Temodex (temozolomide gel) / Belmedpreparaty, Double Bond Pharmaceutical - LARVOL DELTA

TARGLIO: A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Double Bond Pharmaceutical AB | Trial completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

TARGLIO: A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Double Bond Pharmaceutical AB | Trial completion date: May 2024 ➔ Aug 2025 | Trial primary completion date: Mar 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Immunology • Oncology • Solid Tumor • MGMT

"DBP International AB: Australiensisk patent för Temodex/SI-053beviljas https://t.co/6FB7TSLbVp" (@CisionNews)

Talazoparib Plus Low-Dose Temozolomide Improves ORR Over Historical Control in R/R ES-SCLC (OncLive) - "'This is the second trial to demonstrate a benefit of PARP inhibition with low-dose temozolomide in SCLC,' Goldman said in a presentation of the data. 'A phase 3 study is appropriate to confirm the benefit of this approach compared with currently approved options.'"

Media quote

TARGLIO: A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Double Bond Pharmaceutical AB | Trial completion date: May 2023 ➔ May 2024 | Initiation date: Sep 2021 ➔ Sep 2022 | Trial primary completion date: Mar 2023 ➔ Mar 2024

Trial completion date • Trial initiation date • Trial primary completion date • Brain Cancer • Glioblastoma • Immunology • Oncology • Solid Tumor • MGMT

Updated 2-THE-TOP Data Suggest Improvements in Progression-Free Survival, Overall Survival Compared to Matched-Control Patients from EF-14 Trial (Businesswire) - P2 | N=31 | 2-THE-TOP (NCT03405792) | "For patients in the 2-THE-TOP trial, median progression-free survival was 12.1 months, compared with 7.9 months for the matched-control patients in EF-14 (hazard ratio=0.46, p=0.033). Patients in 2-THE-TOP had a median overall survival of 25.2 months, compared with 15.9 months for the matched-control patients in EF-14 (hazard ratio=0.38, p=0.020)."

P2 data • Glioblastoma • Oncology

TARGLIO: A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: Double Bond Pharmaceutical AB

Clinical • New P1 trial • Brain Cancer • Glioblastoma • Immunology • Oncology • Solid Tumor • MGMT • MRI

DBP International AB: Mexico patent for Temodex / SI-053 is granted (Cision) - “Double Bond Pharmaceutical…received information about the granting of Mexican patent application concerning the company's front-line product Temodex / SI-053. Patent approval provides protection for the technology and the product in Mexico until at least 2036.”

Patent • Oncology

DBP International AB: a new patent for SA-033 is granted in USA (Cision) - “Double Bond Pharmaceutical's second patent application for organ-specific administration of hydrophilic cancer drug to the liver which forms the basis for the BeloGal® technology platform has been granted in the United States. Patent approval provides protection for the treatment method and the design of composition for DBP's front-line product SA-033.”

Patent • Oncology

DBP International: IMPD for the SI-053 phase I trial is finalized – nine out of ten milestones for the clinical trial of SI-053 have been completed (Cision) - “Double Bond Pharmaceutical International…takes a step further towards the start of the phase 1 clinical trial of its front-line product SI-053 in patients with glioblastoma – the Investigational Medicinal Product Dossier (IMPD) for the upcoming trial is now compiled…Regulatory: Clinical trial application (CTA) for Phase 1 SI-053 clinical study; Q2 2021.”

European regulatory • CNS Tumor • Glioblastoma • Glioma • Oncology

DBP International: The clinical protocol for the SI-053 phase I trial is finalized (Cision) - “Double Bond Pharmaceutical International…takes a step further towards the start of the phase 1 clinical trial of it’s front-line product SI-053 in patients with glioblastoma - the clinical protocol for the coming trial is now finalized. The clinical protocol is an important document that forms the basis for applying for approval to authorities…CMC: The IMPD is completed; Q2 2021 Regulatory: Clinical trial application (CTA) for Phase 1 SI-053 clinical study; Q2 2021 Financing phase 1; Q2 2021 – issuance of units as a probable alternative.”

Clinical protocol • Financing • Trial status • CNS Tumor • Glioblastoma • Glioma • Oncology

DBP International AB: investigators’ meeting for the SI-053 Phase I study was held (Cision) - “Double Bond Pharmaceutical…hosted an investigators’ meeting for the planned SI-053 Phase I study…The meeting gathered investigators from 4 clinics in 2 countries together with the Clinical Trial Team from DBP and key personnel from the contract research organization (CRO) CATO-SMS Oncology. The purpose of the meeting was to meet the investigator’s and go through the planned SI-053 study in order to ensure that the trial will be conducted in compliance with the Clinical Study Protocol, guidelines and applicable regulations.”

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

DBP International AB: Manufacturing of the excipient for SI-053 is done (Cision) - “The manufacturing of the excipient for SI-053 has been carried out in a European GMP-certified facility, a contract-based manufacturer within the EU. This product will be used for the manufacturing of SI-053 which is scheduled to start next month and which will be used for DBP's clinical trials...and successful SI-053 manufacturing for CTA with associated stability studies, in European GMP-certified environments, which is the basis for today's successful work."

Commercial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

DBP International AB: New patent application for SI-053 (Cision) - “Double Bond Pharmaceutical International…has today, March 25, 2021, filed another patent application regarding the Company's front-line product SI-053. DBP's first patent family for SI-053, which protects a formulation, has been granted in Europe, USA, Eurasia and India and is also expected to be granted in other important markets during 2021-2022.”

Patent • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology