Top Stories for Week of September 21, 2020

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Trump disputes, discredits CDC health officials; sees mass vaccinations by end of year.

During a Senate hearing last Wednesday, the Centers for Disease Control and Prevention’s director, Dr. Robert Redfield, predicted that access to COVID-19 vaccines would be limited until the spring or summer of 2021, immediately drawing comments from President Donald Trump claiming Redfield was “confused.”

But Redfield’s statement was unambiguous: A COVID-19 vaccine, he said, might not be available to much of the American public until mid- or late 2021. STAT News reports that in the next 10 hours following the hearing, the agency’s chief attempted to walk back his prior statement by plainly mischaracterizing his own words, and then, inexplicably, retracted his own reversal.

The persistent “confusion” offers the latest example of the CDC faltering over a basic element of its own mission: communicating vital information about COVID-19 and the US government’s response to the American public and to the world, says STAT. The agency, long viewed as a premier global health organization, has floundered in 2020, first via a COVID-19 testing fiasco in early spring, then with repeated communications missteps, and now, as it succumbs to overt political pressure from a scientifically indifferent president.

It is also the latest example of Trump’s apparent disregard for the scientific expertise within his own government: Throughout his government’s COVID-19 response, he has aggressively contradicted government scientists with decades of experience and, increasingly, surrounded himself only with advisers unlikely to question his views.

Openly contradicting Dr. Redfield, Trump predicted Wednesday that a safe and effective vaccine against the coronavirus could be ready as early as next month and in mass distribution soon after, undermining the CDC director. Trump also disagreed with Dr. Robert Redfield about the effectiveness of protective masks–which the president recommends but almost never wears  and said he’d telephoned Redfield to tell him so.

Redfield had given Congress “incorrect information” on vaccine distribution, the president told reporters at a White House press briefing. Redfield’s assertion that masks might be more effective than vaccines at preventing coronavirus, Trump said, was “a mistake.” The CDC scrambled to explain, claiming Redfield had misunderstood the original question and was referring to the time period when all Americans would have completed their COVID-19 vaccination. The CDC’s initial statement was patently false: During the Senate hearing, a senator asked Redfield when a vaccine will be “ready to administer to the public.”

Redfield acknowledged and responded, “If you’re asking me, when is it going to be generally available to the American public, so we can begin to take advantage of a vaccine to get back to our regular life? I think we’re probably looking at late second quarter, third quarter 2021,” he said.

Separately, according to Johns Hopkins Medical, as of Saturday, Sept. 19, there were over 30.5 million COVID-19 global cases confirmed, and some 953,000 deaths. Confirmed cases in the US totaled 6.7 million with about 200,000 deaths. Both of the US figures comprise 22% and 21%, respectively, of the global totals.

COVID-19 Addenda: The Trump administration reversed guidance Friday on COVID-19 testing for a second time, urging those exposed to people with the virus to get tested even if they are not displaying symptoms. The Centers for Disease Control and Prevention triggered widespread outcry among state public health officials and experts in late August when it said that people who do not have symptoms may not need to get tested.

Before August 24, 2020, the CDC had encouraged testing for all those who were exposed. Friday’s guidance update effectively returns the CDC’s testing guidance to what it said before it was altered in late August. Reuters reported that a majority of US states rejected the CDC’s Aug. 24 guidance in an extraordinary rebuke of the nation’s top agency for disease prevention.

“The return to a science-based approach to testing guidance from the Centers for Disease Control and Prevention is good news for public health and for our united fight against this pandemic,” Thomas File, president of the Infectious Diseases Society of America, said in a statement.

Elsewhere, facing concern that its potential COVID-19 vaccine Ad5-nCoV has limited efficacy, China-based CanSino Biologics Inc. (Tianjin) is now entering a Phase 1 trial studying the ability of two doses to fight off the virus. The trial was scheduled to start Sunday, and will enroll up to 168 adults in Wuhan, China, according to registration records. The candidate, which implements a common cold virus to carry genetic traces of the coronavirus, will be administered at various intervals.

CanSino has said there’s no evidence that existing immunity against the cold virus could hurt Ad5-nCoV’s ability to elicit an antibody response against the new virus, according to Reuters. Still, the company is moving forward with a trial testing whether two doses are better than one. China’s government approved the vaccine for military use back in June, making it the first candidate worldwide to be authorized for limited human use. At the beginning of the month, CanSino said it was beginning a Phase 3 trial in Russia with 40,000 volunteers.

