Roche presents new data on efficacy of MS treatment Ocrevus

Roche said on Thursday new data showed its big-selling multiple sclerosis treatment Ocrevus was a “highly effective treatment option offering a favourable and consistent benefit risk profile”.

The data will be presented at MSVirtual2020 from Sept. 11-13, Roche said in a statement.

It will also present data showing its Enspryng treatment lowered relapse severity in people with Neuromyelitis Optica Spectrum Disorder (NMOSD).

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Roche-presents-new-data-on-efficacy-of-MS-treatment-Ocrevus-31224308/

FMC FRESENIUS MEDICAL CARE AG & CO KGAA: JP Morgan gives a Buy rating

In a research note published by David Adlington, JP Morgan advises its customers to buy the stock.

https://www.marketscreener.com/quote/stock/FRESENIUS-MEDICAL-CARE-AG-436087/news/FMC-FRESENIUS-MEDICAL-CARE-AG-CO-KGAA-JP-Morgan-gives-a-Buy-rating-31225424/

Sanofi/GSK initiate Phase 1/2 COVID-19 trial, first results expected early December September 3, 2020

Sanofi (NASDAQ:SNY) and GlaxoSmithKline (NYSE:GSK) have started the Phase 1/2 clinical trial for their COVID-19 adjuvanted recombinant protein-based vaccine candidate.

The trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 440 healthy adults are being enrolled.

First results, anticipated by early December 2020 will support the initiation of a Phase 3 trial in December. If sufficient data is obtained, companies plan to request regulatory approval in H1 2021.

Pre-clinical studies have shown promising safety and immunogenicity and will be published later this year.

In parallel, both the companies are scaling up manufacturing of the antigen and adjuvant with the target of producing up to 1B doses in 2021.

In July 2020, Sanofi/Glaxo joined Operation Warp Speed, to supply 100M COVID-19 vaccine doses to U.S.

The Warp speed participants include Vaxart (NASDAQ:VXRT), Pfizer (NYSE:PFE), Moderna (NASDAQ:MRNA), Merck (NYSE:MRK), Johnson & Johnson (NYSE:JNJ) and AstraZeneca (NYSE:AZN).

Previously: Sanofi plans to start human testing of COVID-19 vaccine – Bloomberg (Aug. 27)

https://seekingalpha.com/news/3611324-sanofi-gsk-initiate-phase-1-2-covidminus-19-trial-first-results-expected-early-december

Applied Genetic to update on Phase 2/3 XLRP trial data, Q4 results

Applied Genetic Technologies (NASDAQ:AGTC) will provide a management update on its planned Phase 2/3 X-Linked Retinitis Pigmentosa (XLRP) clinical trial design, a re-analysis of dose Groups 2 and 4 data, and new preliminary visual sensitivity data from Group 5 on September 9, 2020.

The Company will also report financial results for Q4 and FY 2020 before the market opens on September 9.

https://seekingalpha.com/news/3611325-agtc-to-update-on-phase-2-3-xlrp-trial-data-and-q4-results-on-september-9

Novavax provides additional data on COVID-19 vaccine candidate

Novavax (NASDAQ:NVAX) announces the publication of Phase 1 data from its Phase 1/2 trial of COVID‑19 vaccine candidate NVX‑CoV2373, adjuvanted with Matrix‑M, in 131 healthy adults 18-59 years of agein The New England Journal of Medicine.

The publication offers further detail on the previously announced NVX‑CoV2373 results with and without the Matrix-M adjuvant.

After randomization, 83 participants were assigned to receive the vaccine with adjuvant and 25 without adjuvant, and 23 participants were assigned to receive placebo.

The addition of adjuvant resulted in enhanced immune responses, was antigen dose–sparing, and induced a T helper 1 (Th1) response. The two-dose 5-μg adjuvanted regimen induced geometric mean anti-spike IgG (63,160 ELISA units) and neutralization (3906) responses that exceeded geometric mean responses in convalescent serum from mostly symptomatic COVID-19 patients (8344 and 983, respectively).

No serious adverse events were noted. Reactogenicity was absent or mild in the majority of participants, more common with adjuvant, and of short duration (mean, ≤2 days).

NVX-CoV2373 appeared to be safe, and it elicited immune responses that exceeded levels in COVID-19 convalescent serum.

The Matrix-M1 adjuvant induced CD4+ T-cell responses that were biased toward a Th1 phenotype.

NVX-CoV2373 is currently in multiple Phase 2 clinical trials.

