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Wednesday, April 14, 2021

Moderna Updates on mRNA Vaccines, Pipeline Development

 CMV 7-month data shows all GMT measures at or above CMV seropositive baselines; pivotal Phase 3 study of at least 8,000 participants expected to begin in 2021

First interim analysis of Phase 1 RSV vaccine candidate (mRNA-1345) shows >11- fold increase in RSV neutralizing antibodies in younger adults (ages 18-49 years); both 50 μg and 100 μg dose levels generally well-tolerated

Phase 1 clinical study of mRNA flu vaccine candidate expected to begin in 2021

Phase 1 study evaluating HIV mRNA vaccines with novel strategy expected to begin in 2021

Company provided update on its COVID-19 Vaccine program on April 13

Vaccines Day to be held on Wednesday, April 14 at 8:00 a.m. ET

https://finance.yahoo.com/news/moderna-announces-clinical-progress-industry-104500013.html

Rocket Pharma: Positive Long-Term Clinical Data from RP-L201 Trial

 — New Long-Term Follow-Up Data Demonstrate Durable CD18 Expression, Improved Skin Lesions, and Consistent Peripheral Vector Copy Numbers Up to 18-Months Post-Treatment —

— Second Patient Nearing One-Year Primary Endpoint for Phase 2 Portion of Study —

— Two Additional Patients with Shorter Follow-Up Demonstrate Evidence of Engraftment —

— RP-L201 was Well Tolerated in All Patients —

— More Comprehensive Phase 2 Results Expected in Second Half of 2021 —

https://finance.yahoo.com/news/rocket-pharmaceuticals-reports-positive-long-110000459.html

Moleculin Awarded New Rare Pediatric Disease Designation

 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPD) to its p-STAT3 inhibitor, WP1066, for the treatment of ependymoma.

Ependymoma is a rare type of tumor that can form in the brain or spinal cord. Ependymoma begins in the ependymal cells in the brain and spinal cord that line the passageways where the fluid (cerebrospinal fluid) that nourishes your brain flows. Ependymoma can occur at any age, but most often occurs in young children.

"The FDA's recognition of the high prevalence and unmet needs in the treatment landscape for ependymoma, especially in pediatric patients is a significant milestone as we continue to advance and expand the WP1066 development program. We currently have Orphan Drug Designation for WP1066 for the treatment of brain tumors, as well as RPD designation for three other pediatric indications, and believe that ependymoma represents another important rare indication. We continue to be encouraged by the data WP1066 has demonstrated to date and believe it has the potential to be an effective therapy for pediatric patients with ependymoma," commented Walter Klemp, Chairman and CEO of Moleculin.

https://finance.yahoo.com/news/moleculin-awarded-rare-pediatric-disease-113500720.html

EU to raise COVID vaccine supplies from Pfizer in Q2 to 250M doses

 European Union countries will receive 50 million more coronavirus vaccines produced by Pfizer and BioNTech in the second quarter, the head of the EU Commission said on Wednesday, as deliveries expected at the end of the year will be brought forward.

European Commission President Ursula von der Leyen said the earlier deliveries, which will start this month instead of in October, will take total supplies to the EU from Pfizer to 250 million doses in the second quarter in a move meant to compensate for lower supplies from AstraZeneca and possible problems with Johnson & Johnson.

"I am pleased to announce that we have reached an agreement with BioNTech-Pfizer to once again speed up the delivery of vaccines," she said.

"This will substantially help consolidate the roll-out of our vaccination campaigns."

Von der Leyen confirmed the Commission was in talks with Pfizer and BioNTech for a new contract for 1.8 billion doses to be delivered in 2022 and 2023, confirming a Reuters report last week.

The EU has already signed two contracts with the two companies for 600 million doses to be delivered this year. About 70 million shots were shipped in the first quarter.

Under the new contract "delivery schedules will be laid out on a monthly instead of quarterly basis," von der Leyen said, adding that production of the vaccines and their essential components will take place in the EU.

