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ArriVent doses first U.S. patient in ARR-002 trial

The Phase 1 study evaluates safety, tolerability, efficacy and pharmacokinetics in advanced or metastatic ovarian or endometrial cancer.

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Form Type
8-K

Rhea-AI Filing Summary

ArriVent BioPharma, Inc. (AVBP) dosed the first patient in the U.S. in the Phase 1 trial of ARR-002, a potential first-in-class MUC16/NaPi2b dual-target tetravalent antibody-drug conjugate for ovarian and endometrial cancer. The trial evaluates safety, tolerability, efficacy and pharmacokinetics in advanced or metastatic ovarian or endometrial cancer. ARR-002 is the company’s second ADC to enter the clinic. In August 2026, ArriVent entered an exclusive licensing agreement with Shanghai Allist Pharmaceuticals Co., Ltd. to develop and commercialize ARR-002 in Greater China, defined as mainland China, Hong Kong, Macau and Taiwan; ArriVent retained all other rights. ARR-002 is also known as AV-P138-ADC and is described as a 2+2 format ADC with site-specific vcMMAE conjugation at a drug-to-antibody ratio of 4.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Patients dosed 1 patient First patient dosed in the U.S. Phase 1 trial
Trial phase Phase 1 ARR-002 trial
ADC entering the clinic Second ADC ARR-002 is ArriVent’s second ADC to enter the clinic
ADC format 2+2 format ARR-002 tetravalent format
Drug-to-antibody ratio 4 Site-specific conjugation to vcMMAE
antibody-drug conjugate (ADC) technical
"dual-target tetravalent antibody-drug conjugate (ADC)"
An antibody-drug conjugate (ADC) is a targeted medical treatment that combines an antibody, which acts like a guided missile seeking out specific cells, with a powerful drug to destroy those cells. It is designed to deliver medication directly to diseased cells, minimizing damage to healthy tissue. For investors, ADCs represent innovative therapies with potential for high growth, especially if they prove effective in treating difficult-to-cure conditions.
tetravalent (2+2 format) technical
"dual-target, tetravalent (2+2 format) ADC"
site-specific conjugation technical
"site-specific conjugation to vcMMAE"
drug-to-antibody ratio (DAR) technical
"drug-to-antibody ratio (DAR) of 4"
vcMMAE technical
"site-specific conjugation to vcMMAE"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did AVBP announce about ARR-002?

ArriVent dosed the first patient in the U.S. in the Phase 1 trial of ARR-002, a potential first-in-class MUC16/NaPi2b dual-target tetravalent antibody-drug conjugate for ovarian and endometrial cancer.

Who has ARR-002 rights in Greater China?

In August 2026, ArriVent entered an exclusive licensing agreement with Shanghai Allist Pharmaceuticals Co., Ltd. to develop and commercialize ARR-002 in Greater China, including mainland China, Hong Kong, Macau and Taiwan. ArriVent retained all other rights.

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false 0001868279 0001868279 2026-10-12 2026-10-12 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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

 

 

 

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

 

 

 

Filing Exhibits & Attachments

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