Anticipation continues to build for the readout of initial Phase III data for Johnson & Johnson’s one-dose COVID-19 vaccine Ad.26.COV2.S. Results are expected in a matter of weeks with management confirming this week the company is in the final stages of analysing the data.
In the meantime, newly published Phase I/IIa results showing antibody production in all participants who received the vaccine have raised expectations for positive Phase III data. If all goes to plan Ad.26.COV2.S could be approved by regulators next month, although reports suggest that manufacturing setbacks mean supply of the vaccine could be limited until April.
Expert quote of the week
“It is unprecedented for a drug in a trial this size to show a clinical benefit.”
Eli Lilly confirmed this week that donanemab, an experimental antibody targeting N3pG-amyloid beta, significantly slowed decline on a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo, meeting the primary endpoint of the Phase II TRAILBLAZER-ALZ trial.
We spoke to a leading key opinion leader who is impressed with the results. More here
Deal round up
Pharma companies have committed $2.6 billion in upfront payments across notable deals announced since the start of the year. This includes the $1.1 billion Sanofi will pay to acquire Kymab and the $650 million it has cost Novartis to in-license BeiGene’s PD-1 inhibitor tislelizumab, which were the standout deals announced this week.
Conference in focus
This year’s virtual edition of the JP Morgan Healthcare conference was a far cry from the grand networking event it has gained a reputation for but was an important scene-setter for the year ahead regardless. Read our key takeaways here
One to watch
The World Conference on Lung Cancer (WCLC) takes place later this month (January 28-31) where updated Phase I/II results will be presented for Daiichi Sankyo’s DS-1062, an antibody-drug conjugate (ADC) that targets TROP-2. In Mid-2020, AstraZeneca paid $1 billion upfront for rights to co-develop DS-1062 for multiple tumour types in a deal which could rise in value to $6 billion. The two companies also share development and commercial responsibilities for the HER-2 targeted ADC Enhertu under an earlier agreement.
An abstract released ahead of the WCLC meeting shows DS-1062 demonstrated response rates for all dosage and 6mg/kg (the dose being advanced into Phase III) of 26% and 25%, respectively, which is on par with earlier data presented at ASCO in June.
Development of DS-1062 also represents an important read across to Gilead Sciences’ TROP-2 directed ADV Trodelvy; developed by Immunomedics who were acquired by Gilead for $21 billion last year. Gilead has yet to confirm when it will release its own Phase II data for Trodelvy (which is approved as a later line treatment for triple negative breast cancer) in lung cancer.
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