SOUTH SAN FRANCISCO, Calif.,
June 1, 2021 /PRNewswire/ -- Sutro
Biopharma, Inc. (NASDAQ: STRO), clinical-stage drug discovery,
development and manufacturing company focused on the application of
precise protein engineering and rational design to create
next-generation cancer and autoimmune therapeutics, today announced
that it has received a milestone payment under its collaboration
and license agreement with the healthcare division of Merck KGaA,
Darmstadt, Germany, related to a
patient enrollment achievement in the Phase 1 dose escalation and
expansion study of M1231 in adult patients with metastatic solid
tumors, including non-small cell lung cancer (NSCLC) and esophageal
squamous cell carcinoma. M1231 is an investigational bispecific
antibody-drug conjugate (ADC) targeting MUC1-EGFR.
"The robustness and flexibility of our cell-free platform and
our wholly-owned manufacturing facility have enabled the discovery
and early clinical supply of M1231," said Bill Newell, Chief Executive Officer of Sutro.
"The continuing progress of the program is indicative of the
commitment both parties have made to drive development of M1231 and
represents an important achievement in the work of the
collaboration to address unmet medical needs of cancer
patients."
Trevor Hallam, Ph.D., Sutro's
President of Research and Chief Scientific Officer added, "This
partnership demonstrates the combined strength of Sutro and Merck
KGaA, Darmstadt, Germany to expand
the boundaries of antibody-drug conjugate. M1231 is a
first-in-class investigational bispecific ADC; by targeting both
MUC1 and EGFR, M1231 could potentially increase tumor selectivity,
payload delivery, and reduce on-target toxicity on normal
tissues."
M1231 was generated using Sutro's XpressCF® and Sutro's
XpressCF+™ cell-free protein synthesis and conjugation technologies
and includes a Sutro proprietary linker-warhead. The ADC is based
on Merck KGaA, Darmstadt, Germany's strand-exchange engineered domain
(SEED) antibody platform. As part of the agreement, Sutro is
manufacturing the antibody and linker-warhead for the early
clinical supply and is eligible for further payments and tiered
royalties ranging from low to mid-single digit percentages, along
with certain additional one-time royalties, on worldwide sales of
any commercial products that may result from the collaboration.
Merck KGaA, Darmstadt, Germany
will be responsible for drug product, clinical development and,
upon regulatory approval, the commercialization of this product
candidate.
About Sutro Biopharma
Sutro Biopharma, Inc., located in South
San Francisco, is a clinical-stage drug discovery,
development and manufacturing company. Using precise protein
engineering and rational design, Sutro is advancing next-generation
oncology therapeutics.
Sutro's proprietary and integrated cell-free protein synthesis
platform XpressCF® and site-specific conjugation
platform XpressCF+™ led to the discovery of STRO-001 and STRO-002,
Sutro's first two internally-developed ADCs. STRO-001 is a
CD74-targeting ADC currently being investigated in a Phase 1
clinical trial of patients with advanced B-cell malignancies,
including multiple myeloma and non-Hodgkin lymphoma. STRO-001 was
granted Orphan Drug Designation by the FDA for multiple myeloma in
October 2018. STRO-002 is a folate
receptor alpha (FolRα)-targeting ADC, currently being investigated
in a Phase 1 clinical trial of patients with ovarian and
endometrial cancers. A third product candidate, CC-99712
(BCMA-targeting ADC), which is part of Sutro's collaboration with
Bristol Myers Squibb (formerly Celgene Corporation), is enrolling
patients for its Phase 1 clinical trial of patients with multiple
myeloma and has received Orphan Drug Designation from the FDA for
multiple myeloma. A fourth product candidate, M1231, (MUC1-EGFR,
first-in-class bispecific ADC), which is part of Sutro's
collaboration with Merck KGaA, Darmstadt, Germany is enrolling patients for its Phase 1
clinical trial of patients with metastatic solid tumors, non-small
cell lung cancer (NSCLC) and esophageal squamous cell carcinoma.
The four product candidates above being evaluated in clinical
trials resulted from Sutro's XpressCF® and
XpressCF+™ technology platforms. Bristol Myers Squibb and Merck KGaA, Darmstadt Germany
have worldwide development and commercialization rights for
CC-99712 and M1231, respectively, for which Sutro is entitled to
milestone or contingent payments and tiered royalties.
Sutro is dedicated to transforming the lives of cancer patients
by creating medicines with improved therapeutic profiles for areas
of unmet need. To date, Sutro's platform has led to cytokine-based
immuno-oncology therapies, ADCs, vaccines and bispecific antibodies
directed at precedented targets in clinical indications where the
current standard of care is suboptimal.
The platform allows it to accelerate discovery and development
of potential first-in-class and best-in-class molecules through
rapid and systematic evaluation of protein structure-activity
relationships to create optimized homogeneous product
candidates.
In addition to developing its own oncology pipeline, Sutro is
collaborating with select pharmaceutical and biotech companies to
discover and develop novel, next-generation therapeutics. As the
pace of clinical development accelerates, Sutro and its partners
are developing therapeutics designed to more efficiently kill
tumors without harming healthy cells.
Follow Sutro on Twitter, @Sutrobio, and
at www.sutrobio.com to learn more about our passion for
changing the future of oncology.
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, anticipated preclinical and clinical
development activities, timing of announcements of clinical
results, potential benefits of the company's product candidates and
platform, potential future milestone and royalty payments, and
potential market opportunities for the company's product
candidates. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements.
Although the company believes that the expectations reflected in
such forward-looking statements are reasonable, the company cannot
guarantee future events, results, actions, levels of activity,
performance or achievements, and the timing and results of
biotechnology development and potential regulatory approval is
inherently uncertain. Forward-looking statements are subject to
risks and uncertainties that may cause the company's actual
activities or results to differ significantly from those expressed
in any forward-looking statement, including risks and uncertainties
related to the company's ability to advance its product candidates,
the receipt and timing of potential regulatory designations,
approvals and commercialization of product candidates, the impact
of the COVID-19 pandemic on the Company's business, clinical trial
sites, supply chain and manufacturing facilities, the Company's
ability to maintain and recognize the benefits of certain
designations received by product candidates, the timing and results
of preclinical and clinical trials, the Company's ability to fund
development activities and achieve development goals, the Company's
ability to protect intellectual property, the value of the
Company's holdings of Vaxcyte common stock, and the Company's
commercial collaborations with third parties and other risks and
uncertainties described under the heading "Risk Factors" in
documents the company files from time to time with the Securities
and Exchange Commission. These forward-looking statements speak
only as of the date of this press release, and the company
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date
hereof.
Investor Contacts
Annie J.
Chang
Sutro Biopharma
(650) 801-5728
ajchang@sutrobio.com
Media Contacts
Maggie
Beller
Russo Partners
(646) 942-5631
Maggie.beller@russopartnersllc.com
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SOURCE Sutro Biopharma