<Weekly Highlight>
Delta Covid-19 variant could be dominant in US in two to three weeks[1] (6/22)
The highly transmissible Delta variant of the Covid-19 virus is spreading so rapidly in the US, that it could become the dominant strain in the next two to three weeks, researchers said, adding urgency to the nationwide vaccination drive.
The Delta strain, which first emerged in India in late 2020 and is also known as B.1.617.2, will probably make up 50% of Covid-19 infections in the US by early to mid-July, said William Lee, vice president of science at population genomics company Helix and an author of the new analysis.
The CDC released data on Tuesday showing that the prevalence of the Delta strain more than doubled over the two weeks ended June 19 to 20.6% of positive Covid-19 test samples genetically sequenced, compared with 9.9% in the week ended June 5.
Details of how mutations have shared the Covid-19 pandemic can be found here.
<COVID-19 News>
Novavax's COVID-19 shot won't see much US use, but a big global market awaits[2] (6/22)
Novavax is developing a Covid-19 vaccine, which has shown to have high efficacy. But the logistics of manufacturing the vaccine has proven to be a more daunting task for the small biotech, which still has yet to file for approval of the shot in the United States, falling behind its expected timetable.
Last year, the US bet big on Novavax, which had never brought a vaccine to the market. Novavax won a $1.6 billion grant in exchange for 100 million doses of the shot. But now those vaccines are likely destined for overseas because US vaccine demand has already been met.
Novavax has secured large manufacturing contracts with the Serum Institute of India and SK Biosciences of South Korea, to go along with deals with Fujifilm Diosynth and GlaxoSmithKline in the UK and with Jubilant HollisterSteir in Spokane, Washington.
Pfizer, Moderna COVID-19 vaccines will get label warning over rare heart risk[3] (6/24)
While Pfizer and Moderna had relatively low safety and supply issues, US experts concluded there is a “likely association” between rare cases of heart inflammation and mRNA vaccines has finally presented the Pfizer-BioNTech and Moderna shots with a dose of adversity.
The FDA said it will move quickly to require the companies to add a label warning that young adults and adolescents are susceptible to the side effect.
The latest ruling comes in response to reports of young people, mostly males, developing myocarditis—inflammation of the heart—or pericarditis—inflammation of the heart’s membrane—mostly after a second dose of either mRNA vaccine. The CDC reports that 309 people have been hospitalized, with all but 14 discharged so far. There have been no reported deaths.
FDA greenlights its first saliva-based COVID-19 antibody test[4] (6/24)
The FDA approved its first antibody test that does not use blood samples to check for evidence of a COVID-19 infection and instead relies on simple, painless mouth swabs.
Developed by Diabetomics, the rapid, lateral-flow diagnostic received an agency emergency authorization allowing it to be used at the point of care for adults and children. Designed to deliver a result within 15 minutes, the test also does not require any additional hardware or instruments.
When administered at least 15 days after the onset of symptoms, when the body’s antibody response reaches higher levels, the test demonstrated a false-negative rate of less than 3% and a false-positive rate of nearly 1%.
Roche obtains FDA emergency authorization for Actemra in severe COVID-19 despite mixed trial results[5] (6/25)
The FDA authorized Roche’s Actemra to be used alongside corticosteroids for hospitalized patients who require some form of oxygen support.
Actemra may have turned up mixed results in COVID-19 clinical trials, but the FDA thinks the rheumatoid arthritis drug has shown enough benefit in some severe patients to deserve an emergency use authorization.
Last year, Chinese doctors first proposed the potential application of Actemra in COVID, suggesting the med's anti-IL-6 effects could tamp down inflammation. Officials quickly included the medicine in the country's treatment guidelines after doctors noted benefits in some patients with severe pneumonia.
Eli Lilly Covid-19 antibody drug shipments paused over variant concerns[6] (6/25)
US health officials have paused the distribution of two Eli Lilly Covid-19 monoclonal antibody treatments, bamlanivimab and etesevimab, because of data showing that they are not effective against virus variants that are becoming increasingly common across the country.
Health administrators cited analyses that found that the two antibody treatments together were not effective against two variants: the Gamma variant, first identified in Brazil, and the Beta variant, first identified in South Africa.
