A Multicenter Phase I/II Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel With or Without NPC-1C in Patients With Metastatic or Locally Advanced Pancreatic Cancer Previously Treated With FOLFIRINOX

This was a Phase 1/2 multi-institution prospective open label study in which subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen received the investigational agent NEO-102 (NPC-1C).
The Phase 1 portion of this study evaluated the safety of NEO-102 in combination with Gemcitabine in a dose de-escalation design with a starting dose of 1.5 mg/kg/dose. If 2 of 6 patients experience DLT, the dose will be de-escalated to 1 mg/kg/dose to evaluate the safety of NEO-102 in combination with Gemcitabine. .
In the Phase 2 portion patients were randomized into one of two arms:
A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel

Start Date01 Apr 2013

Sponsor / Collaborator

Precision Biologics, Inc.

NCT01040000

/ CompletedPhase 1/2

A Phase 1/2 Therapeutic, Open Label, Multi-Center Clinical Trial of NPC-1C, a Chimeric Monoclonal Antibody, in Adults With Recurrent, Locally Advanced Unresectable or Metastatic Pancreatic and Colorectal Cancer After Standard Therapy

The purpose of the phase 2 component of this study is to determine if giving the immune molecule NPC-1C to individuals who have cancer of the pancreas or gastrointestinal tract (colon or rectum) which has not responded to standard treatments can shrink or halt the growth of cancer, and to obtain additional data to study its effect on the immune system. Safety data will also be accumulated and evaluated during this study. NPC-1C is a monoclonal antibody that recognizes a specific tumor target on certain cancers. In laboratory studies, the antibody killed tumor cells in some colon and pancreatic cancers that express the NPC-1C antigen by a process called "antibody-dependent cell cytotoxicity" or ADCC.

Start Date01 Jan 2012

Sponsor / Collaborator

Precision Biologics, Inc.

ACTRN12607000448448

/ Active, not recruitingPhase 2

A Phase 2 Two-Center, Randomized, Double-blind, Placebo-controlled, Paired Treatment Site Comparison Study to Evaluate the Safety and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in Reduction of Wound Bioburden among Adults Treated with Curettage & Electrodessication for Superficial Basal Cell Carcinomas of the Trunk and Extremities

Start Date10 Sep 2007

Sponsor / Collaborator

Neosil, Inc.

100 Clinical Results associated with Ensituximab

100 Translational Medicine associated with Ensituximab

100 Patents (Medical) associated with Ensituximab

Literatures (Medical) associated with Ensituximab

01 Sep 2016·Cancer chemotherapy and pharmacologyQ4 · MEDICINE

A phase 1 dose-escalation study of NEO-102 in patients with refractory colon and pancreatic cancer

Q4 · MEDICINE

Article

Author: Wang, Xue Ping ; Arlen, Philip M ; Beg, Muhammad S ; Torrealba, Jose ; Morse, Michael A ; Patel, Sandip P ; Beatson, Melony A ; Azad, Nilofer S ; Mavroukakis, Sharon

PURPOSE:

NEO-102 is a novel chimeric IgG1 monoclonal antibody which recognizes a variant form of MUC5AC expressed specifically by human pancreatic and colorectal tumors. Preclinical models have demonstrated encouraging signs of anti-tumor activity through antibody-dependent cell-mediated cytotoxicity.

METHODS:

This is a phase 1, dose-escalation trial of NEO-102 (Ensituximab) for patients with refractory pancreatic and colorectal cancer. The primary objective was to determine safety and tolerability of escalating doses of NEO-102. Secondary objectives were to assess pharmacokinetics, anti-tumor activity and biologic correlates. Patients whose tumors express NPC-1 antigen were eligible. Dose-escalation was performed in a 3 + 3 design at doses of 1.5, 2, 3 and 4 mg/kg.

RESULTS:

A total of 19 patients (4 pancreatic and 15 colon cancer) were enrolled at participating institutions in the treatment phase. Most common treatment-related adverse events included anemia, fatigue, fevers, chills and flushing. There was no detectable hemolysis. Of twelve patients evaluable for disease response, the response rate at week 8 included 5 patients with stable disease and 8 patients with progressive disease (PD). Treatment-related grade 3/4 hyperbilirubinemia and anemia were observed at 4 mg/m2. Reversible hypoxia at 3 mg/kg was a dose-limiting toxicity. The maximum tolerated dose was established at 3 mg/kg. Of 74 patients who underwent tissue screening, positive NPC-1 expression was 47 % in colon and 59 % in pancreatic cancer.

