Guardant Health gets U.S. emergency use nod for coronavirus test

The FDA has granted emergency use authorization (EUA) to Guardant Health’s (GH +0.3%) Guardant-19 test for use in the detection of the SARS-CoV-2 virus.

The test is a reverse transcriptase polymerase chain reaction next-generation sequencing test, that detects the coronavirus from upper respiratory nasal specimens. It has a validated limit of detection of 125 copies per mL and results are typically returned the next day.

The company says its testing workflow can be scaled to over 10,000 tests per day.

https://seekingalpha.com/news/3608267-guardant-health-gets-u-s-emergency-use-nod-for-coronavirus-test

Methylene blue — vitamin C –N-acetyl cysteine for critical Covid, Phase-I trial

Daryoush HamidiAlamdari^aAhmad BagheriMoghaddam^bShahramAmini^cMohammad RezaKeramati^dAzam MoradiZarmehri^eAida HamidiAlamdari^fMohammadaminDamsaz^fHamedBanpour^dAmirYarahmadi^gGeorgeKoliakos^h

https://doi.org/10.1016/j.ejphar.2020.173494

PDF: https://www.sciencedirect.com/science/article/pii/S0014299920305860/pdfft?md5=972f36e1f2e46d2b980c467524f14d42&pid=1-s2.0-S0014299920305860-main.pdf

Abstract

COVID-19 is a global catastrophic event that causes severe acute respiratory syndrome. The mechanism of the disease remains unclear, and hypoxia is one of the main complications. There is no currently approved protocol for treatment. The microbial threat as induced by COVID-19 causes the activation of macrophages to produce a huge amount of inflammatory molecules and nitric oxide (NO). Activation of macrophages population into a pro-inflammatory phenotype induces a self-reinforcing cycle. Oxidative stress and NO contribute to this cycle, establishing a cascade inflammatory state that can kill the patient. Interrupting this vicious cycle by a simple remedy may save critical patients’ lives. Nitrite, nitrate (the metabolites of NO), methemoglobin, and prooxidant-antioxidant-balance levels were measured in 25 ICU COVID-19 patients and 25 healthy individuals. As the last therapeutic option, five patients were administered methylene blue-vitamin C–N-acetyl Cysteine (MCN). Nitrite, nitrate, methemoglobin, and oxidative stress were significantly increased in patients in comparison to healthy individuals. Four of the five patients responded well to treatment. In conclusion, NO, methemoglobin and oxidative stress may play a central role in the pathogenesis of critical COVID-19 disease. MCN treatment seems to increase the survival rate of these patients. Considering the vicious cycle of macrophage activation leading to deadly NO, oxidative stress, and cytokine cascade syndrome; the therapeutic effect of MCN seems to be reasonable. Accordingly, a wider clinical trial has been designed. It should be noted that the protocol is using the low-cost drugs which the FDA approved for other diseases.

https://www.sciencedirect.com/science/article/pii/S0014299920305860?via%3Dihub

Odonate under pressure on safety profile of lead drug tesetaxel

Odonate Therapeutics (NASDAQ:ODT) says that the CONTESSA (Phase 3) trial evaluating lead candidate tesetaxel in metastatic breast cancer (MBC) patients met the primary endpoint of improved Progression-free Survival (PFS), with median PFS of 9.8 months for tesetaxel + reduced dose of capecitabine arm, vs. 6.9 months in approved doses of capecitabine alone.

Risk of disease progression/death was reduced by 28.4% (hazard ratio = 0.716) for tesetaxel + capecitabine, compared to capecitabine alone.

On the safety front, tesetaxel plus capecitabine was associated with a manageable safety profile, although Grade 3 (or higher) neutropenia (low levels of white blood cells) occurred in 71.2% of patients versus 8.35 for capecitabine alone.

Other Grade 3+ treatment-emergent adverse events included diarrhea (13.4% vs. 8.3%), hand-foot syndrome (6.8% vs. 12.2%), febrile neutropenia (12.8% vs. 1.2%) and hypokalemia (8.6% vs. 2.7%).

The discontinuation rates were 4.2% from neutropenia and 3.6% from neuropathy. The overall discontinuation rate was 23.1% in the treatment group compared to 11.9% in the capecitabine alone group.

Overall survival (OS) data were not mature. A final analysis of OS is expected in 2022.

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes.

https://seekingalpha.com/news/3608127-odonate-under-pressure-on-safety-profile-of-lead-drug-tesetaxel

Moderna in late-stage talks in Europe to supply COVID-19 vaccine

August 24, 2020

Moderna (NASDAQ:MRNA) confirms that it is in advanced discussions with the European Commission on an agreement to supply 80M doses of its COVID-19 vaccine, currently dubbed mRNA-1273. The deal will include the option to buy 80M additional doses.

It is scaling production aimed at delivering ~500M doses/year, with an upside of 1B doses annually, in 2021 (note that this is a run rate so the actual number of doses delivered next year will be less).

https://seekingalpha.com/news/3608181-moderna-in-late-stage-talks-in-europe-to-supply-covidminus-19-vaccine

FDA OKs BrainsWay TMS system for smoking addiction August 24, 2020

BrainsWay (BWAY +21.1%) has received FDA 510(k) clearance for its deep transcranial magnetic stimulation (Deep TMS) system for use as an aid in short-term smoking cessation in adults.

The company expects to execute a controlled U.S. market release of its H4 Deep TMS coil for this indication early next year.

The company says that this is the first FDA nod in the addiction space for any TMS device. It represents BrainsWay’s third FDA-cleared coil and indication, following clearance of its H1-coil for major depressive disorder (MDD) and the H7-coil as an adjunct therapy for the treatment of obsessive-compulsive disorder (OCD).

https://seekingalpha.com/news/3608196-fda-oks-brainsway-tms-system-for-smoking-addiction

Novavax advances COVID-19 vaccine into Phase 2 development

Novavax (NVAX -11.5%) announces the commencement of enrollment in the Phase 2 portion of its Phase 1/2 clinical trial assessing the safety and immunogenicity of COVID-19 vaccine candidate NVX-CoV2373.

Target enrollment is 1,500 subjects, about half between the ages of 60 and 84 years old.

The study is evaluating two dose levels, 5 and 25 µg, each with 50 µg of adjuvant Matrix‑M in volunteers ages 18 to 84 years old across up to 40 sites in the U.S. and Australia.

The company has secured $2B to fund development, including $388M from the Coalition for Epidemic Preparedness Innovations (CEPI).

Shares are down in reaction to rumors that certain other COVID-19 vaccine developers may be at the front of the line for an emergency use nod in the U.S.

https://seekingalpha.com/news/3608198-novavax-advances-covidminus-19-vaccine-phase-2-development

Turning Point’s repotrectinib Fast Track’d in U.S. for certain solid tumors

The Food and Drug Administration (FDA) granted Turning Point Therapeutics (TPTX +2.0%) a third Fast-Track designation to its lead drug candidate, repotrectinib for treatment of patients with advanced solid tumors that have an NTRK gene fusion.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

The drug was previously granted two Fast Track designations for the treatment of ROS1-positive advanced non-small cell lung cancer patients.

“We believe repotrectinib has the potential to make a meaningful difference in the lives of cancer patients with ROS1- or NTRK-driven tumors. NTRK-driven cancers are estimated to occur in up to 50K patients annually, however there are currently no approved therapies for those patients previously treated with another TRK TKI,” president & CEO Athena Countouriotis, M.D., commented.

https://seekingalpha.com/news/3608212-turning-points-repotrectinib-fast-trackd-in-u-s-for-certain-solid-tumors