Friday Five - The pharma week in review (20 March 2020)

Focus sharpens on the first wave of potential COVID-19 treatments

As one leading expert told FirstWord this week, an unfortunate silver lining of the COVID-19 pandemic is that motivation to develop a vaccine or therapeutic treatments will remain high. You can read the full interview here.

In the meantime, existing therapies may also prove effective; the antiviral agent favipiravir could emerge as one potential treatment option based on data from a 200 patient study in China, as could the anti-malarial hydroxychloroquine.

See ViewPoints: Initial glimmers of hope for COVID-19 therapeutics

Regeneron Pharmaceuticals announced this week that it hopes to progress a multi-antibody therapy into clinical studies by early summer, which could potentially be administered as a prophylaxis before exposure to the SARS-CoV-2 virus or as treatment for those already infected. In collaboration with Sanofi, Regeneron will also launch a clinical trial programme evaluating the IL-6R antibody Kevzara for the treatment of severe COVID-19. Roche announced a similar study evaluating its IL-6 antibody Actemra.

Results published in the NEJM this week suggest that the addition of AbbVie's HIV treatment Kaletra to standard care in seriously ill patients with confirmed SARS-CoV-2 infection did not significantly shorten the time to clinical improvement, nor did it significantly lower mortality rates, compared to standard care alone. A number of analysts were quick to argue, however, that Kaletra does appear to offer significant clinical benefit in cases where it was administered more quickly after diagnosis/symptoms appear.

Vaccine development continues to see early milestones passed at a rapid pace, with Moderna confirming this week that it has dosed the first subject in a Phase I study of its experimental mRNA vaccine.

BioNTech also announced collaborations with Pfizer and Fosun Pharma to develop an mRNA vaccine for immunisation against COVID-19.

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What impact on pharma?

FirstWord Pharma published analysis of from our recent survey of 98 drug industry professionals evaluating the potential impact of COVID-19 on the sector this week. More here

Areas of notable concern include potential disruption to clinical studies, reduced interaction with healthcare professionals (with heightened risk of commercial impact in cases where pharmaceutical companies are in the process of launching new drugs) and overall industry performance for the year ahead.

See ViewPoints: COVID-19 shifts clinical catalysts

Evidence of the impact that COVID-19 will have on the functionality of the pharmaceutical industry is starting to become apparent. A number of pharmaceutical companies have confirmed publicly that all face-to-face interactions with healthcare professionals have been suspended, in many cases moving to virtual models.

To what extent sales are impacted by patients with less serious healthcare conditions reducing or temporarily stopping their medications as a result of social distancing measures will only become apparent over the coming weeks and months. Another factor to consider is the potential delay of certain treatments caused by hospitals reconfiguring facilities to cope with an influx of COVID-19 patients; Biogen said this week, for example, that some spinal muscular atrophy (SMA) patients due to receive Spinraza will have their treatment temporarily delayed.

A number of smaller biotech companies (Arrowhead Pharmaceuticals and Provention Bio) said they were pausing enrolment in clinical studies, while the FDA released a guidance document on the conduct of clinical trials in the face of the COVID-19 pandemic. The agency outlined its expectations for study interruptions during the health crisis, noting that supply chain interruptions, study site closures, and travel restriction may be all mandate "unavoidable protocol modifications."

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The curious case of CureVac

German biotech company CureVac has emerged as a prominent name in pharma industry discussion shaped by the COVID-19 outbreak over the past week, initially by suggesting that its potential low-dose vaccine could allow for a rapid scale up of production if effective and subsequently in rebuffing suggestions that President Trump had sought to acquire the vaccine for a billion dollars in order to prioritise any future access for US citizens. Departure of two chief executives in recent days, dismissed by the company as coincidence, has only intensified speculation about what happened. In response, the European Commission has reportedly met to discuss efforts to prevent hostile US takeovers of EU-based companies developing treatments and vaccines for COVID-19.

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Pfizer builds case for abrocitinib, cancels R&D day

Away from the COVID-19 outbreak, Pfizer confirmed more positive data for its experimental oral JAK inhibitor abrocitinib. In the Phase III JADE COMPARE study abrocitinib not only bettered placebo as in prior studies but was (at a higher dose) shown to be more effective than Sanofi and Regeneron’s Dupixent at reducing itch – a secondary endpoint – after two weeks. Full data, to be presented at some point in the future, will allow comparison of the two agents against the study’s primary endpoint measures.

Pfizer was due to provide an R&D update at the end of the month but this has been cancelled. Alongside the announcement of new data for abrocitinib, Pfizer also top-lined positive results from its Phase III study of a 20-valent pneumococcal conjugate vaccine, designed as a potential follow-up to Prevnar-13.

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IO leader fighting back on TIGIT

Roche is among those making headway with monoclonal antibodies against T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT), which in theory could give its marketed cancer therapy Tecentriq a way to close the gap on market leader Keytruda, but Merck & Co. appears to be making moves of its own.

Last month, Roche highlighted plans to launch an aggressive pivotal programme involving eight studies designed to test tiragolumab, a mAb against TIGIT, in an assortment of tumour types.

This week, Merck quietly posted entries on clinicaltrials.gov outlining three new Phase I/II trials that will get underway next month and evaluate combinations involving MK-7684, an anti-TIGIT mAb, in a variety of subsets covering the full spectrum of melanoma. All are listed as sub-studies under the umbrella of Keynote-U02.

Specifically, Substudy 02A will enrol 200 patients with anti-PD-1 refractory melanoma, and look at MK-7684 plus Keytruda and CTLA inhibitor MK-1308. Substudy 02B will enrol 135 patients and test the TIGIT inhibitor as part of a front-line regimen with Keytruda. Substudy 02C will look at the same combination as neo-adjuvant therapy in 65 patients.

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