Target $75
Monday, July 26, 2021
MorphoSys AG to Update Financial Guidance, Reduce Financial Liabilities
MorphoSys AG (FSE:MOR; NASDAQ:MOR) announces today an update of its financial guidance for 2021 after preliminary completion of the latest evaluation of MorphoSys' half year 2021 financial performance.
Based on the preliminary unaudited consolidated results for the first six months 2021, MorphoSys now expects Group revenues in the range of € 155 to € 180 million (previously: € 150 to € 200 million, provided on March 15, 2021 and reiterated on May 5, 2021). The updated revenue guidance primarily reflects updated Monjuvi (R) product sales expectations.
MorphoSys now expects Group operating expenses, which is comprised of R&D and Selling, as well as General & Administrative expenses, in the range of € 435 to € 465 million (previously: € 355 to € 385 million). R&D expenses now are expected to comprise 52 to 57% of Group operating expenses (previously 45-50%), excluding one-time transaction-related costs. The updated guidance for Group operating expenses mainly reflects the acquisition of Constellation Pharmaceuticals (Constellation), which was completed on July 15, 2021. The revised Group range also includes one-time transaction costs of € 36 million, related to the agreements with Constellation and Royalty Pharma.
As a result of the updated Monjuvi product sales expectations, the balance sheet position "Financial Liabilities from Collaborations, Net of Current Portion" is reduced from € 547.6 million (balance as of March 31, 2021) to € 445.9 million (balance as of June 30, 2021). The balance in "Financial Liabilities from Collaborations, Net of Current Portion", reflects an accounting view of expected profits from the net product sales of Monjuvi in the U.S. in the r/r DLBCL setting owed to our partner Incyte. The reduction in Financial Liabilities from Collaborations has no impact to cash.
Full results will be published as planned on July 28, 2021.
F-star update on cancer trial
F-star Therapeutics, Inc. (NASDAQ: FSTX) (“F-star” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, is providing an interim update on the first-in-human dose-escalation study of SB 11285, a second generation STING agonist. The ongoing multicenter clinical trial (NCT04096638) is evaluating the safety and efficacy of intravenously (IV) administered SB 11285 alone and in combination with the anti-PD-L1 monoclonal antibody, atezolizumab, in patients with advanced solid tumors.
SB 11285 was well tolerated both alone and in combination with atezolizumab across all dose levels tested to-date, including five dose levels as monotherapy and three dose levels as a combination. Initial analysis showed that pharmacokinetics (PK) were in line with the predicted profile for rapid cellular uptake, a characteristic of second generation STING agonists. A further clinical update will be shared in 2022.
Dr. Louis Kayitalire, Chief Medical Officer of F-star said: “While further analysis is ongoing, the positive safety profile, early evidence of disease control, PK and biomarker data encourage further dose escalation.”
https://finance.yahoo.com/news/f-star-therapeutics-provides-interim-120000299.html
Some Americans could need COVID-19 vaccine booster -Fauci
Top infectious disease official Anthony Fauci said on Sunday that Americans who are immune compromised may end up needing COVID-19 vaccine booster shots as the United States deals with increasing cases from the Delta variant of the coronavirus.
"Those who are transplant patients, cancer chemotherapy, auto-immune diseases, that are on immunosuppressant regimens, those are the kind of individuals that if there's going to be a third booster, which might likely happen, would be among first the vulnerable," Fauci said during a CNN interview.
He added health officials are also considering whether to revise mask guidance for vaccinated Americans saying it was "under active consideration."
Citing studies that show there might be waning immunity in vaccinated people, Fauci said U.S. health officials are reviewing data to determine when boosters might be needed.
“It’s a dynamic situation. It’s a work in progress, it evolves like in so many other areas of the pandemic,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases. “You’ve got to look at the data.”
Last week, Israel's health ministry reported a decrease in the effectiveness of the Pfizer vaccine in preventing infections and symptomatic illness. But it added that the two-dose COVID-19 vaccine developed by Pfizer with partner BioNTech still remained highly effective in preventing severe illness.
The decline in efficacy coincided with the spread of the Delta variant, now the dominant strain in Israel.
Israel is administering third doses of the vaccine to immunocompromised people, including those who have had heart, lung, kidney or liver transplants and cancer patients receiving chemotherapy.
The Delta variant, which was first found in India, is driving up infections in the United States.
The sharpest increases in COVID-19 cases are in places with lower vaccination rates. Florida, Texas and Missouri account for 40% of all new cases nationwide, with around one in five of all new U.S. cases occurring in Florida, White House adviser Jeffrey Zients said last week.
The U.S. Centers for Disease Control and Prevention (CDC) on Sunday reported an uptick in the number of vaccine doses administered in the past 24 hours -- 778,996, the highest number given in a 24-hour period since the United States reported giving 1.16 million doses on July 3.
However, that number is far below the peak of 4.63 million doses reported on April 10 and, despite the rise, the pace of vaccinations is still generally declining, CDC data shows.
Since vaccines became widely available in the spring, President Joe Biden's White House has been conducting an aggressive campaign to get shots in arms that has been met with skepticism in some states and communities.
