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.

Start Date09 Jan 2023

Sponsor / Collaborator

Bexion Pharmaceuticals, Inc.

[+2]

NCT05291286

/ CompletedEarly Phase 1

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.

Start Date17 Oct 2022

Sponsor / Collaborator

Bexion Pharmaceuticals, Inc.

[+1]

NCT04771897

/ TerminatedPhase 1

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.

Start Date24 May 2021

Sponsor / Collaborator

Bexion Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with BXQ-350

100 Translational Medicine associated with BXQ-350

100 Patents (Medical) associated with BXQ-350

Literatures (Medical) associated with BXQ-350

15 Nov 2024·CLINICAL CANCER RESEARCH

A First-in-Human Phase I Study of BXQ-350, a First-in-Class Sphingolipid Metabolism Regulator, in Patients with Advanced/Recurrent Solid Tumors or High-Grade Gliomas

Article

Author: Curry, Richard ; Ogretmen, Besim ; Noonan, Anne M. ; Tapolsky, Gilles ; Cruze, Charlie ; Villano, John L. ; Wesolowski, Robert ; Yilmaz, Emrullah ; Wise-Draper, Trisha M. ; Rixe, Olivier ; Takigiku, Ray ; Puduvalli, Vinay K.

Abstract:

Purpose::

BXQ-350, a nanovesicle formulation of saposin C, is an allosteric sphingolipid metabolism regulator that increases proapoptotic ceramide and decreases oncogenic sphingosine-1-phosphate levels. We conducted a first-in-human phase I study of BXQ-350.

Patients and Methods::

Adults (≥18 years old) with advanced/recurrent, treatment-refractory solid tumors or high-grade gliomas received BXQ-350 intravenously in five dose cohorts (0.7–2.4 mg/kg) in a 3+3 dose escalation and expansion design. The primary endpoints during dose escalation were dose-limiting toxicities and maximum tolerated dose; the primary objective in expansion parts was assessment of antitumor activity (RECIST v1.1/Response Assessment in Neuro-Oncology criteria).

Results::

Eighty-six patients were enrolled. Dose-limiting toxicities were not observed during dose escalation (n = 18), and a maximum tolerated dose was not identified. An additional 68 patients received the 2.4 mg/kg dose. Nine patients (10%) discontinued due to adverse events. The most common treatment-related adverse events were nausea (24%) and fatigue (23%). Eight patients had a progression-free survival of ≥6 months. Two of these achieved a partial response, and six had stable disease, among whom three had a reduction in ≥1 target lesion. Of those with progression-free survival of ≥6 months, seven remained on study for >12 months, five for >24 months, and after 7 years, two remained on study without disease progression.

Conclusions::

BXQ-350 was well-tolerated as monotherapy at doses up to 2.4 mg/kg. It provided some lasting clinical benefit in patients with recurrent solid malignancies across several tumor types, consistent with a decreased systemic sphingosine-1-phosphate/ceramide metabolic rheostat. BXQ-350 warrants further clinical investigation alone and combined with standard of care for advanced solid tumors.

01 Dec 2022·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

Author: Curry, Richard C ; Demko, Suzanne ; DeWire Schottmiller, Mariko Dawn ; Her, Leah ; Cruze, Charles A ; 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.

15 Jun 2021·World journal of gastrointestinal oncologyQ4 · MEDICINE

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

Q4 · MEDICINE

Review

Author: 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.

News (Medical) associated with BXQ-350

08 Jan 2025

·www.prnewswire.com

Bexion Pharmaceuticals, Inc. Announces Poster Presentation at ASCO GI 2025

COVINGTON, Ky., Jan. 8, 2025 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel, first-in-class biologic therapy to treat solid tumors and chemotherapy-induced peripheral neuropathy (CIPN), today announced a poster presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), being held January 23-25, 2025, in San Francisco, CA. Poster details are included below. Poster Details: Session Title: Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date: January 25, 2025 Abstract Number: TPS320 Abstract Title: "BXQ-350, a novel sphingolipid metabolism modulator, in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal cancer (mCRC) patients: A phase 1b/2 study." More details on the conference can be found at the ASCO GI website at conferences.asco.org/gi/attend. 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. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for 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 patients treated with oxaliplatin and other chemotoxic agents. 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 has generated data in multiple classes of solid tumors, including metastatic colorectal cancer, high-grade gliomas, and pediatric brain tumors. The Company has completed enrollment in the open label portion of its Phase 1b/2 study evaluating BXQ-350 in combination with the standard of care. The Company is now planning to proceed to the randomized, double-blinded, placebo-controlled portion of the study. The Company has also completed enrollment in a proof-of-concept trial for the treatment of CIPN. 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1ASCO

