No cases of allergic reactions recorded during Pfizer's COVID-19 vax trial - company exec

 There were no cases of severe allergic reactions to Pfizer Inc and partner BioNTech SE’s COVID-19 vaccine candidate during clinical trials, a Pfizer executive said at a regulatory conference on Friday.

A late-stage trial testing the potential vaccine excluded participants who had a prior history of severe allergic reactions to any vaccine or to the constituents of Pfizer/BioNTech vaccine, said Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development.

“We’ve not had any anaphylactic episodes related to the vaccine,” Gruber said during a panel meeting of independent advisers to the U.S. Centers for Disease Control and Prevention.

The trial included about 6,000 participants respectively in both the vaccine and placebo groups with a history of a range of allergic conditions like pollen allergy, food allergy, all the way up to anaphylaxis, Pfizer executive Susan Mather said.

Anaphylaxis is an overreaction by the body’s immune system that could sometimes be life-threatening.

The comments follow British medicine regulator’s advice that people with a history of significant allergic reactions do not get the Pfizer-BioNTech’s vaccine after two people reported adverse effects.

The U.S. Food and Drug Administration is expected to issue an emergency use authorization for the two-dose vaccine as soon as Friday, according to the New York Times.

Once authorized, the first Americans could be immunized as soon as Monday or Tuesday, with healthcare workers expected to be among the first in line.

https://www.reuters.com/article/us-health-coronavirus-vaccines-cdc/no-cases-of-allergic-reactions-recorded-during-pfizers-covid-19-vaccine-trial-company-executive-idUSKBN28L2Q8

U.S. govt secures access to 100 million more doses of Moderna's COVID-19 vaccine

 Moderna Inc said on Friday the U.S. government will get an additional 100 million doses of its COVID-19 vaccine candidate, expected to be delivered in the second quarter of 2021 if authorized.

The government has ordered a total of 200 million doses till date, the vaccine developer said, adding that of first order lot, about 20 million doses will be delivered by December end and the remaining in the first quarter of 2021.

The United States in August entered an agreement with Moderna to acquire 100 million doses of its potential COVID-19 vaccine for around $1.5 billion, with an option to secure an additional 400 million doses.

A panel of outside advisers to the U.S. Food and Drug Administration is scheduled to hold a meeting on Dec. 17 to discuss Moderna’s request for emergency use authorization (EUA) for its vaccine.

https://www.reuters.com/article/us-health-coronavirus-moderna/u-s-govt-secures-access-to-100-million-more-doses-of-modernas-covid-19-vaccine-idUSKBN28L2SY

AbCellera Biologics shares more than triple in stellar debut

 Shares of Peter Thiel-backed AbCellera Biologics Inc, which is co-developing antibody therapies with Eli Lilly and Co for the treatment of COVID-19, surged in their debut on Friday, giving the company a market capitalization of $16.18 billion.

AbCellera’s shares opened at $61 on the Nasdaq, 204% above their upwardly revised initial public offering (IPO) price of $20 apiece on Thursday. The Canadian firm had raised $483 million in its IPO.

https://www.reuters.com/article/abcellera-ipo/abcellera-biologics-shares-more-than-triple-in-stellar-debut-idUSL4N2IR3F1

5 severe-COVID risk genes found, suggesting drug targets

 Five key genes are linked with the most severe form of COVID-19, scientists said on Friday, in research that also pointed to several existing drugs that could be repurposed to treat people who risk getting critically ill with the pandemic disease.

Researchers who studied the DNA of 2,700 COVID-19 patients in 208 intensive care units across Britain found that five genes involved in two molecular processes - antiviral immunity and lung inflammation - were central to many severe cases.

“Our results immediately highlight which drugs should be at the top of the list for clinical testing,” said Kenneth Baillie, an academic consultant in critical care medicine at Edinburgh University who co-led the genome-wide association study.

The genes - IFNAR2, TYK2, OAS1, DPP9 and CCR2 – partially explain why some people become desperately sick with Covid-19, while others are not affected, Baillie said.

The findings, published in the journal Nature, should help scientists speed up the search for potential drugs for COVID-19 by conducting clinical trials of medicines that target specific antiviral and anti-inflammatory pathways.

Among those with the most potential, he said, should be a class of anti-inflammatory drugs called JAK inhibitors, which includes the arthritis drug baricitinib, made by Eli Lilly.

Baillie’s team also found that a boost in the activity of the INFAR2 gene is could create protection against COVID-19, because it is likely to mimic the effect of treatment with interferon.

Various existing drugs are being explored in clinical trials for their potential against COVID-19 including interferon-beta-1a, interleukin-1 receptor antagonist and Sanofi’s arthritis drug Kevzara.

So far, a steroid called dexamethasone and a newly developed antiviral called remdesivir, made by Gilead, are the only drugs authorised around the world to treat COVID-19 patients - although remdesivir is not recommended for severe cases of the disease and has had mixed results in trials.

Last month, the U.S. Food and Drug Administration approved Eli Lilly’s antibody drug for COVID-19, bamlanivimab, for patients who are not hospitalized but are at risk of serious illness because of their age or other conditions.

