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2021-02-22

申办/合作机构

Nascent Biotech, Inc.

[+1]

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项与普立木单抗相关的文献（医药）

2024-01-01·Neuro-oncology advances

A phase 1 dose escalation of pritumumab in patients with refractory or recurrent gliomas or brain metastases

Article

作者: Nomura, Natsuko ; Redfern, Charles ; Shah, Dhaval K ; Gill, Jaya Mini ; Carrick, Sean ; Babic, Ivan ; Carrillo, Jose ; Kesari, Santosh

Abstract:

Background:

This phase 1 (NCT04396717) open-label, multicenter study, evaluated Pritumumab, a IgG1 monoclonal antibody, in patients with gliomas and brain metastases. The primary objective was to evaluate the safety and/or tolerability and to identify a recommended phase 2 dose (RP2D) of Pritumumab.

Methods:

Adult patients with recurrent gliomas or brain metastases were enrolled in the dose cohort that was open at the time of their consent. Study treatment consisted of pritumumab administered intravenously weekly on days 1, 8, 15, and 22 in 28-day cycles. Safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity were evaluated.

Results:

Fifteen patients received Pritumumab in the recurrent setting. Pritumumab was well tolerated, with no serious adverse events related to Pritumumab reported. The most common drug-related toxicities were constipation and fatigue. There were no dose-limiting toxicities observed, and a maximum tolerable dose was not reached. Thus, the maximum feasible dose and recommended phase 2 dose of Pritumumab was established at 16.2 mg/kg weekly. Out of eleven patients evaluated for efficacy, one patient (9.1%) demonstrated partial response based on response assessment in neuro-oncology criteria, and disease stabilization was seen in 3 patients (27.3%).

Conclusions:

Pritumumab was well tolerated with no DLTs observed up to 16.2 mg/kg weekly. Further studies are warranted to determine clinical benefit in patients.

2020-09-04·Human antibodies

Unconventional immunotherapy with an unconventional target

Article

作者: Glassy, Mark C.

Pritumumab, a natural human IgG1 kappa antibody was obtained from a regional draining lymph node of a patient with cervical carcinoma through traditional hybridoma technology. Specificity analysis of the target antigen, an altered form of vimentin called, ecto-domain vimentin (EDV), shows it to be limited to cell surface expression on cancer cells. Clinically, 249 brain cancer patients were treated with a low dose pritumumab regimen, either at 1 mg once a week or 1 mg twice a week, and of those evaluated overall response rates of between 25–30% were seen with several complete and partial responses. A clinical trial assessing higher doses of pritumumab as a therapeutic for brain cancer is expected to begin this year. Overall, these data together suggest pritumumab is suitable for further development as an anti-tumor therapeutic.

2019-02-18·Human antibodies

Pritumumab, the first therapeutic antibody for glioma patients

Review

作者: Glassy, Mark C. ; Yenugonda, Venkata M. ; Nomura, Natsuko ; Nurmemmedov, Elmar ; Babic, Ivan ; Juarez, Tiffany ; Pingle, Sandeep C. ; Kesari, Santosh

Immunotherapy is now at the forefront of cancer therapeutic development. Gliomas are a particularly aggressive form of brain cancer for which immunotherapy may hold promise. Pritumumab (also known in the literature as CLNH11, CLN-IgG, and ACA-11) was the first monoclonal antibody tested in cancer patients. Pritumumab is a natural human monoclonal antibody developed from a B lymphocyte isolated from a regional draining lymph node of a patient with cervical carcinoma. The antibody binds ecto-domain vimentin on the surface of cancer cells. Pritumumab was originally tested in clinical trials with brain cancer patients in Japan where it demonstrated therapeutic benefit. It was reported to be a safe and effective therapy for brain cancer patients at doses 5-10 fold less than currently approved antibodies. Phase I dose escalation clinical trials are now being planned with pritumumab for the near future. Here we review data on the development and characterization of pritumumab, and review clinical trails data assessing immunotherapeutic effects of pritumumab for glioma patients.

