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Wednesday, June 17, 2020

New U.S. pandemic watchdog says data, tech issues challenge oversight work

U.S. government agencies overseeing everything from airlines to hospitals face steep hurdles in tracking and monitoring $2.4 trillion in taxpayer-funded novel coronavirus relief aimed at propping up the U.S. economy, an interagency government watchdog said on Wednesday.
Federal agencies already lacked some data necessary to track government funds and ensure they are spent as Congress intended, a problem compounded by the speed with which the government has shoveled money to businesses, individuals and local governments, the Pandemic Response Accountability Committee (PRAC) said on Wednesday.
Congress created the committee, which comprises independent watchdogs from 21 government offices, as part of a sweeping March aid package. Its job is to make sure the funds were used to help save jobs and keep Americans off breadlines and were not siphoned by fraudsters or otherwise abused or wasted.
In its first report to policymakers, agencies and the public on Wednesday, the committee compiled the challenges facing the 37 agencies involved in the government’s pandemic response.

“This is a foundational report for us. It gives us a starting point both as inspectors general to develop oversight plans and for agencies as they focus their attention,” Robert Westbrooks, director of the PRAC, told Reuters in an interview.
Even in non-pandemic times, government oversight can be hindered by a lack of reliable and timely financial data and other technological deficiencies, raising the prospect of improper payments, double dipping and other misuse, the group said in the 88-page report.
Those issues have been compounded as watchdogs struggle with work-from-home challenges, technology constraints and cybersecurity threats, the report found.

Critics say few safeguards have already allowed companies to mop up cash with few strings attached.
Those include airlines that reduced staff hours after taking billions in stimulus funds and publicly traded companies, including those with considerable cash on hand, that took aid intended for small businesses.
https://www.reuters.com/article/us-health-coronavirus-usa-fraud/new-u-s-pandemic-watchdog-says-data-tech-issues-challenge-oversight-work-idUSKBN23O2D2

CureVac to start early trial of Covid-19 vax candidate in Germany and Belgium

The German Health Authority and the Belgian Federal Agency for Medicines and Health Products have approved CureVac AG’s Phase 1 clinical trial for its vaccine program to prevent SARS-CoV-2 infection.
The trial will be conducted in Germany and Belgium. CureVac’s mRNA vaccine candidate utilizes nucleotides without chemical modifications and provides a strong and balanced activation of the immune system. The mRNA encodes the full-length spike protein of SARS-CoV-2 and is formulated with lipid nanoparticles.
The Phase 1 trial will include 168 healthy subjects between the ages of 18 to 60 and will target a dose range of 2 µg to 8 µg.
The aim is to determine the optimal dose, as well as to evaluate the safety and immune profile of the vaccine in humans.
https://seekingalpha.com/news/3583681-curevac-to-initiate-early-stage-trial-of-covidminus-19-vaccine-candidate-in-germany-and

PTC Therapeutics launches study of PTC299 in COVID-19

The FDA has signed off on a Phase 2/3 clinical trial evaluating PTC Therapeutics’ (NASDAQ:PTCT) PTC299, an oral dihydroorotate dehydrogenase (DHODH) inhibitor, for the potential treatment of COVID-19.
The company says the candidate has two mechanisms of action for treating the infection: addressing high viral replication and the subsequent uncontrolled inflammatory response.
The first stage of the study, expected to launch in the coming days, will enroll 40 hospitalized adult patients, followed by a larger cohort of ~340.
The primary objective will be time to respiratory improvement.
Management hosted a conference call this morning at 8:30 am ET to discuss the trial.
https://seekingalpha.com/news/3583682-ptc-therapeutics-launches-study-of-ptc299-in-covidminus-19

Hookipa to commence additional arm in HB-201 trial for HPV+ cancers

The FDA clears Hookipa Pharma’s (NASDAQ:HOOK) Investigational New Drug (IND) Application for HB-202, to initiate an additional arm in its Phase 1/2 clinical trial for HB-201 for the treatment of Human Papillomavirus 16-positive (HPV 16+) cancers.
The IND clearance will not only examine safety and efficacy of HB-201 alone but also HB-201 in combination with HB-202 as an alternating two-vector therapy.
Hookipa expects to combine HB-202/201 with an approved checkpoint inhibitor, in 2021.
https://seekingalpha.com/news/3583709-hookipa-to-commence-additional-arm-in-hbminus-201-trial-for-hpv-cancers

Kamada antibody therapy OK’d for compassionate use in Israel for COVID-19

Kamada (NASDAQ:KMDA) updates on its development of a plasma-derived immunoglobulin (IgG) product for COVID-19.
The company completed manufacturing of the first batch of its plasma-derived IgG product for COVID-19 and additional production is ongoing. The initial vials are available for compassionate use in Israel.
Kamada intends to initiate a Phase 1/2 clinical study in hospitalized COVID-19 patients in Israel during Q3.
In order to expand its clinical development program to the U.S., Kamada and its partner Kedrion Biopharma, intends to conduct a pre-IND meeting with the FDA early in Q3.
Kedrion is currently collecting COVID-19 convalescent plasma from U.S. recovered patients to manufacture additional batches of the product.
https://seekingalpha.com/news/3583716-kamada-antibody-therapy-okd-for-compassionate-use-in-israel-for-covidminus-19

Armata Pharma nabs $15M DoD award to treat S. aureus bacteremia infections

Armata Pharmaceuticals (NYSEMKT:ARMP) is up 43% premarket after receiving a $15M award for a three-year program from the U.S. Department of Defense (DoD).
The award will be used to partially fund a Phase 1b/2, placebo-controlled, dose escalation clinical study of Armata’s therapeutic phage-based candidate, AP-SA02, for the treatment of complicated Staphylococcus aureus bacteremia infections, a bacterial infection of the bloodstream.
The primary objectives of the study will be to evaluate the safety and tolerability of AP-SA02 as an adjunct to best available antibiotic therapy, and to determine the appropriate dose or doses for future clinical trials of efficacy.
Armata does not expect the clinical trial to initiate prior to mid-2021.
https://seekingalpha.com/news/3583725-armata-pharma-nabs-15m-dod-award-to-treat-s-aureus-bacteremia-infections

Enrollment underway in mid-stage study of BioSig antiviral in COVID-19

BioSig Technologies (NASDAQ:BSGM) and subsidiary ViralClear Pharmaceuticals announce that the first participant has been dosed in a Phase 2 clinical trial evaluating the combination of broad-spectrum antiviral merimepodib oral solution and Gilead Sciences’ (NASDAQ:GILD) IV remdesivir in hospitalized adult COVID-19 patients.
The primary endpoints of the 40-subject study are safety and the proportion of patients alive at day 28 who are not hospitalized or, if hospitalized, free of respiratory failure compared to remdesivir plus placebo.
The estimated completion date is August.
Last month, BSGM announced the publication of preclinical data supporting the potential efficacy of the combination in decreasing SARS-CoV-2 replication.
https://seekingalpha.com/news/3583743-enrollment-underway-in-mid-stage-study-of-biosig-antiviral-in-covidminus-19