Positive clinical progress in the biotech scene

With the dosing of its first patient for lead candidate CDR404, CDR-Life has made significant clinical progress in its M-gager® portfolio for solid tumors, marking important milestones in the company’s mission to deliver innovative, antibody-fragment based immunotherapies for difficult-to-treat cancers.  CDR404 is a novel, bispecific and bivalent antibody fragment-based T cell engager (TCE) targeting MAGE-A4, an intracellular cancer-specific protein that is cleaved into smaller peptide fragments and presented on HLA-A*02:01 molecules at the surface of cancer cells. The Phase 1 study (NCT06402201) is enrolling HLA-A *02:01+ patients with MAGE-A4+ solid cancers in the U.S. and Europe. The trial is evaluating the safety, tolerability and preliminary anti-tumor activity of CDR404 in several common cancers including squamous cell carcinomas in which MAGE-A4 is highly enriched.

Additionally, positive results from the Phase I evaluation of BI 771716, developed by Boehringer Ingelheim with technology licensed from CDR-Life, have been announced. BI 771716 is a highly specific antibody fragment, possibly enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology. GA is an advanced and severe form of late-stage, dry age-related macular degeneration (AMD), a chronic and progressive retinal disease, that can lead to irreversible and permanent vision loss. Based on its molecular properties, BI 771716 has the potential to achieve unprecedented efficacy.  BI 771716 met its primary safety endpoint following intravitreal administration of single and multiple doses. Preparation for the Phase II trial is now underway, with an expected start date in early 2025.

Opna Bio doses first patient with OPN-6602
Opna Bio is a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics. The company’s broad portfolio targets multiple drivers of cancer, including a novel oncology discovery program focused on the fragile-X multifunctional RNA-binding protein (FMRP) and a diversified pipeline of promising oncology assets. The company has dosed the first patient with OPN-6602, a potent and selective EP300/CBP bromodomain inhibitor, in a Phase 1 clinical study in multiple myeloma. The trial is expected to enroll up to 130 total patients with relapsed or refractory multiple myeloma at sites in the U.S. Multiple myeloma is a type of blood cancer derived from malignant plasma cells in the bone marrow. There are approximately 180,000 people worldwide who are diagnosed with multiple myeloma and 117,000 deaths attributable to the disease annually.

Hedera lauches Real-World Data Asset
Hedera Dx, an oncology company specializing in liquid biopsies and real-world data (RWD), has launched its Real-World Data Asset, Hedera Frame, the multi-omics data platform which covers multiomics data, data on a broad set of tumor types and biomarkers, addressing the needs of modern cancer care and drug development. Hedera has also announced the recruitment of the first patients into EMPATHY NSCLC study. EMPATHY NSCLC addresses the limitations caused by narrow inclusion criteria in clinical trials, creating an open RWD registry that also responds to global concerns over restricted clinical trial data access. The study evaluates molecular tumor profiling, treatment choices, and patient outcomes, providing a representative basis for NSCLC management. The initiative ensures data security while granting researchers access under approved protocols. In the study, genomic data is combined with clinical data to create rich clinico-genomics data, including patient-reported outcomes (PROs) and experiences (PREMs). “Unlike many datasets that only aggregate genomic findings, we combine this with rich clinical data, offering deeper and more fit-for-purpose insights”, said Tommi Lehtonen, CEO of Hedera Dx.