CDMO/CMO and Supplier Roundup in Supporting COVID-19 Projects

The latest from CDMOs, CMOs, and suppliers in COVID-19 efforts featuring Ology Bioservices, Univercells, AGC Biologics, Cytovance, and LabVantage.

Biologics Manufacturing

DOD Awards Ology Bioservices $27.3 M for Cell Platform Development
The US Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies has awarded a contract valued at $27.3 million to Ology Bioservices, a biologics CDMO, to establish its proprietary Veroplex cell platform for rapid response to emerging viral diseases.

Source: Ology Bioservices

Univercells, ReiThera, Leukocare Enter Pact for COVID Vaccine

Univercells, a Belgian technology company specializing in bioprocessing, ReiThera, a Rome-based biopharmaceutical company for advanced therapies, and Leukocare, a Munich-based drug-formulation company focused on protein therapeutics, have formed a pact for the development and large-scale manufacturing of an adenoviral vector-based vaccine against COVID-19.

The companies say the vaccine candidate is expected to enter clinical trials during the summer of 2020 with large-scale vaccine production planned to start soon after. The partners say they will contribute to the program to accelerate the development of the vaccine, and the three companies have formed a pan-European consortium to pursue this strategy to develop a single-dose vaccine.

The companies are contributing to the development of an adenoviral vector-based vaccine candidate targeting the spike protein of SARS-CoV-2, the virus that causes COVID-19, and that the vaccine technology is based on a ReiThera-proprietary simian adenoviral vector that has strong immunological potency and low pre-existing immunity in humans. The companies say that other vaccines based on simian adenoviral vectors have been evaluated in Phase I and II clinical trials and were proved to be safe and immunogenic. ReiThera says it is currently preparing for a COVID-19 first-in-human trial to be started in Italy in the summer of 2020.

In parallel to its clinical development, the consortium says it will start manufacturing and stockpiling the vaccine. The companies say approximately six million doses of the vaccine are expected to be available early in 2021. Based on the Phase I/II clinical results and a path agreed with regulatory authorities, the intention with these doses will be to vaccinate the most exposed people such as medical and healthcare professionals and highly vulnerable individuals.

Leukocare says it will contribute to drug-product development with a stable liquid vaccine formulation based on its technology platform for formulations of viruses and viral vectors. Univercells says it will capitalize on the previous successes of its scale-X bioreactor and NevoLine biomanufacturing platform to adapt and scale up the technology platform and enable the mass production of ReiThera’s vaccine candidate. Univercells says it will provide its bioproduction platform for the acceleration of GMP manufacturing of the adenoviral product.

Source: Univercells, ReiThera, and Leukocare 

AGC Biologics, AdaptVac Enter Pact to Develop COVID-19 Vaccine
AGC Biologics, a CDMO for protein-based therapeutics, is partnering with AdaptVac, a Hørsholm, Denmark-based vaccine company, to develop and produce a COVID-19 vaccine.

AdaptVac, together with its EU Horizon 2020-sponsored PREVENT-nCoV consortium partners, is developing a SARS-CoV-2 vaccine. EU Horizon 2020 is a research initiative and funding program of the European Union. AdaptVac is a joint venture between ExpreS2ion Biotechnologies, a provider of custom protein production, and NextGen Vaccines, owned by the inventors of a viral capsid-like virus particle platform technology spun out from the University of Copenhagen.

The agreement will use AGC Biologics manufacturing services to accelerate the development and GMP manufacture of a SARS-CoV-2 capsid-virus like particle vaccine. The companies say this partnership has the potential to advance the initiation of the first clinical trial by the end of 2020.

Source: AGC Biologics and AdaptVac

Cytovance, Akshaya Bio Enter Pact for COVID-19 and HBV Treatments
Cytovance Biologics an Oklahoma City, Oklahoma-based biologics contract manufacturer, has entered into a collaboration agreement with Akshaya Bio, an Edmonton, Alberta, Canada-based development-stage biotechnology company, to provide access to clinical materials using Akshaya’s proprietary Chimigen platform technology, for vaccine development for COVID-19 and hepatitis B virus (HBV).