项与普立木单抗相关的新闻（医药）

2025-01-21

·GlobeNewswire-Health Care

Nascent Biotech Receives Delinquency Notification Related to its Delayed September 30, 2024 Financial Filing

NORTH PALM BEACH, FL, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Nascent Biotech, Inc. (OTCQB:NBIO) (“Nascent Biotech”, “Nascent”, or the “Company”), a clinical-stage biotechnology company developing monoclonal antibodies targeting various cancer types, today announced that it has received a written notification from the OTC Markets Group as a result of its failure to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 (the “Form 10-Q”) in a timely fashion. The Notification Letter advised the Company that it was not in compliance with the OTC Market's continued listing requirements under the timely filing criteria. As a result of this delinquency, the Company’s stock is currently not quoted on the OTC Markets’ regular platforms and is instead quoted on the OTC Markets’ "Expert Market." The Company expects that upon catching up on its filings and returning to compliance with the OTC Market's requirements, its stock will resume normal quotation on the OTC Markets’ trading platforms. The Company is diligently working to file its Form 10-Q as quickly as possible and is collaborating closely with its auditors and legal advisors to ensure accurate and compliant filings. “We are dedicated to promptly resolving this matter and remain committed to full transparency and timely reporting,” said Sean Carrick, CEO of Nascent Biotech. “We appreciate the patience and continued support of our investors as we work diligently towards completing the filing and restoring normal quotation of our stock.” About Nascent Biotech 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 www.nascentbiotech.com. 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 10Q, filed on August 14, 2024, 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. Investor Relations: Crescendo Communications Tel: +1 212-671-1020 Email: NBIO@crescendo-ir.com

临床2期

2024-09-10

·nascentbiotech.com

VIDEO: Nascent Biotech CEO Sean Carrick at the Emerging Grown Conference

NORTH PALM BEACH, FL / ACCESSWIRE / April 16, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) (“Nascent Biotech”, “Nascent”, or the “Company”), a clinical-stage [...] NORTH PALM BEACH, FL and NEW YORK, NY / ACCESSWIRE / February 6, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) (“Nascent Biotech”, “Nascent”), a clinical-stage biotechnology [...] Analysts suggest Nascent Value at $0.60 to $2.84 per share NORTH PALM BEACH, FL / ACCESSWIRE / January 9, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) (“Nascent Biotech”, [...] CLICK HERE TO DOWNLOAD COMPLETE PDF CLICK TO DOWNLOAD PDF NORTH PALM BEACH, FL / ACCESSWIRE / August 22, 2023 / Nascent Biotech, Inc. (OTCQB:NBIO) (“Nascent Biotech”, “Nascent”, or the “Company”), a clinical-stage [...] We came across Nascent Biotech Inc. NBIO last year and it caught our eye despite still trading on the OTC for just pennies per share. The share price of a stock isn’t a very important [...] Jose Arganda Carrillo, Santosh Kesari, Jaya Mini Gill, Charles Redfern, Sean Carrick, Ivan Babic Background: Pritumumab, a fully human IgG1 (kappa) monoclonal antibody (mAb), was originally [...] NORTH PALM BEACH, FL / ACCESSWIRE / May 26, 2023 / Nascent Biotech, Inc. (OTCQB:NBIO) (“Nascent Biotech”, “Nascent”, or the “Company”), a clinical-stage [...]

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

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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	-	厦门南讯股份有限公司	-
胶质瘤	临床2期	-	University of California	-
脑转移瘤	临床1期	美国	Nascent Biotech, Inc.	2021-02-22
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	遞糧鬱構艱膚糧夢憲廠(廠網壓夢鹽淵積遞選艱) = One partial response showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study. 獵網簾顧衊夢構範壓簾 (築獵鏇鬱範夢範廠積憲 )	积极	2024-04-16
NCT04396717 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	脑癌	15	pritumumab	夢鏇襯淵廠獵艱艱鹽鹹(鏇壓淵築範觸鏇簾憲齋) = fatigue (53.3%) and constipation (33.3%) 簾範繭壓鹽築壓範膚觸 (廠鏇構獵觸鹹鹽選繭鬱 )	积极	2023-05-31
AACR2014	临床2期	脑癌	249	Pritumumab	獵獵憲齋積窪淵艱鏇夢(觸窪顧顧製醖艱積範構) = 網鬱蓋衊網夢艱衊製餘繭製獵繭網蓋襯齋遞範 (壓選鬱齋鹹構顧鑰簾簾 )	积极	2014-10-01