CONCLUSIONS:

Treatment with the NEO-102, in this first-in-human study, is well tolerated with a manageable safety profile. A maximum tolerated dose of 3 mg/kg has been established. Toxicity profile is typical for this therapeutic class and allows for combination with conventional cytotoxic therapies.

01 Jun 2013·CANCER IMMUNOLOGY IMMUNOTHERAPY

Anti-tumor activity of a novel monoclonal antibody, NPC-1C, optimized for recognition of tumor antigen MUC5AC variant in preclinical models

Article

Author: Dubeykovskiy, Alex ; Morse, Michael A. ; Wang, Xue-Ping ; Saric, Olga ; Arlen, Philip M. ; Bristol, Andrew ; Patel, Sandip Pravin

PURPOSE:

NPC-1C is a chimeric immunoglobulin IgG1 developed from antigen tested in the Hollinshead tumor vaccine trials that recognizes an immunogenic MUC5AC-related tumor-associated antigen. In this article, we describe the pre-clinical characterization of this antibody that is currently being tested in human clinical trials.

EXPERIMENTAL DESIGN:

The specificity of NPC-1C for pancreatic and colorectal cancer cell lines was tested by flow cytometry assays and immunohistochemical staining. Antibody-dependent cell cytotoxicity was measured using a tumor cell line lysis assay. Anti-tumor efficacy and biodistribution were assessed in nude mice bearing human pancreatic tumor xenografts.

RESULTS:

Human tumor cell binding measured by flow cytometry ranged from 52 to 94 % of cells stained positive with NPC-1C in three colorectal and one pancreatic cell lines, while IHC demonstrated staining of 43 % of colon cancers and 48 % of pancreatic cancer tissues, with little or no cross-reactivity of NPC-1C with normal colon or pancreas tissues. In vitro NPC-1C-mediated tumor cell killing occurred in a median of 44.5 % of four colorectal and three pancreatic tumor cell lines. In vivo anti-tumor efficacy in a human pancreatic CFPAC-1 tumor xenograft model was demonstrated with a twofold to threefold reduction in tumor growth in the NPC-1C-treated mice compared to saline and human IgG controls. Pharmacodynamic studies indicate NPC-1C localizes in antigen-positive tumors and has minimal uptake in normal mouse tissues.

CONCLUSIONS:

NPC-1C, a chimeric monoclonal antibody that reacts with a MUC5AC-related antigen expressed by pancreatic and colorectal tumor tissues, has promising preclinical activity in pancreatic and colorectal adenocarcinoma.

10 Mar 2012·JOP : Journal of the pancreas

Novel agents in early phase clinical studies on refractory pancreatic cancer.

Review

Author: Kostas N Syrigos ; Alexios S Strimpakos ; Muhammad Wasif Saif

The standard current treatment options in advanced pancreatic cancer have demonstrated minimal or modest only efficacy for the majority of patients. Unfortunately, the mortality and morbidity remain high crying out for better treatments and results. With the exception of erlotinib, which received approval by the Food and Drug Administration of the United States in 2005, no other novel agents have since been added in our treatment quiver. Therefore, the search for novel approaches continuous at the laboratory and clinical level. At the 2012 American Society of Clinical Oncology Gastrointestinal Symposium, results of some interesting early phases clinical studies were presented. First, in Abstract #198, toxicity and efficacy results from the phase I/II study of cixutumumab, an insulin growth factor-1 receptor (IGF-1R) antibody combined with the standard gemcitabine and erlotinib treatment were presented, but the outcomes suggest no real clinical benefit. Second, the early safety and clinical data from the novel monoclonal antibody (ensituximab) against the mucin epitope NPC-1C in pancreatic and colon cancer patients were presented (Abstract #233) and again no particular efficacy was observed. Finally, interesting results which definitely deserve further exploration were presented in Abstract #211, which tested the combination of ipilimumab, an antibody against the cytotoxic T-lymphocyte antigen 4 (CTLA-4), with a cell-based vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene in advanced refractory pancreatic cancer. Though, it seems we have not yet found the culprit and the solution of this devastating disease, a small step forward might have been achieved.

