ANP Technologies and its Partner Fulgent Pharma Successfully Reached Targeted Therapeutic Dosage Level in Phase I Clinical Trial for Its Nano-Paclitaxel Drug
Newark, DE (May 19, 2021) – ANP Technologies Inc. (ANP) and its Partner Fulgent Pharma LLC announced that their Phase I clinical trial of FID-007 has reached its targeted dosage level of 125 mg/m2 for the treatment of solid tumors in pre-treated cancer patients. The clinical trial is currently performed at the University of Southern California (USC) Norris Comprehensive Cancer Center. The results are published at the American Society of Clinical Oncology (ASCO) Annual Meeting (ASCO FID-007).
FID-007 consists of paclitaxel encapsulated in a novel polyethyloxazoline (PEOX) polymer excipient designed by ANP Technologies to enhance its pharmacokinetics (PK), biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle preferentially delivers paclitaxel to the tumor through the leaky hyperpermeable vasculature. In xenograft studies, FID-007 reduced or limited tumor volume growth in multiple tumor types including lung, gastric, breast, pancreatic, and ovarian cancer. FID-007 was more effective at lower or comparable doses with fewer side effects when compared with paclitaxel and nab-paclitaxel.
Twenty-five heavily pre-treated patients were treated with FID-007 across 6 dose levels. All grade treatment related adverse events (TRAEs) in ≥ 25% of patients were rash (64%), alopecia (52%), pruritus (44%), anemia (44%) leukopenia, fatigue (40% each), dysgeusia, anorexia, nausea (32% each), and neutropenia (28%). Grade 3/4 TRAEs occurring in > 1 patient were anemia (20%), neutropenia, leukopenia, and maculopapular rash (16%). There were no treatment discontinuations due to toxicity.
FID-007 has a manageable safety profile with maximum tolerated dose (MTD) not reached. Accrual is continuing at 125 mg/m2. PK is linear, dose proportional and comparable to that of nab-paclitaxel. There is preliminary evidence of anti-tumor activity in heavily pre-treated pts across different tumor types.
“This study is an additional clinical validation of our nano-delivery system. The same nano-delivery system has also been applied to a nanoencapsulated antibody cocktail for the treatment of Ebola infection, which was funded by the US Department of Defense.” says Dr. Ray Yin, President and CEO of ANP. “We are currently working on nanoencapsulated small and large molecule drugs for various treatment including cancer and infectious diseases such as COVID-19.”
About ANP Technologies, Inc.
ANP Technologies, Inc. is a clinical stage biopharmaceutical company and a world leader in developing innovative nano-therapeutics and nano-diagnostic tests. ANP has been a premier provider of rapid, multiplexed lateral flow tests for the detection of various biological agents to the Department of Defense over the past decade, as well as successfully licensed various pre-clinical and clinical stage nanotherapeutics to companies such as Celgene/BMS and Fulgent Pharma. In addition, ANP has also developed COVID-19 antigen and neutralizing antibody rapid tests. Visit anptinc.com for more information.
About Fulgent Pharma
Fulgent Pharma is a clinical-stage specialty pharmaceutical company developing oncology therapies that leverage a proprietary nano-drug delivery technology. Fulgent Pharma’s pipeline features three unique drug platforms: nanoencapsulated chemotherapy drugs being developed via the 505(b)(2) pathway, novel targeted therapies, and small molecule based immuno-oncology drugs.
Greg Witham, MS