nanoencapsulated paclitaxel (FID-007) / ANP Technologies, Fulgent Genetics - LARVOL DELTA

A randomized phase II study of FID-007 Plus cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) (ESMO 2025) - P2 | "Background The therapeutic profile of paclitaxel (PTX) is limited by toxicities associated with its water-solubility. Conclusions The current data support further development of the combination of FID-007 and cetuximab for 2L HNSCC treatment. The study is ongoing."

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer (clinicaltrials.gov) - P1 | N=1 | Terminated | Sponsor: University of Southern California | N=10 ➔ 1 | Trial completion date: Apr 2027 ➔ Sep 2025 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2026 ➔ Sep 2025; Slow accrual

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Head and Neck Cancer • Oncology • Otorhinolaryngology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

FID-007 in Treating Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: University of Southern California | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

FID-007-003: FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: Fulgent Pharma LLC. | Trial primary completion date: Mar 2025 ➔ Dec 2025

Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efficacy from the phase 1 study of FID-007, a novel nanoparticle paclitaxel formulation, in patients with head and neck squamous cell carcinoma. (ASCO 2024) - P1 | "Preclinically, FID was more effective at lower or comparable taxane doses, including nab-paclitaxel. FID demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated HNSCC pts across different primary tumor sites, with an ORR 56%, including those with prior taxane exposure. A phase 2 study of FID with cetuximab in pts with HNSCC is planned to begin enrollment in 2024."

Clinical • P1 data • Alopecia • Anemia • Anorexia • Dermatology • Fatigue • Febrile Neutropenia • Head and Neck Cancer • Hematological Disorders • Immunology • Leukopenia • Neutropenia • Oncology • Pain • Pruritus • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Fulgent Data at ASCO 2024 Highlights Antitumor Activity from Lead Therapeutic Oncology Candidate, FID-007, in Head and Neck Cancer (Businesswire) - P1 | N=11 | NCT06338657 | "Of eleven head and neck squamous cell carcinoma (HNSCC) evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, five (45%) had a partial response and three (27%) had stable disease by RECIST. Three out of five HNSCC patients with PR had previously been treated with taxane....No high-grade neuropathy has been noted to date. FID-007 demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated HNSCC patients across different primary tumor sites, with an overall response rate of 45%."

P1 data • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

Fulgent Announces Upcoming Presentation of Clinical Data for Its Lead Therapeutic Oncology Candidate, FID-007, at ASCO 2024 Annual Meeting (Businesswire) - "Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc...announced that Phase 1 clinical data on its lead therapeutic development candidate, FID-007, to treat Head and Neck cancer, will be presented at the American Society for Clinical Oncology (ASCO) Annual Meeting on June 2, 2024 in Chicago, Illinois."

P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: University of Southern California | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery • Head and Neck Cancer • Oncology • Otorhinolaryngology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • BCL6 • BTLA • CCR7 • CD38 • CXCR3 • GZMB • LAG3 • PD-1 • PRDM1 • SIGLEC15 • TIGIT

HNSCC: FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: Fulgent Pharma LLC. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: University of Southern California

New P1 trial • Surgery • Head and Neck Cancer • Oncology • Otorhinolaryngology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • BCL6 • BTLA • CCR7 • CD38 • CXCR3 • GZMB • LAG3 • PD-1 • PRDM1 • SIGLEC15 • TIGIT

HNSCC: FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Fulgent Pharma LLC.

Combination therapy • Metastases • New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

FID-007 in Treating Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: University of Southern California | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2024 ➔ May 2025

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FID-007: nanoencapsulated paclitaxel derived from a novel nano-drug delivery platform (SITC 2023) - P1 | "PK is linear, dose proportional and comparable to that of nab-paclitaxel. Clinical trial information: NCT03537690. Taken together, this example demonstrates the proof of concept for PEOX polymer based nano-drug delivery platform which can be broadly applied to other poorly water-soluble drugs through a simple ‘Plug & Play’ approach."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Fulgent Shares Data from Two Poster Presentations at SITC 2023 Annual Meeting (Businesswire) - P1 | N=36 | NCT03537690 | "Fulgent Genetics... announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting....The poster...highlights progress for Fulgent Pharma’s lead therapeutic oncology candidate, FID-007, in various cancers....Preliminary clinical data suggests FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types. Based on the lack of adverse events, pharmacokinetics, and early indications of treatment effect, 125 mg/m2 has been chosen as the recommended Phase 2 dose. In addition, subgroup analysis based on 7 patients for Head and Neck cancer and 4 patients for Ampullary/Pancreatic cancer showed 57% and 50% objective response rate, respectively."

P1 data • Head and Neck Cancer • Pancreatic Cancer

Fulgent Announces Two Poster Presentations at SITC 2023 Annual Meeting (Businesswire) - "Fulgent Genetics, Inc...announced two upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, to be held virtually and at the San Diego Convention Center from November 1 to 5, 2023."

Clinical • Clinical data • Diagnostic • Oncology • Solid Tumor

A phase 1 dose escalation/expansion study of FID-007, a novel nanoparticle paclitaxel formulation, in patients with solid tumors. (ASCO 2023) - P1 | "Three out of 4 HNSCC patients with PR had previously been treated with docetaxel. FID has a manageable safety profile and demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated pts across different tumor types. No high-grade neuropathy has been noted to date. RP2D of FID is set at 125mg/m2."

