NP-101 / Novatek Pharma - LARVOL DELTA

A phase 1 dose escalation and dose expansion trial of NP-101 in patients with advanced solid tumors (SITC 2025) - P1 | "Bioactive natural products, such as paclitaxel1 2 have long served as anticancer agents. OHRP IRB Registration Number: IRB00000121 FWA #: 00000363Abstract 532 Figure 1Request permissionsNP-101 Phase 1 study design (Created in https://BioRender.com). Abbreviations: BID, twice daily; MTD, maximum tolerated dose; PO, orally; PD, pharmacodynamics; PK, pharmacokinetics; RP2D, recommended phase II dose"

Clinical • Metastases • P1 data • Hepatocellular Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8

EP-NECAs: NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Amr Mohamed MD | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Undergoing Y-90 Treatment (clinicaltrials.gov) - P1 | N=18 | Suspended | Sponsor: University of Florida | Recruiting ➔ Suspended

Trial suspension • Hepatocellular Cancer • Oncology • Solid Tumor

BOSS-002: Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive. (clinicaltrials.gov) - P2 | N=170 | Terminated | Sponsor: Novatek Pharmaceuticals | N=308 ➔ 170 | Trial completion date: Oct 2024 ➔ May 2025 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2024 ➔ May 2025; The interim analysis results met protocol and SAP predetermined criteria for stopping early due to futility or efficacy.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease

Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Undergoing Y-90 Treatment (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: University of Florida | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

EP-NECAs: NP-101 (TQ Formula) with Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Amr Mohamed MD | Trial primary completion date: Oct 2024 ➔ Jun 2025

Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Undergoing Y-90 Treatment (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Initiation date: Nov 2024 ➔ Feb 2025

Trial initiation date • Hepatocellular Cancer • Oncology • Solid Tumor

Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Undergoing Y-90 Treatment (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Initiation date: Aug 2024 ➔ Nov 2024

Trial initiation date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

EP-NECAs: NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Amr Mohamed MD | Recruiting ➔ Active, not recruiting | N=10 ➔ 15 | Trial completion date: Apr 2024 ➔ Apr 2026 | Trial primary completion date: Apr 2024 ➔ Oct 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Undergoing Y-90 Treatment (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida | Initiation date: May 2024 ➔ Aug 2024

Trial initiation date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

EP-NECAs: NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Amr Mohamed MD | Trial completion date: Oct 2023 ➔ Apr 2024 | Trial primary completion date: Oct 2023 ➔ Apr 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

BOSS-002: Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive. (clinicaltrials.gov) - P2 | N=308 | Recruiting | Sponsor: Novatek Pharmaceuticals | Phase classification: P2a/2b ➔ P2 | Trial completion date: Dec 2023 ➔ Oct 2024 | Trial primary completion date: Oct 2023 ➔ Oct 2024

Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Individual ingredients of NP-101 (Thymoquinone formula) inhibit SARS-CoV-2 pseudovirus infection. (PubMed, Front Pharmacol) - "We demonstrated that NP-101, TQ, and other individual ingredients, including oleic, linoleic, and palmitic acids inhibited SARS-CoV-2 infection in the MLV-based pseudovirus model. A large, randomized phase 2 study of NP-101 is planned in outpatient COVID-19 patients."

Journal • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Study of NP-101 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Undergoing Y-90 Treatment (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: University of Florida

New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor