Pharmaceutical Technology Editors

Sanofi has entered into a three-year research collaboration with Stanford University School of Medicine, Sanofi announced on May 6, 2021. The two organizations and their scientists will work together to advance the understanding of immunology and inflammation through open scientific exchange. Sanofi will additionally provide funding and scientific inputs into projects of mutual interest, crossing multiple therapeutic areas, including autoimmune diseases and inflammatory conditions.

Under the collaboration, Sanofi and Stanford Medicine will create a joint steering committee to fund up to three programs per year. Sanofi will host an annual research forum for researchers from both organizations with the goal of further exchanging ideas, sharing knowledge and perspectives on relevant scientific matters, and discussing collaborative research projects.

The collaboration will begin with three "deep-dive" research projects:

Exploring cytokine crosstalk in type 2 inflammation—this project will specifically examine the impact of Sanofi’s investigational molecules on excessive type 2 inflammation.

Decoding molecular drivers of effector and suppressor T cells in autoimmunity—the goal of this project is to better understand the specific antigens that may cause type 1 diabetes.

Defining the mechanisms of immune-related adverse events with immune checkpoint inhibitor therapy—this project will focus on pneumonitis and inflammatory arthritis, exploring the role of genomics and pathogenic cell identification.

“We look forward to working with some of the most innovative scientists in the human immunology community. Together we will explore groundbreaking concepts and obtain deeper insights into underlying inflammatory disease mechanisms,” said Frank Nestle, global head of Research and chief scientific officer, Sanofi, in the company press release. "Sanofi’s collaboration with Stanford University aims to transform how autoimmune disorders and inflammatory conditions are understood and treated. It will help accelerate our ambitious immunoscience programs as we advance a rich pipeline of first- and best-in-class medicines across key therapeutic areas to address unmet patient needs.”

“Stanford Medicine is dedicated to advancing knowledge and discovery with the goal of improving our ability to predict, prevent, and cure disease with the most precise approaches,” said Lloyd Minor, MD, dean of the Stanford School of Medicine, in the press release. “The opportunity for long-term collaboration with our colleagues at Sanofi will allow us to explore together new frontiers in autoimmune diseases and inflammatory conditions.”

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Projects led by collaborating researchers from both Sanofi and Stanford Medicine will focus on autoimmune diseases and inflammatory conditions.

Sanofi Forms Three-Year Immunology Research Collaboration with Stanford Medicine

On May 6, 2021, Eli Lilly and Company (Lilly) announced that it has signed strategic international agreements with four diabetes technology companies—DexCom, Glooko, myDiabby Healthcare, and Roche—to integrate data and technology in a bid to streamline diabetes management in markets outside the United States. These companies offer unique diabetes management platforms that are compatible with Lilly's Tempo Pen (approved in several global markets) and Tempo Smart Button (currently in late-stage development).

Tempo Pen is a modified version of Lilly's existing prefilled, disposable insulin pen. The Tempo Smart Button is designed to attach to the Tempo Pen and is pending Conformité Européenne (or European Conformity) (CE) marking. Lilly said it aims to receive CE mark for the Tempo Smart Button later in 2021 and will launch the Tempo Pen and Tempo Smart Button in several international markets following this certification.

Through Lilly’s new agreements, the Tempo Smart Button will pair with software and/or medical devices offered by Dexcom, Glooko, myDiabby Healthcare, and Roche, via Lilly’s mySugr app. This pairing is expected to facilitate the integration of personalized data and actionable insights, Lilly stated in a company press release.

"We're pleased to work alongside these innovative partners who share our commitment to improving diabetes outcomes by bringing together medicine and digital solutions for the global diabetes community," said Marie Schiller, vice-president of product development for Connected Care and Insulins at Lilly, in the press release. "Insulin dose logging is often an incomplete piece of the diabetes management puzzle for people who use insulin pens and manually track their doses. By integrating data from the connected insulin pen solutions into widely used compatible software, including potential future collaborations, we aim to support improved decision-making for people with diabetes and their healthcare providers with accurate, real-time data collection. These solutions may also help address psychological barriers like fear of hypoglycemia that may negatively impact diabetes management."

"People with diabetes need access to all of the key information about their condition. For those who use insulin pens, tracking how much insulin they delivered and the time of the dose and bringing that information together with glucose data can help them meaningfully improve their management," said Tadej Battelino, head of Endocrinology, Diabetes & Metabolism, UCH professor, at the University of Ljubljana, in the press release. "These agreements mark a meaningful step towards providing useful tools that help provide real-time guidance and holistic support to ease some of the burdens of living with diabetes."

