Pure Biologics’ exploratory Phase 0 study to evaluate pharmacodynamic activity of PBA-0405 in solid tumors
SOUTH SAN FRANCISCO, CA, USA I July 18, 2024 I Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405. PBA-0405 is a fully human IgG1 antibody that was discovered using Twist Biopharma Solutions’ synthetic antibody phage display libraries. Twist Biopharma Solutions, a division of Twist Bioscience, provides an integrated offering of in vitro, in vivo, and in silico tools for antibody discovery research. This exploratory study is designed to provide early insights into the biological effects of PBA-0405 within the tumor environment.
“Solid tumors are historically difficult for drug developers to target and treat. This is the first antibody identified using our Twist Biopharma Solutions Library of Libraries to be tested in patients and it validates the potential of our synthetic antibody libraries to be used to discover novel drug candidates for hard-to-treat cancer indications,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “This is one of two of Pure’s candidates discovered using our synthetic antibody libraries and we look forward to seeing their progression.”
PBA-0405 targets ROR1, a tumor-associated antigen expressed on many solid tumors and B cell malignancies. PBA-0405 is designed to make tumors visible to the immune system, and to induce an immune response by recruiting and activating tumor-killing cytotoxic immune cells.
Pure Biologics’ multi-center, single arm, open-label pharmacodynamic biomarker Phase 0 trial is designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device. The study will evaluate the pharmacodynamic activity of PBA-0405 in solid tumors including head and neck squamous cell carcinoma, certain subtypes of soft-tissue sarcomas and triple-negative breast cancer. Pure Biologics is conducting the clinical study and holds full responsibility for the development and potential regulatory submission of PBA-0405. ClinicalTrials.gov ID NCT06273852
“With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound of its mode of action to enter into studies in patients. We’re encouraged by the preclinical data we’ve seen so far and are eager to evaluate its pharmacodynamic activity in human studies,” said Pieter Spee, PhD, Chief Scientific Officer at Pure Biologics. “By working with Twist Bioscience to leverage their synthetic antibody libraries for early-stage discovery, we were able to move quickly to the development stage. We look forward to continuing to advance our pipeline of immuno-oncology antibody candidates and drive toward our goal of delivering first-in-class therapies to patients.”
About the Collaboration
PBA-0405 was discovered as part of an ongoing collaboration between Twist Bioscience and Pure Biologics. Under the terms of the agreement announced in 2021, Twist Biopharma Solutions, a division of Twist Bioscience, grants Pure Biologics access to select synthetic antibody phage display libraries derived only from sequences that exist in the human body and further optimized by leveraging state-of-the-art approaches, including artificial intelligence and big data analytics. Certain libraries among the portfolio are deliberately tailored to match chosen classes of biological targets as well as to enhance bispecific antibody forming capabilities. Together, the companies work to discover, validate and optimize new antibody candidates against targets useful for immuno-oncology applications. Pure Biologics will pay Twist annual maintenance fees in addition to future payments for clinical and commercial achievement for any antibodies resulting from the collaboration. The Phase 0 study does not trigger a milestone payment for Twist.
About Twist Biopharma Solutions (The Biologics Discovery and Optimization Division of Twist Bioscience)
Twist Biopharma Solutions combines high-throughput DNA synthesis technology, deep expertise in antibody engineering and in vivo, in vitro and in silico discovery methods to provide end-to-end antibody discovery solutions across the preclinical continuum and tailored to our partners’ specific needs. By leveraging our unique ability to manufacture DNA at scale, we can construct proprietary antibody libraries with discovery beginning with either in vivo or in vitro diversity. Our Library of Libraries gives our partners an integral and unbiased resource for antibody therapeutic discovery and optimization. This precise and rational approach to library fabrication combined with sophisticated bioinformatics and software expertise expedites antibody discovery by decreasing risk, increasing speed, and lowering the failure rate for antibody therapeutic development. Additionally, in vivo discovery approaches including single B cell screening and hybridoma discovery enable parallel paths where multiple technology methods can be leveraged to create a panel of highly diverse antibody leads. Our automated screening and panning processes enable us to identify high affinity leads that our partners can move forward into the clinic. We also offer supporting development capabilities, including IgG conversion, expression, purification, biophysical characterization, and functional characterization.
For more information visit: https://www.twistbioscience.com/twist-biopharma-solutions
About Twist Bioscience Corporation
Twist Bioscience is a leading and rapidly growing synthetic biology and genomics company that has developed a disruptive DNA synthesis platform to industrialize the engineering of biology. The core of the platform is a proprietary technology that pioneers a new method of manufacturing synthetic DNA by “writing” DNA on a silicon chip. Twist is leveraging its unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next-generation sequencing (NGS) preparation, and antibody libraries for drug discovery and development. Twist is also pursuing longer-term opportunities in digital data storage in DNA and biologics drug discovery. Twist makes products for use across many industries including healthcare, industrial chemicals, agriculture and academic research.