Under the agreement, the companies will focus on using Akshaya’s proprietary Chimigen platform technology to execute bulk drug products of both COVID-19 and HBV vaccines to be used in Phase I clinical trials. Akshaya says it uses the Chimigen platform to develop therapeutic vaccines for patients with chronic viral infections as well as prophylactic vaccines to prevent infections. Cytovance says it will scale up production using its GMP insect-cell microbial manufacturing platform for evaluation of the Chimigen technology in humans for SARS CoV-2 coronavirus and chronic hepatitis B.

Source: Cytovance Biologics

Artes Biotechnology To Develop COVID-19 Vaccine Candidates on VLP Platform
Artes Biotechnology, a Langenfeld, German-based company specializing in process development for recombinant vaccines, reports that it has entered into development of SARS-CoV-2 vaccine candidates based on its virus-like particle (VLP)-based platform technologies, Metavax and SplitCore.

Metavax is the company’s platform for the development of vaccines built on enveloped virus-like particle nanostructures (eVLPs) based on the duck Hepatitis B small surface antigen. SplitCore is the technology where capsid virus-like particles (cVLPs) are applied as antigen presentation vehicles without involvement of host lipid membrane structures.

Artes says the development approach is designed to present domains of the spike protein of SARS-CoV-2, with or without an antigen derived from the virus’ nucleocapsid protein, on the surface of eVLPs (Metavax) and cVLPs (SplitCore).

Virus-like particles are highly organized protein structures that mimic the conformation of authentic native viruses without being infectious, consisting of one or more structural proteins that have the ability to self-assemble to mimic the structure of real viruses and to present foreign epitopes or complete antigens on their surface, according to information from the company. Because of lacking a viral genome, recombinant VLPs may be better than using native viruses while at the same time maintaining the same potential to trigger a strong immune response.

In September 2019, Artes and Australian Burnett Institute, a non-profit biomedical research institute based in Melbourne, Australia, published data on the production of malaria vaccine candidates using virus-like particles (eVLP) produced with Artes’ Metavax platform presenting malaria transmission-stage antigens, which were capable of inducing transmission-blocking antibodies.

For SplitCore platform, the company says the borrelia antigen presenting cVLP were developed by a research team of the University of Freiburg in Germany and resulted in the induction of neutralizing antibodies against Lyme disease.

Source: ARTES Biotechnology

Formulation/Drug Product Manufacturing

CMIC Supports Avigan Clinical Trials and Mfg for COVID-19 Patients
CMIC Holdings Co. Ltd. (CMIC) is providing clinical monitoring services and manufacturing services for Avigan (favipiravir), an antiviral drug of Fujifilm Toyama Chemical, which is being evaluated as a potential treatment for COVID-19.  

Recently, Fujifilm announced the start of clinical trials of Avigan in Japan and overseas as a potential drug candidate for treating COVID-19. In addition, the company says the Japanese government plans to stockpile two million treatment courses of the drug, a 14-day treatment regimen including two loading doses of 1,800 mg each on Day 1, followed by two maintenance doses of 1,000 mg each on Days 2 through 14

Source: CMIC Holdings Co. Ltd.


LabVantage Launches Biobanking LIMS Accelerator for Managing COVID-19 Testing
LabVantage Solutions, a Somerset, New Jersey-based laboratory informatics provider, has announced the availability of its purpose-built COVID-19 laboratory information management system (LIMS) solution. The solution is designed to jump-start the ability of laboratories to enter biospecimens into a biobank and begin conducting COVID-19-related testing and research. The LabVantage COVID-19 Biobanking Accelerator is built on the company’s LIMS and Biobanking platforms used by clinical laboratories.

Delivered as a Software-As-A-Service (SaaS) solution, LabVantage says its COVID-19 Biobanking Accelerator requires no infrastructure investment and will be ready in less than four weeks (as reported on April 28, 2020). The company says the LIMS Accelerator includes full biobanking capabilities and COVID-19 extraction and testing workflows with related master data, incorporating multiple protocols defined by the US Centers for Disease Control and Prevention  for COVID-19 testing to accommodate the addition of standard and customer-determined protocols for testing, such as RT-PCR, isothermal nucleic acid amplification, and serology.

Source: LabVantage Solutions

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