ArriVent（AVBP）宣布全球首创 MUC16/NaPi2b 双靶四价 ADC（ARR-002）美国 I 期试验完成首例患者给药

----- tm2627450d1_8k.htm -----
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 12, 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 12, 2026, ArriVent BioPharma, Inc. (the “Company”)
issued a press release announcing that the Company dosed its first patient in the Phase 1 trial in the U.S. with ARR-002, a potential
first-in-class MUC16/NaPi2b dual-target tetravalent antibody-drug conjugate for ovarian and endometrial cancer. 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 and third paragraphs 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 12, 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
13, 2026

----- tm2627450d1_ex99-1.htm -----
EX-99.1
2
tm2627450d1_ex99-1.htm
EXHIBIT 99.1
Exhibit 99.1
ArriVent Announces First Patient Dosed with
Novel Tetravalent MUC16/NaPi2b Dual Target ADC, ARR-002
NEWTOWN SQUARE, PA, October 12, 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 that it dosed its first patient in the Phase 1 trial
in the U.S. with ARR-002 (NCT07755436), a potential first-in-class MUC16/NaPi2b dual-target tetravalent antibody-drug conjugate (ADC)
for ovarian and endometrial cancer.
“We are pleased to have dosed our first
patient with ARR-002, our second ADC from our portfolio to enter the clinic,” said Stuart Lutzker, MD, Ph.D., President of Research
and Development at ArriVent. “Both MUC16 and NaPi2b are highly over-expressed in ovarian and endometrial cancer, and the dual targeting
approach of ARR-002 is designed to overcome a key limitation of single-target ADCs in solid tumors where target expression can be heterogenous
and can limit effective payload delivery to all tumor cells.”
Continues Dr. Lutzker, “The
entry
of ARR-002 into the clinic for ovarian and endometrial cancer broadens our clinical pipeline beyond lung and gastrointestinal cancers,
where we also have active programs.”
In August 2026, ArriVent entered into an
exclusive licensing agreement with Shanghai Allist Pharmaceuticals Co., Ltd. to develop and commercialize ARR-002 in Greater China,
which includes mainland China, Hong Kong, Macau and Taiwan, with all other rights retained by ArriVent.
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.
About ARR-002
ARR-002 (also known as AV-P138-ADC) is a first-in-class, Mucin-16 (MUC16)
and sodium-dependent phosphate transport protein 2b (NaPi2b) dual-target, tetravalent (2+2 format) ADC, with site-specific conjugation
to vcMMAE at a drug-to-antibody ratio (DAR) of 4. Preclinical data presented at AACR in 2026 (Abstract #2260) demonstrated that ARR-002
has improved in vitro and in vivo activity over bivalent ADCs and that site-specific conjugation of the vcMMAE payload enhances the stability
and safety profile to potentially broaden the therapeutic window in patients. ARR-002 is being studied in a Phase 1 trial to evaluate
the safety, tolerability, efficacy, and pharmacokinetics of ARR-002 in advanced or metastatic ovarian or endometrial cancer (NCT07755436).
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 our business strategy and plans, activity and safety of ARR-002 compared to available
therapies, anticipated clinical milestones, including the timing of, and results of global development of ARR-002, the expected benefits
of the exclusive license agreement with Allist for ARR-002 in Greater China, 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