Pritumumab is a human IgG1 kappa antibody that binds to a malignant tumor associated antigen, ecto domain-vimentin (EDV) which is expressed in a variety of tumor cells. Pritumumab was shown to have relatively high reactivity with brain cancer cell lines, while no reactivity was demonstrated with normal neurons, astrocytes or fetal cerebral cells. Pritumumab has notable antibody-dependent cellular cytotoxicity (ADCC), brain tumor penetration and antitumor activity in nude mouse human xenograft models.
Primary Objectives
- To determine the safety and/or tolerability and the recommended Phase 2 dose (RP2D) of escalating, intravenously (IV) administered Pritumumab doses in patients with recurrent gliomas or with brain metastases.
Secondary Objectives
To determine pharmacokinetics and pharmacodynamics of Pritumumab
To identify preliminary signals of anti-tumor response to Pritumumab
To explore disease-related, patient-reported outcomes

开始日期2021-03-18

申办/合作机构

Nascent Biotech, Inc.

[+1]

100 项与普立木单抗相关的临床结果

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100 项与普立木单抗相关的转化医学

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100 项与普立木单抗相关的专利（医药）

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120

项与普立木单抗相关的文献（医药）

2023-10-03·Journal of chromatographic science

Application of Taguchi OA and Box–Behnken Design for the Implementation of DoE-based AQbD Approach to HPTLC Method for Simultaneous Estimation of Azilsartan and Cilnidipine

Article

作者: Prajapati, Pintu ; Tailor, Pratik ; Shah, Shailesh ; Shahi, Abhinandan ; Acharya, Aneri

Abstract:

Hypertension is the most prominent disease found in people due to stressful routines and the working environment. The fixed-dose combination (FDC) of azilsartan medoxomil (AZL) and cilnidipine (CLN) is used for the treatment of hypertension. According to the green chemistry approach, organic solvents should be minimized in the development of the analytical method for the safety of the environment. The high-performance thin-layer chromatographic (HPTLC) method required less amount of organic solvent for the analysis of the drug. Hence, it was thought of interest to develop an accurate and robust HPTLC method for the estimation of AZL and CLN in their FDC. The development of the method was carried out by the implementation of the analytical quality by design approach using the Taguchi orthogonal array and BBD for regulatory compliance as per the upcoming ICH Q14 guideline. The analytical design space and control strategy was framed for the lifecycle management of the method. The chromatographic separation was performed using silica gel GF254 and toluene ethylacetate–methanol (6.5 + 1.5 + 2.0, v/v). The method was applied for the assay of FDC and results were found in compliance with the labeled claim. The developed method was also applied for the estimation of spiked human plasma and the recovered amount of drugs was found in the range of 80–85%.

2023-09-20·Microorganisms

Concurrent Brain Subregion Microgliosis in an HLA-II Mouse Model of Group A Streptococcal Skin Infection.

Article

作者: Grove, Bryon ; Nookala, Suba ; Combs, Colin ; Mukundan, Santhosh

The broad range of clinical manifestations and life-threatening infections caused by the Gram-positive bacterium, Streptococcus pyogenes or Group A Streptococcus (GAS), remains a significant concern to public health, with a subset of individuals developing neurological complications. Here, we examined the concurrent neuroimmune effects of subcutaneous GAS infections in an HLA-Class II (HLA) transgenic mouse model of subcutaneous GAS infection. To investigate changes in the skin-brain axis, HLA-DQ8 (DQA1*0301/DQB1*0302) mice (DQ8) were randomly divided into three groups: uninfected controls (No Inf), GAS infected and untreated (No Tx), and GAS infected with a resolution by clindamycin (CLN) treatment (CLN Tx) (10 mg/kg/5 days) and were monitored for 16 days post-infection. While the skin GAS burden was significantly reduced by CLN, the cortical and hippocampal GAS burden in the male DQ8 mice was not significantly reduced with CLN. Immunoreactivity to anti-GAS antibody revealed the presence of GAS bacteria in the vicinity of the neuronal nucleus in the neocortex of both No Tx and CLN Tx male DQ8 mice. GAS infection-mediated cortical cytokine changes were modest; however, compared to No Inf or No Tx groups, a significant increase in IL-2, IL-13, IL-22, and IL-10 levels was observed in CLN Tx females despite the lack of GAS burden. Western blot analysis of cortical and hippocampal homogenates showed significantly higher ionized calcium-binding adaptor-1 (Iba-1, microglia marker) protein levels in No Tx females and males and CLN Tx males compared to the No Inf group. Immunohistochemical analysis showed that Iba-1 immunoreactivity in the hippocampal CA3 and CA1 subregions was significantly higher in the CLN Tx males compared to the No Tx group. Our data support the possibility that the subcutaneous GAS infection communicates to the brain and is characterized by intraneuronal GAS sequestration, brain cytokine changes, Iba-1 protein levels, and concurrent CA3 and CA1 subregion-specific microgliosis, even without bacteremia.

2023-07-31·Pathogens (Basel, Switzerland)

HLA-II-Dependent Neuroimmune Changes in Group A Streptococcal Necrotizing Fasciitis.

Article

作者: Nagamoto-Combs, Kumi ; Combs, Colin K ; Nookala, Suba ; Ambigapathy, Ganesh ; Mukundan, Santhosh

Streptococcus pyogenes (Group A Streptococcus, GAS) bacteria cause a spectrum of human diseases ranging from self-limiting pharyngitis and mild, uncomplicated skin infections (impetigo, erysipelas, and cellulitis) to highly morbid and rapidly invasive, life-threatening infections such as streptococcal toxic shock syndrome and necrotizing fasciitis (NF). HLA class II allelic polymorphisms are linked with differential outcomes and severity of GAS infections. The dysregulated immune response and peripheral cytokine storm elicited due to invasive GAS infections increase the risk for toxic shock and multiple organ failure in genetically susceptible individuals. We hypothesized that, while the host immune mediators regulate the immune responses against peripheral GAS infections, these interactions may simultaneously trigger neuropathology and, in some cases, induce persistent alterations in the glial phenotypes. Here, we studied the consequences of peripheral GAS skin infection on the brain in an HLA-II transgenic mouse model of GAS NF with and without treatment with an antibiotic, clindamycin (CLN). Mice expressing the human HLA-II DR3 (DR3) or the HLA-II DR4 (DR4) allele were divided into three groups: (i) uninfected controls, (ii) subcutaneously infected with a clinical GAS strain isolated from a patient with GAS NF, and (iii) GAS-infected with CLN treatment (10 mg/kg/5 days, intraperitoneal). The groups were monitored for 15 days post-infection. Skin GAS burden and lesion area, splenic and hippocampal mRNA levels of inflammatory markers, and immunohistochemical changes in hippocampal GFAP and Iba-1 immunoreactivity were assessed. Skin GAS burden and hippocampal mRNA levels of the inflammatory markers S100A8/A9, IL-1β, IL-33, inflammasome-related caspase-1 (Casp1), and NLRP6 were elevated in infected DR3 but not DR4 mice. The levels of these markers were significantly reduced following CLN treatment in DR3 mice. Although GAS was not detectable in the brain, astrocyte (GFAP) and microglia (Iba-1) activation were evident from increased GFAP and Iba-1 mRNA levels in DR3 and DR4 mice. However, CLN treatment significantly reduced GFAP mRNA levels in DR3 mice, not DR4 mice. Our data suggest a skin-brain axis during GAS NF, demonstrating that peripherally induced pathological conditions regulate neuroimmune changes and gliotic events in the brain.

项与普立木单抗相关的新闻（医药）

2024-04-16

·BioSpace

Nascent Prepares for Pivotal Phase II Research with Fresh Manufacturing Run

NORTH PALM BEACH, FL / ACCESSWIRE / April 16, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company developing monoclonal antibodies targeting various cancer types, announces that it is embarking on a fresh manufacturing run to ensure Pritumumab ("PTB") supplies are at maximum potency when patient dosing begins in the upcoming Phase II clinical trial. "Taking the time to navigate this opportunity with proper care and diligence is a step that demonstrates our commitment to the best interests of our investors, partners, shareholders, and potential future patients," remarked Sean Carrick, CEO of NBIO. "No one likes delays, but patience and care at this critical stage is necessary in maximizing patient outcomes and long-term shareholder value. We want to be careful not to make hasty decisions while exploring all options. This announcement comes as the Company prepares for a Phase II trial that follows a very successful Phase I trial-where safety at five ascending dose cohorts was observed-involving 15 patients who received PTB for various types of brain tumors. The most common and most challenging to treat tumor type in the trial was Glioblastoma. 12 of 15 patients had this diagnosis. There were no dose-related toxicities. Overall, the study found that single agent Pritumumab is safe up to a dose of 16.2 mg/kg every 7 days in brain tumor patients. One partial response showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study. Mr. Carrick continued, "Phase I demonstrated an excellent safety pro various doses. Phase II will be focused on clinical outcomes, and we are taking no shortcuts. We have been in discussions with potential Phase II study sites to ensure patients are being actively recruited and the most efficient process in place once we are ready to begin dosing." Management anticipates that some research sites will open for the start of Phase II testing late this summer with actual patients involved later in 2024. ABOUT NASCENT Nascent Biotech, Inc. (OTCQB:NBIO) is a phase 2 clinical-stage biotech company pioneering the development of human monoclonal antibodies to be used in the treatment of various cancers, helping people worldwide. The Company's lead candidate, Pritumumab (PTB), is a human monoclonal Antibody (Mab) that has progressed to Phase 2 clinical trials for the treatment of Brain Cancer. For further information please visit our website . Forward Looking Safe Harbor Statement Statements in this press release about our future expectations constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, Nascent Biotech Inc's ability to target the medical professionals; Nascent Biotech Inc's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in the Nascent Biotech Inc's Form 10, filed on May 2, 2015, and future subsequent filings with the Securities and Exchange Commission. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law. Corporate Contact Sean Carrick | President | CEO | Nascent Biotech, Inc. 772.713.0541 Cell | sean.carrick@nascentbiotech.com Public Relations EDM Media, LLC SOURCE: Nascent Biotech Inc. View the original press release on accesswire.com

临床2期临床结果临床1期

2024-03-19

·BioSpace

Nascent Collaborates With Hypospray Pharma on Proprietary Transdermal Delivery System

