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BioXcel Therapeutics Presents Results from Ongoing Phase 2 Trial of BXCL701 in Combination with KEYTRUDA® in Aggressive Forms of Prostate Cancer at ESMO

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BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrates encouraging anti-tumor activity in heavily pre-treated mCRPC patients with adenocarcinoma

BXCL701 combination continues to exhibit favorable safety profile; patient enrollment continues as per protocol

NEW HAVEN, Conn., Sept. 15, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced data from its ongoing Phase 1b/2 trial of BXCL701, the Company’s investigational, oral innate immunity activator, in metastatic castration-resistant prostate carcinoma (mCRPC) in a poster presentation at the 2021 European Society for Medical Oncology (ESMO) Congress.

“These data lay a strong foundation for the broad potential of BXCL701 in combination with pembrolizumab, including for heavily pre-treated mCRPC patients with adenocarcinoma, an aggressive tumor for which there are few available treatment options,” said Vincent J. O’Neill, M.D., Senior Vice President and Chief Medical Officer of BioXcel. “The study demonstrated that 26% of patients in the adenocarcinoma cohort achieved a composite response, and all responders experienced a decrease in tumor size. Further, the majority of these responders who received BXCL701 in combination with pembrolizumab did not have strong predictive markers of pembrolizumab response. We believe BXCL701 has the potential to be the most advanced orally available innate immune activator and to inflame the tumor micro-environment, thus making tumors more responsive to immunotherapies, including the PD-1 inhibitor, pembrolizumab. We look forward to the continued evaluation of BXCL701 in mCRPC in our adenocarcinoma cohort, as well as in our small-cell neuroendocrine carcinoma (SCNC) cohort, which both continue to enroll patients.”

The Phase 1b/2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab, in men with mCRPC adenocarcinoma and SCNC phenotypes. Eligibility criteria include progression as defined by PCWG3 criteria and at least 1 line of taxane chemotherapy for inclusion in the adenocarcinoma cohort, or at least 1 prior line of chemotherapy for inclusion in the SCNC cohort. 32 eligible mCRPC 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 endpoint of the trial is composite response rate, with a target of achieving >15% response. Secondary endpoints include duration of response, progression-free survival, and overall survival.

KEY FINDINGS – ADENOCARCINOMA

  • In the response evaluable patient cohort (n=23), 6 (26%) achieved a composite response; all responders experienced a decrease in tumor size from baseline.
  • In patients with measurable disease (n=19), RECIST-defined partial response was 16%.
  • The disease control rate (defined as PR + SD + non-CR / non-PD) was 63%.
  • In the 29 patients who had at least 1 post-baseline PSA measurement, the PSA50 was 17% including 3 patients who had a PSA decrease of around 90%.
  • From historic data, single agent pembrolizumab saw an objective response rate of approximately 5%, a disease control rate of 12% and a PSA50 response of 6%.1
  • Treatment-related adverse events (AEs) observed with the combination were generally low-grade and consistent with the side effect profiles of each agent. The most common AEs included fatigue (16%), hypotension (13%), and pruritus and rash (13%). There was no evidence that BXCL701 increased immune-related AEs associated with checkpoint inhibitors.

POSTER PRESENTATION DETAILS

Title: BXCL701—1st-in-class oral activator of systemic innate immunity—combined with pembrolizumab, in men with metastatic castration-resistant prostate cancer (mCRPC): Phase 2 results

Poster Session: Genitourinary Tumors, Prostate

Date/Time: September 15, 2021 at 6:05 PM EST

Poster Number: 610P

Additional information can be found at www.esmo.org.

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’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.

BXCL701 is currently being developed as therapy for metastatic castration-resistant prostate cancer of adenocarcinoma and small-cell neuroendocrine carcinoma (SCNC) phenotypes (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 approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel’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. BioXcel’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with psychiatric and neurological disorders, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.

Forward-Looking Statement

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 timing and data from clinical trials for BXCL701 and the potential benefits of treatment with BXCL701,. When used herein, words including “anticipate,” “being,” “will,” “plan,” “may,” “continue,” 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; 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; undesirable side effects caused by the Company’s product candidates; 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; impacts from the COVID-19 pandemic; 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, 2021, 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. 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

Media

Helen O’Gorman
FTI Consulting
[email protected]
1.718.408.0800

Investor Relations

Matt Ventimiglia
FTI Consulting
[email protected]
1.212.850.5624

Source: BioXcel Therapeutics, Inc.

1 Antonarakis et al. “Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study.” Journal of Clinical Oncology 38, no. 5 (February 10, 2020) 395-405. DOI: 10.1200/JCO.19.01638.

