RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Inovio Pharmaceuticals (NASDAQ:INO), the International Vaccine Institute, and Seoul National University Hospital announce a partnership to start a Phase 1/2 clinical trial of Inovio’s COVID-19 vaccine INO-4800 in South Korea.
The 2nd-stage trial of INO-4800 will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand to enroll an additional 120 people aged 19-64 years.
The trial is expected to start later in June.
Some COVID-19 patients can develop a severe inflammatory response called a cytokine storm, which can be deadly and pose a high risk of intubation via mechanical ventilation.
As a result, the FDA granted emergency authorization to a blood test from Roche (OTCQX:RHHBY), called Elecsys IL-6, which can pinpoint those most at-risk people early by measuring levels of interleukin 6 in the blood.
Roche also makes one of the most accurate serology tests, which hunts for coronavirus antibodies to identify past infection.
AstraZeneca (AZN -1.6%) will collaborate with Lexington, MA-based Accent Therapeutics to develop and commercialize RNA-modifying proteins (RMPs) for the treatment of cancer.
The partnership will leverage AZN’s skills in advancing oncology medicines and Accent’s know-how in RMP-targeting therapies, a new field called epitranscriptomics.
Under the terms of the deal, Accent will be responsible for R&D activities for an as-yet-unnamed preclinical program through Phase 1. AZN will lead subsequent development and commercialization following regulatory approvals. Accent will have the option to co-develop and co-commercialize in the U.S. AZN will have an exclusive option to in-license global rights to two additional programs for which Accent will conduct the preclinical work.
Accent will receive $55M upfront, option fees, milestones and tiered mid-single-digit-to-low-double-digit royalties on net sales. If it elects to join AZN in the U.S., it will split profits and losses.
Amyris (AMRS +2.2%) executes a binding funding agreement with institutional investors to raise $200M at $3/share through a private investment in public equity (“PIPE”); comprises 49% of common stock and 51% of preferred stock
The Company expects to use the proceeds for general corporate purposes and to repay certain outstanding indebtedness by ~$61M to lower total debt to ~$162M
“We are very excited to have obtained funding that will enable us to execute our strategic priorities, support business growth, further reduce debt and simplify our balance sheet and help us attain positive cash flow from operations,” said Han Kieftenbeld, Chief Financial Officer.
Jefferies and Cowen served as joint lead placement agents; Oppenheimer served as co-placement agent.
AbbVie (NYSE:ABBV) announces positive long-term results from two Phase 3 clinical trials, SELECT-COMPARE and SELECT-MONOTHERAPY, evaluating Rinvoq (upadacitinib) in rheumatoid arthritis (RA) patients. The data were presented at EULAR.
Patients in the first study who received daily doses of 15 mg of upadacitinib with methotrexate continued to experience improved signs and symptoms of RA at week 72.
Patients in the second trial who received 15 mg of upadacitinib alone each day maintained their improved responses at week 84.
96-week data from another late-stage study, SELECT-EARLY, showed that upadacitinib was effective in inhibiting structural joint damage as monotherapy or in combination with methotrexate.
No new safety signals were observed.
The FDA approved the JAK inhibitor for RA in August 2019. It was approved in Europe in December 2019.
