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Tuesday, August 11, 2020

Bristol-Myers’ Opdivo successful in two late-stage studies

Bristol-Myers Squibb (NYSE:BMY) announces positive results from two Phase 3 clinical trials involving PD-1 inhibitor Opdivo (nivolumab).
CheckMate-577: Opdivo as adjuvant therapy in patients with resected esophageal or gastroesophageal junction (GEJ) cancer. The primary endpoint of disease-free survival (DFS) was met at a prespecified interim analysis.
CheckMate-649: Opdivo plus chemo compared to chemo alone for the first-line treatment of metastatic gastric cancer, GEJ or esophageal adenocarcinoma. Both primary endpoints, overall survival (OS) and progression-free survival (PFS), were met.
Results will be shared with health authorities and presented at upcoming medical conferences.

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LabCorp launches no-charge COVID-19 antibody test service

For the next three months, LabCorp (NYSE:LH) will perform COVID-19 antibody blood tests at no charge to patients, insurance companies or the government.
The program is aimed at boosting donations of convalescent plasma that can be used to treat patients with active infections. People who have tested positive for COVID-19 and have not experienced symptoms for at least two weeks or who have antibodies to SARS-CoV-2 are likely candidates for plasma donation.

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Bio-Techne debuts new SARS-CoV-1/2 Spike RBD antibody

Bio-Techne (NASDAQ:TECH) announces the release of the SARS-CoV-1/2 Spike RBD LlaMABody Recombinant Antibody, which binds to the SARS-CoV-2 spike receptor binding domain (RBD) and blocks the virus from binding to its host receptor inhibiting viral infection.
This is the first camelid antibody offering in the company’s new LlaMABody product line as well as the first commercially available antibody produced using the VHH72 CoV-2 RBD Blocking/Neutralization clone.
“This new SARS-CoV-1/2 Spike RBD LlaMABody Recombinant Antibody is just part of a growing portfolio of tools from Bio-Techne that support SARS-CoV-2 research, diagnostics and therapeutic development,” commented Dave Eansor, President of Bio-Techne’s Protein Sciences Segment.
LlaMABody is a trademark of Bio-Techne. Nanobodies is a trademark of Ablynx N.V.

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CytoDyn announces ‘positive’ results from mid-stage COVID-19 study

CytoDyn (OTCQB:CYDY -1.9%) reports, what it says, are “clinically significant” results from its Phase 2 clinical trial evaluating leronlimab in COVID-19 patients with mild-to-moderate symptoms.
The primary endpoint was the proportion of patients showing clinical improvement, as determined by the change in total clinical symptom score (TCSS), at day 14 compared to placebo, the results of which are not reported.
Instead, it announces day 3 results in a subgroup of patients with a TCSS of at least 4. 90% of patients in this group reported improvements compared to 71% in the placebo arm, a separation that is not indicated to be statistically significant.
One secondary endpoint, the change from baseline in National Early Warning Score 2 (NEWS2), which measures seven clinical parameters such as respiration rate and oxygen saturation, was met. At day 14, 50% of treated patients showed improvement compared to 20% in the control group (p=0.0223).
No data are provided on the other 11 secondary endpoints.
No safety signals were observed.
Management will host a conference call tomorrow, August 12, at 4:00 pm ET to discuss the results.
https://seekingalpha.com/news/3604053-cytodyn-announces-positive-results-from-mid-stage-covidminus-19-study

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Vaccine hopes push rates away from all-time lows

The enthusiasm for COVID vaccine progress is pushing money toward risk and out of traditional safe havens like bond and gold and newer ones like big tech.
The selloff in bonds is lifting interest rates solidly away from the record lows they were testing last week. Yields are rising across the Treasury curve, with the 2-year up to 0.14%, the 5-year at 0.27%, the 10-year rising to 0.64%, the 20-year at 1.1% and the 30-year Treasury up to 1.32%.
The iShares 20+ Treasury Bond ETF (TLT, -1.5%) is falling, with the ProShares UltraShort 20+ Treasury ETF (TBT, +3%) heading the opposite way.
The 10-year yield was threatening to close below 0.5% last week for the first in ever but managed to hold and then climb following the July employment report. It’s now back to around levels seen in mid-to-late July.
Real yields are also rising, with the 10-year Treasury inflation protected yield fighting its way back to above -1% at -0.99%.
Bonds have been rallying for almost two years, with TLT up nearly 50% from its November 2018 low of $112.
But for the landscape to really change, there needs to be sustained adjustment in real growth, Jack Manley, global market strategist at J.P. Morgan, says.
“Certainly things are going to snap back in the third quarter … is that sustainable in the fourth quarter, for next year … I don’t think so,” Manley tells Bloomberg, adding that he’s in the camp for lower-for-longer rates.
He does see some attractiveness in stocks that will benefit from higher rates like banks, though.
Big banks have “fortress balance sheets” and can emerge “reasonably unscathed in 2021, 2022,” he says.

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Moderna slips on potential COVID-19 patent issue

Moderna (MRNA -1.3%) discloses that it “cannot be certain” that it was the first to make the inventions claimed in its patents or pending patent applications related to COVID-19 vaccine candidate mRNA-1273, the first time it has used such language in its financial statement filings.
The National Institutes of Health (NIH) may hold joint ownership claims to the vaccine, pointed out six weeks ago by Axios and Public Citizen. NIH scientists have filed a patent application and have stated that “mRNA coronavirus vaccine candidates [are] developed and jointly owned by NIH and Moderna.”

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Inovio under pressure as investors anxious for COVID-19 vaccine data

Inovio Pharmaceuticals (INO -22.7%) slumps on modestly higher volume on the heels of its Q2 report released after the close yesterday that was apparently light on updated information related to COVID-19 vaccine candidate INO-4800.
A Phase 2/3 study should launch next month.
The company is working to expand production capacity to at least 100M doses in 2021.

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