Pharmaceutical Technology Editors

Veraxa Biotech GmbH, Heidelberg, and Indivumed GmbH, Hamburg, announced that they will work together on the discovery and development of modulatory and functional antibodies against several targets relevant for colorectal cancer.

The targets were identified by Indivumed’s discovery solution platform nRavel. Veraxa will use its microfluidic technology to screen antibodies with modulatory function on complex signal proteins like GPCRs or ion channels. Antibody development and commercialization will be done by Indivumed subsidiary Ix Therapeutics.

“The high quality of data and the artificial intelligence tools that Indivumed utilizes means that we can be more confident in the validity of the targets,” said Christoph Antz, CEO of Veraxa, in a Induvimed press release from August 10, 2021. “With our technology, we can move rapidly into the development of functional antibodies that have the potential to serve as new therapeutics.”

“Having thousands of patient cases complete with comprehensive multi-omics and clinical data coupled with the advanced AI capabilities of nRavel gives us the ability to derive novel insights in just a short period of time,” said Hartmut Juhl, founder and CEO of Indivumed, in the press release. “As we continue to uncover additional targets, having a partner like Veraxa who can develop functional antibodies in an accelerated manner is critical to our ability to discover new possibilities for cancer treatment in the shortest-possible time and fight this disease.”

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Veraxa and Indivumed will work together to develop colorectal antibody drugs.

Veraxa and Indivumed Collaborate on Development of Precision Oncology Antibody Drugs

On Aug. 12, 2021, Lonza and Sheba Medical Center, a Tel Hashomer, Ramat Gan, Israel-based hospital announced success in treating multiple patients with a CD19 chimeric antigen receptor (CAR) T cell immunotherapy targeting B-cell malignancies. Three out of four patients showed complete responses while the fourth patient is still under evaluation. The four patients were dosed with cell therapy product manufactured in Lonza’s Cocoon Platform, an automated, patient-scale cell therapy platform. According to Lonza, the platform streamlines manufacturing, improving process efficiency and reliability, and is customizable.

The data from these patients demonstrates that the Cocoon platform is flexible and has the capability to manufacture immunotherapies for personalized point-of-contact treatment, compared with manual processes. Because there are several CAR-T cell therapies approved in Israel and available commercially, patients treated in the current trial are eligible only if they do not qualify for those already-available therapies, Lonza stated in a company press release. Thus, there is limited patient availability, and patients who would use cell therapies from the Cocoon platform would represent some of the more difficult cases. Lonza and Sheba Medical Center plan to dose additional patients using the Cocoon platform to manufacture the product.

Lonza and Sheba Medical Center have been in collaboration since 2019 to translate Sheba’s manual process to the Cocoon platform. The hospital’s process was successfully transferred to the Cocoon platform in 2020, and the first patient dosed with the CD19 CAR-T cell immunotherapy was done in the second half of that year, following a successful clinical comparability study. The platform aims to decrease manufacturing costs, reduce footprint, lower the risk of manufacturing failures, and minimize turnaround time.

“We have been successfully manufacturing Sheba’s CD19 CAR-T therapy in the Cocoon [p]latform and observing positive clinical outcomes, which is exciting and promising. We are proving that the Cocoon [p]latform can be used to replace open, manual manufacturing processes, which are in most cases expensive and difficult to scale. The [platform] is showing significant advantages when used for centralized, decentralized, and point-of-care manufacturing. We continue to gain traction in the market, with the aim of revolutionizing the production of patient-scale cell therapy and making these lifesaving therapies available to more patients in need,” said Eytan Abraham, head of Personalized Medicine, Lonza, in the press release.

“This unique effort initiated between a leading biotechnology company and Sheba is a prime example of how we are dealing with today's and tomorrow's medicine. The collaborative relationship between innovative medical technologies and medicine enables leading hospitals such as Sheba to create breakthrough personalized medical treatments that are amongst the best within the world of biomed,” said Professor Dror Harats, deputy director for Research and Development and acting director for Clinical Trials, Sheba Medical Center, in the press release.

Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.

Lonza and Sheba Medical Center Demonstrate Successful Cell Therapy Results with Cocoon Automated Platform

On Aug. 10, 2021, Moderna announced that it plans to build a messenger RNA (mRNA) vaccine manufacturing facility in Canada that will include access to the company’s mRNA development technology. The company signed a memorandum of understanding (MoU) with the government of Canada for the facility.

Under the MoU, Moderna and Canada aim to build a foundation on which Canada can have direct access to pandemic response capabilities as well as access to vaccines Moderna is developing against respiratory viruses, including COVID-19, seasonal influenza, respiratory syncytial virus (RSV), and potential other vaccines, pending licensure. Moderna is also in discussion with other governments for potential collaborations built on a similar model, the company stated in a press release.

