Wells Fargo, BlackRock delay office returns over rising COVID-19 cases

 Wells Fargo and BlackRock announced Thursday that they’re pushing back their return-to-office plans to October amid rising cases of COVID-19.

Wells Fargo, the largest workforce of any US bank with almost 260,000 employees, said it will start calling workers back to the office on Oct. 4, rather than Sept. 7 as previously planned, according to an internal memo from Chief Operating Officer Scott Powell.

“The delta variant does not change the basic facts: vaccinated people are at lower risk of becoming infected with Covid-19, and much lower risk of becoming seriously ill and requiring hospitalization if they do become infected,” Powell wrote in the memo.

Wells Fargo is giving workers eight hours paid time off to get vaccinated.

“Please take advantage of the extra time off that Wells Fargo offers for you to get vaccinated,” Powell added.

Moments after Wells Fargo’s decision was reported, BlackRock, the world’s largest asset manager, announced they’re also pushing back their return-to-office plans to Oct. 1.

Blackrock had previously announced a “re-acclimation period” from from July 1 through Sept. 1, during which people were not required to come into the office, but any employee who wanted to go to the office had to be vaccinated.

“During this extended re-acclimation period, we will continue to allow only fully vaccinated individuals in our U.S. offices,” the company said in an internal memo, which was obtained by The Post.

“We will provide an update on our Future of Work pilot in early September and appreciate your patience as we work through the details amidst this evolving situation,” the memo added.

BlackRock’s memo was signed by COO Robert Goldstein, global head of human resources Manish Mehta and Chief Security Officer Larry Knafo.

Other top banks are taking a wait-and-see approach. Goldman Sachs, the first Wall Street firm to demand employees work from the office full time, said it’s observing all local mandates, declining to comment further. Insiders say Goldman executives have yet to make a decision on mandating masks or expanding the option to work from home.

Morgan Stanley, whose CEO James Gorman has demanded workers return to the office or face a pay cut, is still demanding workers are back at their desks after Labor Day. The white shoe firm has no imminent plans to change that requirement.

JPMorgan is re-evaluating their policies and considering upping mask requirements — but they have yet to land on a final decision.

Bank of America and Citibank tell The Post they continue to keep an eye on the Delta variant but have no updates.

https://nypost.com/2021/08/05/wells-fargo-blackrock-delay-office-returns-over-rising-covid-cases/

Aprea: Partial Clinical Hold on Myeloid Malignancy Programs

 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its clinical trials of eprenetapopt in combination with azacitidine in its myeloid malignancy programs. The partial clinical hold does not apply to the Company’s ongoing clinical trials in lymphoid malignancies and solid tumors, or the APR-548 clinical trial.

There are approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in the Company’s myeloid malignancy programs, which includes the MDS, AML and post-transplant maintenance trials, all of which have completed enrollment. Patients who are benefiting from treatment can continue to receive study treatment. As part of the clinical hold, no additional patients can be enrolled to these trials until the partial clinical hold is resolved. Aprea intends to work closely with the FDA to analyze the data, address the specific questions raised, and seek to resolve the partial clinical hold as soon as possible.

https://finance.yahoo.com/news/aprea-therapeutics-announces-partial-clinical-210000544.html

Moderna, citing variants, waning immunity, sees COVID boosters becoming fact of life

 For anyone thinking aggressive COVID-19 vaccine rollouts would bring a quick end to the pandemic, Moderna has a word of caution. While U.S. authorities aren’t yet ready to recommend vaccine boosters, the company believes that add-on shots will become a fact of life for some as the virus sticks around and continues to put up a fight.

As the world battles the Delta variant, Moderna believes the stronger form of the virus—combined with waning immunity for early vaccine recipients—will lead to breakthrough infections in the months to come, company president and R&D chief Stephen Hoge told analysts on Thursday. The company expects a third dose of mRNA vaccines will “likely be necessary” before the winter to keep people “as safe as possible,” Hoge added.

Still, U.S. authorities haven’t yet recommended boosters, as experts debate whether lower neutralizing antibodies will translate into lower protection. In one of its vaccine studies, Moderna said that "neutralizing antibody titers had waned significantly" prior to boosting at six months. 

On the flip side of the argument, Moderna also released data on Thursday showing that its vaccine remains 93% effective six months after the second dose. While those data look solid, the Delta variant has “taught us to be incredibly humble in the face of the virus’ ability to fight back and increase transmission,” Hoge said.  

For potential boosters, Moderna is exploring a three-pronged strategy. First, the company is testing a third dose of its original shot, dubbed mRNA-1273 or Spikevax. In addition, the company is testing variant-specific boosters and multivariant shots. 