The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

After closing with a 2.07% decline at $102.90 in Wednesday’s regular session, shares gained 3.79% and topped $106.80 in after-hours trading.

https://seekingalpha.com/news/3611327-novavax-provides-additional-data-on-covidminus-19-vaccine-candidate

New treatment for drug-resistant bacterial infections

The Centers for Disease Control and Prevention (CDC) has prioritized finding effective treatment of Methicillin-resistant Staphylococcus aureus (MRSA), one of the most common bacterial pathogens and the single most deadly drug-resistant bacteria in the United States. Now, a new study led by Dartmouth Engineering faculty shows promise for an engineered lysin-based antibacterial agent that may enable safe, repeated dosing to treat life-threatening infections by MRSA and other types of S. aureus.

In recent years, lysins–enzymes naturally produced by microbes and associated viruses–have shown potential to treat S. aureus, which can rapidly acquire resistance to other types of antibiotic drugs.

“Lysins are one of the most promising next-generation antibiotics. They kill drug-sensitive and drug-resistant bacteria with equal efficacy, they can potentially suppress new resistance phenotypes, and they also have this laser-like precision,” said Karl Griswold, corresponding author and associate professor of engineering at Dartmouth.

While there is promise in lysins, development has been slowed due to concerns that they prompt humans’ immune systems to develop antidrug antibodies, which can have negative side effects including life-threatening hypersensitivity reactions.

That’s why the Dartmouth Engineering team–which also included researchers in Dartmouth’s computer science department, The Lundquist Institute at Harbor-UCLA Medical Center, Lyticon, and Stealth Biologics–engineered and patented F12, a new lysin-based antibacterial agent. F12 is essentially able to hide from the human immune system (due to T cell epitope deletion), and therefore does not cause the same negative side effects as unmodified, natural lysins.

F12 is the first lysin-based treatment with the potential to be used multiple times on a single patient, making it ideal to treat particularly persistent drug-resistant and drug-sensitive infections. Preclinical studies showed the efficacy of F12 does not diminish with repeated doses, while two other anti-MRSA lysin treatments currently in clinical trials are only designed to be used a single time.

“We have engineered this super potent, super effective anti-MRSA biotherapeutic, and we’ve done it in a way that renders it compatible with and largely invisible to the human immune system. By making it a safer drug, we’ve enabled the possibility of dosing multiple times in order to treat even the most highly refractory infections,” said Griswold.

The team’s paper, “Globally deimmunized lysostaphin evades human immune surveillance and enables highly efficacious repeat dosing,” was published earlier today by Science Advances. The work was the result of two grants from the National Institutes of Health (NIH) totaling $1.7 million.

The paper details the treatment’s positive results in rabbits, mice with partially-humanized immune systems, and studies with extracted human immune cells. Griswold believes the antibacterial agent could be ready for human clinical trials as soon as 2023.

“This is the first report of a translation-ready deimmunized lysin, and F12 has serious, bonafide clinical potential,” said Griswold.

Further studies of F12 will examine synergy with standard-of-care antibacterial chemotherapies; preliminary results suggest the combinations are extremely potent and suppress drug-resistance phenotypes.

https://www.eurekalert.org/pub_releases/2020-09/tsoe-dte090220.php

Scientists are giving themselves, their family DIY coronavirus vaccines

As governments around the world scramble to approve a vaccine against the deadly coronavirus, an increasing number of scientists have started administering DIY vaccines to themselves and even their friends and family members.

The methods, results and claims have varied widely among the dozens of scientists around the world who have taken this unconventional route.

One such effort is by scientist Johnny Stine, who runs North Coast Biologics, a biotech company in Seattle. In June, Washington attorney general slapped Stine with a lawsuit for administering his DIY vaccine to San Juan Island Mayor Farhad Ghatan and around 30 people, charging them $400, the New York Times reported.

Another vaccine effort going outside FDA approval is the Rapid Deployment Vaccine Collaborative, or RaDVaC, which has among its 23 collaborators Harvard geneticist George Church.

Proponents have welcomed the idea of going outside the normal regulatory process, given the extraordinary circumstances of the pandemic. But critics say these DIY vaccines are not being put to the test of placebo-controlled studies and could have unforeseen negative consequences.

Jeffrey Kahn, the director of the Johns Hopkins Berman Institute of Bioethics, said that encouraging others to take DIY vaccines risks going back to the “days of patent medicine and quackery,” a time in which remedies were sold with false promises.

Meanwhile, Mayor Ghatan said he has no regrets about accepting Stine’s vaccine.

“I’d rather have the chance of having some protection than no protection at all and waiting and waiting,” Ghatan said.

https://nypost.com/2020/09/02/scientists-are-giving-themselves-their-family-diy-coronavirus-vaccines/