UK-based biotech Achilles Therapeutics sets terms for $176 million US IPO

 Achilles Therapeutics, a Phase 1/2 biotech developing precision T cell therapies for solid tumors, announced terms for its IPO on Thursday.

The London, UK-based company plans to raise $176 million by offering 9.8 million ADSs at a price range of $17 to $19. At the midpoint of the proposed range, Achilles Therapeutics would command a fully diluted market value of $734 million.

The company's pipeline contains cNeT product candidate ATL001, which is currently being evaluated in two open-label Phase 1/2a trials for advanced NSCLC and metastatic or recurrent melanoma, with interim data expected in the 2H22. The company expects to file INDs for its earlier stage programs, HNSCC and RCC, in the 2H21 and the 2H23, respectively.

Achilles Therapeutics was founded in 2016 and plans to list on the Nasdaq under the symbol ACHL. J.P. Morgan, BofA Securities and Piper Sandler are the joint bookrunners on the deal. It is expected to price during the week of March 29, 2021.

Relevant Profile: ACHL

https://www.renaissancecapital.com/IPO-Center/News/80011/UK-based-biotech-Achilles-Therapeutics-sets-terms-for-$176-million-US-IPO

Cuomo gave family members special access to COVID-19 tests: Washington Post

 New York Governor Andrew Cuomo gave family members, including his brother, CNN anchor Chris Cuomo, special access to state-administered COVID-19 tests in the early days of the pandemic, the Washington Post reported on Wednesday.

Andrew Cuomo, a Democrat, faces bipartisan calls to resign over accusations of sexual harassment or misconduct from at least eight women and disclosures that his administration under-reported nursing home deaths from the pandemic.

The 63-year-old third-term governor has denied the allegations and repeatedly said he would not resign.

The Post, which cited three unnamed people with knowledge of the situation, reported that a top state doctor made house calls to some of the governor’s family members or close associates, including his brother, to administer the tests. Chris Cuomo tested positive for COVID-19 early in the pandemic.

Reuters could not immediately confirm the reports.

“We should avoid insincere efforts to rewrite the past. In the early days of this pandemic, when there was a heavy emphasis on contact tracing, we were absolutely going above and beyond to get people testing,” Cuomo spokesman Richard Azzopardi said in a statement emailed to Reuters in response to the Post article.

Those efforts included “in some instances going to people’s homes - and door to door in places like New Rochelle - to take samples from those believed to have been exposed to COVID in order to identify cases and prevent additional ones,” the statement added.

Among those assisted, “were members of the general public, including legislators, reporters, state workers and their families who feared they had contracted the virus and had the capability to further spread it,” Azzopardi said.

CNN said in a statement emailed to Reuters: “We generally do not get involved in the medical decisions of our employees.”

“However, it is not surprising that in the earliest days of a once-in-a-century global pandemic, when Chris (Cuomo) was showing symptoms and was concerned about possible spread, he turned to anyone he could for advice and assistance, as any human being would,” the network said.

Chris Cuomo had conducted a series interviews - which some critics called gentle or even comical - on CNN with his older brother during the pandemic.

After the nursing home and sexual misconduct scandals broke, the network said its conflict-of-interest policy meant that Chris Cuomo could not report on the governor.

Chris Cuomo tweeted on Monday that he was on vacation. On Tuesday, his television show’s official Twitter handle said he would be back next week.

https://www.reuters.com/article/us-new-york-cuomo/cuomo-gave-family-members-special-access-to-covid-19-tests-washington-post-idUSKBN2BH06D

AstraZeneca vaccine's global rollout faces more complications

 The rollout of AstraZeneca’s COVID-19 vaccine, the shot much of the world is relying on to beat the pandemic, faced further complications on Thursday as India halted exports of the vaccine and Europe discussed its own export controls.

India has put a temporary hold on all major exports of the Anglo-Swedish firm’s vaccine from the Serum Institute of India (SII), the world’s biggest vaccine maker, to meet domestic demand as infections rise, two sources said.

That could delay supplies to dozens of lower-income countries also relying on SII production under the COVAX vaccine-sharing scheme backed by the World Health Organization.

“We understand that deliveries of COVID-19 vaccines to lower-income economies participating in the COVAX facility will likely face delays...,” the programme’s procurement and distributing partner UNICEF told Reuters.

