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 ; 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.

01 Aug 2020·Molecular therapy : the journal of the American Society of Gene TherapyQ1 · MEDICINE

Enhanced Efficacy of Combination of Gemcitabine and Phosphatidylserine-Targeted Nanovesicles against Pancreatic Cancer

Q1 · MEDICINE

Article

Author: Davis, Harold W ; Yeh, Jen Jen ; Franco, Robert S ; Chu, Zhengtao ; Qi, Xiaoyang ; N'Guessan, Kombo F ; Olowokure, Olugbenga ; Bogdanov, Vladimir Y ; Lewis, Clayton S ; Vallabhapurapu, Subrahmanya D ; Ahmad, Syed A

Phosphatidylserine (PS) is often externalized in viable pancreatic cancer cells and is therapeutically targetable using PS-selective drugs. One of the first-line treatments for advanced pancreatic cancer disease, gemcitabine (GEM), provides only marginal benefit to patients. We therefore investigated the therapeutic benefits of combining GEM and the PS-targeting drug, saposin C-dioleoylphosphatidylserine (SapC-DOPS), for treating pancreatic ductal adenocarcinoma (PDAC). Using cell-cycle analyses and a cell surface PS-based sorting method in vitro, we observed an increase in surface PS as cells progress through the cell cycle from G1 to G2/M. We also observed that GEM treatment preferentially targets G1 phase cells that have low surface PS, resulting in an increased median surface PS level of PDAC cells. Inversely, SapC-DOPS preferentially targets high surface PS cells that are predominantly in the G2/M phase. Finally, combination therapy in subcutaneous and orthotopic PDAC tumors in vivo with SapC-DOPS and GEM or Abraxane (Abr)/GEM (one of the current standards of care) significantly inhibits tumor growth and increases survival compared with individual treatments. Our studies confirm a surface PS and cell cycle-based enhancement of cancer cytotoxicity following SapC-DOPS treatment in combination with GEM or Abr/GEM. Thus, PDAC patients treated with Abr/GEM may benefit from concurrent administration of SapC-DOPS.

News (Medical) associated with BXQ-350

07 Jan 2026

·www.prnewswire.com

Bexion Pharmaceuticals, Inc. Announces Poster Presentations at the American Society for Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2026

COVINGTON, Ky., Jan. 6, 2026 /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 the Company will participate in the American Society for Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2026 taking place January 8-10, 2026, in San Francisco, California. Details of the posters are included below. First Poster Details: Abstract Title: BXQ-350 efficacy and safety evaluation in first line mCRC patients: A phase 1b/2 study of BXQ-350, a first-in-class sphingolipid metabolism modulator, in combination with mFOLFOX7 plus bevacizumab in newly diagnosed metastatic colorectal carcinoma. Abstract Number: 242 Poster Board Number: K2 Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date: Saturday, January 10, 2026 Session Time: 7:00-7:55 AM Presenter: Dr. Reema Patel Second Poster Details: Abstract Title: A phase 1b/2 study on the efficacy and safety of BXQ-350, a first-in-class sphingolipid metabolism modulator, in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal carcinoma. Abstract Number: TPS273 Poster Board Number: L7 Session Title: Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date: Saturday, January 10, 2026 Session Time: 7:00-7:55 AM Presenter: Dr. Tariq Arshad Third Poster Details: Abstract Title: Bxq-350 in combination with FOLFOX7 and bevacizumab: Evaluation of effect on oxaliplatin-induced CIPN—A phase 1b/2 trial to assess the efficacy and safety of BXQ-350, a first-in-class sphingolipid metabolism modulator, in newly diagnosed metastatic colorectal carcinoma. Abstract Number: 105 Poster Board Number: D17 Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date: Saturday, January 10, 2026 Session Time: 7:00-7:55 AM Presenter: Michael Gazda, Ph.D. The abstracts are scheduled to be posted to the ASCO GI Online Program at 5 PM ET on Monday, January 6. 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 has also completed enrollment in a proof-of-concept trial for the treatment of CIPN. Investor and Media Contact: Joyce LaViscount Bexion Pharmaceuticals 859-446-7386 [email protected] SOURCE Bexion Pharmaceuticals, Inc. 21% more press release views with Request a Demo

