Adagene Expands ADG126/KEYTRUDA Colorectal Cancer Trial; Data Due 2024

TL;DR

**Adagene is expanding its ADG126 cancer trial with KEYTRUDA, expecting new data in 2024; watch for efficacy in colorectal cancer.**

AI Summary

Adagene Inc. announced on February 9, 2024, the expansion of its clinical collaboration for ADG126 (muzastotug), a masked anti-CTLA-4 SAFEbody, in combination with Merck's KEYTRUDA (pembrolizumab). This expansion focuses on patients with metastatic microsatellite-stable (MSS) colorectal cancer, with interim data from patients dosed at 10 mg/kg every three weeks expected in 2024. This matters to investors because positive results could significantly increase the market potential for ADG126, potentially boosting Adagene's stock value by demonstrating efficacy in a challenging cancer type.

Why It Matters

This filing signals Adagene's progress in a key clinical trial, and positive interim data could unlock a significant market opportunity for its drug, directly impacting future revenue and stock performance.

Risk Assessment

Risk Level: medium — While the expansion shows progress, clinical trials inherently carry risk, and the anticipated interim data in 2024 could be positive or negative, impacting the stock.

Analyst Insight

A smart investor would closely monitor Adagene's progress and the upcoming interim data release in 2024, as positive results in metastatic MSS colorectal cancer could be a significant catalyst for the stock.

Key Numbers

• 10 mg/kg — ADG126 dosage (The specific dosage being evaluated every three weeks in the expanded clinical trial for metastatic MSS CRC patients.)
• 2024 — Anticipated data release year (The year when interim data from the additional MSS CRC patients is expected to be presented at a medical conference.)

Key Players & Entities

• Adagene Inc. (company) — the registrant and developer of ADG126
• Peter Luo (person) — Chief Executive Officer of Adagene Inc.
• ADG126 (muzastotug) (drug) — Adagene's masked anti-CTLA-4 SAFEbody drug candidate
• KEYTRUDA (pembrolizumab) (drug) — Merck's immunotherapy drug used in combination with ADG126
• 10 mg/kg (dollar_amount) — dosage of ADG126 in the expanded trial
• February 9, 2024 (date) — date of the 6-K filing and press release update

Forward-Looking Statements

• Adagene's stock price will react significantly to the interim data release in 2024. (Adagene Inc.) — high confidence, target: 2024
• The expanded trial for ADG126 in MSS CRC will demonstrate improved efficacy compared to existing treatments. (ADG126) — medium confidence, target: 2024

FAQ

From the Filing

0001104659-24-012518.txt : 20240209 0001104659-24-012518.hdr.sgml : 20240209 20240209060842 ACCESSION NUMBER: 0001104659-24-012518 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 29 CONFORMED PERIOD OF REPORT: 20240209 FILED AS OF DATE: 20240209 DATE AS OF CHANGE: 20240209 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: 24611014 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 tm245450d1_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 February 2024 Commission File Number: 001-39997 Adagene Inc. (Exact Name of Registrant as Specified in Its Charter) 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 o EXPLANTATORY NOTE On February 9, 2024, Adagene Inc. (the “Company”) updated information reflected in a press release and an investor presentation, which is attached as Exhibit 99.1 and Exhibit 99.2 to this Current Report on Form 6-K, respectively. Representatives of the Company intend to use the updated presentation and information contained in the press release in meetings with investors from time to time. 2 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: February 9, 2024 3 EXHIBIT INDEX Exhibit Description 99.1 Press Release 99.2 Investor Presentation 4 EX-99.1 2 tm245450d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Adagene Announces Progress and Expansion of Clinical Collaboration Program for Masked, Anti-CTLA-4 SAFEbody® ADG126 (muzastotug) in Combination with KEYTRUDA® (pembrolizumab) to Demonstrate Further Efficacy in Patients with Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC) - Interim data from additional MSS CRC patients dosed at 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab anticipated in 2024 at a medical conference – - Initiated evaluation of 20 mg/kg loading doses of ADG126 in combination with pembrolizumab to explore enhanced efficacy given superior therapeutic index of ADG126 – - Received clearance from China’s Center for Drug Evaluation (CDE) to evaluate ADG126 in combination with pembrolizumab – SAN DIEGO and SUZHOU, China, February 9, 2024 – Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced progress and expansion of the clinical collaboration development program for its masked, anti-CTLA-4 SAFEbody, ADG126 in combination with Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with metastatic microsatellite-stable (MSS) colorectal cancer (CRC). “Following completion of enrollment of 12 additional patients at the end of last year, together with our ongoing expansion plans, we are on track to deliver data in 2024 that support the findings