Delving into the Latest Updates on Inodiftagene vixteplasmid(BioCancell Therapeutics, Inc.) with Synapse

Overview

Basic Info

Drug Type

Gene therapy

Synonyms

diphtheria-toxin-A-H19, Inodiftagene vixteplasmid, BC-819

+ [4]

Target-

Mechanism

Gene transference

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication-

Inactive Indication

Locally Advanced Pancreatic AdenocarcinomaNon-Muscle Invasive Bladder NeoplasmsNon-Muscle Invasive Bladder Urothelial Carcinoma+ [3]

Originator Organization

BioCancell Therapeutics, Inc.

Active Organization-

Inactive Organization

Anchiano Therapeutics Israel Ltd.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 29258282

Source: *****

This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.

Start Date20 Mar 2019

Sponsor / Collaborator

Anchiano Therapeutics Israel Ltd.

NCT01878188 / CompletedPhase 1

Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs)
Recurrence after treatment with BC-819/PEI and BCG
Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder
After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly

Start Date01 Feb 2013

Sponsor / Collaborator

Anchiano Therapeutics Israel Ltd.

NCT01413087 / TerminatedPhase 2

A Multi-Center, Open-Label, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma

This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following intratumoral administration of BC-819 and intravenously administered gemcitabine. Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS).
Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival.
Secondary Objectives: To compare the effects of intratumoral injection of BC-819 administered in combination with intravenous gemcitabine vs. intravenous gemcitabine alone on:
Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life, Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival

Start Date01 Sep 2011

Sponsor / Collaborator

Anchiano Therapeutics Israel Ltd.

100 Clinical Results associated with Inodiftagene vixteplasmid(BioCancell Therapeutics, Inc.)

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100 Translational Medicine associated with Inodiftagene vixteplasmid(BioCancell Therapeutics, Inc.)

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100 Patents (Medical) associated with Inodiftagene vixteplasmid(BioCancell Therapeutics, Inc.)

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12

Literatures (Medical) associated with Inodiftagene vixteplasmid(BioCancell Therapeutics, Inc.)

01 Apr 2020·Clinica chimica acta; international journal of clinical chemistryQ3 · MEDICINE

Long non-coding RNA in bladder cancer

Q3 · MEDICINE

Review

Author: Zheng, Shuyun ; Wu, Xiaoli ; Xie, Kaipeng ; Wang, Chao ; Xu, Hanzi ; Cao, Yuepeng ; Li, Weijian ; Wu, Wanke ; Wu, Xuhong ; Zhan, Chuanfei ; Tian, Tian

Bladder cancer (BC) is the ninth most common malignant disease and ranks fourteenth in cancer mortality worldwide. Moreover, among cancers, the incidence and mortality of BC in males increased to the 6th and 9th place, respectively. The overall survival (OS) declines dramatically as the cancer progresses, especially when urothelial cells transition from noninvasive to invasive. It is well known that epithelial cells can acquire invasive properties and a propensity to metastasize through the epithelial-to-mesenchymal transition (EMT) process in tumourigenesis and progression. However, the potential molecular mechanisms and key pathways are still unclear. As the sequencing technology advances, long non-coding RNAs (lncRNAs) have been proven to play an important role in regulating biological processes and cellular pathways. Here, we reviewed important lncRNAs, such as H19, UCA1 and MALAT1, that participate in the malignant phenotype of BC and regulate EMT signalling networks in the invasion-metastasis cascade during BC development. We further discuss MALAT1, PCAT-1 and SPRY4-IT1, and also urine and blood exosomal H19 and PTENP as potential noninvasive biomarkers. Moreover, antisense oligonucleotides (ASOs) and a double-stranded DNA plasmid (BC-819) have been designed for use in preclinical cancer models and clinical trials in patients. Therefore, the results of investigations have gradually prompted the utility of lncRNAs.

01 Mar 2017·Archives of gynecology and obstetricsQ4 · MEDICINE

A phase 1/2a, dose-escalation, safety, pharmacokinetic, and preliminary efficacy study of intraperitoneal administration of BC-819 (H19-DTA) in subjects with recurrent ovarian/peritoneal cancer

Q4 · MEDICINE

Article

Author: Fishman, Ami ; Lavie, Ofer ; Levy, Tally ; Segev, Yakir ; Raveh, Eli ; Gilon, Michal ; Hochberg, Avraham ; Edelman, David ; Hubert, Ayala

BACKGROUND:

H19 is a paternally imprinted, oncofetal gene expressed in various embryonic tissues and in 85% of the ovarian tumors. H19-DTA (BC-819) is a DNA plasmid that drives the expression of the diphtheria toxin gene under the regulation of the H19 promoter sequence and therefore is a potential treatment for various tumors that overexpress the H19 gene, among them-ovarian cancer.

