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

Start Date18 Mar 2021

Sponsor / Collaborator

Nascent Biotech, Inc.

[+1]

100 Clinical Results associated with Pritumumab

100 Translational Medicine associated with Pritumumab

100 Patents (Medical) associated with Pritumumab

126

Literatures (Medical) associated with Pritumumab

01 Apr 2024·Journal of Applied Microbiology

Synergistic interactions of essential oil components with antibiotics against multidrug-resistant Corynebacterium striatum

Article

Author: Ünlü, Mehmet ; Coşkun, Ahmet Gökhan ; Yilmaz, Umut ; Vardar-Ünlü, Gülhan ; Özel, Yener

AbstractAimIn this study, it was aimed to examine the antibacterial activity of the essential oil components (EOCs), carvacrol (CAR), cinnamaldehyde (CIN), thymol (TH), alpha pinene (α-PN), eucalyptol (EU), limonene (LIM), and the antibiotics, linezolid (LZD), vancomycin (VAN), gentamicin (GEN), ciprofloxacin (CIP), clindamycin (CLN), and penicillin (PEN) against 50 multidrug resistant Corynebacterium striatum strains, and the synergistic interactions of CAR and CIN with the antibiotics against 10 randomly selected Coryne. striatum strains to explore synergistic interactions to determine if their combined use could enhance antibiotic activity and potentially reduce resistance.Methods and resultsThe activity of the EOCs and the antibiotics against Coryne. striatum strains isolated from clinical specimens, was examined by broth microdilution method. The synergistic interactions of the EOCs with the antibiotics against 10 randomly selected Coryne. striatum strains were determined by checkerboard method. EOCs, CIN, and CAR and antibiotics, LZD, VAN, GEN, CIP, and CLN were detected to have antibacterial activity against Coryne. striatum strains alone and either synergistic interactions were observed in combinations of the antibiotics with EOCs.ConclusionsAll Coryne. striatum strains were determined to be susceptible to VAN and LZD and resistant to GEN, PEN, CIP, and CLN. Synergistic interactions were observed in all combinations of antibiotics tested with CAR and CIN.

03 Jan 2024·Journal of Animal Science

Feeding or pen surface application of clinoptilolite with different particle sizes: impact on nitrogen utilization and manure ammonia emissions in feedlot cattle

Article

Author: de Haro Marti, Mario E ; Chahine, Mireille ; Myers, Cheyanne A ; Chibisa, Gwinyai E

AbstractThis study investigated the effects of feeding clinoptilolite (CLN; 2.5% of diet dry matter) with a particle size of either 30- or 400-µm on ruminal fermentation characteristics, measures of nitrogen (N) utilization, and manure ammonia-N (NH3) emissions in feedlot cattle. The impact of directly applying 30- or 400-µm CLN to the pen surface (2,250 kg/ha) on manure NH3–N emissions was also evaluated. Six beef heifers were used in a replicated 3 × 3 Latin square design with 21-d periods. Dietary treatments were 1) finishing ration with no supplement (CON), 2) CON + 30-µm CLN (CLN-30), and 3) CON + 400-µm CL (CLN-400). Intake was measured daily. To evaluate fermentation characteristics, ruminal fluid was collected on day 19. Indwelling pH loggers were used to measure ruminal pH from days 15 to 21. Blood was collected 3-h post-feeding on day 21 for metabolite analysis. Fecal grab and urine spot samples were also collected from days 19 to 21 to measure nutrient digestibility, route of N excretion, and in vitro NH3 emissions. There was no diet effect (P ≥ 0.12) on nutrient intake and apparent total tract digestibility, and ruminal short-chain fatty acid profile and pH. Ruminal NH3 concentration, which was lower (P = 0.04) for CLN-30 than CON heifers, did not differ between CON and CLN-400 heifers. Although there was no diet effect (P = 0.50) on plasma urea-N (PUN) concentration, proportion of urea-N excreted in urine was lower (P = 0.01) for CLN-30 than CON and CLN-400 heifers. Urinary NH3–N excretion, which was greater (P ≤ 0.04) for CLN-400 than CON heifers, did not differ between CLN-30 and CLN-400 heifers. Feeding CLN also increased (P ≤ 0.02) fecal excretion of potassium (K) and iron (Fe) and reduced (P = 0.01) urinary excretion of calcium (Ca). There was a treatment × time interaction (P = 0.01) for NH3 emission rate, which was greatest within the first 36 h of incubation and was lower for manure from CLN-400 compared to CON and CLN-30 heifers and pen surface application treatments. Cumulative NH3 emissions were lower (P < 0.01) for manure from CLN-400 compared to CON and CLN-30 heifers and the pen surface application treatments. Although surface application was ineffective, feeding 400-µm CLN to finishing cattle could result in a beneficial decrease in manure NH3 emissions. However, changes in fecal and urine excretion of minerals like K and Ca, which suggest a decrease in bioavailability, need to be considered when feeding CLN in finishing cattle diets.

01 Jan 2024·Neuro-Oncology Advances

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

Article

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

AbstractBackgroundThis 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.MethodsAdult 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.ResultsFifteen 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%).ConclusionsPritumumab was well tolerated with no DLTs observed up to 16.2 mg/kg weekly. Further studies are warranted to determine clinical benefit in patients.

News (Medical) associated with Pritumumab

16 Apr 2024

·www.biospace.com

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

Phase 2Clinical ResultPhase 1

19 Mar 2024

·www.biospace.com

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

Phase 2

06 Feb 2024

·www.biospace.com

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

Phase 2ImmunotherapyLicense out/inPhase 1ADC

100 Deals associated with Pritumumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Pritumumab	-	-

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Brain Cancer	Phase 2	US	Nascent Biotech, Inc.	26 May 2023
Glioma	Phase 2	-	Xiamen Nanxun Co., Ltd	-
Glioma	Phase 2	-	University of California	-
Brain metastases	Discovery	US	Nascent Biotech, Inc.	18 Mar 2021
COVID-19	Discovery	US	Nascent Biotech, Inc.	05 Mar 2020
Pancreatic Cancer	Discovery	US	Nascent Biotech, Inc.	23 Jan 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04396717 (Biospace) Manual	Phase 1	Brain Cancer	15	Pritumumab	(zwjwzbnatg) = One partial response showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study. rqlkyihawc (tujcsikdpx )	Positive	16 Apr 2024
NCT04396717 (ASCO2023) Manual	Phase 1	Brain Cancer	15	pritumumab	(likngcizih) = fatigue (53.3%) and constipation (33.3%) kjrwxmuqjk (yrphxioknq )	Positive	31 May 2023
AACR2014	Phase 2	Brain Cancer	249	Pritumumab	(ewvvllmsja) = snsxowbjuk kydnaejtft (qxemufgbbw )	Positive	01 Oct 2014

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Pritumumab

Overview

Basic Info

Gene Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation