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BioXcel Therapeutics
Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of
BXCL701
in Patients with
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
of
Adenocarcinoma
Phenotype
2023-11-08
·
BioSpace
临床2期
临床结果
免疫疗法
孤儿药
临床3期
Median overall survival of 15.5 months with
BXCL701
+
KEYTRUDA
® (
pembrolizumab
), compared to 9.6 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2 trial1 59% of studied patients alive at one year following treatment with
BXCL701
+
KEYTRUDA
Median progression-free survival of 4.2 months with
BXCL701
+
KEYTRUDA
compared to 2.1 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2 trial1 Company plans to determine program development path following end of Phase 2 meeting with FDA scheduled for December NEW HAVEN, Conn., Nov. 08, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced positive overall survival (OS) data from its Phase 2 trial of
BXCL701
, the Company's investigational oral innate immune activator, in combination with
KEYTRUDA
® (
pembrolizumab
) in patients with
metastatic castration-resistant prostate cancer (mCRPC)
of
adenocarcinoma
phenotype, the most common form of the disease. As of a September 6, 2023 data cutoff, evaluable patients with
adenocarcinoma
(n=29) showed a median OS of 15.5 months (95% CI 9.6–NR), and a 12-month survival rate of 59%. “Patients with
mCRPC
who have failed androgen deprivation and
taxane
-based chemotherapy have few remaining treatment options and, unfortunately,
KEYTRUDA
to date has not shown additional benefit in this setting,” said Vincent J. O’Neill, M.D., Chief R&D Officer, OnkosXcel Therapeutics, a wholly owned subsidiary of BioXcel Therapeutics. “Therefore, we are highly encouraged by these combination data bearing in mind historical data with
checkpoint inhibitor
monotherapy. In addition, we now have a second positive dataset in a separate
cold tumor
histology, further increasing our belief that
BXCL701
has the potential to inflame the
tumor
microenvironment of
cold tumors
, thereby sensitizing them to checkpoint inhibition. We believe the data warrant further evaluation of
BXCL701
in this setting and look forward to determining the development path for this program following our end of Phase 2 meeting with the FDA scheduled for December.” In 2023 in the United States, there are expected to be an estimated 288,3002 new patients with
prostate cancer
, which is classified as a “
cold” tumor
. Of those, 20% are expected to advance to
mCRPC
, a form of
advanced prostate cancer
that is no longer responding to testosterone-lowering hormone treatments and has spread to other areas of the body such as the lymph nodes, bones, bladder, rectum, liver, or lungs. Approximately 80% of mCRPC cases are of the
adenocarcinoma
phenotype, which represent approximately 46,128 patients. In addition to the new OS data, the Company recently presented an update on response rate data from the Phase 2 adenocarcinoma cohort at the
Prostate Cancer
Foundation Annual Scientific Retreat. The Company reported a RECIST partial response rate of 28% with a median duration of response of 19 months. This is in contrast to a RECIST response rate of 5% with a median duration of response of 16.8 months from the KEYNOTE-199 trial of
pembrolizumab
monotherapy in a similar patient population. The Company’s Phase 2 trial is an open-label, multicenter study to evaluate the safety and efficacy of
BXCL701
in combination with
pembrolizumab
in men with
mCRPC
of
adenocarcinoma
phenotype as well as in men with SCNC. Twenty-nine (29) evaluable
adenocarcinoma
patients received 0.3 mg of
BXCL701
twice daily (BID) on days 1 through 14 of a 21-day cycle (0.2 mg BID the first week of Cycle 1) plus 200 mg of
pembrolizumab
administered intravenously on day 1 and every subsequent 21 days. The primary objective of the trial is a composite response rate defined as either objective response by RECIST 1.1 criteria and/or PSA50 and/or CTC count conversion. Secondary objectives include duration of response, progression-free survival, overall survival, and biomarker evaluation as measured by changes in circulating cytokines and correlation of outcome with baseline
tumor
characteristics. The Company is continuing to actively evaluate strategic options for OnkosXcel Therapeutics, including potential financing, strategic partnership, or M&A. About OnkosXcel Therapeutics, LLC and
BXCL701
OnkosXcel Therapeutics, LLC is a wholly owned subsidiary of BioXcel Therapeutics, Inc., focused on developing transformative medicines in oncology utilizing artificial intelligence. The subsidiary was formed in 2022 to develop
BXCL701
.
