BioLineRx Ltd. and Hemispherian AS Establish Joint Venture to Develop GLIX1, a First-in-Class, Oral, Small Molecule Targeting DNA Damage Response in Glioblastoma and Other Cancers

by Paul Lelieveld | Sep 29, 2025 | Meneldor News

September 29, 2025 PDF Version – GLIX1 restores TET2 activity in cancer, resulting in double stranded DNA breaks  in cancer cells only – – FDA IND clearance received for Phase 1/2a study, expected to initiate in Q1 2026 – – Glioblastoma...

Hemispherian Receives U.S. FDA Orphan Drug Designation for GLIX1 for the Treatment of Malignant Glioma

by Paul Lelieveld | Jul 1, 2025 | Meneldor News

OSLO, NORWAY — July 1, 2025 — Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for GLIX1 for the...

Hemispherian receives positive opinion for Orphan Medicinal Product Designation in the EU for GLIX1 in glioma

by Paul Lelieveld | Jun 6, 2025 | Meneldor News

OSLO, NORWAY — June 6, 2025 — Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive...

Tagworks Pharmaceuticals Announces FDA Clearance of IND Application and Initiation of Phase 1 Clinical Trial for TGW101 and Appoints Keith Orford, MD, PhD, as Chief Medical Officer

by Paul Lelieveld | Apr 22, 2025 | Meneldor News

TGW101 is a next-generation, first-in-class ADC targeting TAG-72 with an MMAE payload, developed based on Tagworks proprietary Click-to-Release linker chemistry; TGW101 is the first bioorthogonal, in vivo click chemistry-activated ADC, which enables superior control...

Tagworks Pharmaceuticals Appoints Ken Mills as Chief Executive Officer

by Paul Lelieveld | Oct 1, 2024 | Meneldor News

Biotech industry veteran to lead Tagworks as the company prepares to bring its novel platform and lead antibody-drug conjugate (ADC) program for solid tumors into the clinic in 2025 Founding CEO Marc Robillard, Ph.D., will continue in role of Chief Scientific Officer...