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Thursday, April 9, 2020

Biohaven on go with study of vazegepant in COVID-19

The FDA has signed off on a Phase 2 clinical trial evaluating intranasal administration of Biohaven Pharmaceutical Holding Company’s (NYSE:BHVN) migraine med vazegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, in COVID-19 patients with pulmonary complications who need supplemental oxygen. Shares up 4% premarket.
The rationale is that the drug may mitigate hyperimmune reactions that could prove fatal in these patients.
https://seekingalpha.com/news/3559624-biohaven-on-go-study-of-vazegepant-in-covidminus-19-others-take-action-amid-pandemic

Fauci hopes to see steps to normalization by summer

Dr. Anthony Fauci, an infectious diseases expert who regularly speaks at the White House coronavirus task force briefings, tells NBC he hopes that steps to normalization will be underway by summer.
Fauci, who is director of the National Institute of Allergy and Infectious Diseases, also said he thinks New York may be beginning to turn the corner and starting to see a flattening of the coronavirus curve.
The U.S. has ~432K confirmed cases of COVID-19 and 14,808 deaths, according to the Johns Hopkins University Coronavirus Resource Center; New York state has 151K of those cases and 6,269 of those deaths.
https://seekingalpha.com/news/3559618-fauci-hopes-to-see-steps-to-normalization-summer-nbc

Pfizer Advances Battle Against COVID-19 on Multiple Fronts

  • Anti-viral compounds show activity against SARS-CoV-2 in preclinical screening
  • Pfizer and BioNTech enter into collaboration agreement to co-develop potential COVID-19 vaccine
  • Company shares additional data and analysis of azithromycin
  • Launch of two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2
  • Pfizer explores studies of JAK inhibitor tofacitinib in patients with COVID-19-related pneumonia

