#United States #New York #Cancer Research #Novita Pharmaceuticals #NP-G2-044

Insights from Phase 2 Clinical Trial Findings on NP-G2-044

Recently, during the American Association for Cancer Research Immuno-oncology (AACR IO) Annual Meeting, Novita Pharmaceuticals, Inc. presented compelling data from their ongoing Phase 2 clinical trial of NP-G2-044. This investigational drug is designed to tackle advanced solid tumors specifically resistant to existing anti-PD-1 therapies. Utilizing proprietary fascin inhibitor technology, the trial showcases an innovative approach to meet the substantial unmet needs in cancer treatment.

Study Overview

This Phase 2 study, registered under NCT05023486, focused on evaluating the effectiveness of NP-G2-044 in conjunction with standard-of-care (SOC) anti-PD-1 treatment. The patient population primarily consisted of individuals suffering from advanced solid tumors who had shown resistance to previous anti-PD-1 therapies.

The presentation 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" detailed crucial findings that suggest NP-G2-044 may offer a significant therapeutic advantage when paired with immune checkpoint inhibitors (ICIs).

Positive Outcomes

The trial enrolled 45 patients as follows:

• - Disease Control Rate: An impressive 76%, covering patients with stable disease and those showing objective responses.
• - Objective Response Rate (ORR): Reported at 21%, with 4 individuals achieving a Partial Response (PR) and 3 achieving Complete Responses (CR), one of which is a Pathological Complete Response (PCR).

These results indicate durable responses observed in a variety of cancer types. Noteworthy mentions include:

• - A CR recorded in a patient with cervical cancer.
• - Target lesion CR in an endometrial cancer patient.
• - PCRs seen in patients with pancreatic and gastroesophageal junction adenocarcinoma.
• - PRs noted in cases of cutaneous squamous cell carcinoma, non-small cell lung cancer, and cholangiocarcinoma.

Seven participants are actively receiving treatment, with the longest duration exceeding 18 months among patients with endometrial and pancreatic cancers.

Next Steps

Noticing the positive trends, Novita announced amendments to expand the study. The new cohorts aim to explore combinations of NP-G2-044 with anti-PD-1 therapies across various solid tumor subtypes. Future analyses will focus on identifying biomarkers for predicting patient responses, helping tailor treatments for those resistant to current options.

Novita aims to begin enrollment in a pivotal Phase 3 study assessing NP-G2-044 paired with PLD for treating platinum-resistant ovarian cancer by the third quarter of 2025, paving the way for more targeted therapies.

About Novita Pharmaceuticals

Established as a privately held, clinical-stage biopharmaceutical company, Novita Pharmaceuticals focuses on pushing forward innovative cancer therapies by leveraging their proprietary fascin inhibitor technology. Their ongoing commitment illustrates a significant movement towards addressing both the complexities of cancer metastasis and enhancing immune responses within the patient's body.

To learn more about their groundbreaking initiatives, visit www.novita-pharm.com.

Conclusion

The latest findings presented by Novita Pharmaceuticals at the AACR IO Annual Meeting signify a strong step forward in the battle against advanced solid tumors. As the company continues to divulge more information from ongoing clinical trials, it may potentially transform the landscape of cancer treatment through innovative research and promising therapies.