SOURCE: go.nature.com/344ksHV Nature, online December 11, 2020.

https://www.reuters.com/article/health-coronavirus-genetics/five-severe-covid-risk-genes-found-suggesting-drug-targets-idUSKBN28L256

Breast cancer study fails to lift SELLAS Life Sciences

 

• Investors seem to disappointed after SELLAS Life Sciences (SLS -34.8%) announces final data with up to 6 months follow-up from Phase 2 trial, VADIS evaluating its nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in ductal carcinoma in situ (DCIS) of the breast.
• Preliminary data previously reported showed that treatment with even a single dose of NPS was capable of newly inducing NPS-specific cytotoxic T-lymphocytes in peripheral blood. Updated data demonstrated that CD8+ T-cell responses persist long-term post-NPS treatment.
• When compared to baseline (BL, prior to NPS administration), relative frequency of NPS-specific CD8 CTLs as a percentage (NPS-CLT%) in peripheral blood at the 1-month and 6-month post-operative time-points increased in NPS+GM-CSF group (n=9) by 11- and 14-fold: 0.01+0.02% [BL] vs. 0.11+0.12% [1-mo] and 0.14+0.12% [6-mo], respectively,
• In GM-CSF alone group (n=4), NPS-CLT% in peripheral blood increased by only 2.25- and 3.75-fold: 0.04+0.07% [BL] vs. 0.09+0.15% [1-mo] and 0.15+0.03% [6-mo], respectively.
• Relative change in NPS-CTL% mean values at 6 months post-vaccination was +1,300+450% for the NPS+GM-CSF group vs. 250+150% in the GM-CSF alone group.
• Almost all patients in both arms experienced at least mild toxicities, and the incidence of moderate toxicities was 6.7% in the GPS+GM-CSF arm and 10.7% in the GM-CSF only arm.
• https://seekingalpha.com/news/3643738-nelipepimut-s-data-from-breast-cancer-study-fails-to-lift-sellas-life-sciences

Broader Vaccine Plan in West Hit by Sanofi-Glaxo Delay

 Drugmakers Sanofi SA and GlaxoSmithKline PLC on Friday said their coronavirus vaccine won't be available in the middle of next year as expected after receiving mixed effectiveness data from a clinical trial, complicating plans in the U.S. and Europe to quickly vaccinate broad swaths of their populations.

The U.S. and Europe were counting on tens of millions of doses of the Sanofi-GSK vaccine to be available as early as spring, a key part of their vaccination strategies for the coming year. The vaccine constitutes 10% of total global coronavirus vaccine doses that were expected from Western pharmaceutical companies next year, according to U.S. investment bank Jefferies Group.

The companies said that interim results showed the compound produced a weak immune response in people older than 50, who are a key demographic because they are more vulnerable to Covid-19. Sanofi and GSK plan to reformulate the vaccine to fix the problem and start new clinical trials in February, with the goal of making it available in the fourth quarter of next year.

"This shows what we know, that it is not always easy to develop a new vaccine to the point of being used to prevent the disease," said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. "It is possible that adjustment of doses and constituents of the vaccine could improve responses in the elderly, but again that is not guaranteed."

Sanofi and GSK received $2.1 billion from Operation Warp Speed, the U.S. government's coronavirus vaccine program, to accelerate the development and commercialization of the vaccine -- the biggest grant handed out by the U.S. program. That deal called for the companies to supply the U.S. with 100 million doses and gave the government an option to order an additional 500 million. The European Union ordered 300 million doses, and the U.K. another 60 million.

France was planning to begin its vaccination campaign this winter with the compound produced by Pfizer Inc. and BioNTech SE, the first coronavirus vaccine to be approved by regulators in the West, targeting nursing home residents. In the second phase, the authorities plan to use vaccines made by Moderna Inc., AstraZeneca and others on other at-risk populations. France was planning to use the Sanofi-GSK vaccine as it starts inoculating the general public in the spring.

The vaccine relies on technology used by Sanofi to produce influenza vaccines combined with an "adjuvant" -- a substance that augments immune responses to a vaccine -- made by GSK, one of the world's leading vaccine manufacturers. The vaccine was expected to help ease the logistical challenges of mass vaccination since it can be stored at nonfreezing temperatures, unlike the Pfizer-BioNTech vaccine.

That vaccine must be transported and stored at around -70 Celsius, requiring massive investments in ultracold storage facilities. The next vaccine likely to be approved, by Moderna, doesn't need ultracold storage but must still be kept at subfreezing temperatures.

One downside of the kind of vaccine technology used by Sanofi-GSK is that it was known going into the trial to produce weaker immune responses in older patients, said Penny Ward, visiting professor in Pharmaceutical Medicine at King's College London.

To address the problem, Sanofi and GSK said that they would increase the vaccine's concentration of antigen, substances that spark the immune system to generate antibodies and other forms of immune protection against the coronavirus.

"The results of the study are not as we hoped," said Roger Connor, president of GSK's vaccines division. "Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation."

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Broader-Vaccine-Plan-in-West-Dealt-Setback-by-Sanofi-GSK-Delay-31994075/

Novartis gets EU approval for potential blockbuster cholesterol drug Leqvio

 Novartis said on Friday it received approval from the European Commission for Leqvio, also known as inclisiran, a drug to lower cholesterol that the Swiss drugmaker bought last year in a deal worth nearly $10 billion and expects to be a top seller.

Leqvio was approved for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, making it the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol (LDL-C) lowering treatment in Europe, Novartis said in a statement.

"Cardiovascular disease remains the leading cause of mortality in Europe, which demonstrates the urgent need for innovative treatments for patients struggling to reach their LDL-C goals,” Marie-France Tschudin, President Novartis Pharmaceuticals, was quoted as saying in the statement.

Novartis bought the treatment last year in its $9.7 billion takeover of The Medicines Co in a bid to challenge cardiovascular medicines from Amgen Inc, Sanofi and Regeneron Pharmaceuticals.

Leqvio, for use on top of statins by heart patients who struggle to lower their cholesterol levels with traditional therapy, complements Novartis’s business with its heart-failure medicine Entresto.

Leqvio is currently under review by the U.S. Food and Drug Administration and other health authorities, Novartis said.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-gets-EU-approval-for-potential-blockbuster-cholesterol-drug-Leqvio-31989936/