New data reveal Americans’ enthusiasm is consistently falling regarding the coronavirus vaccine, according to The Hill. As the race to get a COVID-19 vaccination to market is heating up, public sentiment surrounding the vaccine is conversely cooling down. New data from Morning Consult suggest that only 51% of the US population would receive a COVID-19 vaccine if one became available–a sizable decline from the 72% of Americans who said they would take a dose of a future vaccine back in April.

The latest statistic was taken from a poll conducted from Sept. 2-6, and saw double-digit declines across most demographics, including women, men, Democrats, Republicans, Independents, urbanites, suburbanites and rural residents. The public sentiment surrounding a vaccine has steadily declined since March, when Morning Consult researchers began tracking opinions about a treatment.

“Over the past month alone–a period in which President Donald Trump has repeatedly promised a vaccine will be delivered by the end of 2020 and possibly before the Nov. 3 election–the share of adults who say they would get vaccinated has fallen 8 points,” researchers said.

And more than 20 states either don’t release or have incomplete data on the rapid antigen tests now considered key to containing the coronavirus, which has sickened more than six million Americans. The lapses leave officials and the public in the dark about the true scope of the pandemic as untold numbers of cases go uncounted, Kaiser Health News reports. The gap will only widen as tens of millions of antigen tests sweep the country. Federal officials are prioritizing the tests to quickly detect COVID-19’s spread over slower, but more accurate, PCR tests.

Relying on patchy data on COVID testing carries enormous consequences as officials decide whether to reopen schools and businesses: Go back to normal too quickly and risk even greater outbreaks of disease. Keep people at home too long and risk an even greater economic crisis.

“The absence of information is a very dangerous thing,” said Janet Hamilton, executive director of the Council for State and Territorial Epidemiologists, which represents public health officials. “We will be blind to the pandemic. It will be happening around us and we will have no data.”

Lilly, Amgen partner to manufacture potential COVID-19 drugs.

Eli Lilly & Co. (Indianapolis) and Amgen Inc. (Thousand Oaks CA) on Thursday said they inked an antibody manufacturing pact that seeks to significantly increase the supply capacity available for Lilly’s potential COVID-19 therapies.

“Based on our initial clinical studies, we believe that virus neutralizing antibodies, including LY-CoV555, could play an important role in the fight against COVID-19,” remarked Daniel Skovronsky, president of Lilly Research Laboratories, adding that its deal with Amgen is “a crucial next step, and together we hope to be able to produce many millions of doses even next year.”

Esteban Santos, who heads operations at Amgen, said his company will contribute to the collaboration by “[leveraging] our deep technical expertise in antibody development and, in particular, our strong capabilities in the scale up and manufacturing of complex biologics.” The news follows the release last week of early findings from the mid-stage BLAZE-1 trial showing that LY-CoV555, a monoclonal antibody directed against the spike protein that SARS-CoV-2 uses to gain entry into host cells, cut the need for hospitalizations and emergency room visits compared to placebo in mild-to-moderate COVID-19 patients.

“We are impressed with Lilly’s data, in particular the reduction in hospitalizations,” commented David Reese, president of R&D at Amgen.

Lilly indicated that it would discuss the interim data with global regulators, including the FDA, and that discussions could also include the possibility of an emergency-use authorization. The companies indicated that the collaboration will allow them to “quickly scale up production,” should one or more of Lilly’s antibody therapies ultimately obtain regulatory approval. The ongoing BLAZE-1 trial is also testing LY-CoV555 in combination with LY-CoV016, a second Lilly antibody that binds a different target in the virus’ spike region.

It’s not the first time during the novel coronavirus pandemic that Lilly and Amgen have combined forces to boost COVID-fighting antibodies. In late June, both drugmakers joined a brain trust alongside AstraZeneca PLC, GlaxoSmithKline PLC, Roche Holding AG’s Genentech and AbCellera Biologics Inc.’s to share monoclonal antibody manufacturing secrets in an effort to get each member up to speed on manufacturing best practices. The unusual arrangement won the backing of the Department of Justice’s antitrust division, which said in a statement at the time that all six drugmakers wouldn’t be allowed to discuss pricing as part of their collaboration. (Ref: FirstWord Pharma)

Pfizer, Moderna divulge designs for Coronavirus vaccine trials.

Two drug companies that are leading the crucial race to develop coronavirus vaccines caved to public pressure on Thursday, ending their traditional secrecy and releasing broad blueprints of how they are assessing their vaccines. The companies, Pfizer Inc. (NYC) and Moderna Inc. (Cambridge MA), revealed details about how participants are being selected and monitored, the conditions under which the trials could be stopped early if there were problems, and the evidence researchers will use to determine whether people who got the vaccines were protected from COVID-19.

Moderna’s study will involve 30,000 participants, and Pfizer’s 44,000. Companies typically share these documents after their studies are complete. The disclosures while the trials are still underway, a rare move, are aimed at addressing growing suspicion among Americans that President Trump’s drive to produce a vaccine before the election on Nov. 3 could result in a product that was unsafe.

The plan released by Moderna on Thursday morning included a likely timetable that could reach into next year for determining whether its vaccine works. It does not match up with the president’s optimistic predictions of a vaccine widely available to the public in October. Pfizer’s plan does not appear to estimate when its results could be available. Its chief executive has said repeatedly that the company hopes to have an answer as early as October. Moderna has said only that it could have a result before the end of the year.

Moderna’s 135-page plan, or protocol, indicated that the company’s first analysis of early trial data might not be conducted until late December, though company officials now say they expect the initial analysis in November. In any case, there may not be enough information then to determine whether the vaccine works, and the final analysis might not take place until months later, heading into the spring of next year.

Moderna’s timeline meshes with the cautionary estimates from many researchers, including Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, who told senators last Wednesday that a vaccine would not be widely available until the middle of next year. Hours later, Mr. Trump sharply contradicted him, making unsubstantiated projections that a vaccine could become widely available weeks from now.

On Wednesday, Joseph R. Biden Jr., the Democratic presidential nominee, said in Wilmington, DE, that the process used to evaluate and approve a vaccine would have to be “totally transparent” to win public confidence. He has said that Mr. Trump’s calls for companies and regulators to speed the process have shaken the public’s faith in vaccines and that politics has no place in vaccine development. (Ref: The New York Times)

IPO Sector: Inhibikase Therapeutics Inc., a clinical stage biotech developing kinase inhibitors for Parkinson’s and related disorders, announced terms for its initial public offering. The Atlanta, GA-based company plans to raise $25 million by offering 2.3 million shares at a price range of $10 to $12. At the midpoint of the proposed range, Inhibikase would command a fully diluted market value of $151 million. The company’s pipeline contains lead candidate IkT-148009, a c-Abl protein kinase inhibitor being developed for Parkinson’s disease (PD) and related disorders that arise inside and outside of the brain. The company has filed two INDs for IkT-148009, one for PD and one for the treatment of PD-related gastrointestinal complications. Inhibikase Therapeutics was founded in 2008 and booked $1 million in grant revenue for the 12 months ended June 30, 2020. It plans to list on the Nasdaq under the symbol “IKT.” ThinkEquity is the sole bookrunner on the deal.

Elsewhere, Metacrine Inc., a Phase 1 biotech developing FXR agonist therapies for nonalcoholic steatohepatitis (NASH), raised $85 million by offering 6.5 million shares at $13, within the range of $12 to $14. At pricing, the company commands a fully diluted market value of $364 million. The company’s pipeline contains lead candidate MET409, a potent and sustained FXR agonist with the ability to be dosed orally once daily. MET409 demonstrated notable reductions in liver fat and improvements in other NASH biomarkers and was generally well tolerated in its Phase 1b trial as a monotherapy. The company plans to submit an IND in the 4Q20 and initiate a Phase 2a combination trial in the 1H21, with topline data expected in the 1H22. The San Diego, CA-based company was founded in 2014 and lists on the Nasdaq under the symbol “MTCR.” Metacrine lists on the Nasdaq under the symbol “MTCR.” Jefferies, Evercore ISI and RBC Capital were lead deal managers. Shares closed the week down 22% at $10.10.

Processa Pharmaceuticals Inc., which is developing an analog therapy for necrotic skin disease, lowered the proposed deal size for its upcoming IPO on Thursday. In its latest filing, the Hanover, MD-based company now plans to raise $18 million by offering 2.2 million shares at $8.45, the September 15th close of its shares on the OTCQB (PCSA). The company had previously filed to offer 2.5 million shares at a range of $7 to $9. At the revised price, Processa Pharmaceuticals will raise 9% less in proceeds than previously anticipated. Processa was founded in 2011 and plans to list on the Nasdaq under the symbol “PCSA.” Craig-Hallum Capital Group and The Benchmark Company are the joint bookrunners on the deal.

