Warp Speed accelerates
Just to what extent a potential COVID-19 vaccine becomes a power play in the forthcoming US presidential election remains unclear at this stage, but all signs point towards President Trump accelerating 'Operation Warp Speed' in a bid to maximise its influence.
This week via the initiative, the US government awarded $1.6 billion to Novavax to progress development of its experimental vaccine NVX CoV2373. Regeneron Pharmaceuticals also signed a contract with the US government worth $450 million to manufacture and supply its investigational double antibody cocktail REGN-COV2 for the treatment and prevention of COVID-19.
Expectations for novel antibody therapies that are designed to mimic an immune response to COVID-19 have steadily risen in recent months, with Regeneron and Eli Lilly both expected to unveil preliminary clinical data within the next few months. Regeneron also announced this week that it has started a Phase III study investigating the ability of REGN-COV2 to prevent infection in uninfected people who have had close exposure to a COVID-19 patient.
Funding for Regeneron confirms that the remit of Operation Warp Speed has now extended, presumably to hedge against any failure in aggressive vaccine development timelines being met. That said, the US government remains willing to plough funding into this contemporary 'space race' with China as the notable competitor, with eyebrows raised at the award of $1.6 billion to a company which has yet to successfully bring a product to market.
Politicisation of COVID-19 treatments or a potential vaccine must be considered a genuine concern for the pharmaceutical industry under current circumstances and was all too apparent this week when President Trump called on the FDA to approve hydroxychloroquine despite major questions being asked of a new study that appears to show the antimalarial reduced mortality in COVID-19 patients. President Trump previously confirmed he had taken hydroxychloroquine as a preventative therapy despite a lack of clinical evidence to support its use in this way.
Q2 results imminent
Pharmaceutical companies will begin reporting their second-quarter results next week, with the vast majority expected to absorb some revenue impact from COVID-19 lockdowns and social distancing measures, which peaked in intensity during April and May. As a reminder, virtually all large cap-pharmaceutical and biotechnology companies played down the threat of any sustained impact on top- and bottom-line performance in the second half of the year; only Merck & Co. outlined a more cautious outlook for its business.
Although lockdown measures have continued to ease in Europe, however, rising COVID-19 infection rates in many US states threaten to see social distancing initiatives re-imposed in parts of the world's largest pharmaceutical market. In a note to investors, analysts at Bernstein predict that some companies may use their second-quarter earnings calls as a platform to cautiously re-evaluate their growth prospects for the rest of year. US prescription data for certain drug categories has started to show weakness in recent weeks, they add.
Thrown in the mix are results from a recent survey we fielded to 1188 physicians in France, Germany, Italy, Spain, the UK and the US showing that new patient treatment starts and treatment switching rates are still materially down versus 12 months ago as a result of the pandemic.
Biogen files aducanumab
Rewind seven months and this year's biggest story in bio-pharma was poised to be Biogen's push to get its controversial drug aducanumab approved as a new treatment for Alzheimer's disease.
Having said previously that it hoped to file aducanumab with the FDA in early 2020, Biogen was able to finally confirm its application had been submitted this week, though Wall Street expectations for regulatory success appear to have steadily declined (from what was already widely considered an uncertain outcome) over the course of the year.
Furthermore, Biogen is in need of convincing the FDA that aducanumab works more than ever, having recently lost a US patent dispute over its flagship multiple sclerosis treatment Tecfidera and with competition in the spinal muscular atrophy (SMA) market – where it sells Spinraza – set to intensify with pending US approval of Roche's risdiplam – see Spotlight On: Six new drug approvals to watch in H2 2020.
With the FDA now in receipt of Biogen's application, the agency has 60 days with which to decide whether to accept it or issue a complete response letter.
Keytruda picks up a rare regulatory setback
Sticking with the FDA, the agency has gained a reputation in recent years for approving novel cancer therapies at speed and on the basis of provisional clinical data sets. This week, in issuing a rare complete response letter for Merck & Co.'s cancer immunotherapy Keytruda – as part of a first-line combination treatment for liver cancer, the agency may have made a decisive move to reposition the regulatory goalposts.
That is not to suggest that the FDA's decision is not understandable. The agency appears to have rejected an application for the combination of Keytruda plus Eisai's Lenvima as a first-line treatment for liver cancer based on overall survival and remission rates demonstrated in a single-arm study simply because it has already approved an alternative treatment option on the strength of more complete data. In June, it cleared the use of Roche's Tecentriq plus Avastin combination, which was shown to reduce the risk of death by 42% versus Bayer's Nexavar.
Keytruda is approved as a second-line treatment for liver cancer, but Merck will need to wait for results from another study evaluating Keytruda plus Lenvima versus Lenvima monotherapy before seeking to re-pitch it as a competitor to Tecentriq in the first-line setting. These data are expected in 2022.
Sanofi endorsement cements U-turn for Kiadis
In a small but nevertheless interesting deal, Sanofi announced this week it will pay €17.5 million upfront to in-license exclusive rights to a previously undisclosed natural killer (NK) cell therapy from Kiadis Pharma. The latter is also eligible to receive €857.5 million upon the achievement of certain preclinical, clinical, regulatory and commercial milestones.
The deal also marks a turnaround for the Dutch company, which was forced to scrap a pivotal-stage study of the T-cell based therapy ATIR101 last November. Kiadis gained its NK-cell technology platform just five months prior to this setback through the all-share acquisition of CytoSen Therapeutics.
Sanofi plans to evaluate the preclinical programme it has in-licensed in combination with its anti-CD38 monoclonal antibody Sarclisa for the treatment of multiple myeloma. NK cells represent the human body's first-line of defence against cancer and can synergistically work with antibodies to kill tumour cells. However, when multiple myeloma is treated with anti-CD38 mAbs such as Sarclisa, NK cells are depleted as they also express CD38.
Kiadis' proprietary NK cells are modified to prevent expression of CD38 and could therefore be resistant to this effect. It is hoped that adjunctive use of the allogeneic NK cell product K-NK004 will reinvigorate natural synergies and optimise the efficacy of Sarclisa by virtue of higher remission rates and fewer relapses.
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