White House Chief of Staff Ronald Klain on Sunday hailed the CDC numbers as a sign vaccinations were picking back up.
Pfizer and BioNTech said on Friday that the United States had purchased 200 million more doses of their vaccine to help with pediatric vaccination as well as possible booster shots.
https://finance.yahoo.com/news/1-americans-could-covid-19-135331425.html
Iterum Gets Complete Response Letter from FDA for Oral Sulopenem
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) on July 23, 2021. The CRL provided that the FDA has completed its review of the NDA and has determined that it cannot approve the NDA in its present form.
In the CRL, the FDA acknowledged that the Phase 3 SURE-1 clinical trial demonstrated statistical significance in difference in overall response rate of oral sulopenem compared to ciprofloxacin in the ciprofloxacin-resistant population. However, the FDA determined that additional data are necessary to support approval for the treatment of adult women with uncomplicated urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone. The FDA recommended that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug. Additionally, the FDA recommended that Iterum conduct further nonclinical investigation to determine the optimal dosing regimen, although the FDA stated that this recommendation does not raise an approvability issue. The FDA indicated its willingness to work with Iterum on the design of the clinical trial(s) to address the deficiencies noted.
There were no chemistry, manufacturing or controls (CMC) issues identified in the CRL, nor were there any safety issues found in over 1,800 patients treated with sulopenem across the Company’s clinical development program.
“We are disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” said Corey Fishman, Chief Executive Officer. “Regardless, we will evaluate the points raised in the CRL for discussion with the FDA to determine an expeditious path forward. We remain confident in the value of, and unmet medical need for, oral sulopenem to treat multi-drug resistant infections, including fast-growing quinolone non-susceptible pathogens.”
Sunday, July 25, 2021
HMO: Early vaccinees are twice as likely to catch COVID as later recipients
Latest research ‘definitely’ reinforces argument for giving boosters to the elderly, says lab chief at Israeli health care provider Leumit
People vaccinated before late February are twice as likely to catch the coronavirus than other inoculated Israelis, according to new research.
“We looked at tens of thousands of people tested in the month of June, alongside data on how long had passed since their second shot, and found that those vaccinated early were more likely to test positive,” Dr. Yotam Shenhar, who headed the research, told The Times of Israel.
“This definitely reinforces the argument for giving a third vaccine dose to the elderly.”
The report, published by the healthcare provider Leumit, comes on the heels of other Israeli studies that suggest a decreasing vaccine effectiveness, partly as a result of the Delta variant and partly because of the passage of time. However, British data indicates the Israeli studies may be overstating the case.
Data released by the Health Ministry on Thursday suggested that people vaccinated in January were said to have just 16% protection against infection now, while in those vaccinated in April the effectiveness was at 75%
The Leumit study looked only at the apparent waning of protection over time, and divided the vaccinated population into two based on inoculation dates, comparing early vaccinators to late vaccinators.
Shenhar, head of Leumit’s labs, acknowledged that the early vaccinators group includes many people who raced to get shots because they have underlying illnesses, which may make them more vulnerable to infection. But he said that could not fully account for the stark effect seen in the data.
Shenhar said the data should prompt the government to seriously consider booster shots for over-70s.
“Now we see vaccination effectiveness drops, so it seems we definitely need to think about a third vaccine,” he said. “We have started already by giving the immunocompromised, but in my assessment we need to consider giving third shots to everyone over 70 or 80. We shouldn’t wait long; we need to make a decision fast.”
If he were formulating policy, Shenhar said, he would “definitely” start giving boosters to elderly Israelis.
In his study, the apparent waning effect in immunity was felt across all ages. For all age groups, early vaccinators were 1.95 times more likely to be confirmed coronavirus positive. Among those aged 60-plus, early vaccinators are twice as likely to get infected. For those aged 40-59 early vaccinators are 2.1 times more vulnerable, and among under 39s they are 1.6 more likely to catch the coronavirus.
“In a previous analysis we showed that as time passes since the vaccine, the level of antibodies drops at a rate of about 40% per month. This new study builds a clearer picture of the effect seen in the months after vaccination,” said Shenhar.
Israel has seen a dramatic rise in recent COVID-19 infections, with the daily caseload rising from several dozen to over 1,400 in recent days.
Gargling, other underused interventions may slow spread of SARS-CoV-2 when schools reopen
As the largest mass vaccination campaign in human history progresses, the landscape of immunity against SARS-CoV-2 within the U.S. is changing. The vaccine strategy that began with focused protection for some and rapidly expanded to protection for all, continues to serve as the crucial step in decoupling COVID-19 deaths from infections. Approximately 50% of our total population is fully vaccinated, as are 80% of those 65 and older. This "community immunity" has largely deescalated the risk to those most likely to experience severe outcomes, while simultaneously placing those who cannot or will not be vaccinated in the spotlight. As adult vaccinations continue to rise, the totality of COVID-19 risk is diminished.
