ANP Technologies, in Partnership with Fulgent Pharma, Teams with Moffitt Cancer Center to Develop a New Class of Leukemia Therapies
Newark, DE (Jan. 10, 2020 ) – ANP Technologies Inc. (ANP) and Fulgent Pharma LLC through their partner Moffitt Cancer Center have successfully licensed the rights to develop a novel targeted therapy in the area of leukemia to Celgene (CELG), now Bristol Myers Squibb (BMY), a landmark deal that leverages ANP’s nanotherapeutic platform technology. The partners will work together to develop a new cancer therapy for Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). The potential new therapy will target a novel pathway receptor.
The Moffitt research team recently discovered that a specific pathway receptor is up-regulated in MDS and AML malignant cells, and in particular the malignant stem cells, thus offering a potentially favorable disease-specific target for therapies. By utilizing a ligand specific for this pathway receptor along with a covalently linked nanoparticle developed by ANP and licensed to Fulgent Pharma, the team was able to show potential for treating this type of leukemia at the stem cell level.
“Moffitt takes a team approach when it comes to cancer care and research. Our immunology and hematology teams worked together on this novel therapy. We are taking it to the next level, partnering with ANP/Fulgent Pharma to help accelerate translating this discovery from the laboratory to patients in need,” said Jarett Rieger, Sr. Director, Innovation & Industry Alliances of Moffitt.
“With our proprietary nano-delivery and nanotherapeutic technology platform, ANP has successfully developed multiple therapies including nanoencapsulated pactlitaxel, which is currently in clinical and licensed to Fulgent Pharma, as well as a nanoencapsulated antibody cocktail of drugs for the treatment of Ebola infection, which was funded for nonhuman primate testing by the US Department of Defense,” says Dr. Ray Yin, President and CEO of ANP. “The Moffitt collaboration expands our nanotechnology platform and spectrum of drug development, enabling ANP and Fulgent Pharma to develop new targeted therapies to benefit cancer patients.”
About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 51 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 6,500 team members, Moffitt has an economic impact in the state of $2.4 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter, Instagram and YouTube.
About ANP Technologies, Inc.
ANP Technologies, Inc. is a world leader in developing innovative nano-therapeutics. In addition to the novel targeted therapy, ANP has also developed nanoencapsulated chemotherapeutics, antibody therapies, immune-oncology and mRNA-based vaccines. 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. The Company’s lead asset, FID-007, is a nanoencapsulated paclitaxel with improved drug solubility and efficacy, as well as decreased toxicity, and is currently tested in clinical trials. Fulgent Pharma was founded in 2015 and is headquartered in Temple City, California. Fulgent Pharma was spun off from Fulgent Genetics, Inc., (NASDAQ:FLGT) a comprehensive genetic testing company, in 2016.
CONTACT:
Greg Witham, MS
302-283-1730
ANP Technologies, in Partnership with Fulgent Pharma, Teams with Moffitt Cancer Center to Develop a New Class of Leukemia Therapies
Newark, DE (Jan. 10, 2020 ) – ANP Technologies Inc. (ANP) and Fulgent Pharma LLC through their partner Moffitt Cancer Center have successfully licensed the rights to develop a novel targeted therapy in the area of leukemia to Celgene (CELG), now Bristol Myers Squibb (BMY), a landmark deal that leverages ANP’s nanotherapeutic platform technology. The partners will work together to develop a new cancer therapy for Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). The potential new therapy will target a novel pathway receptor.
The Moffitt research team recently discovered that a specific pathway receptor is up-regulated in MDS and AML malignant cells, and in particular the malignant stem cells, thus offering a potentially favorable disease-specific target for therapies. By utilizing a ligand specific for this pathway receptor along with a covalently linked nanoparticle developed by ANP and licensed to Fulgent Pharma, the team was able to show potential for treating this type of leukemia at the stem cell level.
“Moffitt takes a team approach when it comes to cancer care and research. Our immunology and hematology teams worked together on this novel therapy. We are taking it to the next level, partnering with ANP/Fulgent Pharma to help accelerate translating this discovery from the laboratory to patients in need,” said Jarett Rieger, Sr. Director, Innovation & Industry Alliances of Moffitt.