News (Medical) associated with Ensituximab

05 Nov 2025

·www.prnewswire.com

Precision Biologics to Reveal Preclinical Efficacy of Novel Tumor-Specific ADC against multiple human cancer types at SITC 2025

BETHESDA, Md., Nov. 5, 2025 /PRNewswire/ -- Precision Biologics, Inc. announces in vitro and in vivo efficacy of its novel tumor-specific ADC (PB-vcMMAE-5) against human carcinomas expressing truncated core 2 O-glycans. Recent data for several human cancer types expressing truncated core 2 O-glycans will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 7th, 2025, National Harbor, MD, USA. Poster title: In vitro and in vivo efficacy of the antibody-drug-conjugate (ADC) PB-vcMMAE-5 against human carcinoma expressing truncated core 2 O-glycans Presentation of the poster will be made in person on the following date and location: Friday, November 7th,  12:15pm –  1:45pm ET; & 5:35pm – 7pm ET Gaylord National Resort and Convention Center,  National Harbor, MD, USA Lower Level Atrium – Prince George's ABC Primary Category: Immuno-Conjugates and Chimeric Molecules Abstract Number: 949 BACKGROUND: Solid tumors remain largely unresponsive to immune checkpoint inhibitors, in part due to their ability to suppress the cytotoxic activity of immune cells infiltrating the tumor microenvironment. One of the disrupted pathways in these cancers is O-glycosylation, a feature particularly associated with cancer progression, metastasis, and poor prognosis. One strategy to overcome resistance of solid tumor to immunotherapy is the employment of antibody-drug-conjugates (ADCs) selectively targeting cancer cells and not healthy tissues. We developed an ADC, designated PB-vcMMAE-5, composed of the following: The monoclonal antibody (mAb): We used PB-223, an innovative mAb developed through affinity maturation of clinical stage mAb NEO-102 (Ensituximab), a chimeric human IgG1 mAb that targets truncated core 2 O-glycans, specifically expressed by cancer cells and not by healthy tissues. PB-223 does not bind to normal tissues and it internalizes into human cancer cell lines expressing its target. The payload: Monomethyl auristatin E (MMAE) was used as payload. MMAE is a potent antimitotic agent that inhibits cell division by blocking the polymerization of tubulin and is the most common ADC payload used to be linked to antibodies in clinical development for oncologic applications. The linker: mc-vc-PABc was used as a cleavable linker. PB-223 was conjugated to the linker-payload through a cysteine-based conjugation method. The drug-to-antibody ratio (DAR) of PB-vcMMAE-5 is 3.92. Study presented at SITC Annual Meeting 2025 includes the following data: PB-223 specific binding to human tumor tissues by immunohistochemistry (IHC): PB-223 binds selectively to human tumor tissues and not to human normal tissue. PB-223 strongly reacted with colorectal, pancreatic, lung, prostate, and ovarian tumor tissues. In vitro  efficacy of PB-vcMMAE-5 against several human cancer cell lines: The in vitro cytotoxicity of PB-vc-MMAE-5 was evaluated in 9 human cancer cell lines, including prostate (PC-3, LnCAP), triple negative breast (HCC1937, MDA-MB-231), ER+,PR+,HER2+ breast (BT-474), squamous cell carcinoma of the lung (NCI-H226), ovarian (OV-90), colorectal (SW403), and pancreatic (CFPAC-1) cancer cell lines. This study shows that PB-vcMMAE-5 effectively killed all cell lines tested, with the highest percentage of killing observed against MDA-MB-231 (triple negative breast), LnCAP (prostate), OV-90 (ovarian), and NCI-H226 (lung) cancer cell lines. In contrast, naked PB-223 mAb showed no killing in all cell lines tested. In vivo safety of PB-vcMMAE-5 in mice: NOD-SCID mice bearing OV-90 (ovarian) xenografts were treated with weekly doses of PBS, MMAE alone, or PB-vc-MMAE-5 (1, 3, 6, or 9 mg/kg) for five weeks. Animal body weight was monitored regularly, twice a week, as an indirect measure of toxicity.  The ADC PB-vcMMAE-5 was well tolerated in mice. No sign of distress and no loss of body weight were observed. No significant changes in body weight, blood parameters including hematology and clinical chemistry, nor pathological changes in the liver, spleen, brain, or heart of mice treated with efficacious doses of the ADC were observed compared with control groups. In vivo  efficacy of PB-vcMMAE-5 in mice: The efficacy of the ADC PB-vcMMAE-5 was assessed in OV-90 (ovarian) subcutaneous xenograft model established in NOD-SCID mice. The ADC PB-vcMMAE-5 was administered intravenously at doses 1, 3, 6 or 9 mg/kg, once per week for five weeks. On day 31 from the first ADC infusion, most alive mice were sacrificed, and tumors were excised for histological analysis using Ki-67 staining to assess proliferating viable tumor cells. To further assess systemic toxicity and prolonged efficacy, three mice each from the 6 and 9 mg/kg groups were followed to day 45. Data presented in this study show that  PB-vcMMAE-5 induced significant tumor growth inhibition compared to controls in a dose-dependent manner. The highest tumor growth inhibition was observed at 6 and 9 mg/kg doses. In addition, analysis of tumors at day 45 showed absence of viable tumor cells and presence of tumor cells in necrosis, in mice treated with PB-vcMMAE-5 at 9 mg/kg. Findings from this study showed that PB-vcMMAE-5 can kill human cancer cells expressing PB-223's target, is not toxic in vivo in mice, and is highly effective in vivo at 9 mg/kg in NOD-SCID mice bearing human ovarian cancer. In addition, in a poster presented at AACR Annual Meeting 2025 we reported that PB-vcMMAE-5 is stable in human plasma. All these data suggest that PB-vcMMAE-5 has promising potential as a therapeutic option for a range of human malignancies expressing core 2 O-glycans. The PDF of the poster will be available starting from November 5th, 2025, at the following link: SOURCE Precision Biologics 21% more press release views with Request a Demo

