Arcturus Therapeutics (ARCT) : "underwhelming" coronavirus vaccine results

•  ARCT stock plunged 54.2% to 42.36 on Tue, Dec 30.

chart 1 week later

(Tue 12/30/20) The biotech company said late Monday it received approval from Singapore health officials to begin a Phase 2 study of its experimental Covid-19 vaccine. The study will enroll up to 600 volunteers and evaluate two dosing regimens of the drug.

In early-stage testing, the coronavirus vaccine — dubbed ARCT-021 — generated neutralizing antibodies after a single dose. However, the levels of antibodies were lower than other rival vaccines that were able to match or exceed the levels in people recovered from Covid-19.

Raymond James analyst Steven Seedhouse called the results "underwhelming." In a report to clients, he said the lower number of antibodies than expected "reduces our confidence that ARCT-021 will be able to achieve competitive levels of vaccine (effectiveness) with single-shot dosing."

In the early-stage test, the levels of antibodies in volunteers were largely below what vaccines from Moderna (MRNA) and Pfizer (PFE) with its partner BioNTech (BNTX) were able to generate. Those coronavirus vaccines are now authorized and rolling out in the U.S. and other countries.

Pfizer's vaccine is 95% effective and Moderna's is 94.1%, but Arcturus' drug might be only 62% effective at blocking Covid-19, Seedhouse said. Still, anything north of 60% would be a decent outcome for this type of vaccine, the ARCT stock analyst added.

Single-Shot Coronavirus Vaccine?

Like Pfizer and Moderna, Arcturus' vaccine uses messenger RNA technology. But the biotech company had been hoping to use a single shot, making it easier to administer. Both Pfizer's and Moderna's vaccines require two doses given several weeks apart.

CureVac (CVAC) and EU in advanced talks for 225 million Covid-19 vaccine doses

• CureVac has said its Covid-19 vaccine could be ready for the public by mid-2021

Shares of CureVac NV soared Thursday after the German biotech firm said it was in advanced talks for the supply of at least 225 million doses of a potential Covid-19 vaccine to EU member states.

CureVac said talks with the EC, the European Union’s executive arm, include an option to supply an additional 180 million doses, once the mRNA-based vaccine has proven to be safe and effective against Covid-19, bringing the total to up to 405 million doses.

The EC is also in talks with Johnson & Johnson (JNJ) and France’s Sanofi (SNY) for their vaccines under development. It also reached an agreement last week with AstraZeneca (AZN) to buy at least 300 million doses of its potential Covid-19 vaccine which it is developing with Oxford University.

CureVac (CVAC) is specializing in the messenger RNA technology that is the basis of many of the leading Covid-19 vaccine programs, including Moderna Inc. (MRNA) and BioNTech S.E. (BNTX).

“In the current pandemic, we are very pleased to further strengthen the European Commission’s endeavor to provide rapid access to a safe and effective vaccine against the Covid-19 virus across Europe and beyond,” Franz-Werner Haas, chief executive of CureVac said.

“Assuming positive results from our ongoing clinical trials and approval from the regulatory authorities, we are fully committed to ensure broad access to our vaccine,” he added.

Backed by Microsoft founder and billionaire Bill Gates, CureVac listed on the Nasdaq Stock Market on Aug. 14, raising $213 million.

In July, GlaxoSmithKline PLC (GSK) said it was taking a stake in CureVac, the latest move by a major drugmaker to boost capabilities to fight pandemics. FTSE 100-listed Glaxo said CureVac’s mRNA technology would complement its own capabilities as it inked a deal worth up to £866 million ($1.09 billion).

-=MediciNova (MNOV) : SARS-CoV-2 vaccine joint development with BioComo and Mie University Japan

Co announced an agreement with BioComo and Mie University (Mie prefecture, Japan) for joint development of a SARS-CoV-2 vaccine using BC-PIV, a human parainfluenza virus type 2 vector developed by BioComo and Tetsuya Nosaka, M.D., Ph.D., professor of the Department of Microbiology and Molecular Genetics, Mie University Graduate School of Medicine. MediciNova has been granted exclusive worldwide development rights to use BC-PIV for SARS-CoV-2 vaccine development from BioComo and Mie University.

=RedHill Biopharma (RDHL) Accelerates Phase 2/3 COVID-19 Program with Addition of Brazil and Mexico

RedHill Biopharma adds Mexico and Brazil to Phase 2/3 clinical study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia

The co submitted a Clinical Trial Application (CTA) with the Mexican Federal Committee for the Protection against Sanitary Risks (COFEPRIS) and initiated CTA submission with the Brazilian Health Regulatory Agency.

Phase 2/3 study process initiated in Brazil and Mexico.

The global Phase 2/3 study with opaganib in patients with severe COVID-19 has already been approved in the UK and Russia.

