Covid-19 roundup: Amgen tosses Otezla into anti-inflammatory mix; Trump thickens plot around US probe into virus origin
Following in the footsteps of other large drugmakers who have repurposed their entrenched therapies against Covid-19, Amgen has released another weapon in its arsenal that could play a more immediate role in the pandemic.
Otezla — the blockbuster psoriasis drug Amgen snagged from Celgene in a $13.4 billion deal last year — will enter the clinic “in the coming weeks to be investigated as a potential immunomodulatory treatment in adult patients with the disease,” R&D chief David Reese said in an earnings call.
The hope is that by blocking the PDE4 enzyme, the drug can help prevent the respiratory distress seen in late-stage Covid-19 patients, CEO Bob Bradway added.
In the absence of an antiviral proven to stop the infection — although Gilead promises to change that very soon with buoyant data on remdesivir — mitigating the inflammation that devastates and kills patients has become a popular goal. Among the most high-profile are a pair of IL-6 drugs, Kevzara from Sanofi/Regeneron and Actemra from Roche, although data have been mixed. Novartis and Incyte have also launched Phase III programs for the JAK inhibitor Jakafi.
PDE4, though, appears to be a new mechanism in the mix. While Otezla is only approved for plaque psoriasis and psoriatic arthritis, a similar drug, AstraZeneca’s Daliresp, is approved to treat chronic obstructive pulmonary disease.
With the new move Amgen is now deploying three of its core expertise areas — genetics, antibody and immunology — against the coronavirus. Its deCODE subsidiary is engaging in epidemiology work while the R&D team has partnered with Adaptive to develop an antibody, backed by a capacity to manufacture at scale.
“Our goal also is to really identify a very high quality therapeutic candidate, and it’s my belief that there may well be more than one generation of antibody therapeutics entering the clinic,” Reese said. “And as work progresses, we are up and running in the laboratory.” — Amber Tong
China ushers another inactivated vaccine candidate into clinic
A second inactivated vaccine candidate from China’s Sinopharm Group has been cleared for human trials, China Daily reported, just as its first program was hustled into Phase II.
Beijing Institute of Biological Products, a subsidiary of its China National Biotech Group, was behind this new vaccine, which is essentially a version of the SARS-CoV-2 virus that has lost disease-producing capacity. Another subsidiary, Wuhan Institute of Biological Products, co-developed the first program with the Wuhan Institute of Virology (before it was embroiled into heated accusations of being ground zero of the pandemic, the research institute enjoyed prestige as the first biosafety level 4 lab in China).
Sinopharm chairman Jingzhen Liu said the company has set aside around $141.33 million (RMB$1 billion yuan) to support both R&D programs.
Its sprawling operations have capacity to produce 100 million vials of vaccines per year if they prove effective, the company added.
China has now approved three inactivated vaccines in total for clinical trials, in addition to CanSino’s recombinant adenovirus vector. Chengdu-based Clover Pharmaceuticals has also notched approval to begin testing its subunit vaccine — boosted by GSK’s adjuvant — in Australia. Other preclinical efforts are ongoing to advance recombinant protein vaccines, nucleic acid vaccines as well as vaccines that use attenuated flu viruses as vectors.
“The world is racing to develop COVID-19 vaccines, yet it is not a competition between countries, but rather a race between humans and the virus,” Xiaoming Yang, president of CNBG, said in an interview. — Amber Tong
While intelligence officials probe origin of virus, Trump says he’s seen evidence of links to Wuhan lab
A day after US intelligence agencies broke with usual practice to acknowledge that it is investigating the origin of the virus that causes Covid-19, President Donald Trump went one step further and claimed he’s seen evidence to make his own assessment.
Whatever he said he knows — and he declined to elaborate when pressed — has given him a “high degree of confidence” that the Wuhan Institute of Virology is linked to the origin of the virus, he told reporters in a press briefing.
Since the early days of the outbreak in China there have been rumors that SARS-CoV-2 was man-made or genetically modified — a theory that’s been widely refuted and debunked. On Thursday, the Office of the Director of National Intelligence issued a statement saying it concurs with that scientific consensus.
A related yet distinctively different concern has emerged that the virus might have been passed onto humans, by accident, in a Wuhan lab where it was being studied.
Top US officials, from the president himself and Secretary of State Mike Pompeo, have fueled the idea. Just two days ago Pompeo said again: “We still haven’t gained access, the world hasn’t gained access to the WIV (Wuhan Institute of Virology) there. We don’t know precisely where this virus originated from.”
The ODNI “will continue to rigorously examine emerging information and intelligence to determine whether the outbreak began through contact with infected animals or if it was the result of an accident at a laboratory in Wuhan.” — Amber Tong
Clinical trial snapshot in Asia-Pacific presents different picture from global disruption
While much of the world grapples with a new state of clinical trial research, one region appears to have found a way to thrive under the pandemic: Asia-Pacific. According to data provided by Novotech to Endpoints News, the number of biotech-sponsored trials initiated in Asia-Pacific during March and April is about 20% higher than the number of new trials in North America over the same period.
Places like Australia, South Korea, Taiwan, Hong Kong and New Zealand have adapted the best to the situation, the CRO noted, having kept the infection rates low, testing rates high and mortality down. When you look at the top 10 biotech sites in each of these five locations, 70% of the sites are allowing recruitment and 95% are open for monitoring, both remote or onsite. — Amber Tong
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