Pfizer’s COVID-19 push: antiviral candidate identified as anti-inflammatory Xeljanz starts trial

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For its latest COVID-19 initiatives, Pfizer has identified a lead antiviral candidate and announced the planned start of a Phase II study of anti-inflammatory Xeljanz in Italy. The updates came as the pharma unveiled details of its mRNA vaccine partnership with BioNTech, announced March 17.

Pfizer Inc. (NYSE:PFE) said it could begin clinical testing in 3Q20 of a lead small molecule inhibitor of a SARS-CoV-2 protease, 3CLpro. After preliminary data indicated antiviral activity, the company is planning additional preclinical studies to confirm antiviral activity and determine the 3CLpro inhibitor’s suitability for IV administration.

The investigator-initiated trial of oral JAK inhibitor Xeljanz tofacitinib to treat patients with SARS-CoV-2 interstitial pneumonia will seek to address the excess inflammation associated with severe COVID-19. The study, sponsored by Università Politecnica delle Marche and funded by Pfizer, is to begin this week in Italy. The pharma is discussing additional trials of Xeljanz and other immune modulators with other institutions.

COVID-19 clinical trials for at least two other JAK inhibitors have been announced. Theravance Biopharma Inc. (NASDAQ:TBPH) said Thursday it would advance TD-0903, a lung-selective nebulized JAK inhibitor, to clinical development to prevent the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients. And on April 2, Novartis AG (NYSE:NVS; SIX:NOVN) and partner Incyte Corp. (NASDAQ:INCY) revealed plans to start a Phase III trial of Jakafi/Jakavi ruxolitinib in patients with severe COVID-19.

The JAK programs are three of the nearly 120 therapies and vaccines in clinical testing, according to BioCentury’s COVID-19 Resource Center.

The emergence of new information about COVID-19 disease progression has continued to support the link between excess inflammation and more severe disease, and has underscored the rationale for using anti-inflammatory therapies in more serious cases (see “Slotting Anti-Inflammatories into COVID-19 Treatment”).

U.K. trials, deal details

Pfizer has partnered with the Liverpool School of Tropical Medicine to launch a pair of trials to determine whether bacterial pathogen Streptococcus pneumoniae interacts with SARS-CoV-2. The company will provide funding and in-kind lab testing support; it expects to finalize the collaboration agreement in the coming days.

The partners have already begun patient enrollment in the U.K.-based SAFER and FASTER studies, with about 100 healthcare workers in SAFER and about 400 patients suspected to have COVID-19 in FASTER. The studies will test whether COVID-19 patients have a higher risk of developing pneumococcal pneumonia and if co-infection by SARS-CoV-2 and S. pneumoniae leads to more severe disease and poorer outcomes. Data are expected over the next few months.

Under the pharma’s deal to co-develop BNT162 with BioNTech SE (NASDAQ:BNTX), the German biotech will receive an upfront payment of $185 million, including an equity investment of about $113 million, and is eligible for $563 million in milestones.

Pfizer also reiterated plans to begin clinical testing by the end of April. The companies, which are scaling up manufacturing capacity for the mRNA vaccine at risk, estimate that they could supply “millions” of vaccine doses by year end and rapidly scale up to produce “hundreds of millions” of doses in 2021.

The partners will jointly run clinical trials of BNT162 in the U.S. and Europe. They plan to co-commercialize the vaccine outside China, where Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKEX:2196) has rights. Pfizer will fund all of the development costs, of which BioNTech repay half during commercialization.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

Targets

3CLpro (Coronavirus NSP5; Mpro) - Coronavirus 3C-like proteinase

JAK - Janus kinase

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