Twist Bioscience Announces Clinical Progression of Pure Biologics’ Antibody Candidate Discovered Using Twist’s Antibody Libraries
Twist Bioscience (NASDAQ: TWST) announced the first patient dosing in Pure Biologics' exploratory Phase 0 clinical study of PBA-0405, a fully human IgG1 antibody discovered using Twist's synthetic antibody phage display libraries. The study aims to evaluate the pharmacodynamic activity of PBA-0405 in solid tumors, including head and neck squamous cell carcinoma, certain soft-tissue sarcomas, and triple-negative breast cancer.
PBA-0405 targets ROR1, a tumor-associated antigen, and is designed to make tumors visible to the immune system and induce an immune response. This marks the first antibody identified using Twist Biopharma Solutions' Library of Libraries to be tested in patients, validating the potential of their synthetic antibody libraries for discovering novel drug candidates for hard-to-treat cancers.
- First patient dosed in Phase 0 clinical study of PBA-0405, validating Twist's synthetic antibody libraries
- PBA-0405 targets ROR1, a tumor-associated antigen expressed on many solid tumors and B cell malignancies
- Potential for Twist's synthetic antibody libraries to discover novel drug candidates for hard-to-treat cancers
- None.
The initiation of Pure Biologics’ exploratory Phase 0 study for PBA-0405 represents a significant milestone in the clinical development of antibody therapies targeting solid tumors, a notoriously challenging area in oncology. The fact that PBA-0405 targets ROR1, a tumor-associated antigen expressed on various solid tumors and B-cell malignancies, is particularly noteworthy. ROR1 is an attractive target due to its limited expression in normal tissues, which potentially reduces off-target effects.
Phase 0 trials are pivotal for gathering preliminary data on pharmacodynamics and biological effects within the tumor microenvironment. This can accelerate the development pipeline by allowing researchers to make early go/no-go decisions based on biological activity rather than clinical efficacy alone. The use of the CIVO device to administer microdose quantities intratumorally is an innovative approach, which may offer more direct insights into the compound's action within the tumor, minimizing systemic exposure.
However, it's essential to manage expectations as Phase 0 trials do not assess clinical efficacy or safety on a larger scale. The implications for retail investors include the necessity for a long-term perspective, as this early-stage trial is just a preliminary step in a lengthy and costly development process.
For investors, this announcement underscores Twist Bioscience's capabilities in providing cutting-edge tools for antibody discovery, highlighting the practical applications of their synthetic antibody phage display libraries. The collaboration with Pure Biologics is a validation of Twist’s technology and raises the company's profile in the competitive biopharma market.
From a market perspective, the successful dosing of the first patient in a Phase 0 trial can serve as a catalyst for investor optimism, especially given the tough nature of targeting solid tumors. The news may positively impact Twist Bioscience's stock as it demonstrates progress and potential future revenues from licensing agreements or royalties if the candidate progresses through the clinical stages.
However, it's important to note that the financial impact is contingent on further successful development stages and eventual market approval. Investors should consider the inherent risks and lengthy timelines associated with drug development.
Twist Bioscience’s announcement of Pure Biologics’ Phase 0 clinical study initiation for PBA-0405 could have notable financial implications. The collaboration highlights Twist’s business model of leveraging their synthetic DNA technology for biopharma applications, which could lead to future revenue streams through partnerships and licensing.
Financially, this milestone may translate into increased investor confidence and a potential uplift in stock price given the validation of Twist’s technology platform. For retail investors, it’s important to understand that while this news is promising, the revenue realization from such developments can be a long-term process, dependent on successful progression through clinical trials and eventual regulatory approval.
Moreover, investors should also consider the costs involved in prolonged clinical developments and the competitive landscape of antibody therapeutics. The potential for future financial gains must be balanced against these risk factors.
Pure Biologics’ exploratory Phase 0 study to evaluate pharmacodynamic activity of PBA-0405 in solid tumors
“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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Twist Bioscience Legal Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including but not limited to, statements regarding the potential of Twist Bioscience’s synthetic antibody libraries to be used to discover candidates for hard-to-treat cancer indications; the potential benefits of any of Pure Biologics’ current or future product candidates in treating patients, including the potential of PBA-0405 to make tumors visible to the immune system and to induce an immune response by recruiting and activating tumor-killing cytotoxic immune cells; and the potential achievement of any clinical and commercial milestones resulting from the collaboration between Twist Bioscience and Pure Biologics. Forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Twist Bioscience’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the ability to achieve the expected benefits of Twist Bioscience’s restructuring activities and reduced investments in DNA data storage; the ability to attract new customers and retain and grow sales from existing customers; the ability of Twist Bioscience to achieve sufficient revenue to achieve or maintain positive cash flow from operations or profitability in any given period; risks and uncertainties of rapidly changing technologies and extensive competition in synthetic biology that could make the products Twist Bioscience is developing obsolete or non-competitive; uncertainties of the retention of significant customers; the ability of Twist Bioscience to successfully integrate acquired companies and to achieve expected benefits from acquisitions; supply chain and other disruptions; risks of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Twist Bioscience’s patents or proprietary rights; and the risk that Twist Bioscience’s proprietary rights may be insufficient to protect its technologies. For a description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Twist Bioscience’s business in general, see Twist Bioscience’s risk factors set forth in Twist Bioscience’s Annual Report on Form 10-K filed with the SEC on November 21, 2023 and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Twist Bioscience specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Source: Twist Bioscience Corporation
FAQ
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