06 Dec 2024

·www.prnewswire.com

Charles R. Scheper, Chairman of Bexion Pharmaceuticals Board, Named Great Living Cincinnatian

COVINGTON, Ky., Dec. 6, 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), today announced that its Chairman of the Board, Charles R. Scheper, has been named a Great Living Cincinnatian by The Cincinnati Regional Chamber. Being named a Great Living Cincinnatian is regarded as the preeminent honor in the Cincinnati community. According to The Cincinnati Regional Chamber, Great Living Cincinnatians are recognized by the Cincinnati Regional Chamber for service to the community; business and civic attainment on a local, state, national or international level; leadership; awareness of the needs of others; and distinctive accomplishments that have brought favorable attention to their community, institution, or organization. Mr. Charles "Chuck" Scheper joined Bexion as Chairman of the Board in 2010. He was the Chief Operating Officer at Great American Financial Resources, a $20 billion life and annuity company until his retirement in 2010. Prior to that position, Mr. Scheper was president and chief executive officer of Manhattan National Life Insurance Company and president of Pioneer Financial Services. Chuck is a cancer survivor and his journey to wellness led him to become active in various causes related to cancer, including Cancer Support Community, where he has served as the National Board Chairperson and board member. Currently, he is also the Chair of Catalytic Development Funding Corp of Northern Kentucky and Covington Economic Development Authority. "We are incredibly proud to celebrate our Chairman of the Board, Chuck Scheper, as a Great Living Cincinnatian," said Jim Beach, Bexion's Chief Executive Officer. "This recognition reflects his outstanding leadership and significant impact on our community. Chuck embodies the values we strive for at Bexion and inspires us to continue making a difference in people's lives." More information about the award and upcoming award ceremony in 2025 is available here. 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. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for 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 patients treated with oxaliplatin and other chemotoxic agents. 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 has generated data in multiple classes of solid tumors, including colorectal cancer, high-grade gliomas, and pediatric brain tumors. The Company has completed enrollment in the open label portion of its Phase 1b/2 study evaluating BXQ-350 in combination with the standard of care. The Company is now planning to proceed to the randomized, double-blind, placebo-controlled portion of the study. The Company has also completed enrollment in a proof-of-concept trial for the treatment of CIPN. About the Cincinnati Regional Chamber The Cincinnati Regional Chamber is the premier business and civic organization dedicated to growing the vibrancy and economic prosperity of the Cincinnati region. To achieve its vision that Cincinnati is a growing, thriving region where everyone belongs, the Chamber seeks to grow their economy, grow their population, and grow their cultural vibrancy — with the foundation of a strong business community — to foster a welcoming environment for all. The Chamber's membership offerings, signature leadership programs, government and regional advocacy efforts, community events such as BLINK and Oktoberfest as well as key partnerships with organizations like Cincinnati Experience, Cincinnati Compass, Cincinnati Minority Business Accelerator, and the Workforce Innovation Center lead the way in making that vision a reality. For more information, visit . 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Executive Change

18 Nov 2024

·www.prnewswire.com

Bexion Pharmaceuticals, Inc. Announces Completion of Enrollment in Open Label Portion of Phase 1b/2 ASIST Study in mCRC

COVINGTON, Ky., Nov. 18, 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), today announced completion of enrollment in the open label portion of Phase 1b/2 ASIST study of BXQ-350 in combination with Standard-of-Care (SOC) for the first line treatment of metastatic colorectal cancer (mCRC). "I am delighted that Bexion has completed enrollment for its Phase 1b/2 clinical trial and am especially pleased my clinical site has made significant contributions toward this effort," said Reema A. Patel, MD, Associate Professor of Medicine at the Markey Cancer Center of the University of Kentucky. "BXQ-350's mechanism of action lends itself to potential benefit in metastatic colorectal patients and peripheral neuropathy. Severe neuropathy is a key reason that patients drop off chemotherapy for colorectal cancer, and BXQ-350 has been shown to possess potential anti-neuropathy properties. I am excited by the potential of BXQ-350 to reduce or even potentially reverse neuropathic pain in these patients." The ASIST study will assess the safety and efficacy of BXQ-350 plus SOC, modified FOLFOX7 (mFOLFOX7) and bevacizumab, in patients with newly diagnosed mCRC. The study is also evaluating whether the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish CIPN, enabling participants to receive the total and planned doses of mFOLFOX7. "We extend our gratitude to all the patients, clinical investigators, and site research staff who continue to contribute to the advances we are making," said Jim Beach, Chief Executive Officer of Bexion. "We are excited about advancing to the next stage of clinical development, including further discussions with FDA on study design, and we look forward to providing updates as we reach upcoming milestones in 2025." More information about the clinical trial is available at clinicaltrials.gov (ASIST study; NCT05322590). 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. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for 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 patients treated with oxaliplatin and other chemotoxic agents. About Bexion Pharmaceuticals Bexion Pharmaceuticals, a clinical-stage biopharmaceutical company, is advancing a new class of biologic therapy aimed at treating solid tumors and chemotherapy-induced peripheral neuropathy (CIPN), with the potential to expand its portfolio into additional cancer types and broader neuropathic pain treatments. Bexion has generated positive data across various solid tumor types, including colorectal cancer, high-grade gliomas and pediatric brain tumors. The Company has completed enrollment in the open-label portion of its Phase 1b/2 trial, which evaluates BXQ-350 in combination with the standard of care for newly diagnosed patients with metastatic colorectal cancer (mCRC). Additionally, Bexion has completed patient enrollment in a proof-of-concept study for treating CIPN. 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1

100 Deals associated with BXQ-350

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 2	United States	Bexion Pharmaceuticals, Inc.	09 Jan 2023
Peripheral Nervous System Diseases	Phase 2	United States	Bexion Pharmaceuticals, Inc.	09 Jan 2023
Diffuse midline glioma, point mutation K27M in histone H3	Phase 1	United States	Bexion Pharmaceuticals, Inc.	24 May 2021
Neoplastic Processes	Phase 1	United States	Bexion Pharmaceuticals, Inc.	08 Jun 2020
Brain Cancer	Phase 1	United States	Bexion Pharmaceuticals, Inc.	15 Apr 2019
Diffuse Intrinsic Pontine Glioma	Phase 1	United States	Bexion Pharmaceuticals, Inc.	15 Apr 2019
Relapsed Solid Neoplasm	Phase 1	United States	Bexion Pharmaceuticals, Inc.	15 Apr 2019
Advanced Malignant Solid Neoplasm	Phase 1	United States	Bexion Pharmaceuticals, Inc.	01 Sep 2016
Ependymoma	Phase 1	United States	Bexion Pharmaceuticals, Inc.	01 Sep 2016
Glioblastoma Multiforme	Phase 1	United States	Bexion Pharmaceuticals, Inc.	01 Sep 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05322590 (P-73 BXQ-350, ESMO_GI2023)	Phase 1/2	Metastatic Colorectal Carcinoma	-	BXQ-350	ujbxwaudlm(zjocqsihpb) = 4 out of 10 patients with chronic CIPN at time of enrollment experienced an improvement of their symptoms ascyaquwei (gdthcyacdn )	Positive	01 Jul 2023
NCT02859857 (ASCO_GI2023) Manual	Phase 1	Advanced Malignant Solid Neoplasm \| Peripheral Nervous System Diseases	73	BXQ-350	ewxeszjrir(ufnakkrelm) = bzrhfklqux ujsstqcqij (wvmcvjacgl ) View more	Positive	24 Jan 2023
NCT02859857 (ASCO_GI2023) Manual	Phase 1	Advanced Colorectal Adenocarcinoma	73	BXQ-350	slpxfendet(ubcnpkxnxl) = jmipbrfzyd oalsahqlaz (htccprbhie ) View more	Positive	24 Jan 2023
NCT02859857 (ASCO_GI2023) Manual	Phase 1	Advanced Colorectal Adenocarcinoma	73	BXQ-350 (patients with PFS > 6 months)	fngabxkemw(sbyelgtjzy) = lbkcneiqya cnossuxwhe (amdlcnpnzh )	Positive	24 Jan 2023
NCT02859857 (028559857, ASCO2022)	Phase 1	Advanced Malignant Solid Neoplasm	-	BXQ-350	pdvsuaztgx(fufalgcxwi) = srtvbvgppc ckxshkzolt (pxenhnasnh ) View more	-	02 Jun 2022
NCT02859857 (BXQ-350, SNO2018)	Phase 1	High grade glioma externalized phosphatidylserine	17	BXQ-350 0.7 mg/kg	ahpntjnrdv(gvxnuoqyhq) = ECOG scores declining from a baseline 0-1 in 2/9 (22%) to 3 nbnuddnxjt (wugpuqzrrz ) View more	Positive	05 Nov 2018
NCT02859857 (BXQ-350, SNO2018)	Phase 1	High grade glioma externalized phosphatidylserine	17	BXQ-350 1.1 mg/kg		Positive	05 Nov 2018

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