A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA As Boron Carrier in Recurrent Meningioma

This Phase I/II study, titled 'A Study to Evaluate the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as a Boron Carrier in Recurrent Meningioma', aims to assess the efficacy of B10 L-BPA with BNCT in patients with recurrent meningioma. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for recurrent meningioma treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.

Start Date14 Oct 2024

Sponsor / Collaborator-

JPRN-jRCT2031240246

/ SuspendedPhase 1/2IIT

Phase I/II basket trial: Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for patients with recurrent solid malignant thoracic tumors that are unresectable and perceived challenging to treat with standard treatment - SJ-BT001

Start Date31 Jul 2024

Sponsor / Collaborator-

CTR20241076

/ RecruitingPhase 1

NBB-001和硼中子俘获治疗系统的硼中子俘获疗法（BNCT）治疗复发性头颈部恶性肿瘤患者的安全性、耐受性、药代动力学及有效性的I期研究

[Translation] A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Boron Neutron Capture Therapy (BNCT) with NBB-001 and the Boron Neutron Capture Therapy System in Patients with Recurrent Head and Neck Malignancies

Ia期:主要目的：评价使用NBB-001和硼中子俘获治疗系统的硼中子俘获疗法（BNCT）在复发性头颈部恶性肿瘤患者中的安全性、耐受性；确定NBB-001的II期推荐剂量（RP2D）。次要目的：评估NBB-001在复发性头颈部恶性肿瘤患者中的药代动力学（PK）特征；评估NBB-001和硼中子俘获治疗系统的硼中子俘获疗法（BNCT）在复发性头颈部恶性肿瘤患者中的有效性；BNCT实施中硼中子俘获治疗系统的器械性能。评估18F-BPA-PET/CT检查提示的肿瘤与正常组织的硼浓度比（TNR）与疗效的关系。 Ib期：主要目的：评估NBB-001和硼中子俘获治疗系统的硼中子俘获疗法（BNCT）治疗复发性头颈部恶性肿瘤患者中的有效性。次要目的：评估NBB-001和硼中子俘获治疗系统的硼中子俘获疗法（BNCT）治疗复发性头颈部恶性肿瘤患者中的安全性；评估BNCT实施中硼中子俘获治疗系统的器械性能；评估18F-BPA-PET/CT检查提示的肿瘤与正常组织的硼浓度比（TNR）与疗效的关系。

[Translation]

Phase Ia: Primary objective: To evaluate the safety and tolerability of boron neutron capture therapy (BNCT) using NBB-001 and BNCT system in patients with recurrent head and neck malignancies; to determine the recommended Phase II dose (RP2D) of NBB-001. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of NBB-001 in patients with recurrent head and neck malignancies; to evaluate the effectiveness of BNCT of NBB-001 and BNCT system in patients with recurrent head and neck malignancies; and the device performance of BNCT system during BNCT implementation. To evaluate the relationship between the tumor-to-normal tissue boron concentration ratio (TNR) indicated by 18F-BPA-PET/CT examination and the efficacy. Phase Ib: Primary objective: To evaluate the effectiveness of BNCT of NBB-001 and BNCT system in the treatment of patients with recurrent head and neck malignancies. Secondary objectives: To evaluate the safety of NBB-001 and BNCT system in the treatment of patients with recurrent head and neck malignancies using boron neutron capture therapy (BNCT); to evaluate the device performance of the BNCT system during BNCT implementation; and to evaluate the relationship between the tumor-to-normal tissue boron concentration ratio (TNR) indicated by 18F-BPA-PET/CT examination and the therapeutic effect.

