Catalent Inc. said it will provide vial filling and packaging
capacity to AstraZeneca PLC at Catalent’s manufacturing facility in
Anagni, Italy, and prepare for large-scale commercial supply of the
University of Oxford’s Covid-19 vaccine candidate, AZD1222.
Catalent shares were up 11% to $77 premarket.
The agreement accelerates the rapid scale-up of capacity over the
coming months to support the dedicated production of AZD1222, the
provider of advanced delivery technologies, development, and
manufacturing solutions for drugs.
Catalent said it will prepare the facility to enable manufacturing
schedules and supply hundreds of millions of doses of the vaccine
candidate from August 2020, and potentially through to March 2022 if the
product is approved by regulatory agencies.
https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Catalent-in-Agreement-with-AstraZeneca-to-Manufacture-Covid-19-Vaccine-Candidate-30771704/
Monday, June 15, 2020
Dosing underway in mid-stage study of Immunic’s IMU-838 in COVID-19
Immunic (IMUX -1.6%) announces the start of dosing in a Phase 2 clinical trial, CALVID-1, evaluating IMU-838 plus standard-of-care treatment in COVID-19 patients. Topline data should be available later this year.
The company says IMU-838 is
an orally available, next-generation immune modulator that dampens the
immune response by inhibiting an enzyme called dihydroorotate
dehydrogenase (DHODH) that plays a key role in intracellular metabolism
of activated immune cells.
https://seekingalpha.com/news/3583016-dosing-underway-in-mid-stage-study-of-immunics-imuminus-838-in-covidminus-19Humanigen rallies on positive lenzilumab data in COVID-19 patients
Humanigen (OTCQB:HGEN +37.3%) announces
data on the first clinical use of lenzilumab, the proprietary
Humaneered anti-human granulocyte macrophage-colony stimulating
factor, in 12 COVID-19 patients.
Patients showed rapid clinical improvement with a
median time to recovery of five days, median time to discharge of five
days and 100% survival to the data cut-off date.
Rapid improvement in oxygenation, temperature,
inflammatory cytokines and key hematological parameters consistent with
improved clinical outcomes was also observed.
No treatment-emergent adverse events were attributable to lenzilumab and it was well-tolerated.
https://seekingalpha.com/news/3583023-humanigen-rallies-on-positive-lenzilumab-data-in-covidminus-19-patientsMomenta’s nipocalimab shows positive action in neuromuscular disorder
Momenta Pharmaceuticals (MNTA +0.9%) announces positive topline results from a proof-of-concept Phase 2 clinical trial, Vivacity-MG,
evaluating nipocalimab (formerly M281) in patients with generalized
myasthenia gravis (MG), a disorder characterized by weakness and rapid
fatigue of skeletal muscles caused by disrupted communication between
nerves and muscles.
All four treatment arms demonstrated efficacy as
measured by the change from baseline in a scale of daily activities
called MG-ADL at day 57, the primary endpoint. Specifically, 52% of
treated patients experienced at least a two-point reduction in MG-ADL
scores compared to 15% in the control arm (p=0.017).
On the safety front, nipocalimab was well-tolerated with no severe (grade 3) or worse treatment-related adverse events.
The trial should wind up next quarter. The company
will announce 16-week data, along with duration of efficacy and
analysis of secondary endpoints, in Q4.
The company plans to meet with regulators before year-end. A Phase 3 study will follow.
Nipocalimab is a fully human anti-neonatal Fc
receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal
antibody engineered to reduce circulating IgG antibodies by blocking IgG
recycling. MG is an antibody-mediated autoimmune disorder.
Most (~80%) of MG sufferers have serum antibodies to acetylcholine
receptors which leads to the disruption in communication between nerves
and muscles.
https://seekingalpha.com/news/3582998-momentas-nipocalimab-shows-positive-action-in-neuromuscular-disorderBeyondSpring’s lead drug successful in late-stage neutropenia study
BeyondSpring (NASDAQ:BYSI) announces positive results from a Phase 3 clinical trial, PROTECTIVE-2, evaluating lead candidate Plinabulin, combined with Amgen’s (NASDAQ:AMGN) Neulasta (pegfilgrastim) compared to Neulasta alone for the prevention of chemo-induced neutropenia (low levels of white blood cells called neutrophils).
Interim data showed that the combination
significantly improved the rate of Grade 4 (life-threatening)
neutropenia prevention compared to Neulasta alone (p<0.01), the
primary endpoint.
A key secondary endpoint, the duration of severe neutropenia in cycle 1, was also met.
Plinabulin is a small molecule activator of a protein called GEF-H1.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
https://seekingalpha.com/news/3582941-beyondsprings-lead-drug-successful-in-late-stage-neutropenia-study
Edesa Biotech rockets 160% on launch of COVID-19 study in Canada
Edesa Biotech (NASDAQ:EDSA) is up 160% premarket after receiving expedited
approval from Health Canada to begin a Phase 2/3 clinical study of its
investigational drug, EB05, as a potential treatment for moderate to
severe COVID-19 patients.
The company is seeking government grants to accelerate the initiation and rollout of the study, beginning at up to 30 sites.
Edesa plans to enroll up to 355 patients in the
first phase of the trial. Patients will be infused intravenously with
EB05 or placebo. Should the drug treatment demonstrate promising results
at the Phase 2 readout, the enrollment will continue as a pivotal Phase
3 study.
EB05 is a monoclonal antibody that has
demonstrated the ability to suppress the release of proinflammatory
cytokines that are often observed in severe COVID-19 patients.
https://seekingalpha.com/news/3582952-edesa-biotech-rockets-160-on-launch-of-covidminus-19-study-in-canadaDosing underway in aTyr Pharma’s ATYR1923 study in COVID-19 patients
ATyr Pharma (NASDAQ:LIFE) has dosed
the first patient in a Phase 2 study evaluating ATYR1923, in
hospitalized COVID-19 patients with severe respiratory complications who
do not require mechanical ventilation.
The study is expected to enroll 30 patients at up
to 10 centers in U.S. and the company expects to have the majority of
centers enrolling within the coming weeks.
The trial is designed to evaluate the preliminary
safety and efficacy of ATYR1923 as compared to placebo through the
assessment of key clinical outcome measures such as fever and hypoxia as
well as inflammatory biomarkers.
ATYR1923 is an immunomodulator that has been shown
to preclinically downregulate T-cell responses and improve inflammation
and lung function.
https://seekingalpha.com/news/3582954-dosing-underway-in-atyr-pharmas-atyr1923-study-in-covidminus-19-patients
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