BXCL701’s dual mechanism of action targets DPP8/9, stimulating effector T cells and NK cells while inhibition of FAP helps to clear an immune obstructive tumor microenvironment, thus promoting a robust pro-inflammatory response. While BXCL701 potentially acts as an activator of the innate immune system in Prostate and Pancreatic cancer, it may act as a direct cytotoxic agent in AML. The median age at diagnosis is 68 years old, with rising age associated with a progressively worsening prognosis.The FDA Office of Orphan Products Development grants Orphan Drug Designation to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. BTI believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.BTI may not realize its expectations, and its beliefs may not prove correct.
When used herein, words including “anticipate,” “being,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. Expands global footprint for lead immuno-oncology program, BXCL701 FAP is associated with immune system evasion and suppression in cancer biology. As a consequence, the counts of mature red blood cells, platelets, and normal white blood cells decline, causing fatigue, shortness of breath, bleeding, and increased susceptibility to infection. Forward-looking statements in this press release include, but are not limited to the Company’s clinical development initiatives and trials for BXCL701, the benefits to the Company of ODD, and the efficacy of BXCL701 in the treatment of AML. It has shown single agent activity in … BXCL701 is currently being developed for treatment of a rare form of prostate cancer and for pancreatic cancer in combination with other immuno-oncology agents.BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes novel artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology. The combination therapy also achieved a notable reduction in FAP expressing cells and cytokines associated with tumor invasion and migration.
The triplet therapy leverages the power of both innate and adaptive immunity to attain complete tumor regression in these preclinical studies by recruiting increased levels of immuno-stimulatory cytokines, effector T cells and NK cells while reducing the cytokines involved in immune evasion. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. BXCL701 has been observed to directly attack and kill AML cells in multiple preclinical studies, corroborating our belief that BXCL701 presents an opportunity to address this rare and deadly disease. For more information, please visit www.bioxceltherapeutics.com. BXCL701’s dual mechanism of action targets DPP8/9, stimulating effector T cells and NK cells while inhibition of FAP helps to clear an immune obstructive tumor microenvironment, thus promoting a robust pro-inflammatory response.NKTR-214 in combination with anti-PD-1 has shown a strong anti-cancer response in multiple murine cancer models and in combination with nivolumab in multiple human cancersThis preclinical study aimed to utilize the triple combination of BXCL-701, NKTR-214 and anti-PD-1 to potentiate more robust and durable anti-tumor activity and help overcome an immune refractory tumor microenvironment. BioXcel Therapeutics, Inc. (BTI) (BTAI), today announced an update of its immuno-oncology program for BXCL701, an orally-available systemic innate-immune activator with dual mechanisms of action. For patients who don’t respond adequately to induction therapy or who quickly relapse (about 50% of all patients), outcomes can be particularly poor. Charych, Deborah, et al. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents. BTI plans to present additional data demonstrating BXCL701’s potential to generate anti-cancer immunity.Dr. Full details of the accepted ASCO poster are below:1. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support
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