AZN’s Covid Jab & Immunosenescence, PFE/BNTX To Seek Emergency Nod For Vaccine, QURE Aces HOPE-B

Today’s Daily Dose brings you news about the encouraging immune response triggered by AstraZeneca’s Covid-19 vaccine candidate in older adults, the first combination regimen authorized for emergency use by FDA for COVID-19, Pfizer/BioNTech mulling to file for emergency use approval of their COVID-19 shot, and uniQure’s gene therapy trial results in Hemophilia B patients.

Read on…

1. AstraZeneca’s Covid Shot Produces Encouraging Immune response in Older Adults

AstraZeneca PLC’s (AZN) Covid-19 vaccine, AZD1222, licensed from the Oxford University, appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose in a phase II/III study, according to the findings reported in the journal Lancet.

The study involved 560 healthy participants – 160 in the age group of 18-55 years, 160 aged 56-69 years, and 240 aged 70 years and older.

The participants in the 18-55 years group were randomized 1:1 to either two doses of AZD1222 or two doses of a control vaccine MenACWY; in the 56-69 years group, 3:1:3:1 to one dose of AZD1222, one dose of MenACWY, two doses of AZD1222, or two doses of MenACWY; and in the 70 years and older, 5:1:5:1 to one dose of AZD1222, one dose of MenACWY, two doses of AZD1222,, or two doses of MenACWY. Prime-booster regimens were given 28 days apart.

A number of studies have shown that immunogenicity, i.e., the ability of a vaccine to cause an immune response, tends to decrease with increasing age, i.e. immunosenescence. However, the promising immune response obtained in older adult population in the AZD1222 study are very encouraging, say the study authors.

AZD1222, formerly known as ChAdOx1 nCoV-19, is under phase III studies in the UK, Brazil, and the U.S. Results from the late-stage trials are anticipated later this year.

Pfizer Inc. (PFE) and BioNTech SE’s (BNTX) mRNA-based COVID-19 vaccine candidate, BNT162b2, has demonstrated a vaccine efficacy rate of 95% in their ongoing phase III study and Moderna Inc.’s (MRNA) COVID-19 vaccine candidate mRNA-1273 has demonstrated an efficacy of 94.5% in its phase III trial.

AZN closed Thursday’s trading at $54.03, up 0.07%.

2. FDA Approves Arthritis Drug/Velkury Combo for Emergency Use to Treat COVID-19

The FDA has granted emergency use approval for Eli Lilly and Co. (LLY) and Incyte’s (INCY) arthritis drug Olumiant to be used in combination with Gilead Sciences’ Velkury in hospitalized patients with COVID-19.

To be specific, this first combination regimen authorized by FDA for COVID-19 can be used in adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

In a clinical trial, dubbed ACTT-2, based on which the emergency use approval was granted, patients treated with Olumiant in combination with Velkury had a significant reduction in median time to recovery from 8 to 7 days compared to Velkury. The proportion of patients who progressed to ventilation (non-invasive or invasive) or died by Day 29 was 23% in the combination arm compared to 28% in the Velkury arm. The proportion of patients who died by Day 29 was 4.7% for the combination arm and 7.1% for the Velkury arm, a relative reduction of 35%.

Olumiant, known generically as Baricitinib, is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Gilead’s antiviral med Veklury, administered intravenously, which was previously authorized for emergency use, was granted full FDA approval in October for treating adults and children aged 12 and above with COVID-19 infections requiring hospitalization.

Early this month, the FDA had granted emergency use approval to Lilly’s Bamlanivimab for the treatment of recently diagnosed, mild to moderate COVID-19 in high-risk patients.

LLY closed Thursday’s trading at $143.41, up 2.31%.

3. Pfizer/BioNTech May File for Emergency Use Approval of COVID-19 vaccine Today

Pfizer Inc. (PFE) and BioNTech SE (BNTX) are expected to file for emergency use authorization for their mRNA-based COVID-19 vaccine candidate BNT162b2 on Friday, reports CNN.

In a phase III global study, BNT162b2 has demonstrated a vaccine efficacy rate of 95%. BNT162b2 is being tested at a 30 micrograms (mcg) dose level in a two-dose regimen, given 21 days apart.

BioNTech CEO Ugur Sahin believes that BNT162b2 could gain emergency nod in the U.S. by the middle of December and conditional approval in the European Union in the second half of December, according to Reuters TV.

PFE closed Thursday’s trading at $36.19, down 0.36%.

4. uniQure’s Gene Therapy Aces Pivotal Hemophilia B Study

uniQure N.V.’s (QURE) pivotal phase III trial of Etranacogene Dezaparvovec gene therapy in patients with Hemophilia B has yielded positive results.

Hemophilia B, also called as Christmas disease, is caused due to insufficient amounts of clotting factor IX, a naturally occurring protein in blood that helps to control bleeding.

The trial, dubbed HOPE-B, involving 54 hemophilia B patients, met the primary endpoint – with mean Factor IX activity increasing from less than or equal to 2% to a mean of 37.2% at 26 weeks. During the 26-week period after dosing, 72 percent of patients (39/54) reported no bleeding events. Fifteen patients reported a total of 21 bleeds. The mean annualized usage of Factor IX replacement therapy, a secondary endpoint in the clinical trial, declined by 96 percent, according to the company.

Etranacogene dezaparvovec, the investigational gene therapy, consists of an adeno-associated virus five (AAV5) viral vector carrying a gene cassette with the patent-protected Padua variant of Factor IX. In the clinical trial, Etranacogene dezaparvovec was found to be generally well-tolerated with no treatment-related serious adverse events.

The company plans to schedule a pre-BLA meeting with the FDA related to Etranacogene Dezaparvovec in Hemophilia B in the first quarter of 2021.

QURE closed Thursday’s trading at $46.16, up 7.95%.

5. Stocks Hitting New Highs/Lows

Infinity Pharmaceuticals Inc. (INFI) closed Thursday’s trading at a 2-year high of $2.12, up 19.77%.

TRACON Pharmaceuticals Inc. (TCON) closed at a 52-week high of $8.52, up 14.36%.

Replimune Group Inc. (REPL) closed at an all-time high of $49.12, up 0.92%.

180 Life Sciences Corp. (ATNF) closed at an all-time low of $2.15, down 4.44%.

PolyPid Ltd. (PYPD) closed at an all-time low of $8.99, down 7.42%.

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