3.01.2024
Abzyme Awarded NIH Phase II SBIR Grant for Developing Multi-specific Long-acting Antibodies for Treatment of Retinal Neovascular Diseases
Royersford, PA, March 01, 2024. Retinal neovascular diseases including neovascular age-related macular degeneration (AMD), diabetic macular edema and retinal vein occlusion are the most vision-threatening diseases among the developed world working-age population. Around 200 million people worldwide, and 20 million adults in the U.S are thought to be living with AMD. The risk of getting advanced AMD increases from 2% for those ages 50-59, to nearly 30% for those over the age of 75. Therapies targeting vascular endothelial growth factor (VEGF) delay the development of neovascularization in some, but not all patients, implicating additional factor(s) in retinal neovascular pathogenesis. In addition, the currently required frequent intraocular injection is a significant burden for both patients and physicians, and entails a small risk of endophthalmitis, uveitis, vitreous hemorrhage and other complications. Thus, there is much needed a retinal neovascular disease treatment that can be delivered less frequently and yet provides the same or better improvement in vision than current anti-VEGF therapies.
Abzyme Therapeutics LLC and its collaborators, Drs. Yoonjee Park of The University of Cincinnati and Bärbel Rohrer of The Medical University of South Carolina, have been awarded a $1,657,994 Small Business Innovation Research (SBIR) Phase II Grant by the National Eye Institute (NEI). This project entitled “Multi-specific long-acting antibodies for the treatment of retinal neovascular diseases” is aimed at developing a potent and long-acting camelid-derived multi-specific antibody targeting both VEGF and extracellular MMP inducer (Emmperin/Basigin/CD147) to prevent choroidal neovascularization. The phase II award is the continuation of a successful prior SBIR phase I research grant awarded by NIH/NEI.
The NIH SBIR program is a highly competitive program for small businesses that seek to commercialize innovative technologies with biomedical applications. The program helps small businesses participate in federal research and development, develop life-saving technologies and medicines, and create jobs.
“We are extremely pleased to be recognized with this highly competitive award from the NIH SBIR program” said Dr. Tran, CEO and co-founder of Abzyme. “This SBIR grant will provide us additional funding to develop a novel therapeutic that covers a broader spectrum of retinal neovascular disease patients and with less frequency of dosing”.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on developing and engineering modular antibodies with novel attributes for immunotherapy using proprietary antibody generation platforms. Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties, such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity. The platforms have been successfully applied to develop antibodies with defined attributes as well as to re-engineer existing antibodies to be conditionally active. Abzyme offers fee-for-services in antibody discovery and engineering, including conditionally active antibodies.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
7.05.2023
Abzyme's Abz495: pH-dependent Anti-CD3 T-cell Engager Available for Licensing
Royersford, PA, July 05, 2023. T-cell-engaging antibodies bound to target cells are known to trigger the cytotoxic activity of T-lymphocytes by crosslinking to CD3, irrespective of T-cell receptor specificity, major histocompatibility (MHC) restriction, or MHC downregulation on tumor cells. However, expression of tumor antigens on normal tissues can lead to “on-target, off-tumor” activation of T-cells outside of tumors. Cytotoxic T-cell activity to normal cells can cause life-threatening side effects that limit the dose escalation required to achieve therapeutic efficacy against solid tumors.
Due to poor vascular perfusion, regional hypoxia, and fermentative glycolysis, the extracellular pH in most solid tumors is in the 6.0–6.8 range while non-cancerous cells maintain their extracellular pH at physiological levels (7.3–7.4). Thus, an antibody that binds strongly to tumor-associated antigens (TAA) at acidic pH (pH 6.0 – pH 6.8), but with no or reduced binding at normal pH, will significantly reduce on-target, off-tumor toxicity. Abzyme Therapeutics has successfully engineered an anti-CD3 antibody that binds to the T-cell CD3 receptor in a pH-dependent manner.
The patent-pending pH-dependent anti-CD3 antibody (Abz495) is now available for those who are interested in generating pH-dependent T-cell engagers for treatment of solid tumors. Abzyme also provides tailored pH engineering for your existing antibodies. Avoiding unwanted T-cell activation outside the tumors would reduce potential T-cell-mediated side effects and allows dose escalation in the course of treatment. The technology will allow dose-escalation and improve tumor antibody accumulation to achieve therapeutic efficacy end-points.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on antibody discovery and engineering using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation, in combination with a FACS single-cell sorting approach to identify desired antibodies. Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties, such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity. The platforms have been successfully applied to develop antibodies with defined attributes as well as to re-engineer existing antibodies to be conditionally active. Abzyme offers fee-for-services in antibody discovery and engineering, including conditionally active antibodies.