NORTH PALM BEACH, FL / ACCESSWIRE / March 19, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company developing monoclonal antibodies targeting various cancer types, and HypoSpray Pharma ("HypoSpray®"), a clinical and commercial stage drug delivery technology company, announced today a collaboration to develop an alternative delivery mechanism for patients who can benefit from Pritumumab ("PTB"), Nascent's lead monoclonal antibody cancer treatment asset, which is now in Phase II clinical research for the treatment of Brain Cancer. Once successfully commercialized, the Company hopes to eliminate bi-weekly weekly infusions, allowing patients to administer Pritumumab and avoid inconvenient, tedious, and uncomfortable multi hour cancer center treatment visits. HypoSpray Pharma of Palm Beach Gardens FL has developed innovative technology for delivering active ingredients across the skin and mucosa. The company has a Drug Master File of record with the FDA for its delivery system, which enables measured application of a biological peptide to mucosal membranes or intact skin, promoting rapid absorption and bioavailability. Nascent CEO, Sean Carrick, commented: "We couldn't be more excited to work with HypoSpray's team and its leading delivery system technology. This collaboration has the potential to drive tangible breakthroughs in cancer treatment and patient care that enable home administration, eventually eliminating the need for bi-weekly multi-hour visits to the infusion center, materially improving quality of life for patients undergoing treatment." HypoSpray® Chairman and co-developer of the HypoSpray® technology, Kenneth Kirby, commented, "We are optimistic about our ability to enable effective delivery of Pritumumab. We have already successfully demonstrated our ability to accomplish similar objectives with several other peptides, including Melanocortin, Insulin, and Incretins, saving patients precious time and energy avoiding traditional infusion delivery." Cancer Drug researcher and Drug Delivery expert, Dr. Chandan Alam, formerly of the William Harvey Institute at the Royal London School of Medicine, said, "Our experience in multiple trials of the HypoSpray® DS technology with small molecules and peptides in pre-clinical trials has demonstrated its ability to rapidly deliver effective doses while enhancing blood-brain cross-over." Dr. William Kirsh, University of Miami Hospital Faculty and expert on End-of-life care, commented, "For patients with life-challenging illness, every minute counts. Eliminating hours of preparation, commuting, and the infusion process will be seen as a significant upgrade by GBM patients - for them, every hour is precious." ABOUT NASCENT Nascent Biotech, Inc. (OTCQB:NBIO) is a phase 2 clinical-stage biotech company pioneering the development of human monoclonal antibodies to be used in the treatment of various cancers, helping people worldwide. The Company's lead candidate, Pritumumab (PTB), is a human monoclonal Antibody (Mab) that has progressed to Phase 2 clinical trials for the treatment of Brain Cancer. For further information please visit our website ABOUT HYPOSPRAY HypoSpray Pharma (Private) is clinical and commercial stage drug delivery technology company, enabling transdermal and transmucosal delivery of small molecules to peptides. The company has opened INDAs with FDA and MHRA and registered the HypoSpray DS as a Phase 4 Drug Master File. The technology provided in a cGMP form is available to licensed, compounding pharmacists to enable their practice. The company's technology is patented and patent pending. For further information please visit our website Forward Looking Safe Harbor Statement Statements in this press release about our future expectations constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, Nascent Biotech Inc's ability to target the medical professionals; Nascent Biotech Inc's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in the Nascent Biotech Inc's Form 10, filed on May 2, 2015, and future subsequent filings with the Securities and Exchange Commission. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law. Corporate Contact: Sean Carrick | President | CEO | Nascent Biotech, Inc. 772.713.0541 Cell | sean.carrick@nascentbiotech.com Public Relations: EDM Media, LLC SOURCE: Nascent Biotech Inc. View the original press release on accesswire.com

临床2期

2024-02-06

·BioSpace

Nascent Biotech and Manhattan BioSolutions Collaborate to Explore Pritumumab Antibody-Drug Conjugates

