Top Stories for Week of June 8, 2020

White House picks five COVID-19 vaccine candidates for Warp Speed initiative.

The Trump administration has chosen five companies as the most likely contenders to produce a vaccine for the coronavirus, senior officials said, a critical step in the White House’s effort to deliver on its promise of being able to begin widespread immunization of Americans by year’s end. By examining the field in weeks from a pool of about a dozen companies, the government is betting that it can identify the most promising vaccine projects at an early stage, speed along the process of determining which will work and ensure that the winner or winners can be quickly manufactured in huge quantities and distributed across the country.

Noah Weiland and David E. Sanger of The New York Times report that the five companies are Moderna Inc., a Massachusetts-based biotechnology firm, which Dr. Anthony S. Fauci said he expected would enter the final phase of clinical trials next month; the combination of Oxford University and AstraZeneca PLC, on a similar schedule; and three large pharmaceutical companies: Johnson & Johnson, Merck & Co. and Pfizer Inc. Each is taking a somewhat different approach.

The announcement of the decision will be made at the White House in the next few weeks, government officials said. Dr. Fauci, the federal government’s top epidemiologist and the director of the National Institute of Allergy and Infectious Diseases, hinted at the action when he told a medical seminar that “by the beginning of 2021, we hope to have a couple of hundred million doses.”

Despite promising early results and the administration’s strong interest in nurturing a government-industry partnership, substantial hurdles remain. Many scientists consider President Trump’s goal of having a vaccine widely available by early next year to be optimistic, if not unrealistic. Vaccine development is notoriously difficult and time-consuming; the record is four years, and a decade is not unusual.

Separately, the coronavirus pandemic has sickened more than 6,713,300 people, according to official counts. As of Saturday morning, at least 394,500 people have died, and the virus has been detected in nearly every country. In the US, more than 1.9 million cases have been confirmed (28% of the global total) and over 109,000 people (also 28%) have died. These numbers are unacceptably high, given the US population comprises just 4.25% of the global total. The coronavirus pandemic is receding in some of the countries that were hit hard early on, but the number of new cases is growing faster than ever worldwide, with more than 100,000 reported each day.

COVID-19 Addenda: 1) Dr. Anthony Fauci says there’s a chance coronavirus vaccine may not provide immunity for long; 2) Convalescent plasma safe, promising in small COVID-19 study; 3) Surgeon General warns of coronavirus outbreaks from Floyd protests; 4) Genes may leave some people more vulnerable to severe COVID-19; and 5) Blood-pressure drugs linked to lower death risk, more sensitive test recommended for blood clot risk.

White House health advisor Dr. Anthony Fauci said he worries about the “durability” of a potential coronavirus vaccine, saying there’s a chance it may not provide long-term immunity.

If COVID-19 acts like other coronaviruses, “it likely isn’t going to be a long duration of immunity,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said during an interview Tuesday evening with JAMA Editor Howard Bauchner. “When you look at the history of coronaviruses, the common coronaviruses that cause the common cold, the reports in the literature are that the durability of immunity that’s protective ranges from three to six months to almost always less than a year,” he said. “That’s not a lot of durability and protection.”

Convalescent plasma was found to be safe and effective in 14 of 25 (76%) severely ill COVID-19 patients in the first peer-reviewed study of the treatment in the US. The treatment, which involves infusing patients with the plasma from people who have recovered from COVID-19 and have developed antibodies, has been used in the treatment of severe microbial infections for more than 100 years, with varied success. The findings by Eric Salazar, MD, PhD, of the Department of Pathology and Genomic Medicine at Houston Methodist Hospital in Texas, and colleagues were published on May 26 in the American Journal of Pathology.

US Surgeon General Dr. Jerome Adams said to expect new outbreaks of the coronavirus resulting from the nationwide protests over the death of George Floyd that have seen thousands of people gather in close proximity. While a majority of protesters nationwide have worn masks and face coverings as they demand justice for Floyd, an African-American man who died last week while in police custody, the large crowds have made it difficult to social distance. The coronavirus pandemic has also disproportionately affected communities of color, an issue Adams has highlighted.