Start Date08 May 2024

Sponsor / Collaborator

China Boron (Xiamen) Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Borofalan (10B)

100 Translational Medicine associated with Borofalan (10B)

100 Patents (Medical) associated with Borofalan (10B)

11,798

Literatures (Medical) associated with Borofalan (10B)

01 Dec 2025·JOURNAL OF BIOLOGICAL PHYSICS

Microplastic contaminant adsorption by graphene oxide layer

Article

Author: Kartono, Agus ; Hardhienata, Hendradi ; Handayasari, Faridah ; Sumaryada, Tony ; Nabilah, Fasya

The increasing prevalence of microplastics in water sources poses significant threats to both human health and environmental sustainability. Bisphenol A (BPA) and polyethylene terephthalate (PET), two hazardous microplastic contaminants, are known to cause endocrine disruption and other health risks. This study investigates the potential of graphene oxide (GO) as an efficient adsorbent for the removal of these contaminants through detailed molecular interaction analysis. The adsorption efficiencies of GO were quantitatively assessed, demonstrating strong binding affinities of ∆G = - 9.50 kcal/mol for BPA and ∆G = - 6.90 kcal/mol for PET. The adsorption process is primarily governed by π-π stacking interactions between the aromatic structure of the microplastics and the polycyclic surface of GO, with additional contributions from hydrogen bonding and van der Waals forces. Computational simulations revealed consistent binding across specific active sites on the GO surface, indicating minimal variation in adsorption performance. These findings highlight the potential of GO-based filtration systems for large-scale water treatment applications, offering a promising approach to mitigating microplastic contamination and ensuring safer water supplies. These findings highlight the potential of GO-based filtration systems for large-scale water treatment applications, offering a promising approach to mitigating microplastic contamination and ensuring safer water supplies. Future research should focus on optimizing GO-based filtration techniques and exploring their long-term environmental impact.

01 Aug 2025·Journal of Environmental Sciences

Paternal bisphenol A exposure alters craniofacial cartilage development in rare minnow (Gobiocypris rarus) descendants

Article

Author: Huang, Yutong ; Zhu, Long ; Yu, Jiachen ; Wang, Xiaotian ; Wang, Zaizhao ; Huang, Li ; Zhou, Shangjie

Bisphenol A (BPA) is a recognized estrogenic endocrine disruptor that poses a threat to the reproductive health of fish. However, it remains unclear whether and how paternal BPA exposure can lead to developmental toxicity in offspring. To explore the potential paternal BPA exposure impacts on craniofacial cartilage growth in offspring, male rare minnows were subjected to BPA and subsequently mated with normal females to produce progeny. Our results demonstrated that paternal BPA exposure resulted in increased malformation and delayed craniofacial cartilage development in the F1 offspring. Furthermore, BPA exposure led to differential expression of 28 miRNAs in paternal sperm in F0 generation (13 upregulated and 15 downregulated), among which 7 miRNAs were involved in the regulation of bone development. BPA also downregulated the expression of bmp2a and Runx1 during F1 embryonic development. The inhibited bmp2a expression might derive from BPA's stimulation of one miRNA, aca-miR-16a-5P, due to bmp2a being one of its target genes. Notably, paternal BPA exposure did not affect craniofacial cartilage development or gonadal development in the F2 generation. Overall, our study sheds light on the molecular mechanisms underlying the impact of paternal BPA exposure on facial chondrogenesis in offspring and provides theoretical support for the ecological protection of fish populations.

01 Jul 2025·JOURNAL OF HAZARDOUS MATERIALS

High performance persistent organic pollutants removal using stabilized enzyme aggregates over amino functionalized magnetic biochar

Article

Author: He, Lingzhi ; Yang, Yadong ; Jian, Yangyang

Herein, a highly efficient and recyclable biocatalyst was developed using stabilized enzyme aggregates on amino-functionalized magnetic biochar for removing persistent organic pollutants from water. The biochar derived from biomass featured abundant hydroxyl functional groups, after functionalization with amino functional groups and magnetic nanoparticles, it was employed for laccase immobilization via enzyme electrostatic adsorption, precipitation and cross-linking in a favorable orientation. This immobilized enzyme aggregates exhibited enhanced pH tolerance, thermal and storage stability than free enzyme. Complete removal of 20 mg/L bisphenol A was achieved within 60 min via C-C bond cleavage and hydroxylation. Notably, the removal efficiency remained at approximately 90 % even after six cycles. Furthermore, this biocatalyst was also successfully applied to efficiently remove other various persistent organic pollutants and demonstrated applicability in real environmental water samples. This study highlights the substantial potential of enzyme-based biocatalysts, presenting a sustainable and efficient approach for water purification and biomass resource recovery.

