Numab Therapeutics Begins Phase 1 Study of NM32 in Solid Tumor Patients

Numab Therapeutics AG has announced the commencement of a Phase 1 clinical trial for NM32, a pioneering tri-specific immuno-oncology therapeutic. NM32 targets the receptor tyrosine kinase-like orphan receptor 1 (ROR1) and the T-cell receptor associated antigen CD3. Additionally, it includes a domain that targets serum albumin, which extends the drug's half-life, enabling bi-weekly dosing and maintaining a lower molecular weight. This design allows for higher tumor concentrations compared to larger immunoglobulin G molecules, the current standard for CD3 engagers.

The trial marks a significant step in the development of NM32, which leverages Numab's proprietary Lambda-cap and MATCH technology platforms. NM32 is designed to help the patient's immune system identify and combat tumor cells. ROR1 is an antigen that is overexpressed in various prevalent solid tumors but has limited presence in normal tissues, making it an ideal target for a CD3 engager. This feature enhances the specificity and potential efficacy of NM32 in treating solid tumors.

David Urech, Ph.D., the Founder and CEO of Numab Therapeutics, expressed optimism about the trial. He highlighted that NM32 aims to offer a novel therapeutic option for patients with advanced solid tumors, providing durable anti-tumor activity with a manageable safety profile. Martin Stern, the Senior Vice President of Clinical Science at Numab Therapeutics, noted that patient enrollment is progressing well, with participants completing the initial treatment cycle of the first dose level. Stern pointed out the challenges faced by current therapies, such as checkpoint inhibitors and commercially available CD3 engagers, in treating solid tumors. The limited success in this area is often due to the lack of highly tumor-specific antigens that can selectively activate T-cells against tumor cells.

The Phase 1 study of NM32 is a dose-escalation trial aimed at understanding the drug's pharmacokinetic properties, pharmacodynamic effects, and safety profile. The trial will also determine the optimal dosing regimen for further clinical development. Up to 60 patients with solid tumors overexpressing ROR1 will be enrolled from major clinical sites across the United States. Preclinical data from non-human primates suggest that NM32 has high potency and an excellent safety profile.

NM32 (NM32-2668) is a next-generation tri-specific immuno-oncology drug that targets ROR1 and CD3. The drug's third domain targets serum albumin to extend its half-life, allowing for bi-weekly dosing. T-cell redirection using CD3 engagers has shown high response rates and durable activity in hematological malignancies and promising results in solid tumors with selected targets. ROR1 is a clinically validated tumor-associated antigen found in several cancers with high unmet medical needs, including lung, breast, ovarian, endometrial, renal, and gastric cancers, while having limited expression in healthy tissue.

Numab Therapeutics AG is focused on developing multi-specific antibody-based immunotherapies for inflammation and cancer. Their reproducible therapeutic design process, using proprietary λ-Cap and MATCH platforms, positions them uniquely to overcome historical drug discovery challenges and build a pipeline of novel medicines aimed at maximizing patient benefits. The company's diverse research pipeline spans multiple therapeutic areas, offering the potential for the next generation of first-in-class and best-in-class medicines. Numab's lead candidate, NM26, is designed to target IL-4/13 and IL-31 for best-in-class efficacy, with the vision of providing a lifelong cure for patients with atopic dermatitis and other conditions. Numab's partnerships with leading pharmaceutical companies validate their platform and development capabilities.