Enrollment planned to be initiated this month - 270 subjects to be enrolled in up to 40 clinical sites.

Potential submission of emergency use applications planned for Q4/2020.

Enrollment in parallel U.S. Phase 2 study in severe COVID-19 patients expected to be completed in August.

=BioNTech (BNTX) and Pfizer (PFE) to deliver 600 mln doses of SARS-CoV-2 vaccine candidate

BioNTech (BNTX) and Pfizer (PFE) reach agreement with the US government for up to 600 mln doses of SARS-CoV-2 vaccine candidate

Pfizer and BioNTech today announced the execution of an agreement with the US Department of Health and Human Services and the Department of Defense to meet the U.S. government's Operation Warp Speed program goal to begin delivering 300 mln doses of a vaccine for COVID-19 in 2021. Under the agreement, the US government will receive 100 mln doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from the FDA.

• The US government will pay the companies $1.95 bln upon the receipt of the first 100 mln doses, following FDA authorization or approval. The US government also can acquire up to an additional 500 mln doses.

Americans will receive the vaccine for free, consistent with US government's commitment for free access for COVID-19 vaccines.

The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 mln doses by the end of 2020 and potentially more than 1.3 bln doses by the end of 2021.

-=Rigel Pharma (RIGL) initiates a COVID-19 trial

Rigel Pharma and Imperial College London initiates two-stage trial to evaluate the efficacy of fostamatinib for the treatment of COVID-19 pneumonia

Announced the initiation of an investigator-sponsored trial being conducted by Imperial College London to evaluate the efficacy of oral SYK inhibitor fostamatinib for the treatment of COVID-19 pneumonia. The primary objective of the two-stage trial, which is to be supported by co and Novartis (NVS), will be to determine the efficacy of fostamatinib and of ruxolitinib vs standard of care.

Equillium (EQ) : Positive Covid-19 results

Equillium (EQ) announced that a clinical trial conducted in India by its partner Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19.

 

Equillium reports data for Itolizumab demonstration reduction in mortality in patients hospitalized with COVID-19

Co announced that as reported by its partner, Biocon Limited, a clinical trial conducted in India by Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19. Biocon has announced that the Drugs Controller General of India (DCGI), the regulatory agency that oversees drug approvals, has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India. Based on the encouraging topline results of the study reported by Biocon and subsequent DCGI approval to treat COVID-19 patients, Equillium is planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).

Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month. As reported by Biocon:

• In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered.
• The mortality benefit observed in the itolizumab arm was statistically significant.
• Consistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFa.

-=VBI Vaccines (VBIV)

The company was formerly known as SciVac Therapeutics Inc. and changed its name to VBI Vaccines Inc. in May 2016.
Sector: Healthcare

• Industry: Biotechnology
• Full Time Employees: 123
• HQ in Cambridge, Massachusetts.
• http://www.vbivaccines.com

In March, VBI Vaccines announced that it was collaborating with the National Research Council of Canada to develop a pan-coronavirus vaccine candidate. This vaccine would target not only COVID-19 but also two other members of the coronavirus family -- severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

This vaccine candidate is currently only in preclinical testing. VBI Vaccines has stated that "clinical study materials" are expected to be available for use in clinical studies in the fourth quarter of this year. However, it's uncertain when clinical trials will begin for the company's pan-coronavirus vaccine candidate.

VBI's lead pipeline candidate is hepatitis B vaccine Sci-B-Vac, which is already approved for sale in Israel. VBI hopes to start filing for regulatory approvals in other countries, including the U.S., in the fourth quarter of this year. If all goes well, Sci-B-Vac could become only the second hepatitis B vaccine approved by the Food and Drug Administration in more than 25 years.

-=Novavax (NVAX) selected to participate in Operation Warp Speed

Novavax has been selected to participate in Operation Warp Speed, U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021

Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, as early as late 2020. NVX-CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax' proprietary Matrix-Madjuvant. Under the terms of the agreement, Novavax will demonstrate it can rapidly stand up large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 when needed. The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020.

Today's agreement also allows for a follow-on agreement with the U.S. government for additional production and procurement to support OWS' vaccine production goal. This latest federal funding supports Novavax plans to file submissions for licensure with the U.S. Food and Drug Administration (FDA).

-=Corvus Pharma (CRVS) initiated a Phase 1 study for patients with COVID-19

Corvus Pharmaceuticals initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19
The first cohort of five patients enrolled in the study was treated at Temple University Hospital in Philadelphia, PA. The study is expected to enroll up to 30 patients at several sites in the United States. This follows the U.S. Food and Drug Administration's (FDA) review and acceptance of the Company's investigational new drug (IND) application for the COVID-19 study.