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas, including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
6.5.2023
Abzyme Awarded National Institutes of Health SBIR Grant for Selecting Immune Escape Protein Variants
Royersford, PA, June 05, 2023. Biologics have been widely accepted for treatment of a variety of human diseases, including cancer, arthritis and infectious diseases. Many therapeutic biologics are derived from non-human organisms and consequently, administration of the foreign proteins into humans will cause immune reactions from the human host. One consequence of these reactions is that the host will produce anti-drug antibodies (ADA) to neutralize the administered biologics, thus reducing its therapeutic efficacy, preventing repeated use and causing other adverse effects. Abzyme is addressing the problem of immunogenicity to biologics by developing a system to generate glycosylated protein mutants and a method for selecting immune-escaping but functionally active variants.
Abzyme and collaborator, Dr. Naomi Schlesinger, gout disease expert of the University of Utah, have been awarded a $299,999 Small Business Innovation Research (SBIR) Phase I Grant by the National Institute of Allergy and Infectious Diseases (NIAID). The SBIR grant project entitled “Novel immune-escape uricase for treatment of hyperuricemia” is aimed at developing glycosylated uricases capable of escaping the host immune system for treatment of hyperuricemia.
The NIH SBIR program is a highly competitive program for small businesses that seek to commercialize innovative technologies with biomedical applications. The program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs.
“We are extremely pleased to be recognized with this highly competitive award from the NIH SBIR program” said Dr. Tran, CEO and co-founder of Abzyme. “This SBIR grant plays a vital role in expanding our antibody development and engineering capabilities. We are grateful for the continued support towards our mission of developing therapeutic antibodies”.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on antibody discovery and engineering using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation, in combination with a FACS single-cell sorting approach to identify desired antibodies. Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties, such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity. The platforms have been successfully applied to develop antibodies with defined attributes as well as to re-engineer existing antibodies to be conditionally active. Abzyme offers fee-for-services in antibody discovery and engineering, including conditionally active antibodies.
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas, including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
5.15.2023
Abzyme to Present at 19th PEGS Congress in Boston, Massachusetts
Royersford, PA, May 15, 2023. Abzyme Therapeutics LLC will present at the PEGS’ 19th, “The Essential Protein Engineering and Cell Therapy Summit,” from May 15 to May 19, 2023, in Boston, Massachusetts. Dr. Hiep Tran, Chief Scientific Officer, will present Abzyme Therapeutic’s new data related to progressive multiple sclerosis immunotherapy. His presentation title is “Dual Action Antibodies for Treatment of Progressive Multiple Sclerosis.”
Abzyme Therapeutics has developed two cross-species reactive nanobodies capable of overcoming the blood-brain barrier. The first antibody is a potent complement pathway inhibitor, designed to inhibit antibody-mediated inflammation and cell destruction. The second antibody is an analog to brain-derived neurotrophic factor, BDNF, capable of stimulating nerve cell growth. Therapeutic efficacy of these antibodies was validated in a well-characterized murine model of progressive MS, Theiler’s murine encephalomyelitis virus-induced demyelinating disease (TMEV-IDD). Treatment with either one antibody significantly improved the progressive neurological impairment in TMEV-IDD mice. These exciting results were obtained thanks to the funding from the National Institutes of Health under the SBIR grant R43 NS120624-01, in collaboration with Dr. Francesca Gilli, professor of Neurology at Dartmouth College, Hanover, New Hampshire. Abzyme is seeking partners to further validate these antibodies in other CNS disorders, including traumatic brain injuries (TBI) and Alzheimer’s Diseases.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on antibody discovery and engineering using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation, in combination with a FACS single-cell sorting approach to identify desired antibodies. Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties, such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity. The platforms have been successfully applied to develop antibodies with defined attributes as well as to re-engineer existing antibodies to be conditionally active. Abzyme offers fee-for-services in antibody discovery and engineering, including conditionally active antibodies
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas, including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
8.24.2022
Abzyme Files Patent Application for Selecting Immune Escape Protein Variants
Royersford, PA, August 24, 2022. Abzyme Therapeutics LLC, a biotech company focused on developing biologics for therapeutic applications, has filed a patent application entitled “A System for Selecting Immune Escape Protein Variants”, USPTO number 17/821,885. This patent application is an important step forward for Abzyme Therapeutics solidifying its intellectual property position in the field of biotherapeutic development.
Biologics have been widely accepted for treatment of a variety of human diseases, including cancer, arthritis and infectious diseases. Many therapeutic biologics are derived from non-human organisms and consequently administration of the foreign proteins into humans will cause immune reactions from the human host. One consequence of these reactions is that the host will produce anti-drug antibodies or ADA to neutralize the administered biologics, thus reducing its therapeutic efficacy, preventing repeated use and causing other adverse effects.
To reduce immunogenicity, foreign enzymes of non-human origin such as Uricases or Asparaginase typically are subjected to chemical conjugation with polyethylene glycols (PEGylation). However, the dense polyethylene glycol (PEG) multimers do not prevent antigenicity. Analysis of pre-existing IgG and IgM antibodies against polyethylene glycol (PEG) in the general population reveals detectable levels of anti-PEG Ab in ∼72% of contemporary specimens. Most patients exhibit seroconversion following administration of the initial dose. After six months of PEGylated-uricase (pegloticase) treatment, 89% of patients had measurable anti-pegloticase antibodies, 41% had high titers and became non-responders. Anti-PEG antibodies can accelerate the clearance of pegylated medicines from the circulation, resulting in loss of drug efficacy. Hence PEGylation of biologics, while improving therapy, does not resolve the current limitation on use of foreign proteins for treatment of human disease.
