Top Stories for Week of May 18, 2020

tookapic / Pixabay

COVID-19 cases slacken in US, but as more states reopen, the future is shaky.

More than two-thirds of US states have lifted or relaxed restrictions on business and public life as of Friday, joining others that have pressed for a speedy reopening in recent weeks. In Maryland, new regulations allow retail stores to open at 50% capacity, while still being encouraged to offer delivery and curbside pickup.

Churches and other houses of worship were pressed to halve their capacity and offer outdoor services where possible. Salons and barbershops can only take appointments, says The New York Times. In Oregon, retail stores can reopen statewide, so long as they follow distancing guidelines.

Thirty one of the state’s 36 counties were approved for other, limited reopenings. Restaurants and bars can provide dine-in service until 10 p.m. Gyms must follow new social distancing guidelines, limit the size of fitness classes, and consider holding classes and activities outdoors. Reopenings might ease the nation’s intense economic pain: More than 36 million people have filed unemployment claims in the past two months, and the Commerce Department reported that retail sales fell a record 16.4% in April.

But in testimony before Congress last week, Dr. Anthony S. Fauci, the nation’s top infectious disease expert, said that relaxing restrictions too soon could prompt another uncontrollable outbreak. The number of new coronavirus cases confirmed in the US has steadily declined in recent days. In New York, the figure has dropped over the past month. The numbers have also plunged in hard-hit Massachusetts and Rhode Island, and some states, including Vermont, Hawaii and Alaska, are reporting hardly any new cases.

But that progress is fragile and inexact. Only about 3% of the population has been tested. More than 20,000 new cases are identified on most days. The total now stands at 1.47 million. And almost every day this past week, more than 1,000 people in the US died from the virus. The total death toll has now surpassed 88,000. That has left the nation at a perilous moment, beginning to reopen businesses and ease social distancing measures despite the risk of a resurgence.

Global coronavirus deaths passed 308,000 early Saturday as infections approached 4.6 million, according to a Reuters tally, with the US responsible for more than a quarter of all fatalities. The United Kingdom and Italy accounted for another 10-11% each, while France and Spain accounted for 9% each.

The number of deaths linked to COVID-19 in just four months is now equal to about three-quarters of the number of people who die annually from malaria, one of the world’s most deadly infectious diseases. And while the current trajectory falls far short of the 1918 Spanish flu, which infected an estimated 500 million people and killed at least 10% of patients, public health experts worry the available data is underplaying the true impact of the pandemic.

COVID-19 Addenda: 1) Even talking can propel the droplets that spread the coronavirus; 2) Oxford coronavirus vaccine found protective in small monkey study; 3) CureVac’s COVID-19 vaccine candidate triggers immune response at low dose in preclinical testing; 4) The new vaccine czar says finding one by January is a credible but difficult goal; and 5) Which specialists are most at risk from SARS-CoV-2.

Coughs or sneezes may not be the only way people transmit infectious pathogens like the coronavirus to one another. Talking can also propel thousands of droplets so small they can remain suspended in the air for eight to 14 minutes, according to a new study. The research, published in the Proceedings of the National Academy of Sciences, could help explain how people with mild or no symptoms may infect others in close quarters such as offices, nursing homes, cruise ships and other confined spaces. The findings strengthen the case for wearing masks and taking other precautions to reduce the spread of the virus.

A closely watched coronavirus vaccine being developed by scientists at Oxford University appears protective in a small study of six monkeys, promising findings that led to the start of human trials late last month, US and British researchers reported on Thursday. The preliminary findings, reported by Reuters, which have not undergone rigorous review by other scientists, appeared on the preprint server bioRxiv on Thursday. British drugmaker AstraZeneca PLC (London) last month announced it had teamed up with researchers at the Oxford Vaccine Group and the Jenner Institute, which are developing the vaccine.

According to the report, some of the monkeys given a single shot of the vaccine developed antibodies against the virus within 14 days, and all developed protective antibodies within 28 days, before being exposed to high doses of the virus.

