an Omicron specific booster vaccine candidate of their SpikeVax vaccine. Similarly, on Jan. 25, 2022, Pfizer and BioNTech announced the initiation of a clinical study into an Omicron-specific variant of their vaccine.

The Moderna study will feature two cohorts of participants receiving mRNA-1273, Moderna’s COVID-19 vaccine booster specifically tailored for the Omicron variant. One group includes participants who received the primary vaccine doses and a booster (with the booster dose being administered at least three months prior), while the other group is composed of individuals who only received the two-dose primary series (completed at least six months before the booster).

Conversely, the Pfizer study will feature three groups:

615 individuals who received two doses of the current Pfizer-BioNTech COVID-19 vaccine 90–180 days prior to enrollment; they will receive one or two doses of the Omicron-based vaccine

600 individuals who received three doses of the current Pfizer-BioNTech COVID-19 vaccine 90–180 days prior to enrollment; they will receive one dose of the Omicron-based vaccine

200 vaccine-naïve participants will receive three doses of the Omicron-based vaccine

"We are reassured by the antibody persistence against Omicron at six months after the currently authorized 50 µg booster of mRNA-1273. Nonetheless, given the long-term threat demonstrated by Omicron's immune escape, we are advancing our Omicron-specific variant vaccine booster candidate and we are pleased to begin this part of our Phase [II] study," said Stéphane Bancel, CEO of Moderna, in a company press release. "We are also evaluating whether to include this Omicron-specific candidate in our multivalent booster program. We will continue to share data with public health authorities to help them make evidence-based decisions on the best booster strategies against SARS-CoV-2."

“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, senior vice-president and head of Vaccine Research & Development at Pfizer, in a company press release. “Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts to towards this goal.”

Both Pfizer and Moderna have started clinical trials for their respective Omicron COVID-19 variant vaccine.

Pfizer and Moderna Begin Omicron Vaccine Trials

IonSense, a US-based provider of direct analysis in real time mass spectrometry (DART) for rapid mass spectral analysis, has been selected to have its DART-MS technology used as part of the “Rapid Analysis of Drugs” program, a new drug screening program that is being piloted in five states across the United States. The pilot program is being used to test drugs and drug paraphernalia by utilizing the high-accuracy, fast detection mass spectrometry capability enabled by IonSense’s DART technology to identify the contents of drugs within minutes at the point of need.

The screening program was first launched by the Governor of Maryland, in conjunction with the Maryland State Police, Maryland Department of Health, and National Institute of Standards and Technology in December 2021, to identify illicit drugs and counter recent increase in overdose deaths. The program has also been adopted by four further states with Alabama, Virginia, Texas and Washington DC implementing the scheme and more states expected to follow in quick succession, according to a Jan. 13, 2022 press release.

DART is an ionization source that uniquely analyzes a variety of particles (including solids, liquids and gases) without the need for sample preparation, which removes a major time-consuming step, allowing users to rapidly identify samples, including many that do not ionize well, at the point of need.

IonSense’s DART-MS technology offers rapid drug analysis without the need for sample preparation.

IonSense’s DART-MS Technology Selected for New Drug Screening Program

Texcell—North America, part of the Texcell Group of biosafety contract research organizations (CROs), is expanding its capabilities in customized R&D cell culture, good laboratory practice viral clearance studies, and select good manufacturing practice assay capabilities for viral safety testing with the construction of a new laboratory facility in Frederick, Md. The multimillion-dollar facility, which broke ground in December 2021, will add 27,000 ft2 of laboratory and office space, which more than doubles Texcell’s current capacity. The facility is expected to be complete in the first quarter of 2023, the company stated in a Jan. 7, 2022 press release.

The new facility will house eight new independent client suites designed to be flexible based on the specific needs of the project and the client. The suites will be stocked with mobile equipment, including new pure chromatography systems (ÄKTA, Cytiva) and nanofiltration units, which can be transferred from suite to suite as necessary, according to Texcell in the press release. The facility will also offer scaled-down manufacturing models and offer the ability to transfer work on specific projects to a dedicated viral clearance team.