AACRImmunotherapyClinical ResultADC

19 Sep 2025

·www.prnewswire.com

Precision Biologics to Unveil In Vitro and In Vivo Efficacy of New ADC against human ovarian cancer at AACR Special Conference

BETHESDA, Md., Sept. 19, 2025 /PRNewswire/ -- Precision Biologics, Inc. reports that in vitro and in vivo efficacy of the novel ADC, using its anti-core 2 O-glycans anti-human carcinoma mAb PB-223 (PB-vcMMAE-5), against human ovarian cancer expressing truncated core 2 O-glycans will be presented in a poster at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Advances in Ovarian Cancer Research on September 20th, 2025, Grand Hyatt Denver, Denver, Colorado, USA. Poster title: In vitro and in vivo efficacy of the antibody-drug-conjugate (ADC) PB-vcMMAE-5 against human ovarian cancer expressing truncated core 2 O-glycans The presentation of the poster will be made in person on the following date and location: Saturday, September 20, 6:30 p.m. – 8:00 p.m. Grand Hyatt Denver, Denver, Colorado, USA Poster Section: B Abstract Control Number: B068 BACKGROUND: Ovarian cancers remain largely unresponsive to immune checkpoint inhibitors, in part due to their ability to suppress the cytotoxic activity of immune cells infiltrating the tumor microenvironment. One of the disrupted pathways in these cancers is O-glycosylation, a feature particularly associated with ovarian cancer progression, metastasis and poor prognosis. This underscores the urgent need for alternative therapeutic strategies. We developed an ADC, designated PB-vcMMAE-5, composed of the following: The mAb: We used PB-223, an innovative mAb developed through affinity maturation of mAb NEO-102 (Ensituximab), a chimeric human IgG1 mAb that targets truncated core 2 O-glycans, specifically expressed by cancer cells and not by healthy tissues. The binding affinity of PB-223 for its target was improved, compared to NEO-102, by optimizing its VH and VL sequences through Fast Screening for Expression Biophysical Properties and Affinity. PB-223 demonstrated a binding affinity (KD) at least 4-fold lower than NEO-102, indicating stronger tumor binding. PB-223 does not bind to normal tissues and it can be internalized into human cancer cell lines expressing its target. The payload: Monomethyl auristatin E (MMAE) was used as payload. MMAE is a potent antimitotic agent that inhibits cell division by blocking the polymerization of tubulin and is the most common ADC payload used to be linked to antibodies in clinical development for oncologic applications. The linker: mc-vc-PABc was used as a cleavable linker. PB-223 was conjugated to the linker-payload through a cysteine-based conjugation method. STUDY PRESENTED AT AACR Special Conference in Cancer Research: Advances in Ovarian Cancer Research, 2025 After development of the ADC PB-vcMMAE-5, we evaluated its efficacy in vitro and in vivo In vitro efficacy: The in vitro cytotoxicity of PB-vc-MMAE-5 was tested in four human cancer cell lines: triple-negative breast cancer (HCC1937, MDA-MB-231), ER+/PR+/HER2+ breast