Becton Dickinson (BDX) : Rapid antigen test for COVID-19 authorized by FDA

Becton Dickinson launches portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, dramatically expanding access to COVID-19 testing.

• Co is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce 2 million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through September. This is the company's third diagnostic test to receive Emergency Use Authorization by U.S. FDA for detecting COVID-19 . 

Becton Dickinson's test can be used on its existing BD Veritor System platform, which is employed in about 25,000 healthcare facilities across the United States.

Antigen tests are a relatively new type of test for COVID-19 that work by scanning for proteins that can be found on or inside a virus.

The authorization was based on a robust sample size of 226 specimens from sites across the United States, Evercore ISI analyst Vijay Kumar said in a research note.

"We think the new antigen test will play a big role in the coming flu season as a rapid, rule out test," Kumar said.

The FDA has touted the rapid tests as an important tool for combating the pandemic because they can be produced quickly, at relatively low costs, and test patients in a variety of settings.

The regulator in May approved the first COVID-19 antibody test, which is made by Quidel Corp.

-=T2 Biosystems (TTOO) announces US launch of molecular diagnostic test for COVID-19

T2 Biosystems announces US launch of molecular diagnostic test for COVID-19

T2 Biosystems today announced the completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after validation meeting requirements for an Emergency Use Authorization request to FDA.

The T2SARS-CoV-2 Panel, designed to detect SARS-CoV-2, provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample. Clinical testing on known positive and negative patient samples showed a sensitivity of 95% and specificity of 100%. The T2SARS-CoV-2 Panel runs on the company's FDA-cleared T2Dx Instrument.

Arca Biopharma (ABIO) to develop a coronavirus treatment

 

Arca said it will study an experimental drug called AB201 in patients with Covid-19 and abnormal blood clotting. Abnormal blood clotting is one of the serious complications of Covid-19. Arca has already tested AB201 in more than 700 patients with other conditions.

The drug already has "substantial safety data, which the company believes may enable more rapid development," Arca said in a news release. The biotech company plans to ask the Food and Drug Administration for permission to begin testing as a coronavirus treatment during the third quarter.

Why It Could Work In Coronavirus Treatment
Arca's potential coronavirus treatment works by blocking the tissue factor, or TF, protein, which is tied to the inflammatory response to viral infections. The biotech company has already studied AB201 in more than 700 patients for various conditions in Phase 1 and Phase 2 tests.

Recent research suggests Covid-19 has several factors in common with blood disorders in which the blood's ability to clot has been impaired, Arca said. There's also evidence to indicate AB201 could have natural and anti-inflammatory abilities, the company said.

"Collectively, the company believes these observation provide a strong rationale for investigating AB201 as a treatment for Covid-19, the disease caused by SARS-CoV-2 virus," Arca said.

The need for an effective coronavirus treatment continues to grow alongside the number of cases. As of Thursday morning, there were more than 5.8 million confirmed cases of Covid-19 globally. The U.S. accounts for about 30% of the caseload.

-=PhaseBio Pharmaceuticals (PHAS) receives FDA clearance to launch clinical trial evaluating PB1046 as a treatment for hospitalized COVID-19 patients

PhaseBio Pharmaceuticals receives FDA clearance to launch clinical trial evaluating PB1046 as a treatment for hospitalized COVID-19 patients

PhaseBio Pharmaceuticals today announced FDA authorization to proceed with VANGARD, a potentially pivotal clinical trial to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).

Having received FDA clearance to initiate the VANGARD trial, PhaseBio expects to begin dosing patients by the end of June.

Subject to the pace of enrollment and any further impacts from the COVID-19 pandemic, PhaseBio is targeting to report trial results late in the fourth quarter of 2020.

Based on feedback from the FDA, PhaseBio believes that positive, clearly interpretable and clinically meaningful results from this trial may enable PhaseBio to submit a Biologics License Application.

VIP is a neurohormone known to have anti-inflammatory, antifibrotic, inotropic, lusitropic and vasodilatory effects and several cardiopulmonary disorders are associated with alterations in levels of VIP or its receptors, VPAC1 and VPAC2. Importantly, VIP has also been observed to have potent bronchodilatory and immunomodulatory effects in the respiratory system. Specifically, VIP has been shown to regulate proinflammatory cytokines including TNF-a, IFN-y, IL-12, IL-17A, and IL-6. In animal models, treatment with VIP peptide prevented acute lung injury and inhibited cytokine-mediated inflammatory responses that are characteristic of ARDS.