Eli Lilly and Company has partnered with leading diabetes tech firms to offer app compatibility with insulin smart pens to streamline diabetes management with automated data collection.

Lilly Forms Pact with Diabetes Tech Companies to Integrate Connected Insulin Pen Solutions

On May 5, 2021, GlaxoSmithKline (GSK) announced that the European Commission (EC) approved the expanded use of intravenous (IV) and subcutaneous (SC) Benlysta (belimumab), in combination with background immunosuppressive therapies, for treating active lupus nephritis (LN) in adults in Europe, in addition to systemic lupus erythematosus (SLE). This marketing authorization follows the recent approval for the similar expanded LN indication in the United States, GSK stated in a company press release.

The marketing authorization application was based on data from a study that showed belimumab, over two years, added to increased renal response rates with standard therapy and helped to prevent worsening of kidney disease in patients with active LN compared to standard therapy alone.

Benlysta is a BLyS-specific inhibitor human monoclonal antibody (mAb) that binds to soluble BLyS. By binding BLyS, the mAb inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Belimumab was first approved in the European Union in July 2011 for use as an add-on IV therapy in adults with SLE and as a SC formulation in November 2017. The SLE indication was extended for the use in children for the IV formulation in October 2019.

“Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than [one] million patients worldwide. Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease,” said Hal Barron, chief scientific officer and president R&D, GSK, in the press release.

“In the [study], the addition of Benlysta to standard therapy resulted in a 49% decrease in risk to patients of experiencing a renal-related event as well as a significantly higher number of study participants reaching the PERR [prior event rate ratio]. I’m encouraged that progress is being made for people with lupus nephritis as we work toward the overarching goal to delay the need for kidney replacement therapies, such as dialysis and transplantation,” said Y.K.O. (Onno) Teng, MD, PhD, Nephrology clinician-scientist at the Department of Internal Medicine of the Leiden University Medical Center, The Netherlands, in the press release.

“This achievement is derived from decades of research. For years, we have not been able to achieve remission for more than one-third of patients with lupus nephritis and, despite all of our efforts, 10% to 30% of patients with lupus kidney disease still progress to end-stage kidney disease. The data from the [study] show that Benlysta added to standard therapy in management of active lupus nephritis may lead to improved long-term outcomes for patients by both increasing response rates and delaying further kidney disease progression,” added Richard Furie, chief of the Division of Rheumatology and professor at the Feinstein Institutes for Medical Research at Northwell Health, and lead investigator of the study, in the press release.

The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.

EC approves GSK’s Benlysta for Adults with Active Lupus Nephritis

Roche announced on May 5, 2021 that the European Commission (EC) has approved Tecentriq (atezolizumab) as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high programmed death-ligand 1 (PD-L1) expression and have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The approval makes Tecentriq the first and only single-agent cancer immunotherapy with three dosing options (two weeks, three weeks, or four weeks), allowing for greater flexibility in managing the disease, according to a Roche press release.

Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets globally. The biologic now has four approved indications in NSCLC in Europe, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy).

Tecentriq is approved in the United States, European Union (EU), and countries around the world either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer, and for hepatocellular carcinoma. In the US, the therapy is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

“We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, in the company press release. “Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease.”

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

EC Approves Additional Indication for Roche’s Tecentriq in Lung Cancer Treatment

Sandoz, a Novartis division, announced on May 3, 2021 that it is progressing into late-stage clinical development for its proposed biosimilar aflibercept (brand name EYLEA under Regeneron Pharmaceuticals). Sandoz will soon begin enrolling the first patient in a clinical Phase III confirmatory efficacy and safety study, the company stated in a press release.

Aflibercept is indicated to improve visual acuity in patients with neovascular age-related macular degeneration (nAMD), diabetic macular oedema, macular oedema secondary to retinal vein occlusion, and other specific neovascular retinal diseases.

“nAMD accounts for 10% of all age-related macular degeneration cases but is responsible for 90% of AMD-related blindness,” said Florian Bieber, global head of Biopharmaceuticals Development, Sandoz, in the press release. “Aflibercept is a key treatment in ophthalmology. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. As with all our biosimilar programs, we aim to expand access to high-quality, more affordable biologics.”

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Sandoz Begins Late-Stage Clinical Development for Biosimilar Aflibercept

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

In a May 3, 2021 press release, the agency revealed that its Committee for Medicinal Products for Human Use (CHMP) will perform an accelerated assessment of data submitted by the company that markets Comirnaty. The data includes results from a large ongoing clinical study that involves adolescents from 12 years of age.

Any decision made by CHMP will be submitted to the European Commission, which will issue a final legally binding decision for the European Union. EMA will provide further information on the evaluation as it becomes available, which is expected to be in June should no additional information be required.