A Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination With mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma

The study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish oxaliplatin induced sensory neurotoxicity, enabling participants to receive the total and planned doses of mFOLFOX7.
All participants will receive BXQ-350 by intravenous (IV) infusion along with standard of care doses of mFOLFOX and bevacizumab. The study is divided into two stages: Stage 1 will be open label and will enroll participants at increasing dose levels of BXQ-350 in order to determine the Stage 2 dose. Stage 2 will be blinded; participants will receive BXQ-350 at the established Stage 1 dose or placebo.

开始日期2023-01-09

申办/合作机构

Bexion Pharmaceuticals, Inc.

[+2]

NCT05291286 / Active, not recruiting早期临床1期

A Pilot Proof of Concept Pharmacokinetic/Pharmacodynamic Study of BXQ-350 in Cancer Patients Exposed to Oxaliplatin and/or Taxane-Based Chemotherapy

This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized, placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.

开始日期2022-10-17

申办/合作机构

Bexion Pharmaceuticals, Inc.

[+1]

NCT04771897 / Active, not recruiting临床1期

A Phase 1 Open Label, Multi-Center Study to Evaluate the Safety and Tolerability of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)

This study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children with newly diagnosed DIPG or DMG. All patients will receive BXQ-350 by intravenous (IV) infusion and radiation therapy. The study is divided into two parts: Part 1 will enroll patients at increasing dose levels of BXQ-350 in order to determine the MTD. Part 2 will enroll patients requiring a biopsy in order to assess BXQ-350 concentrations in the biopsied tumor.

开始日期2021-05-24

申办/合作机构

Bexion Pharmaceuticals, Inc.

[+1]

100 项与 BXQ-350 相关的临床结果

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100 项与 BXQ-350 相关的转化医学

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100 项与 BXQ-350 相关的专利（医药）

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项与 BXQ-350 相关的文献（医药）

2022-12-01·Heliyon

An open-label multi-center phase 1 safety study of BXQ-350 in children and young adults with relapsed solid tumors, including recurrent malignant brain tumors

Article

作者: Curry, Richard C ; Demko, Suzanne ; DeWire Schottmiller, Mariko Dawn ; Cruze, Charles A ; Her, Leah ; Casey, Denise ; Setty, Bhuvana ; Abdelbaki, Mohamed S ; Cripe, Timothy P

Background:

BXQ-350 is a novel anti-neoplastic agent composed of saposin C (SapC) and phospholipid dioleoylphosphatidyl-serine sodium (DOPS) that selectively binds tumor cell phosphatidylserine (PS), inducing apoptosis. BXQ-350 has demonstrated preclinical antitumor effects in high-grade gliomas (HGG) and clinical activity in adult patients with recurrent HGG.

Methods:

A phase 1 study was conducted in pediatric patients with relapsed/refractory solid tumors, including recurrent brain tumors. Primary objectives were to characterize safety and determine maximum tolerated dose (MTD) and preliminary antitumor activity. Sequential dose cohorts were assessed up to 3.2 mg/kg using an accelerated titration design. Each cycle was 28 days; dosing occurred on days 1-5, 8, 10, 12, 15, and 22 of cycle 1, and day 1 of subsequent cycles, until disease progression or toxicity.

Results:

Nine patients, median age 10 years (range: 4-23), were enrolled. Seven patients (78%) had central nervous system (CNS) and two (22%) had non-CNS tumors. Eight patients completed cycle 1. No dose limiting toxicity (DLT) or BXQ-350-related serious adverse events (SAEs) were observed. Six patients experienced at least one adverse event (AE) considered possibly BXQ-350-related, most were grade ≤2. One patient with diffuse intrinsic pontine glioma experienced stable disease for 5 cycles. The study was terminated after part 1 to focus development on the frontline setting.

Conclusion:

No DLTs or BXQ-350-related SAEs were reported, and the maximal planned dose of 3.2 mg/kg IV was tolerable. Limited safety and efficacy data support continued BXQ-350 development in pediatric HGG; however, early discontinuations for progression suggest novel therapies be assessed at earlier disease stages.

