CureVac and GSK’s Bivalent Second-Generation mRNA Vaccine Candidate Shown to be Highly Effective Against SARS-CoV-2 Variants in Preclinical Study

On April 21, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported preclinical data demonstrating immune responses and protective efficacy of a bivalent second-generation COVID-19 vaccine candidate jointly developed with GSK, combining two mRNAs encoding for the Beta and the Delta variant (Press release, GlaxoSmithKline, APR 21, 2022, View Source [SID1234612733]).

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The preclinical study, conducted in collaboration with the Friedrich-Loeffler-Institut, Germany, assessed the bivalent candidate in comparison to the corresponding monovalent candidates targeting either variant in a mouse model. Despite containing only half the dose per variant-mRNA, the combined Beta/Delta candidate elicited neutralizing antibody titers fully comparable to the monovalent candidates of the respective variant. During exposure of the vaccinated animals to either the Beta or the Delta variant, the bivalent mRNA vaccine significantly reduced the viral load in the animals. High neutralizing antibody titers were accompanied by robust T cell responses. Notably, the bivalent Beta /Delta vaccine candidate induced two-fold higher virus neutralizing antibody titers against the Omicron variant than against the Delta variant in a rat model. This finding provides evidence for a potentially increased breadth of immune responses of the bivalent approach. The full manuscript of the preclinical data is available on the preprint server bioRxiv.

"Since the beginning of the pandemic, new COVID-19 variants have continued to evolve, each characterized by different virulence and transmissibility," said Dr. Igor Splawski, Chief Scientific Officer of CureVac. "New vaccine strategies, such as multivalent approaches, combining several variant-specific mRNAs within one vaccine, can be essential to take control over the COVID-19 virus dynamic and set new standards for broadly effective vaccines against other infectious diseases. Following our recent multivalent approach for influenza, we are now taking advantage of this advanced technology approach in our COVID-19 vaccine program.

Within the study, transgenic mice expressing the human ACE2 receptor were immunized on day 0 and day 28 with a 0.5 µg dose of the monovalent second-generation vaccine candidate against either the ancestral virus (CV2CoV), the Beta (CV2CoV.351) or the Delta (CV2CoV.617.2) variant, or with a 0.5 µg dose of the bivalent vaccine candidate combining the Beta and Delta variant (CV2CoV.351+ CV2CoV.617.2). Vaccinated animals were challenged on day 56 with either the Beta or the Delta virus variant. Vaccine induced T cells, including lung-resident memory CD8+ T cells, were characterized by flow cytometry. Additionally, the neutralizing capacity of the mono- and bivalent candidates was tested against multiple virus variants, including Omicron in serum samples of immunized Wistar rats.

Binhui Raises $47 Million for Oncolytic Virus Products

On April 21, 2022 Binhui Biopharm reported that it has closed a $47 million Series B financing to support its R&D of oncolytic virus products (Press release, Binhui Biotechnology, APR 21, 2022, View Source [SID1234612731]). The company’s oncolytic herpes simplex virus (oHSV2) technology platform has produced its first product, BS001 (OH2) injection, which has been approved in China for single and combination drug trials. In August 2021, BS001 was approved to start US trials in various solid tumors. The company also develops viral vector vaccines, recombinant protein drugs and nucleic acid drugs. The B+ round was led by Yangtze River Pharmaceutical Group.

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Cerus Corporation to Release First Quarter 2022 Financial Results on May 5, 2022

On April 21, 2022 Cerus Corporation (Nasdaq: CERS) reported that its first quarter 2022 financial results will be released on Thursday, May 5, 2022, after the close of the stock market (Press release, Cerus, APR 21, 2022, View Source [SID1234612727]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8280547. The replay will be available approximately three hours after the call through May 19, 2022.

Catalent to Invest $350 Million in Integrated Biologics Drug Substance and Drug Product Manufacturing at Bloomington, Indiana, Facility

On April 21, 2022 Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported a multi-year $350 million investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities (Press release, Catalent, APR 21, 2022, https://www.catalent.com/catalent-news/catalent-to-invest-350-million-in-integrated-biologics-drug-substance-and-drug-product-manufacturing-at-bloomington-indiana-facility/ [SID1234612725]). The project will serve the industry’s robust biologics pipeline across various modalities with new bioreactors, syringe filling lines, and additional lyophilization capacity, supported by quality control laboratories and complex automated packaging.

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The expansion includes the installation of new 2,000-liter single-use bioreactors and expanded downstream processing capabilities for drug substance, with the versatility to meet customers’ needs with batches of up to 4,000-liters using single-use technology, or 5,000-liters using existing stainless-steel bioreactors. Also included are new quality control laboratories and complex packaging space with additional high-speed, automated cartoning and auto-injector device assembly capabilities. It is envisioned that these new capabilities will be fully operational later this calendar year.

The site will also be adding to its drug product fill/finish capacity, with new syringe filling lines under barrier isolator technology and additional lyophilized vial capacity. When completed in 2024, the site’s broad range of fill/finish offerings will provide great flexibility in dose form presentations and batch sizes to serve customers with everything from early- and late-stage development programs to high-volume commercial supply across various modalities.

Altogether, these expansions are expected to add over 1,000 new jobs to Catalent’s Bloomington workforce in the coming years.

"We continue to see strong growth in demand for biologics development and manufacturing with a deep pipeline across multiple indications," commented Mike Riley, President of Biotherapeutics at Catalent. "These investments will enable us to expand our flagship Bloomington facility and extend our leadership as one of the largest and most comprehensive global centers for integrated manufacturing capabilities. The site offers highly flexible and scalable solutions to companies developing new biological drugs, vaccines, RNA therapies, and other innovative treatments for patients around the world."

This expansion follows a series of recent investments in Catalent Biologics’ global network, including the modernization of its fill/finish and packaging facility in Limoges, France, and the acquisition of a new biologics development and manufacturing facility near Oxford, U.K.

Arbutus to Report First Quarter 2022 Financial Results and Provide Corporate Update

On April 21, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported that it has scheduled its first quarter 2022 financial results and corporate update for Thursday, May 5, 2022 (Press release, Arbutus Biopharma, APR 21, 2022, View Source [SID1234612720]). The schedule for the press release and conference call/webcast are as follows:

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• Q1/2022 Press Release: Thursday, May 5, 2022 at 7:30 a.m. ET
• Q1/2022 Conference Call/Webcast: Thursday, May 5, 2022 at 8:45 a.m. ET
• Domestic Dial-In Number: (866) 393-1607
• International Dial-In Number: (914) 495-8556
• Conference ID Number: 6287124
A live webcast of the conference call can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 6287124.