Sutro Biopharma hits clinical supply milestone in Merck KGaA agreement

Sutro Biopharma (STRO +1.0%) has achieved a clinical supply milestone under its license agreement for M1231 with Merck KGaA, triggering an undisclosed amount of milestone payment.

M1231 is a MUC1-EGFR bispecific antibody drug conjugate for solid tumors, and was discovered using Sutro’s XpressCF and XpressCF+ technologies and includes a proprietary linker-warhead, also discovered by Sutro.

As part of the 2014 agreement, Sutro will manufacture M1231 for early clinical supply and is eligible for further milestones and royalties. Merck KGaA will be responsible for filling and finishing the drug product, in addition to its clinical development and commercialization.

https://seekingalpha.com/news/3608582-sutro-biopharma-achieves-clinical-supply-milestone-under-merck-kgaa-agreement

Financials lead market; rates bounce on expected shift in Fed

Stocks are higher as money moves out of bonds following a report that Fed chief Jerome Powell will unveil a major shift in the way the central bank looks at inflation.

The S&P is up 0.2% and the Dow is up 0.3%. The Nasdaq is lagging, as it did yesterday, off 0.2%. The Dow may face some additional pressure until it recalibrates and trades with three new stocks on Monday.

Powell’s Thursday speech from the virtual Jackson Hole gathering is expected to introduce new measure, including inflation averaging, which would let price gains run hotter than the 2% target.

Nominal and real rates are climbing. The 10-year Treasury yield is above 0.7%, nearly six basis points higher. The 10-year inflation-protected yield is up to -1.01%.

Banks, which benefit from higher rates, are pushing the Financials (NYSEARCA:XLF) up to the top of the sectors. Citi, BofA, Wells Fargo and J.P. Morgan are all up more than 1%.

Technology (NYSEARCA:XLK) is having trouble getting in gear for the second day in a row. It’s the weakest sector.

The megacaps are mixed, with Facebook leading and Apple down more than 1%.

In commodities, spot gold is off 0.2%, but crude futures are up nearly 2%.

https://seekingalpha.com/news/3608544-financials-lead-market-rates-bounce-on-expected-shift-in-fed

FDA accepts Sarepta application for DMD med casimersen

The FDA accepts for review Sarepta Therapeutics’ (NASDAQ:SRPT) marketing application seeking approval of casimersen (SRP-4045), branded as AMONDYS 45, for the treatment of Duchenne muscular dystrophy (DMD) patients amenable to exon 45 skipping.

At this point, no advisory committee meeting is planned.

The agency’s action date is February 25, 2021.

https://seekingalpha.com/news/3608517-fda-accepts-sarepta-application-for-dmd-med-casimersen

REGENXBIO on go with mid-stage study of gene therapy for diabetic retinopathy

The FDA has signed off on a Phase 2 clinical trial, ALTITUDE, evaluating REGENXBIO’s (NASDAQ:RGNX) gene therapy RGX-314 in patients with diabetic retinopathy (DR).

The primary endpoint is the proportion of participants showing improved DR at week 48 as measured by a scale called ETDRS-DRSS.

Dosing should begin in H2. Preliminary data should be available in 2021.

https://seekingalpha.com/news/3608521-regenxbio-on-go-mid-stage-study-of-gene-therapy-for-diabetic-retinopathy

AstraZeneca Begins Phase 1 Trial of Potential Covid-19 Antibody Treatment

AstraZeneca PLC said Tuesday that it has started a Phase 1 clinical trial of AZD7442, a combination of two monoclonal antibodies, for the prevention and treatment of Covid-19.

The British pharmaceutical giant, which is separately developing a Covid-19 vaccine together with researchers at the University of Oxford, said the trial will assess the safety, tolerability and pharmacokinetics of the combination.

Should it achieve favorable results, AstraZeneca will move the treatment into late-stage Phase 2 and Phase 3 trials to evaluate its efficacy as a potential preventative and treatment approach against Covid-19, it said.

The trial will include up to 48 healthy participants in the U.K. aged 18 to 55 years, AstraZeneca said.

The U.S. Defense Advanced Research Projects Agency and the Biomedical Advanced Research and Development Authority are providing funding for the trial, the company said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Begins-Phase-1-Trial-of-Potential-Covid-19-Antibody-Treatment-31169811/

Altimmune rallies on encouraging data on intranasal COVID-19 vaccine

Altimmune (NASDAQ:ALT) announces additional positive data from preclinical studies at the University of Alabama at Birmingham on AdCOVID, its intranasal COVID-19 vaccine candidate.

Results showed potent stimulation of antigen-specific CD4+ and CD8+ T cells in the lungs of CD-1 mice as early as 10 days following a single intranasal vaccination, with responses strongly biased toward CD8+ T cells.

The company says the mucosal T cell response in the respiratory tract is thought to be dependent on the intranasal route of administration and it believes that AdCOVID has the potential to provide additional protection against COVID-19, adding that the induction of mucosal T cell response in the lungs has yet to be demonstrated in intramuscularly administered COVID-19 vaccine candidates currently in late-stage development.

On July 13, it reported that AdCOVID stimulated a strong systemic neutralizing antibody response in addition to a 29x mucosal IgA antibody response against the coronavirus spike protein in the respiratory tract of mice.

Development is ongoing. 

https://seekingalpha.com/news/3608474-altimmune-rallies-on-encouraging-data-on-intranasal-covidminus-19-vaccine-candidate

Mereo Bio launches mid-stage alvelestat trial in COVID-19 August 25, 2020

Mereo BioPharma (NASDAQ:MREO) jumps 10% premarket after initiating a Phase 1b/2 clinical trial to evaluate the safety and efficacy of alvelestat in hospitalized, adult patients with moderate to severe COVID-19 respiratory disease.

Alvelestat is a novel, oral small molecule designed to inhibit neutrophil elastase (NE), a key enzyme involved in the destruction of lung tissue.

The trial will enroll approx. 15 patients. The primary endpoint is safety and tolerability of alvelestat at day 10, with a safety follow up to day 90.

Additional endpoints include blood biomarkers (NETosis, inflammation and hypercoagulation) and oxygen deficit at day 10.

The trial will also assess clinical outcomes, including effect on disease progression and disease severity at day 29.

https://seekingalpha.com/news/3608506-mereo-bio-launches-mid-stage-alvelestat-trial-in-covidminus-19