AstraZeneca Plc expects its COVID-19 vaccine could receive U.S. Emergency Use Authorization at the beginning of April and could immediately deliver 30 million doses of the shot there, a top executive said at a hearing in the U.S. House of Representatives on Tuesday.
Ruud Dobber, executive vice president at AstraZeneca, said that the drugmaker expects to be able to deliver 50 million doses of the vaccine by the end of April.
Vascular Biogenics Ltd (NASDAQ: VBLT) announces results from the independent Data Safety Monitoring Committee (DSMC) pre-planned review of the ongoing OVAL Phase 3 study of VB-111 in recurrent ovarian cancer.
According to the results, the committee found no safety issues with the trial and recommended its continuation.
The following DSMC review is scheduled for the third quarter of 2021, followed by completion of enrollment at the end of 2021 or in early 2022
In March last year, interim analysis in the OVAL study demonstrated an overall response rate of 53%. The response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was at least 10% higher than in the control arm. According to the Company update in November, a high response rate of greater than 50% in the total evaluable patient population was maintained with approximately 200 patients enrolled.
VB-111 (ofranergene obadenovec) is an investigational targeted anti-cancer gene-therapy that uses a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today that it has augmented its inhaled AR-711 monoclonal antibody (mAb) to COVID-19 with a second mAb (AR-713) that is designed to neutralize newly emerging COVID-19 mutated variants including those from South Africa, Brazil and Japan. Together, the enhanced dual antibody cocktail will be delivered as an inhaled treatment and is expected to provide broad coverage of all known high-risk strains. In addition, Aridis is pleased to announce preclinical development services support from NIAID. The preclinical development services support is also provided by the Coronavirus Immunotherapy Consortium (CoVIC). Aridis is on track to initiate the program's Phase 1/2/3 clinical trial in 2H 2021.
AR-711 is being developed as a self-administered, at-home inhaled treatment for COVID-19 patients who are not yet hospitalized. The Company's vision is that if highly effective immunotherapies such as mAbs could be formulated as inhaled therapy, then COVID-19 patients could be treated much earlier in the course of their disease within their own homes. This could offer convenience to patients and reduce pressure on medical infrastructure, including outpatient infusion centers and hospitals. As the pandemic evolves, new mutant and more contagious strains of the SARS-CoV-2 virus have emerged, rendering most available vaccines and monoclonal antibodies less effective. In response, the Company is now adding a second mAb AR-713, which has been shown to completely neutralize in vitro the 'E484K' mutation containing SARS-CoV-2 variant, associated with the Brazilian and Japanese variants (P.1) and the South African variant (B.1.351). This enhanced cocktail is designed to neutralize these variants as well as the original strain, the D614G strain, and the UK strain (B.1.1.7), providing broad coverage of all currently known high-risk strains.
CM Life Sciences II, the second blank check company formed by Casdin Capital and Corvex Management targeting a life science business, raised $240 million by offering 24 million units at $10. The company offered 4 million more units than anticipated. Each unit consists of one share of common stock and one-fifth of a warrant, exercisable at $11.50. The company may raise an additional $75 million at the closing of an acquisition pursuant to forward purchase agreements with Casdin Capital and Corvex Management.
The company is led by CEO and Director Eli Casdin, the founder and CIO of life science investment firm Casdin Capital, and Chairman Keith Meister, the founder, Managing Partner, and CIO of investment management firm Corvex Management. The company plans to target the life science industry, specifically businesses in the life science tools, synthetic biology, and diagnostics fields.
Management's first SPAC, CM Life Sciences (CMLFU; +115% from $10 offer price), went public in September 2020 and recently announced a merger agreement with genomic platform Sema4.
CM Life Sciences II plans to list on the Nasdaq under the symbol CMIIU. Jefferies acted as a lead manager on the deal.
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the addition of two new study sites to further the expansion of its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion ("AP-014"). Principal Investigator Luciano Lemos-Filho, M.D., in Pulmonary and Critical Care and Medical Center Intensive Care Unit Director at Swedish Hospital in Denver, CO, and Principal Investigator David King, M.D., Medical Director at Bozeman Health Clinical Research in Bozeman, MT, bring additional experience to the study and will accelerate the enrollment of patients in the trial.
"Patients suffering from life-threatening lung inflammation due to COVID-19 have a desperate need for treatments," said Dr. David King of Bozeman Health Clinical Research. "Ampion's anti-inflammatory effects and its method of action suggest it may offer relief to our patients. We are pleased to be able to work with Ampio Pharmaceuticals in this early-stage trial of Ampion in treating COVID-19 related respiratory distress."
Europe's drugs regulator said on Tuesday it is evaluating the use of remdesivir in COVID-19 patients who do not need oxygen support, after developer Gilead Sciences submitted an application to extend the medicine's use.
Europe had conditionally approved remdesivir, sold under the brand name Veklury, in July for treating COVID-19 in adults and adolescents with pneumonia requiring oxygen support.
