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.
Diagnostics and Reagents Technology
Click Below to Quickly Search this Page:
The NIDS® technology enables lateral flow assays to increase sensitivity, improve precision, reduce false positive rates and Hook effect, as well as establish quantitation. To demonstrate the reach and versatility of its patented NIDS® technology, ANP has developed rapid lateral flow immunoassays for the quantitative measurement in a 5 µL sample of whole blood of myeloperoxidase (MPO)* and C-Reactive Protein (CRP)*. Assay test strips are measured using the NIDS® standalone handheld reader.
Myeloperoxidase (MPO) POCT Rapid Assay
By using a diluted fingerstick whole blood sample and ANP’s nanomanipulation technology based rapid assays, the NIDS® MPO rapid assay overcomes the challenges faced by MPO ELISAs of unreliable quantitation of the protein in whole blood and the instability of protein levels in serum and plasma due to the protein’s continued release from leukocytes over time. MPO is the earliest detectable biomarker released when a patient with chest pains is truly suffering a myocardial infarct (MI). Its levels are also predictive of a recurrent MI event 30 days and 6 months after the initial event. The assay requires only 5 µL of fingerstick whole blood from the patient.
Figure 1. POCT rapid assays for Myeloperoxidase (MPO) and C-Reactive Protein (CRP)
C-Reactive Protein (CRP) POCT Rapid Assay
CRP levels are being used to stratify a healthy person’s risk for future cardiovascular disease. It is also an efficient tool to distinguish between viral and bacterial infection in sick individuals. The assay requires only 5 µL of fingerstick whole blood from the patient. ANP offers diagnostic assay development services and technology licensing opportunities to potential partners to fully exploit and commercialize these assays and other emerging targets.
Nanomanipulation-NIDS® High Sensitivity HyperBind ELISA Plates
Reference: Vallejo YR, Li J, Yin R. Enhancing assay performance using nanoscale detection. IVD Technology,Volume 16, May/June 2010
Please click here for a list of available HyperBind activated ELISA plates
High Sensitivity NIDS® HyperBind activated streptavidin or neutravidin-coated ELISA plates have proven to be the most sensitive ELISA plates for Serological Assays. These plates deliver dramatically enhanced sensitivity using significantly reduced levels of antigens for serological assays such as those for the detection of antibodies to proteins associated with HIV, HCV, the TORCH panel (toxoplasma, rubella, CMV, herpes simplex), various viral, bacterial and parasitical infectious diseases such as influenza, typhoid fever, lyme disease, allergy and a wide range of autoimmune diseases. Serological assays are also important in detecting the immunogenicity of biotherapeutic proteins.
Advantages:
-
High Efficiency Coating
-
Low-cost
-
Ready to use: plates are pre-blocked with BSA
-
Sensitive: Detection of < 1 ng/mL of antibody or protein is easily attainable
-
Specific: High signal to noise ratios with low background
-
Stable: > 18 months at room temperature
Serologic methods have in common the use of a solid surface onto which is coated a bioreactive immunogenic protein. These biomolecules are typically complex long chain structures possessing optimal 3-dimensional conformation with specific loci for binding sites or epitopes. The conventional deposition of bioactive molecules onto solid surfaces is an inefficient and random process. For example, antibodies can easily be coated onto a plastic surface but only a subset of the deposited molecules will have the Fab binding regions available for reaction (Figure 1). This randomness limits both the binding capacity and sensitivity of assays that depend on conventional coating technology.
The Nano-Intelligent Detection System (NIDS®) technology has been designed to control the orientation of bioactive molecules at the nanoscale level by using a polymeric scaffold covalently conjugated to a binder such as an antibody1. Within this conjugate structure, the polymeric scaffold preferentially attaches itself to the solid surface, and extends the antigen away from the surface for most advantageous immunoreaction.The result of this innovation is a coated surface that exhibits greater binding efficiency.
Figure 2. Orientation of antibodies is random in conventional coating and optimally oriented with NIDS® nano-orientation technology
High Sensitivity NIDS® HyperBind plates deliver to users assays of greater sensitivity along with significantly reduced reagent usage, which is a critical consideration when these coating proteins are difficult to isolate and expensive to acquire.
High Sensitivity HyperBind plates are available in clear, black, and white formats for colorimetric, fluorometric and chemiluminescent assay formats, respectively. Our plates have been compared to many commercial plates. The nanoscale orientation achieved by conjugating Streptavidin or Neutravidin to the anchoring polymeric scaffold has led to impressive performance enhancements.
Comparison of Direct Binding of Biotinylated Proteins for Serological Assays
High Sensitivity HyperBind strreptavidin (SA) coatedplates exhibit greater binding efficiency of biotinylated proteins than leading commercial SA plates (Figure 2). In a representative model serological assay, 100 μL of increasing concentrations of biotinylated mouse IgG antibody are added to the wells of a High Sensitivity HyperBind, a Nunc Immobilizer™, a Pierce HBC Reacti-Bind™, and an R&D Systems EvenCoat™ plate and incubated for an hour on a platform shaker. After washing, 100 μL of rabbit anti-mouse IgG conjugated to horseradish peroxidase (HRP) are added to the wells and allowed to incubate for an hour and a half on a platform shaker. Following a wash step, the substrate/chromogen reagent consisting of hydrogen peroxide and tetramethylbenzidine(TMB) is added to the wells and color allowed to develop for 20 minutes, stopped with 2N sulfuric acid and the absorbance measured at 450 nm.
