Conference Call to be Held at 9:00am ET
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the
“Company”) will host an earnings call to announce its second
quarter 2024 financial results and provide an operational update
for the Company on Tuesday, August 6, 2024, before the market
opens.
Summit will host a live webcast of the earnings conference call
at 9:00am ET, which will be accessible through our website
www.smmttx.com. An archived edition of the session will be
available on our website.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories,
the United States, Canada, Europe, Japan, Latin America, including
Mexico and all countries in Central America, South America, and the
Caribbean, the Middle East, and Africa, 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 with over 18-fold increased
binding affinity to PD-1 in the presence of VEGF in vitro, and over
4-times increased binding affinity to VEGF in the presence of PD-1
in vitro (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 1,800 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.
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).
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 squamous NSCLC.
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 (PD-L1 TPS >1%).
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.
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., including the expected
benefits of the amendment to the collaboration and license
agreement, the intended use of the net proceeds from the private
placement, 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 use 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, including 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, and 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240729797050/en/
Summit Investor Relations: Dave Gancarz Chief Business
& Strategy Officer
Nathan LiaBraaten Senior Director, Investor Relations
investors@smmttx.com
Summit Therapeutics (NASDAQ:SMMT)
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