Abzyme is addressing the problem of biologics immunogenicity by developing a system to generate a glycosylated protein repertoire and a method for selecting its immune escape functional variants.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on developing modular single domain VHH antibody fragments for immunotherapy using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation in combination with a FACS single cell sorting approach to identify desired antibodies. Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity.
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information and interest in licensing this technology, please contact:
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
4.5.2022
Abzyme Awarded Highly Competitive National Institutes of Health SBIR Grant for Multiple Sclerosis Treatment
Royersford, PA, April 05, 2022. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic applications, has been awarded a $399,107 Small Business Innovation Research (SBIR) Phase I Grant by the National Institute of Neurological Disorders and Stroke (NINDS) to develop brain-cell penetrating therapeutic antibodies for treatment of progressive multiple sclerosis. The SBIR grant project entitled “Brain-cell penetrating antibodies for treatment of progressive multiple sclerosis” is aimed at developing bispecific antibodies that can overcome the blood-brain barrier and can prevent CNS inflammation caused by classic complement reaction and simultaneously stimulate nerve cell growth. In this project, Abzyme is collaborating with Dr. Francesca Gilli’s group from the Dartmouth University where therapeutic efficacy of the engineered antibodies will be evaluated in the progressive multiple progressive TMEV-IDD mouse model.
The NIH SBIR program is a highly competitive program for small businesses that seek to commercialize innovative technologies with biomedical applications. The program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs. Abzyme will use its innovative antibody development and engineering platforms to produce multi-specific antibodies that inhibit enzymatic activities of the complement pathway on one hand and stimulate nerve cell growth on the other.
“We are extremely pleased to be recognized with this highly competitive award from the NIH SBIR program” said Dr. Tran, CEO and co-founder of Abzyme. “This SBIR grant plays a vital role in expanding our antibody development capabilities. We are grateful for the continued support towards our mission of developing therapeutic antibodies”.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on developing modular single domain VHH antibody fragments for immunotherapy using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation in combination with a FACS single cell sorting approach to identify desired antibodies. Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity.
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
4.6.2021
Abzyme Patent for Generating Bispecific Functional Agents Issued
Royersford, PA, April 06, 2021. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic applications can report another important achievement: USPTO has reviewed and approved its patent application entitled “Method for Generating Bispecific Functional Agents“, with the issuance of US patent number 10,968,444. The issuance of this patent is another important milestone for Abzyme Therapeutics in expanding its IP portfolio. The present invention provides a method for preparing a modular scaffold that can bind to a target antigen and a method for engineering a bispecific functional agent consisting of an existing polypeptide binder fused at its C-terminus with said modular scaffold. In a particular application of the invention, an existing antibody can be rapidly transformed into an IgG-like bispecific antibody while preserving its original target binding affinity and Fc effector function.
Compared to traditional antibodies, bispecific antibodies offer a significant improvement in therapeutic index. However, the use of bispecific antibodies has been hindered by difficulties in producing them in sufficient quantity and purity. The two main limitations for the use of bispecific functional agents are manufacturabity (e.g., difficulties in large scale production of pure bispecific antibodies, aggregation caused by non-natural structure, heavy- and light-chain mispairing in the case of scFv) and poor pharmacokinetic and pharmacodynamic properties including immunogenicity, short serum half-life, or loss of Fc effector function caused by the lack of the fragment crystallizable (Fc) region. Accordingly, there remains a critical need for easily engineered bispecifics with superior properties, like low immunogenicity and long half-life in humans that can be readily produced at high yield from mammalian cell culture while preserving the functional activity of the antibody components. The present invention addresses each of these problems by providing a method and composition for rapid reformatting of existing IgG antibody into well-expressing IgG-like bispecific antibody.
“This invention is very important step forward for Abzyme Therapeutics”, said Dr. Tran, CEO and co-inventor of this patent. “This patent issuance not only further solidifies our IP position in the field of antibody engineering, but also allows open conversation with our clients. We are excited to see how this technology can rapidly convert existing antibodies into well-expressing easy-to-purify IgG-like bispecific antibodies. The invention truly makes our work easier”.
For further information and interest in licensing these novel anti-CD3 antibodies, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
11.16.2020
Abzyme Files Patent Application for pH-dependent anti-CD3 Antibodies
Royersford, PA, November 16, 2020. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic applications, has filed a patent application entitled “Antibodies Binding to Human CD3 at Acidic pH”, USPTO number 63/109,005. This patent application is an important step forward for Abzyme Therapeutics solidifying its intellectual property position in the field of therapeutic antibody development.
