Pharmaceutical Technology Editors

Sanofi and GlaxoSmithKline (GSK) announced on May 17, 2021 that their adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses in all adult age groups in a Phase II study with 722 volunteers. These results are in line with those measured in people who have recovered from COVID-19, the companies stated in a press release. The partners intend to start a global pivotal Phase III study in the coming weeks.

The Phase II interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses. Further, there was acceptable tolerability and no safety concerns. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection. Higher levels of antibodies were observed in younger adults (18 to 59 years old). After a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.

Based on these positive Phase II interim results, the companies plan to initiate a global Phase III, randomized, double-blind study with the 10-µg dose, in combination with GSK’s pandemic adjuvant, in the coming weeks. The companies plan to enroll more than 35,000 adult participants from a broad range of countries in this Phase III trial and will assess the efficacy of two vaccine formulations, including the D614 (Wuhan) and B.1.351 (South African) variants.

The companies also intend to conduct booster studies with various variant formulations in parallel to the Phase III study to assess the ability of a lower dose of the vaccine. The aim of the booster studies is to generate a strong booster response regardless of the initial vaccine platform received. Pending positive Phase III outcomes and regulatory reviews, the companies expect that the vaccine will be approved in the fourth quarter of 2021, according to the press release.

“Our Phase [II] data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and booster vaccines, which can be stored at normal temperatures, increases,” said Thomas Triomphe, executive vice-president and global head of Sanofi Pasteur, the global vaccines business unit of Sanofi, in the press release. “With these favorable results, we are set to progress to a global Phase [III] efficacy study. We look forward to generating additional data and working with our partners around the world to make our vaccine available as quickly as possible.”

“These positive data show the potential of this protein-based adjuvanted vaccine candidate in the broader context of the pandemic, including the need to address variants and to provide for booster doses. We believe that this vaccine candidate can make a significant contribution to the ongoing fight against COVID-19 and will move to Phase [III] as soon as possible to meet our goal of making it available before the end of the year,” added Roger Connor, president of GSK Vaccines, in the press release.

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Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Sanofi and GSK Report Strong Immune Response with COVID-19 Vaccine Candidate

On May 17, 2021, Sandoz, a Novartis company, announced that the US Supreme Court has denied its petition to review a July 2020 decision passed by the Federal Circuit concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept), an Amgen innovator biologic for treating autoimmune and inflammatory diseases. The Federal Circuit previously ruled against Sandoz in a divided decision upholding Amgen’s patents.

The decision not to review the Federal Circuit’s July 2020 ruling continues to prevent Sandoz from launching Erelzi in the United States. The company will be required to wait until 2029 to launch its biosimilar product, Sandoz said in a company press release. Erelzi was approved by FDA in August 2016.

Enbrel is Amgen’s top-selling drug, with nearly $5 billion in global sales in 2020, accounting for 21% of the company’s total global product sales in that year (1).

“We are disappointed the Supreme Court decided not to review our case,” said Keren Haruvi, president of Sandoz US and head of North America, in the company press release. “Today’s decision means Erelzi, a more affordable biosimilar, will not be available to US patients with autoimmune and inflammatory diseases until 2029; nonetheless we remain committed to providing important treatment options for patients affected by these diseases.”

Erelzi is a registered trademark of Novartis.

1. Amgen, “Chairman and CEO Letter and Amgen Inc. 2020 Annual Report,” 

The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.

US Supreme Court Denies Sandoz Biosimilar Etanercept Petition

Charles River announced on May 17, 2021 that it has acquired Vigene Biosciences, a US-based gene therapy contract development and manufacturing organization (CDMO), for up to $350 million.

Under the terms of the agreement, Charles River will provide an initial payment of $292.5 million in cash along with additional payments of up to $57.5 million based on future performance, Charles River said in a company press release. The transaction is set to close at the beginning of the third quarter of 2021.

Charles River plans to enhance its gene therapy capabilities through the acquisition. Specifically, the company will expand its CDMO capabilities for vectors and plasmid DNA; further develop its existing non-clinical development and manufacturing portfolio; increase its exposure in the high-growth market sector; and produce profitable growth and shareholder value, according to the press release.

“The addition of Vigene Biosciences’ extensive gene therapy expertise will enable us to expand our comprehensive cell and gene therapy portfolio to span each of the major CDMO platforms – cell therapy, viral vector, and plasmid DNA production. In these emerging, high-growth, value-added segments, we intend to continue to differentiate ourselves by bringing our high-science, customizable approach to support the complex needs of cell and gene therapy developers and innovators worldwide,” said James C. Foster, chairman, president, and CEO of Charles River, in the press release. “Our goal is to become our clients’ scientific partner of choice for advanced drug modalities from discovery and non-clinical development to CGMP manufacturing [current good manufacturing practice]. We look forward to welcoming Vigene’s dedicated employees to the Charles River family.”

Charles River plans to enhance its gene therapy capabilities through the acquisition of Vigene Biosciences. 

