Global Roundup: Astellas Eyes European Approval of Urothelial Cancer Drug


Astellas Pharma announced its marketing authorization application for enfortumab vedotin was accepted by the European Medicines Agency. Japan’s Astellas is seeking approval for enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in the European Union for people living with urothelial cancer.

Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA’s Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for evaluation.

The MAA is based on the global Phase III EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

Elsewhere around the globe:

Mogrify – U.K. Mogrify was awarded the Hewitsons Award for Innovation in Business and Price Bailey Award for Business of the Year at the CambridgeshireLive Business Excellence Awards 2020. The awards recognize potential of Mogrify’s technology to accelerate the development of regenerative cell and in vivo reprogramming therapies. The company’s technologies, MOGRIFY and EpiMOGRIFY, deploy next-generation sequencing, gene regulatory and epigenetic network data to enable the prediction of the transcription factors and culture medium conditions required to produce any target cell type from any source cell type. Mogrify will use these platforms to engineer therapeutic cell types that exhibit efficacy and safety profiles necessary to transform the development of ex vivo cell therapies, and pioneer a new class of in vivo reprogramming therapies for indications of high unmet clinical need in immuno-oncology, ophthalmology and other disease areas.

GlaxoSmithKline – GlaxoSmithKline announced the Committee for Medicinal Products for Human Use of the EMA has adopted a positive opinion recommending the use of intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN). The CHMP opinion is one of the final steps in the marketing authorization procedure prior to approval by the European Commission. If approved, Benlysta would become the first and only biologic approved for both Systemic Lupus Erythematosus (SLE) and LN in the European Union.

LianBio – China’s LianBio and Tarsus Pharmaceuticals announced a strategic partnership to develop and commercialize TP-03 in Greater China. TP-03 is a first-in-class investigational therapeutic in development for the treatment of Demodex blepharitis and Meibomian Gland Disease (MGD), eye conditions with significant unmet treatment needs. As part of this strategic partnership, LianBio will obtain exclusive rights to develop and commercialize TP-03 in Greater China, and Tarsus will receive a $15 million upfront payment.

CureVac –Germany’s CureVac and Switzerland-based Celonic Group announced a partnership for the production of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV. The parties entered into a commercial supply agreement to produce CureVac’s coronavirus vaccine candidate at Celonic’s state-of-the-art commercial manufacturing facility for biologics and ATMPs, in Heidelberg, Germany. In total Celonic will be prepared to manufacture more than 100 million doses of CVnCoV. More than 50 million doses are expected to be produced before the end of 2021. Under the terms of the initial agreement, technology and knowledge transfer is already underway. The commercial supply agreement includes manufacturing of the mRNA drug substance as well as LNP formulation of the bulk drug product.

Confo Therapeutics – Belgium-based Confo Therapeutics has been awarded a €1 million grant from Flanders Innovation & Entrepreneurship (VLAIO). The grant will support the pre-clinical development of CFTX-1554, Confo’s lead candidate for neuropathic pain, which was initially discovered under a previous VLAIO research grant. Confo is developing CFTX-1554 based on its promise as a potential treatment for patients living with peripheral neuropathic pain, a debilitating condition for which current treatment methods are ineffective or often result in severe side-effects or even addiction. The grant covers clinical trial application (CTA)-enabling studies to further characterize the pharmacology and safety of CFTX-1554 and the development of appropriate manufacturing protocols, as well as translational biomarker studies to examine the mechanism of action of AT2R modulation.

Dotmatics Ltd. – Based in the U.K., Dotmatics announced the implementation of a ‘Data to Value’ initiative with BASF’s Agricultural Solutions division. The Dotmatics electronic lab notebook (ELN) directly feeds data into the Agricultural Solutions’ division knowledge base as part of the execution of scientific workflows, by capturing experimental data and storing it in a usable format.

Nexelis – Canada’s Nexelis and China’s JOINN Laboratories signed a Letter of Intent to partner on bioanalytical studies in China. Nexelis, a portfolio company of Ampersand Capital Partners, is a leading provider of advanced assay development and laboratory testing services in the infectious diseases, metabolic diseases and oncology fields working with leading pharmaceutical companies, innovative biotechnology companies, and prestigious governmental and non-governmental institutions who seek to include China in their international clinical programs.

Amarin Corporation – Following a review from the EMA, Ireland’s Amarin Corporation won approval for VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor. The drug is marketed as Vascepa in the U.S. The EC approval for VAZKEPA is based on efficacy and safety data from the REDUCE-IT cardiovascular outcomes study. Results from this study, in which all patients remained treated with statins (and with other contemporary therapies) and where half the patients received icosapent ethyl and the other half received placebo, demonstrated a 25% relative risk reduction in the first occurrence of MACE in the intent-to-treat patient population with use of icosapent ethyl compared with placebo.

Evive Biotech – Singapore-based Evive submitted a Biologics License Application for Ryzneuta (also known as F-627) to the US Food & Drug Administration. The submission follows the successful conclusion of Evive’s Global Phase III Clinical Trials, which met its primary and secondary endpoints, demonstrating strong and lasting benefit for patients. Ryzneuta is a novel treatment for chemotherapy-induced neutropenia (CIN). Neutropenia is a common side-effect of many forms of chemotherapy and is a condition characterized by low levels of neutrophils, a type of white blood cell that fights infection.

Ipsen – France’s Ipsen announced the European approval of Cabometyx (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). This decision marks the first approval for Cabometyx in combination with another therapy in Europe and the third indication of Cabometyx in renal cell carcinoma (RCC). The EC approval is based on results from the pivotal Phase III CheckMate -9ER trial, that showed the combination treatment demonstrated significant improvements across all efficacy endpoints. In patients receiving the combination, median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone.

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