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Monday, June 8, 2020

Oxford Biomedica snags manufacturing gear to ramp production of Covid-19 vax

In the race for a COVID-19 vaccine, the University of Oxford has stormed to an early lead with the commercial manufacturing support of British drugmaker AstraZeneca. Now, in an effort to scale up capacity for global demand, one of AstraZeneca’s manufacturing partners has struck a deal for new equipment.
Oxford Biomedica has inked a five-year deal with the U.K.’s Vaccines Manufacturing and Research Institute (VMRI) to build out the CDMO’s Oxbox facility to help produce doses of the university’s adenovirus-based COVID-19 vaccine.
As part of their deal, VMRI will supply manufacturing equipment for two suites at Oxford Biomedica’s 84,000-square-foot Oxbox facility in Oxford, U.K., the CDMO said. The suites will be dedicated to producing Oxford’s vaccine, AZD1222, but can also be used to manufacture other viral vector vaccines.
In return, Oxford Biomedica will provide VMRI with “training and technical assistance” for its staff to scale up manufacturing of viral vector vaccines at its new facility at the Harwell Science and Innovation Campus at Oxford scheduled to open in mid-2021.
The manufacturing supply agreement will help Oxford Biomedica begin churning out doses of Oxford’s vaccine candidate––which is currently in phase 2/3 trials in the U.K.––beginning this summer.

Late last month, Oxford and British drugmaker AstraZeneca agreed to a one-year deal covering “multiple batches” of the university’s vaccine as part of a consortium aimed at speeding production of the shot.
As part of the agreement, AstraZeneca received access to the OxBox facility with the goal of supplying clinical and commercial doses through 2020 with the possibility of expansion in the future.
AstraZeneca and the university agreed to tie up in April, with the drugmaker taking on commercialization and large-scale manufacturing of the school’s vaccine, which was developed by Oxford’s Jenner Institute.

As Oxford Biomedica aims to ramp up its own manufacturing, AstraZeneca recently secured a massive tie-up to bring billions of doses of AZD1222 on the market in the coming years.
Last week, the British pharma inked a $750 million deal with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance to manufacture and distribute 300 million doses of Oxford’s vaccine by the end of 2020, the drugmaker said Thursday.
AZ also agreed to a licensing deal with the Serum Institute of India to provide 1 billion doses of the vaccine to low- and middle-income countries, with the goal of 400 million produced by year’s end. In total, the deals bring AstraZeneca’s overall supply capacity for Oxford’s vaccine to more than 2 billion doses per year, the drugmaker said.
https://www.fiercepharma.com/manufacturing/oxford-biomedica-reaches-manufacturing-equipment-deal-to-ramp-up-production-covid-19

Aimmune’s Palforzia shows durable effect in study

Aimmune Therapeutics (AIMT +3.6%) announces positive data from a follow-on study to its Phase 3 PALISADE trial of peanut allergy product Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp].
At year 2, patients dosed daily showed ongoing immunomodulation and higher rates of desensitization that increased over time compared to non-daily-dosed patients while experiencing lower rates of adverse events. 80% of these patients who underwent a food challenge demonstrated desensitization to 2,000 mg of peanut protein (~14 kernels), higher than the non-daily group.
The FDA approved Palforzia in January.

Surmodics SurVeil device CE Mark’d

Surmodics (SRDX +3.5%) announces CE Mark certification of its SurVeil drug-coated balloon used to treat peripheral artery disease (PAD).
The action triggers a $10.8M milestone payment from exclusive licensee Abbott (ABT +0.9%). Under the terms of the agreement, SRDX is responsible for manufacture and supply.
The device is not yet available in the U.S.
https://seekingalpha.com/news/3581155-surmodics-surveil-device-ce-markd

Kiniksa’s mavrilimumab shows encouraging effect in COVID patients

Kiniksa Pharmaceuticals Ltd (NASDAQ:KNSA) announces 28-day data from an open-label study testing mavrilimumab in 13 hospitalized severely ill COVID-19 patients with pneumonia and hyperinflammation who received a single IV dose of 6 mg/kg of the granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα) inhibitor. The results were virtually presented at EULAR.
After 28 days of follow-up the mortality rate was 0% compared to 27% (n=7/26) in a control group (26 non-mechanically ventilated patients with similar baseline characteristics).
8% (n=1/13) of patients in the mavrilimumab group progressed  to mechanical ventilation versus 35% (n=9/26) in the control group
100% (n=13/13) of patients in the mavrilimumab group achieved the clinical improvement endpoint compared to 65% (n=17/26) in the control group.
A Phase 2/3 study is next up.
https://seekingalpha.com/news/3581093-kiniksas-mavrilimumab-shows-encouraging-effect-in-covid-patients

Applied DNA updates on COVID-19 vaccine program

Applied DNA Sciences (NASDAQ:APDN) is up 9% premarket on the heels of an announcement related to the development of linear-DNA form of COVID-19 vaccine candidates with development partner Takis Biotech.
The results of linear-DNA dose-response trials are expected in this month.
The companies’ development program utilizes the plasmid-based DNA templates to determine baseline results in preclinical animal models.
Th results are anticipated to reduce risk of antibiotic resistance and genomic integration, and speed of production.
If found to be as efficacious as the plasmid-based templates, the company and Takis will engage a third-party to conduct toxicology studies to generate necessary data for potential human clinical trials of the linear-DNA vaccines.
https://seekingalpha.com/news/3581095-applied-dna-updates-on-covidminus-19-vaccine-program

Sarepta gene therapy shows positive effect in rare type of muscular dystrophy

Sarepta Therapeutics (NASDAQ:SRPT) announces positive results from a Phase 1/2 clinical trial evaluating gene therapy SRP-9003 in six patients with limb-girdle muscular dystrophy type 2E (LGMD2E), also called beta-sarcoglycanopathy, a rare type of muscular dystrophy characterized by weakness in the pelvic and shoulder girdle.
A strong dose-dependent increase in transduction and expression was observed in the high-dose cohort (n=3) at day 60 compared to the low-dose cohort (n=3), showing a mean expression of 72.3% of transduced beta-sarcoglycan (beta-SG) (the absence of this protein causes progressive muscle degeneration and shortened life expectancy in LGMD2E sufferers) properly localized to the muscle sarcolemma (tubular sheath that envelops skeletal muscle fibers).
SRP-9003 is a gene construct that transduces skeletal and cardiac muscle, delivering a gene that codes for full-length beta-SG.
Development is ongoing.
https://seekingalpha.com/news/3581103-sarepta-gene-therapy-shows-positive-effect-in-rare-type-of-muscular-dystrophy

FDA authorizes Phosphorus Diagnostics’ COVID-19 saliva test for emergency use

OraSure Technologies (OSUR +0.7%) announces that Phosphorus Diagnostics was granted an Emergency Use Authorization by the FDA allowing individuals to self-collect saliva specimens with company’s Oragene Dx (OGD-510) collection kit for the detection of SARS-CoV-2 using the Phosphorus COVID-19 RT-qPCR test.
The Phosphorus COVID-19 RT-qPCR test detects nucleic acid in the saliva of individuals who are suspected of COVID-19 infection.
https://seekingalpha.com/news/3581116-fda-authorizes-phosphorus-diagnostics-covidminus-19-saliva-test