Charles River to Acquire Vigene Biosciences for up to $350 million

WuXi Biologics and WuXi STA, a subsidiary of WuXi AppTec, announced on May 14, 2021 that they have established a joint venture company named WuXi XDC to provide contract development and manufacturing of bioconjugates, including antibody-drug conjugates (ADCs).

Under the terms of the agreement, the companies will make capital contributions of $120 million and $80 million to the new company, with WuXi Biologics owning 60% of the company and WuXi STA owning 40%, WuXi Biologics said in a company press release. Additionally, WuXi XDC will become a non-wholly owned subsidiary of WuXi Biologics.

“We’re excited about establishing WuXi XDC, a dedicated end-to-end bioconjugate CDMO [contract development and manufacturing organization], which will combine the world-class capacities and capabilities of both WuXi Biologics and WuXi STA to provide a superior one-stop service for global partners in an effort to expedite development and lower costs,” said Chris Chen, CEO of WuXi Biologics and chairman of WuXi XDC, in the press release.

“In the past years, WuXi STA worked closely with WuXi Biologics on ADC therapeutics as well as other novel bioconjugates to provide our customers an expedited development pathway,” said Minzhang Chen, CEO of WuXi STA, in the press release. “Now with the initiative of WuXi XDC, we will further combine industry leading resources from both WuXi STA and WuXi Biologics, empowering more partners with a further optimized bioconjugates development and manufacture platform to launch their novel therapeutics faster to market for the benefit of global patients.”

“I am very honored for the opportunity to lead WuXi XDC,” added Jimmy Li, WuXi XDC’s newly appointed CEO, in the press release. “By leveraging both the robust capacities and state-of-the-art technologies of WuXi Biologics and WuXi STA, WuXi XDC will further increase its unique presence in the bioconjugates industry to enable global partners as they build their innovative ideas into transformative new treatments for patients worldwide.”

WuXi Biologics and WuXi STA have established a joint venture company named WuXi XDC to provide contract development and manufacturing of bioconjugates, including antibody-drug conjugates. 

WuXi Biologics and WuXi STA to Establish WuXi XDC for Bioconjugate Development and  Manufacturing

CordenPharma announced on May 13, 2021 that it plans to expand its non-GMP capacity at its Centre of Excellence for Peptide Process Development in Frankfurt, Germany, and increase its upstream capacity at its CordenPharma Colorado site with the introduction of a new 3000-L solid phase peptide synthesis (SPPS) vessel.

The capacity expansions fall in line with CordenPharma’s strategy to provide its customers with quick and economically appealing solutions, the company said in a press release. In addition to the new SPPS vessel, CordenPharma plans to add a second 100-cm high-pressure chromatography column at its CordenPharma Colorado site.

“This additional column will provide the capacity to purify several tons of peptide annually, which in conjunction with our existing 100 and 80-cm columns, gives us more flexibility and redundancy to maximize supply security for all of our partners,” said Matthieu Giraud, PhD, global director of the Peptides, Lipids & Carbohydrates Platform, CordenPharma, in the press release.

The expansions will add peptide manufacturing capacity.

CordenPharma Announces New Capacity Expansions at its US and Germany Sites

Biogen and Capsigen, a US-based adeno-associated virus (AAV) vector development company, announced on May 10, 2021 that they have entered into a strategic research collaboration to engineer novel AAV capsids to deliver gene therapies that address the underlying genetic causes of various central nervous system (CNS) and neuromuscular disorders for up to $1.37 billion.

Under the terms of the agreement, Capsigen will receive a $15 million upfront payment and is eligible to receive up to $42 million in potential research milestones, with an additional $1.25 billion in potential development and commercial payments, Biogen said in a company press release. Biogen will obtain an exclusive license under Capsigen’s proprietary technology for an undisclosed number of CNS and neuromuscular disease targets through the collaboration.

Additionally, as part of the agreement, Capsigen will utilize its TRADE platform and associated technologies to develop and classify novel AAV capsids designed to meet disease-specific transduction profiles.

“Through this collaboration, we aim to solve key technological challenges in the delivery of gene therapies to target tissues. One of our priorities for technology innovation is the discovery of AAV capsids with improved delivery profiles,” said Alfred Sandrock, Jr., MD, PhD, head of Research and Development at Biogen, in the press release. “We are investing for the long-term by building platform capabilities and advanced manufacturing technologies with the goal of accelerating our efforts in gene therapy.”

“At Capsigen, we believe the next revolution in gene therapy will be driven by engineered AAV capsids designed to meet disease-specific transduction profiles,” added John Bial, CEO, Capsigen, in the press release. “Biogen is a leader in neuroscience, and we are excited for the opportunity to work with them to potentially bring new treatments to patients. This collaboration is consistent with our strategy to work with world-class companies to develop the next generation of gene therapies.”

Biogen and Capsigen have entered into a strategic research collaboration to engineer novel AAV capsids to deliver gene therapies that address the underlying genetic causes of various central nervous system and neuromuscular disorders. 