News (Medical) associated with Borofalan (10B)

17 Dec 2024

·www.businesswire.com

TAE Life Sciences and CNAO Announce Definitive Agreement on BNCT, a Next-Generation Cancer Therapy

PAVIA, Italy--( BUSINESS WIRE )--TAE Life Sciences (TLS), a leading developer of Boron Neutron Capture Therapy (BNCT) systems and drugs, and the Italian National Center for Oncological Hadrontherapy (CNAO), a premier hadrontherapy center in Europe, today announced a definitive agreement to collaborate on groundbreaking global drug research and development initiatives for the implementation of BNCT. This strategic partnership will bring together the expertise of two innovative leaders in cancer treatment, with the purpose to revolutionize cancer care through BNCT, a targeted radiation therapy designed to improve outcomes for patients with complex and metastatic cancers. CNAO’s extensive experience in hadrontherapy, encompassing proton, carbon ions and other particles, complements TLS’s leadership in advancing cancer treatment with BNCT technology and drug development. BNCT is a type of combination cancer treatment that uses neutron radiation and a special boron compound to target and destroy cancer cells. The process involves two main steps. In the first one, a boron-rich compound is administered to the patient, typically via injection or infusion. This compound is designed to be selectively absorbed by cancer cells, with minimal uptake by normal tissues. In the second step, after the boron compound has been absorbed by the cancer cells, the patient is exposed to a beam of low-energy neutrons. These neutrons interact with the boron atoms within the cancer cells and destroy them. In late 2020, CNAO had already entered into an agreement with TLS to adopt the BNCT system and install an accelerator-based neutron source in Italy. Now, the new agreement completes the collaboration, including the drug development as well. Prof. Gianluca Vago , CNAO President, commented: “ Our mission has always been to leverage cutting-edge technologies to expand treatment opportunities for the benefit of cancer patients. Being chosen by TLS for such an important collaboration is a further recognition of CNAO's expertise in particle therapies, both in clinical and research activities. For this project, our center will work in close cooperation with University of Pavia, Polytechnic University of Milan, National Institute for Nuclear Physics and Fondazione IRCCS Policlinico San Matteo of Pavia. The partnership with TLS will enable us to open up new frontiers in BNCT and make CNAO a unique facility in the world to combine treatments with protons, heavy ions (carbon ions and other species) and neutrons.” Planned Milestones and Key Objectives: Installation and Clinical Trials: The installation of TLS’s Alphabeam ® BNCT system at CNAO is scheduled to begin in 2025, with clinical trials launching in 2026. The initial trials will leverage Steboronine ® (Boronophenylalanine, BPA)—an boron drug developed by Stella Pharma for BNCT and distributed by TLS in Europe and the US. Steboronine® selectively accumulates boron in cancer cells and is already approved in Japan for recurrent head and neck cancers, the focus of these first trials. Advancing Cancer Treatment: The collaboration is poised to expand the clinical applications of BNCT to address a wide range of cancers, including metastatic cancers, offering new hope for patients worldwide. CNAO NEXT Services: The partnership includes efforts to promote the range