Monoclonal antibodies are widely used for treatment of various cancers. On-target off-tumor binding to normal tissues is an obvious toxicity concern as many tumor-associated antigens are expressed in both tumor and normal tissues. Optimization of specific tumor targeting could be achieved by taking advantage of the extracellular acidity of solid tumors relative to normal tissues. Due to poor vascular perfusion, regional hypoxia, and fermentative glycolysis, the extracellular pH in most solid tumors is in the 6.0–6.8 range. In contrast, non-cancerous cells maintain their extracellular pH at physiological levels (7.3–7.4). Thus, an antibody with high binding affinity at acidic pH (pH 6.0 – pH 6.8), but with none or reduced binding affinity at normal pH will significantly minimize the on-target off-tumor toxicity. Tumor-microenvironment or TME-specific antibodies with reduced or no on-target off-tumor binding would find potential application in various forms of antibody-mediated and cell-mediated therapies including antibody monotherapies, antibody-drug conjugate or ADC therapy, T cell-engaging immunotherapy and CAR-T. TME-specific antibodies will reduce on-target off-tumor adverse effects while allowing dose-escalation
The invention provides for new anti-hCD3 antibodies that, in contrast to prior art anti-CD3 antibodies, bind specifically to human CD3 at acidic pH, but do not significantly bind to human CD3 at neutral or physiological pH, methods to produce these antibodies and therapeutic uses of these antibodies. These antibodies are able to activate T cells at acidic pH while having significantly reduced activity at neutral or physiological pH.
“We successfully created anti-CD3 antibodies that bind and activate human T cells at acidic pH that will be an important foundation for engineering bispecific T-cell engaging antibodies for solid tumors. As we pride ourselves as innovators, we are extremely pleased to achieve this milestone filing this application” said Dr. Tran, CEO and co-founder of Abzyme. “In addition, using the same approach, we were able to develop other pH-dependent antibodies targeting the acidic tumor microenvironment”.
For further information and interest in licensing these novel anti-CD3 antibodies, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
10.29.2019
Abzyme to Present at Drug Discovery Conference at Princeton University
Royersford, PA, October 29, 2019. Abzyme Therapeutics LLC will present at the Drug Discovery Conference at Princeton University on Friday, November 1, 2019. Dr. Rajesh Singh, Laboratory Director will be a presenter.
Dr. Singh’s presentation will focus on the uniqueness and advantages of camelid VHH single domain antibodies over conventional antibodies, Abzyme’s high-throughput VHH antibody development approach and application of VHHs in multi-specific antibody engineering and immunotherapy. He will present data related to discovery of agonist and antagonist VHH antibodies to two therapeutic targets. Agonist VHHs act as cell signaling activators, while antagonist VHHs are enzymatic inhibitors. Multi-specific antibodies were generated combining both agonistic and antagonistic activities.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on developing modular single domain VHH antibody fragments for immunotherapy using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation in combination with a FACS single cell sorting approach to identify desired antibodies. . Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity.
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
10.20.2019
Abzyme Awarded Highly Competitive National Institutes of Health SBIR Grant for Pemphigus Treatment
Royersford, PA, October 20, 2019. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic application, has been awarded a $280,352 Small Business Innovation Research (SBIR) Phase I Grant by the National Institutes of Health (NIH) to develop pemphigus-specific T cell engagers for pemphigus targeted immunotherapy. The engagers are designed to direct host T-cells to eliminate only pathological pemphigus-specific autoantibody-producing B cells, while sparing normal antibody-producing B cells.
The NIH SBIR program is a highly competitive program for small businesses that seek to commercialize innovative technologies with biomedical applications. The program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs. Abzyme will use its innovative antibody development and engineering platforms to produce multispecific antibodies capable of directing the patient’s T-cells to seek and eliminate pathological pemphigus-specific antibody-producing B cells.
“We are extremely pleased to be recognized with this highly competitive award from the NIH SBIR program” said Dr. Tran, CEO and co-founder of Abzyme. “This SBIR grant plays a vital role in expanding our antibody development capabilities. We are grateful for the continued support towards our mission of developing therapeutic antibodies”.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on developing modular single domain VHH antibody fragments for immunotherapy using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation in combination with a FACS single cell sorting approach to identify desired antibodies. Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity.
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
09.16.19
Abzyme to Present at MarketsandMarkets Next Gen Immuno-Oncology Congress
Royersford, PA, September 16, 2019. Abzyme Therapeutics LLC will present at the 2nd Annual MarketsandMarkets Next Gen Immuno-Oncology Congress on Thursday, September 19, 2019, in Philadelphia, USA. Dr. Rajesh Singh, Laboratory Director will present at the conference at 9:40 a.m. Eastern standard time.
Dr. Singh’s presentation will focus on the uniqueness and advantages of camelid VHH single domain antibodies over conventional antibodies, Abzyme’s high-throughput VHH antibody development approach and application of VHHs in multi-specific antibody engineering and immunotherapy.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on developing modular single domain VHH antibody fragments for immunotherapy using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation in combination with a FACS single cell sorting approach to identify desired antibodies. . Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity.