BXCL701
is an investigational, oral
innate immune activator
designed to initiate
inflammation
in the
tumor
microenvironment. Approved and experimental immunotherapies often fail to address
cancers
that appear “cold.” Therefore,
BXCL701
is being evaluated to determine if it can 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. OnkosXcel Therapeutics’ preclinical data support
BXCL701
’s potential synergy with both current checkpoint inhibitors and emerging immunotherapies directed to activate T-cells.
BXCL701
is currently being developed as a potential therapy for the treatment of aggressive forms of
prostate cancer
and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.
BXCL701
has received Orphan Drug Designation from the U.S. Food & Drug Administration in four indications:
acute myelogenous leukemia
,
pancreatic cancer
,
stage IIb to IV melanoma
, and
soft tissue sarcoma
. An 800+-subject clinical database, with data collected by the Company and others, supports the ongoing development of
BXCL701
. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology. 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 indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: the Company’s expected timing of, trial design and data results from, future clinical trials of
BXCL701
with
pembrolizumab
, potential benefits from treatment with
BXCL701
, the Company’s planned discussions with FDA, the future clinical development of
BXCL701
, the Company’s plans to evaluate strategic options for OnkosXcel Therapeutics and potential market size and opportunity for product candidates. The words “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. 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; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its ability to successfully negotiate amended terms under the financing agreements to be able to access funding and to obtain relief under financial covenants; its significant indebtedness and potential payment obligations related to such indebtedness and other contractual obligations; risks associated with the strategic reprioritization; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY II Phase 3 trial and related audit; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502 BXCL701 and BXCL702 and other product candidates; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; 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; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; impacts from the COVID-19 pandemic; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; 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, 2023, which are accessible on the SEC’s website at . 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. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information Corporate BioXcel Therapeutics Erik Kopp 1.203.494.7062 ekopp@bioxceltherapeutics.com Investor Relations BioXcel Therapeutics Brennan Doyle 1.475.355.8462 bdoyle@bioxceltherapeutics.com Media Russo Partners David Schull T: 858-717-2310 David.schull@russopartnersllc.com Scott Stachowiak T: 646-942-5630 Scott.stachowiak@russopartnersllc.com Source: BioXcel Therapeutics, Inc. BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel Therapeutics, Inc. All other trademarks are the properties of their respective owners. Copyright © 2023, BioXcel Therapeutics, Inc. All rights reserved. 1. FOR ILLUSTRATIVE PURPOSES ONLY: Analysis based on results from
Pembrolizumab
KEYNOTE-199 study.
Pembrolizumab
for Treatment-Refractory Metastatic
Castration-Resistant Prostate Cancer
: Multicohort, Open-Label Phase II KEYNOTE-199 Study. Emmanuel S. Antonarakis et al. Journal of Clinical Oncology; published at ascopubs.org/journal/jco on November 27, 2019: DOI .
Pembrolizumab
is not an approved therapy for the treatment of any form of
mCRPC
, and no head-to-head clinical trial has been conducted evaluating
BXCL701
against
pembrolizumab
or other candidates or products. Notable differences exist between the Company’s trial designs, conditions under study and subject characteristics as compared to the third-party results discussed above and caution should be exercised when comparing data across these studies. 2. American
Cancer
Society. Key Statistics for
Prostate Cancer
. Retrieved October 9, 2023. 's%20estimates,34%2C700%20deaths%20from%20prostate%20cancer
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机构
BioXcel Therapeutics, Inc.
适应症
急性髓性白血病
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药物
Talabostat Mesylate
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