Covid-19 roundup — Regeneron zooms in on cocktail; BioNTech shares skyrocket on quick Pfizer alliance
On the morning after the Bay Area ordered residents of six counties to “shelter in place” amid varying levels of lockdown around the world, here are the latest industry updates:
— Leading the hunt for antibodies that can neutralize the coronavirus that causes Covid-19, Regeneron said it’s assembled a large pool of candidates — hundreds of antibodies — from which it will select two to make a “cocktail treatment.” While the antibodies are being selected, the company will get its VelociMab platform in place to prepare cell lines for clinical-scale production. Regeneron envisions entering human studies in a couple months, with a goal to produce “hundreds of thousands of prophylactic doses per month” by the end of summer. All of this comes a little over a month after Regeneron first threw its name into the coronavirus R&D hat. Following this same approach has led the biotech to an Ebola regimen that bested three other treatments. In addition to developing antibodies that can serve both as treatment and as a prophylaxis before people are exposed to SARS-CoV-2 (an approach Vir is also taking), Regeneron has also rushed its IL-6 drug Kezvara — approved for arthritis — into a late-stage trial testing its ability to tackle the lung inflammation that results from the viral infection.
— Almost a year ago Provention Bio began what Jeffrey Bluestone called the “real hard work” on the resurrected diabetes drug teplizumab, dosing the first patient with newly diagnosed type 1 diabetes with the anti-CD3 antibody. The work has just gotten harder as the Covid-19 pandemic is forcing the biotech to temporarily pause randomizing and treating new patients — while those currently taking the therapy complete their course. This delay, though, does not hinder Provention’s plan to wrap up its rolling BLA submission for the at-risk population by the end of the year. That was partly supported by Phase II data suggesting teplizumab delayed diabetes diagnoses for patients who appear poised to develop the disease. The Phase III PROTECT study was designed to see if the drug could help patients who already have diabetes — such as to lower their dependence on insulin. “Our decision was not based on any study-related COVID-19 infections or other safety events, but rather a preponderance of caution relating to the ongoing pandemic, and our concern for the well-being of recently diagnosed T1D pediatric patients and their caregivers,” CEO Ashleigh Palmer said in a statement. “The demands on medical institutions and their clinicians during this unprecedented global crisis were also a main consideration in this decision.”
— Shutdowns are becoming more common, and they’ve been filling the BioTwitter channel:
I have been CEO of @MERUSNV, a Dutch/US biotech company, for only 11 weeks. I have now instructed our team to temp. close down our laboratory research activities, by Wednesday March 18. We plan to continue to support clinical trial activities and patients during this time. 1/n
— Bill Lundberg (@aslundberg) March 17, 2020
— In the year of coronavirus, there’s no time to dot every i and cross every t in a biopharma deal. Early Tuesday Pfizer and BioNTech $BNTX were ready to hitch up on one of the big messenger RNA vaccine programs aimed at the devastating spread of Covid-19. And they made it clear they were rolling ahead of any formal signatures on a final contract. Quietly revealed just days ago, BioNTech says that BNT162 should be ready to go in the clinic by the end of next month. It follows a leading mRNA effort from Moderna as well as a hurry-up project from CureVac, where the revolving door at the CEO suite is spinning. The collaboration work starts now, with a plan to utilize multiple R&D sites across both companies in the US and Germany, where BioNTech is based. They expect to finalize the details of their partnership in the next few weeks. If there are any basics in the letter of agreement, they’re not talking about it yet. In the meantime, BioNTech’s shares rocketed up 55%.
— In the spirit of donations, Biogen said its philanthropic arm has committed $10 million to support Covid-19 relief efforts in the US and around the world. “We are deeply affected by the impact of COVID-19 globally and we understand the critical importance of access to testing and other materials to support healthcare providers,” said CEO Michel Vounatsos, who’s now presiding over the hardest-hit drugmaker in the industry. A strategy meeting held at Boston Marriott Long Wharf has led to the infection of 100 Biogen staffers and their household contacts in Massachusetts, where a total of 197 cases have been reported as of Monday afternoon — and that’s not counting other local transmission. In addition to providing medical equipment and supplies to Partners HealthCare and supporting two local hospitals in their front line work, Biogen’s funds will also go toward expending testing options, easing the strains on medical systems, offering training and securing access to necessities like food in places such as North Carolina, where at least five Biogen staffers have been tested positive after attending the leadership gathering.
— Amid warnings that people who get mild symptoms of Covid-19 and recover are driving the spread of the disease, scientists at the University of Minnesota are turning their focus to this particular population. They are launching a new clinical trial to see if an old malaria drug — chloroquine or hydroxychloroquine — is a better post-exposure prophylaxis than the current standard of care: observation. The trial will enroll 1,500 individuals who have had exposure to a Covid-19 case within 3 days, namely either healthcare workers of household contacts. The University of Oxford is planning a similar study with 10,000 participants in May. Clinicians in China and Australia have reported encouraging results treating Covid-19 patients with chloroquine.
— Chinese scientists may now begin testing a subunit vaccine developed by the Academy of Military Medical Sciences in collaboration with CanSino Biologics. The Hong Kong-listed company said its candidate uses a replication-defective adenovirus type 5 as a vector to express the spike protein on SARS-CoV-2. It’s also begun pre-screening of healthy volunteers in anticipation of the trial, which was greenlighted Monday night. CanSino has previously worked with Wei Chen, the senior bioengineer credited with leading the research work, on China’s first Ebola vaccine.
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