She also said on Wednesday that 100 million doses of vaccine had been so far administered in the 27-nation bloc, which has a population of nearly 450 million, since the beginning of the rollout in late December.

https://finance.yahoo.com/news/1-eu-raise-covid-vaccine-122118179.html

Greenwich LifeSciences Updates on GP2 Phase III Trial Design at AACR

 

  • The GP2 Phase III clinical trial design was presented in a poster during the 2021 American Association for Cancer Research (AACR) Annual Meeting, introduced by the Global Principal Investigator, Professor Mothaffar F. Rimawi of Baylor College of Medicine.

  • The Company plans to complete manufacturing of GP2 by the end of the 3rd quarter 2021 and plans to commence the Phase III clinical trial thereafter.

Tuesday, April 13, 2021

COVID-19 in our dust may help predict outbreaks: study

 A study done in rooms where COVID-19 patients were isolated shows that the virus's RNA -- part of the genetic material inside a virus -- can persist up to a month in dust.

The study did not evaluate whether dust can transmit the virus to humans. It could, however, offer another option for monitoring COVID-19 outbreaks in specific buildings, including nursing homes, offices or schools.

Karen Dannemiller, senior author of the study, has experience studying dust and its relationship to potential hazards like mold and microbes.

"When the pandemic started, we really wanted to find a way that we could help contribute knowledge that might help mitigate this crisis," said Dannemiller, assistant professor of civil, environmental and geodetic engineering and environmental health sciences at The Ohio State University.

"And we've spent so much time studying dust and flooring that we knew how to test it."

The study, published today (April 13, 2021) in the journal mSystems, found some of the genetic material at the heart of the virus persists in dust, even though it is likely that the envelope around the virus may break down over time in dust. The envelope -- the crown-like spiked sphere that contains the virus's material -- plays an important role in the virus's transmission to humans.

The study offers another non-invasive avenue for monitoring buildings for COVID-19 outbreaks, especially as more people are vaccinated and return to communal spaces.

Municipalities and others have tested wastewater to evaluate the prevalence of COVID-19 in a given community -- gene copies and fragments of the virus live in human waste, and by testing wastewater, local governments and others can determine how widespread the virus might be, even if people are asymptomatic.

Dust monitoring could offer similar understanding on a smaller scale -- say, a specific nursing home, hospital or school.

"In nursing homes, for example, you're still going to need to know how COVID is spreading inside the building," said Nicole Renninger, lead author of the paper and an engineering graduate student in Dannemiller's lab. "For surveillance purposes, you need to know if you are picking up an outbreak that's going on right now."

For this study, the research team worked with the crews responsible for cleaning the rooms at Ohio State where students who tested positive for COVID-19 were isolated. They also collected samples from two homes where people who tested positive for COVID-19 lived. They gathered vacuum bags of dust from the cleaning crews and from the homes.

The researchers also tested swabs collected from surfaces in the rooms.

They found genetic material from the SARS-CoV-2 virus -- the virus that causes COVID-19 -- in 97% of the bulk dust samples and in 55% of the surface swabs.

The cleaning crews sprayed a chlorine-based disinfectant in the rooms prior to cleaning; the researchers believe that disinfectant destroyed the envelope and/or capsid -- the outer coat surrounding the virus -- likely defanging it for transmission.

The research team tested the samples when they arrived at the lab, shortly after the rooms were cleaned, then tested the samples again weekly. After four weeks, the virus's RNA did not significantly decay in the vacuum bags.

"We weren't sure that the genetic material would survive -- there are many different organisms in dust, and we weren't sure we'd see any viral RNA at all," Renninger said. "And we were surprised when we found that the actual RNA itself seems to be lasting a pretty long time."

Testing dust to monitor for COVID-19 outbreaks would likely be most useful for smaller-scale communities with a high-risk population -- a nursing home, for example, Dannemiller said. Testing indoor dust is also likely less expensive at that scale than testing wastewater or all individuals directly on a routine basis.

