Summit Therapeutics is Currently Enrolling in a
Phase III Study with Additional Phase III Study Planned for Third
Quarter 2023 for Ivonescimab
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the
“Company”) today announced that data for its novel, potential
first-in-class investigational bispecific antibody, ivonescimab,
will be presented at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago, IL. The poster with updated
clinical data from Phase II clinical trials will be displayed on
Sunday June 4 from 8:00 to 11:00am Central Time during the Lung
Cancer – Non-Small Cell Metastatic Poster Session.
The poster, which is presented by Dr. Li Zhang, Sun Yat-Sen
University Cancer Center1 with data generated and analyzed by our
collaboration and licensing partner, Akeso, Inc. (HKEX Code:
9926.HK), provides updated results from the Phase II study
(NCT04736823) centered around the cohort of patients in which
ivonescimab is combined with chemotherapy (n=135) for first line
treatment of advanced or metastatic non-small cell lung cancer
(NSCLC) in patients without actionable genomic alterations (i.e.,
positive for endothelial growth factor receptor (EGFR) mutations or
anaplastic lymphoma kinase (ALK)). The poster provides updated data
supporting promising anti-tumor activity of ivonescimab in first
line advanced or metastatic NSCLC, while displaying that
ivonescimab may have an acceptable safety profile in combination
with platinum-doublet chemotherapy for patients with squamous or
non-squamous advanced or metastatic NSCLC in this clinical
study.
Ivonescimab, known as SMT112 in the United States, Canada,
Europe, 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. There is higher expression (presence) of both PD-1
and VEGF in tumor tissue and the tumor microenvironment (TME) as
compared to normal, healthy tissue in the body. Ivonescimab’s
tetravalent structure (four binding sites) enables higher avidity
(accumulated strength of multiple binding interactions) with over
10 fold increased binding affinity to PD-1 in the presence of VEGF
in vitro in tumor cells.2 This tetravalent structure, the
intentional design of the molecule, and bringing these two targets
into a single bispecific antibody have the potential to steer
ivonescimab to the tumor tissue versus healthy tissue, which are
intended to improve side effects and safety concerns associated
with these targets and have the potential to focus the antitumor
activity of both targets. Over 750 patients have been treated with
ivonescimab across multiple clinical studies in different
indications in China and Australia.
Summit has begun its clinical development of ivonescimab in two
NSCLC indications:
- Ivonescimab combined with chemotherapy in patients with
epidermal growth factor receptor (EGFR)-mutated, locally advanced
or metastatic non-squamous NSCLC who have progressed after
treatment with a third-generation EGFR tyrosine kinase inhibitor
(TKI) (HARMONi trial or AK112-301)
- Ivonescimab combined with chemotherapy in first-line metastatic
squamous NSCLC patients (HARMONi-3 trial)
In May 2023, the first patient was treated in Summit’s licensed
territories in the Phase III HARMONi clinical trial. Summit intends
to dose patients in the HARMONi-3 trial during the second half of
2023. Lung cancer is believed to impact approximately 238,0003
people in the United States each year and approximately 477,0004 in
Europe. NSCLC is the most prevalent type of lung cancer and
represents approximately 80% to 85% of all incidences.5 Among
patients with non-squamous NSCLC, approximately 15% have
EGFR-sensitizing mutations in the United States and Europe.6
Patients with squamous histology represent approximately 25% to 30%
of NSCLC patients.7
About the ASCO Poster
Poster Title: Phase II results of Ivonescimab (AK112/SMT112) a
novel PD-1/VEGF bispecific in combination with chemotherapy for
first line treatment of advanced or metastatic non-small cell lung
cancer (NSCLC) without actionable genomic alterations (AGA) in
EGFR/ALK
ASCO Abstract No.: 9087
ASCO Poster Session: Lung Cancer – Non-Small Cell Metastatic
Poster Session.
Session Date & Time: Sunday June 4, 8:00 to 11:00am CT
Summit Therapeutics’ Mission Statement
To build a viable, long-lasting health care organization that
assumes full responsibility for designing, developing, trial
execution and enrollment, regulatory submission and approval, as
well as successful commercialization of patient, physician,
caregiver, and societal-friendly medicinal therapy intended to:
improve quality of life, increase potential duration of life, and
resolve serious medical healthcare needs. To identify and control
promising product candidates based on exceptional scientific
development and administrational expertise, develop our products in
a rapid, cost-efficient manner, and to engage commercialization
and/or development partners when appropriate.
We accomplish this by building a team of world class
professional scientists and business administrators that apply
their experience and knowledge to this mission. Team Summit exists
to pose, strategize, and execute a path forward in medicinal
therapeutic health care that places Summit in a well-deserved, top
market share, leadership position. Team Summit assumes full
responsibility for stimulating continuous expansion of knowledge,
ability, capability, and well-being for all involved stakeholders
and highly-valued shareholders.
About Summit Therapeutics
Summit was founded in 2003 and our shares are listed on the
Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Menlo
Park, California, and we have additional offices in Oxford, UK.
For more information, please visit https://www.smmttx.com and
follow us on Twitter @summitplc.
About Ivonescimab
Ivonescimab, known as SMT112 in the United States, Canada,
Europe, and Japan (Summit’s license territories), 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 was discovered by Akeso Inc. (HKEX Code: 9926.HK) and
is currently engaged in multiple Phase III clinical trials in
China. Summit has begun its clinical development of ivonescimab in
NSCLC, enrolling the first patient in its license territory in
2023, with multiple Phase III clinical trials intended to be
initiated in 2023. Over 750 patients have been treated with
ivonescimab in clinical studies in China and Australia.
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 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, the
impact of the COVID-19 pandemic on the Company’s operations and
clinical trials, potential acquisitions 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 results of our evaluation of the underlying
data in connection with the development and commercialization
activities for SMT112, 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, and global
public health crises, including the coronavirus COVID-19 outbreak,
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 SMT112. 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.
1 Poster Authors: Li Zhang, Wenfeng Fang, Yuanyuan Zhao, Yunpeng
Yang, Ningning Zhou, Likun Chen, Yan Huang, Jianhua Chen, Li
Zhuang, Yingying Du, Qitao Yu, Wu Zhuang, Yanqiu Zhao, Ming Zhou,
Weidong Zhang, Yu Zhang, Yixin Wan, Weifeng Song, Michelle Xia 2
Zhong et al, SITC 2022 3 American Cancer Society: Lung Cancer
Statistics | How Common is Lung Cancer? 4 World Health
Organization: 908-europe-fact-sheets.pdf (iarc.fr) 5 Schabath MB,
Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer
Epidemiology, Biomarkers & Prevention. (2019). 6 About
EGFR-Positive Lung Cancer | Navigating EGFR (lungevity.org) 7
Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer.
Cancer Epidemiology, Biomarkers & Prevention. (2019).
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version on businesswire.com: https://www.businesswire.com/news/home/20230601005388/en/
Dave Gancarz SVP, Stakeholder Relations, Business Development,
& Corporate Strategy investors@smmttx.com
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