Delving into the Latest Updates on ALT-836 with Synapse

This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-836 in combination with standard of care gemcitabine in participants who have locally advanced or metastatic solid tumors. The purpose of this study is to determine the maximum tolerated dose (MTD), and to assess the safety and pharmacokinetic profile of ALT-836 given with gemcitabine. The clinical benefit, progression-free survival and overall survival of study participants will also be assessed.

Start Date01 May 2011

Sponsor / Collaborator

Altor BioScience Corp.

NCT00879606 / CompletedPhase 2

Efficacy and Safety Evaluation of ALT-836 in Patients With Sepsis and Acute Lung Injury/Acute Respiratory Distress Syndrome

This is a prospective, randomized (1:1), double-blind, multi-center, Phase II clinical study to test the safety and efficacy of a recombinant chimeric anti-tissue factor antibody (ALT-836) versus placebo in patients with sepsis and acute lung injury/acute respiratory distress syndrome (ALI/ARDS). This study was divided into two parts and the first part of the study has been completed. In the first part of the study, sixty patients were randomized at a 1:1 ratio to receive one dose of the study drug or placebo. In the second part of the study, ninety patients will be randomized at a 1:1 ratio to receive a multi-dose treatment regimen of single doses every 72 hours up to a maximum of 4 doses of the study drug or placebo, provided there are no safety concerns.

Start Date01 Apr 2009

Sponsor / Collaborator

Altor BioScience Corp.

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NCT01438853 / CompletedPhase 1

The Safety, Pharmacokinetics, and Pharmacodynamic Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome

This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15 minutes. Three cohorts of subjects were enrolled to the study and safety and pharmacokinetics of the study treatment were evaluated.

Start Date01 Dec 2004

Sponsor / Collaborator

Altor BioScience Corp.

[+2]

100 Clinical Results associated with ALT-836

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100 Translational Medicine associated with ALT-836

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100 Patents (Medical) associated with ALT-836

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13

Literatures (Medical) associated with ALT-836

01 Jul 2020·Advanced ScienceQ1 · MATERIALS SCIENCE

Tissue Factor‐Targeted ImmunoPET Imaging and Radioimmunotherapy of Anaplastic Thyroid Cancer

Q1 · MATERIALS SCIENCE

ArticleOA

Author: Wei, Weijun ; Cai, Weibo ; Engle, Jonathan W. ; Liu, Jianjun ; Jiang, Dawei ; Kutyreff, Christopher J. ; Liu, Qiufang ; Zhao, Haitao

AbstractAnaplastic thyroid cancer (ATC) is the most aggressive subtype of thyroid cancers with a dismal prognosis. It is aimed to explore a new biomarker and devise a marker‐dependent theranostic pair for ATC. Flow cytometry is used to determine tissue factor (TF) expression in thyroid cancer cell lines. ALT‐836, a TF‐specific monoclonal antibody, is radiolabeled with 64Cu to develop 64Cu‐NOTA‐ALT‐836. The diagnostic utility is assessed by immuno‐positron emission tomography (immunoPET) imaging in ATC models. To facilitate total surgical removal of orthotopic ATCs, a near‐infrared fluorescent imaging probe IRDye 800CW‐ALT‐836 is designed. As the therapeutic component, 131I‐ALT‐836 is further developed and the radioimmunotherapy (RIT) efficacy of this agent is interrogated in orthotopic ATC models. The results demonstrate that TF is highly expressed on the ATC cell line THJ‐16T. 64Cu‐NOTA‐ALT‐836 immunoPET imaging clearly delineates both subcutaneous and orthotopic ATCs, with a peak tumor uptake of 19.93 ± 2.17% ID per g (n = 3) and 37.20 ± 1.71% ID per g (n = 3), respectively. Fluorescent imaging with IRDye 800CW‐ALT‐836 facilitates the total resection of orthotopic ATCs. Moreover, 131I‐ALT‐836 RIT prolongs the survival of ATC‐bearing mice. Taken together, TF is a promising marker for ATC and successive use of 64Cu‐NOTA‐ALT‐836 and 131I‐ALT‐836 can realize precise management of ATC.

04 May 2020·Molecular PharmaceuticsQ2 · MEDICINE

^86/90Y-Labeled Monoclonal Antibody Targeting Tissue Factor for Pancreatic Cancer Theranostics

Q2 · MEDICINE

Article

Author: Sun, Tuanwei ; Rosenkrans, Zachary T. ; Ferreira, Carolina A. ; Cai, Weibo ; Ehlerding, Emily B. ; Engle, Jonathan W. ; Ni, Dalong ; Aluicio-Sarduy, Eduardo ; Jiang, Dawei