“Viral clearance and safety testing are an integral part of the development of biologics and gene therapies. This expansion will give us the opportunity to scale up our testing capabilities to meet the rising demand for these life-saving products,” said Jeff Schubert, president of Texcell—North America, in the press release. “As the number of candidate molecules in clinical pipelines continues to grow rapidly, this additional capacity permits us to provide research support to even more [clients].”

Texcell North America’s new lab facility in Frederick, Md., will expand the CRO’s capabilities in R&D cell culture, viral clearance studies, and viral safety testing.

Texcell North America Builds New Laboratory Facility

Announced in January 2022, Refeyn’s SamuxMP mass photometer is designed to be used with only basic training. Intended for use in adeno-associated virus (AAV) analytics, it has a mass range tailored for AAV analysis and provides accurate results in less than five minutes from sample loading to final result. Combined with low-operational costs and a small footprint, the SamuxMP enables routine quantification of empty/full AAV capsid ratios, even in smaller labs, to set a new standard in AAV characterisation.

According to a company press release, the SamuxMP is designed to overcome the drawbacks of the current analytical methods by enabling users to rapidly and cost-effectively determine empty/full capsid ratios for AAVs of any serotype at the bench using very low sample volumes and concentrations with minimal sample preparation. This is intended to enhance productivity and speed up workflows through more frequent analyses in-house, making R&D and process development of gene therapies and AAV-based therapeutics significantly more efficient.

“We are delighted to announce the launch of our SamuxMP mass photometer for fast, accurate, and accessible AAV analysis”, said Anthony Fernandez, CEO, Refeyn, in the press release. “Mass photometry provides an opportunity to overcome the analytical bottleneck in the gene therapy sphere for AAV-based therapeutics and we wanted to develop an instrument that would enable a real gain in efficiency. The SamuxMP delivers precise results from the bench whilst reducing cost and preparation time. It will enable researchers to focus on what they do best, and make AAV analytics just another part of their day-to-day workflows. We look forward to working with the bioscience research community to continue delivering innovative instruments that will simplify biomolecule characterisation.”

Refeyn’s SamuxMP enables routine quantification of empty/full AAV capsid ratios, even in smaller labs, to set a new standard in AAV characterization

Refeyn Announces SamuxMP for AAV Characterization

On Jan. 27, 2022, Samsung Biologics announced that it has reached an agreement with Biogen to buy out Biogen’s 50% stake in their previously formed Samsung Bioepis joint venture for $2.3 billion.

The transaction has been approved by Samsung Biologics’ board of directors, and payment for the shares will be made in installments over the next two years. Under the agreement, full ownership will take effect at the time the first payment of $1.0 billion is made. The Samsung Biologics board has also agreed to issue new shares to raise KRW 3 trillion (approximately US$2.5 billion) in capital. Proceeds from this capital will be used to fund the company’s strategic growth plans, including the purchase of the Samsung Bioepis shares, Samsung Biologics stated in a company press release.

Initially, Biogen had invested in a 15% stake in Samsung Bioepis when it was established in 2012. Under the terms of that original agreement, Biogen had the right to purchase up to 50% less one share of Samsung Bioepis, which Biogen exercised in June 2018.

The full buyout of Biogen’s stake by Samsung Biologics is expected to accelerate Samsung Bioepis’ biosimilar development capabilities and future performance in novel drug development. Samsung Bioepis has thus far launched five biosimilars globally, three in autoimmune and two in oncology. Another product is about to be released as well, and the company currently has four biosimilars in Phase III clinical trials.

Samsung Biologics is currently building Plant 4 and 

will begin construction this year of a new facility

, Plant 5, which will offer multi-modal product services. The company is also in the process of securing an additional 350,000 m2 of land for its Bio Campus II, which will be 30% larger than the size of the current site.

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.