Summit and Pfizer Seek to Accelerate
Development Opportunities of Ivonescimab and Vedotin-based ADCs
Pfizer to Contribute Multiple ADCs to Evaluate
with Ivonescimab in Unique Solid Tumor Settings
Clinical Trials Expected to Start in the Middle
of This Year
Summit Therapeutics Inc. (NASDAQ: SMMT) today announced a
clinical trial collaboration with Pfizer Inc. (NYSE: PFE) to
evaluate ivonescimab, a novel, investigational PD-1 / VEGF
bispecific antibody, in combination with several of Pfizer’s
antibody drug conjugates (ADCs) across multiple solid tumor
settings.
“Rapidly developing novel mechanisms that go beyond what is
currently available to patients and physicians is what we believe
will make the most significant impact for those facing the greatest
challenges from cancer today,” noted Bob Duggan and Dr. Maky
Zanganeh, Summit’s Co-CEOs. “As we seek to accelerate the
development of our potentially transformative ivonescimab across
non-small cell lung cancer and other solid tumor settings, this
collaboration will allow us to quickly advance beyond our promising
late-stage development plan to evaluate ivonescimab in combination
with some of the most innovative ADCs from Pfizer.”
The goal of the collaboration is to evaluate ivonescimab, in
combination with several unique Pfizer ADCs across multiple solid
tumor settings to accelerate the advancement of potentially
landscape-changing combinations, which seek to improve the
standards of care for patients facing serious unmet needs. Each
study intends to evaluate ivonescimab plus one of Pfizer’s vedotin
ADCs in individual, distinct solid tumor settings to determine the
safety profile and potential anti-tumor activity of the
combinations.
"We are excited to partner with Summit Therapeutics to explore
the clinical synergy of our therapies," said Megan O’Meara, M.D.,
Head, Oncology Early Stage Development, Pfizer. "Together, we are
advancing the exploration of our ADCs in rational, differentiated
combinations with a bispecific antibody designed to address the
unique complexities of tumor biology. This collaboration represents
the next wave of investigational targeted combinations with the
potential to transform treatment options for people living with
cancer."
Under the terms of the agreement, Summit will provide
ivonescimab for use in the proposed studies, and Pfizer will be
responsible for conducting the operations of the studies. The
studies will be overseen by both Summit and Pfizer. Both parties
retain their respective rights to their products. The studies
combining ivonescimab with Pfizer’s vedotin ADCs are planned to
begin in the middle of this year. Further details on the clinical
trials will be announced at a later date.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories,
North America, South America, Europe, the Middle East, Africa, and
Japan, and as AK112 in China and Australia, is a novel, potential
first-in-class investigational bispecific antibody combining the
effects of immunotherapy via a blockade of PD-1 with the
anti-angiogenesis effects associated with blocking VEGF into a
single molecule. Ivonescimab displays unique cooperative binding to
each of its intended targets with multifold higher affinity when in
the presence of both PD-1 and VEGF.
This could differentiate ivonescimab as there is potentially
higher expression (presence) of both PD-1 and VEGF in tumor tissue
and the tumor microenvironment (TME) as compared to normal tissue
in the body. Ivonescimab’s tetravalent structure (four binding
sites) enables higher avidity (accumulated strength of multiple
binding interactions) in the TME (Zhong, et al, SITC, 2023). This
tetravalent structure, the intentional novel design of the
molecule, and bringing these two targets into a single bispecific
antibody with cooperative binding qualities have the potential to
direct ivonescimab to the tumor tissue versus healthy tissue. The
intent of this design, together with a half-life of 6 to 7 days
(Zhong, et al, SITC, 2023), is to improve upon previously
established efficacy thresholds, in addition to side effects and
safety profiles associated with these targets.
Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK)
and is currently engaged in multiple Phase III clinical trials.
Over 2,300 patients have been treated with ivonescimab in clinical
studies globally.
Summit has begun its clinical development of ivonescimab in
non-small cell lung cancer (NSCLC), commencing enrollment in 2023
in two multi-regional Phase III clinical trials, HARMONi and
HARMONi-3, and the Company has begun to activate clinical trial
sites in the United States for HARMONi-7.
HARMONi is a Phase III clinical trial which intends to evaluate
ivonescimab combined with chemotherapy compared to placebo plus
chemotherapy in patients with EGFR-mutated, locally advanced or
metastatic non-squamous NSCLC who have progressed after treatment
with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in
HARMONi was completed in the second-half of 2024, and top-line
results are expected to be announced in the middle of this
year.