=BioNTech (BNTX) and Pfizer (PFE) : first clinical trial of COVID-19 vaccine candidates

BioNTech and Pfizer (PFE) announce regulatory approval from German authority to commence first clinical trial of COVID-19 vaccine candidates

BioNTech and Pfizer have announced that the German regulatory authority the Paul-Ehrlich-Institut has approved the Phase 1/2 clinical trial for BioNTech's BNT162 vaccine program to prevent COVID-19 infection. BioNTech and Pfizer are jointly developing BNT162. The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and is part of a global development program. Pfizer and BioNTech will also conduct trials for BNT162 in the US upon regulatory approval, which is expected shortly.

The four vaccine candidates are the first candidates from BioNTech's COVID-19-focused project "Lightspeed", each representing different mRNA formats and target antigens. Two of the four vaccine candidates include a nucleoside modified mRNA, one includes a uridine containing mRNA, and the fourth vaccine candidate utilizes self-amplifying mRNA. Each mRNA format is combined with a lipid nanoparticle formulation. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor binding domain (RBD) from the spike protein is included in the other two candidates. The RBD-based candidates contain the piece of the spike that is thought to be most important for eliciting antibodies that can inactivate the virus.

COVID-19 vaccines and treatments

As clinical trials related to COVID-19 continue to ramp up, the focus next week will start to shift on which vaccines and treatments have the best chance to make it to mass production. There has been a lot of discussion about

• Gilead Sciences' (NASDAQ:GILD) remdesivir, Regeneron Pharmaceuticals' (NASDAQ:REGN) cocktail antibodies and 
• Moderna's (NASDAQ:MRNA) vaccine candidate. 

Other companies racing ahead with vaccine trials at various stages include

• BioNTech (NASDAQ:BNTX), 
• Pfizer (NYSE:PFE), 
• Dynavax Technologies (DVAX), 
• Vaxart (NASDAQ:VXRT), 
• GlaxoSmithKline (NYSE:GSK), 
• Heat Biologics (NASDAQ:HTBX), 
• Inovio Pharmaceuticals (NASDAQ:INO), 
• Translate Bio (NASDAQ:TBIO), 
• Heron Therapeutics (HRTX)
• Johnson & Johnson (JNJ), 
• Arcturus Therapeutics (NASDAQ:ARCT), CSL Behring and Novavax (NASDAQ:NVAX). Treatment candidates are being worked on by privately-held CalciMedica, Amgen (NASDAQ:AMGN), 
• Adaptive Biotechnologies (ADPT), Takeda Pharmaceutical (NYSE:TAK), CytoDyn (OTCQB:CYDY), Roche Holdings (OTCQX:RHHBY), Regeneron Pharmaceuticals, Tiziana Life Sciences (NASDAQ:TLSA), Vir Biotechnology (NASDAQ:VIR), Eli Lilly (NYSE:LLY), Sanofi (NASDAQ:SNY) and more.

News:

• (7/16/20) Dynavax (DVAX) and the Icahn School of Medicine at Mount Sinai have entered into a collaboration to develop a universal influenza vaccine. Mount Sinai's current work in this area is funded under a contract award as part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. The Mount Sinai CIVICs team will evaluate a novel approach they have developed called chimeric hemagglutinin designed to protect against all strains of influenza in combination with Dynavax's CpG 1018TM adjuvant.
• (7/16/20) Heron Therapeutics (HRTX) announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with COVID-19. The study initiation follows clearance from the FDA of Heron's Investigational New Drug application for CINVANTI for the treatment of COVID-19.

Long trade : Inovio Pharma (INO) +220%

• Inovio shares rally after biotech says human trials of coronavirus vaccine will start in April
• The company said it’s accelerating the timeline for development of a vaccine to treat the coronavirus COVID-19 and expects to start human trials in the U.S. next month.

 

Market update (31 January 20)

The stock market sold off to end the week, and month, on growing concerns about the coronavirus and the negative effect it could have on economic growth.  

The coronavirus angst was exacerbated by increasing reports of worldwide cases; Delta Air Lines (DAL), United Airlines (UAL), and American Airlines (AAL) suspending U.S.-China flights; and the White House declaring a public health emergency in addition to announcing some travel restrictions. 

 

Fri, Jan 31, 20

Worried by the mounting death toll from the coronavirus and drastic efforts to contain it, investors dashed for the exits,

coronavirus-related stocks on Fri Jan 31, 20

S&P 500, 14 months

YTD

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Dow Jones Industrial Average -1.0%  

Russell 2000 -3.3%  

GSG commodity index, renko chart

 

The Economist cover; sold out masks at CVS

Latest coronavirus news:  

- Chinese authorities have reported more than 350 fatalities

- China has banned burials or funerals for virus victims

- There are over 14,000 confirmed cases worldwide

- Hong Kong, Japan, Singapore, UAE and the US have confirmed more infections

- The outbreak has reached more than two dozen countries and regions globally

- Several countries are halting flights to and from China

- WHO declared the virus was a public health emergency of international concern