Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a clinical-stage biopharmaceutical company advancing
medicines for solid tumors, and Lonza, a global development and
manufacturing partner to the pharma, biotech, and nutrition
industries, today announced that the companies are collaborating to
manufacture CTIM-76, Context’s clinical development candidate.
CTIM-76 is a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific
antibody targeting CLDN6 positive tumors.
Under the terms of the agreement, Lonza will
provide manufacturability assessment, gene and cell line
construction, and process development. The drug substance will be
manufactured at Lonza’s Slough (UK) site, and the drug product will
be manufactured at the Stein and Visp (CH) sites. Context will
leverage Lonza’s expertise in developing and manufacturing complex
proteins, as well as the extensive regulatory competence and
manufacturing network.
Martin Lehr, CEO, Context,
commented: “Bispecific antibody drug candidates
targeting cancer signaling pathways pose unique challenges related
to their development and manufacturing. We are delighted to entrust
Lonza with manufacturing Context’s clinical development candidate,
CTIM-76, to target CLDN6-positive tumors. We believe this
collaboration will provide us with high-quality drug substance and
drug product for clinical development and beyond.”
Jennifer Cannon, Executive Vice President,
Global Head of Mammalian Biologics, Lonza,
added: “With the biopharmaceutical sector shifting
towards more complex protein formats, it is crucial to ensure
manufacturability and scalability of these novel therapies. Context
has an exciting portfolio, including its CTIM-76 bispecific
antibody product, that can benefit from our expertise and
experience in supporting the manufacturing of complex
therapeutics.”
About Claudin 6 and CTIM-76
Claudin 6 (CLDN6) is differentially expressed
on cancer cells with no or very low expression in normal, healthy
tissue. CLDN6-enriched cancers include ovarian, endometrial,
testicular, and gastric, among others. With the potential to reach
a large patient population and selective expression on cancer
cells, CLDN6 has emerged as an important drug target.
CTIM-76 is a CLDN6 and CD3 bispecific antibody
currently in preclinical development that is capable of binding to
tumor cells expressing CLDN6 and stimulating intra-tumoral T cells
by the CD3 arm that is designed to be activated only upon tumor
engagement while silent elsewhere. CLDN6 is expressed on multiple
solid tumors such as ovarian cancer, sarcoma, testicular cancer,
endometrial cancer, and gastric cancer. Preclinical studies of
CTIM-76 show it effectively maintains a strong tumor binding
property and anti-tumor activity attributable to a synergistic
effect of both CLDN6 antibody and CD3 antibody while avoiding
systemic immunotoxicity commonly seen with CD3 antibodies as a drug
class. CTIM-76 has the potential for convenient dosing and scalable
manufacturing to address the significant number of patients who are
potentially eligible for CTIM-76 therapy.
About Context
Therapeutics®Context Therapeutics Inc.
(Nasdaq: CNTX) is a clinical-stage biopharmaceutical company
committed to advancing medicines for solid tumors, with a primary
focus on female cancers. The Company’s pipeline includes small
molecule and bispecific antibody drug candidates that target cancer
signaling pathways. Context is developing CTIM-76, a selective
Claudin 6 (CLDN6) x CD3 bispecific antibody for CLDN6 positive
tumors, currently in preclinical development. Additionally, the
company is advancing onapristone extended release (ONA-XR), a
novel, first-in-class, potent, and selective progesterone receptor
antagonist, currently in three Phase 2 clinical trials and one
Phase 1b/2 clinical trial in hormone-driven breast, ovarian,
and endometrial cancers. Context is headquartered in
Philadelphia.
For more information, please
visit www.contexttherapeutics.com or
follow the Company
on Twitter and LinkedIn.
About LonzaLonza is a preferred
global partner to the pharmaceutical, biotech and nutrition
markets. We work to enable a healthier world by supporting our
customers to deliver new and innovative medicines that help treat a
wide range of diseases. We achieve this by combining technological
insight with world-class manufacturing, scientific expertise and
process excellence. Our unparalleled breadth of offerings enables
our customers to commercialize their discoveries and innovations in
the healthcare industry.
Founded in 1897 in the Swiss Alps, today, Lonza
operates across five continents. With more than 17,000 full-time
employees, we comprise high-performing teams and individual talent
who make a meaningful difference to our own business, as well as to
the communities in which we operate. The company generated sales of
CHF 3 billion with a CORE EBITDA of CHF 987 million in H1 2022.
Find out more at www.lonza.com.
Follow @Lonza
on LinkedInFollow @LonzaGroup
on Twitter
Context Therapeutics Contact
Details
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations
Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
Lonza Contact
Detailsmedia@lonza.com
Forward-looking StatementsThis
press release contains “forward-looking statements” that involve
substantial risks and uncertainties for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995.
Any statements, other than statements of historical fact, included
in this press release regarding strategy, future operations,
prospects, plans and objectives of management, including words such
as "may," "will," "expect," "anticipate," "plan," "intend," and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
forward-looking statements. These include, without limitation,
statements regarding (i) the selectivity, dosing convenience,
potency, binding, scalable manufacturing, and safety profile of
CTIM-76, (ii) the potential benefits of the agreement, including
the ability of Lonza to perform as expected and to provide Context
with the necessary drug substance and drug product, (iii) the
potential benefits of our product candidates, and (iv) the
likelihood data will support future development. Forward-looking
statements in this release involve substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by the forward-looking statements,
and we, therefore cannot assure you that our plans, intentions,
expectations or strategies will be attained or achieved. Other
factors that may cause actual results to differ from those
expressed or implied in the forward-looking statements in this
press release are discussed in our filings with the U.S. Securities
and Exchange Commission, including the section titled “Risk
Factors” contained therein. Except as otherwise required by law, we
disclaim any intention or obligation to update or revise any
forward-looking statements, which speak only as of the date they
were made, whether as a result of new information, future events or
circumstances or otherwise.
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