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
05.29.19
Abzyme Awarded NIH Contract for Strategies to Improve HIV Envelope Protein Expression and Yield
Royersford, PA, May 29, 2019. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic applications, has been awarded a $299,808 Small Business Innovation Research (SBIR) Phase I Contract by the National Institute of Allergy and Infectious Diseases for implementation of strategies to improve HIV envelope protein expression and yield.
The National Institutes of Health (NIH) SBIR program is a highly competitive program for small businesses that seeks to commercialize innovative technologies with biomedical applications. This highly competitive program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs.
The promising efficacy seen in the clinical trials of HIV-1 vaccine RV144 creates a critical need for new strategies/technologies that enable development of high yielding GMP manufacturing processes for HIV antigens. Current production processes are low yielding and commercially difficult. Using its proprietary antibody generation platform, Abzyme Therapeutics will develop camelid VHH antibodies that are capable of enhancing gp120 production when they are co-expressed. The effort in Phase II will be to develop stable VHH-assisted gp120 protein production CHO-cell lines with significant improvement in yield for HIV vaccine manufacturing.
Following a thorough evaluation of Abzyme’s proposal the NIH review panel awarded the application a Highly Innovative SBIR application rating. According to the NIH review panel, this innovative technology is expected to have high potential impact on recombinant vaccine development.
“We are extremely pleased to be recognized with this highly competitive award from the NIH SBIR program and are grateful for the continued support towards our mission of developing biologics for treatment of various human diseases” said Dr. Tran, CEO and cofounder of Abzyme. “This SBIR Contract plays a vital role in expanding the application of our technology capabilities”.
About Abzyme Therapeutics:
Abzyme Therapeutics is a biopharmaceutical company focused on developing modular single domain VHH antibody fragments for immunotherapy using proprietary antibody generation platforms. Unique to Abzyme is its proprietary and highly engineered eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody affinity maturation in combination with a FACS single cell sorting approach to identify desired antibodies. Abzyme’s modular antibody discovery platform incorporates a real-time screening ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity.
Today, the Company has over 60 proprietary and partnered programs in development in therapeutic and diagnostic areas including infectious diseases, immuno-oncology, ophthalmology, inflammation and central nervous system disorders.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
02.10.18
Abzyme Therapeutics Announces New Website Launch
Royersford, PA, February 10, 2018. Abzyme Therapeutics LLC, a biopharmaceutical company announced today the launch of its newly re-vamped and re-energized website. This redesigned site offers quick overview of company essential information and features while offering a more comprehensive understanding of the Company’s value proposition and overall business strategy. The new website is re-designed to reflect the Company’s focus on developing modular single domain VHH antibody fragments and VHH-based therapeutics for immunotherapy using the Company’s proprietary antibody generation platforms.
Created with the user engagement and experience in mind, the new website has a clean uncluttered design and enhanced rich content focused on the Company’s mission to develop life-saving medicines. Companies seeking to either license in new targets, optimize their existing antibodies or partner to create new ones can benefit from our expertise. The new website clearly defines our mission and industry value proposition. The new website goes live today, February 10, 2018 and is located at the same address: www.abzymetx.com.
“We are excited about our new website launch and the essential information it provides for visitors, partners and investors to better understand our value proposition, expertise and expanding antibody pipeline,” said Dr. Hiep Tran, President and CEO of Abzyme Therapeutics. “We believe that this new site will allow our visitors to have a very informative experience as we continue to grow and make our impact on developing life-saving medicines.”
Abzyme’s new website will be updated on a regular basis with news of drug development progress, business activity, corporate milestones, events, and press releases. Visitors are encouraged to explore the website and sign up for direct emails from the Company at http://abzymetx.com/contact/contact-us
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
11.16.17
Abzyme Awarded Highly Competitive Department of Defense Phase II SBIR Contract
Royersford, PA, November 16, 2017. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic application, has been awarded a $1,000,000 Small Business Innovation Research (SBIR) Phase II Contract by the US Department of Defense (DoD) to continue development of therapeutic antibodies against equine encephalitis viruses and to advance them into clinical trials.
The DOD SBIR program is a highly competitive program for early stage small businesses that are seeking to commercialize innovative technologies with military and civilian applications. Regarding the biomedical research, the program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs. In Phase I of this project, Abzyme has successfully demonstrated the feasibility of its antibody development platform with self-diversifying antibody libraries in generating broadly reactive single domain camelid VHH antibodies against E3E2 proteins of Eastern, Western and Venezuelan equine encephalitis viruses (EEV). In addition, VHH antibodies against human transferrin receptor TfR have been isolated. Obtained EEV E3E2/E2 and TfR antibodies will serve as a foundation for developing bispecific EEVxTfR capable of traversing the blood brain barrier or BBB and effective as countermeasures for live EEV exposure in small animal studies (phase II). Therapeutic antibodies broadly reactive to equine encephalitis viruses and capable of overcoming the BBB could find application by military and civilian entities as safe medical countermeasures for treatment of viral induced encephalitis.
