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EMA Safety Committee To Further Review AZD1222, RUBY Sparkles, DMD Trial Data Fails To Ignite SLDB

biotech march16 lt

Today's Daily Dose brings you news about the EMA pursuing investigation on AstraZeneca's COVID-19 vaccine AZD1222 on reports of blood clots, Intec Pharma's planned business combination with Decoy Biosystems, Solid Biosciences' encouraging data from DMD trial, Regeneron Pharmaceuticals Inc. (REGN) and Sanofi's (SNY) phase III trial of Libtayo monotherapy in cervical cancer, and Rubius' encouraging initial data from its ongoing phase I/II clinical trial of RTX-240 in patients with advanced solid tumors.

Read on…

1. EMA's Safety Committee To Further Review Thrombotic Events of COVID-19 Vaccine AstraZeneca

With several European Union countries temporarily pausing vaccination with AstraZeneca's COVID-19 vaccine AZD1222 due to reports of blood clots in people receiving that jab, the European Medicines Agency is rigorously pursuing the investigation.

Events involving blood clots, some with unusual features such as low numbers of platelets, have occurred in a very small number of people who received the vaccine, according to the European Medicines Agency (EMA).

Ann Taylor, Chief Medical Officer of AstraZeneca, said: "Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population". So far across the EU and UK, there have been 15 events of deep vein thrombosis and 22 events of pulmonary embolism reported among those given the vaccine.

The Pharmacovigilance Risk Assessment Committee, i.e., the EMA's safety committee, is all set to further review the information Tuesday and an extraordinary meeting is to be convened on Thursday to conclude on the information gathered and address any additional measures that may be needed.

AZD1222, now referred to as COVID-19 Vaccine AstraZeneca, was authorized for emergency use in the UK on Dec.30, 2020. The vaccine, developed by AstraZeneca and University of Oxford, is also approved for emergency use in India, Argentina, Dominican Republic, El Salvador, Mexico and Morocco.

AstraZeneca has partnered with Serum Institute of India (SII), the world's largest vaccine manufacturer, for the supply of the vaccine to the Indian Government and also to a large number of low and middle-income countries. In India, COVID-19 Vaccine AstraZeneca is known by the name Covishield.

AZN closed Monday's trading at $48.77, up 0.72%.

2. Intec To Combine With Decoy

Intec Pharma Ltd. (NTEC) has entered into a definitive agreement for a business combination with Decoy Biosystems Inc., a privately-held, preclinical-stage biotechnology company.

Upon completion of the merger, the former Decoy stockholders are expected to own approximately 75% of the combined company, and the Intec shareholders are expected to own about 25% of the combined company. The merger is expected to close in the third quarter of 2021, subject to the approval of the shareholders of each company.

NTEC closed Monday's trading at $5.96, up 29.85%.

3. Encouraging DMD Trial Data Fails to Ignite Solid Biosciences Stock

Solid Biosciences Inc. (SLDB), on Monday, reported efficacy and safety data from its ongoing IGNITE DMD trial of SGT-001 and resumption of patient dosing in the trial under its amended clinical protocol and using SGT-001 manufactured with a second-generation process.

IGNITE DMD is a Phase I/II study of SGT-001 microdystrophin gene therapy in patients with Duchenne muscular dystrophy. The IGNITE DMD trial was placed on hold by the FDA in November 2019, following one case of serious adverse event deemed related to the study drug. The FDA hold was lifted last October.

Interim data from six patients in the IGNITE DMD provide evidence of a potential benefit of SGT-001 in functional endpoints of North Star Ambulatory Assessments (NSAA), 6-minute walk test (6MWT), pulmonary function tests (PFTs), and clinically validated patient reported outcome measures (PROMs), according to the company.

With patient dosing resuming in the IGNITE DMD trial, patient 7 became the first patient to be dosed in IGNITE DMD under a previously reported clinical protocol amendment and using SGT-001 manufactured with a second-generation process.

The company expects to report clinical outcomes from additional patients in the IGNITE DMD trial in the second half of 2021.

SLDB closed Monday's trading at $9.51, down 0.11%. In after-hours, the stock was down nearly 16% at $8.00.

4. Regeneron/Sanofi's Cervical Cancer Trial Stopped Early For Benefit

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi's (SNY) phase III trial of Libtayo monotherapy compared to chemotherapy in advanced cervical cancer has been stopped early, following positive result on overall survival.

In the phase III trial, Libtayo improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy.

In the U.S., Libtayo is approved for certain patients with advanced stages of cutaneous squamous cell carcinoma, basal cell carcinoma and non-small-cell lung carcinoma with more than 50% PD-L1 expression. Outside of the U.S., Libtayo is approved for certain patients with advanced CSCC in the European Union and six other countries, including Australia, Brazil, the United Kingdom and Canada.

Regeneron records net product sales of Libtayo in the United States while Sanofi records net product sales of Libtayo outside the United States. The drug raked in total annual sales of $348.2 million in 2020 compared to $193.8 million in 2019.

REGN closed Monday's trading at $483.94, up 2.65%.

5. Rubius Sparkles on RTX-240 Data

Rubius Therapeutics Inc. (RUBY) soared more than 80% on Monday, following encouraging initial safety and preliminary efficacy data from its ongoing phase I/II clinical trial of RTX-240 in patients with advanced solid tumors.

According to the company, 16 patients were evaluable for safety (primary outcome measure) and 15 patients were evaluable for efficacy (secondary outcome measure).
In the trial, RTX-240 generated partial responses in metastatic anal cancer and metastatic uveal melanoma patients where other treatments have failed to induce responses in patients.

The company is planning to initiate a Phase 2 expansion cohort in the first quarter of 2022, and a new Phase 1 arm of the ongoing RTX-240 clinical trial to evaluate RTX-240 in combination with anti-PD-1 therapy in patients with advanced solid tumors during the second half of 2021.

In other news, Rubius announced that it has commenced an underwritten public offering of $150 million of shares of its common stock. The company also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock sold in the public offering.

RUBY closed Monday's trading at $30.29, up 84.36%.

6. Stocks That Hit A New High

Sol-Gel Technologies Ltd. (SLGL) closed Monday's (Mar.15, 2021) trading at $15.49, up 23.92%.

Amneal Pharmaceuticals Inc. (AMRX) closed at $6.98, up 15.95%.

Soliton Inc. (SOLY) closed at $16.71, up 13.44%.

Community Health Systems Inc. (CYH) closed at $12.7, up 12.68%.

Gemini Therapeutics Inc. (GMTX) closed at $18.00, up 5.88%.

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