“I remain concerned about the public health consequences both of individual and institutional racism [and] people out protesting in a way that is harmful to themselves and to their communities,” Adams told Politico in an interview.

Why do some people infected with the coronavirus suffer only mild symptoms, while others become deathly ill? Geneticists have been scouring our DNA for clues. Now, a study by European scientists is the first to document a strong statistical link between genetic variations and COVID-19, the illness caused by the coronavirus. Variations at two spots in the human genome are associated with an increased risk of respiratory failure in patients with COVID-19, the researchers found. One of these spots includes the gene that determines blood types.

Having Type A blood was linked to a 50% increase in the likelihood that a patient would need to get oxygen or go on a ventilator, according to the new study, which is currently going through peer review. The findings suggest that relatively unexplored factors may be playing a large role who develops life-threatening COVID-19.

And regularly taking drugs to control high blood pressure appears to lower the risk of becoming severely ill or dying if people with hypertension become infected with the new coronavirus, a new study found. Among nearly 2,900 people hospitalized in China with COVID-19, patients with high blood pressure had twice the risk of death and were more likely to need mechanical ventilation than those without hypertension, a known risk factor for severe COVID-19. But those taking drugs to control their blood pressure had a significantly lower risk of death from COVID-19 than those not treated for their hypertension, researchers reported on Thursday in the European Heart Journal.

The Lancet withdraws controversial hydroxychloroquine study.

A study that said a malaria drug touted by President Donald Trump to treat and prevent coronavirus raised the risk of heart side effects and death has been retracted by the authors, Bloomberg reports. The study was published on May 22 in The Lancet, a prestigious U.K. medical journal.

Questions soon arose about the accuracy of the underlying data, said researchers led by Mandeep Mehra, the medical director of Brigham and Women’s Hospital Heart and Vascular Center, in the retraction note published by the journal Thursday. While the company that produced the original data, Surgisphere Corp. (Palatine IL), had signaled that it would cooperate with an independent review, it ultimately reneged and said doing so would violate confidentiality agreements, wrote the study authors.

“As such, our reviewers were not able to conduct an independent and private peer review,” the authors said. “We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic,” the authors said. “We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”

The retraction is the latest turn for a drug that has been followed by controversy since Trump took it up as a possible coronavirus treatment earlier this year. Repeated efforts have been launched to study the drug and whether it might be used as a therapy for patients with the disease or as a preventive. So far, the results have been largely negative.

One large study published last week examining the drug’s use as a preventive showed that it didn’t stop at-risk people from being infected by the coronavirus. Controversy has also grown around Surgisphere, which says it consolidates medical records from around the world. The company’s data were used in another major study of heart drugs called ACE inhibitors, and what impact their use might have on COVID-19 patients. On Thursday, the New England Journal of Medicine said that study’s authors had retracted it, as well.

“Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article,” they wrote.

On Wednesday, Surgisphere CEO Sapan Desai said in an emailed statement that the company “stands behind the integrity of our studies.” Following the retraction, the company said that Desai was “unavailable to make any further public comment at this time.”

A nutritional intervention with a focus on fatty acids appears to reduce mood swings in patients with bipolar disorder (BD) when used as an adjunct to pharmacotherapy, early research suggests. In a single-center study, patients with BD who received a diet consisting of high omega-3 plus low omega-6 fatty acids (H3-L6), in addition to usual care, showed significant reductions in mood variability, irritability, and pain compared with their counterparts who received a diet with usual levels of omega-3 and omega-6 fatty acids commonly consumed in regular US diets.

“Our findings need replication and validation in other studies,” study co-investigator Erika Saunders, MD, professor and chair of the Department of Psychiatry and Behavioral Health at Penn State College of Medicine, Hershey, told Medscape. “While we got really exciting findings, it’s far from confirmatory or the last word on the subject. The fatty acids do two broad things. They incorporate into the membranes of neurons in the brain and they also create signaling molecules throughout the brain and the body that interact with the immune system and the inflammatory system,” he added.

Many patients with BD do not achieve complete mood stability with medication, making the need for additional treatments imperative, she added.