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Artificial Intelligence

XtalPi Unveils XtalGazer: A Comprehensive AI-Driven Polymorph Selection Platform

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CAMBRIDGE, Mass., March 28, 2024 /PRNewswire/ — XtalPi Inc., a leading global technology company in integrating artificial intelligence (AI) and robotics to advance the discovery of groundbreaking medicine and innovative materials, announced today the launch of its proprietary comprehensive solid form discovery and selection platform, XtalGazer. This advanced platform aims to significantly improve the polymorph selection process for the pharmaceutical industry by integrating AI- and automation-powered experimental and computational approaches.

XtalGazer provides a total solution for delivering high-quality polymorph screening and selection methods to expedite drug development and mitigate risks. It represents a paradigm shift in solid-state research, moving from the traditional trial-and-error approach to a data-driven, design-led methodology. The platform provides an expansive suite of foundational tools to accelerate polymorph discovery, characterization, and selection process, empowering pharmaceutical companies to conduct thorough research with less active pharmaceutical ingredient (API) in shorter development cycles.
A key component of XtalGazer is XtalCSP, a crystal structure prediction platform to perform global searches of crystal structures for target molecules and the other optional components in the corresponding searching space, offering a deep insight into possible stable forms. Furthermore, crystallization strategy recommendations will provide AI-backed experimental design to help avoid human bias. XtalGazer also utilizes MicroED to rapidly elucidate crystal structures from powder samples, reducing the need for growing single crystals.
XtalPi’s launch of XtalGazer marks another significant step in the company’s ongoing exploration of solid-state research. From crystal structure prediction platforms being one of the first products to launch at XtalPi, to today’s comprehensive polymorph selection platform, XtalPi will keep fulfilling its promise to solving challenging problems in this space. XtalPi will continue to deliver faster, more accurate, and more comprehensive approaches to building an ecosystem for the R&D process in solid-state, pre-formulation and crystallization.
For more information about XtalPi, please visit www.xtalpi.com.
About XtalPi:
XtalPi is an innovative technology company powered by artificial intelligence (AI) and robotics. Founded in 2015 on the MIT campus, XtalPi is dedicated to driving intelligent and digital transformation in the life science and new materials industries. With tightly interwoven quantum physics, AI, cloud computing, and large-scale clusters of robotic workstations, XtalPi offers a range of technology solutions, services, and products to accelerate and empower innovation for biopharmaceutical and new materials companies worldwide.
Media Contact: Vivienne [email protected]
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ICIS and Base Oil News Announce Partnership to Enhance Market Insights

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LONDON, March 28, 2024 /PRNewswire/ — ICIS, a global source of commodity intelligence, is pleased to announce a strategic partnership with Base Oil News, a premier news outlet founded by industry expert Iain Pocock that provides in-depth coverage of the base oils and lubricants market. This collaboration marks a significant milestone in the dissemination and exchange of critical market data and insights.

With more than two decades of journalism experience at Bloomberg, Reuters, and Argus Media, Iain Pocock brings unparalleled expertise to this partnership. His deep understanding of illiquid energy markets makes him a credible and influential figure in the industry. Since November 2023, Iain has been working closely with ICIS to share and exchange valuable data and insights, enhancing the services both platforms offer to the base oils and lubricants market.
Through the collaboration, Iain integrates ICIS’ extensive content and data resources in Base Oil News market coverage. In return, he contributes market insights to ICIS News, including expert and exclusive analysis of supply and demand dynamics, price margins, and other critical market drivers. This exchange ensures that subscribers of both ICIS and Base Oil News have access to the most comprehensive, timely, and accurate market information, empowering them to make informed decisions.
“It’s a very exciting partnership – where we leverage each other’s strengths and provide actionable insights to our customers,” said Iain Pocock, Founder of Base Oil News. “The market is the winner.”
“As ICIS is already the world’s most trusted pricing benchmark for base oils, this collaboration with Iain Pocock and Base Oil News provides an even stronger and deeper service to our customers,” said Stephen Burns, Editorial Director at ICIS. “Iain’s expertise and extensive industry connections are invaluable, and we have established a fruitful partnership that benefits the market at large.”
For the latest insights from Iain Pocock on ICIS News, visit ICIS News.  
About ICIS
ICIS – Independent Commodity Intelligence Services – helps businesses through seamlessly delivering data and analytics, across the chemical, fertilizer and energy markets. A trusted source and benchmark for price information and insight across key commodities markets worldwide. Our independent, transparent market intelligence informs thousands of quality decisions every day, taking the pressure out of negotiations and giving customers space for more innovative thinking, through published datasets including price assessments, price forecasts, supply and demand fundamentals and more.
Over 150 years of shaping the world by connecting markets to optimise the world’s valuable resources. With a global team of more than 600 experts, ICIS has employees based in London, New York, Houston, Karlsruhe, Milan, Mumbai, Singapore, Guangzhou, Beijing, Shanghai, Dubai, Sao Paulo, Seoul, Tokyo and Perth.
ICIS is part of RELX, a FTSE15 company with a market cap of £64bn and an employee base of over 30,000 experts across 40 countries.
About RELX
RELX is a global provider of information and analytics for professional and business customers across industries. The Group serves customers in more than 180 countries and has offices in about 40 countries. It employs approximately 30,000 people of whom almost half are in North America. RELX PLC is a London listed holding company which owns 52.9% of RELX Group. RELX NV is an Amsterdam listed holding company which owns 47.1% of RELX Group. The shares are traded on the London, Amsterdam and New York Stock Exchanges using the following ticker symbols: London: REL; Amsterdam: REN; New York: RELX and RENX. Total market capitalisation is approximately £64bn | €75bn | $81bn.
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Trianz Welcomes Israel Abraham as Vice President of Services for Extrica.ai – The Data to AI Platform