The follow-up shots are intended to act as a safeguard against viral mutations and waning immunity, Hoge explained. While Delta is posing serious challenges right now, the company is anticipating future mutations that will serve as moving targets.

In addition, existing mutations could combine in “new and scary ways," Hoge said. With Moderna’s multivalent approach, the company is trying to get ahead of that threat, Hoge said. 

For its part, the World Health Organization this week called for a moratorium on coronavirus booster shots until poorer countries can get parts of their population immunized. Disregarding that plea, France and Germany plan to start offering boosters next month, Reuters reported Thursday. Israel has started offering booster doses, as well.

Moderna plans to comply with health officials’ recommendations and is only offering its own viewpoint on the evolving situation, Hoge said.

A Massachusetts mRNA specialist, Moderna has made a global name for itself during the pandemic. The company has taken COVID-19 vaccine orders worth about $20 billion in 2021, and its supply for the year of up to 1 billion doses is all bought up.

For next year, Moderna expects to produce between 2 billion and 3 billion vaccine doses. The company has already inked supply deals worth $12 billion for next year, and those agreements include options worth another $8 billion. In the longer term, some “forward-thinking” countries are negotiating 2023 supply deals, Moderna said.

Moderna believes this is “not the last round of the fight” with SARS-CoV-2, Hoge said. In fact, the company expects several more challenges from the virus in the years to come.

While the company hopes the virus will get weaker with time, Moderna thinks the virus is “here to stay” and that high-risk populations will need regular boosters to stay protected, the exec said.

https://www.fiercepharma.com/pharma/moderna-citing-variants-and-waning-immunity-expects-covid-19-boosters-to-become-a-fact-life

Cardinal Health tumbles after big Q4 profit miss and downbeat outlook

 Shares of Cardinal Health Inc. CAH, -14.26% tumbled 13.7% toward a nine-month low in afternoon trading Thursday, after the distributor of drugs and laboratory products reported a big fiscal fourth-quarter earnings miss, and provided a downbeat outlook, as results were hurt by a $197 million COVID-related inventory reserve, related to personal protective equipment. The stock, which paced the S&P 500's SPX, +0.60% decliners, was also on track to suffer the biggest one-day selloff since May 2018. Net income for the quarter to June 30 fell to $116 million, or 40 cents a share, from $656 million, or $2.23 a share, in the year-ago period. Excluding nonrecurring items, adjusted earnings per share came to 77 cents, missing the FactSet consensus of $1.20. Revenue grew 16% to $42.59 billion, topping the FactSet consensus of $40.39 billion. Pharmaceutical revenue increased 15% to $38.3 billion, topping expectations of $36.7 billion, while medical revenue grew 23% to $4.2 billion but came up short of expectations of $4.28 billion. For fiscal 2022, the company expects adjusted EPS of $5.60 to $5.90, while the current FactSet EPS consensus $6.13. The stock has shed 4.9% year to date, while the SPDR Health Care Select Sector ETF XLV, -0.41% has rallied 17.0% and the S&P 500 SPX, +0.60% has advanced 17.7%.

https://www.marketwatch.com/story/cardinal-health-stock-tumbles-to-pace-sp-500-losers-after-big-q4-profit-miss-and-downbeat-outlook-2021-08-05

Sierra picks up AstraZeneca cancer drug to pair with Gilead castoff

 AstraZeneca has offloaded its BRD4 BET inhibitor AZD5153 to Sierra Oncology. Sierra plans to start a phase 2 trial testing the drug in combination with the JAK inhibitor it picked up from Gilead Sciences in 2018.

Work on a phase 1 trial of AZD5153, as well as a platform study featuring multiple drugs, wrapped up earlier this year. Preliminary data posted in 2019 from the phase 1 solid tumor and lymphoma study found AZD5153 was safe and tolerated, but at that stage AstraZeneca was yet to generate evidence that the bivalent binding of the drug translates into improved anti-tumor activity in humans.

AstraZeneca removed AZD5153 from its phase 1 pipeline late last year, but Sierra sees promise in the candidate, leading it to pay $8 million upfront and commit to up to $208 million in milestones for the exclusive global rights. The deal sets Sierra up to assess the effect of giving AZD5153 in combination with JAK1/JAK2 inhibitor momelotinib to patients with the bone marrow cancer myelofibrosis.

News of the planned combination study comes as Sierra waits for results from a pivotal clinical trial that is testing momelotinib as a monotherapy in myelofibrosis. Results are due in the first quarter of 2022. In a statement, CEO Stephen Dilly said AZD5153 may “enhance and extend” Sierra’s ability to treat myelofibrosis patients. 