Lilly said that the company is working with governments and regulators to ensure antibodies are available to appropriate patients as variants continue to evolve.
All distribution of the products will be paused until further notice.
<Industry News>
FDA approves first oral blood thinning medication for children[7] (6/21)
The FDA approved Boehringer Ingelheim’s Pradaxa to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.
Pradaxa is the first FDA-approved blood thinning medication that children can take by mouth; the only other approved blood thinning medication for children is given by injection.
Pradaxa was originally approved in 2010 to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
FDA approved Biogen Alzheimer’s drug despite some staff concerns[8] (6/22)
The FDA approved the first new Alzheimer’s drug in decades over the objection of agency statisticians who said there was insufficient evidence to support approval, according to newly released internal memos.
In the internal memos released Tuesday, FDA officials discussed whether to approve the drug from Biogen over objections from the agency’s drug statistics office, which said that clinical trial data fell short of the proof typically required to put a new product on the market.
Ultimately, top officials decided that the evidence indicating that the drug worked, while inconclusive, was strong enough to allow doctors and patients to decide for themselves whether to take it, according to the memos.
Monte Rosa makes Nasdaq IPO, banking $222M for 'molecular glues'[9] (6/24)
Monte Rosa Therapeutics is going through a $222.3 million IPO to get two of its “molecular glue” treatments into the clinic and advance its other discovery-stage programs. Molecular glues are small molecules designed to treat disease by commandeering the body’s own protein degrading process. As their name suggests, they work by sticking proteins to each other.
Despite being a preclinical biotech with much to prove, it increased its IPO goal up to $213 million earlier this week, eventually collecting $222.3 million by offering 20% more shares than originally planned.
A biotech going public without any human data isn’t unusual these days; even before the COVID-19 pandemic spurred interest and investment in the sector, companies had been hitting Wall Street at increasingly earlier stages of development.
Pfizer suspends global distribution of Chantix smoking-cessation pill on contamination concerns[10] (6/25)
Pfizer has suspended distribution world-wide of antismoking pill Chantix and recalled some lots after finding they contained heightened levels of a probable carcinogen. The company is doing more testing to determine whether additional Chantix lots contain elevated amounts of the likely carcinogen, known as nitrosamines, at the request of the FDA.
As a precaution, Pfizer suspended distribution while determining the extent of the contamination.
Canadian health regulators posted online a recall notice for the drug, which is called Champix outside the U.S. Chantix isn’t currently on the FDA’s online list of recalled products. The FDA didn’t immediately respond to a request for comment.
FDA advisers vote down Incyte cancer drug as agency takes tougher line[11] (6/25)
A group of advisers to the Food and Drug Administration urged the agency wait for more clinical trial results before approving an experimental cancer drug from biotech company Incyte, voting 13-4 to recommend deferring a decision.
The FDA isn't obligated to follow its advisers' recommendations, although it usually does. In this case, the agency appears to share its advisers' doubts about Incyte's application, laying out significant concerns.
Incyte is already running a larger study of its drug, for the treatment of metastatic anal cancer, and said it would work closely with the agency. If eventually approved, the drug, called retifanlimab, would be the eighth marketed cancer immunotherapy that works by blocking protein receptors known as PD-1 or PD-L1.
Graphite pulls off $238M IPO to sketch out path to clinic for gene-editing sickle cell treatment[12] (6/25)
In less than a year, Graphite Bio has sped from series A to Wall Street welcome as it rustles up capital to fund gene-editing treatments for sickle cell disease, an immune system disorder and Gaucher disease.
In a move that’s starting to look like a formality in biotech, Graphite filed to raise up to $100 million in its Nasdaq debut in early June. That goal was amended to as much as $213 million, eventually taking $238 million by offering 12% more shares than originally planned.
Graphite is a preclinical-stage company going public without any human data—a choice once unheard of that has become commonplace in a sector buoyed by optimism and its role in fighting the COVID-19 pandemic.
Alzheimer's biotech Acumen prices $125M IPO, targets phase 2 data on amyloid-beta prospect[13] (6/25)
Acumen Pharmaceuticals has set the terms for its IPO to raise around $125 million to take an antibody against amyloid-beta oligomers to the end of phase 2 in Alzheimer’s disease.