CureVac AG (Tübingen DEU) on Thursday reported preclinical results for its vaccine candidate against SARS-CoV-2, saying a low dose showed “fast induction of a balanced immune response with high levels of virus neutralizing titers and T-cell responses.”

Acting CEO Franz Werner-Haas said, “With recurring positive results for flu, [respiratory syncytial virus], rabies and now our coronavirus vaccine candidate, we have demonstrated the sustained performance of our mRNA platform.”

CureVac says it now intends to initiate the first Phase 1/2a trial of its lead vaccine candidate in healthy volunteers in June.

And new survey data of resident physicians in New York revealed that anesthesiology, emergency medicine, and ophthalmology were the specialties associated with the highest risk of contracting COVID-19. The close proximity between ophthalmologists and their patients, as well as evidence that SARS-CoV-2 can be spread through the eyes, helps explain that specialty’s surprising inclusion in the most at-risk group. The survey is not considered a definitive account, considering variables such as PPE availability and use, hospital protocols, and physician experience. However, the authors hope that the information could provide some indication of specialties that may require increased protection should a second wave of COVID-19 occur.

House of Reps passes $3-trillion relief package which McConnell, Senate GOP declare DOA.

House Speaker Nancy Pelosi pushed ahead with a vote Friday on a $3 trillion Democratic-only virus relief bill despite the misgivings of some liberals and moderates in her party and the fact it has no chance of ever getting signed into law. Lawmakers began consideration of the stimulus package and a measure to allow proxy voting under restrictions that have now become common place during the coronavirus pandemic: face covers and limits on the number of members on the floor at any one time.

The circumstances didn’t diminish the partisan rancor surrounding the House bill, according to Bloomberg News. Rules Committee Chairman Jim McGovern of Massachusetts lashed out at Republicans for describing the legislation as a Democratic “messaging exercise.”

McGovern fumed, “I don’t give a damn about sending a message, Madame Speaker. I want to send help to those in desperate need.”

Representative Tom Cole of Oklahoma, the top Republican on the Rules panel, replied that the bill “is nothing more than a Democratic policy agenda masquerading as a response to the coronavirus crisis.”

Pelosi is counting on key parts of the legislation–aid to states, more payments to individuals and extending unemployment insurance–to generate enough public support that the White House and the GOP will be forced into negotiations on another round of stimulus for a hobbled US economy.

“I am optimistic that the American people will weigh in and make their views known,” the speaker said on Thursday, deflecting questions about pressing ahead with a partisan vote without any active negotiations with Senate Majority Leader Mitch McConnell or President Donald Trump’s administration.

But Trump, who has said he’s in no rush for another stimulus package, said Friday he has the upper hand.

“We have all the cards because we have the cards of the American people. I know what they want,” he said. “Phase four is going to happen but it’s going to happen in a much better way for the American people.”

McConnell said he’s spoken with Trump and Treasury Secretary Steven Mnuchin about the next phase of stimulus but they’ve set no date for getting it done. He dismissed the House Democratic legislation, known as the Heroes Act, as “a $3 trillion left-wing wish list,” having earlier added it was “dead on arrival.”

The White House said Trump would veto it if it ever got to his desk. Adding to pressure on lawmakers and the White House is the prospect of an autumn election campaign with the economic hardship continuing. In a speech on Wednesday, Federal Reserve Chairman Jerome Powell warned that the US economy faces unprecedented risk if additional fiscal support doesn’t come through. Minneapolis Fed President Neel Kashkari said direct cash payments are needed.

“Putting money directly in the hands of laid-off Americans is, I think, the most direct way to get assistance, and then they will spend the money where they need it,” Kashkari said Thursday.

Whistleblower tells House panel that lives were lost because administration didn’t heed early warnings, mismanaged response.

Amid widespread speculation on COVID-19 vaccine timelines, former Biomedical Advanced Research and Development Authority (BARDA) chief turned whistleblower Rick Bright, MD, joined the skeptics discounting the idea that immunizations could be made available in 12 to 18 months. 

