ArriVent 8-K 备案 ARR-217(CDH17 ADC) ESMO 一期末线CRC 44.8% ORR 数据——同一通稿的 SEC 行政备案，非新增事实

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 25, 2026
ARRIVENT
BIOPHARMA, INC.
(Exact name of registrant as specified in its
charter)
Delaware
001-41929
86-3336099
(State
or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS
Employer
Identification No.)
18 Campus Boulevard
,
Suite 100
Newtown Square
,
PA
19073
(Address
of principal executive offices)
(zip
code)
Registrant’s telephone number, including
area code:
(
628
)
277-4836
N/A
(Former name or former
address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨
Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock,
$0.0001 par value per share
AVBP
The
Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange
Act of 1934 (17 CFR §240.12b-2).
Emerging Growth Company
x
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
¨
Item
7.01
Regulation FD Disclosure.
On October 25, 2026, ArriVent BioPharma, Inc. issued a press
release announcing initial Phase 1 data for cadherin-17 (CDH17)-targeted antibody-drug conjugate ARR-217 (MRG007), in patients with gastrointestinal
cancers at the European Society for Medical Oncology Congress 2026. A copy of the press release is filed as Exhibit 99.1 hereto and
is hereby incorporated by reference into this Item 7.01.
The information in this Item 7.01 is being furnished and shall not
be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any registration
statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by
specific reference in such filing
.
Item
8.01
Other Events.
The information set forth in the press release referred to in Item
7.01 above, other than the second paragraph thereof, is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.
Description
99.1
Press Release dated October 25, 2026.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ARRIVENT BIOPHARMA, INC.
By:
/s/ Winston Kung
Winston Kung
Chief Financial Officer and Treasurer
Date: October 26, 2026

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EX-99.1
2
tm2628237d1_ex99-1.htm
EXHIBIT 99.1
Exhibit 99.1
ArriVent Announces Initial Phase 1 Data for
CDH17-targeted ADC ARR-217 in Patients with Gastrointestinal Cancers at ESMO Congress 2026
·
44.8%
ORR at 6mg/kg dose in late-line CRC patients
·
ARR-217 was generally well-tolerated
·
ArriVent to host virtual webinar on Monday,
October 26, 2026, at 8 am ET to discuss the data from the ARR-217 program
NEWTOWN SQUARE, PA, October 25, 2026 (GLOBE
NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the
global development of innovative biopharmaceutical therapeutics, today announced initial encouraging Phase 1 results for ARR-217, (MRG007),
a cadherin-17 (CDH17)-targeting antibody-drug conjugate (ADC) developed in partnership with Lepu Biopharma Co., Ltd., in patients
with gastrointestinal malignancies. The findings were presented as part of an oral presentation at the 2026 European Society for Medical
Oncology (ESMO) Congress 2026.
"These initial results reinforce our confidence
in ARR-217 and in CDH17 as a potential therapeutic target for patients with gastrointestinal cancers who face limited treatment options
following prior lines of therapy," said Bing Yao, Ph.D., Chief Executive Officer of ArriVent. "We believe the responses observed
in this heavily pretreated patient population, together with a manageable safety profile, provided a strong foundation for advancing ARR-217
into a Phase 1b dose optimization study. As the first ADC from our pipeline to enter clinical development, ARR-217 represents an important
milestone for our ADC pipeline, and we look forward to dose optimization data expected in 2027."
The ongoing multicenter, open-label Phase 1 study
(NCT07066657) conducted in the US and China is evaluating the safety, tolerability, efficacy, and pharmacokinetics of ARR-217 in patients
with unresectable, locally advanced, or metastatic solid tumors, with an initial clinical development focus in colorectal, pancreatic,
and other gastrointestinal (GI) cancers. As of the August 5, 2026 data cutoff, 123 patients with heavily pretreated GI malignancies
were treated across 6 dose levels ranging from 2 mg/kg to 8 mg/kg, including 113 patients with Colorectal Cancer (CRC).
Key Highlights for ARR-217 Phase 1 Study Include:
·
Strong Anti-tumor Activity with ARR-217 at
Multiple Dose Levels
o
At 6 mg/kg Q3W dose, 44.8% (13/29) objective response rate (ORR) observed in pre-treated CRC patients,
including 7 confirmed partial responses, 4 partial responses pending confirmation, and 2 unconfirmed partial responses
o
At 6 mg/kg Q3W dose, 93.1% (27/29) disease control rate (DCR) observed
o
At doses 4 mg/kg Q3W and higher, 34.2% (25/73) ORR observed in CRC patients, including 15 confirmed partial
responses, 5 partial responses pending confirmation and 5 unconfirmed partial responses
o
At doses 4 mg/kg Q3W and higher, 91.8% DCR observed
o
Majority of the responding patients remained on study treatment as of the August 5, 2026 data cutoff
·
Generally, Well Tolerated Safety Profile
o
The most common treatment-related adverse events were Grade 1/2
o
Across all doses, 30.1% (37/123) patients experienced Grade 3 or higher treatment-related adverse events,
including neutropenia (12.2%) and diarrhea (8.9%)
o
At 6.0 mg/kg Q3W dose, Grade 3 or higher TRAE was 20.4% (10/49) including 2.0% diarrhea (1/49)
o
No grade 5 TRAE or ILD observed
Dose Optimization and Next Steps
ARR-217 has advanced into Phase 1b dose optimization
at doses of 5 and 6 mg/kg Q3W with further dose optimization data expected in 2027.
About ARR-217
ARR-217 (also known as MRG007) is a potentially
best-in-class cadherin-17 (CDH17)-targeted antibody-drug conjugate (ADC), utilizing a glycan-linked, exatecan-based payload. CDH17 is
a membranous cell adhesion molecule frequently overexpressed in colorectal cancer and several other gastrointestinal cancers, with limited
expression in normal intestinal tissue and pancreatic duct, making it an attractive target for ADC therapy. ArriVent obtained exclusive
rights to develop and commercialize ARR-217 worldwide outside of Greater China under a collaboration agreement with Lepu Biopharma Co., Ltd.
ARR-217 is the lead clinical candidate from ArriVent's growing ADC portfolio.
About ArriVent
ArriVent is a clinical-stage biopharmaceutical
company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs
of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its
lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates,
through approval and commercialization.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about
us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained
in this press release, including statements regarding, business strategy and plans; the activity safety and tolerability of ARR-217; the
expected timing and future results of the ongoing clinical study of ARR-217, and objectives of management for future operations, are forward-looking
statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,”
“contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,” “target,”
“will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements
are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult
to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described
more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31,
2025, filed with the Securities and Exchange Commission on March 5, 2026 and our other filings with the Securities and Exchange Commission.
Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information
except as required under applicable law.
Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com