Twist Bioscience Announces Clinical Progression of Pure Biologics’ Antibody Candidate Discovered Using Twist’s Antibody Libraries
July 18 2024 - 7:00AM
Business Wire
Pure Biologics’ exploratory Phase 0 study to
evaluate pharmacodynamic activity of PBA-0405 in solid tumors
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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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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For Investors: Angela Bitting SVP, Corporate Affairs
925-202-6211 abitting@twistbioscience.com
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774-265-5334 ahoulihan@twistbioscience.com
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