Dr. Saunders added, “We were interested in looking at treatments that improved mood stability in bipolar disorder that are well-tolerated by patients and that can be added to pharmacological treatments. We studied this particular nutritional intervention because biologically it does some of the same things that effective medications for bipolar disorder do and it has been investigated as an effective treatment for conditions like migraine headaches, which has a lot of overlap and comorbidity with bipolar disorder.”

The researchers randomized 41 patients with BD to receive the nutritional intervention of high omega-3 plus low omega-6 (H3-L6) and 41 patients with BD to receive a control diet of usual US levels of omega-3 and omega-6 fatty acids. The patients ranged in age from 20 to 75 years (mean age, 43) and 83% were women. They had similar mean levels of mood symptoms and pain.

All patients received group-specific study foods and oils, as well as intensive dietary counseling from a dietician, access to a website with recipes, and guidance for eating in restaurants. All participants were blinded to the composition of the food that they were eating. Both the interventional diet and the control diet were tailored for the purposes of the study, noted co-investigator Sarah Shahriar, BS, Penn State College of Medicine. After 12 weeks, significant reductions were seen in mood variability, energy, irritability, and pain in the H3-L6 group. The only symptom that was significantly lowered in the control group was impulsive thoughts.

“The best message for doctors to tell their patients at this point is one of general nutritional health and the importance of nutrition in overall body and brain health, and that that can be a very important component of mood,” Saunders said.

The findings were presented at the American Society of Clinical Psychopharmacology (ASCP) 2020 Virtual Conference.

IPO Sector: Pliant Therapeutics Inc., a Phase 2 biotech developing therapies for the treatment of fibrosis, raised $144 million by offering 9.0 million shares at $16, the high end of the $14 to $16 range. Earlier last week, Pliant filed an amendment adding 3.0 million shares to the offering, a 50% increase from the original deal size. Existing shareholder and collaboration partner Novartis invested an additional $10 million in a concurrent private placement. Pliant Therapeutics was founded in 2016 and booked $86 million in revenue for the 12 months ended March 31, 2020. It lists on the Nasdaq under the symbol “PLRX.” Citi, Cowen, and Piper Sandler are the joint bookrunners on the deal. Shares closed the week up 39% at $22.25.

Elsewhere, Legend Biotech Inc., a clinical stage CAR-T immuno-oncology biotech being spun out of GenScript, raised $424 million by offering 18.4 million ADSs at $23, above the range of $18 to $20. Legend’s extensive pipeline contains lead candidate LCAR-B38M/JNJ-4528, a CAR-T therapy being developed with Janssen Biotech for the treatment of multiple myeloma. It is in the process of enrolling patients for a Phase 2 clinical trial in China and is in a Phase 1b trial in the US and Japan. The Nanjing and Somerset, NJ-based company was founded in 2014 and booked $57 million in revenue for the 12 months ended December 31, 2019. It lists on the Nasdaq under the symbol “LEGN.” Legend Biotech filed confidentially on March 9, 2020. Morgan Stanley, J.P. Morgan and Jefferies are the joint bookrunners on the deal. Shares closed the week up 61% to $37.

Calliditas Therapeutics AB, a Swedish biotech developing therapies for orphan kidney and liver diseases, raised $90 million in an upsized IPO by offering 4.6 million ADS equivalents at $19.50 per ADS. It originally planned to raise $75 million by offering 3.8 million ADS equivalents. Calliditas now commands a fully diluted market value of $467 million. The company’s lead candidate, Nefecon, is a novel oral formulation of local immunosuppressant budesonide for the treatment of the autoimmune renal disease IgA nephropathy (IgAN). Nefecon met the key primary and secondary endpoints in a Phase 2b trial and is currently in a global pivotal Phase 3 trial, with topline data expected in the 4Q20. The Stockholm-based company was founded in 2004 and booked $19 million in licensing revenue for the 12 months ended March 31, 2020. It lists on the Nasdaq under the symbol “CALT.” Citi, Jefferies, and Stifel are the joint bookrunners on the deal. Shares closed the week up 1% at $19.60.