Clinical • P1 data • Alopecia • Anemia • Anorexia • Dermatology • Fatigue • Febrile Neutropenia • Head and Neck Cancer • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Pain • Pancreatic Cancer • Pruritus • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Fulgent Data at ASCO 2023 Highlights Progress for Its Lead Therapeutic Oncology Candidate, FID-007, in Various Cancers (Businesswire) - P1/1b | N=36 | NCT03537690 | "Fulgent Genetics...announced data from a Phase 1/1b clinical study of FID-007 in treating various solid tumors was presented in a poster session at the...ASCO Annual Meeting....Of 40 evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, 7 (18%) had a partial response by RECIST 1.1 (pancreatic, biliary tract, and HNSCC) and 14 (35%) had stable disease. Three out of 4 HNSCC patients with PR had previously been treated with taxane. The duration of follow-up (months), median (range) is 12.0 (0.4 - 38.9). No high-grade neuropathy has been noted to date. FID-007 demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated patients across various tumor types....'We look forward to next steps with this program, including initiation of a Phase 2 clinical study for the treatment of head and neck cancer later this year or early next year'."

New P2 trial • P1 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Fulgent Announces Upcoming Presentation of Clinical Data for Its Lead Therapeutic Oncology Candidate, FID-007, at ASCO 2023 Annual Meeting (Businesswire) - "Fulgent Genetics...announced that Phase 1/1b clinical data on its lead therapeutic development candidate, FID-007, to treat various solid tumors, will be presented at the American Society for Clinical Oncology (ASCO) Annual Meeting at 8:00 a.m. Central Time on June 3, 2023 in Chicago, Illinois."

P1 data • Oncology • Solid Tumor

FID-007 in Treating Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: University of Southern California | Trial completion date: May 2023 ➔ May 2025 | Trial primary completion date: May 2022 ➔ May 2024

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Fulgent Genetics Acquires Fulgent Pharma, Creating a New Paradigm in Precision Medicine for The Company (Fulgent Genetics Press Release) - "Fulgent Genetics...announced today that it has completed an acquisition of Fulgent Pharma Holdings, Inc. ('Fulgent Pharma'), an independent clinical-stage, therapeutics development company focused on the development of innovative cancer treatments. Under the terms of the agreement, Fulgent Genetics acquired Fulgent Pharma for a total purchase price of approximately $100 million, subject to adjustments, to be paid with a combination of cash on hand and shares of common stock of Fulgent Genetics. The combined company plans to offer a vertically integrated solution to combat cancer with the potential to unlock significant long-term upside for both the therapeutic and diagnostic businesses, while effectively managing risk....Attractive Lead Therapeutic Candidate FID-007...is a proprietary nanoencapsulated formulation of paclitaxel developed to improve the overall solubility profile of paclitaxel."

Diagnostic • M&A • Oncology

ANP’s Polymeric Drug Excipient Drug Master File (DMF) Accepted and Published by the U.S. Food and Drug Administration (FDA) (Businesswire) - "ANP Technologies...announced that its drug master file (DMF) on its novel, nano-encapsulating polymer-based drug excipient, ANP001B has been accepted and published by the U.S. Food & Drug Administration (FDA)....The novel nano-encapsulating polymer, ANP001B, is a proprietary polymer composition developed by ANP and has been successfully used in the chemotherapy drug, FID-007 during the clinical trial conducted by ANP and its Partner Fulgent Pharma for the treatment of solid tumors in pre-treated cancer patients."

FDA event • Oncology • Solid Tumor

FID-007 in Treating Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: University of Southern California; Trial completion date: May 2021 ➔ May 2023; Trial primary completion date: May 2020 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

[VIRTUAL] A phase 1 trial of FID-007, a novel nanoparticle paclitaxel formulation, in patients with solid tumors. (ASCO 2021) - P1 | "Clinical Trial Registry Number: NCT03537690 Funding: Fulgent Background: FID-007 (FID) consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability . FID has a manageable safety profile with MTD not reached . Accrual is continuing at 125 mg/m2 . PK is linear, dose proportional and comparable to that of nab-paclitaxel ."

Clinical • P1 data • Alopecia • Anemia • Anorexia • Dermatology • Fatigue • Hematological Disorders • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pruritus • Solid Tumor

EVALUATION OF CYTOTOXIC AND GENOTOXIC EFFECTS OF PACLITAXEL-LOADED PLGA NANOPARTICLES IN NEUROBLASTOMA CELLS. (PubMed, Food Chem Toxicol) - "This study aimed to evaluate the cytotoxicity and genotoxicity of paclitaxel nanoencapsulated with PLGA. Additionally, DNA damage increased with the increase of nanoparticle dose when the cells exposed to paclitaxel loaded PLGA nanoparticles for 24, 48 and 72 hours. It can be concluded that PLGA nanoparticles can be considered as a biocompatible carrier system for drug delivery and might be promising agent against neuroblastoma."

Journal • Immunology • Neuroblastoma • Oncology • Solid Tumor

Longer Patency, Fewer Repeat Procedures With Paclitaxel DCBs in Dialysis Patients - "Robert Lookstein, MD (Icahn School of Medicine at Mount Sinai, New York, NY), lead investigator of the study, said the drug-coated balloon (DCB) fills an unmet need for end-stage renal disease patients, giving them a better overall quality of life. 'From the perspective of a patient who is on hemodialysis several hours a day, multiple days a week, to have a 50% reduction in the number of procedures needed to maintain access patency just at 6-month follow-up, as we saw in this study, is a huge benefit,' he told TCTMD."

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