Pharmaceutical Technology Editors

The European Commission (EC) has granted marketing authorization for Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19 who do not require supplemental oxygen and who are at an increased risk of disease progression, Celltrion Group announced on Nov. 15, 2021.

EC’s decision follows on from the positive opinion that was granted by the European Medicines Agency’s Committee for Medicinal Products for Human Health (CHMP) on Nov. 11, 2021. The approval has been based upon clinical trial data from a global Phase III study involving more than 1315 participants. In the study, it was demonstrated that regdanvimab, a monoclonal antibody therapy, significantly reduced the risk of COVID-19 related hospitalizations or death in high-risk patients.

“Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” said HoUng Kim, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “Typically, the recommendations from the CHMP are passed on to the EC for rapid legally binding decisions within a month or two, however, given the unprecedented times, we have received the EC approval within a day. As part of our global efforts to accelerate access, we have been communicating with the governments and contractors in 30 countries in Europe, Asia, and [Latin America]. We will continue working with all key stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments.”

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EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.

Celltrion Gains Nod from EC for Regdanvimab

Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, has announced a £10 million (US$13.5 million) investment into process development and manufacturing capacity at its site in Dudley, United Kingdom.

This latest investment, which forms part of a multi-year investment strategy being undertaken by Sterling at its Dudley site, will involve the building and commissioning of new process development laboratories, as well as the installation of additional commercial-scale manufacturing equipment to meet growing demand for small-molecule API manufacturing.

Equipment to be installed include a 4.5 cubic meter hydrogenator, which is capable of press reactions up to 10 bar, in addition to supplemental conical and filter dryers in the existing manufacturing plant. Furthermore, new kilo-scale and technology laboratories will be built at the Material Science Centre, located on the same site. Completion of the project is expected by mid-2022.

“The next phase of our strategic plan is to increase and enhance our capacity to develop and scale up processes for commercial readiness, and is testament to the continued, strong interest that we are seeing in small molecule development,” said Kevin Cook, CEO at Sterling, in the press release. “Having the capabilities and expertise across a range of advanced technologies is crucial to ensure that Sterling can continue to be an industry-leading partner for API development and manufacturing, and meet the future demands of our customers.”

Sterling Pharma Solutions has announced a £10 million (US$13.5 million) investment into process development and manufacturing capacity at its site in Dudley, UK.

Sterling Pharma Solutions Invests in Process Development and Manufacturing in Dudley, UK

Biotechnology company, Novavax, has announced in a Nov. 17, 2021 press release that the European Medicines Agency (EMA) has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

NVX-CoV2373 is a protein-based vaccine candidate that has been engineered from the genetic sequence of the first strain of SARS-CoV-2. Confirmation that all data for the regulatory evaluation have been submitted by the company to EMA was announced earlier in November 2021. EMA has also indicated that it will be pursuing the evaluation under an accelerated timeframe, as stated in Novavax’s press release.

“Today's announcement from EMA brings Novavax another step closer to our goal of ensuring broad global access to our protein-based COVID-19 vaccine across Europe,” said Stanley C. Erck, president and CEO, Novavax, in the press release. “Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform, and thanks the European Commission for its ongoing partnership and confidence in our COVID-19 program.”

The vaccine, which will be marketed in the European Union under the brand name of Nuvaxovid, has already been granted Emergency Use Authorization in Indonesia and the Philippines. Additionally, Novavax and its manufacturing partner, the Serum Institute of India (SII), have filed for Emergency Use Listing of the vaccine with the World Health Organization (WHO).

Furthermore, the company has filed for regulatory approval of the vaccine in the United Kingdom, Australia, New Zealand, Canada, and with WHO. The company has also announced the submission of a biologics license application, along with SK bioscience, to the South Korean regulatory body. It is expected that the complete package for the vaccine will be submitted to the FDA by the end of 2021.

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

EMA Begins Evaluation of Novavax COVID-19 Vaccine Marketing Authorization Application

Lonza announced on Nov. 16, 2021 that it has invested in additional microbial development capabilities at its Visp, Switzerland, site and will increase the capacity of its development services targeting microbial-derived proteins by expanding laboratory space and equipment, which will be ready to use by the end of 2021.

Under the expansion, a dedicated pilot suite will be installed, housing a 50-L fermenter and corresponding downstream equipment. The suite is expected to generate non-good manufacturing practice product for use in formulation and toxicology studies. The pilot suite will also enhance Lonza’s internal technology transfer strategy and capability by providing a representative primary recovery scale. Furthermore, the expanded laboratory capacity will be aligned with available manufacturing capacity and will support new mid-scale assets that are coming online in 2022.

This current extension will support new projects in Lonza’s existing manufacturing programs as well as a previously announced mid-scale microbial capacity expansion, the company stated in a press release. Because microbial expression systems demand complex manufacturing processes, this expansion will strengthen upstream, downstream, and process analytics support for the new projects.

The company expects that the new development capacity will consolidate its microbial footprint at Visp and add new high-throughput equipment and automation processes, which will drive efficiency and project delivery. Upgrades in automation will include three liquid handling workstations and other enabling equipment dedicated to upstream and downstream process development and analytical method development, which will enhance data generation.

“The microbial-derived pipeline is growing at a healthy rate driven by an increase in alternatives to antibodies, such as nanobodies, designed ankyrin repeat proteins (DARPins), single-chain antibodies, etc. For some of these molecules, microbial systems show better and more efficient productivities, which is increasing the trend toward outsourcing as customers need to rely on key microbial expertise. Expanding our development laboratories will enable us to support new customers with the development and manufacture of these molecules and other recombinant proteins for both clinical and commercial projects,” said Shiva Khalafpour, vice-president, head of Microbial Business Unit, Lonza, in the press release.

Lonza is expanding its microbial development capabilities at its Visp, Switzerland, site to support clinical and commercial drug development programs.

Lonza Invests in Microbial Development Lab Expansion

Kala Pharmaceuticals, a biopharmaceutical company focused on eye disease therapies, announced on Nov. 15, 2021 that it had acquired Combangio, a clinical-stage company developing regenerative biotherapies for severe ocular surface diseases. This approximately $16 million acquisition adds CMB-012 (now known as KPI-012), a novel investigational secretome therapy, to Kala’s pipeline.

KPI-012 is intended to treat persistent corneal epithelial defect (PCED), a condition characterized by persistent non-healing corneal defects or wounds that are resistant to conventional treatments, and other ocular diseases of a similar nature. According to a company press release, PCED is a rare disease with an estimated 238,000 cases in the United States, European Union, and Japan combined. As a result, KPI-012 received orphan drug designation from FDA for the treatment of PCED.

In a Phase 1b clinical trial in which seven of eight PCED patients were treated with KPI-012 twice-daily, seven of eight PCED patients showed improvement in their PCED, and six of eight achieved complete healing over the course of the treatment period (one to eight weeks). Four patients were completely healed within a week of beginning treatment, while two healed within two-to-four weeks. According to the press release, it was well-tolerated with no treatment-related safety issues observed. Kala plans to submit an investigational new drug application to FDA and initiate a Phase II/III trial of KPI-012 in the third quarter of 2022.

“Today’s acquisition marks a pivotal moment for Kala and a meaningful acceleration toward our goal of strengthening Kala’s pipeline for the treatment of front and back of the eye diseases,” said Mark Iwicki, CEO of Kala, in the press release. “[KPI-012] is a natural fit with our R&D and commercial expertise, and along with our internal pipeline provides an additional opportunity to leverage our deep ophthalmic expertise to address substantial, underserved markets. We are excited to have completed the acquisition of Combangio and look forward to working alongside their talented team to integrate KPI-012 into our portfolio and ultimately deliver this therapy to transform the treatment of rare ocular surface diseases.”

Kala’s acquisition of Combangio expands its clinical-stage biologic pipeline.

Kala Pharmaceuticals Acquires Combangio

Synthace, a US-based life sciences software company specializing in automating biology experimentation announced on Nov. 16, 2021, that it has raised $35 million in Series C funding to fuel commercial and go-to-market (GTM) growth for its life sciences R&D technology. The company also plans to expand its senior leadership team in the United States by appointing new vice presidents of marketing and sales.

The raised funding follows the recent release of Synthace’s life sciences R&D cloud, which is a no-code software platform that addresses simplification, speed, and reproducibility for scientists. Launched in August 2021 (1), the software platform removes barriers to innovation, allowing scientists to globally benefit from a significant leap in experimentation capabilities. This, in turn, could accelerate development timelines and allow scientists to perform experiments that may not have been possible for them to conduct before.

According to Synthace in a company press release, seven of the top 10 global pharmaceutical companies have adopted Synthace’s next-gen R&D cloud platform with the aim of fundamentally changing their experimentation process. More companies are currently evaluating the adoption of the platform. Synthace’s automated experimentation solutions will allow customers to run increasingly complex experiments that will automatically generate data and insights. Ultimately, this could result in increased competitiveness and accelerated innovation.

“Synthace’s R&D cloud platform is helping life scientists completely change the way they develop new cures and therapeutics to solve humanity’s most pressing problems,” said Guy Levy-Yurista, CEO of Synthace, in the press release. “But to maximize impact, we need to expand access and reach to customers across the globe—at scale. This investment serves as a strong vote of confidence from world-class investors in the biopharmaceutical and innovation technology industries. With their support, we’ll be able to better deploy human and financial capital to help transform scientific dreams into drugs and alternative food sources.”

“I envisaged an automated platform where our molecular biology and protein purification workflows proceeded end to end with sample tracking and barcoding throughout,” said Tony Keeley, senior protein scientist at Syngenta, a provider of science-based agtech, in the press release. “Working closely with the Synthace team has enabled this to happen.”

"Synthace has been a key partner of Wheeler’s in establishing a digital R&D lab environment. Their automation engineers worked side-by-side with our process scientists to automate multiple end-to-end workflows creating more walkaway time for scientists who can now focus on data analysis, interpretation, planning and communication directly with customers,” said Jesse McCool, co-founder and CEO at Wheeler Bio, a biomanufacturing company specializing in the integration of drug discovery with drug development to accelerate clinical impact, in the press release.

1. Synthace, “First Ever No-Code Platform Lowers Barriers to Automated Biological Experimentation and Insight Sharing,” Press Release, Aug. 2, 2021.

Synthace has raised $35 million in funding to fuel growth of its life sciences R&D technology.