Unique to Abzyme is its proprietary eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody maturation, and a FACS single cell sorting approach to identify desired antibodies. These combined technologies enable Abzyme Therapeutics to shorten typical monoclonal antibody development/optimization times from 4.5 – 6 months to 6 – 10 weeks. Abzyme’s antibody discovery platform incorporates the ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity into real-time screening.
“We are extremely pleased to be recognized with this highly competitive award from the DoD SBIR program and are grateful for the continued support towards our mission of developing therapeutic antibodies for treatment of various human diseases” said Dr. Tran, CEO and co-founder of Abzyme. “This SBIR Phase II Contract plays a vital role in expanding our antibody development capabilities”.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
10.24.17
Abzyme Awarded NIH Grant For BBB-Penetrating Bispecific Antibody Engineering
Royersford, PA, October 24, 2017. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic application, has been awarded a $236,646 Small Business Innovation Research (SBIR) Phase I Grant by the National Institute of Neurological Disorders and Stroke for modular antibody engineering to overcome the blood brain barrier (BBB).
The National Institutes of Health (NIH) SBIR program is a highly competitive program for small businesses that are seeking to commercialize innovative technologies with biomedical applications. This highly competitive program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs.
Biologics such as antibodies or enzymes are an emerging class of medicines with great potential to treat various diseases including central nervous system (CNS) disorders. However, following intravenous administration of biologics, the blood-brain barrier prevents brain uptake and hence, their CNS therapeutic potential.
Abzyme has developed a patent-pending Abz2 technology for reformatting traditional antibodies to create IgG-like bispecific antibodies. In contrast to other bispecific antibody formats, Abz2 IgG-like molecule is easy to produce with excellent biophysical properties. Using this technology, traditional antibodies in combination with anti-transferrin receptor (TfR) and anti-leptin receptor (LepR) modular antibodies will be converted into bispecific antibodies that can overcome the BBB via receptor-mediated transcytosis and binding its specific target in the brain.
The NIH review panel has thoroughly evaluated this proposal awarding the application an Excellent Phase I SBIR application rating. According to NIH review panel, this innovative technology is expected to have high potential impact on neurological healthcare outcomes, leading to accelerated generation of BBB penetrating antibodies.
“We are very grateful for the continued support towards our mission of developing therapeutic antibodies” said Dr. Tran, CEO and co-founder of Abzyme. “We are very excited with our Abz2 technology and its potential. This SBIR grant funding will help us to advance this technology in developing BBB-penetrating antibodies for treatment of various CNS disorders”.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
10.09.17
Abzyme Patent Application for Generating Bispecific Functional Agents Filed
Royersford, PA, October 09, 2017. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic applications, has filed a patent application entitled “Method for Generating Bispecific Functional Agents“, USPTO number 62/530,960. Filing of this patent application, the third in the last eight months, is another important milestone for Abzyme Therapeutics in expanding its IP portfolio. In general the present invention provides a method for preparing a modular scaffold that can bind to a target antigen and a method for engineering a bispecific functional agent consisting of an existing polypeptide binder fused at its C-terminus with said modular scaffold. In a particular application of the invention, an existing antibody can be rapidly transformed into an IgG-like bispecific antibody while preserving its original target binding affinity and Fc effector function.
Compared to traditional antibodies, bispecific antibodies offer a significant improvement in therapeutic index. However, the use of bispecific antibodies has been hindered by difficulties in producing them in sufficient quantity and purity. The two main limitations for the use of bispecific functional agents are manufacturabity (e.g. difficulties in large scale production of pure bispecific antibodies, aggregation caused by non-natural structure, heavy- and light-chain mispairing in the case of scFv) and poor pharmacokinetic and pharmacodynamics properties including immunogenicity, short serum half-life, or loss of Fc effector function caused by the lack of the fragment crystallizable (Fc) region. Accordingly, there remains a critical need for easily engineered bispecifics with superior properties, like low immunogenicity and long half-life in humans that can be readily produced at high yield from mammalian cell culture while preserving the functional activity of the antibody components. The present invention addresses these problems by providing a method and composition for rapid reformatting of existing IgG antibody into well-expressing IgG-like bispecific antibody.
“This invention is very important step forward for Abzyme Therapeutics”, said Dr. Tran, CEO and co-founder of Abzyme. “Filing this patent application not only further solidifies our IP position in the field of antibody engineering, but also allows open conversation with our clients. We are excited to see how this technology can rapidly convert existing antibodies into well-expressing easy-to-purify IgG-like bispecific antibodies. The invention truly makes our work easier”.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
9.15.2017
Abzyme Awarded Highly Competitive National Institutes of Health Phase I SBIR Grant
Royersford, PA, September 15, 2017. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic application, has been awarded a $224,926 Small Business Innovation Research (SBIR) Phase I Grant by the National Institutes of Health (NIH) to develop antibodies recognizing a post-translation arginylation.
The NIH SBIR program is a highly competitive program for small businesses that are seeking to commercialize innovative technologies with biomedical applications. The program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs. Abzyme will use innovative yeast display of a highly diverse human antibody Fab library with self-diversifying ability to select for arginylation-specific binders.
