Novita Shares More Positive Phase 2 Data on NP-G2-044 for Advanced Tumors at AACR IO Meeting

Novita Pharmaceuticals, Inc., a clinical-stage pharmaceutical company based in New York, recently shared promising results from its Phase 2 study of NP-G2-044. This innovative drug combines with standard anti-PD-1 therapy to treat patients with advanced solid tumors resistant to previous anti-PD-1 treatments. The data was presented at the American Association for Cancer Research Immuno-oncology Annual Meeting and highlighted in a poster titled "Phase 2 Study of NP-G2-044, a Novel Fascin Inhibitor, in Combination with Anti-PD-1 Therapy in Patients with Solid Tumors Resistant to Prior Anti-PD-1 Therapy."

NP-G2-044 is a fascin inhibitor developed to tackle cancer cell mobility, which often leads to metastasis. The study's promising results suggest that this novel drug, in conjunction with immune checkpoint inhibitors (ICIs), may offer new treatment avenues for patients with various solid tumors. Dr. Jillian Zhang, President and Chief Scientific Officer of Novita, expressed satisfaction with the study’s outcomes, noting the drug's safety and effectiveness both as a standalone treatment and when combined with ICIs. She emphasized the potential of this approach to inhibit metastasis and boost cancer immunotherapy, underlining its broad applicability across different tumor types.

The trial involved 45 patients who had previously shown progression despite anti-PD-1 treatments. The study focused on several endpoints, including the objective response rate (ORR), progression-free survival, metastasis-free interval, overall survival, safety, and tolerability. The results revealed a Disease Control Rate of 76%, encompassing stable disease and objective responses. Furthermore, the ORR was 21%, with partial and complete responses observed in various cancer types.

Significantly, the study reported durable responses and tumor control across at least seven cancer types. Noteworthy cases included a complete response in a cervical cancer patient, target lesion CR in an endometrial cancer patient, pathological CRs in pancreatic cancer and gastroesophageal junction adenocarcinoma patients, and partial responses in cutaneous squamous cell carcinoma, non-small cell lung cancer, and cholangiocarcinoma. Seven patients are still receiving treatment, with the longest treatment duration exceeding 18 months for patients with endometrial and pancreatic cancers.

To further explore NP-G2-044's capabilities, the study is being amended to include additional cohorts that will evaluate the drug's efficacy across various patient populations and tumor subtypes. Future research will delve into identifying biomarkers for predicting responses and understanding resistance mechanisms, which could inform personalized treatment strategies for resistant cancer cases. Novita is preparing to launch a pivotal Phase 3 trial of NP-G2-044 combined with PLD for treating platinum-resistant ovarian cancer in the third quarter of 2025.

Novita Pharmaceuticals is committed to advancing cancer treatment by focusing on fascin inhibitors. These inhibitors target proteins that are crucial for tumor cell movement and are highly expressed in both tumor cells and antigen-presenting cells in tumors. NP-G2-044 has shown a capacity to block metastasis and reinvigorate anti-tumor immune responses. The ongoing Phase 2 trial, titled "NP-G2-044 as Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies," continues to explore the potential of this groundbreaking treatment.