MRNA Faces AdCom On Dec.17, NVAX To Begin Phase 3 COVID Vaccine Trials In US, Mexico, AMGN On Watch

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Today's Daily Dose brings you news about the progress in the COMMUNITY trial being conducted by members of the COVID R&D Alliance, vaccine efficacy of Moderna's COVID-19 vaccine as revealed in the primary analysis of its phase III trial, update regarding Novavax' phase III trial of its COVID-19 vaccine candidate NVX-CoV2373 in the U.S. and Mexico, and reverse merger of Viracta with Sunesis.

Read on…

1. Amgen, Takeda, UCB Kick-start First-of-Its-Kind Trial in COVID-19

Amgen Inc. (AMGN), Takeda Pharmaceutical Co. Ltd. (TAK), and UCB, which are members of the COVID R&D Alliance, have enrolled the first patient in an adaptive platform trial that enables an array of therapeutic candidates to be studied in hospitalized COVID-19 patients.

In the trial, dubbed COMMUNITY, a range of therapeutics, say, Amgen's approved drug for psoriasis and psoriatic arthritis, Otezla, Takeda's investigational drug Lanadelumab, and UCB's drug candidate Zilucoplan will be evaluated for their potential efficacy and safety relative to the condition severity of patients hospitalized with COVID-19.

The investigation of Otezla in the COMMUNITY trial began this week. It is expected that testing of Lanadelumab and Zilucoplan in the study will begin in the coming weeks. Other anti-viral, immunomodulating and vascular agents may also be evaluated in the trial in the coming months, the companies noted.

The global sites of the COMMUNITY trial include the United States, Brazil, Mexico, Russia, South Africa and other countries.

There are a total of 20 pharmaceutical and biotech companies as members in the COVID R&D Alliance.

AMGN closed Monday's trading at $222.04, down 1.23%.

2. FDA Advisory Committee to Review Moderna's COVID-19 Vaccine on Dec.17

Shares of Moderna Inc. (MRNA) closed at an all-time high of $152.74 on Monday, following the submission for an Emergency Use Authorization with the FDA and an application for Conditional Marketing Authorization with the European Medicines Agency for its COVID-19 vaccine candidate mRNA-1273.

According to the primary analysis of the phase III study of mRNA-1273, the results of which were reported today, the vaccine efficacy is 94.1%, in line with the efficacy of 94.5% observed at the first interim analysis.

The primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group compared to 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group indicating 100% vaccine efficacy against severe COVID-19.

The company has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO).

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) is slated to review the safety and efficacy data package for mRNA-1273 on December 17.

MRNA closed Monday's trading at $152.74, up 20.24%. In after-hours, the stock was up another 7.04% at $163.50.

3. Novavax to Begin Phase III Trials of COVID-19 vaccine in US, Mexico

Novavax Inc. (NVAX) is all set to begin a phase III trial of its COVID-19 vaccine candidate NVX-CoV2373 in the U.S. and Mexico in the coming weeks.

Enrollment in a pivotal phase III trial of the vaccine candidate in the U.K. has been completed, with interim data expected as soon as early first quarter 2021. These data are expected to serve as the basis for approval in the U.K., European Union and other countries.

A phase IIb trial underway in South Africa is now fully enrolled, which also includes medically stable, HIV-positive participants. As in the U.K., the availability of efficacy data from the South African trial may be available as soon as the first quarter 2021. The trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University and is funded in part by the Bill & Melinda Gates Foundation. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

Novavax was awarded $1.6 billion in funding from the U.S. government and this award is funding the U.S. and Mexico pivotal Phase 3 trial and manufacturing scale-up.

NVAX closed Monday's trading at $139.50, up 10.99%.

4. Viracta to Reverse Merge with Sunesis

Viracta Therapeutics Inc., a privately held precision oncology company targeting virus-associated malignancies, is all set to go public, following a reverse merger with Nasdaq-listed Sunesis Pharmaceuticals Inc. (SNSS) in an all-stock transaction.

Upon completion of the merger, the combined company will operate under the name Viracta Therapeutics, Inc. and intends to be listed on the Nasdaq Global Market under the ticker symbol "VIRX."

Viracta plans to initiate a registration trial of Valganciclovir for the treatment of EBV-positive lymphoma in the first half of 2021, and also plans to initiate a Phase 1b/2 trial in EBV-positive solid tumors in 2021.

The total cash balance of the combined company is expected to be about $120 million, which is anticipated to last into 2024.

SNSS closed Monday's trading at $1.86, up 24%.

5. Stocks that hit new highs

Apollo Endosurgery Inc. (APEN) closed Monday's trading at 52-week high of $4.81, up 76.84%.

CureVac N.V. (CVAC) closed at an all-time high of $105.17, up 22.29%.

Arcturus Therapeutics Holdings Inc. (ARCT) closed at a 5-year high of $91.76, up 20.74%.

Moderna Inc. (MRNA) closed at an all-time high of $152.74, up 20.24.

Generation Bio Co. (GBIO) closed at an all-time high of $48.22, up 11.47%.

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