Novita Pharmaceuticals has announced positive results from its Phase 2 trial evaluating NP-G2-044, a first-in-class fascin inhibitor, in combination with standard-of-care anti-PD-1 therapy for patients with advanced solid tumors resistant to prior immune checkpoint inhibitor (ICI) treatment. The data was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
The study enrolled 45 patients who had progressed on prior anti-PD-(L)1 therapies, with a median of two prior treatment lines and 20% having received at least four prior lines of therapy. NP-G2-044 was administered at the recommended Phase 2 dose (RP2D) of 1600 mg once daily in 4-week cycles.
Promising Efficacy Across Multiple Tumor Types
The trial demonstrated a disease control rate of 76%, which includes patients achieving stable disease and objective responses. The objective response rate (ORR) reached 21%, comprising three patients with partial responses (PR) and four with complete responses (CR), including two pathologic complete responses.
"We are encouraged by the continued positive data from our Phase 2 trial of NP-G2-044, which highlight the therapeutic opportunity of our first-in-class fascin inhibitor for patients with advanced and metastatic solid tumors," said Jillian Zhang, Ph.D., President & Chief Scientific Officer of Novita. "Continued safety and durable efficacy findings across multiple tumor types speak to the impact of our novel therapy, as we see favorable response rates and no new metastases from more than half of patients."
Notably, 55% of all patients showed no new metastases during treatment, addressing a critical aspect of cancer progression. The responses were observed across at least seven different cancer types, including cases where patients were converted from ICI-non-responsive to ICI-responsive.
Durable Responses and Tumor Control
The trial revealed particularly impressive durability of responses, with four patients still receiving ongoing treatment. Two of these patients have maintained responses for more than 80 weeks in pancreatic cancer and endometrial cancer, respectively.
Specific outcomes of note include:
- Complete response in a cervical cancer patient
- Target lesion complete response in an endometrial cancer patient
- Pathological complete responses in both a pancreatic cancer patient and a patient with gastroesophageal junction adenocarcinoma
- Clinical complete response in a cutaneous squamous cell carcinoma patient
- Partial responses in non-small cell lung cancer and cholangiocarcinoma
Mechanism of Action and Immune Enhancement
The study provided insights into NP-G2-044's mechanism of action, showing increased T-cell infiltration and enhanced proliferation in the tumor microenvironment. Additionally, researchers observed expanded activated dendritic cells, supporting the therapeutic function of fascin inhibition and immune activation.
These findings align with Novita's research focus on fascin, a protein highly expressed in tumor cells and antigen-presenting cells within tumor tissues that plays a key role in tumor cell motility.
Future Development Plans
Based on these encouraging results, Novita is expanding the study with additional cohorts to further evaluate the combination of NP-G2-044 with anti-PD-1 therapy across various patient populations and solid tumor subtypes.
"These data set the foundation for our Phase 3 study of NP-G2-044 plus PLD in platinum-resistant ovarian cancer, which we plan to start enrolling later this year," added Dr. Zhang.
The company plans to share additional data from the Phase 2 expansion cohort in the second half of 2025, with enrollment in the pivotal Phase 3 study expected to begin in the third quarter of 2025.
Addressing Critical Unmet Needs
Novita's approach targets two significant challenges in cancer treatment. First, cancer metastasis causes over 90% of cancer-related deaths, yet there are currently no approved drugs specifically targeting this process. Second, while immune checkpoint inhibitors have revolutionized cancer treatment, many patients fail to respond to these therapies.
NP-G2-044 represents a novel approach by targeting fascin to potentially block metastasis while simultaneously enhancing immune responses when combined with checkpoint inhibitors. This dual mechanism could provide new options for patients with limited treatment alternatives, particularly those who have developed resistance to immunotherapy.
About Novita Pharmaceuticals
Novita Pharmaceuticals is a privately held, clinical-stage biopharmaceutical company focused on developing therapies using its proprietary fascin inhibitor technology. The company aims to prevent and treat cancer metastasis while simultaneously enhancing anti-cancer immune responses.
The ongoing Phase 2 clinical trial, titled "NP-G2-044 as Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies," continues to evaluate this novel approach across multiple cancer types.