Applied Molecular Transport Inc., a Phase 1 biotech developing novel oral therapies for inflammatory diseases, raised $154 million by offering 11 million shares at $14, the high end of the range of $12 to $14. South San Francisco-based Applied Molecular’s pipeline contains lead candidate AMT-101, an oral, selective interleukin 10 that has completed a Phase 1b trial for ulcerative colitis (UC). The company plans to initiate Phase 2 trials of AMT-101 in UC and related inflammatory indications between 2020 and 2021. Applied Molecular was founded in 2010 and lists on the Nasdaq under the symbol “AMTI.” BofA Securities, Jefferies and SVB Leerink acted as lead managers on the deal. Shares closed the week up 28% to $17.98.

ArcherDX Inc., which provides genomic testing products for cancer, filed on Friday with the SEC to raise up to $100 million in an IPO. ArcherDX is a genomics company that offers a suite of products and services for clinicians, as well as biopharmaceuticals looking to cost-effectively accelerate drug development. Its product development platform enables it to develop products and services for therapy optimization and cancer monitoring. It has developed and commercialized research-use-only products and is currently developing in-vitro diagnostic products. The Boulder, CO-based company was founded in 2013 and booked $56 million in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “RCHR.” J.P. Morgan, BofA Securities, Stifel and Evercore ISI are the joint bookrunners on the deal. No pricing terms were disclosed.

Akouos Inc., a preclinical biotech developing gene therapies for inner ear disorders, filed on Friday with the SEC to raise up to $100 million in an IPO. Akouos’s pipeline contains lead candidate AK-OTOF, a gene therapy for the treatment of hearing loss due to mutations in the otoferlin gene. The company estimates that AK-OTOF has a potential addressable population of roughly 7,000 individuals, and it reported promising preclinical data for the candidate. The Boston, MA-based company was founded in 2016 and plans to list on the Nasdaq under the symbol “AKUS.” Akouos filed confidentially on March 24, 2020. BofA Securities, Cowen, Piper Sandler and BTIG are the joint bookrunners on the deal. No pricing terms were disclosed.

Burning Rock Biotech Co. Ltd., which provides DNA sequencing-based cancer therapy selection tests in China, registered up to $100 million in an IPO. The company provides next generation sequencing-based (NGS-based) cancer therapy selection tests that are used to assist physicians in selecting the most effective therapy for cancer patients. It currently offers 13 NGS-based cancer therapy selection tests applicable to a broad range of cancer types, including lung, gastrointestinal, prostate and breast, among others. The Guangzhou, China-based company was founded in 2014 and booked $49 million in revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “BNR.” Burning Rock filed confidentially on November 4, 2019. Morgan Stanley, BofA Securities, and Cowen are the joint bookrunners on the deal.

PolyPid Ltd., a Phase 3 biotech developing extended-release drugs to prevent surgical site infections, filed on Friday with the SEC to raise up to $58 million in an IPO. This is the third time PolyPid has filed to go public. It last filed in February 2018 but withdrew a month later, citing market conditions. PolyPid’s lead candidate D-PLEX100 is currently in a Phase 3 trial for bone surgical site infections (SSIs) and the company is planning to initiate a Phase 3 trial for abdominal SSIs set to begin in the 3Q 2020. The Petah Tikva, Israel-based company was founded in 2008 and plans to list on the Nasdaq under the symbol “PYPD.” Barclays and BMO Capital Markets are the joint bookrunners on the deal. No pricing terms were disclosed.

And Fusion Pharmaceuticals Inc., a Phase 1 biotech developing precision medicines for solid tumors, filed on Friday with the SEC to raise up to $100 million in an IPO. Fusion’s pipeline contains lead candidate FPI-1434, which is designed to target and deliver an alpha emitting isotope to cancer cells expressing the insulin-like growth factor 1 receptor (IGF-1R), a receptor that is overexpressed on many tumor types. The company is currently conducting a Phase 1 trial for solid tumors expressing IGF-1R and plans to report initial data approximately three to six months after it resumes clinical activities due to disruptions caused by COVID-19. The Hamilton, Canada-based company was founded in 2014 and plans to list on the Nasdaq under the symbol “FUSN.” Morgan Stanley, Jefferies, and Cowen are the joint bookrunners on the deal. No pricing terms were disclosed.

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