Arginylation is essential for mammalian embryogenesis and regulation of the cytoskeleton function in cell migration, a process that plays key roles during tissue morphogenesis and cancer metastases. A recent explosion of studies has put arginylation on the map of intracellular metabolic pathways and biological processes and demonstrated its key involvement in the central events of cell metabolism, normal function of multiple physiological systems, and cell transition to metastatic cancers. Research in the protein arginylation field is however hampered by the lack of antibodies or other tools that selectively recognize arginylated proteins.
Abzyme will utilize its combined expertise in generating arginylated linkage peptides and yeast genetics to generate a diverse array of antibodies that will advance the field of cell biology. In Phase I, synthetic peptides which encompass both the isopeptide bond and the sequence surrounding the arginine attachment sites in alpha-synuclein will be employed. In Phase II this approach will be expanded to include the development of arginylation antibodies of global specificity, which can serve as major tools for biomedical research including inverse correlation of arginylation and ageing, neurodegeneration and clinical diagnostics.
Unique to Abzyme is its proprietary eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody maturation, and a FACS single cell sorting approach to identify desired antibodies. Abzyme’s antibody platform incorporates the ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability and target-specificity into real-time screening.
“We are extremely pleased to be recognized with this highly competitive award from the NIH SBIR program” said Dr. Tran, CEO and co-founder of Abzyme. “This SBIR grant plays a vital role in expanding our antibody development capabilities. We are grateful for the continued support towards our mission of developing diagnostic and therapeutic antibodies”.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
8.2.17
Abzyme Files Patent Application for Self-Diversifying Antibody Platform
Royersford, PA, August 02, 2017. Abzyme Therapeutics LLC, a biotechnology company focused on developing antibodies for diagnostic and therapeutic applications, has filed a patent application entitled “Composition and Method for Diversifying Polypeptide Libraries“, USPTO number 62/387,511. This is an important milestone for Abzyme Therapeutics in protecting its intellectual property and solidifying its IP position as a leader in the field of antibody engineering and development. The invention provides a method and composition for diversifying polypeptide libraries displayed on the surface of yeast cells. The antibody library built in this self-diversifying platform has potentially unlimited diversity. One application of this technology is in vivo rapid generation of therapeutic antibody candidates with desired attributes. It can also be used for maturation of existing antibodies to achieve higher target binding affinity or protein expressibility.
As provided by this invention, a polypeptide library is displayed on the cell surfaces of a highly engineered yeast strain. The yeast strain incorporates an inducible hypermutation system that exclusively introduces base substitutions into a gene of interest. In combination with biological panning, an antibody molecule displayed on the yeast cell surface sequentially undergoes diversification followed by affinity selection to achieve higher binding affinity to a target of interest. Using this technology platform, Abzyme develops various types of antibodies including, but not limited to camelid and human single domain antibodies, human ScFv and full human IgG.
“Filing this application is very important milestone for Abzyme Therapeutics. This patent application further solidifies our IP position in the field of antibody development and engineering” said Dr. Tran, CEO and co-founder of Abzyme. “We use this technology every day to generate therapeutic antibody candidates to difficult targets including non-immunogenic or toxic antigens. This invention actually makes work easier and significantly faster in discovering antibodies with desired therapeutic attributes”.
For further information, please contact:
Abzyme Therapeutics LLC
Steve Manobianco
Director of Business Development
Phone: 610-990-7531
E-mail: [email protected]
2.15.17
Abzyme and Ibex Expand Partnership for the Discovery of Antibodies
Royersford, PA, February 15, 2017 Abzyme Therapeutics, a biopharmaceutical company developing novel therapeutic antibodies using Self-Diversifying Antibody Library Platform (SDALib), announces a collaborative agreement with Ibex Biosciences, LLC (Ibex), a privately held biotechnology company focused on treating and diagnosing cancer and other diseases. This collaboration in developing new antibodies is the extension of a previous successful Abzyme/Ibex partnership for developing VHH antibodies. The collaboration will leverage Abzyme’s SDALib technology and Ibex’s expertise in the development of therapeutics for treatment of cancers to generate single domain camelid antibodies which can specifically bind to cancer-related target isoforms. Using Abzyme’s yeast-based camelid single domain VHH antibody library with self-diversifying ability, VHH antibodies against Ibex’s proprietary targets will be developed. Due to their small size and unique structure, single domain camelid VHH antibodies are ideal for labeling/targeting studies and as building blocks for the generation of novel biological drugs with multiple advantages. Under the agreement, Ibex will make upfront payments to Abzyme. Abzyme will also receive research funding and is eligible for technical milestone payments. Ibex will retain worldwide commercial rights to these therapeutic products. Financial terms of the partnership were not disclosed.
It is our pleasure to work closely with Ibex, they have been a great partner “said Hiep Tran, Chief Executive Officer and Co-Founder of Abzyme”. I am delighted to have Ibex’s continuing trust in our technologies and our antibody development capacities. We look forward to continue our partner in developing many more antibody candidates and to move them forward into clinical trials.