Phase 1ASCO

28 May 2025

·www.prnewswire.com

Bexion Pharmaceuticals, Inc. Announces Acceptance of Abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

COVINGTON, Ky., May 28, 2025 /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 two abstracts were accepted at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30, 2025 - June 3, 2025, in Chicago, Illinois. Details of the abstracts are included below. Abstract Details: Title: Effect of BXQ-350, a novel sphingolipid metabolism modulator, on neuronal environments through modulation of gene pathways Abstract Number: e24058 Author: Michael Gazda, Tariq Arshad, Jim Beach, Nikhil Wilkins, Adam Creighbaum, Timothy Stephens Session Title: Publication Only: Symptom Science and Palliative Care Title: A phase 1 study to evaluate the safety and tolerability of BXQ-350, a novel sphingolipid metabolism modulator, in pediatric diffuse intrinsic pontine glioma and diffuse midline glioma Abstract Number: e14044 Author: Tariq Arshad, Michael Gazda, Jim Beach, Kathleen Dorris, Margot Lazow, Trent Hummel, Richard Curry III, Adam Creighbaum Session Title: Publication Only: Central Nervous System Tumors The full abstracts are currently available in the ASCO digital program. 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 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

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

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 (ASCO_GI2026)	Phase 1/2	Metastatic Colorectal Carcinoma First line	33	BXQ-350 + mFOLFOX7 + Bevacizumab (metastatic colorectal carcinoma)	pquhcuutir(nfdesnztfz) = Analysis of Neurofibrillary Light Chain (NfL) biomarkers suggests concordance with physician and patient reported outcomes. enifcehrqk (wvqldxarcn )	Positive	08 Jan 2026
NCT05322590 (ASCO_GI2026)	Phase 1/2	Metastatic Colorectal Carcinoma First line	34	BXQ-350+mFOLFOX7+Bevacizumab	dfxhgiyzdq(zrrefsowmv) = uqwuspghra iucgahgfol (ckntkrnegy )	Positive	08 Jan 2026
NCT05322590 (P-73 BXQ-350, ESMO_GI2023)	Phase 1/2	Metastatic Colorectal Carcinoma	-	BXQ-350	dnzampezuk(mbnqjotzyn) = 4 out of 10 patients with chronic CIPN at time of enrollment experienced an improvement of their symptoms uaqlfmfams (dkzaxwhgqr )	Positive	01 Jul 2023
NCT02859857 (ASCO_GI2023) Manual	Phase 1	Advanced Colorectal Adenocarcinoma	73	BXQ-350	nbrpsljckl(ooywwbqhtt) = iewjxvyydw jngtmgcnib (riwwcitxlt ) View more	Positive	24 Jan 2023
NCT02859857 (ASCO_GI2023) Manual	Phase 1	Advanced Colorectal Adenocarcinoma	73	BXQ-350 (patients with PFS > 6 months)	dhpsaqameq(mtvraodbbf) = xuopumryha fgkodddngq (ykwhfhwcdi )	Positive	24 Jan 2023
NCT02859857 (ASCO_GI2023) Manual	Phase 1	Advanced Malignant Solid Neoplasm \| Peripheral Nervous System Diseases	73	BXQ-350	cwjsznlext(rddkejeivp) = awbnntvrgo wicqnubnck (rdodayblir ) View more	Positive	24 Jan 2023
NCT02859857 (028559857, ASCO2022)	Phase 1	Advanced Malignant Solid Neoplasm	-	BXQ-350	beqfcpkhha(jbnlkshbks) = dgaopordxd wgqtekknzl (tgcosptfqs ) View more	-	02 Jun 2022
NCT02859857 (RARE-10, SNO2018)	Phase 1	Ependymoma	1	BXQ-350 2.4 mg/kg IV infusion	ffxizzkrzk(mytiaigkrr) = stable disease per RANO and ECOG of 1 eucuoqepxq (iiknjfswpk ) View more	Positive	05 Nov 2018
NCT02859857 (BXQ-350, SNO2018)	Phase 1	High grade glioma externalized phosphatidylserine	17	BXQ-350 0.7 mg/kg	kygppycdab(magmyugzgp) = ECOG scores declining from a baseline 0-1 in 2/9 (22%) to 3 jotarjcxci (urclisfpiz ) 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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