U.S loans $1.1 billion to Ginkgo Bioworks for pandemic effort

 

The U.S. government has agreed to loan privately-held biotechnology firm Ginkgo Bioworks $1.1 billion for COVID-19 testing and the production of raw materials for therapies that may help address future pandemics.

Boston-based Ginkgo, which is backed by Bill Gates's private investment firm Cascade Investment and hedge fund Viking Global, has worked on projects including helping optimize a piece of the manufacturing process of Moderna's messenger RNA vaccine and making coronavirus tests.

The company said it would use the loan from the U.S. International Development Finance Corp, or DFC, for its ongoing COVID-19 programs and to retain its infrastructure for any future pandemic.

"Because we haven't faced a global pandemic in 100 years, we haven't had a global biosecurity infrastructure," Ginkgo Chief Executive Officer Jason Kelly said in an interview. "What excites me about this loan is that we can help to build it."

Many of the vaccines under development for COVID-19, including Moderna's and Pfizer Inc's, are new types of therapies that use the nucleic acid messenger RNA to prompt a patient's own body to create the antibodies that fight off the virus.

Ginkgo's manufacturing systems can produce the raw materials for such vaccines, including nucleic acids, which until now have never been produced at the scale needed to vaccinate billions of patients around the world.

While Moderna and Pfizer have their own, independent manufacturing plans in place, Ginkgo hopes its expertise in making raw materials will help similar products in development.

While mRNA vaccines remain an emerging field, recent data suggest they could be a promising new type of therapy that has the potential to rapidly speed up traditional vaccine development timelines.

DFC has issued loans to U.S. companies under the direction of President Donald Trump to support the country's response to the coronavirus pandemic.

The agency's proposed $765 million loan to Eastman Kodak Co to support the camera company's move into pharmaceutical manufacturing came under fire after Kodak's CEO received company stock options prior to the announcement. An independent legal review later cleared the executive of wrongdoing.

Last week, DFC said it would loan $590 million to a company called ApiJect Systems Corp to help it manufacture pre-filled injectors used in vaccine production, including coronavirus vaccine candidates.

To date, Ginkgo has received $900 million in funding outside of the DFC loan and has a valuation of $4.5 billion, according to the company.

https://www.marketscreener.com/news/latest/U-S-loans-1-1-billion-to-Ginkgo-Bioworks-for-pandemic-effort--31864634/

Ampio updates on Phase 1 study with inhaled Ampion in COVID-19

 

• Ampio (AMPE +0.2%) provides following update on clinical trials.
• Phase I trial of inhaled Ampion (AP-014), the third of three initial safety groups of patients have completed five days of treatment and three days of follow up for Safety Monitoring Committee review, as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA.
• If SMC provides confirmation regarding no safety concerns for this third group, the trial will complete the remaining thirty-four patients at the speed of recruitment with additional hospital groups added as required to support enrollment.
• On another front, it submited its proposal to the FDA concerning the evaluation of data in its Phase 3 trial evaluating Ampion in patients with severe osteoarthritis of the knee. Enrollment was suspended in March due to pandemic disruptions. The FDA notified the Company that a formal response will be provided by the end of this year.
• https://seekingalpha.com/news/3639424-ampio-updates-on-phase-1-study-inhaled-ampion-in-covidminus-19-patients

FDA OKs expanded use of Applied DNA COVID-19 test via further amendment

 

• The FDA has granted a further amendment to Applied DNA Sciences' (NASDAQ:APDN) Emergency Use Authorization (EUA) of installed base of RT-PCR platforms that can process Linea COVID-19 Assay Kit.
• The EUA amendment extends the platform authorization from QuantStudio Dx and 5 Real-Time PCR systems to include Applied Biosystems 7500 Fast Dx Real-Time PCR System (ABI 7500).
• The ABI 7500 has the capacity to perform 400 – 800 tests in 24 hours and is found in the majority of clinical laboratories nationally.
• “With this amendment to our EUA, we significantly increase the number of authorized devices on which our assay kit can run and remove a gating factor to the more widespread adoption of our high sensitivity test,” said Dr. James A. Hayward, president and CEO, Applied DNA. “We are actively engaged with clinical laboratories nationally with which our opportunities for assay kit contracts are bolstered by the addition of an RT-PCR system in wide use by the diagnostics industry. Additional planned amendments, we believe, will further differentiate our assay in the marketplace and to operators of clinical diagnostic labs.”
• Update on Applied DNA Clinical Laboratories CLEP-CLIA Certification
• Separately, the Company announced that an inspection report from the State of New York Department of Health (DoH) highlighted deficiencies in Applied DNA Clinical Laboratories' (ADCL) clinical standard of practice and that it requires remediation prior to the submission of a re-inspection request.
• The Company expects to complete remediation actions during Q1 2021.
• https://seekingalpha.com/news/3639408-fda-oks-expanded-use-of-applied-dnas-covidminus-19-test-via-amendment

RenalytixAI soars as FDA OK's emergency use of Kantaro COVID antibody test

 

• Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI (NASDAQ:RNLX), has received Emergency Use Authorization (EUA) from the FDA for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit.
• Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in COVID-19.
• COVID-SeroKlir has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.
• Through a commercial partnership with Bio-Techne Corporation (NASDAQ:TECH) the test kits are being manufactured at scale with a capacity of up to 10M tests per month and the ability to scale up.
• The Kantaro test kit received CE mark in October 2020 and is available in 29 European countries.
• https://seekingalpha.com/news/3639385-renalytixai-soars-20-fda-oks-emergency-use-of-kantaros-covidminus-19-antibody-test

'Mutations not making coronavirus able to spread more rapidly': study

 The COVID-19-causing coronavirus is mutating as it spreads around the world in the pandemic, but none of the mutations currently documented appears to be making it able to spread more rapidly, scientists said on Wednesday.