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SANTA CLARA, Calif., March 28, 2024 /PRNewswire/ — Digital transformation technology & services company Trianz is pleased to announce the appointment of Israel Abraham as Vice President of Extrica Platform Services.

Trianz has embarked on a transformative journey, redefining its value proposition with an ‘IP Led’ model, with a commitment to deliver the fastest time to value, lowest human dependence, and highest ROI. Central to this approach are our hyper-automated platforms, Concierto.Cloud, Extrica.AI, and Pulse, driving industry-leading transformations in cloud, data and analytics, AI, and the digital workplace.
Israel Abraham is a very well-known pioneer and industry leader in AI, data management, and analytics systems, with over three decades of experience. He joins as the services leader for Extrica- the Trianz Data to AI platform, which productizes data, provides data a face and purpose, and accelerates time to insights and AI by 50% or more. In the role of Extrica Services leader, Israel will lead the shaping, visioning, and delivery of Extrica.ai based enterprise wide datamesh, BI, and AI solutions for customers worldwide.
“We are thrilled to welcome Israel Abraham to the Trianz family,” said Sri Manchala, CEO of Trianz and author of Crossing the Digital Faultline. “He is a leader in modernization as well as conceptualization of data platforms anew. Israel’s prior background in the industry with financial services and insurance giants underscores our commitment to securing top-tier talent that brings real-world experiences and needs to our technology platforms. As we continue to broaden our footprint in the digital transformation space, Israel’s visionary leadership and practical experience will serve as the cornerstone in accelerating insights and AI to deliver transformative value to our clients.”
Having played pivotal roles in highly reputed and large organizations such as Liberty Mutual Insurance, MassMutual, Safeco, and CNA Insurance, Israel has garnered recognition as a seasoned leader in big data and AI cloud implementations. His accolades include the prestigious 2014 Ventana Research IT Innovation Award, the 2009 Informatica MDM Innovation Award, and three filed Data Engineering patents in the last four years.
“Trianz has been at the forefront of digital innovation, and Extrica.ai is a paradigm shifting data to AI platform that completely changes how analytics and AI are delivered- much faster, taking business ahead of change. I am excited to scale the adoption of the Extrica platform, which has attracted attention from giants across the industry and hyperscalers,” said Israel Abraham. “I look forward to engaging with customers, bringing my own experiences, and collaborating with the talented team at Trianz to further enhance the capabilities of the Extrica Platform Services to transform data & AI strategies, execution, and outcomes for customers.”
About Trianz
Trianz is a leading-edge technology platforms and services company that accelerates digital transformations at Fortune 100 and emerging companies worldwide in data & analytics, digital experiences, cloud infrastructure, and security. Our ‘IP Led Transformations’ approach, informed by insights from a recent global study spanning 20+ industries and 5000+ companies, addresses challenges posed by the rapid pace of AI-driven transformation, digital talent scarcity, and economic uncertainty. Our IP and platforms, including Concierto, Extrica, and Pulse, revolutionize cloud adoption, data analytics, and AI insights, empowering organizations to navigate the complexities of digital transformation seamlessly.
Founded in California and with an organization of over 2,000 associates across the United States and India, Trianz is a Premier Partner of AWS, consistently rated #1 by clients for value delivery over the past five years. Trianz has been ranked as one of the best Consulting Firms by Forbes and has been certified as a Great Place to Work for three years in a row. To learn more about Trianz, email [email protected] or visit www.trianz.com.
Watch Trianz CEO Sri Manchala’s insightful interview with Bloomberg on Partner | Crossing The Digital Faultline & Leading Towards Transformative Success – YouTube and delve deeper into his book Crossing the Digital Faultline at Crossing the Digital Faultline | Trianz.
Trianz Media [email protected] +1-408-387-5800
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