“With our proprietary nano-delivery and nanotherapeutic technology platform, ANP has successfully developed multiple therapies including nanoencapsulated pactlitaxel, which is currently in clinical and licensed to Fulgent Pharma, as well as a nanoencapsulated antibody cocktail of drugs for the treatment of Ebola infection, which was funded for nonhuman primate testing by the US Department of Defense,” says Dr. Ray Yin, President and CEO of ANP. “The Moffitt collaboration expands our nanotechnology platform and spectrum of drug development, enabling ANP and Fulgent Pharma to develop new targeted therapies to benefit cancer patients.”
About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 51 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 6,500 team members, Moffitt has an economic impact in the state of $2.4 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter, Instagram and YouTube.
About ANP Technologies, Inc.
ANP Technologies, Inc. is a world leader in developing innovative nano-therapeutics. In addition to the novel targeted therapy, ANP has also developed nanoencapsulated chemotherapeutics, antibody therapies, immune-oncology and mRNA-based vaccines. 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. The Company’s lead asset, FID-007, is a nanoencapsulated paclitaxel with improved drug solubility and efficacy, as well as decreased toxicity, and is currently tested in clinical trials. Fulgent Pharma was founded in 2015 and is headquartered in Temple City, California. Fulgent Pharma was spun off from Fulgent Genetics, Inc., (NASDAQ:FLGT) a comprehensive genetic testing company, in 2016.
CONTACT:
Greg Witham, MS
302-283-1730
ANP Technologies Achieves ISO 9001:2008 Certification for Quality Management
Newark, DE (March 11, 2013) – ANP Technologies, Inc., a world leader in developing and commercializing various nanobiotechnology-based products for applications related to immunogenicity, biodefense, biologic drug development and therapeutic drug delivery, today announced that it has received the International Organization for Standardization ISO 9001:2008 certification for its quality management system.
ISO 9001:2008 is accepted worldwide as the standard that defines quality. The certification demonstrates ANP’s continued
commitment to meeting the high standards required for the development and manufacturing of assay for biological/chemical
substances and laboratory reagents. ANP‘s quality system was assessed by TUV USA Inc., which conducted multiple audits and
awarded certification in March 2013.
“We believe that receiving ISO 9001:2008 certification is a significant accomplishment and an important milestone as we approach the global commercialization of many of our new products, such as our PEG Immunogenicity ELISA Kit and ACE Acetylcholinesterase Inhibitor Detection Test," said Florence Malinowski, ANP’s Director of Quality Assurance.
“Achieving the ISO 9001:2008 certification reflects our continuous efforts to achieve superior product quality and reliability, and assures our customers that our processes are well-documented and products are well-tested,” said Dr. Ray Yin, president and CTO of ANP.
About ANP Technologies, Inc.
ANP Technologies, Inc. is a world leader in developing and commercializing various nanobiotechnology-based products for applications related to immunogenicity, biodefense, biologic drug development/testing and therapeutic drug delivery.
The U.S. Food and Drug Administration (FDA) has granted approval for ANP Technologies, Inc. and its partner to begin Phase I clinical trials with its first drug – nanoencapsulated paclitaxel.
Newark, DE (February 27, 2018 ) – The U.S. Food and Drug Administration (FDA) has granted approval for ANP Technologies, Inc. and its partner to begin Phase I clinical trials with its first drug – nanoencapsulated paclitaxel. This new broad-spectrum cancer therapy is designed for intravenous (IV) delivery to combat several types of cancer, including breast, lung, ovarian, prostate, and others. Utilizing ANP’s patented nano-drug delivery platform, nanoencapsulated paclitaxel has performed exceptionally well in pre-clinical investigations, boasting similar or better efficacy over existing blockbuster treatment, such as Abraxane (Celgene). “Getting the FDA’s approval is an important validator for our platform drug delivery technology,” explains Dr. Ray Yin, president and CTO of ANP. “It paves the way for ANP to further develop and implement the platform technology in a variety of drug-related applications.”
ANP and its partners have several other drugs in their pipeline, including an antibody cocktail against the Ebola virus, targeted therapies to treat Acute Myeloid Leukemia (AML), as well as several other immune-oncology and mRNA-based vaccine therapies.
About ANP Technologies, Inc.
ANP Technologies, Inc. is a world leader in developing and commercializing various Nano-biotechnology-based products for applications in Nano-therapeutics, immunogenicity testing, chemical and biological defense, medical diagnostics, and food safety testing.
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.
CONTACT:
Greg Witham, MS
302-283-1730