In a study using a global dataset of virus genomes from 46,723 people with COVID-19 from 99 countries, researchers identified more than 12,700 mutations, or changes, in the SARS-CoV-2 virus.

“Fortunately, we found that none of these mutations are making COVID-19 spread more rapidly,” said Lucy van Dorp, a professor at University College London’s Genetics Institute and one of the co-lead researchers on the study.

She added, however: “We need to remain vigilant and continue monitoring new mutations, particularly as vaccines get rolled out.”

Viruses are known to mutate all the time, and some - such as flu viruses - change more frequently than others.

Most mutations are neutral, but some can be either advantageous or detrimental to the virus, and some can make vaccines against them less effective. When viruses change like this, vaccines against them have to be adapted regularly to ensure they are hitting the right target.

With the SARS-CoV-2 virus, the first vaccines to show efficacy against the disease it causes could get regulatory approval and begin to be used to immunise people before the end of the year.

Francois Balloux, a UCL professor who also worked on the study, said that its findings, for now, posed no threat to COVID-19 vaccine efficacy, but cautioned that the imminent introduction of vaccines could exert new selective pressures on the virus to mutate to try to evade the human immune system.

“The news on the vaccine front looks great,” he said. “The virus may well acquire vaccine-escape mutations in the future, but we’re confident we’ll be able to flag them up promptly, which would allow updating the vaccines in time if required.”.

The mutation study, preliminary findings of which were originally made public in May as a pre-print before being reviewed by other scientists, was published in full on Wednesday in the peer-reviewed journal Nature Communications.

The research team from Britain’s UCL and Oxford University, and from France’s Cirad and Université de la Réunion, analysed virus genomes from 46,723 people with COVID-19 from 99 countries, collected up until the end of July 2020.

Among more than 12,706 mutations identified, some 398 appeared to have occurred repeatedly and independently, the researchers said.

Of those, the scientists focused in on 185 mutations which they found had occurred at least three times independently during the course of the pandemic.

The researchers found no evidence that any of the common mutations are increasing the virus’s transmissibility. Instead, they said, most common mutations are neutral for the virus.

https://www.reuters.com/article/health-coronavirus-mutations/mutations-not-making-coronavirus-able-to-spread-more-rapidly-study-idUSKBN28518O

BioNTech, Fosun start Phase II trial of COVID-19 vaccine in China

 

BioNTech and Shanghai Fosun Pharmaceutical said on Wednesday they would launch a Phase II clinical trial of BioNTech's experimental COVID-19 vaccine in China.

The vaccine, known as BNT162b2, will be tested on volunteers at the Jiangsu Provincial Center for Disease Control and Prevention to assess safety and immunogenicity, eyeing future approval in China, the two companies said in a statement.

BioNTech is also working with U.S. pharma giant Pfizer on the vaccine and the partners said last week they were hoping to win approval in the United States and Europe this year after trial results showed the compound had a 95% efficacy rate and caused no serious side effects.

https://www.marketscreener.com/quote/stock/SHANGHAI-FOSUN-PHARMACEUT-6548924/news/BioNTech-Fosun-start-Phase-II-trial-of-COVID-19-vaccine-in-China-31862789/

MediciNova's MN-166 can reduce retinal thinning in progressive MS

 

• MediciNova (NASDAQ:MNOV) announces that positive Optical Coherence Tomography (OCT) results from the SPRINT-MS Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS) were published in Multiple Sclerosis Journal. OCT was a secondary outcome measure in the trial.
• The authors conclude that retinal thinning in MS may be attenuated by MN-166 (ibudilast) and that sample size estimates suggest OCT can be a viable outcome measure in progressive MS trials if a therapy has a large treatment effect.
• 183 participants were imaged with Cirrus and 61 participants with Spectralis.
• All OCT measures showed less loss of retinal tissue for MN-166 compared to placebo. Key results included:
• Change in pRNFL (peripapillary retinal nerve fiber layer) thickness was +0.0424 uM/year for MN166 versus −0.2630 uM/year for placebo (n = 244, p = 0.22).
• Macular volume change was −0.00503 mm³/year for MN-166 versus −0.03659 mm³/year for placebo in the Spectralis cohort (n = 61, p = 0.044).
• For the Cirrus cohort, macular volume change was −0.00040 mm³/year for MN-166 (ibudilast) compared to −0.02083 mm³/year for placebo (n = 183, p = 0.1734).
• Ganglion cell-inner plexiform layer thickness change, available from Cirrus, was −0.4893 uM/year for MN-166 (ibudilast) versus −0.9587 uM/year for placebo (n = 183, p = 0.12).
• https://seekingalpha.com/news/3639336-medicinovas-mnminus-166-can-reduce-retinal-thinning-in-progressive-multiple-sclerosis