"We wanted to demonstrate that dust could be complementary to wastewater for surveillance," Dannemiller said. "Wastewater is great for a large population, but not everybody sheds the virus in feces, and you have to collect wastewater samples, which not everyone wants to do. People are already vacuuming these rooms, so dust may be a good option for some groups."

Even before this study was published, Dannemiller said the researchers presented their findings to an industry group that represents maintenance and cleaning staff, with a recommendation: "If they can wait at least an hour or more after a person leaves the room to clean, they should," she said, citing previous studies of viral viability on other materials and in aerosols.

Other Ohio State researchers who worked on this study include Nick Nastasi, Ashleigh Bope, Samuel Cochran, Sarah Haines, Neeraja Balasubrahmaniam, Katelyn Stuart and Natalie Hull. Kyle Bibby, an associate professor of engineering at the University of Notre Dame, and Aaron Bivins, a postdoc in his group, also contributed.


Story Source:

Materials provided by Ohio State University. Original written by Laura Arenschield. Note: Content may be edited for style and length.


Journal Reference:

  1. Nicole Renninger, Nicholas Nastasi, Ashleigh Bope, Samuel J. Cochran, Sarah R. Haines, Neeraja Balasubrahmaniam, Katelyn Stuart, Aaron Bivins, Kyle Bibby, Natalie M. Hull, Karen C. Dannemiller. Indoor Dust as a Matrix for Surveillance of COVID-19mSystems, April 13, 2021 DOI: 10.1128/mSystems.01350-20

Truist Analyst Turns Bullish On Bristol-Myers Squibb Pipeline

 Key recent clinical pipeline developments have prompted an analyst at Truist Securities to turn bullish on pharma giant Bristol-Myers Squibb Company 

BMY 1.4%.

The Bristol-Myers Squibb Analyst: Gregg Gilbert upgraded Bristol-Myers Squibb from Hold to Buy and increased the price target from $66 to $74.

The Bristol-Myers Squibb Takeaways: Since October, when Truist initiated coverage of Bristol-Myers Squibb with a Hold rating, the company has received approvals for Abecma, a cell therapy for multiple sclerosis; Breyanzi, a cell-based gene therapy for large B-cell lymphoma; and also reported positive late-stage results for a psoriasis drug and the cancer drug relatlimab, Gilbert said in the upgrade note. 

"Our valuation construct yields a theoretical value of ~$30/share for the 150 programs, which represents the second highest value per share in the group," the analyst said. 


The company has sounded bullish on the data from the pivotal trial for its psoriasis drug deucravacitinib and said it is confident of establishing it as a first-line oral treatment of choice for moderate to severe plaque psoriasis, he said. 

The investigational asset has been proved superior to Otezla, which is a $2.2-billion drug and is growing, Gilbert said. 

The analyst now models sales of $2 billion for deucravacitinib by 2026 given Otezla's success and the potential for deucravacitinib to be a more effective oral option.

Bristol-Myers Squibb is developing deucravacitinib for additional indications that could significantly expand its market potential, including ulcerative colitis and Crohn's disease, he said. 

The company's positive Phase 2/3 topline readout for Opdivo in combination with relatlimab, an anti-LAG-3 antibody, for the first-line treatment of melanoma represented the first Phase 3 data to be reported for a LAG-3 antibody, Gilbert said. 

Truist added relatlimab sales to its model to give the company credit for this novel immuno-oncology asset, the analyst said.

The firm expects a 2022 launch schedule, with sales reaching $500 million by 2027.

The company is testing relatlimab in numerous additional solid tumor settings, Gilbert said. 

https://www.benzinga.com/analyst-ratings/analyst-color/21/04/20601968/why-this-bristol-myers-squibb-stock-analyst-is-turning-bullish-on-the-pharma-compan