Pfizer Inc. (NYSE: PFE) today announced important advances in the battle against the global COVID-19 pandemic.
As outlined in Pfizer’s five-point plan, the company has been collaborating across the healthcare innovation ecosystem ranging from large pharmaceutical companies to the smallest of biotech companies, from government agencies to academic institutions to address the COVID-19 global health care crisis. Researchers and scientists have been relentlessly working to develop an investigational antiviral compound to treat SARS-CoV-2, which causes the current pandemic of coronavirus infections (COVID-19), a vaccine to prevent infection as well as evaluating other therapies that have scientific potential to help infected patients fight the virus.
“We are committed to making the impossible possible,” said Dr. Albert Bourla, Chairman and CEO. “In the spirit of the Five Point Plan that Pfizer issued, we are facing this public health challenge head on by collaborating with industry partners and academic institutions to develop potential novel approaches to prevent and treat COVID-19. Our researchers and scientists also have been exploring potential new uses of existing medicines in Pfizer’s portfolio to help infected patients globally. We are leaving no stone unturned as we explore every option to help provide society with a treatment or cure.”
Pfizer announced key advances in its commitment to protect humankind from this escalating pandemic and prepare the industry to better respond to future global health crises.
Anti-Viral Compound Screening
Pfizer confirmed a lead compound and analogues are potent inhibitors of the SARS-CoV-2 3C-like (3CL) protease, based on the results of initial screening assays. In addition, preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2. Consequently, Pfizer will perform pre-clinical confirmatory studies, including further anti-viral profiling and assessment of the suitability of the lead molecule for IV administration clinically. In parallel, the company is also investing in materials that will accelerate the start of a potential clinical study of the lead molecule to third quarter 2020, three or more months in advance of earlier estimates, subject to positive completion of the pre-clinical confirmatory studies.
Applying Pfizer’s Long History in Vaccine Research Development Expertise to Finalize Our Agreement with BioNTech
Pfizer Inc. and BioNTech SE have entered into a global collaboration agreement to co-develop BioNTech’s potential first-in-class, mRNA-based coronavirus vaccine program aimed at preventing COVID-19 infection. In March 2020, the companies announced a letter of intent to collaborate and began working together at that time. The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple research sites. BioNTech and Pfizer intend to initiate clinical trials as early as the end of April 2020, assuming regulatory clearance. The companies estimate that there is potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval of regulatory authorities and then rapidly scale up to capacity to produce hundreds of millions of doses in 2021. For the terms of the agreement, please see the press release page of Pfizer’s website.
Analysis of Azithromycin as an Agent with Antiviral Activity
In an effort to share information that could benefit COVID-19 mitigation efforts, Pfizer researchers will publish a review in Clinical Pharmacology and Therapeutics which assesses published in vitro and clinical data regarding azithromycin as an agent with antiviral properties. This open access review may serve to facilitate the use of azithromycin in future research on COVID-19. Azithromycin is not approved for the treatment of viral infections.
Studying Pfizer’s Existing Medicines for Critical Patient Populations in Need
Pfizer Inc. and the Liverpool School of Tropical Medicine’s Respiratory Infection Clinical Research Group are launching two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2. Pfizer is expected to finalize in the coming days, a research collaboration agreement with Liverpool to provide funding and in-kind laboratory testing support for this research. The studies (SAFER study (SARS-CoV-2 Acquisition in Frontline Health Care Workers – Evaluation to Inform Response) and the FASTER study (Facilitating A SARS CoV-2 Test for Rapid triage)) will help demonstrate whether patients infected with COVID-19 have a higher risk of also developing pneumococcal pneumonia and if having both infections leads to more severe disease and poorer outcomes. The SAFER study will enroll 100 healthcare workers at the Royal Liverpool Hospital and examine rates of SARS-CoV-2 acquisition and dynamics of pneumococcal colonization. The FASTER study will recruit 400 patients from the infectious disease ward at the Royal Liverpool Hospital suspected of having coronavirus. Enrollment has already begun, and data are expected over the next few months.
An independent Phase 2 investigator-initiated study for the use of tofacitinib, an oral Janus Kinase (JAK) inhibitor, in patients with SARS-CoV-2 interstitial pneumonia is planned to be initiated in Italy later this week. The study is supported by a Pfizer grant. For more details about the study, please see clinicaltrials.gov.
Pfizer is also in discussions with other institutions about additional studies involving tofacitinib and potentially other immune modulators in our portfolio. This research is based on the hypothesis that JAK inhibition could mitigate systemic and alveolar inflammation in patients with COVID-19-related pneumonia by inhibiting essential cytokine signaling involved in immune-mediated inflammatory response that could lead to damage of the lungs, resulting in acute respiratory distress syndrome in patients with COVID-19-related pneumonia. It is important to note, tofacitinib is not currently approved for this use and should not be used in patients with an active serious infection.
“While this work can generally take years, we are working to find opportunities to save time wherever we can and work in parallel rather than in a linear capacity,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. “This pursuit requires a crucial multi-pronged approach with a deep collaboration and partnership across the health innovation ecosystem – from the academic community, industry partners, policymakers and regulatory bodies. We announced in March that we are collaborating with BioNTech to co-develop a potential first-in-class, mRNA-based COVID-19 vaccine. A public threat like coronavirus COVID-19 pushes each of us to urgently bring forward our resources and expertise to overcome this most challenging moment in the medical history of this century.”
The company will continue to share information from its portfolio and emerging candidates that could benefit the many companies and organizations who are working quickly to provide solutions to combat this unprecedented healthcare crisis.
https://www.marketscreener.com/PFIZER-INC-23365019/news/Pfizer-Advances-Battle-Against-COVID-19-on-Multiple-Fronts-30390638/

IBIO up 26% premarket on advancement of COVID-19 vaccine development

Nano cap iBio (NYSEMKT:IBIO) is up 26% premarket on increased volume in reaction to its announcement that it has inked two Master Services Agreements and a Memorandum of Understanding (MoU) with the Infectious Disease Research Institute (IDRI) aimed at advancing its SARS-CoV-2 Virus-Like Particle vaccine candidate.
Under the agreements, IDRI will support preclinical development and will oversee clinical trials while the company will provide process development and manufacturing services.
The MoU calls for a separate agreement within 60 days between the parties if the company opts to include one of IDRI’s adjuvants in the program (called IBIO-200).
https://seekingalpha.com/news/3559610-ibio-up-26-premarket-on-advancement-of-covidminus-19-vaccine-development

Biden adviser Emanuel: US should prep for coronavirus rules to last 18 months

Dr. Zeke Emanuel, an adviser to Democratic presidential candidate Joe Biden on the coronavirus, said this week that Americans could be dealing with strict social distancing measures to combat the coronavirus for 18 months and that the U.S. “will not be able to return to normalcy until we find a vaccine or effective medications.”
Emanuel, one of the architects of the Affordable Care Act, also known as ObamaCare, is on the Biden campaign’s “Public Health Advisory Committee,” which is set up to “provide science-based, expert advice regarding steps the campaign should take to minimize health risks for the candidate, staff, and supporters,” according to a March press release.
His comments are partially consistent with statements from the Trump administration’s medical advisors and federal government documents on the pandemic. But they seem to paint a more grim picture of the country’s ability to roll back shutdowns of businesses and public life in general that are aimed at reducing the spread of the virus, which causes the disease known as COVID-19.

