MorphoSys Licensing Partner GSK Shared Prelim Otilimab Study Results in Pulmonary COVID Related Disease

 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical

company and a leader in antibody, protein and peptide technologies, announced today that its licensing partner 
GlaxoSmithKline plc (LSE/NYSE: GSK) reported preliminary results of the OSCAR (Otilimab?in Severe COVID-19 Related 
Disease) study using otilimab (formerly MOR103/GSK3196165) for the treatment of severe pulmonary COVID-19 related 
disease. Given these data suggest an important clinical benefit in a pre-defined sub-group of high-risk patients and 
the urgent public health need, GSK has amended the OSCAR study to expand this cohort to confirm these potentially 
significant findings. 
This event of the first patient dosed in the expanded study triggers milestone payments of a total of EUR16 million to 
MorphoSys. 
Otilimab is an investigational human monoclonal antibody directed against GM-CSF (granulocyte-macrophage 
colony-stimulating factor) that was generated by MorphoSys and outlicensed to GSK in 2013. GSK is also developing 
otilimab for the treatment of rheumatoid arthritis in the ongoing Phase 3 ContRAst trials. 
"The preliminary study results with otilimab are encouraging news for patients 70 and older with severe COVID-19 
related pulmonary disease," said Dr. Malte Peters, Chief Research and Development Officer of MorphoSys AG. "We are 
pleased that our licensing partner GSK is expanding the study in order to further explore otilimab as a potential 
treatment option for this group of older adults suffering from severe forms of COVID-19." 
About the OSCAR study 
This global, randomised, double-blind, placebo-controlled, multi-centre, proof-of-concept phase 2a OSCAR study 
(NCT04376684) assessed the efficacy and safety of a single intravenous infusion of otilimab 90 mg given over an hour or 
placebo in addition to standard of care in 806 hospitalised adults (ages 18 to 79 years) with severe COVID-19 related 
pulmonary disease. Standard of care permitted the use of corticosteroids (including dexamethasone), remdesivir, and 
convalescent plasma according to local hospital/institutional policies. Study participants were enrolled at 130 sites 
around the world, including in the United States, Europe, Asia, Russia, South Africa and South America. All 
participants had a positive SARS-CoV-2 test result; been hospitalised due to a diagnosis of pneumonia; had new onset of 
oxygenation impairment requiring high-flow oxygen, non-invasive ventilation or mechanical ventilation <48 hours before 
dosing; and had increased biological markers of systemic inflammation. 
Participants were considered 'alive and free of respiratory failure' if they were off significant oxygen support 
measured using a GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) 
scale 2020. A full analysis is ongoing and will be made available in an upcoming pre-print publication when available. 

https://www.marketscreener.com/quote/stock/MORPHOSYS-AG-436425/news/PRESS-RELEASE-MorphoSys-s-Licensing-Partner-GSK-Shared-Preliminary-Results-From-OSCAR-Study-with-Ot-32586349/

Amgen: BLINCYTO Ups Survival In Pediatric Acute Lymphoblastic Leukemia

 Amgen (NASDAQ:AMGN) today announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association (JAMA).1

BLINCYTO demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) compared with chemotherapy. After a median of 22.4 months follow-up, 69% of patients treated with BLINCYTO were alive and event-free compared with 43% of patients treated with chemotherapy. Additionally, following treatment with BLINCYTO, 93% of patients with MRD at baseline achieved MRD negative remission compared with 24% of patients treated with chemotherapy. The 36-month overall survival (OS) estimate in the BLINCYTO group was 81.1% versus 55.8% in the chemotherapy group, and the median OS has not been met.

https://www.prnewswire.com/news-releases/blincyto-blinatumomab-demonstrated-significantly-prolonged-event-free-survival-compared-with-consolidation-chemotherapy-in-pediatric-patients-with-relapsed-acute-lymphoblastic-leukemia-301238918.html

U.S. trial of COVID-19 blood plasma halted after no benefit found

 The U.S. National Institutes of Health (NIH) said on Tuesday that it has halted a trial of convalescent blood plasma in the treatment of patients with mild-to-moderate COVID-19 symptoms as it was unlikely to benefit this group.

The NIH said its decision was based on the findings of an independent data monitoring board. (bit.ly/3rbOIdh)

The health agency’s move comes less than two months after an international trial of convalescent plasma was halted as no benefit was found. Other studies conducted in India and Argentina have also found no apparent benefit for those severely ill with the disease.

The U.S trial had enrolled 511 of 900 participants, who were either given blood plasma from recovered COVID-19 patients or a placebo.

