Sutro Biopharma Highlights Potential Multi-Cancer Opportunity for Luvelta, a FolRα-targeting ADC
05 January 2024 - 8:05AM
Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a
clinical-stage oncology company pioneering site-specific and
novel-format antibody drug conjugates (ADCs), is hosting an
investor webcast today highlighting the significant potential of
luveltamab tazevibulin (luvelta), a novel folate receptor-α (FolRα)
targeting ADC. The presentation will include an overview of the
clinical data supporting luvelta’s broad opportunity to address the
unmet need in several FolRα-expressing cancers, including
platinum-resistant ovarian cancer (PROC), endometrial cancer,
CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia
(AML), and non-small cell lung cancer (NSCLC).
“Luvelta has been studied in over 180 patients to-date, and has
demonstrated both promising clinical activity and a tolerable
safety profile. We are optimistic about its potential to change the
cancer treatment landscape,” said Bill Newell, Sutro’s Chief
Executive Officer. “This includes the potential to be the first ADC
to treat ovarian cancer patients with low to medium FolRα
expression, which could double the current eligible patient
population relative to the FolRα-targeting ADC on the market. In
2024, we look forward to advancing two synergistic registrational
clinical trials for luvelta in ovarian cancer and CBF/GLIS AML,
while continuing to progress the development of additional
indications.”
The event will feature presentations by key members of Sutro's
senior management team and external oncology expert, Bradley Monk,
M.D., Professor, the Division of Gynecologic Oncology, University
of Arizona College of Medicine and Creighton University School of
Medicine and Vice President and Co-Director, GOG Partners. Sutro
management and Dr. Monk will participate in a Q&A session at
the end of the presentation.
Luvelta FolRα-targeting ADC Franchise
Upcoming Milestones:
- The registration-directed trial, REFRαME-O1, in PROC is
enrolling, with 26 active sites across 5 countries and an
anticipated ~140 sites in ~20 countries by the end of 2024. Part 1
of the trial is expected to be completed in the first half of
2024.
- Initiation of REFRαME-P1, a registration-enabling trial for
pediatric patients with CBF/GLIS AML, is planned for the first half
of 2024.
- An Investigational New Drug (IND) application submission is
planned in non-small cell lung cancer (NSCLC) in the first half of
2024.
- Continued clinical development is planned in endometrial cancer
and in combination with bevacizumab for the treatment of ovarian
cancer.
Compelling Luvelta Data:
- Sutro presented an aggregated analysis of nearly 100 women with
ovarian cancer from Company’s Phase 1 program.
- Treatment with luvelta demonstrated improved clinical outcomes
and tolerability compared to historical results with standard of
care chemotherapy in an evaluable patient population matching the
eligibility criteria for the REFRαME-O1 trial.
- The safety profile across the aggregated analysis remained
consistent with previously reported data.
- Safety data from an additional cohort with prophylactic G-CSF
treatment showed significant reduction of neutropenia and resulting
dose delays.
- New data in combination with bevacizumab demonstrated clinical
activity in treated patients regardless of FolRα expression
level.
- Preclinical data in a model of NSCLC demonstrated that a single
dose of luvelta produced potent anti-tumor activity and that the
combination of luvelta and PD-1 blockade (avelumab) demonstrated
benefit and complete tumor regression.
- Promising clinical data in late-stage endometrial cancer and
CBF/GLIS AML have been presented at ESMO and ASH in 2023.
Webcast Information:To access the live audio
webcast beginning at 1:30 p.m. PT / 4:30 p.m. ET please go
to https://ir.sutrobio.com/news-events/ir-calendar.
An archived replay of the webcast will be available on the
Company’s website following the event.
About Luveltamab Tazevibulin Luveltamab
tazevibulin, abbreviated as “luvelta” and formerly known as
STRO-002, is a FolRα-targeting antibody-drug conjugate (ADC)
designed to treat a broad range of patients with ovarian cancer,
including those with lower FolRα-expression who are not eligible
for approved treatment options targeting FolRα. Developed and
manufactured with Sutro’s cell-free XpressCF® platform, luvelta is
a homogeneous ADC with four hemiasterlin cytotoxins per antibody,
precisely positioned to efficiently deliver to the tumor while
ensuring systemic stability after dosing. Sutro recently initiated
REFRαME-O1, a Phase 2/3 registration-directed study for patients
with platinum-resistant ovarian cancer. The Company has ongoing
trials in patients with endometrial cancer and in combination with
bevacizumab in patients with ovarian cancer. In the first half of
2024, the Company expects to initiate REFRαME-P1, a Phase 2/3
registration-directed study for patients with CBF/GLIS2 acute
myeloid leukemia, a rare subtype of pediatric cancer, and expects
to file an Investigational New Drug (IND) Application for the
initiation of a non-small cell lung cancer study. The U.S. Food and
Drug Administration (FDA) has granted luvelta a Fast Track
designation for Ovarian Cancer, as well as Orphan and Rare
Pediatric Disease designations for CBF/GLIS2 Pediatric
AML.
About Sutro Biopharma Sutro Biopharma,
Inc., is a clinical-stage company relentlessly focused on the
discovery and development of precisely designed cancer
therapeutics, transforming what science can do for patients.
Sutro’s fit-for-purpose technology, including cell-free XpressCF®,
provides the opportunity for broader patient benefit and an
improved patient experience. Sutro has multiple clinical stage
candidates, including luveltamab tazevibulin, or luvelta, a
registrational-stage folate receptor alpha (FolRα)-targeting ADC in
clinical studies. A robust pipeline, coupled with high-value
collaborations and industry partnerships, validates Sutro’s
continuous product innovation. Sutro is headquartered in South San
Francisco. For more information, follow Sutro on social
media @Sutrobio, or visit www.sutrobio.com.
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, including enrollment and site
activation; timing of announcements of clinical results, trial
initiation, and regulatory filings; outcome of regulatory
decisions; potential benefits of luvelta and the Company’s other
product candidates and platform; potential expansion into other
indications and combinations, including the timing and development
activities related to such expansion; and potential market
opportunities for luvelta and the Company’s other 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 and the
Company’s ability to successfully leverage Fast Track designation,
the market size for the Company’s product candidates to be smaller
than anticipated, 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.
Contact Emily White Sutro
Biopharma (650)
823-7681 ewhite@sutrobio.com
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