2021-06-15·World journal of gastrointestinal oncology4区 · 医学

Targeting of elevated cell surface phosphatidylserine with saposin C-dioleoylphosphatidylserine nanodrug as individual or combination therapy for pancreatic cancer

4区 · 医学

Review

作者: Davis, Harold W ; Qi, Xiaoyang ; Kaynak, Ahmet ; Vallabhapurapu, Subrahmanya D

Pancreatic cancer is one of the deadliest of cancers with a five-year survival of roughly 8%. Current therapies are: surgery, radiation and chemotherapy. Surgery is curative only if the cancer is caught very early, which is rare, and the latter two modalities are only marginally effective and have significant side effects. We have developed a nanosome comprised of the lysosomal protein, saposin C (SapC) and the acidic phospholipid, dioleoylphosphatidylserine (DOPS). In the acidic tumor microenvironment, this molecule, SapC-DOPS, targets the phosphatidylserine cancer-biomarker which is predominantly elevated on the surface of cancer cells. Importantly, SapC-DOPS can selectively target pancreatic tumors and metastases. Furthermore, SapC-DOPS has exhibited an impressive safety profile with only a few minor side effects in both preclinical experiments and in phase I clinical trials. With the dismal outcomes for pancreatic cancer there is an urgent need for better treatments and SapC-DOPS is a good candidate for addition to the oncologist's toolbox.

2020-12-01·Cell communication and signaling : CCS2区 · 生物学

SapC-DOPS – a Phosphatidylserine-targeted Nanovesicle for selective Cancer therapy

2区 · 生物学

ReviewOA

作者: Patel, Priyankaben H ; N'Guessan, Kombo F ; Qi, Xiaoyang

Abstract:

Phosphatidylserine (PS) is normally located in the inner leaflet of the membrane bilayer of healthy cells, however it is expressed at high levels on the surface of cancer cells. This has allowed for the development of selective therapeutic agents against cancer cells (without affecting healthy cells). SapC-DOPS is a PS-targeting nanovesicle which effectively targets and kills several cancer types including pancreatic, lung, brain, and pediatric tumors. Our studies have demonstrated that SapC-DOPS selectively induces apoptotic cell death in malignant and metastatic cells, whereas untransformed cells remain unaffected due to low surface PS expression. Furthermore, SapC-DOPS can be used in combination with standard therapies such as irradiation and chemotherapeutic drugs to significantly enhance the antitumor efficacy of these treatments. While the PS-targeting nanovesicles are a promising selective therapeutic option for the treatment of cancers, more preclinical studies are needed to fully understand the mechanisms leading to non-apoptotic PS expression on the surface of viable cancer cells and to determine the effectiveness of SapC-DOPS in advanced metastatic disease. In addition, the completion of clinical studies will determine therapeutic effects and drug safety in patients. A phase I clinical trial using SapC-DOPS has been completed on patients with solid tumors and has demonstrated compelling patient outcomes with a strong safety profile. Results from this study are informing future studies with SapC-DOPS.Graphical abstract

项与 BXQ-350 相关的新闻（医药）

2024-05-31

·PRNewswire

Bexion Pharmaceuticals, Inc. to Present at BIO International Convention 2024

COVINGTON, Ky., May 31, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), today announced that the Company will present at the 2024 Biotechnology Innovation Organization (BIO) International Convention taking place June 3-6, 2024, in San Diego, California. Presentation Details: Location: Theater 1, Hall A, Exhibition Hall Session Date and Time: Wednesday, June 5 at 11:15am PT "We are delighted to participate in the BIO International Convention in San Diego," said Scott Shively, Bexion's Chief Executive Officer. "Bexion is approaching critical milestones for our mCRC and CIPN clinical programs, and we look forward to sharing the tremendous progress our team has made." To schedule a meeting at the BIO International Convention with Bexion Pharmaceuticals, please submit a meeting request through the BIO One-on-One Partnering™ platform. More details are available on the BIO International Convention 2024 website. About BIO International Convention The BIO International Convention is the largest and most comprehensive event for biotechnology, representing the full ecosystem of biotech with over 20,000 industry leaders from across the globe. The convention includes innovative programming around the current and future state of biotech including areas like therapeutic frontiers, the business of biotech, regulatory and policy outlooks, and human capital. About BXQ-350 Bexion's lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, sphingolipid activator protein, Saposin C, and a phospholipid. BXQ-350 has pre-clinical antitumor effects in vitro and in vivo, particularly in colorectal, brain and other solid tumors. Two Phase 1 clinical trials, one in adults and one in pediatric DIPG patients, demonstrated a strong safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumors. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy. About Bexion Pharmaceuticals Bexion Pharmaceuticals, a clinical-stage biopharmaceutical company, is developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN) with potential portfolio expansion opportunities in other cancers and broader neuropathic pain indications. Bexion currently has three clinical trials open for enrollment. Investor Contact: William Windham Solebury Strategic Communications 646-378-2946 [email protected] Media Contact: Joyce LaViscount Bexion Pharmaceuticals 859-446-7386 [email protected] SOURCE Bexion Pharmaceuticals, Inc.

临床1期

2024-04-10

·BioSpace

Bexion Pharmaceuticals, Inc. Announces Poster Presentation on BXQ-350 at the American Association for Cancer Research (AACR) Annual Meeting 2024

COVINGTON, Ky., April 10, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), announced today that the Company presented a poster on BXQ-350 during the American Association for Cancer Research (AACR) Annual Meeting 2024 which took place April 5-10, 2024, in San Diego, CA. Poster details are included below. Poster Details: Abstract Title: BXQ-350: A novel biologic that allosterically activates glucosylcerebrosidase and demonstrates signs of activity in cancer patients Abstract Number: 3072 Poster Board Number: 12 Session Title: Signaling Pathways That Regulate Metabolism 1 Session Date: Monday Apr 8, 2024 Presenter: Gilles Tapolsky, PhD, Vice President of Pharmacology & Translational Sciences, Bexion Pharmaceuticals The abstracts were posted to the AACR Online Program Planner at 4:30 PM ET on Tuesday, March 5. About AACR The American Association for Cancer Research (AACR) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer. The AACR Annual Meeting program covers the latest discoveries across the spectrum of cancer research—from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy—and highlights the work of the best minds in research and medicine from institutions all over the world. About BXQ-350 Bexion's lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, sphingolipid activator protein, Saposin C, and a phospholipid. Clinically, two Phase 1 clinical trials, one in adults and one in pediatric DIPG patients, have demonstrated a robust safety pro BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in solid tumor patients treated with oxaliplatin and other chemotoxic agents. About Bexion Pharmaceuticals Bexion Pharmaceuticals, a clinical-stage biopharmaceutical company, is developing a novel class of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN) with potential portfolio expansion opportunities in other cancers and broader neuropathic pain indications. Bexion currently has three clinical trials open for enrollment. Investor Contact: William Windham Solebury Strategic Communications 646-378-2946 wwindham@soleburystrat.com

临床1期AACR会议

2024-02-28

·BioSpace

Bexion Pharmaceuticals, Inc. Appoints Dr. Tariq Arshad as Chief Medical Officer

COVINGTON, Ky., Feb. 28, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), today announced the appointment of Tariq Arshad, MD, MBA as Chief Medical Officer. Dr. Arshad is an oncologist with more than 25 years of experience and a successful track record of strategic planning, clinical development, and commercialization. "We are thrilled to appoint Dr. Arshad as Bexion's Chief Medical Officer," said Scott Shively, Bexion's Chief Executive Officer. "With over 25 years in the biotechnology and pharmaceutical industry, Dr. Arshad's immense experience will greatly benefit our team as we move forward with our mCRC and CIPN clinical programs. We are eager to leverage his extensive skill set and welcome him on board." This is a very exciting time to join Bexion with the evaluation of BXQ-350 for the treatment of mCRC and CIPN firmly in the clinic," said Dr. Arshad, "I am eager to drive the clinical programs forward and develop a potential first-in-class product that could help the vast number of patients currently lacking effective treatments." Dr. Arshad brings extensive experience from various leadership roles at early and late-stage biopharmaceutical companies. Most recently, as Chief Medical Officer and Head of R&D at Qualigen Therapeutics in Carlsbad, CA, Dr. Arshad played a crucial role in obtaining significant milestones and advancing the company's lead asset QN-302 as well as it's Pan-RAS portfolio. Dr. Arshad previously led medical strategies for blockbuster biologic therapies approved for clinical use in major immunology indications and other groundbreaking therapies as Head of Medical Affairs for Immunology at Sanofi, and he served as Chief Medical Officer and Head of Clinical Research at Humanigen, developing novel immune-oncology therapies. Dr. Arshad is a trained clinical oncologist and actively participates in professional societies such as the American Society of Clinical Oncology (ASCO), the American Association of Cancer Research (AACR) and SITC (Society for Immunotherapy of Cancer), among others. About Bexion Pharmaceuticals Bexion Pharmaceuticals, a clinical-stage biopharmaceutical company, is developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN) with potential portfolio expansion opportunities in other cancers and broader neuropathic pain indications. Bexion currently has three clinical trials open for enrollment. Investor Contact: William Windham Solebury Strategic Communications 646-378-2946 wwindham@soleburystrat.com