“Realistically, COVID-19 will be here for the next 18 months or more. We will not be able to return to normalcy until we find a vaccine or effective medications,” Emanuel said Monday on MSNBC’s “Last Word with Lawrence O’Donnell.”
“I know that’s dreadful news to hear,” the Biden adviser continued. “How are people supposed to find work if this goes on in some form for a year and a half? Is all that economic pain worth trying to stop COVID-19? The truth is we have no choice. … We cannot return to normal until there’s a vaccine. Conferences, concerts, sporting events, religious services, dinner in a restaurant, none of that will resume until we find a vaccine, a treatment, or a cure.”
He added: “We need to prepare ourselves for this to last 18 months or so and for the toll that it will take.”
The stark warning from Emanuel seems to contrast with Tuesday night comments by Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and the face of the White House’s coronavirus response. He predicted that American students would be able to return to school this fall even if the virus is still lingering.

“I fully expect – though, I’m humble enough to know that I can’t accurately predict – that by the time we get to the fall that we will have this under control, enough that it certainly will not be the way it is now where people are shutting schools,” Fauci said.
Fauci said that with increased testing for coronavirus antibodies, doctors will be able to identify people who have caught the disease and now have a natural immunity to it, therefore showing how much herd immunity the U.S. as a whole has to the virus. Additionally, more widespread testing for the virus itself would allow health authorities to better “identify, to isolate, to contact trace” in a way that countries with more successful early responses to the coronavirus have been able to.
An internal government document planning the coronavirus response, which was first obtained by the New York Times, predicted that the “pandemic will last 18 months or longer and could include multiple waves of illness.”

Fauci has also said there could be further waves of the coronavirus, particularly this fall.
The difference between the suggestions from Emanuel and those of figures in the Trump administration is Emanuel appears to be warning of serious challenges, absent a vaccine or medication, with prudently relaxing current protocols that have Americans working from home, wearing masks in public and canceling sporting events and religious services. Emanuel’s comments differ particularly from those of President Trump himself, who previously suggested the U.S. could try to get its economy running again by Easter before reversing himself to extend the White House’s social distancing guidelines through April.
“If we prematurely end that physical distancing and the other measures keeping it at bay, deaths could skyrocket into the hundreds of thousands if not a million,” Emanuel said. “One thing I’ve learned as a cancer doctor is that it’s wrong to paint an overly rosy picture in order to maintain a patient’s hope. It’s wrong because it fails. It’s false.”

As of Wednesday morning, the United States had just under 400,000 total coronavirus cases and nearly 13,000 deaths because of the virus. New York state, the hardest-hit area of the country so far, has 140,386 total cases and has seen 5,489 deaths.
“The crisis is not going to go away in a few weeks or after the 30-day plan comes to an end,” Emanuel concluded. “Although COVID-19 is affecting us in different ways, we have to be up to it and fight together.”
https://www.foxnews.com/politics/biden-obamacare-architect-zeke-emanuel-says-u-s-should-prepare-ourselves-for-coronavirus-social-distancing-to-last-18-months

Vapotherm up on accelerated review status for Oxygen Assist Module

The FDA has granted Breakthrough Device Designation for Vapotherm’s (NYSE:VAPO) Oxygen Assist Module (OAM).
The designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application.
Vapotherm OAM is a module for use with most versions of Vapotherm’s Precision Flow systems.
Shares are up 10% premarket.
https://seekingalpha.com/news/3559591-vapotherm-up-10-premarket-on-accelerated-review-status-for-oxygen-assist-module

Mesoblast on go with study of remestemcel-L in COVID-19

Mesoblast’s (NASDAQ:MESO) remestemcel-L will be evaluated in a placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by COVID-19.
This Phase 2/3 trial will be conducted as a public-private partnership in collaboration with the Cardiothoracic Surgical Trials Network, established by the U.S. National Institutes of Health’s National Heart, Lung and Blood Institute as a flexible platform for conducting collaborative trials.
https://seekingalpha.com/news/3559604-mesoblast-on-go-study-of-remestemcel-l-in-covidminus-19