Two promising COVID-19 vaccines move into late-stage testing
Two mRNA vaccines being developed by Moderna and BioNTech/Pfizer moved respectively into Phase III and Phase II/III studies this week, potentially allowing emergency authorisation approvals in the fourth quarter if interim data are positive.
Moderna said there is a 75-80% chance of its vaccine being shown to work in late-stage testing, whilst Pfizer management described the likelihood of Phase III success as "very high" based on available data.
Notably, BioNTech and Pfizer have chosen to advance a different candidate from the one that generated promising provisional data (BNT162b2 instead of BNT162b1), with this decision "based on the totality of available data from our preclinical and clinical studies, including select immune response and tolerability parameters," the companies said.
BNT162b2 encodes for an optimised SARS-CoV-2 full-length spike glycoprotein, which the companies said is targeted by virus neutralising antibodies, whilst BNT162b1 encodes an optimised SARS-CoV-2 receptor binding domain (RBD) antigen.
Despite being one of the front runners in the COVID-19 vaccine race, Moderna cannot completely shake its controversies, most of which come from an argument that the company is overvalued, is yet to successfully launch a drug or vaccine from its mRNA platform and will potentially be competing for government contracts with other developers who have promised to supply their COVID-19 vaccines at cost price.
This week, Moderna secured additional funding to the tune of $472 million for its vaccine from US taxpayers (via BARDA and Operation Warp Speed), whilst simultaneously running into potential issues around intellectual property for its lipid nanoparticle (LNP) technology, after failing in an attempt to invalidate a US patent held by Arbutus Biopharma.
On Thursday, AstraZeneca upped the ante by confirming that the adenovirus vector vaccine for COVID-19 it is co-developing with the University of Oxford could be priced at as little as a few dollars a dose. By comparison, Pfizer has suggested the vaccine it is developing with BioNTech could cost around $20, while unverified reports indicate that Moderna's could be priced at up to $60.
Pharma doesn't go to Washington
Intersecting with the themes of COVID-19 and the forthcoming US election in November, PhRMA turned down an opportunity to send executives to meet President Trump this week to discuss four executive orders on drug pricing that were issued last Friday. The productivity of such a meeting was not only in doubt, said PhRMA, but could diminish the industry's current focus on combating the pandemic.
If the lack of response from pharma (and the market) undermined the Trump administration's proposals, so too does a lack of detail and overambitious timeframes, making it easy for these orders to be perceived as a push for voter support. If effective COVID-19 vaccines and treatments emerge over the coming months, pharma could find its ability to push back against the US drug pricing debate further strengthened.
AstraZeneca doubles down on Daiichi Sankyo's ADCs
AstraZeneca announced this week that it will pay $1 billion upfront to Daiichi Sankyo to in-license co-development rights for the investigational TROP2-directed antibody-drug conjugate (ADC) DS-1062 as a potential treatment for multiple tumour types. DS-1062 is currently in Phase I development for non-small-cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). As part of the agreement, AstraZeneca will make further payments of up to $1 billion for the successful achievement of regulatory approvals and as much as $4 billion in sales-related milestones.
AstraZeneca indicated that the collaboration reflects its strategy to invest in ADCs as a class, the innovative nature of the technology and its successful existing collaboration with Daiichi Sankyo. In March last year, AstraZeneca paid $1.35 billion upfront as part of a deal potentially worth up to $6.9 billion to jointly develop and commercialise Daiichi Sankyo's ADC Enhertu. The drug gained FDA approval in December for adults with unresectable or metastatic HER2-positive breast cancer who have received at least two prior anti-HER2-based regimens in the metastatic setting.
This no doubt put AstraZeneca in an advantageous position, with Stuart Mackey, head of global business development at Daiichi Sankyo, noting to FirstWord that the Japanese company had attracted "quite a lot of third-party interest in partnering" on DS-1062, boosted by provisional data in NSCLC presented at the ASCO annual meeting in June.
Mackey acknowledged that Daiichi Sankyo had considered retaining rights to DS-1062. However, “once we saw the data and began to understand the range of patients that might be able to benefit from the programme, we determined the best way to fully develop this was to explore it in multiple indications in parallel rather than in series, so it made the most sense to partner,” he said.
COVID-19 continues to drag on Q2 earnings
More of the industry's largest pharmaceutical and biotech companies reported their second-quarter financial results during the past week, illustrating various levels of exposure from the COVID-19 pandemic on revenue performance.
Of the 10 large-cap biopharma companies to have reported their earnings to date, all but one recorded a sequential decline in sales of innovative drugs in the second quarter versus the first quarter (with Amgen recording a marginal increase).
Reporting this week, GlaxoSmithKline became the second company (after Roche, which reported last week) to record a sequential decline in sales greater than $1 billion, noting that its vaccine business had been adversely impacted by the pandemic. The UK drugmaker has retained its full-year guidance currently, but said this would be dependent on sales of its adult vaccines making a sharp recovery in Q3.
Q2 results analysis…
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