For further information, please contact:
Abzyme Therapeutics LLC
Rolf K. Swoboda, PhD.
Director of Antibody Development and Production
Phone: 610-990-7531
E-mail: [email protected]
01.10.17
Abzyme receives Milestone Payment from Ibex for Anti-cancer VHH Antibodies
Royersford, PA, January 10, 2017 Abzyme Therapeutics LLC., which has developed a world leading platform for rapid antibody generation, has received a milestone payment from Ibex Biosciences, LLC, (Ibex) following the successful completion of the objectives from a 2014 research collaboration agreement. The project focused on developing highly specific VHH antibodies to Ibex’s proprietary cancer targets. Using Abzyme’s yeast-based camelid single domain VHH antibody library with self-diversifying ability, VHH antibodies against Ibex’s proprietary targets have been developed. Due to their small size and unique structure, single domain camelid VHH antibodies are ideal for labeling/targeting studies and as building blocks for the generation of novel biological drugs with multiple advantages. Financial terms of the milestone payment were not disclosed. Abzyme will continue to receive research funding and is eligible for technical milestone payments. Ibex will retain worldwide commercial rights to these therapeutic products.
“Ibex has been a great partner,” said Hiep Tran, Chief Executive Officer and Co-Founder of Abzyme. “We are thrilled to have Ibex’s continuing trust in our antibody development capacity. We are confident that with our antibody generation platform, Ibex will rapidly develop and move many more antibody candidates into clinical trials.”
For further information, please contact:
Abzyme Therapeutics LLC
Rolf K. Swoboda, PhD.
Director of Antibody Development and Production
Phone: 610-990-7531
E-mail: [email protected]
12.12.16
Steve Manobianco joins Abzyme Therapeutics as Director of Business Development
Royersford, PA, December 12, 2016 Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic application, is pleased to announce the appointment of Steve Manobianco in the role of Director of Business Development.
Steve has an impressive background in global sales, business development and strategic marketing. For a significant part of his professional career Steve has been working in the pharmaceutical R&D service industry. Steve has a broad knowledge and working experience in the global research and development marketplace.
“I couldn’t be happier to have such a seasoned professional as Steve to be our new team member,” said Hiep Tran, PhD, Abzyme’s co-founder and president. “Steve’s deep knowledge of the biopharmaceutical industry in both business development, sales and marketing will be an invaluable asset to Abzyme Therapeutics as we enter our 7th year in business.”
Steve has a successful track record of creating and executing go-to-market business development strategies to effectively drive double digit revenue growth. Prior to joining Abzyme, he was the Vice President of Global Sales and Business Development for GENEWIZ. Steve holds a Bachelor’s degree in Economics from Syracuse University and an MBA from Regis University, Denver Colorado.
For further information, please contact:
Abzyme Therapeutics LLC
Rolf K. Swoboda, PhD.
Director of Antibody Development and Production
Phone: 610-990-7531
E-mail: [email protected]
9.01.16
Abzyme Awarded Highly Competitive National Institutes of Health Phase II SBIR Grant
Royersford, PA, September 01, 2016. Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic application, has been awarded a $1,500,000 Small Business Innovation Research (SBIR) Phase II grant by the National Institutes of Health (NIH) to continue application of an in vitro single domain camelid VHH antibody generation platform and advance developed VHH antibodies into clinical trials.
The NIH SBIR program is a highly competitive program for early stage small businesses that are seeking to commercialize innovative biomedical technologies. The program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs. After successfully completing Phase I late last year, Abzyme has demonstrated the feasibility of its antibody development platform with self-diversifying antibody libraries in generating highly specific VHH antibodies to influenza H5N1 neuraminidase. Phase II Abzyme’s research will focus on investigation of the therapeutic efficacy of developed H5N1 neuraminidase antibodies in animal models challenged with live viruses as well as generation of novel T-cell engaging antibodies for cancer treatment.
Unique to Abzyme is its proprietary eukaryotic in vitro antibody discovery/optimization platform based on yeast display self-diversifying libraries, rapid target-directed antibody maturation, and a FACS single cell sorting approach to identify desired antibodies. These combined technologies enable Abzyme Therapeutics to shorten typical monoclonal antibody development/optimization times from 4.5 – 6 months to 6 – 10 weeks. Abzyme’s antibody discovery platform incorporates the ability to select for key properties such as epitopic diversity, binding affinity, expressibility, solubility, developability, broad-reactivity and target-specificity into real-time screening.
“We are extremely pleased to be recognized with this highly competitive award from the NIH and are grateful for the continued support towards our mission of developing therapeutic antibodies for treatment of human diseases” said Dr. Tran, CEO and co-founder of Abzyme. “This SBIR grant plays a vital role in expanding our antibody development capabilities”.
For further information, please contact:
Abzyme Therapeutics LLC
Rolf K. Swoboda, PhD.
Director of Antibody Development and Production
Phone: 610-990-7531
E-mail: [email protected]