“I would like to thank the Government of Canada for the partnership they have built with us and for their faith in our data, science, and early confidence in our mRNA platform in addressing the COVID-19 pandemic. We recently announced data from the final analysis of the Phase [III] COVE study demonstrating that vaccination with the Moderna COVID-19 vaccine showed 93% efficacy, with this efficacy remaining durable six months after administration of the second dose,” said Stéphane Bancel, CEO of Moderna, in the press release. “As a company, we are committed to global public health. While we are still responding to this pandemic, we also want to ensure we and society learn from it. As Moderna expands internationally, we are delighted to bring mRNA manufacturing to Canada. We believe that this innovative business model will have global impact and implications.”

“We are excited to expand our presence and continue our long-term collaboration with Canada,” said Patricia Gauthier, Moderna’s Canadian general manager, in the press release. “With our industry-leading mRNA technology platform and rapid drug development capabilities, we look forward to being an active participant in Canada’s robust life sciences ecosystem.”

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada

Evotec SE announced the opening of its J.POD 1 late-stage clinical and commercial biologics biomanufacturing facility, in Redmond, Wash., part of Just - Evotec Biologics' J.DESIGN platform, which integrates data analytics and machine learning for the discovery, development, and manufacturing of biologic drugs.

The current good manufacturing practice (cGMP) facility, which totals 130,000 sq.ft. and uses J.POD technology, features a manufacturing ballroom and autonomous cleanrooms to run small, intensified product processes with fed-batch or continuous processing up to 1000 L scale and deliver clinical- or commercial-grade drug substance in batchs of a few kilograms to metric tons, the company reported in an Aug. 11, 2021 press statement.

The site also has dedicated quality control and process development laboratories, a warehouse, and office and meeting space for approximately 200 employees at full capacity.

The facility was constructed in 19 months, a construction schedule that is faster relative to traditional biologics manufacturing, the company reports, reducing costs and promoting sustainability. The facility is designed to use less water, electricity, and chemicals compared with conventional facilities.

"Evotec's mission is all about access to innovative, highly effective medicines.” said Evotec CEO Wener Lanthaler in a company press release. “With this uniquely flexible manufacturing facility, Evotec now has the capabilities in house to not only discover and develop innovative biologics therapies, but also deliver them to the patients who urgently need them.”

The Just - Evotec Biologics facility in Redmond, Wash., uses the company’s J.POD technology.

Evotec Opens Integrated Biologics Manufacturing Facility

On August 9, 2021, AstraZeneca announced that the European Commission (EC) approved its drug Forxiga (dapagliflozin) in the European Union for the treatment of chronic kidney disease (CKD) in adult patients with or without type-2 diabetes.

Dapagliflozin is a inhibitor of human sodium-glucose cotransporter 2 (SGLT2). In a DAPA-CKD Phase III trial, it was demonstrated that dapagliflozin, in addition to standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, “reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39% (the primary composite endpoint), compared to placebo (absolute risk reduction [ARR]=5.3%, p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion,” according to a company press release.

CKD is a condition where kidneys do not function optimally. It is estimated that 840 million people worldwide and 47 million in the EU have CKD. However, diagnosis rates are low, with up to 90% of affected individuals not knowing they have the condition.

“Today’s approval establishes dapagliflozin as the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status in the EU,” said Hiddo L. Heerspink, a professor at University Medical Center Groningen, the Netherlands, in the company press release. “Based on the unprecedented results from the DAPA-CKD Phase III trial, dapagliflozin delays disease progression providing physicians a critical opportunity to improve the prognosis of patients with chronic kidney disease.”

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

European Commission Approves AstraZeneca’s Forxiga for Treatment of Chronic Kidney Disease

On August 12, 2021, German contract development and manufacturing organization (CDMO) ProBioGen announced that Japanese pharmaceutical company Nobelpharma had signed a license agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX to develop Nobelpharma’s lead vaccine.

The appeal of the manufacturing platform is that it is designed as a true cell suspension line. Because it grows in a chemically defined medium, it is free of any adventitious agents. Consequently, cultivation can be done in large bioreactors, resulting in reduced lead times and a more controlled production process in closed systems.

Established in 2003, Nobelpharma has developed 18 new drugs and one new medical product with a focus on products for underserved patient populations. AGE.CR.plX will be used in the development of their viral vaccine.

"Cell-based systems for vaccine production offer a cost-effective, efficient and flexible alternative to traditional vaccine production,” said Gabriele Schneider, chief business officer at ProBioGen, in a company press release. “With the AGE1.CR.pIX, we have created an exceptionally robust and scalable system, which is becoming increasingly important and we are pleased about the increased demand."

Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.