Natera, Genentech Initiate Phase 3 Trial of Early-Stage Muscle-Invasive Bladder Cancer Treatment

 Signatera used to identify muscle-invasive urothelial carcinoma patients who are MRD-positive after surgery, for enrollment in IMvigor011 study evaluating adjuvant immunotherapy with atezolizumab

Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the first patient has been screened in a new phase III clinical trial that uses its tumor-informed, personalized molecular residual disease (MRD) test, Signatera, as a companion diagnostic to identify muscle-invasive urothelial carcinoma (MIUC) patients eligible for investigational treatment with Genentech's, a member of the Roche group, cancer immunotherapy drug atezolizumab (Tecentriq)®.

The IMvigor011 study, sponsored by Genentech, is a global, randomized, placebo-controlled, phase III clinical trial to evaluate the safety and efficacy of adjuvant treatment with the PD-L1 inhibitor, atezolizumab, in patients with MIUC who are MRD-positive after surgery. Eligible patients will be screened with Signatera within the first 20 weeks after surgery, and the first approximately 500 patients who test MRD-positive will be enrolled and randomized to receive either atezolizumab or placebo for 12 cycles, or up to one year. The primary endpoint of the study will be disease-free survival.

"There is a strong unmet need in this population, as bladder cancer patients with residual disease post-surgery are known to be at the highest risk of recurrence," said Thomas Powles, M.D., Professor, Barts Cancer Institute, and Principal Investigator of the study. "The Signatera MRD test offers a personalized, real-time diagnostic to identify bladder cancer patients who need additional therapy and may benefit from adjuvant treatment with Tecentriq."

In an exploratory analysis from the phase III, randomized, controlled IMvigor010 trial, presented at the ESMO Immuno-Oncology conference in December 2020, the 37% of patients who tested MRD-positive with Signatera after surgery experienced significant benefit from adjuvant atezolizumab vs. observation (HR 0.59, p<0.001), while the 63% of patients who tested MRD-negative experienced zero treatment benefit. In an independent study of 68 patients with MIUC, published in the Journal of Clinical Oncology in 2019, Signatera detected relapse with 100% sensitivity and 98% specificity, reporting a median lead time of 96 days.1

https://finance.yahoo.com/news/natera-genentech-initiate-phase-iii-140300214.html

Pulmonix upped to Buy from Neutral by B of A

 Target $72

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

AbCellera-discovered bamlanivimab combo shows promise in late-stage COVID-19 trial

 

• AbCellera (ABCL +6.0%) announces that bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by AbCellera and developed with Eli Lilly (NYSE:LLY), and etesevimab 1400 mg (LY-CoV16) together reduced COVID-19-related hospitalizations and deaths by 87% in high-risk patients recently diagnosed with COVID-19.
• The results from this new randomized, double-blind, placebo-controlled Phase 3 BLAZE-1 study provide additional efficacy and safety data that support the use of the dose recently granted both EUA by the U.S. FDA, and a positive scientific opinion by the EMA CHMP.
• 87% reduction in COVID-19-related hospitalizations and deaths versus placebo (p<0.0001).
• No COVID-19-related deaths in the treatment group. All deaths occurred in patients treated with the placebo.
• Bamlanivimab alone and together with etesevimab are authorized under special/emergency pathways, in the context of the pandemic, in the U.S. and the European Union, the company said.

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Lilly's combo therapy for COVID-19 cuts serious illness and death in large study

 Eli Lilly and Co said on Wednesday that its combination antibody therapy to fight COVID-19 reduced the risk of hospitalization and death by 87% in a study of more than 750 high-risk COVID-19 patients.

It is the second large, late-stage study to show that combination therapy of two antibodies, bamlanivimab and etesevimab, is effective at treating mild to moderate cases of COVID-19.

The previous study, which published data in January, used a higher dose of the drugs and reduced risk of hospitalization by 70%.

“I expect this data to continue to drive more utilization” of the antibodies,” said Daniel Skovronsky, chief scientific officer at Eli Lilly.

“We have few other diseases where we have drugs that can offer this magnitude of benefit.”

U.S. regulators authorized the combination therapy in February for use in COVID-19 patients 12 and over with a high risk of developing serious complications. European regulators greenlighted its use in March.

The United States agreed in February to purchase a minimum of 100,000 doses of the combination treatment.

Regulators authorized bamlanivimab alone for use against COVID-19 last year and the U.S. government agreed to purchase nearly 1.5 million doses.

Skovronsky said the combination therapy has the benefit of offering greater protection against new strains of COVID-19.

A variant of COVID-19 originally discovered in Britain has infected patients in most U.S. states and is expected to become the country's dominant strain.

“We are quite confident this combo covers all of the variants in the U.S.,” Skovronsky said, adding Lilly is studying an additional treatment for new COVID strains first identified in South Africa and Brazil, which have not become widespread in the United States.