Pancreatic cancer is highly aggressive, with a median survival time of less than 6 months and a 5-year overall survival rate of around 7%. The poor prognosis of PaCa is largely due to its advanced stage at diagnosis and the lack of efficient therapeutic options. Thus, the development of an efficient, multifunctional PaCa theranostic system is urgently needed. Overexpression of tissue factor (TF) has been associated with increased tumor growth, angiogenesis, and metastasis in many malignancies, including pancreatic cancer. Herein, we propose the use of a TF-targeted monoclonal antibody (ALT836) conjugated with the pair ^86/90Y as a theranostic agent against pancreatic cancer. For methods, serial PET imaging with ⁸⁶Y-DTPA-ALT836 was conducted to map the biodistribution the tracer in BXPC-3 tumor-bearing mice. ⁹⁰Y-DTPA-ALT836 was employed as a therapeutic agent that also allowed tumor burden monitoring through Cherenkov luminescence imaging. The results were that the uptake of ⁸⁶Y-DTPA-ALT836 in BXPC-3 xenograft tumors was high and increased over time up to 48 h postinjection (p.i.), corroborated through ex vivo biodistribution studies and further confirmed by Cherenkov luminescence Imaging. In therapeutic studies, ⁹⁰Y-DTPA-ALT836 was found to slow tumor growth relative to the control groups and had significantly smaller (p < 0.05) tumor volumes 1 day p.i. Histological analysis of ex vivo tissues revealed significant damage to the treated tumors. The conclusion is that the use of the ^86/90Y theranostic pair allows PET imaging with excellent tumor-to-background contrast and treatment of TF-expressing pancreatic tumors with promising therapeutic outcomes.

01 Oct 2017·Journal of Controlled ReleaseQ1 · MEDICINE

ImmunoPET imaging of tissue factor expression in pancreatic cancer with 89Zr-Df-ALT-836

Q1 · MEDICINE

Article

Author: Cai, Weibo ; England, Christopher G ; Liu, Bai ; Valdovinos, Hector F ; Wong, Hing C ; Yang, Yunan ; Barnhart, Todd E ; Hernandez, Reinier

Overexpression of tissue factor (TF) has been associated with increased tumor growth, tumor angiogenesis, and metastatic potential in many malignancies, including pancreatic cancer. Additionally, high TF expression was shown to strongly correlate with poor prognoses and decreased survival in pancreatic cancer patients. Herein, we exploited the potential targeting of TF for positron emission tomography (PET) imaging of pancreatic cancer. The TF-targeted tracer was developed through radiolabeling of the anti-human TF monoclonal antibody (ALT-836) with ⁸⁹Zr. The tracer was characterized by fluorescence microscopy and flow cytometry assays in BXPC-3 and PANC-1 cells, two pancreatic cancer cell lines with high and low TF expression levels, respectively. Non-invasive PET scans were acquired in tumor-bearing mice injected with ⁸⁹Zr-Df-ALT-836. Additionally, ex vivo biodistribution, blocking, and histological studies were performed to establish the affinity and specificity of ⁸⁹Zr-Df-ALT-836 for TF in vivo. ⁸⁹Zr-labeling of Df-ALT-836 was achieved in high yield and good specific activity. Flow cytometry and microscopy studies revealed no detectable difference in TF-binding affinity between ALT-836 and Df-ALT-836 in vitro. Longitudinal PET scans unveiled a lasting and prominent ⁸⁹Zr-Df-ALT-836 uptake in BXPC-3 tumors (peak at 31.5±6.0%ID/g at 48h post-injection; n=3), which was significantly abrogated (2.3±0.5%ID/g at 48h post-injection; n=3) when mice were pre-injected with a blocking dose (50mg/kg) of unlabeled ALT-836. Ex vivo biodistribution data confirmed the accuracy of the PET results, and histological analysis correlated high tumor uptake with in situ TF expression. Taken together, these results attest to the excellent affinity and TF-specificity of ⁸⁹Zr-Df-ALT-836. With elevated, persistent, and specific accumulation in TF-positive BXPC-3 tumors, PET imaging using ⁸⁹Zr-Df-ALT-836 promises to open new avenues for improving future diagnosis, stratification, and treatment response assessment in pancreatic cancer patients.

100 Deals associated with ALT-836

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Malignant Solid Neoplasm	Phase 2	US	Altor BioScience Corp.	01 May 2011
Acute Lung Injury	Phase 2	US	Altor BioScience Corp.	01 Apr 2009
Respiratory Distress Syndrome, Acute	Phase 2	US	Altor BioScience Corp.	01 Apr 2009
Shock, Septic	Phase 2	US	Altor BioScience Corp.	01 Apr 2009
Sepsis	Phase 2	CA	Genentech, Inc.	01 Dec 2004
Sepsis	Phase 2	CA	Altor BioScience Corp.	01 Dec 2004
Sepsis	Phase 2	US	Genentech, Inc.	01 Dec 2004
Respiratory Distress Syndrome, Adult	Phase 2	-	Sunol Molecular Corp.	-
Thrombosis	Phase 1	-	Sunol Molecular Corp.	-
Thrombosis	Discovery	US	-	-