BioXcel Therapeutics Announces Formation of OnkosXcel Therapeutics to Develop Medicines Focused in Oncology

BioXcel Therapeutics, Inc. recently announced the formation of wholly owned subsidiary OnkosXcel Therapeutics, Inc. to develop transformative medicines in oncology.

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 MD Anderson Cancer Center, with additional efficacy data expected in the second half of 2022. BioXcel Therapeutics believes BXCL701 is one of the most advanced orally available, innate immune activators in the clinic and it has been evaluated in approximately 800 healthy subjects and cancer patients. OnkosXcel plans to explore the BXCL701 clinical development program in hematological malignancies and other solid tumors.

“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 Vimal Mehta, PhD, CEO of BioXcel Therapeutics. “For BioXcel Therapeutics, this is the logical next step as we advance our five-year vision of becoming the premier AI-driven neuroscience company, exemplified by the recent FDA approval of IGALMI for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. For our immuno-oncology assets, we believe this new structure will sharpen our strategic focus and help us further maximize the value of our oncology portfolio with increased flexibility in the future.”

The company plans to provide additional details regarding OnkosXcel in the second half of 2022.

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 US FDA in four indications.

BioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience. The company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. The company’s commercial product, IGALMI (developed as BXCL501) is a proprietary, sublingual film formulation of dexmedetomidine approved by the FDA for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. BXCL501 is also being evaluated for the acute treatment of Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. For more information, visit www.bioxceltherapeutics.com.

OnkosXcel Therapeutics, Inc. is a clinical-stage, independent, private subsidiary of BioXcel Therapeutics, Inc., focused on developing transformative medicines utilizing artificial intelligence approaches in oncology. The subsidiary was formed to develop BXCL701, a Phase 2, investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors, as well as other immuno-oncology focused assets.