Pharmaceutical Technology Editors

Sanofi announced on Dec. 21, 2021, that it agreed to acquire Amunix Pharmaceuticals, an immuno-oncology company, for approximately $1 billion, with an additional payment of $225 million contingent on various developmental milestones. Amunix’s portfolio includes conditionally-activated biologics in the field of immuno-oncology.

Amunix’s lead candidate is AMX-818, a masked human epidermal growth factor receptor 2-directed T-cell engager (TCE). According to a Sanofi press release, Amunix’s proprietary XTEN polypeptide masks allow biologics to become active preferentially in disease-specific micro-environments. This effect is designed to overcome challenges associated with TCE bi-specific antibodies for solid tumors, including unwanted immune attack of normal healthy cells and systematic widespread immune system activation.

“The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues, thus bringing the promise of more effective and safer treatment options for cancer patients,” said John Reed, global head of research and development, Sanofi, in the press release. “We are excited to rapidly advance Amunix’s promising pipeline and to combine their innovative candidate medicines with complementary molecules in Sanofi’s immuno-oncology portfolio.”

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Sanofi’s acquisition of Amunix will grant access to their promising immuno-oncology pipeline.

Sanofi Acquires Amunix Pharmaceuticals for $1 Billion

AstraZeneca and Amgen announced on Dec. 17, 2021, that FDA approved Tezspire (tezepelumab-ckko) as an add-on maintenance treatment for severe asthma in patients aged 12 years and older. According to an AstraZeneca press release, clinical trial data showed that tezepelumab-ckko is the first biologic to reduce asthma exacerbations consistently and significantly in a broad population of patients with severe asthma.

Tezepelumab-ckko is a first-in-class biologic that was developed through a collaboration between AstraZeneca and Amgen that began in 2012. The drug functions by targeting thymic stromal lymphopoietin (TLSP), an epithelial cytokine. By inhibiting the action of TLSP, it can prevent the initiation and persistence of allergic, eosinophilic, and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.

FDA made the decision following publication of results from the NAVIGATOR study, a Phase III, randomized, double-blinded, placebo-controlled trial in adults aged 18–80. The trial measured the annualized rate of asthma exacerbations, finding that patients who received tezepelumab-ckko had a rate of 0.93, while those given placebo had a rate of 2.10. Results from two other trials, PATHWAY and SOURCE, were also considered.

“Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to experience frequent exacerbations, an increased risk of hospitalization and a significantly reduced quality of life,” said Andrew Menzies-Gow, director of the lung division, Royal Brompton Hospital, and principal investigator of the NAVIGATOR trial, in the release. “[Tezepelumab-ckko] represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma.”

“Today’s positive decision marks the first time the FDA has approved a biologic for asthma without phenotypic limitation and irrespective of biomarker levels,” said Mene Pangalos, executive vice-president, biopharmaceuticals R&D, AstraZeneca, in the release. “With the approval of [tezepelumab-ckko], physicians will now be able to offer an important new treatment that has the potential to transform care for a broad population of severe asthma patients.”

Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

FDA Approves AstraZeneca and Amgen’s Tezpire

The European Medicines Agency (EMA) announced on Dec. 20, 2021, that it has recommended conditional marketing authorization for Novavax’s COVID-19 vaccine for people ages 18 and older. Conditional marketing authorization is used to fast-track the authorization procedure with fewer data than normally required to fulfill an unmet medical need. The protein-based vaccine, Nuvaxovid, is the fifth COVID-19 vaccine recommended in the European Union.

According to the agency, two main clinical trials, which involved 45,000 people, showed that the vaccine was effective at preventing COVID-19 in people 18 years and older. The first study was conducted in Mexico and the United States and showed a 90.5% reduction in symptomatic cases from seven days after the second dose in those who received the vaccine compared to those who received a placebo. The second study, which was conducted in the United Kingdom, had a similar result with an efficacy rate of 89.7%.

“Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,” EMA stated in a press release.

The recommendation goes to the European Commission for approval for use in vaccination programs across the EU.

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

EMA Recommends Conditional Authorization for Novavax’s COVID-19 Vaccine

Syngene International, a research, development, and manufacturing services company, announced on Dec. 16, 2021 that the company and Amgen have extended their long-standing multi-discipline research collaboration to the end of 2026.