OBJECTIVE:

To assess the safety and efficacy of intra-peritoneal (IP) instillations of H19-DTA (BC-819) plasmid in treating ovarian/peritoneal cancer patients with advanced recurrent disease.

METHODS:

A phase 1-2A multi-centric trial included 14 eligible patients who were either platinum-refractory or platinum-resistant with positive H19 expression. Patients were treated IP with escalating weekly doses of BC-819 for a maximum of 6-9 weeks. Dose-limiting toxicities (DLT) were assessed after the first course of treatment for each patient and each subsequent cohort was enrolled once each subject had completed the first course of treatment and its 4-week follow-up period. The occurrence of adverse events (AEs) and response to treatment were assessed after the induction course and then periodically.

RESULTS:

During the study, no DLTs were observed. Only 5 grade 1 and 2 AEs, which occurred in 4 patients were considered as possibly related to BC-819. The best tumor response seen was stable disease. Median survivals of 3.2, 5.3 and 6.5 months were observed for the 60, 120 and 240 mg cohorts, respectively.

CONCLUSIONS:

BC-819 can be considered safe and well tolerated in intraperitoneal doses up to 240 mg. Hybridization of intraperitoneal chemotherapy with the biological treatment of BC-819 should be further evaluated in phase 2 and 3 studies.

01 Jun 2014·The Journal of urologyQ1 · MEDICINE

DNA Based Therapy with Diphtheria Toxin-A BC-819: A Phase 2b Marker Lesion Trial in Patients with Intermediate Risk Nonmuscle Invasive Bladder Cancer

Q1 · MEDICINE

Article

Author: Lamm, Donald L. ; Dotan, Zohar ; Halachmi, Sarel ; Ehrlich, Nahum ; Yutkin, Vladimir ; Gofrit, Ofer N. ; Benjamin, Shalva ; Leibovitch, Ilan ; Ben-Am, Monique ; Hochberg, Abraham

PURPOSE:

H19 is a paternally imprinted oncofetal gene expressed in various embryonic tissues and in 85% of bladder tumors but suppressed in the adult healthy bladder. BC-819 is a DNA plasmid that carries the gene for diphtheria toxin-A under regulation of the H19 promoter sequence. We assessed the efficacy and toxicity of intravesical BC-819 instillations to prevent tumor recurrence and ablate a marker lesion in a phase 2b trial.

MATERIALS AND METHODS:

A total of 47 patients with recurrent, multiple nonmuscle invasive bladder tumors in whom prior intravesical therapy had failed underwent transurethral resection of all except 1 marker tumor. Patients expressing H19 received a 6-week induction course of intravesical BC-819. Patients who achieved a complete response (absent new tumors at 3 months) were given 3 maintenance courses of 3-weekly instillations every 3 months.

RESULTS:

All patients were evaluable for adverse effects and 39 were evaluable for efficacy. Complete tumor ablation was achieved in 33% of patients and in 64% there were no new tumors at 3 months. Median time to recurrence was 11.3 months in all cases but significantly longer (22.1 months) when analyzed by response status at 3 months. Adverse events were mild. The study was limited by the small number of patients.

CONCLUSIONS:

BC-819 prevented new tumor growth in two-thirds of the patients and ablated a third of the marker lesions. Prolonged time to recurrence was observed in responding patients. These results along with the good safety profile make BC-819 a potential medication for bladder cancer.

1

News (Medical) associated with Inodiftagene vixteplasmid(BioCancell Therapeutics, Inc.)

28 Nov 2022

·www.businesswire.com

2022 Bladder Cancer Update Bulletin: Key Opinion Leader (KOL) Views on Recent Developments - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Bladder Cancer: Update Bulletin #2" newsletter has been added to ResearchAndMarkets.com's offering. This edition presents leading key opinion leader (KOL) views on recent developments in the Bladder Cancer market. Topics covered include: Bristol-Myers Squibb (BMS) presenting positive data from a Phase I/II study investigating a combination of its PD-1 inhibitor Opdivo (nivolumab) with its pipeline indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, BMS-986205, in heavily pretreated patients with advanced bladder cancer; BioCanCell announcing final results for its Phase IIb combination trial investigating its lead compound BC-819 in combination with the BCG vaccine in 38 patients with intermediate-and high-risk non-muscle invasive bladder cancer (NMIBC); KOLs offering their updated opinions on the the supply status of the BCG vaccine in the US and key European markets. Business Questions: How do the KOLs perceive the Phase II combination results for BMS' Opdivo with the IDO inhibitor BMS-986205 in patients with advanced bladder cancer? Do KOLs view PD-1/PD-L1 and IDO inhibition as a viable combination approach going forward? What are experts' thoughts on PD-L1 expression and its future use as a biomarker in patients with bladder cancer? Do KOLs hold any other concerns about dual immunotherapy combinations such as cost, access or increased risk of toxicity? If approved, how and when would KOLs consider using the combination approach of Opdivo with an IDO inhibitor? Based on published Phase II data, how do the experts view the results so far for BC-819 with BCG in patients with NMIBC? Are the KOLs enthusiastic about intravesical gene therapies as treatments for NMIBC and if so, why? How do the experts perceive the planned Phase III trial investigating BC-819 in patients that are BCG-recurrent? If approved, can BC-819 gain market share in patients with high-risk or intermediate-risk NMIBC? What are KOLs' opinions on the supply shortages previously reported for the BCG vaccine and are they being addressed? For more information about this newsletter visit https://www.researchandmarkets.com/r/9ke1kl