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SOURCE: Pure Biologics
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Pure Biologics’ exploratory Phase 0 study to evaluate pharmacodynamic activity of PBA-0405 in solid tumors
SOUTH SAN FRANCISCO, CA, USA I July 18, 2024 I Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405. PBA-0405 is a fully human IgG1 antibody that was discovered using Twist Biopharma Solutions’ synthetic antibody phage display libraries. Twist Biopharma Solutions, a division of Twist Bioscience, provides an integrated offering of in vitro, in vivo, and in silico tools for antibody discovery research. This exploratory study is designed to provide early insights into the biological effects of PBA-0405 within the tumor environment.
“Solid tumors are historically difficult for drug developers to target and treat. This is the first antibody identified using our Twist Biopharma Solutions Library of Libraries to be tested in patients and it validates the potential of our synthetic antibody libraries to be used to discover novel drug candidates for hard-to-treat cancer indications,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “This is one of two of Pure’s candidates discovered using our synthetic antibody libraries and we look forward to seeing their progression.”
PBA-0405 targets ROR1, a tumor-associated antigen expressed on many solid tumors and B cell malignancies. PBA-0405 is designed to make tumors visible to the immune system, and to induce an immune response by recruiting and activating tumor-killing cytotoxic immune cells.
Pure Biologics’ multi-center, single arm, open-label pharmacodynamic biomarker Phase 0 trial is designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device. The study will evaluate the pharmacodynamic activity of PBA-0405 in solid tumors including head and neck squamous cell carcinoma, certain subtypes of soft-tissue sarcomas and triple-negative breast cancer. Pure Biologics is conducting the clinical study and holds full responsibility for the development and potential regulatory submission of PBA-0405. ClinicalTrials.gov ID NCT06273852
“With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound of its mode of action to enter into studies in patients. We’re encouraged by the preclinical data we’ve seen so far and are eager to evaluate its pharmacodynamic activity in human studies,” said Pieter Spee, PhD, Chief Scientific Officer at Pure Biologics. “By working with Twist Bioscience to leverage their synthetic antibody libraries for early-stage discovery, we were able to move quickly to the development stage. We look forward to continuing to advance our pipeline of immuno-oncology antibody candidates and drive toward our goal of delivering first-in-class therapies to patients.”
About the Collaboration
PBA-0405 was discovered as part of an ongoing collaboration between Twist Bioscience and Pure Biologics. Under the terms of the agreement announced in 2021, Twist Biopharma Solutions, a division of Twist Bioscience, grants Pure Biologics access to select synthetic antibody phage display libraries derived only from sequences that exist in the human body and further optimized by leveraging state-of-the-art approaches, including artificial intelligence and big data analytics. Certain libraries among the portfolio are deliberately tailored to match chosen classes of biological targets as well as to enhance bispecific antibody forming capabilities. Together, the companies work to discover, validate and optimize new antibody candidates against targets useful for immuno-oncology applications. Pure Biologics will pay Twist annual maintenance fees in addition to future payments for clinical and commercial achievement for any antibodies resulting from the collaboration. The Phase 0 study does not trigger a milestone payment for Twist.
About Twist Biopharma Solutions (The Biologics Discovery and Optimization Division of Twist Bioscience)
Twist Biopharma Solutions combines high-throughput DNA synthesis technology, deep expertise in antibody engineering and in vivo, in vitro and in silico discovery methods to provide end-to-end antibody discovery solutions across the preclinical continuum and tailored to our partners’ specific needs. By leveraging our unique ability to manufacture DNA at scale, we can construct proprietary antibody libraries with discovery beginning with either in vivo or in vitro diversity. Our Library of Libraries gives our partners an integral and unbiased resource for antibody therapeutic discovery and optimization. This precise and rational approach to library fabrication combined with sophisticated bioinformatics and software expertise expedites antibody discovery by decreasing risk, increasing speed, and lowering the failure rate for antibody therapeutic development. Additionally, in vivo discovery approaches including single B cell screening and hybridoma discovery enable parallel paths where multiple technology methods can be leveraged to create a panel of highly diverse antibody leads. Our automated screening and panning processes enable us to identify high affinity leads that our partners can move forward into the clinic. We also offer supporting development capabilities, including IgG conversion, expression, purification, biophysical characterization, and functional characterization.
For more information visit: https://www.twistbioscience.com/twist-biopharma-solutions
About Twist Bioscience Corporation
Twist Bioscience is a leading and rapidly growing synthetic biology and genomics company that has developed a disruptive DNA synthesis platform to industrialize the engineering of biology. The core of the platform is a proprietary technology that pioneers a new method of manufacturing synthetic DNA by “writing” DNA on a silicon chip. Twist is leveraging its unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next-generation sequencing (NGS) preparation, and antibody libraries for drug discovery and development. Twist is also pursuing longer-term opportunities in digital data storage in DNA and biologics drug discovery. Twist makes products for use across many industries including healthcare, industrial chemicals, agriculture and academic research.
Follow us on LinkedIn | X | YouTube | Instagram
SOURCE: Pure Biologics
Post Views: 4,255
