Adagene Inc. Reports Phase 1b/2 Study Data Update

Ticker: ADAG · Form: 6-K · Filed: 2025-01-27T00:00:00.000Z

Sentiment: neutral

Topics: clinical-trial, data-update, foreign-issuer

TL;DR

Adagene dropped new Phase 1b/2 data, check the press release!

AI Summary

Adagene Inc. filed a Form 6-K on January 27, 2025, reporting updated data from its Phase 1b/2 study. The filing includes a press release titled "Adagene Announces Updated Data from Phase 1b/2 S", indicating new developments in their clinical trials.

Why It Matters

This filing provides investors with crucial, up-to-date information on Adagene's clinical trial progress, which can significantly impact the company's valuation and future prospects.

Risk Assessment

Risk Level: medium — Clinical trial data updates can be highly volatile, with positive results boosting stock and negative results causing significant drops.

Key Players & Entities

FAQ

What specific updated data was announced from the Phase 1b/2 study?

The filing references a press release titled "Adagene Announces Updated Data from Phase 1b/2 S", but the specific details of the data are not included in the provided text.

What is the primary purpose of this Form 6-K filing?

This Form 6-K is a Report of Foreign Private Issuer, used by Adagene Inc. to report material information to the SEC, in this case, likely related to updated clinical trial data.

Who signed this report on behalf of Adagene Inc.?

Peter Luo, Chief Executive Officer, signed the report on behalf of Adagene Inc.

What is Adagene Inc.'s principal executive office address?

Adagene Inc.'s principal executive office is located at 4F, Building C14, No. 218 Xinghu Street, Suzhou Industrial Park, Suzhou, Jiangsu Province, 215123, People's Republic of China.

Does Adagene Inc. file annual reports under Form 20-F or Form 40-F?

Adagene Inc. indicated that it files annual reports under Form 20-F.

From the Filing

0001104659-25-006124.txt : 20250127 0001104659-25-006124.hdr.sgml : 20250127 20250127070042 ACCESSION NUMBER: 0001104659-25-006124 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20250127 FILED AS OF DATE: 20250127 DATE AS OF CHANGE: 20250127 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Adagene Inc. CENTRAL INDEX KEY: 0001818838 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: E9 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39997 FILM NUMBER: 25555730 BUSINESS ADDRESS: STREET 1: 4F, BUILDING C14, NO. 218, XINGHU STREET STREET 2: SUZHOU INDUSTRIAL PARK CITY: JIANGSU STATE: F4 ZIP: 00000 BUSINESS PHONE: 86-512-87773632 MAIL ADDRESS: STREET 1: 4F, BUILDING C14, NO. 218, XINGHU STREET STREET 2: SUZHOU INDUSTRIAL PARK CITY: JIANGSU STATE: F4 ZIP: 00000 6-K 1 tm254514d1_6k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a- 16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2025 Commission File Number: 001-39997 Adagene Inc. 4F, Building C14, No. 218 Xinghu Street, Suzhou Industrial Park Suzhou, Jiangsu Province, 215123 People’s Republic of China +86-512-8777-3632 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F x Form 40-F ¨ 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. Adagene Inc. By: /s/ Peter Luo Name: Peter Luo Title: Chief Executive Officer Date: January 27, 2025 EXHIBIT INDEX Exhibit Description 99.1 Press release titled “Adagene Announces Updated Data from Phase 1b/2 Study of Muzastotug in Combination with KEYTRUDA ® (pembrolizumab) in Colorectal Cancer at ASCO Gastrointestinal Cancers Symposium.” EX-99.1 2 tm254514d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Adagene Announces Updated Data from Phase 1b/2 Study of Muzastotug in Combination with KEYTRUDA® (pembrolizumab) in Colorectal Cancer at ASCO Gastrointestinal Cancers Symposium Muzastotug (ADG126), an Anti-CTLA-4 SAFEbody® in Combination with pembrolizumab showed 33% overall response rate in microsatellite stable colorectal cancer Four confirmed partial responses out of twelve patients with 20 mg/kg loading dose followed by 10 mg/kg Q3W + pembrolizumab No Grade 4/5 treatment related adverse events were observed and no discontinuations occurred to date SAN DIEGO and SUZHOU, China, Jan 27, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, announced updated clinical data from ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA. “These data, from the loading dose expansion cohort of our Phase 1b/2 trial, continue to demonstrate ADG126’s potential for patients with colorectal cancer. Seeing four confirmed partial responses out of twelve patients, with no treatment related discontinuations, also highlights the differentiated therapeutic index of ADG126. CTLA-4 is clinically validated with a known correlation between dose, efficacy and toxicity to improve outcomes with PD-1 inhibitors, and now we know that our SAFEbody can deliver benefit to patients in a safe and efficacious way,” said Peter Luo, Chairman, CEO & President of R&D at Adagene. Dr. Marwan Fakih, Professor of Medical Oncology and Therapeutics Research at City of Hope added, “Masking technology, which leads to increased intra-tumoral accumulation of cleaved ADG126 and maintains an optimal p

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