高管变更

100 项与 BXQ-350 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性结直肠癌	临床2期	美国	Bexion Pharmaceuticals, Inc.	2023-01-09
周围神经系统疾病	临床1期	美国	Bexion Pharmaceuticals, Inc.	2022-10-17
弥漫内生性脑桥神经胶质瘤	临床1期	美国	Bexion Pharmaceuticals, Inc.	2021-05-24
组蛋白H3中K27M点突变的弥漫性中线胶质瘤	临床1期	美国	Bexion Pharmaceuticals, Inc.	2021-05-24
癌症	临床1期	美国	Bexion Pharmaceuticals, Inc.	2020-06-08
脑癌	临床1期	美国	Bexion Pharmaceuticals, Inc.	2019-04-15
复发性实体肿瘤	临床1期	美国	Bexion Pharmaceuticals, Inc.	2019-04-15
晚期恶性实体瘤	临床1期	美国	Bexion Pharmaceuticals, Inc.	2016-09-01
胶质瘤	临床1期	美国	Bexion Pharmaceuticals, Inc.	2016-09-01

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05322590 (P-73 BXQ-350, ESMO_GI2023)	临床1/2期	转移性结直肠癌	-	BXQ-350	餘壓鹽鏇鹽淵選憲夢範(遞醖觸襯構衊窪簾齋窪) = 4 out of 10 patients with chronic CIPN at time of enrollment experienced an improvement of their symptoms 獵廠糧築築艱鹽鏇範鑰 (夢衊遞憲糧鹽製積願糧 )	积极	2023-07-01
NCT02859857 (ASCO_GI2023) 人工标引	临床1期	晚期结直肠腺癌	73	BXQ-350	襯窪簾蓋糧襯窪積鏇蓋(衊簾獵構構壓觸鬱遞鬱) = 鏇選構築構顧齋鑰憲醖鹹選壓鑰鹹糧餘壓壓艱 (鬱艱獵鏇鹹構願網選選 ) 更多	积极	2023-01-24
NCT02859857 (ASCO_GI2023) 人工标引	临床1期	晚期结直肠腺癌	73	BXQ-350 (patients with PFS > 6 months)	齋鹽鹹膚窪鑰夢齋獵鑰(壓廠衊製繭獵鏇淵壓憲) = 製範積鹹構鬱夢製窪廠製艱網遞齋願獵鹹積顧 (膚鹹鏇醖製夢憲獵簾夢 )	积极	2023-01-24
NCT02859857 (ASCO_GI2023) 人工标引	临床1期	晚期恶性实体瘤 \| 周围神经系统疾病	73	BXQ-350	製艱願遞鹽構鹽窪獵鏇(獵鹽鬱廠積餘鹽觸艱膚) = 艱積製觸範鏇衊鹽鬱醖繭餘範衊淵鹹衊觸築醖 (築憲鬱遞鑰鏇淵夢衊餘 ) 更多	积极	2023-01-24
ASCO2022	临床1期	晚期恶性实体瘤	-	BXQ-350	齋艱襯積糧鹽齋範窪製(選淵觸膚衊鏇糧蓋遞製) = 餘獵糧膚襯獵遞願範艱鹹壓窪簾鹽艱衊觸範鏇 (製構觸蓋顧繭鏇選製襯 ) 更多	-	2022-06-02