HARMONi-3 is a Phase III clinical trial which is designed to
evaluate ivonescimab combined with chemotherapy compared to
pembrolizumab combined with chemotherapy in patients with
first-line metastatic NSCLC.
HARMONi-7 is a Phase III clinical trial which is intended to
evaluate ivonescimab monotherapy compared to pembrolizumab
monotherapy in patients with first-line metastatic NSCLC whose
tumors have high PD-L1 expression.
In addition, Akeso has recently had positive read-outs in two
single-region (China), randomized Phase III clinical trials for
ivonescimab in NSCLC, HARMONi-A and HARMONi-2.
HARMONi-A was a Phase III clinical trial which evaluated
ivonescimab combined with chemotherapy compared to placebo plus
chemotherapy in patients with EGFR-mutated, locally advanced or
metastatic non-squamous NSCLC who have progressed after treatment
with an EGFR TKI.
HARMONi-2 is a Phase III clinical trial evaluating monotherapy
ivonescimab against monotherapy pembrolizumab in patients with
locally advanced or metastatic NSCLC whose tumors have positive
PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved
by any regulatory authority in Summit’s license territories,
including the United States and Europe. Ivonescimab was approved
for marketing authorization in China in May 2024. Ivonescimab was
granted Fast Track designation by the U.S. Food & Drug
Administration (FDA) for the HARMONi clinical trial setting.
About Summit Therapeutics
Summit Therapeutics Inc. is a biopharmaceutical oncology company
focused on the discovery, development, and commercialization of
patient-, physician-, caregiver- and societal-friendly medicinal
therapies intended to improve quality of life, increase potential
duration of life, and resolve serious unmet medical needs.
Summit was founded in 2003 and our shares are listed on the
Nasdaq Global Market (symbol "SMMT"). We are headquartered in
Miami, Florida, and we have additional offices in Menlo Park,
California, and Oxford, UK.
For more information, please visit https://www.smmttx.com and
follow us on X @SMMT_TX.
Summit Forward-looking Statements
Any statements in this press release about the Company’s future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of the
Company’s product candidates, entry into and actions related to the
Company’s partnership with Akeso Inc., the intended use of the net
proceeds from the private placements, the Company's anticipated
spending and cash runway, the therapeutic potential of the
Company’s product candidates, the potential commercialization of
the Company’s product candidates, the timing of initiation,
completion and availability of data from clinical trials, the
potential submission of applications for marketing approvals,
potential acquisitions, statements about the previously disclosed
At-The-Market equity offering program (“ATM Program”), the expected
proceeds and uses thereof, and other statements containing the
words "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict,"
"project," "should," "target," "would," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including the
Company’s ability to sell shares of our common stock under the ATM
Program, the conditions affecting the capital markets, general
economic, industry, or political conditions, the results of our
evaluation of the underlying data in connection with the
development and commercialization activities for ivonescimab, the
outcome of discussions with regulatory authorities, including the
Food and Drug Administration, the uncertainties inherent in the
initiation of future clinical trials, availability and timing of
data from ongoing and future clinical trials, the results of such
trials, and their success, global public health crises, that may
affect timing and status of our clinical trials and operations,
whether preliminary results from a clinical trial will be
predictive of the final results of that trial or whether results of
early clinical trials or preclinical studies will be indicative of
the results of later clinical trials, whether business development
opportunities to expand the Company’s pipeline of drug candidates,
including without limitation, through potential acquisitions of,
and/or collaborations with, other entities occur, expectations for
regulatory approvals, laws and regulations affecting government
contracts and funding awards, availability of funding sufficient
for the Company’s foreseeable and unforeseeable operating expenses
and capital expenditure requirements and other factors discussed in
the "Risk Factors" section of filings that the Company makes with
the Securities and Exchange Commission. Any change to our ongoing
trials could cause delays, affect our future expenses, and add
uncertainty to our commercialization efforts, as well as to affect
the likelihood of the successful completion of clinical development
of ivonescimab. Accordingly, readers should not place undue
reliance on forward-looking statements or information. In addition,
any forward-looking statements included in this press release
represent the Company’s views only as of the date of this release
and should not be relied upon as representing the Company’s views
as of any subsequent date. The Company specifically disclaims any
obligation to update any forward-looking statements included in
this press release.
Summit Therapeutics and the Summit Therapeutics
logo are trademarks of Summit Therapeutics Inc. Copyright 2025,
Summit Therapeutics Inc. All Rights Reserved.
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Contact Summit Therapeutics: Dave Gancarz Chief Business
& Strategy Officer
Nathan LiaBraaten Senior Director, Investor Relations
investors@smmttx.com media@smmttx.com
Summit Therapeutics (NASDAQ:SMMT)
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