of services offered by CNAO NEXT, an independent company set up by CNAO, which operates in the field of precision therapies, providing technical and clinical consultancy and assisting other centers in implementing particle therapies. A significant aspect of the collaboration involves the clinical implementation and commercialization of new TLS BNCT drugs, such as Boronotyrosine (BTS), which has shown promising preclinical results in animal models. “ Our partnership with CNAO marks a transformative step in advancing BNCT as a next-generation cancer therapy,” said Rob Hill , CEO of TAE Life Sciences. “ Together, we aim to push the boundaries of cancer treatment and provide groundbreaking solutions to patients who need them most.” Additionally, prof. Lisa Licitra, Scientific Director of CNAO, Chief of Head and Neck Cancer Medical Oncology Dept at Fondazione IRCCS Istituto Nazionale dei Tumori, Associate Professor at the University of Milan, has joined the TLS Clinical Advisory Board as an internationally recognized leader in head and neck oncology. She will serve as leading oncologist for the BNCT clinical trials at CNAO focusing on head and neck cancer and will oversee the clinical trial at CNAO, further strengthening the collaboration’s scientific foundation. Prof. Lisa Licitra , Scientific Director of CNAO, affirmed: “ BNCT has demonstrated compelling responses for recurrent or refractory tumours, such as head and neck cancers. Therefore, working with Prof. Ester Orlandi, Head of CNAO Clinical Department, we will initially focus on patients with this type of tumours. With the introduction of BNCT, we can reduce treatment to 1-2 sessions, expand therapeutic indications and potentially offer new hope to patients with metastatic tumours. Our goal will be to offer increasingly customized therapeutic options, by having at our disposal a wide range of particles: not only protons and carbon ions but also neutrons for BNCT, helium and oxygen.” About TAE Life Sciences: TAE Life Sciences is a privately held biotechnology company committed to developing a new biologically targeted radiation therapy based on Boron Neutron Capture Therapy (BNCT). TAE Life Sciences is the only company developing the next-generation targeted boron drugs and low-energy accelerator-based neutron system optimized for an in-hospital BNCT program that delivers cancer-killing radiation with cellular-level precision to treat patients with aggressive and refractory cancers. TAE Life Sciences’ Alphabeam™ BNCT system and proprietary boronated drugs are still in the investigational stage, and not available commercially. More information about TAE Life Sciences is available at taelifesciences.com . About CNAO: The National Center for Oncological Hadrontherapy (CNAO), located in Pavia, Italy, is one of the only six centers in the world able to perform hadrontherapy with both protons and carbon ions and has treated about 5,500 oncological patients, working in the particle therapy field for 15 years. CNAO mission is to be at the forefront of providing cutting-edge cancer therapies with the goal of offering highly targeted, precision treatments for patients with complex and rare cancers. CNAO is dedicated to advancing research and clinical applications of hadrontherapy, making a significant contribution to the improvement of cancer care, also through the establishment of a network of national and international collaborations. More information about CNAO is available at https://fondazionecnao.it/en/ .

