l*******2
发帖数: 1 | 1 【 以下文字转载自 Military 讨论区 】
发信人: lubbock12 (非老非小将), 信区: Military
标 题: 季博士公司股票狂涨是因为他们有一个药被FDA批准2期临床了
发信站: BBS 未名空间站 (Mon Jul 20 11:32:36 2020, 美东)
这个是个化学药,是EGFR BTK TKI双重抑制计
给COVID-19 中重型病人用
https://www.prnewswire.com/news-releases/fda-clears-abivertinib-for-phase-2-
safety-and-efficacy-study-in-hospitalized-patients-with-moderate-to-severe-
covid-19-301095327.html
FDA clears Abivertinib for Phase 2 safety and efficacy study in hospitalized
patients with moderate to severe COVID-19
- Abivertinib is a novel Tyrosine Kinase Inhibitor with dual selective
targeting of mutant forms of EGFR and BTK that has completed a registration
trial (lung cancer) and been administered to over 600 patients worldwide.
- The compound demonstrated in-vitro the ability to simultaneously lower
multiple critical inflammatory cytokines associated with cytokine storm and
poor prognosis in COVID-19 patients.
- It is to be tested next in a Phase 2 trial in moderate to severe COVID-19
patients, hospitalized with developing cytokine storm in the lungs.
SAN DIEGO, July 20, 2020 /PRNewswire/ -- Sorrento Therapeutics, Inc. (Nasdaq
Phase 2 trial of Abivertinib in patients with COVID-19 who have moderate to
severe pulmonary symptoms.
Abivertinib is a novel small molecule tyrosine kinase inhibitor (TKI) that
selectively targets both mutant forms of the epidermal growth factor
receptor (EGFR) and Bruton's tyrosine kinase (BTK). On May 21, 2020,
Sorrento announced that it had entered into a binding term sheet for an
exclusive license to ACEA Therapeutics' Abivertinib across all indications
for all territories outside of China. The parties have since entered into
an exclusive license agreement.
Abivertinib irreversibly binds to the BTK receptor, preventing the
phosphorylation of the receptor. Due to this effect, it has shown potent
immunomodulatory activities in vitro by inhibiting key pro-inflammatory
cytokine production, including IL-1beta, IL-6 and TNF-alpha. These cytokines
are associated with cytokine release syndrome (CRS) or cytokine storm and
COVID-19 disease progression with poor outcomes in patients with acute
respiratory distress syndrome (ARDS).
Since Abivertinib targets multiple cytokines simultaneously, Sorrento
anticipates that the effects of Abivertinib will be incremental to the
initial published findings by others for IL-6 inhibitors targeted for COVID-
19 trials, and the clinical benefits will be more pronounced given the
broader range of anti-cytokine activity.
The trial, titled A Phase 2, Double Blinded, Randomized Study of the
Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care
Versus Standard of Care in Subjects Hospitalized With COVID-19 (NCT04440007)
, will be initially conducted in centers in the USA.
Abivertinib has been studied in over 600 patients worldwide in various
oncologic indications, including one registration trial in non-small cell
lung cancer. Most treatment-related adverse events (AEs) were grade 1 or 2,
the most common of which were transaminase elevations and diarrhea, which
are generally considered common for TKIs. Other common treatment-related
AEs included anemia, neutropenia and thrombocytopenia, each of which are
generally considered typical AEs with long-term use of TKIs. No unexpected
AEs were reported.
About ACEA Therapeutics
ACEA Therapeutics is committed to developing and delivering innovative
treatments to improve the lives of patients with life-threatening diseases.
ACEA has expanded drug discovery efforts to encompass development in both
targeted cancer therapy and immunotherapy areas. Alongside a robust R&D
organization, ACEA has established drug manufacturing in China to support
its long-term growth. This infrastructure provides ACEA greater control over
drug supply chain to make sure products are delivered to patients on-time
and at the highest quality. ACEA is well positioned to deliver on its
promise to bring innovative treatments to patients living with life-
threatening diseases while creating value for shareholders, employees, and
society.
For more information visit www.aceatherapeutics.com |
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