Taysha Gene Therapies Inc., an early stage biotech developing AAV-based gene therapies for central nervous system (CNS) disorders, announced terms for its IPO. The Dallas, TX-based company plans to raise $125 million by offering 6.6 million shares at a price range of $18 to $20. At the midpoint of the proposed range, Taysha Gene Therapies would command a fully diluted market value of $725 million. Founded in partnership with The University of Texas Southwestern Medical Center (UT Southwestern), Taysha Gene Therapies is focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations. One of its most advanced candidates, TSHA-101, is being developed for the treatment of GM2 gangliosidosis. The company plans to initiate a Phase 1/2 trial for TSHA-101 under a CTA in Canada by the end of 2020. In addition, it plans to submit INDs for four additional programs to the FDA by the end of 2021. Taysha Gene Therapies was founded in 2019 and plans to list on the Nasdaq under the symbol “TSHA.” Goldman Sachs, Morgan Stanley and Jefferies are the joint bookrunners on the deal. It is expected to price this week.

American Well Inc., which provides a telehealth platform for insurers and patients, raised $742 million by offering 41.2 million shares at $18, above the range of $14 to $16. Google agreed to invest $100 million in a concurrent private placement at the offer price. At the $18 offer price, the company commands a fully diluted market value of $4.5 billion. The Amwell Platform is a complete digital care delivery solution that equips its health system, health plan, and innovator clients with the tools to enable new models of care for their patients and members. Its scalable technology enables care delivery across a wide variety of clinical, retail, school, and home settings. The Boston, MA-based company was founded in 2006 and booked $202 million in revenue for the 12 months ended June 30, 2020. American Well lists on the NYSE under the symbol “AMWL.” Morgan Stanley and Goldman Sachs, among others, acted as lead managers on the deal. Shares closed the week up 28% at $23.02.

COMPASS Pathways PLC, a British Phase 2 biotech developing a psilocybin-based therapy for depression, raised $128 million by offering 7.5 million ADSs at $17, above the range of $14 to $16. The company offered 0.8 million more ADSs than anticipated. The company is focusing on using its proprietary formulation of psilocybin, COMP360, in conjunction with psychological support as a way to help individuals who have treatment-resistant depression, or TRD, a subset of major depressive disorder, or MDD. COMPASS is currently evaluating COMP360 in conjunction with psychological support in a Phase 2b trial and plans to report data from this trial in late 2021. Classified as a Schedule I drug, psilocybin is considered a serotonergic hallucinogen and is an active ingredient in some species of mushrooms. The Cheshire, UK-based company was founded in 2015 and lists on the Nasdaq under the symbol “CMPS.” Cowen, Evercore ISI and Berenberg are the joint bookrunners on the deal. Compass shares closed the week up 71% at $29.

Athira Pharma Inc., a Phase 2/3 biotech targeting the novel HGF/MET pathway for Alzheimer’s, raised $204 million by offering 12 million shares at $17, the high end of the range of $15 to $17. The company is developing small molecule therapies to restore neuronal health and stop neurodegeneration through its ATH platform. Athira’s lead candidate, ATH-1017, demonstrated improvements in brain network activity indicating potentially positive effects on brain function in nonclinical studies and Phase 1 clinical trials. The company plans to initiate a Phase 2/3 clinical trial for ATH-1017 by the end of 2020. The Seattle, WA-based company was founded in 2011 and lists on the Nasdaq under the symbol “ATHA.” Goldman Sachs, Jefferies and Stifel acted as lead managers on the deal. Shares closed the week up 1% at $17.11.

And BioVie Inc., a Phase 2 biotech developing therapies for cirrhosis, raised $16 million by offering 1.6 million shares at $10, below the last close of its shares on the OTC (BIVI). BioVie’s lead candidate, BIV201, is based on a drug (terlipressin) that is approved in about 40 countries to treat related complications of liver cirrhosis but is not yet available in the US. The company announced top-line results for its Phase 2a trial in April 2019, and it plans to begin a randomized 24-patient Phase 2 study in 2020 followed by a larger pivotal Phase 3 clinical trial targeted to begin in 2021. The Los Angeles, CA-based company was founded in 2013 and lists on the Nasdaq under the symbol “BIVI.” ThinkEquity and Kingswood Capital Markets acted as lead managers on the deal. Shares closed the week off one cent at

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