Radiation TherapyClinical StudyDrug Approval

14 Nov 2024

·www.businesswire.com

TAE Life Sciences and Stella Pharma Announce Strategic Agreement for Development and Commercialization of BPA for BNCT Cancer Therapy in the USA and Europe

IRVINE, Calif.--( BUSINESS WIRE )--TAE Life Sciences (TLS), a leader in developing boron neutron capture therapy (BNCT) technology and associated innovative boron target drugs, and Stella Pharma, the pioneering developer of boronophenylalanine (BPA) under the product name Steboronine® for BNCT, are pleased to announce a strategic collaboration focused on the development, commercialization and expansion of BNCT using BPA in the United States and European markets. Stella Pharma’s BPA drug is the world’s first and only clinically approved boron drug for BNCT, marking a breakthrough in cancer treatment. Japan became the first country to approve BNCT for the treatment of head and neck cancers, using Stella Pharma’s pioneering BPA drug. Now, Stella Pharma, as the leading producer and supplier of BPA, has joined forces with TAE Life Sciences to expand the adoption of BNCT worldwide. Supporting the Future of BNCT Therapy The collaboration objectives include extensive international cooperation in the development and commercialization of BNCT and BPA across the USA and Europe with clinical trials anticipated to begin in 2026. TLS will serve as the exclusive commercial partner for Stella Pharma’s BPA in these regions, representing a significant expansion of BNCT accessibility outside of Asia. “ Our partnership with Stella Pharma combines our shared commitment to advancing BNCT as a viable cancer treatment for patients worldwide,” said Rob Hill, CEO of TAE Life Sciences. “ We are excited to bring the proven benefits of BPA to U.S. and European healthcare institutions and to support BNCT globally with this powerful therapeutic solution.” Both companies have also committed to supporting BNCT equipment vendors across all markets in implementing BPA-based BNCT treatments. By fostering partnerships within the BNCT ecosystem, TLS and Stella Pharma aim to enhance the clinical reach of BNCT in treating recurrent head and neck cancers and advancing clinical studies for other cancers, including brain, skin, breast, esophagus, and lung cancers. “ Our alliance with TAE Life Sciences marks a significant step in expanding the reach of BPA-based BNCT treatments beyond Asia,” said Koki Uehara, President and Chief Operating Officer of Stella Pharma. “ We look forward to collaborating internationally to develop and commercialize BNCT and aim to deliver these advancing cancer treatments to patients and their families worldwide.” Exploring Future Opportunities Together Stella Pharma and TAE Life Sciences share a vision of advancing BNCT treatment for hard-to-treat cancers and pledge to explore additional areas for collaboration. Through this alliance, they seek to accelerate innovation, expand treatment options, and ultimately improve outcomes for cancer patients worldwide.

Drug Approval

21 Aug 2024

·www.drugs.com

Phenol, Paraben Exposure Linked to Hypertension During Pregnancy

WEDNESDAY, Aug. 21, 2024 -- Phenol and paraben exposure may be associated with hypertension during pregnancy, according to a study published online Aug. 14 in Environmental Health Perspectives . Julia R. Varshavsky, M.P.H., Ph.D., from the Bouvé College of Health Sciences at Northeastern University in Boston, and colleagues examined associations between individual phenols, parabens, and their mixture on maternal blood pressure (BP) measurements and hypertension during pregnancy among 1,433 women. The relationships were examined cross-sectionally at two time points during pregnancy (16 to 20 and 24 to 28 weeks of gestation) and longitudinally. The researchers found that exposure to multiple analytes and the overall mixture was associated with a trend toward higher odds of hypertension during pregnancy, especially at 24 to 28 weeks of gestation (adjusted mixture odds ratio, 1.57). Individual analytes were also associated with lower systolic BP (SBP) and higher diastolic BP (DBP), with the results from the linear mixed models most consistent for methyl paraben or propyl paraben with increased DBP (β = 0.78 and 0.85, respectively), and for bisphenol A, which was associated with lower SBP (β = −0.57). There was evidence of effect modification by fetal sex, with a strong inverse association between overall exposure mixture and SBP among those carrying female fetuses. "These everyday products that we think are safe may be actually harming us and our babies at a critical time during pregnancy," Varshavsky said in a statement. "In the largest study to date, we found that the combined effect of phenol and paraben mixtures increased risk of hypertension during pregnancy among a vulnerable population of women in Puerto Rico who are also dealing with a disproportionate burden of exposure to other toxic chemicals, poverty, and climate change-related disasters like hurricanes and flooding." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Borofalan (10B)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX	DB06973

