inodiftagene vixteplasmid (BC 819) / ChemomAb - LARVOL DELTA

Patient Data Presented at 2023 EULAR Congress Highlights How Serum CCL24 Levels Can Predict Vascular and Fibrotic Complications of Systemic Sclerosis (Yahoo Finance) - "New Patient Data Further Implicates CCL24 in Fibrotic Disease Pathology and Prognosis and Supports Rationale for the Role of Chemomab's CCL24-Neutralizing Antibody CM-101...1 - CCL24 serum concentration predicts both vascular and fibrotic complications in systemic sclerosis...Francesco Del Galdo."

Chemomab Announces FDA Clearance of Investigational New Drug Application for Phase 2 Clinical Trial of CM-101 in Patients with Systemic Sclerosis (Pharma Focus Asia) - "Professor Del Galdo noted, 'Preclinical studies conducted by me and my colleagues show that CCL24, the disease target of CM-101, appears to be a key driver of the immune-driven fibrosis affecting tissues including the lung, skin and blood vessels that are key aspects of SSc pathology. Our patients and we, as their physicians, urgently need an effective therapy able to treat the multiple manifestations of scleroderma. I welcome the opportunity to help launch and coordinate this innovative clinical trial for patients with SSc in the U.S., Europe and Israel, scheduled to open later this year.'"

Announcement • Media quote

Phase II trial of BC-819 intravesical gene therapy in combination with BCG in patients with non-muscle invasive bladder cancer (NMIBC). (ASCO-GU 2018) - P1; "These data demonstrate that administration of BC-819 in combination with BCG is feasible and exhibits clinically meaningful activity in all three induction schedules. The safety profile suggests that BC-819 is well tolerated and does not add substantial toxicity to intravesical therapy. A phase 3 randomized trial of BC-819 and BCG in patients with NMIBC is planned."

Clinical • Combination therapy • P2 data • Bladder Cancer

Long non-coding RNA in bladder cancer. (PubMed, Clin Chim Acta) - "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."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC (clinicaltrials.gov) - P2; N=32; Terminated; Sponsor: Anchiano Therapeutics Israel Ltd.; N=140 ➔ 32; Trial completion date: Nov 2021 ➔ Dec 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Nov 2021 ➔ Nov 2019; Lack of efficacy

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Phase 1/2a, dose-escalation, safety, pharmacokinetic and preliminary efficacy study of intratumoral administration of BC-819 in patients with unresectable pancreatic cancer (Cancer Gene Ther) - P1/2, N=9; The maximum tolerated dose of BC-819 was not reached in this study at the highest dose; Three of the six subjects in cohort no. 2 evaluated at month 3 had a PR; BC-819 can be safely administered intratumorally via EUS- or CT-guided injection at a dose of at least 8mg per injection weekly twice

P1/2 data • Pancreatic Cancer

Anchiano Therapeutics reports year-end 2019 financial results (GlobeNewswire) - "Entered into an exclusive worldwide collaboration and option to license agreement on September 20, 2019 with ADT Pharmaceuticals, LLC ('ADT') to develop novel small-molecule pan-RAS inhibitors and PDE10/β-catenin inhibitors...Announced the discontinuation of Anchiano’s Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer..."

Licensing / partnership • Trial termination

Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC (clinicaltrials.gov) - P2; N=140; Active, not recruiting; Sponsor: Anchiano Therapeutics Israel Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed

Anchiano discontinues phase 2 Codex study evaluating inodiftagene vixteplasmid in patients with non-muscle-invasive bladder cancer (NMIBC); Company focuses on advancing pan-RAS inhibitor program (GlobeNewswire) - P2, N=140; NCT03719300; Sponsor: Anchiano Therapeutics Israel Ltd; "Anchiano Therapeutics Ltd....announced the discontinuation of its Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). After a thorough analysis of the data, Anchiano determined that there is a low probability of surpassing the pre-defined futility threshold at the planned interim analysis, which required 10 complete responses in 35 patients. The data also indicate a low probability of achieving an efficacy profile that in the company’s estimation would be necessary to support regulatory approval."

Trial termination

Phase 2b, Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer (clinicaltrials.gov) - P2b; N=47; Completed; Sponsor: Anchiano Therapeutics Israel Ltd.; Active, not recruiting ➔ Completed; Phase classification: P2 ➔ P2b

Clinical • Phase classification • Trial completion

LAPC-BC-819: Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2b; N=12; Terminated; Sponsor: Anchiano Therapeutics Israel Ltd.; N=70 ➔ 12

Clinical • Enrollment change

Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma (clinicaltrials.gov) - P1; N=38; Completed; Sponsor: Anchiano Therapeutics Israel Ltd.; Recruiting ➔ Completed; N=18 ➔ 38; Trial completion date: Sep 2014 ➔ Oct 2017

Clinical • Enrollment change • Trial completion • Trial completion date