The scope of the collaboration includes integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development. Under the extended contract, Syngene will build and operate a dedicated laboratory, which will enable the acceleration of R&D projects. Syngene currently operates the existing Syngene Amgen R&D Center (SARC) under the companies’ original collaboration deal.

SARC was established in 2016 and was expanded in 2017. The center currently consists of 60,000 ft2 of floor space. A dedicated team of multi-disciplinary Syngene scientists are working closely with Amgen researchers on the discovery and development of innovative medicines.

"While SARC was established in 2016, our collaboration with Amgen dates back to 2012. During this time, we have partnered on research and development to address some of the most serious diseases in the world. We have progressively expanded our areas of collaboration, co-authored research papers on novel science, and supported the advancement of multiple development projects, while adhering to global standards of quality and safety,” said Jonathan Hunt, CEO and managing director, Syngene International, in a company press release.

“Amgen is pleased with the success of the long-standing collaboration with Syngene that has contributed to the advancement of a number of molecules into clinical trials,” said Margaret Chu-Moyer, vice-president of Research and head of Chemistry, Characterization & Technology at Amgen, in the press release. “We look forward to continuing to work together with the shared goal of addressing serious disease for patients in need.”

Amgen and Syngene International have extended their research collaboration to 2026.

Amgen Extends Collaboration with Syngene International

Genezen, a cell and gene therapy contract development and manufacturing organization, has officially opened its new process development and analytical lab for viral vector production, the company announced in a Dec. 3, 2021 press release.

The lab includes a full suite of process development capabilities to support current good manufacturing practice (CGMP) and commercial readiness, upstream and downstream process improvements, research-grade and preclinical vector production, and analytical assay development and validation.

This lab is the first phase of a multiphase master plan to build an over 75,000-ft2 CGMP-compliant lentiviral and retroviral vector production facility. The next phase includes CGMP production suites, construction of which is currently underway and due to be complete in early 2022.

When finished, the new facility will conduct aseptic manufacturing of lentiviral and retroviral vectors from multiple CGMP production suites and will offer capabilities for host cell expansion, host cell banking, and viral vector production using transient transfection and producer cell lines. The site will also include analytical testing services, such as recombinant competent lentivirus testing, vector stability testing, and safety and sterility testing. The facility’s end-to-end capabilities will enable Genezen to deliver optimized closed and semi-automated processes for viral vector production.

Genezen will meanwhile continue providing cell manufacturing and patient sample testing through its existing academic partnerships.

“The opening of our dedicated viral vector process and analytical development lab is a key milestone for us in launching our additional early stage capabilities needed to drive the cell and gene therapy industry forward,” said Ray Kaczmarek, CEO of Genezen, in the press release. “Our deep expertise in development and manufacture of viral vectors coupled with this new facility and equipment will accelerate our partners’ abilities to advance life-saving therapies into the clinic.”

Genezen has opened its new process development and analytical lab for viral vector production.

Genezen Starts Up Operations at Lenti- and Retroviral Vector Process Development Lab

Bionique Testing Laboratories, a provider of mycoplasma testing services, has been 100% acquired by a subsidiary of the Japan-based healthcare company, Asahi Kasei Medical. With the acquisition, Bionique will be joined with ViruSure, an Austria-based viral and prion safety testing services company, which is a part of the global biosafety testing services unit of Asahi Kasei Medical’s Bioprocess Division. Both Bionique and ViruSure will continue operations under their existing brands, which Bionique announced in a Dec. 15, 2021 press release.

The acquisition combines Bionique’s mycoplasma and viral safety capabilities with ViruSure’s expertise, expanding Asahi Kasei Medical’s biosafety testing services. Asahi Kasei Medical is also actively investing in facility and employment expansion at various operating sites of both Bionique and ViruSure, according to the press release.

“Joining the Asahi Kasei group will enable Bionique to consolidate its leadership position in the global mycoplasma testing arena and afford our clients access to ViruSure’s service portfolio, satisfying their end-to-end biosafety testing needs from discovery through commercialization,” said Gladis Zamparo, CEO of Bionique, in the press release.

“We are excited to have a strategic partner like Bionique as part of the Asahi Kasei group, and

the expertise in mycoplasma testing that they bring will further strengthen our goal to better

service our customers in all areas of biosafety testing,” said Andy Bailey, CEO of ViruSure, in the press release.

Bionique Testing Laboratories has been acquired by Asahi Kasei Medical and will join the company’s biosafety testing services unit.