NORTH PALM BEACH, FL and NEW YORK, NY / ACCESSWIRE / February 6, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent"), a clinical-stage biotechnology company pioneering the development of monoclonal antibodies for the treatment of various cancers and viral infections, announced today it has entered into a research collaboration agreement with Manhattan BioSolutions, Inc. (Manhattan Bio), an emerging biotech company focused on precision biologics, to explore antibody-drug conjugates (ADCs) using Nascent's lead clinical candidate pritumumab (PTB) as the tumor-targeting antibody element. Pritumumab (PTB) is a natural human antibody. This monoclonal antibody targets extracellular form of vimentin, a protein that has been linked to cancer growth and metastasis and is overexpressed in both brain and pancreatic cancers as well as other hard tumor cancers. PTB is a targeted immunotherapy that binds to vimentin in tumors and recruits the immune system to eliminate cancer cells. PTB has demonstrated a promising safety pro preliminary efficacy in completed Phase I study in glioblastoma patients. Nascent has been recently cleared by the FDA to begin Phase II clinical trials for brain cancer. In preclinical experiments, PTB antibody has shown the capacity to cross the blood-brain barrier with the additional potential to transport conjugated drugs into brain tissues, and Nascent holds a patent covering this specialized delivery mechanism. Under the terms of the agreement, Manhattan Bio will perform PTB conjugations to industry standard linker-payloads and will evaluate the resulting ADCs in the in vitro cell assays. The most promising candidates will be prioritized for further development for the treatment of vimentin-positive and potential secondary targets in advanced or metastatic tumors. Nascent CEO, Sean Carrick, commented: "We are thrilled to unlock the full disruptive potential of pritumumab against cancer by collaborating with Manhattan Bio's world-leading scientists. This collaboration serves as an exciting first step in uncovering the possibilities of better targeted cancer therapies." "Pritumumab offers unexplored potential as an ADC vector, and we are excited to test that promise leveraging our expertise in ADC discovery and development. This could pave the way for applying our newest linker-payload innovations to pritumumab in the future" said Dr. Borys Shor, CEO of Manhattan Bio. About Nascent Biotech Nascent Biotech, Inc. (OTCQB:NBIO) is a clinical-stage biotech company pioneering the development of human monoclonal antibodies to be used in the treatment of various cancers, helping people worldwide. Its products are not yet commercially available. The Company's lead candidate, Pritumumab (PTB), is a human monoclonal Antibody (Mab) that has progressed to Phase 2 clinical trials for the treatment of Brain Cancer. For further information please visit our website . Forward Looking Safe Harbor Statement Statements in this press release about our future expectations constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, Nascent Biotech Inc's ability to target the medical professionals; Nascent Biotech Inc's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in the Nascent Biotech Inc's Form 10, filed on May 2, 2015, and future subsequent filings with the Securities and Exchange Commission. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law. Corporate Contact: Sean Carrick sean.carrick@nascentbiotech.com About Manhattan BioSolutions Manhattan BioSolutions, Inc is a privately held biotechnology company focused on the development of biologic immunotherapies targeting host defense pathways for the treatment of advanced cancers. The company advances two technology platforms for drug discovery: RNA-degrader proteins, and antibody-drug conjugates (ADCs) - through collaborations with leading academic institutions. Manhattan Bio has established partnerships with the National Cancer Institute (NCI), Stony Brook University, The University at Buffalo, Binghamton University, INSERM, Nascent Biotech, EVQLV, and has been awarded grants by the National Institutes of Health (NIH), the National Science Foundation (NSF), the New Jersey Commission on Science, Innovation and Technology (CSIT), the New York State Center For Biotechnology and the University at Buffalo Center for Advanced Technology in Big Data and Health Sciences (UBCAT). Learn more at manhattanbiosolutions.com and follow Manhattan BioSolutions on LinkedIn or Twitter. Contact for investor inquiries: Borys Shor, Ph.D. ir@manhattanbiosolutions.com SOURCE: Nascent Biotech Inc. View the original press release on accesswire.com

临床2期免疫疗法引进/卖出临床1期抗体药物偶联物

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适应症	最高研发状态	国家/地区	公司	日期
脑癌	临床2期	美国	Nascent Biotech, Inc.	2023-05-26
胶质瘤	临床2期	日本	Nascent Biotech, Inc.	2016-01-14
脑转移瘤	临床1期	美国	Nascent Biotech, Inc.	2021-03-18
新型冠状病毒感染	临床前	美国	Nascent Biotech, Inc.	2020-03-05
胰腺癌	临床前	美国	Nascent Biotech, Inc.	2018-01-23

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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


NCT04396717 (Biospace) 人工标引	临床1期	脑癌	15	Pritumumab	遞鑰鏇鑰壓醖鬱網觸廠(糧壓範獵糧繭醖襯遞襯) = One partial response showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study. 構糧鑰糧夢鹹遞窪顧醖 (鬱積淵鑰夢蓋廠壓鑰餘 )	积极	2024-04-16
NCT04396717 (ASCO2023) 人工标引	临床1期	脑癌	15	pritumumab	繭觸顧憲糧簾廠顧糧醖(鬱選糧蓋憲膚鏇顧觸衊) = fatigue (53.3%) and constipation (33.3%) 鹹積網願遞簾餘觸鬱糧 (願觸鬱夢鬱積壓鹹艱鬱 )	积极	2023-05-31
AACR2014	临床2期	脑癌	249	Pritumumab	蓋製觸夢獵鹹壓襯蓋遞(構鹽選獵構製鏇襯積蓋) = 餘鏇鹹獵製構範製鏇鏇積淵願鏇艱艱觸積鑰選 (艱廠鹹憲襯壓遞蓋遞齋 )	积极	2014-10-01