A recent analysis indicated no significant difference in the proportion of patients who needed emergency treatment, had to be hospitalized or died within 15 days of entering the trial, NIH said.

https://www.reuters.com/article/us-health-coronavirus-plasma/u-s-trial-of-covid-19-blood-plasma-halted-after-no-benefit-found-idUSKCN2AU29B

Facebook’s growth rate could be hit by Covid vaccines: CFO

 Facebook CFO David Wehner on Tuesday said the social media company’s advertising growth rate could be impacted as more consumers receive their Covid-19 vaccinations and shift their spending back toward services like travel instead of consumer goods.

We “expect some of consumer expenditures to shift back into services in places like travel as we get further into the year and people get vaccinated,” Wehner said, speaking at the Morgan Stanley Technology, Media and Telecom Conference. “That could impact us in terms of growth rate because we tend to under index relative to the overall economy in some of the service sectors.”

Wehner said that it is still tough to forecast for 2021 with so much uncertainty, but, in general, Facebook expects the growth in e-commerce ad sales to slow down. E-commerce was a key sector that fueled Facebook’s growth in the third and fourth quarters of 2020, Wehner said.

“The acceleration that we saw in the e-commerce growth side, that’s going to slow down because we’re not going to have the same drivers of acceleration pushing people to shift online,” Wehner said. “We do think that online is going to be a bigger component of people’s businesses going forward, so we think we’ll lock in those gains. But I don’t think the shift will be happening as quickly, so that’ll be somewhat of a headwind to our business.”

https://www.cnbc.com/2021/03/02/facebooks-growth-rate-could-be-impacted-by-covid-vaccines-cfo-says-.html

House to investigate One Medical's vaccination practices: report

 Congress is launching an investigation into concierge healthcare provider One Medical following allegations that the company has been administering COVID-19 vaccinations to ineligible patients, according to a new report.

The House Select Subcommittee on the Coronavirus Crisis plans to examine the San Francisco-based company's practices, NPR reported. This comes on the heels of an NPR investigation that found One Medical administered COVID-19 vaccinations to those with connections to leadership as well as ineligible patients.

"Despite being warned that the company's lax oversight of vaccine eligibility rules was allowing ineligible patients to jump the line, One Medical has reportedly failed to properly implement an effective protocol to verify eligibility and instructed staff not to police eligibility," wrote subcommittee Chairman James Clyburn in a letter sent to One Medical late Monday night, the publication reported.

The letter demands documents and information on One Medical's COVID-19 vaccination practices within two weeks, with a deadline of March 15. Among other topics, it seeks demographic breakdowns of COVID-19 vaccines administered to date and communications related to vaccination appointments arranged for those close to the company's executives, according to NPR.

The company has refuted the claims, and, during an earnings call last week, One Medical Chairman, CEO, and President Amir Dan Rubin said "any assertions the company broadly and knowingly disregarded eligibility guidelines are not true and in contradiction to its approach."

One Medical responded to news of the probe Monday, saying: "We remain dedicated to lending our time and resources to providing equitable and accessible care for the communities we serve, and are confident that we will be able to clear up these misunderstandings," according to NPR.

In a statement on its website, One Medical said it routinely turns people away who do not meet eligibility criteria.

"Our data currently shows nationally 96% of individuals vaccinated by One Medical have eligibility documentation and the remaining 4% generally were vaccinated in accordance with zero wastage protocols," the company said.

After reviewing internal communications, NPR found multiple instances across multiple states in which medical staffers working for One Medical sounded the alarm about improper procedures and lax oversight over eligibility requirements. "We are not policing," a top One Medical staffer told doctors and other medical providers after they raised concerns. One Medical claims that it does not knowingly permit ineligible patients to be vaccinated.

As the congressional investigation begins, numerous local public health departments have halted cooperation with One Medical based on investigations that found vaccination line-skipping. 

https://www.fiercehealthcare.com/practices/congress-to-investigate-one-medical-s-vaccination-practices-report

AbbVie bags option to buy Mitokinin for Parkinson's prospect

 AbbVie has landed an option to buy Mitokinin for a neurodegenerative disease pipeline led by a Parkinson’s disease prospect. The option positions AbbVie to buy Mitokinin upon the completion of IND-enabling studies on the biotech’s lead PINK1 compound. 

Mitokinin is based on technology discovered by Nicholas Hertz, Ph.D., and Kevan Shokat, Ph.D., at the University of California, San Francisco. In 2013, Hertz and Shokat co-authored a paper in Cell that described the use of a neo-substrate to increase the activity of PINK1. The approach represented a way to work around the lack of known allosteric regulatory sites for PINK1 and thereby treat an autosomal recessive form of early onset Parkinson’s.

