Completed the Phase 1b safety lead-in, identifying recommended Phase 2 dose of BXCL701 in combination with pembrolizumab (KEYTRUDA®) in advanced prostate cancer
Initial interim data readout expected in the fourth quarter of 2020
NEW HAVEN, CT, USA I April 28, 2020 I BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced the initiation of the Phase 2 efficacy portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab (KEYTRUDA®) for treatment emergent Neuroendocrine Prostate Cancer (tNEPC). Initial interim data from this study is expected in the fourth quarter of 2020.
Results from the Phase 1b safety assessment of BXCL701, an investigational oral innate immunity activator, indicated that a split dose totaling 0.6 mg per day is the recommended dose when used in combination with KEYTRUDA®, a PD-1 inhibitor. The 0.6 mg total daily dose has shown on-target side effects consistent with cytokine activation. Splitting the daily dose can be associated with an improved safety profile and will be used in the efficacy portion of the clinical program.
“Identifying the recommended Phase 2 dose of BXCL701, in combination with KEYTRUDA®, is a critical step for our immuno-oncology program, as it allows us to evaluate the anti-tumor activity in patients with tNEPC and other cancer types,” commented Vincent J. O’Neill, M.D., Senior Vice President and Chief Medical Officer of BTI. “tNEPC is a rare and highly aggressive form of prostate cancer, the most common malignancy in men, with no current standard treatments. With the DPP8/9 target amplified in some tNEPC tumors, we believe BXCL701 has the potential to facilitate a strong adaptive immune response, making tumors more responsive to immunotherapies, including the PD-1 inhibitor pembrolizumab. We believe BXCL701 has potential to treat this subpopulation, and if successfully developed and approved, could fill the gap in prostate cancer treatment.”
The Phase 1b/2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 administered orally and daily, combined with pembrolizumab (KEYTRUDA®), in men with tNEPC. With the initial assessment of safety and the identification of the recommended Phase 2 BXCL701/PEMBRO dose schedule complete, the Company can now initiate the Phase 2 efficacy portion of the trial. Approximately 30 eligible tNEPC patients will receive 0.3 mg of BXCL701 twice daily (BID) on days 1 through 14 of a 21-day cycle plus 200 mg of pembrolizumab administered intravenously on day 1 and every subsequent 21 days. The primary endpoint of the trial is the composite response rate, with a target of achieving a greater than 15% composite response rate. Secondary endpoints include duration of response, overall survival and progression-free survival.
To learn more about the trial, visit: https://clinicaltrials.gov/
About Treatment-Emergent Neuroendocrine Prostate Cancer (tNEPC)
tNEPC is a hormone-refractory manifestation of prostate cancer occurring secondary to treatment with androgen deprivation therapies, such as Zytiga® (Johnson & Johnson) and Xtandi® (Pfizer). This form of highly aggressive tumor, with no current treatment, is observed in approximately 20%-30% of patients treated with androgen inhibitors and has a median survival time of less than one year. Single agent checkpoint inhibitor therapy produces very low response rates in hormone refractory prostate cancer, creating a major unmet medical need for tNEPC patients.
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. BTI’s preclinical data supports BXCL701’s synergy with both current checkpoint inhibitor-based therapies and emerging immunotherapies directed to activate T-cells, such as IL-2.
This candidate is currently being developed as therapy for treatment emergent Neuroendocrine Prostate Cancer (tNEPC) and pancreatic cancer (both “cold” tumors) and other advanced solid cancers that are “hot” or have become resistant to checkpoint inhibitors.
About BioXcel Therapeutics, Inc.:
BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI’s drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. 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. For more information, please visit http://www.bioxceltherapeutics.com.
SOURCE: BioXcel Therapeutics
Post Views: 59
Completed the Phase 1b safety lead-in, identifying recommended Phase 2 dose of BXCL701 in combination with pembrolizumab (KEYTRUDA®) in advanced prostate cancer
Initial interim data readout expected in the fourth quarter of 2020
NEW HAVEN, CT, USA I April 28, 2020 I BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced the initiation of the Phase 2 efficacy portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab (KEYTRUDA®) for treatment emergent Neuroendocrine Prostate Cancer (tNEPC). Initial interim data from this study is expected in the fourth quarter of 2020.
Results from the Phase 1b safety assessment of BXCL701, an investigational oral innate immunity activator, indicated that a split dose totaling 0.6 mg per day is the recommended dose when used in combination with KEYTRUDA®, a PD-1 inhibitor. The 0.6 mg total daily dose has shown on-target side effects consistent with cytokine activation. Splitting the daily dose can be associated with an improved safety profile and will be used in the efficacy portion of the clinical program.
“Identifying the recommended Phase 2 dose of BXCL701, in combination with KEYTRUDA®, is a critical step for our immuno-oncology program, as it allows us to evaluate the anti-tumor activity in patients with tNEPC and other cancer types,” commented Vincent J. O’Neill, M.D., Senior Vice President and Chief Medical Officer of BTI. “tNEPC is a rare and highly aggressive form of prostate cancer, the most common malignancy in men, with no current standard treatments. With the DPP8/9 target amplified in some tNEPC tumors, we believe BXCL701 has the potential to facilitate a strong adaptive immune response, making tumors more responsive to immunotherapies, including the PD-1 inhibitor pembrolizumab. We believe BXCL701 has potential to treat this subpopulation, and if successfully developed and approved, could fill the gap in prostate cancer treatment.”
The Phase 1b/2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 administered orally and daily, combined with pembrolizumab (KEYTRUDA®), in men with tNEPC. With the initial assessment of safety and the identification of the recommended Phase 2 BXCL701/PEMBRO dose schedule complete, the Company can now initiate the Phase 2 efficacy portion of the trial. Approximately 30 eligible tNEPC patients will receive 0.3 mg of BXCL701 twice daily (BID) on days 1 through 14 of a 21-day cycle plus 200 mg of pembrolizumab administered intravenously on day 1 and every subsequent 21 days. The primary endpoint of the trial is the composite response rate, with a target of achieving a greater than 15% composite response rate. Secondary endpoints include duration of response, overall survival and progression-free survival.
To learn more about the trial, visit: https://clinicaltrials.gov/
About Treatment-Emergent Neuroendocrine Prostate Cancer (tNEPC)
tNEPC is a hormone-refractory manifestation of prostate cancer occurring secondary to treatment with androgen deprivation therapies, such as Zytiga® (Johnson & Johnson) and Xtandi® (Pfizer). This form of highly aggressive tumor, with no current treatment, is observed in approximately 20%-30% of patients treated with androgen inhibitors and has a median survival time of less than one year. Single agent checkpoint inhibitor therapy produces very low response rates in hormone refractory prostate cancer, creating a major unmet medical need for tNEPC patients.
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. BTI’s preclinical data supports BXCL701’s synergy with both current checkpoint inhibitor-based therapies and emerging immunotherapies directed to activate T-cells, such as IL-2.
This candidate is currently being developed as therapy for treatment emergent Neuroendocrine Prostate Cancer (tNEPC) and pancreatic cancer (both “cold” tumors) and other advanced solid cancers that are “hot” or have become resistant to checkpoint inhibitors.
About BioXcel Therapeutics, Inc.:
BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI’s drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. 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. For more information, please visit http://www.bioxceltherapeutics.com.
SOURCE: BioXcel Therapeutics
Post Views: 59