cancer (BT474), and ovarian cancer (OV-90). Cells were treated with varying ADC concentrations for 5 days. This study shows that PB-vcMMAE-5 effectively killed all cell lines tested. At the highest concentration, the percentage of cell killing for PB-vcMMAE-5 was 52.72% in HCC1937 and 88.36% in MDA-MB-231. At the highest concentration, the percentage of cell killing for PB-vcMMAE-5 was 92.51% in OV-90 and 83.22% in BT474. In contrast, naked PB-223 mAb showed no killing in all cell lines tested In vivo safety: In a study presented in April 2025, at AACR Annual Meeting 2025, we showed that PB-vcMMAE-5 was well tolerated in rats. No sign of distress nor loss of body weight were observed after administration. In this study we confirm the same pattern in mice. NOD-SCID mice bearing OV-90 xenografts were treated with weekly doses of PBS, MMAE alone, or PB-vc-MMAE-5 (1, 3, 6, or 9 mg/kg) for five weeks. Animal body weight was monitored regularly, twice a week, as an indirect measure of toxicity. The ADC PB-vcMMAE-5 was well tolerated in mice. No sign of distress and loss of body weight were observed No significant hematological or pathological changes were detected in the liver, spleen, brain, or heart of mice treated with efficacious doses of the ADC compared with controls. In vivo efficacy: The efficacy of the ADC PB-vcMMAE-5 was assessed in OV-90 subcutaneous xenograft model established in NOD-SCID mice. The ADC PB-vcMMAE-5 was administered intravenously at doses 1, 3, 6 or 9 mg/kg, once per week for five weeks. On day 31 from first ADC infusion, most alive mice were sacrificed, and tumors were excised for histological analysis using Ki-67 staining to assess proliferating viable tumor cells. To further assess systemic toxicity and prolonged efficacy, three mice each from the 6 and 9 mg/kg groups were followed to day 45. Data presented in this study show that PB-vcMMAE-5 at 1 mg/kg did not significantly reduce tumor volume compared with PBS, whereas PB-vcMMAE-5 at 6 and 9 mg/kg induced robust reduction of tumor volume. In addition, analysis of tumor viability at day 45 (Ki67 H-score) showed no tumor activity in mice treated with PB-vcMMAE-5 at 9 mg/kg Findings from this study showed that PB-vcMMAE-5 can kill human cancer cells expressing PB-223's target, is not toxic in vivo in mice and is highly effective in vivo at 9 mg/kg in NOD-SCID mice bearing human ovarian cancer. In addition, in a poster presented at AACR Annual Meeting 2025 we reported that PB-vcMMAE-5 is stable in human plasma. All these data suggest that PB-vcMMAE-5 has promising potential as a therapeutic option for human ovarian tumors and for a range of human malignancies expressing core 2 O-glycans. The PDF of the poster will be available starting from September 19th, 2025, at the following link: SOURCE Precision Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AACRClinical Result

06 Nov 2024

·www.prnewswire.com

Precision Biologics to Announce Development of New Monoclonal Antibody (mAb) PB-223 at SITC, Houston, TX, November 7-8, 2024

