CureVac Bids to Develop First mRNA Coronavirus Vaccine

Labiotech | February 03, 2020

RNA vaccine developer CureVac will receive a grant of up to €8.3M from a global partnership to develop an mRNA vaccine against the new coronavirus strain from China. The agreement follows on from an existing collaboration launched in 2019, when the Coalition for Epidemic Preparedness Innovations, or CEPI, granted CureVac €30M to develop facilities that can ‘print’ mRNA vaccines. The aim of the new grant is to help CureVac’s preclinical-stage mRNA vaccine for the coronavirus strain to reach clinical trials as quickly as possible.

Spotlight

Animation video about cell culture and the scale-up and manufacturing process of biologics.

Spotlight

Animation video about cell culture and the scale-up and manufacturing process of biologics.

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INDUSTRIAL IMPACT

Charles River Expands Strategic Partnership With SAMDI Tech

Charles River Laboratories International, Inc. | January 28, 2022

Charles River Laboratories International, Inc. announced the expansion of their strategic partnership with Chicago, Illinois-based SAMDI Tech, Inc. Under the existing partnership, established in 2018, SAMDI Tech clients have access to Charles River’s collection of lead-like compounds for high-throughput screening. The expanded agreement establishes Charles River as the exclusive partner for the promotion of SAMDI Tech’s technology. This partnership will provide Charles River’s clients seamless access to the premiere, label-free high-throughput screening mass spectrometry (MS) platform in drug discovery. The SAMDI technology combines self-assembled monolayers and MALDI MS, and addresses the throughput and sample preparation limitations of traditional MS screening methods. The combination of Charles River’s end-to-end portfolio and industry-leading scientific bench with SAMDI Tech’s innovative technology and expertise in assay solutions has the potential to significantly accelerate and augment clients’ discovery efforts by measuring biochemical activities and binding events for virtually any target. Approved Quotes “Our collaboration with SAMDI Tech is another step that we’re taking toward accelerating drug discovery and development. By generating quality data faster during hit identification, we can help our clients make critical go/no go decisions earlier in the process, to advance their programs.” –Wilbert Frieling, D.V.M., Corporate Senior Vice President, Global Discovery Services, Charles River “With over a decade of industry experience, SAMDI Tech has a well-respected track record of producing high quality data. We are excited to partner with them to bring this technology to our clients.” – Julie Frearson, Ph.D., Corporate Senior Vice President, Chief Scientific Officer, Charles River “We are excited to expand on our successful partnership with Charles River, whose clients will join our global client base to benefit from our label-free SAMDI technology, which continues to deliver cutting-edge solutions backed by high-quality, data-driven results.” –Emilio Cordova, PhD, MBA, Chief Executive Officer, SAMDI Tech About Charles River Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.

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Research Solutions Announces Partnership with BIO Business Solutions to Bring One-Click Scientific Literature Access to the Biotech Industry

Research Solutions | October 12, 2020

Research Solutions/Reprints Desk (NASDAQ: RSSS), a pioneer in providing cloud-based workflow solutions for R&D driven organizations, today announced that it has partnered with BIO Business Solutions to help life sciences companies save time and money on scholarly literature access via its award-winning Article Galaxy research platform. Operated by the Biotechnology Innovation Organization (BIO), BIO Business Solutions is the industry's largest cost savings purchasing program. More than 4,500 member companies worldwide—including biotechnology and biopharmaceutical firms, medical device firms, academic institutions, state biotechnology centers, and related organizations—together save more than $511 million annually through the BIO Business Solutions® program.

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INDUSTRIAL IMPACT

Inhibrx Receives FDA Orphan-Drug Designation for INBRX-101 for the Treatment of Alpha-1 Antitrypsin Deficiency

Inhibrx, Inc. | March 04, 2022

Inhibrx, Inc. a biotechnology company with four clinical programs in development and a strong emerging pipeline, announced that the U.S. Food and Drug Administration, or FDA, has granted orphan-drug designation for INBRX-101 for the treatment of alpha-1 antitrypsin deficiency, or AATD. "We believe this designation from the FDA acknowledges the significant unmet need for novel therapeutic options in a patient community where the standard of care has not seen an improvement in many decades. We believe INBRX-101 can greatly improve the quality of life for AAT patients and look forward to working closely with regulators, key opinion leaders, patients and their families to achieve this." Inhibrx Chief Executive Officer, Mark Lappe The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan-drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval. About AATD and INBRX-101 Alpha-1 antitrypsin deficiency, or AATD, is an inherited orphan disease affecting an estimated 100,000 patients in the United States. AATD is characterized by deficient levels of the AAT protein, which causes loss of lung tissue and function and decreased life expectancy. Plasma-derived AAT is the current standard of care but does not maintain patients in the normal AAT range, and requires frequent and inconvenient once-weekly IV dosing, while relying on plasma collection practices that might not be sustainable. INBRX-101 is a precisely engineered recombinant human AAT-Fc fusion protein designed to safely achieve and maintain levels of AAT found in healthy individuals with a favorable safety profile and the potential for once-monthly dosing. In October 2021, the Company announced interim functional PK data from 21 AATD patients in the Phase 1 study. Dose related increases in maximal and total INBRX-101 exposure occurred across the entirety of the tested single ascending dose range of 10 to 120 mg/kg. Data from the first multiple ascending dose cohort of INBRX-101 at 40 mg/kg IV every three weeks showed the expected accumulation of functional AAT levels with observed trough levels exceeding the goal of the current standard augmentation therapy with plasma-derived AAT. Interim safety data from 24 patients with AATD showed no drug-related severe or serious adverse events at doses up to and including 120 mg/kg single dose and 80 mg/kg multiple dose. Drug-related adverse events were predominantly mild with a few moderate events, and all were transient and reversible. No signs of neutralizing anti-drug antibodies have been observed. About Inhibrx, Inc. Inhibrx is a clinical-stage biotechnology company focused on developing a broad pipeline of novel biologic therapeutic candidates in oncology and orphan diseases. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary sdAb platform. Inhibrx has collaborations with 2seventy bio Bristol-Myers Squibb and Chiesi, among others.

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