Phase 2VaccineImmunotherapyClinical ResultASCO

100 Deals associated with Inodiftagene vixteplasmid(BioCancell Therapeutics, Inc.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	US	Anchiano Therapeutics Israel Ltd.	01 Sep 2011
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	IL	Anchiano Therapeutics Israel Ltd.	01 Sep 2011
Pancreatic adenocarcinoma	Phase 2	US	Anchiano Therapeutics Israel Ltd.	01 Sep 2011
Pancreatic adenocarcinoma	Phase 2	IL	Anchiano Therapeutics Israel Ltd.	01 Sep 2011
Pancreatic carcinoma non-resectable	Phase 2	US	Anchiano Therapeutics Israel Ltd.	01 Aug 2009
Pancreatic carcinoma non-resectable	Phase 2	IL	Anchiano Therapeutics Israel Ltd.	01 Aug 2009
Ovarian Cancer	Phase 2	IL	Anchiano Therapeutics Israel Ltd.	01 Jun 2009
Non-Muscle Invasive Bladder Neoplasms	Phase 2	US	Anchiano Therapeutics Israel Ltd.	01 Jan 2008
Non-Muscle Invasive Bladder Neoplasms	Phase 2	IL	Anchiano Therapeutics Israel Ltd.	01 Jan 2008
Non-Muscle Invasive Bladder Urothelial Carcinoma	Phase 1	IL	Anchiano Therapeutics Israel Ltd.	01 Feb 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03719300 (CTgov)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	32	inodiftagene vixteplasmid	lqytpecjwd(qewreqqkwj) = yedrcowlcz uuzvatrqel (lqyyixnaxk, ztbbpjlagu - niiuxgcquk) View more	-	19 Aug 2020
NCT01413087 (CTgov)	Phase 2	Pancreatic adenocarcinoma \| Locally Advanced Pancreatic Adenocarcinoma	12	Biological/Vaccine: BC-819 (8 mg BC-819 and Gemcitabine)	yesjzfnfxo(nmugiwwpzs) = vvgsvoefik rbtplydarb (ociezhwoar, xeesxnswxn - kqdtjdvqnc) View more	-	01 Nov 2019
NCT01413087 (CTgov)	Phase 2		12	Biological/Vaccine: BC-819 (12 mg BC-819 and Gemcitabine)	yesjzfnfxo(nmugiwwpzs) = jsrirlpqef rbtplydarb (ociezhwoar, eyrsxmvgtb - kxvzxyykew) View more	-	01 Nov 2019
NCT01878188 (ASCO_GU2018)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	38	BC-819 and BCG	uswbmwubua(kvvvimamwx) = hfvmelyghn yvugwsldcf (ctqiwhirvl ) View more	Positive	26 Feb 2018
NCT00711997 (CTgov)	Phase 1/2	Pancreatic carcinoma non-resectable	9	BC-819 (BC-819 4 mg)	psfbuqugot(cjvkgiemif) = jszqqurzop jcxjaawyeb (crxjiyvcrj, iqlwyxyfin - vjeyofuxsv) View more	-	02 Dec 2013
NCT00711997 (CTgov)	Phase 1/2	Pancreatic carcinoma non-resectable	9	BC-819 (BC-819 8 mg)	psfbuqugot(cjvkgiemif) = nwwfoelfdz jcxjaawyeb (crxjiyvcrj, zdncfcmuem - dngdatmdcz) View more	-	02 Dec 2013
NCT00595088 (CTgov)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	47	BC-819/PEI	qgrwmrvcjm(waamzllpek) = dqlhucfvch oppspktrpr (nmucykiozz, evbyblocsi - nuajzdayvq) View more	-	21 Aug 2013