Precision Biologics will present affinity maturation and characterization of a novel core 2 O-glycan epitope targeting anti-human carcinoma mAb PB-223 at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting on November 7-8, 2024 BETHESDA, Md., Nov. 6, 2024 /PRNewswire/ -- Precision Biologics, Inc. reports that affinity maturation and characterization of its novel anti-core 2 O-glycan monoclonal antibody PB-223, will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting on November 7-8, 2024, George R. Brown Convention Center, Houston, Texas, USA, Poster title: Affinity Maturation and Characterization of a Novel O-glycan Epitope Targeting Anti-Human Carcinoma Monoclonal Antibody (mAb) PB-223 Presentation of the poster will be made in person on the following dates and locations: November 7th, 2024: SITC Immune Engineering Workshop, 3.10 p.m-5 p.m. CST, George R. Brown Convention Center, Level 3 - Grand Ballroom AB, Houston, Texas, USA November 8th, 2024: Poster Session Immuno-Engineering, abstract number 1101, 12:15–1:45 p.m. CST and 5:30-7 p.m. CST, George R. Brown Convention Center, Level 1-Exhibit Halls A B, Houston, Texas, USA BACKGROUND: PB-223 is an innovative mAb developed through immune engineering from the chimeric IgG1 NEO-102 (Ensituximab). It targets a unique core 2 O-glycan (variant of MUC5AC), Preclinical and clinical data showed that NEO-102 specifically binds to and kills colorectal and pancreatic cancer cells through ADCC. NEO-102 did not bind to healthy tissues. In a phase 2 study, NEO-102 showed promising results in heavily pretreated patients with advanced, refractory metastatic colorectal cancer. In general, the efficacy of using a monoclonal antibody as a single agent in cancer immunotherapy can be impaired not only by the resistance of cancer cells in the tumor microenvironment (TME), but also by a low binding affinity to target antigens expressed on cancer cells. One strategy to improve the therapeutic efficacy of monoclonal antibodies is to enhance their binding affinity to target antigens. STUDY PRESENTED AT SITC 2024: The objective of this study was to enhance the binding affinity of NEO-102 to its target antigen. By engineering the VH and VL sequences of NEO-102 through Fast Screening for Expression Biophysical Properties and Affinity (FASEA), while maintaining the binding specificity to the target antigen, allowed us to develop a new clone with a lower KD and markedly improved characteristics. This new biologic asset developed by affinity maturation was given the name PB-223. Binding kinetics of PB-223 and NEO-102 to the target antigen were compared by ELISA. Results show that PB-223 has a KD of 4.5-fold less than NEO-102, suggesting a higher affinity for the target antigen by PB-223 compared to NEO-102. The binding affinity of PB-223 and NEO-102 to various human tumor cell lines was also evaluated by flow cytometry. Flow cytometry analysis showed that PB-223 not only has markedly enhanced comparative binding to colorectal and pancreatic cancer cell lines recognized by NEO-102, but that PB-223 is also able to bind to many additional tumor cell lines that were not recognized by NEO-102. Further study by O-glycan array analysis showed that 1) PB-223 binds specifically to core-2 O-glycans, and that 2) core 2 O-glycans recognized by PB-223 are expressed on tumor cell lines positive for PB-223 binding in flow cytometry. Immunohistochemistry (IHC) analysis performed on human tumor tissues shows that PB-223 does not bind to healthy tissues. IHC analysis also shows that PB-223, in addition to binding to both colorectal cancer and pancreatic cancer, it also binds to additional tumor tissues not reactive with NEO-102, including triple negative breast cancer, prostate cancer, kidney cancer, head and neck cancer, liver cancer, and bladder cancer. In addition, this study demonstrated that PB-223 is internalized into human cancer cell lines expressing core 2 O-glycans. Findings from this study suggest that PB-223 has a strong binding affinity for human cancers expressing core 2 O-glycans and that PB-223 may be a potential candidate for the development of antibody-drug conjugates (ADC) for treatment of various human carcinomas. The PDF of the poster will be available starting from November 5, 2024, at the following link: SOURCE Precision Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 2AACR

100 Deals associated with Ensituximab

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KEGG	Wiki	ATC	Drug Bank
D09898	Ensituximab	-	DB12342

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer, Adult	Phase 2	United States	Precision Biologics, Inc.	01 Apr 2013
Metastatic Colorectal Carcinoma	Phase 2	United States	Precision Biologics, Inc.	01 Jan 2012
Metastatic Pancreatic Cancer	Phase 2	United States	Precision Biologics, Inc.	01 Jan 2012
Colorectal Cancer	Phase 2	United States	Precision Biologics, Inc.	-
Colorectal Cancer	Phase 2	-	Neogenix Oncology, Inc.	-
Pancreatic Cancer	Phase 2	-	Neogenix Oncology, Inc.	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01834235 (CTgov)	Phase 1/2	Pancreatic Cancer, Adult	81	NPC+Gemcitabine (Phase 1-Dose Finding Dose Level 1)	oawfyzauyg = rantqpecqh zupxeqxvpm (fszmdejety, xajkpyzdyh - egvslqrxtq)	-	07 May 2025
NCT01834235 (CTgov)	Phase 1/2	Pancreatic Cancer, Adult	81	Abraxane+Gemcitabine (Arm A: Abraxane, Gemcitabine, NPC-1C)	oawfyzauyg = worjoaueit zupxeqxvpm (fszmdejety, yrscatxlsl - mlkrzhmkoy) View more	-	07 May 2025
NCT01834235 (AACR2022) Manual	Phase 2	Pancreatic Cancer Second line	80	Ensituximab+gemcitabine+Albumin-Bound Paclitaxel	gkjwrcxtre(iwqhveotbl) = qmoaeskfar yeqjmtdmfn (rcjydmfwsz, 3.3 - 6.5) View more	Negative	15 Nov 2022
NCT01834235 (AACR2022) Manual	Phase 2	Pancreatic Cancer Second line	80	gemcitabine+Albumin-Bound Paclitaxel	gkjwrcxtre(iwqhveotbl) = gvzpfdoxjg yeqjmtdmfn (rcjydmfwsz, 4.7 - 8.4) View more	Negative	15 Nov 2022
NCT01040000 (Pubmed \| Clin Cancer Res) Manual	Phase 2	Colorectal Cancer	63	Ensituximab	gemxbbmhih(idcpbketcb) = cgegkpffvn osfiprtagp (xhatqsgstq ) View more	Positive	15 Jul 2020
NCT01040000 (ASCO2017)	Phase 1/2	Metastatic colon cancer	63	Ensituximab	noifwypkws(vhlxsobbiy) = aqvbbgappd boekkiqyhb (pslaltxmui, 5.39 - 8.02) View more	Positive	30 May 2017
NCT01040000 (NEO-102, ASCO_GI2016)	Phase 2	Metastatic colon cancer	47	NEO-102	ephpcykdwg(queydagecs) = jkwbtnolcv agumieodkg (dihokwadco ) View more	Positive	01 Feb 2016
NCT01040000 (ASCO2015)	Phase 2	Refractory Colorectal Carcinoma	43	NEO102 (N)	dxrwixbyhx(bxemiepjov) = jewumbavir lgmtdvosbk (exyomkfglb )	-	20 May 2015
NCT01040000 (ASCO_GI2015)	Phase 1/2	Refractory Cancer	94	NEO102	jmikuuoofq(pdykrdijhe) = gcnikljsqi yklazytbsi (yqxlzgazrl ) View more	-	20 Jan 2015
AACR2013	Phase 1	Neoplasms \| Colorectal Cancer \| Pancreatic Cancer	15	NPC-1C	pmfjupelis(lddrboykgy) = oldzlpvbmm bjpebksldf (rzwyjzvjsq )	-	15 Apr 2013
ASCO2012	Phase 1	Neoplasms \| Colorectal Cancer \| Pancreatic Cancer	15	NPC-1C	fjtldmrrxm(lbikdluyxb) = ibostreiof cuwiskcxyf (lvrrjyhayp )	-	20 May 2012
ASCO_GI2012	Phase 1/2	Neoplasms \| Colorectal Cancer \| Pancreatic Cancer	-	NPC-1C	ofptaqdemm(ladymqzwxj) = vfcxtsnsqj sqbnaahjow (aktgyrzblh )	-	01 Feb 2012

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