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Head and Neck Neoplasms	Japan	Stella Pharma Corp.	25 Mar 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Head and Neck Carcinoma	Phase 1	China	China Boron (Xiamen) Biopharmaceutical Co., Ltd.	08 May 2024
Hemangiosarcoma	Phase 1	Japan	Stella Pharma Corp.	19 Nov 2019
Melanoma	Phase 1	Japan	Stella Pharma Corp.	19 Nov 2019
Advanced Head and Neck Squamous Cell Carcinoma	IND Approval	China	Hainan Poly Pharm. Co., Ltd.	08 Feb 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	IND Approval	China	Hainan Poly Pharm. Co., Ltd.	08 Feb 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2024	Not Applicable	Hypersensitivity	-	Oral Bisphenol A Administration at 50 Î¼g/kg body weight	fvutgczztk(fdqrrpxbkd) = imkbnvllex mlgumvyrgi (ftlomqsmtd, 0.01)	-	21 Jun 2024
				Bisphenol A (Oral Placebo Administration)	fvutgczztk(fdqrrpxbkd) = vbhlhxisen mlgumvyrgi (ftlomqsmtd, 0.01)
UEGW2023	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	-	BISPHENOL A (Healthy individuals)	puntlxwybo(ceqsquyinq) = ozrrsttrtb ludwlrvzdl (fisfkvtylq )	-	15 Oct 2023
				BISPHENOL A (NASH patients)	puntlxwybo(ceqsquyinq) = pebnuxxbkv ludwlrvzdl (fisfkvtylq )
ODP276 (ENDO2022)	Not Applicable	Thyroid Cancer	-	BISPHENOL-A (Nthy-ori 3-1 cells)	klmcxeljjm(juzeuqholo) = lhqiakhixn jsxqrtwqsh (natrfloqcm )	-	01 Nov 2022
				BISPHENOL-A (TPC-1 cells)	klmcxeljjm(juzeuqholo) = pmzddbmudk jsxqrtwqsh (natrfloqcm )
EASD2021	Not Applicable	Insulinoma	-	Bisphenol-A (BPA) 1 μM	plkgxpbvht(ztxgwrrtpg) = zngemwzcus qetneenifj (fghdknymhf )	Negative	28 Sep 2021
EASD2020	Not Applicable	-	-	bisphenol-A (3T3-L1 cells)	hroilubmtk(kbzxodyfld) = not enhanced by BPA exposure qbyyllgsth (bkmtermper ) View more	-	22 Sep 2020
				bisphenol-A (NIH-3T3 cells)
JPRN-JapicCTI-194640 (ESMO2019)	Phase 2	Recurrent Head and Neck Carcinoma \| Recurrent Squamous Cell Carcinoma of the Head and Neck	-	borofalan(10B) (SPM-011) (AB-BNCT with borofalan(10B))	roapcjsrty(qjyhixoeji) = ihxfpsoyva mtxzzooxqn (vcluzeyofc ) View more	-	30 Sep 2019
ASN2017	Not Applicable	Bisphenol A (BPA)	-	Bisphenol A (BPA-free polynephron dialyzers)	nhpgrqilta(rscomegmui) = kxbpqxrtok mxlnoumjix (eixjmcydqf, 7.97)	Positive	31 Oct 2017
				Bisphenol A (BPA-containing polysulfone dialyzers)	nhpgrqilta(rscomegmui) = qiaoxuybjg mxlnoumjix (eixjmcydqf, 20.38)
SP491 (ERA2017)	Not Applicable	Bisphenol A (BPA)	58	Polinephron (PN)	dqjkuzukfy(dmzfycfeyn) = bifozkikbf vihqecgogk (xdfmhigclt )	Positive	26 May 2017
				Bisphenol A (BPA) (Polysulphone (PS))	dqjkuzukfy(dmzfycfeyn) = omovejzofc vihqecgogk (xdfmhigclt )
FP520 (ERA2015)	Not Applicable	BPA	69	Polinephron (PN)	jnbkyneuuc(fwmsytfntu) = mlbcfhgnea ermdrzkxxk (dnhmmntylw ) View more	Negative	21 May 2015
				Bisphenol A (BPA) (Polysulphone (PS))	jvqoapadln(llsdncfyrb) = fefkjeiqrb mbglowhxaj (gnejttynkx ) View more
Pubmed \| JAMA Pediatr	Not Applicable	-	208	Bisphenol A	imzuiwoltj(wdtkqldaun) = tvuqjulwmx sgunwrmwoq (hdvwovsteu, 1.55 - 0.91-2.63)	-	01 Dec 2014

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