Figure 3. The binding efficiency of HyperBind clear plates is significantly greater than leading commercial plates.
White plates were also treated with NIDS®-activated Streptavidin for use in chemiluminescence-based assays. The binding efficiency of the HyperBind™ plates was shown to be superior to that of the Nunc Immobilizer™ white plate using the test procedure with biotinylated mouse IgG previously described and a chemiluminescent substrate reagent.
Figure 4. Binding efficiency of HyperBind™ black Streptavidin (SA) and Neutravidin (NA) plates is superior to that of commercial plates.
White plates were also treated with NIDS®-activated Streptavidin for use in chemiluminescence-based assays. The binding efficiency of the HyperBind™ plates was shown to be superior to that of the Nunc Immobilizer™ white plate using the test procedure with biotinylated mouse IgG previously described and a chemiluminescent substrate reagent.
Figure 5. Binding efficiency of HyperBind white Streptavidin (SA) plates is superior to that of a commercial plate.
The conclusion derived from the above experiments is that for a given concentration of biotinylated protein added to the microwells, more is bound by the High Sensitivity NIDS® HyperBind clear, black, and white plates than the Pierce, R&D Systems, and Nunc plates. This finding translates to significantly better assay performance and major reductions in reagent use and cost when designing Serological Assays.
In addition, High Sensitivity NIDS® HyperBind plates can also be used for competitive assays and direct detection analytical methods which require immobilization of antigens directly on a solid surface.
Endogenous Protein Extraction Using NIDS® Nanoparticles
Development of a clinical assay for measuring anti-drug antibodies against a monoclonal antibody drug: Overcoming soluble target interference. Qiang Qu, Alok Rathi, Boris Gorovits, Deborah Finco, Rosalin Arends, Chun-Hua Cai, Jim McNally, poster, AAPS NBC Meeting, May 2013 (Pfizer Research and Development)
Methods for measuring analytes in biological matrices are susceptible to endogenous interfering proteins which can significantly affect the accuracy and validity of test results. Interfering substances such as endogenous binding proteins, free drug molecules, blockers, immune complexes, and receptors can be removed from the sample using a binding agent (such as an antibody) attached to our NIDS® extracting nanoparticles. ANP is the only company that offers a simple and effective solution for a broad range of customers that need to remove such interfering substances in their bioanalytical assays.
Our NIDS® nanoparticle based universal protein extraction kits exhibit the following advantages:
1. Smaller diameter, greater surface area compared to micron-size magnetic particles which are the current particles of choice. Extraction efficiency and capacity are significantly enhanced. Up to 1 µg/mL of endogenous interfering protein can be removed.
2. Binding agents are optimally oriented. The binding agents are attached using our NIDS® chemistry which employs proprietary linkers that orient the binding sites outwardly to capture their targets most efficiently. Other particle-coating chemistries will not work as well.
3. Less binding agent used. As much as 100-fold less of scavenging agents such as antibodies is required.
4. Easy to use procedure. Optimal loading and particle usage are easily calculated.
5. Flexible universal platform. Any protein or nucleic acid can be coated onto our nanoparticles. The customer can choose from a list of binding agents for 140 different endogenous proteins currently available or provide their own binding agents for attachment to the extraction nanoparticles.
Bioanalytical methods such as diagnostic, pharmacokinetic, pharmacodynamic, and immunogenicity assays have shown improved accuracy and sensitivity after sample pretreatment using these innovative extraction nanoparticles linked to target-specific off-the-shelf binding reagents such as antibodies. Our NIDS® nanoparticle based protein extraction kits are currently being used by leading biopharmaceutical companies in various stages of drug development.
NIDS® High Throughput Screening (HTS) System for Antibody Drugs
ANP has developed a high throughput system for high volume screening of test samples on rapid immunogenicity assay test strips. A multistrip carrier, a tray that can hold test strips for 12 patient samples, is the basic test device in this system. This carrier has the same footprint and layout of a 96-well ELISA microplate so that it is fully compatible with available ELISA robotic systems. Sample incubation and transfer to test strips can therefore be automated, with the finished strips being read in their trays by the NIDS® HTS reader. With antigen usage substantially reduced, the HTS provides a significantly faster (less than 15 min) and simpler (one-step) low-cost alternative to multi-step ELISA-based screening for the development of antibody drugs.
Figure 6. A Multistrip Carrier holding 12 rapid assay test strips
Figure 7. The ANP NIDS® High Throughput Screening reader. Two multistrip carriers are ready to be read on the two trays on the right. Results are displayed on the top screen as shown.