At a House of Representatives hearing focused on Bright’s whistleblower complaint against the Trump administration, he told lawmakers current vaccine expectations require everything going “perfectly” in the R&D process during the first go-round. But “we’ve never seen everything go perfectly,” he added. Americans have routinely been told COVID-19 vaccines could be available in 12 to 18 months–with that timeline starting from January when scientists began R&D work. A federal “Operation Warp Speed” group is promising future programs–with the goal of delivering vaccine doses by the end of the year.

For his part, National Institute of Allergy and Infectious Diseases chief Anthony Fauci testified last week that he’s “cautiously optimistic” about one of the leading vaccines succeeding. At least eight are already in human testing, he said. At Thursday’s hearing, Bright raised safety concerns about moving vaccines ahead at unprecedented speeds. In all, Bright said an 18-month timeline is “aggressive,” and he believes the process will and should take longer.

“My concern is if we rush too quickly, and consider cutting out critical steps, we might not have a full assessment of the safety of the vaccine,” he told lawmakers.

The congressional hearing came after Bright said he was involuntarily transferred from his BARDA director post to a new position centered on COVID-19 testing. In a whistleblower complaint, Bright alleged the transfer was a retaliation for his disagreements with Department of Health and Human Services officials throughout the pandemic response. He’s not the only expert who believes current timelines are optimistic. In a note to clients, SVB Leerink analyst Geoffrey Porges has said creating a vaccine within 12 to 18 months would be as tough as hitting a bull’s-eye with a dart from 24 feet on the first try. (Ref: FiercePharma)

Gilead selects five generic manufacturers to expand supply of COVID-19 drug remdesivir.

Seeking to dampen concerns about access to its remdesivir treatment for COVID-19, Gilead Sciences Inc. (Foster City CA) signed deals with five generic companies in India and Pakistan to manufacture and distribute the experimental medicine to 127 countries. Under the agreements, STAT reports, the companies can set their own prices, but will not have to pay royalties to Gilead until the World Health Organization declares an end to the public health emergency for the novel coronavirus, or until another medicine or vaccine is approve to treat or prevent COVID-19.

The companies include Cipla, Hetero Labs, Jubilant Lifesciences, Mylan, and Ferozsons. The arrangements are formally called non-exclusive voluntary licenses, which is a similar approach Gilead has taken in the past in response to pressure to widen access to its hepatitis C medicines. In this instance, the deals cover mostly low-income and lower-middle income countries, but also some upper-middle- and high-income countries that Gilead said face significant obstacles to access.

The move follows the release of preliminary trial results which indicated remdesivir can successfully treat serious cases of COVID-19. The disclosure prompted the Food and Drug Administration to quickly authorize emergency use for hospitals. For the moment, Gilead plans to eventually donate 1.5 million doses, which could cover between 140,000 and 280,000 patients, depending on dosing. The news ignited intense global interest, but also a new round of concern over access to COVID-19 treatments. This reflects the fact both that much of the current supply of the drug is earmarked for the US and that Gilead has sparred with many countries and patient advocacy groups in the past over access to its HIV and hepatitis C treatments.

Although Gilead has previously issued voluntary licenses to generic companies for some of its other medicines, the company has still encountered pushback over criticism that its efforts simply did not go far enough, since some countries with battered healthcare systems were excluded. But as noted previously, a new executive team is trying to get ahead of critics by pursuing far-reaching deals with remdesivir. For the moment, it is unclear the extent to which remdesivir may become a standard of care, since full study results have not yet been released.

IPO Sector: Calliditas Therapeutics AB, a Swedish biotech developing novel therapies for inflammatory kidney disease, filed on Thursday with the SEC to raise up to $75 million in an initial public offering. The company’s stock currently trades on the Nasdaq Stockholm under the symbol “CALTX” and currently has a market cap of $369 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, subject to any further impact from the COVID-19 pandemic.

The Stockholm-based company was founded in 2004 and booked $19 million in licensing revenue for the 12 months ended March 31, 2020. It plans to list on the Nasdaq under the symbol “CALT.” Citi, Jefferies, and Stifel are the joint bookrunners on the deal. No pricing terms were disclosed.

Elsewhere, ADC Therapeutics SA, a Swiss Phase 2 biotech developing next-gen antibody drug conjugates for difficult-to-treat cancers, raised $233 million by offering 12.2 million shares at $19, above the range of $16 to $18.

The Épalinges, Switzerland-based company had originally filed to sell 7.4 million shares before upsizing the proposed deal size to 10.3 million on Thursday morning. That happened after ADC reported promising pivotal data for its lead COVID-19 drug–ADCT-402, or loncastuximab tesirine–with a 45% overall response rate and a complete response rate of 20% for diffuse large B cell lymphoma (DLBCL) that they’re taking to regulators.

ADC Therapeutics was founded in 2011 and booked $2 million in revenue for the 12 months ended December 31, 2019. ADC Therapeutics lists on the NYSE under the symbol “ADCT.” Morgan Stanley, BofA Securities and Cowen acted as lead managers on the deal. Shares closed the week up 56% at $29.65.

Legend Biotech Inc., a clinical stage oncology biotech being spun-out of GenScript’s cell therapy unit, filed with the SEC to raise up to $100 million in an IPO. 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 Somerset, NJ-based company was founded in 2014 and booked $57 million in revenue for the 12 months ended December 31, 2019. It plans to list 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. No pricing terms were disclosed.

Lantern Pharma Inc., a Phase 2 oncology biotech using AI to redevelop abandoned drugs for targeted groups, announced terms for its IPO on Tuesday. The Dallas, TX-based company plans to raise $25 million by offering 1.6 million shares at a price range of $15 to $17. At the midpoint of the proposed range, Lantern Pharma would command a fully diluted market value of $108 million.

The company’s AI platform, RADR, allows Lantern Pharma to identify potential therapies which were deemed ineffective in previous studies but may show promise in alternative indications. Lantern Pharma’s most advanced candidate is LP-100, a potential treatment for prostate cancer that is in a Phase 2 trial with out-licensing partner Oncology Venture. Lantern Pharma was founded in 2013 and plans to list on the Nasdaq under the symbol “LTRN.” ThinkEquity and Dougherty & Co. are the joint bookrunners on the deal.

Kiromic BioPharma Inc., a preclinical biotech developing immunotherapies for blood cancers and solid tumors, filed with the SEC to raise up to $20 million in an IPO. Kiromic’s pipeline consists of four early-stage product candidates targeting blood cancers and solid tumors. Kiromic utilizes its proprietary target discovery platform, Diamond, to identify new cancer immunological targets for T cells and B cells.

The company is also developing a non-viral gene editing mechanism, called ABBIE (A Binding-Based Integrase Enzyme), for delivering its product candidates. The Houston, TX-based company traces its roots to 2006 and plans to list on the NYSE American under the symbol “KRBP.” ThinkEquity is the sole bookrunner on the deal. No pricing terms were disclosed.

Aditx Therapeutics Inc. has filed a preliminary prospectus for an IPO of 1.9 million units at $5.50. Each unit consists of one common share and one five-year warrant to purchase one common share at $6.875. The Loma Linda, CA-based life sciences firm develops nucleic acid-based technologies designed to improve the health of the immune system through immune reprogramming and monitoring aimed at addressing organ transplant rejection, autoimmune disorders and allergies. The company says its immune reprogramming technology “is designed to retrain the immune system to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies. The company hopes to list on the NASDAQ under the symbol “ADTX.”

And Pliant Therapeutics Inc. has filed a preliminary prospectus for an $86 million IPO. The South San Francisco, CA-based biopharmaceutical firm develops treatments for fibrosis (scarring). Lead candidate is PLN-74809, a small molecule inhibitor of certain integrins (class of proteins that plays a key role in cell-extracellular matrix adhesion), for the potential treatment of idiopathic (cause unknown) pulmonary fibrosis (IPF) and a liver disorder called primary sclerosing cholangitis (PSC) characterized by inflammation and scarring of the bile ducts. Enrollment is underway in two Phase 2a studies in IPF. A Phase 2a study in PSC should launch in H2. Pliant hopes to list on the NASDAQ market under the symbol “PLRX.”

Print Friendly, PDF & Email