Hertz and Shokat co-founded Mitokinin with Daniel de Roulet to take the science forward, leading to a series A round that attracted Mission BioCapital and Pfizer Ventures. Mitokinin used the money to take its Parkinson’s program to the IND-enabling stage while doing early-stage work on Huntington's and Alzheimer’s diseases. 

Now, AbbVie has signed up to help Mitokinin get to the next stage in its evolution. In return for the option to buy Mitokinin, AbbVie is making an upfront payment that will help the biotech take its lead program through IND-enabling studies. AbbVie has an option to buy Mitokinin once the IND-enabling work is complete. 

If AbbVie takes up the option, it will secure the rights to a drug that could unlock the therapeutic potential of PINK1. A body of evidence going back around 20 years links mutations to mitochondrial kinase PINK1 to Parkinson’s. PINK1 is involved in repairing mitochondrial dysfunction. Mutations to the kinase stop those repairs, leading to the buildup of improperly folded proteins in mitochondria associated with Parkinson’s. 

Multiple groups have identified PINK1 as a potential target, but the interest is yet to translate into clinical candidates. With AbbVie in its corner, Mitokinin could now lay the groundwork for a move into the clinic and secure an exit for its investors in the process. 

https://www.fiercebiotech.com/biotech/abbvie-bags-option-to-buy-mitokinin-for-parkinson-s-prospect

J&J’s next COVID vax challenge? Beating ‘66%’ perception to win vaccine-hesitant public

 With an FDA green light for emergency use, Johnson & Johnson’s COVID-19 shot now faces a communications hurdle. How will the company handle the comparisons with its vaccine rivals?

Already, there's wide and spreading chatter on social media and real-world word-of-mouth discussions about the J&J shot's 66% overall effectiveness rate. The company's response has been communication—and lots of it, with some help from its friend in public health.

J&J CEO Alex Gorsky, government officials—and even Pfizer board member and ex-FDA chief Scott Gottlieb—took to multiple media outlets on Sunday and Monday to lay out the detailed facts and nuances in the data.

Gorsky hit the media circuit Monday morning, appearing on CBS’ Good Morning America, NBC’s Today Show and CNBC news.

His repeated answer to the 66% question when compared to Pfizer and Moderna’s 95% and 94% effectiveness rates? Different trial timing—namely, after new variants emerged—and the global nature of J&J’s testing delivered different outcomes.

While 40% of its trial participants were in the U.S., another 40% were in Latin America and 15% were in South Africa, where almost all trial participants faced the more-contagious B.1.351 variant.

Plus, in all his interviews, Gorsky pointed to the vaccine’s 85% effectiveness rate against serious illness and 100% effectiveness at preventing death.

“Our data actually includes these most challenging, pernicious, virulent strains and what we saw was an 85% effectiveness rate in the severe disease,” Gorsky said on CNBC.

On Sunday, Anthony Fauci, NIAID chief and the White House's chief medical adviser, appeared on Meet the Press and Face the Nation with a similar message about reductions in hospitalizations and deaths.

The White House COVID-19 Response Team released a social media video featuring Fauci answering questions about the J&J vaccine. He opens the video by saying, “I would definitely take the Johnson & Johnson vaccine.”

Former FDA Commissioner Scott Gottlieb called the J&J vaccine effective in a media appearance on CBS’ Face the Nation Sunday. He said he would take the shot himself and urged people to be confident in its worth.

While J&J’s vaccine may face greater communications challenges than the first two COVID-19 vaccines did, the company and public health officials should continue to aim for transparency and simple, clear messages, experts said.

“One of the most important things is not overgeneralizing the message and saying ‘Oh, you should just get it whatever it is,’ ” said Rob Jekielek, managing director at The Harris Poll. “Because there are people who are hesitant because they don’t think they have enough access to information or they don’t understand it. So it’s really important to be specific. … [M]ost important, across the board, is that the vaccines directly address severe COVID-19.”

Vaccine makers should also look to make sure physicians and nurses on the front lines are informed, because they remain American’s most trusted sources of vaccine information, according to Harris Poll data.

“As you have new drugs coming in and new data being released, it’s going to cause confusion with people, but it’s particularly critical you don’t have that confusion with healthcare providers,” Jekielek said.

https://www.fiercepharma.com/marketing/j-j-s-covid-vaccine-gets-fda-ok-but-can-pharma-hurdle-66-perception