India’s move comes as the European Union meets on Thursday to consider giving member states greater scope to block vaccines being exported outside the bloc, much of which is struggling to bring infections down and ramp up immunisation campaigns.

The proposal would apply to all vaccines including AstraZeneca’s, on which the EU had originally been relying to meet a goal of inoculating 70% of its adult population by this summer.

AstraZeneca’s vaccine is seen as crucial in tackling the pandemic as it is cheaper and easier to transport than many rival shots.

The EU accuses the drugmaker of over-selling its vaccine and unfairly favouring Britain, where AstraZeneca developed the shot with Oxford University - a charge denied by the company.

Brussels agreed with London this week to strive for a “win-win” solution, but even if the EU resists export controls, it faces another problem: declining confidence in the AstraZeneca shot due to concerns over side-effects and efficacy data.

Denmark will suspend its use of the vaccine for another three weeks pending further investigations into a potential link between the vaccine and blood clots, Danish broadcaster TV 2 reported on Thursday, citing sources.

More than 10 other nations also suspended rollout of the vaccine over similar concerns but most have since restarted. The European Medicines Agency said last week it was safe and not linked with a rise in overall risk of blood clots.

However, many Europeans remain wary.

A third of Danes would refuse the AstraZeneca vaccine, according to a survey published by Danish media on Wednesday. Confidence has also taken a big hit in Spain, Germany, France and Italy.

AstraZeneca revised down, slightly, the vaccine’s efficacy to 76% in a new analysis of its U.S. trial. Interim data published on Monday had put the vaccine’s efficacy rate at 79% but had not included more recent infections, leading to a highly unusual public rebuke from U.S health officials.

AstraZeneca, which is awaiting U.S. regulatory approval, also reiterated the shot was 100% effective against severe or critical forms of COVID-19.

“The vaccine efficacy against severe disease, including death, puts the AZ vaccine in the same ballpark as the other vaccines,” said William Schaffner, an infectious disease expert from the Vanderbilt University School of Medicine, adding he expects the shot to gain U.S. approval.

The vaccine has already been granted conditional marketing or emergency use authorisation in more than 70 countries.

In Europe, the leaders of France and Germany admitted on Thursday that the problem of slow vaccine rollouts inside the EU went beyond the question of whether to control exports.

German Chancellor Angela Merkel said EU leaders would also discuss how to boost internal production of vaccines.

“British production sites are manufacturing for Britain and the United States is not exporting, so we are reliant on what we can make in Europe,” she told German lawmakers.

French President Emmanuel Macron said the EU itself should take some blame - that its vaccine plans had lacked ambition.

“We didn’t shoot for the stars,” he told Greek television channel ERT. “That should be a lesson for all of us.”

https://www.reuters.com/article/us-health-coronavirus-astrazeneca/astrazeneca-vaccines-global-rollout-faces-more-complications-idUSKBN2BH1S1

Bristol-Myers: Antibody + Opdivo Meets Primary Endpoint of Progression-Free Survival in Melanoma

• First Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody

Relatlimab is the company’s third distinct checkpoint inhibitor to demonstrate a benefit for patients

Bristol Myers Squibb (NYSE: BMY) today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. The trial met its primary endpoint of progression-free survival (PFS). Follow up for overall survival, a secondary endpoint, is ongoing. The fixed-dose combination was well-tolerated and there were no new safety signals reported in either the relatlimab and Opdivo combination arm or the Opdivo arm. These are the first Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody. Relatlimab is the third distinct checkpoint inhibitor (anti-PD-1, anti-CTLA-4 and anti-LAG-3) for Bristol Myers Squibb and, with Opdivo, the first fixed-dose combination to demonstrate a benefit for patients.

https://finance.yahoo.com/news/bristol-myers-squibb-announces-relativity-105900120.html

eHealth cut to Neutral from Buy by Goldman Sachs

 Target $63

https://finviz.com/quote.ashx?t=EHTH

ImmunoPrecise Antibody, 23-H7, Binds All Tested SARS-CoV-2 Variants of Concern

 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, today announced the identification of antibody 23-H7, which preclinical data obtained to date indicates provides strong, protective anti-viral effects in SARS-CoV-2 (COVID-19) infected Syrian hamsters via an uncommon mechanism of action.

