FDA OKs expanded use of Agilent PD-L1 IHC 22C3 pharmDx in breast cancer

• Agilent Technologies (NYSE:A) has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as an aid in identifying patients with triple-negative breast cancer (TNBC) for treatment with Merck's (NYSE:MRK) Keytruda (pembrolizumab).
• The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible for Keytruda treatment.
• PD-L1 IHC 22C3 pharmDx also helps physicians identify lung cancer, gastric cancer, esophageal squamous cell carcinoma, cervical cancer, urothelial carcinoma, and head and neck squamous cell carcinoma patients.
• https://seekingalpha.com/news/3636418-fda-oks-expanded-use-of-agilents-pd-l1-ihc-22c3-pharmdx-in-breast-cancer
  

Tyson turns to COVID-19 algos to maintain meat output

• Back in April, widespread coronavirus outbreaks among employees in the U.S. meatpacking industry forced companies and others to shut dozens of plants across the country.
• More than 16,000 workers were infected and 86 died, according to the CDC, while farmers had to euthanize tens of thousands of animals and some supermarkets had to ration meat purchases.
• The industry has responded. Besides spending heavily on protective gear and redesigning workstations, companies like Tyson (NYSE:TSN) are using infection-tracking algorithms and ongoing employee testing.
• The system compares positive employee tests with where they work in the plants, along with publicly reported infection rates in the counties and towns around its 241 U.S. processing facilities.
• "We can dial up the algorithm when we sense there’s something going on in the community, and we're much more prepared for a second wave," said CEO Dean Bank Banks. Right now, less than 1% of Tyson’s employees are infected with COVID-19.
• Tyson is also hiring about 200 new nurses and health personnel for its plants and is building seven clinics near major facilities that will provide healthcare (often free) for employees.
• https://seekingalpha.com/news/3636424-tyson-turns-to-covidminus-19-algos-to-maintain-meat-output
  

Arbutus' AB-729 shows encouraging results in chronic hepatitis B

• Arbutus Biopharma (NASDAQ:ABUS) announces updated clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its GalNAc delivered RNAi compound in chronic hepatitis B infection.
• Single-doses of AB-729 studied to date, 60 mg, 90 mg and 180 mg, resulted in comparable mean HBsAg declines at week 12, followed by a sustained plateau phase.
• 60 mg of AB-729 dosed every 4 weeks resulted in continuous declines in HBsAg, reaching a mean of –1.44 log10 IU/ML at week 16.
• Data beyond week 16 demonstrate further declines in HBsAg with no plateau seen to date.
• AB-729 also resulted in meaningful decreases in both HBV RNA and HBcrAg and was generally safe and well tolerated.
• The data was presented at The Liver Meeting Digital Experience, The American Association for the Study of Liver Diseases Meeting.
• Arbutus will hold conference call and webcast on November 16, at 8:00 am ET to provide an update on AB-729.
• https://seekingalpha.com/news/3636408-arbutus-abminus-729-shows-encouraging-results-in-chronic-hepatitis-b
  

Tonix COVID-19 vaccine candidate shows encouraging preclinical action

• Tonix Pharmaceuticals (NASDAQ:TNXP) rises 5% in premarket after announcing preliminary results from animal studies of COVID-19 vaccine candidate, TNX-1800. The research is part of an ongoing collaboration between Southern Research Institute, the University of Alberta and Tonix.
• At day 14 after a single vaccination, all eight of the TNX-1800 vaccinated animals made anti-CoV-2 neutralizing antibodies as compared to none in TNX-801 vaccinated control animals, or placebo group. The level of neutralizing anti-CoV-2 antibody production was similar between the low and high dose TNX-1800 groups.
• The company plans to initiate human clinical trials with the vaccine candidate in 2021.
• TNX-1800 is a live modified horsepox virus vaccine that is designed to express the Spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response.
• https://seekingalpha.com/news/3636465-tonix-pharmas-covidminus-19-vaccine-candidate-shows-encouraging-preclinical-action
  

Adamis Pharma plunges on FDA rejection of Zimhi application for opioid overdose

• Adamis Pharmaceuticals (NASDAQ:ADMP) slumps 43% premarket in reaction to the announcement that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for its ZIMHI high dose naloxone injection product for the treatment of opioid overdose.
• The CRL stated that the FDA cannot approve the NDA in its present form and provided recommendations needed for resubmission.
• The questions raised were generally related to new Chemistry, Manufacturing and Controls issues. No issues related to “extractables and leechables testing”, that were associated with the previous CRL were noted.
• The company plans to provide the Agency with additional analysis and information in order to satisfy the CRL items and will request a Type A meeting or consider other options to resolve the issues.
• https://seekingalpha.com/news/3636453-adamis-pharma-plunges-43-on-fda-rejection-of-zimhi-application-for-opioid-overdose
  

Moderna COVID-19 Vaccine Candidate Meets Primary Efficacy Endpoint in 1st Interim Analysis of Phase 3 Study

First interim analysis included 95 participants with confirmed cases of COVID-19

Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001)

Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).

A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.

The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).

The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived. These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis.

Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.

As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication. 

https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

Gilead, Novo Nordisk insights from mid-stage trial of triple combo in NASH

• Gilead Sciences (NASDAQ:GILD) and Novo Nordisk (NYSE:NVO) presents results from a Phase 2 proof-of-concept trial. The five-arm trial evaluated combinations of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, with Gilead’s investigational FXR agonist cilofexor and/or ACC inhibitor firsocostat over 24 weeks in 108 people with non-alcoholic steatohepatitis (NASH), at The Liver Meeting Digital Experience (TLMdX), November 13–16, 2020.
• The trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis all regimens were well tolerated.
• The most common adverse events (AEs) were gastrointestinal. Minimal pruritus (itching) was observed in people treated with cilofexor. 5–14% of people discontinued any trial treatment.
• Exploratory efficacy endpoints assessing biomarkers of liver health at 24 weeks showed statistically significant improvements in hepatic steatosis and liver injury in the combination arms versus semaglutide alone.
• Although liver stiffness declined in all groups, statistically significant differences were not observed.
• The companies are also presenting preclinical data supporting the development of combination approaches in NASH.
• In the preclinical trial, semaglutide alone and in combination with cilofexor and/or GS-834356 (an analog of firsocostat) were administered daily for 12 weeks in a murine model of diet-induced NASH (n=15-16/group).
• The results demonstrated that while semaglutide significantly improved NASH and fibrosis-related endpoints, the addition of either cilofexor or the firsocostat analog further improved liver fat reduction. The combination of all three agents had the greatest impact on changes in the NAFLD Activity Score.
• The safety and efficacy of firsocostat, GS-834356 and cilofexor have not been established.
• https://seekingalpha.com/news/3636417-gilead-novo-nordisk-provide-insights-from-mid-stage-trial-describing-triple-combo-regimen-in