OnkosXcel, a Company subsidiary, to utilize proprietary AI-powered platform to progress therapies to address difficult-to-treat cancers with high unmet need
New structure to unlock growth opportunities and maximize value of neuroscience and immuno-oncology franchises
Lead pipeline asset, BXCL701, has shown clinical proof-of-concept in aggressive forms of prostate cancer and is currently in Phase 2 clinical trials
OnkosXcel is focused on the sustained expansion and optimization of the oncology franchise, while providing maximum strategic and financial flexibility. OnkosXcel plans to progress the development of BXCL701, an investigational orally administered innate immune activator designed to initiate inflammation in the tumor microenvironment.
BXCL701 is being evaluated in combination with KEYTRUDA® (pembrolizumab) in an ongoing Phase 2 trial in metastatic castration-resistant prostate cancer (mCRPC) patients with either adenocarcinoma or small cell neuroendocrine carcinoma (SCNC) phenotype. Most recently, the Company announced positive efficacy and safety data at the 2022 ASCO Genitourinary Cancers Symposium, reinforcing the broad potential of BXCL701 to extend the activity of checkpoint inhibitor (CPI) therapy into “cold” tumor settings. BXCL701 is also being evaluated in combination with KEYTRUDA in advanced, “hot” and CPI-resistant tumors in an investigator-initiated, Phase 2 study led by
“We believe the formation of OnkosXcel will unlock significant value for both our neuroscience and immuno-oncology franchises and build a foundation for sustainable growth,” said
The Company plans to provide additional details regarding OnkosXcel in the second half of 2022.
About BXCL701
BXCL701 is an investigational orally administered innate immune activator designed to initiate inflammation in the tumor microenvironment. Approved and experimental immunotherapies often struggle to address cancers that appear “cold” or uninflamed. Therefore, BXCL701 may render “cold” tumors “hot,” making them more detectable by the adaptive immune system and thereby facilitating the development of a strong anti-cancer immune response. BioXcel Therapeutics’ preclinical data supports BXCL701’s synergy with both current checkpoint inhibitor-based therapies and emerging immunotherapies directed to activate T-cells. BXCL701 is currently being developed as therapy for mCRPC of adenocarcinoma and SCNC phenotypes (both “cold” tumors) and other advanced solid cancers that are “hot” or have become resistant to checkpoint inhibitors. BXCL701 has received Orphan Drug Designation (ODD) from the
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Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to: the Company’s plans for its OnkosXcel subsidiary; clinical development plans, including the ongoing development of BXCL701 and data from clinical trials of BXCL701 and BXCL701’s status as one of the most advanced orally available, innate immune activators in the clinic; and the Company’s future growth plans;. When used herein, words including “anticipate,” “will,” “plan,” “potential,” “may,” “continue,” “intend,” “designed,” “goal” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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; the Company’s need for substantial additional funding and ability to raise capital when needed; the Company’s dependence on the success and commercialization of IGALMI, 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; the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable; the Company has limited experience in drug discovery and drug development; regulatory agencies, may not accept or agree with the Company’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and the Company in general; the Company has no experience in marketing and selling drug products and has not entered into arrangements for the sale and marketing of IGALMI™; IGALMI™ or the Company’s other product candidates may not be accepted by physicians or the medical community in general; the Company may not be able to obtain marketing approvals for BXCL501 or BXCL701; the Company may need substantial additional funding to develop and conduct clinical trials with respect to its product candidates and support its operations; the Company must comply with extensive regulations applicable to it; and healthcare reform could adversely impact future commercial success. These and other important factors are discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the year ended
Contact Information
Corporate
1.203.494.7062
ekopp@bioxceltherapeutics.com
Investor Relations
FTI Consulting
1.212.850.5624
matthew.ventimiglia@fticonsulting.com
Media
FTI Consulting
Helen O’Gorman
1.718.408.0800
helen.ogorman@fticonsulting.com
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