Other groups have identified the same opportunity. Late last year, Constellation Pharmaceuticals shared phase 2 data from myelofibrosis patients who took its BET inhibitor pelabresib in combination with Incyte’s Jakafi. Constellation is betting dual inhibition of JAK and BET will improve on the single agent effects of Jakafi, which is already approved in myelofibrosis.

Sierra thinks its combination may have an edge over rival cocktails. Myelosuppression is typically an issue when combining drugs to treat myelofibrosis, leading to patients developing grade 3 and worse anemia, and Sierra predicts its combination will have an advantage in that regard.

“Unlike currently available JAK inhibitors, momelotinib is not myelosuppressive, therefore the combination of momelotinib and AZD5153 may provide an efficacy and safety advantage over other JAK inhibitor plus BET inhibitor combinations and allow for prolonged dose intensity and treatment duration,” Sierra said.

A phase 2 trial of the AZD5153-momelotinib combination is set to start in the first half of next year. Sierra plans to run the study to provide preliminary proof of concept for a future confirmatory study.

The study is the result of Sierra’s identification of opportunities to pick up assets that have fallen out of favor at larger companies. Gilead paid $510 million to acquire YM BioSciences and get its hands on momelotinib, only for setbacks in the clinic to persuade it to offload the drug candidate to Sierra for $3 million upfront. Now, Sierra has bet a further $8 million to put together a midphase combination without breaking the bank. 

https://www.fiercebiotech.com/biotech/sierra-raids-bargain-bin-again-picking-up-astrazeneca-cancer-drug-to-pair-gilead-cast-off

Novavax again delays seeking U.S. approval for COVID-19 vaccine

 Novavax Inc on Thursday again delayed its timeline for seeking authorization for its two-dose vaccine in the United states, and the company now expects to file for emergency use authorization in the fourth quarter of 2021.

It had previously said it would seek authorization from the U.S. Food and Drug Administration (FDA) in the third quarter of 2021.

Novavax shares dropped more than 11% in after-hours trading on the news.

"It's a matter of getting validation work done" to demonstrate consistency in its vaccine manufacturing process to the FDA, said Chief Executive Officer Stanley Erck, adding that other countries' regulators have been more aggressive in moving Novavax's vaccine through the authorization process.

Despite promising clinical data, the Maryland-based company has lagged rival vaccine makers such as Pfizer Inc and Johnson & Johnson. It has repeatedly delayed its regulatory filings and timeline for ramping up production as it struggled to access raw materials and equipment needed to make its vaccine.

The company said it has filed for regulatory authorization of NVX-CoV2373 in India, Indonesia and the Philippines and expects to file for World Health Organization's emergency listing for its vaccine this month, which is a prerequisite for exports to numerous countries participating in the COVAX Facility.

Erck told Reuters the company is on track to submit regulatory filing in the United Kingdom in September followed within weeks by submissions in Australia and Canada.

He expects Novavax to emerge as a major distributor of vaccines to lower and middle-income countries in 2021.

Separately, Novavax said a single booster shot of its vaccine given six months after an initial two-dose regimen, elicited a 4.6-fold increase in antibodies.

According to Erck, the company will file a separate application with the FDA once its emergency use authorization submission is processed.

The company said it remained on track to produce 100 million doses per month by the third quarter and 150 million doses by the fourth quarter.

"We appear to have got past (certain) supply issues and are now being able to produce at scale," Erck said.

https://www.marketscreener.com/quote/stock/NOVAVAX-INC-58256108/news/Novavax-again-delays-seeking-U-S-approval-for-COVID-19-vaccine-36085094/

Amazon postpones return to office until January 2022

 Amazon is postponing a return to the office for its corporate employees until early next year, becoming the latest tech company to do so amid a rise in Covid-19 cases due to the highly contagious delta variant.

Corporate employees in the U.S. and some other countries will begin returning to the office beginning Jan. 3, 2022, the company confirmed to CNBC. Previously, Amazon had said it expected most of its employees to begin returning regularly to the office the week of Sept. 7 of this year.

GeekWire previously reported Amazon’s updated return-to-work guidance.

In recent weeks, other technology companies including Google, Facebook, Apple and Twitter have adjusted their return-to-work plans amid a rise in Covid-19 cases.

Unlike Google and Facebook, Amazon won’t require workers returning to its office to be vaccinated. Amazon CFO Brian Olsavsky confirmed this in a call with reporters following the company’s second-quarter earnings report last week.

The company will require employees to wear masks in the office, unless they show proof of full vaccination, Amazon said.

Amazon in June walked back its guidance around remote work. The company said it expects employees to work in the office three days a week, leaving them the option to work remotely up to two days a week. That was a significant U-turn from its March guidance, when it said its goal was to “return to an office-centric culture as our baseline.”

https://www.cnbc.com/2021/08/05/amazon-postpones-return-to-office-until-january-2022-.html