While 23-H7 is able to perturb the interaction between the Receptor Binding Domain (RBD) and the host receptor ACE2, its epitope is not located on the mutation prone RBD/ACE2 interface, unlike the spike protein regions targeted by current, commercial SARS-CoV-2 therapies. As a result, 23-H7 is anticipated to be less vulnerable to escape mutations within the spike protein/ACE2 binding interface, like escape mutation of concern E484K. In line with this, IPA demonstrated that 23-H7 maintained binding to the full (cell-associated) spike trimer of emerging SARS-CoV-2 variants of concern B.1.1.7 (UK), B.1.351 (S. African), and P.1 (Brazilian), despite published data stating that many highly neutralizing antibody therapies against SARS-CoV-2, as well as most convalescent sera and vaccine-induced immune sera, show reduced activity against viral variants.

Notably, in vivo efficacy evaluation of antibody 23-H7 when administered as a passive vaccine, twenty-four hours prior to infecting Syrian hamsters with the SARS-CoV-2-D614G, resulted in undetectable replication competent virus titer in the lungs of four of the five animals 4 days post infection, with the remaining animal showing a replication competent viral titer barely above the lowest level of detection. As binding of this antibody to multi- and single-mutated spike protein trimers and fragments, respectively, appears to be unaffected, IPA anticipates that this antibody has the potential to maintain similar in vivo protective efficacy against corresponding viral variants.

https://www.businesswire.com/news/home/20210325005338/en/ImmunoPrecise-Identifies-a-Unique-Antibody-23-H7-That-Demonstrates-In-Vivo-Efficacy-an-Alternative-Mechanism-of-Action-and-Binds-all-Tested-SARS-CoV-2-Variants-of-Concern

La. Gov. opens vaccine accessibility to all over age 16 Monday

 With coronavirus vaccine supplies growing and immunization appointments going unused, Louisiana will end its limits Monday on which adults can receive the shots, giving access to anyone 16 and older who wants to schedule an appointment.

Gov. John Bel Edwards announced the eligibility change Wednesday, joining a growing list of states throwing open vaccine access to any adult who is interested in a shot. President Joe Biden’s administration wants all states to make every adult eligible for the vaccine by May 1.

In addition to expanding vaccine access, Edwards said Louisiana also will significantly ramp up its large community vaccination events to try to reach more people and make it easier for them to obtain a shot.

Louisiana already allowed most adults to have access to any of the three available coronavirus vaccines, if they meet one of two dozen medical conditions or were employed in one of the fields on a long list of “essential” jobs. The Democratic governor’s announcement simply removes the need for someone to claim one of those conditions or jobs.

Those who are 16 or 17 only have access to the Pfizer vaccine because it’s currently the lone vaccine available in the United States authorized for people that age.

The state already has been doing drive-thru and walk-in mass immunizations at convention centers, sports stadiums, fairgrounds, event centers and churches — in coordination with hospitals, clinics and pharmacies and using the Louisiana National Guard to help staff the sites.

But still, some vaccination sites have reported available appointments that are not filled.

The health department last week launched a broad outreach campaign aimed at getting vaccines to people in underserved areas and persuading those who are skeptical. Officials said removing all eligibility restrictions for adults will remove questions and uncertainty about who can get a shot.

Edwards’ decision comes as the Biden administration announced it’s increasing the vaccine doses shipped to states each week, particularly as more of the one-dose Johnson & Johnson shot becomes available. The White House said 27 million doses of vaccines will be distributed across states next week, more than three times the number when Biden took office two months ago.

Nearly 1.1 million people in Louisiana — 23% of the state’s total population — has received at least one dose of the vaccine, according to state health department data. More than 611,000 people have been fully immunized. The Pfizer and Moderna vaccines require two doses; the Johnson & Johnson vaccine requires only one.

Louisiana continues to lag behind many other states in vaccine distribution. The state ranked 40th among states Wednesday in the number of vaccine doses administered per capita, according to the U.S. Centers for Disease Control and Prevention.

The health department has launched a grassroots campaign modeled after get-out-the-vote efforts in elections, with organizations knocking on doors and making phone calls to encourage vaccination, provide information about the shots and help people sign up for appointments.

https://www.klfy.com/health/coronavirus/gov-edwards-opens-vaccine-accessibility-to-everyone-over-age-16/