Skovronsky said that Lilly is prepared to manufacture 1 million doses of the combination therapy in the coming months and is in active talks to supply governments around the world with the treatment.

https://www.reuters.com/article/health-coronavirus-lilly/eli-lillys-combo-therapy-for-covid-19-cuts-serious-illness-and-death-in-large-study-idUSL1N2L72VV

UK COVID-19 variant has significantly higher death rate: study

 A highly infectious variant of COVID-19 that has spread around the world since it was first discovered in Britain late last year is between 30% and 100% more deadly than previous strains, researchers said on Wednesday.

In a study that compared death rates among people in Britain infected with the new SARS-CoV-2 variant, known as B.1.1.7, against those infected with other strains, scientists said the new variant had “significantly higher” mortality.

The B.1.1.7 variant was first detected in Britain in September 2020, and has since been found in more than 100 countries.

It has 23 mutations in its genetic code - a relatively high number of changes - and some of these have made it far more able to spread. UK scientists say it is about 40%-70% more transmissible than previously dominant circulating coronavirus variants.

In the UK study, published in the British Medical Journal on Wednesday, infection with the new variant led to 227 deaths in a sample of 54,906 COVID-19 patients, compared with 141 among the same number of patients infected with other variants.

“Coupled with its ability to spread rapidly, this makes B.1.1.7 a threat that should be taken seriously,” said Robert Challen, a researcher at Exeter University who co-led the research.

https://www.reuters.com/article/us-health-coronavirus-variant-britain/uk-covid-19-variant-has-significantly-higher-death-rate-study-finds-idUSKBN2B213E

Pfizer wants to make vaccine in India if faster clearance, export freedom assured

 Pfizer Inc has told the Indian government it wants to produce its coronavirus vaccine locally if assured of faster regulatory clearance and freedom on pricing and exports, two sources with direct knowledge of the matter told Reuters.

The U.S. company pulled an application last month seeking emergency approval for its product in India after the drug regulator declined its request to skip a small local safety trial. That has kept its vaccine, developed with Germany’s BioNTech SE, out of one of the world’s biggest drug markets.

Pfizer was the first company to apply for emergency use authorisation in India, proposing to import doses from its U.S. and European facilities instead of producing locally.

“U.S. companies want to produce vaccines in India under joint ventures,” said one of the sources, citing Pfizer and fellow U.S. drugmaker Moderna Inc.

“They want faster approvals for clinical trials and emergency authorisation use. They fear the government will introduce price control policies.”

Another source confirmed Pfizer was interested in manufacturing in India but Reuters could not find a second confirmation on Moderna.

The companies did not immediately respond to requests for comment. India’s health ministry directed Reuters to the foreign ministry, which did not immediately respond to emailed queries.

While withdrawing its application in early February, Pfizer said it would again seek emergency use approval to launch its COVID-19 vaccine in India, potentially a market of 1.35 billion people, and would provide more data as it becomes available.

On the government’s demand to manufacture in India, the company earlier told Reuters: “Once the pandemic supply phase is over and we enter a phase of regular supplies, Pfizer will evaluate all additional opportunities available.”

An Indian official told Reuters in January the government had held discussions with Pfizer and Moderna - both of which have reported more than 90% efficacy for their vaccines - to make the shots in India given its large pharmaceuticals capacity.

The Serum Institute of India, the world’s largest vaccine maker, is already bulk-manufacturing the Oxford University/AstraZeneca product and plans to start producing the Novavax Inc shot from next month.

India’s government has not allowed it to sell on the higher-priced private market, however, and is also controlling exports. Pfizer and Moderna, whose shots are more expensive than the AstraZeneca one being used in India’s immunisation campaign, are not comfortable with strict price and export restrictions, one of the sources said.

This week, Reuters reported that leaders of the Quad alliance - Australia, Japan, India and the United States - plan to announce financing agreements to increase India’s vaccine manufacturing capacity at their first meeting on Friday.

The initiative will mainly involve production of the Novavax and Johnson & Johnson shots for supplying to regions including Southeast Asia, where their common rival China is making gains.

https://www.reuters.com/article/us-health-coronavirus-india-pfizer/exclusive-pfizer-wants-to-make-vaccine-in-india-if-faster-clearance-export-freedom-assured-sources-idUSKBN2B21AY

Mallinckrodt $1.3B Lenders Back Restructuring

 Mallinckrodt plc (OTCMKTS: MNKKQ) ("Mallinckrodt" or the "Company") today announced that it has reached agreement with an ad hoc group of first lien term lenders holding approximately $1.3 billion of its outstanding First Lien Term Loans (the "First Lien Term Loan Lenders") to support the Company's previously announced restructuring support agreement ("RSA"). The agreement, which is based on providing new term loans financing to replace the First Lien Term Loans, resolves the open dispute between the Company and the First Lien Term Loan Lenders as to how such Lenders are to be treated under the restructuring plan and serves to extend near-term debt maturities.

https://www.prnewswire.com/news-releases/mallinckrodt-gains-support-for-its-restructuring-support-agreement-from-lenders-holding-approximately-1-3-billion-of-its-first-lien-term-loans-301244231.html