Virginia-based Acumen filed the paperwork for its proposed Nasdaq IPO days after the FDA granted accelerated approval to Biogen’s Aduhelm. Acumen made the move, which was initially penciled in to raise $100 million, to support the development of an Alzheimer’s candidate that emerged out of a collaboration with Merck that ran from 2003 to 2011.
The start of the study was held up by a clinical hold the FDA imposed over concerns about potential off-target binding. Now, with that regulatory barrier cleared and the Aduhelm approval revealing an accelerated path to market, Acumen is seeking money for further development of ACU193.
<Policies & Announcements>
HHS releases statement following CDC ACIP meeting from nation’s leading doctors, nurses and public health leaders on benefits of vaccination[14] (6/23)
The US Department of Health and Human Services (HHS), CDC, and other agencies co-signed a statement on the benefits of vaccination following a CDC Advisory Committee on Immunization Practices (ACIP) meeting, held to discuss the latest data on reports of mild cases of inflammation of the heart muscle and surrounding tissue called myocarditis and pericarditis following COVID-19 vaccination among younger people.
The statement mentions, “the facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”
FDA encourages inclusion of patients with incurable cancers in oncology clinical trials regardless of prior therapies[15] (6/24)
The FDA issued a draft guidance encouraging industry to include patients with incurable cancers in cancer clinical trials, regardless of whether they have received existing alternative treatment options. Historically, many clinical trials have required that participating patients previously received multiple therapies.
The FDA believes patients with incurable cancers, if provided adequate information to make an informed decision, should be eligible to participate in oncology clinical trials. If there is no scientific rationale for excluding these patients, then clinical trial eligibility criteria should be broadened to include these patients, with appropriate informed consent.
The draft guidance document, “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings,” when finalized, will provide recommendations to sponsors designing clinical trials of drug and biological products to expand eligibility to patients with incurable cancers.
The details of the guidance can be found here.
[1] https://www.wsj.com/articles/delta-covid-19-variant-could-be-dominant-in-u-s-in-two-to-three-weeks-study-says-11624387427 [2] https://www.fiercepharma.com/pharma/novavax-covid-19-vaccine-delays-will-impact-u-s-uptake-but-big-global-market-still-awaits [3] https://www.fiercepharma.com/pharma/fda-says-label-warning-coming-for-heart-inflammation-pfizer-bnt-moderna-covid-19-vaccines [4] https://www.fiercebiotech.com/medtech/fda-greenlights-its-first-saliva-based-covid-19-antibody-test [5] https://www.fiercepharma.com/pharma/roche-nabs-fda-emergency-authorization-for-actemra-for-severe-covid-19-despite-mixed-results [6] https://www.wsj.com/articles/eli-lilly-covid-19-antibody-drug-shipments-paused-over-variant-concerns-11624652980 [7] https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-blood-thinning-medication-children [8] https://www.wsj.com/articles/fda-approved-biogen-alzheimers-drug-despite-some-staff-concerns-11624393800 [9] https://www.fiercebiotech.com/biotech/monte-rosa-sticks-its-nasdaq-landing-banking-222m-for-molecular-glues [10] https://www.wsj.com/articles/pfizer-suspends-global-distribution-of-chantix-smoking-cessation-pill-on-contamination-concerns-11624633298 [11] https://www.biopharmadive.com/news/incyte-fda-odac-committee-vote-accelerated-approval/602443/ [12] https://www.fiercebiotech.com/biotech/graphite-pulls-off-238m-ipo-to-push-gene-editing-sickle-cell-treatment-into-clinic [13] https://www.fiercebiotech.com/biotech/alzheimer-s-biotech-acumen-prices-125m-ipo-targets-phase-2-data-amyloid-beta-prospect [14] https://www.hhs.gov/about/news/2021/06/23/statement-following-cdc-acip-meeting-nations-leading-doctors-nurses-public-health-leaders-benefits-vaccination.html [15] https://www.fda.gov/news-events/press-announcements/fda-brief-fda-encourages-inclusion-patients-incurable-cancers-oncology-clinical-trials-regardless