The focus now shifts to the immunologically naïve, especially children. Children less than 12 years old are unable to be vaccinated in the U.S. at this time. Moreover, concerns regarding post-vaccine myocarditis in younger populations may shift the favorable perception of risk/benefit analysis. These implications are significant as COVID-19 outcomes among younger populations are not always benign. With cases currently surging and the seasonality of the virus, we can expect a continued surge in cases this fall -- just in time for a return to school.
So, what measures -- both new and old -- do we need to take to ensure a safe return to classrooms for all kids?
When considering the protection of our school children, a balanced approach is key. It's a complicated calculus to weigh the risks of viral infection and masking our children (as the American Academy of Pediatrics recently recommended for all students inside schools) in the long- and short-term while overlaying vaccination. If indeed Delta, Gamma, Lambda, or other variants remain ascendant in the autumn we can reliably fall back on our pillars of infection control. But will these measures be sufficient to allay the fears of concerned parents, teachers, institutions, and communities? Additional strategies need to be considered, especially since we can ill afford to deny our children the much needed in-person educational experience.
One underexplored strategy to better control transmission of SARS-CoV-2 in schools may involve the use of a dilute oral antiseptic gargle or oral rinse. Similar to the two-way protection afforded by masks, treating the mouth with a safe, effective dilute antiseptic can better protect students by reducing spread and preventing infection. The idea is simple. If a child is asymptomatically infected and shedding virus, a before- and after-school oral treatment can potentially diminish the quantity or quality of active virus entering infectious droplets/aerosols making them less infectious. On the other hand, if a child is healthy but exposed to the virus, the treatment might provide prophylaxis against or at least mitigate infection. These ideas are not new, but the science of oral antiseptics and their effects on viral transmission dynamics during the last year has taken a big leap forward.
Gargles have been used for thousands of years dating back to the ancient Romans, Egyptians, and Chinese. Modern gargle science, especially with the use of alcohols, was pulled forward with the discovery of microbes by Antonie van Leeuwenhoek and later 19th century interventions of surgeon Joseph Lister. In Asia, there exists a more developed culture around gargling and its salubrious effects. Early in this millennium a group of Japanese doctors termed "The Great Cold Investigators" began to examine the influence of gargling on upper respiratory tract infections and influenza-like illnesses. What they and other investigators found is significant. A series of randomized controlled trials support the notion that gargling with interventions like water, green tea, and dilute povidone-iodine (PVI) may indeed reduce the incidence of these illnesses. Interestingly, the act of gargling water may reduce oropharyngeal proteases, which are critical to viral infection, and the chlorine present in tap water may be of sufficient concentration to inactivate viruses. Oral gargles do not represent a new frontier in children either. They have been used to prevent and treat dental caries and recalcitrant biofilms. In one landmark study conducted in Japan, middle school children from Yamagata City who routinely gargle with dilute PVI for 3 months during the winter reported less absenteeism secondary to the common cold and influenza.
The amount of scientific information generated during the COVID-19 pandemic has been extraordinary. Gargle science has certainly benefitted, as scientists and clinicians desperately looked for ways to augment infection control mechanisms. Numerous in-vitro reports have highlighted the efficacy of gargle active pharmaceutical ingredients like PVI, chlorhexidine, essential oils, alcohols, and hydrogen peroxide against SARS-CoV-2. The difference this time is that these studies carried over into in-vivo, smaller scale clinical trials.
Of all the studied active pharmaceutical ingredients, perhaps the best data has been generated with dilute PVI. This is a broad-spectrum microbiocide with years of data supporting its ability to decontaminate human tissues and kill contagions capable of pandemic spread. It is safe, makes the World Health Organization list of essential medicines, and has not been implicated in antimicrobial resistance. Importantly, its use is not known to alter healthy, supportive populations of the microbiome. Independent clinical trials in the setting of active COVID-19 have shown that administration of dilute PVI decreases viral RNA quantification, decreases infectious viral titers, decreases active virus in whole mouth fluid and respiratory droplets, speeds viral clearance, and protects against infection.
From the outset of this pandemic, the idea of oral rinses with safe and effective antiseptics was well-founded but lacked supportive data. Given the existence of these expanding reports to better inform, the evidence is supportive that use of dilute oral antiseptics may be a safe way to reduce viral transmission. The relatively small-scale of gargle-based clinical trials leaves them vulnerable to the criticism of being poorly performed and underpowered. While large-scale randomized controlled trials are certainly lacking, there is still much to be gleaned from other types and levels of evidence, especially when backed by millennia of favorable experience and implemented for clinical necessity during a pandemic. The low-cost, safety, and preventative practice of gargling or oral rinsing is also consistent with the precautionary principle and the oath of Hippocrates (do no harm or injustice!) making it perhaps an ideal intervention for our vulnerable children when they return to school, especially in combination with other public health measures. It may strike the right balance between doing something and doing nothing, between showing that we are still thinking, evolving, and considering rather than falling back into the same reactive patterns that ultimately led to school closings.
Jesse Pelletier, MD, is a private practice ophthalmologist in Miami, and co-founder/chief medical officer of Veloce BioPharma. Terrence P. O'Brien, MD, is a professor of ophthalmology and the Charlotte Breyer Rodgers Distinguished Chair at the Bascom Palmer Eye Institute in Miami.
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