Adagene's ADG126 Shows Clinical Benefit in Colorectal Cancer Trial

Ticker: ADAG · Form: 6-K · Filed: 2024-01-16T00:00:00.000Z

Sentiment: bullish

Topics: clinical-trial, biotech, drug-development, colorectal-cancer

TL;DR

**Adagene's ADG126 shows promising clinical benefit in colorectal cancer, potentially boosting future value.**

AI Summary

Adagene Inc. filed a 6-K on January 16, 2024, announcing interim results for its masked anti-CTLA-4 SAFEbody® ADG126 (muzastotug) in combination with Pembrolizumab for metastatic microsatellite-stable (MSS) colorectal cancer (CRC). The data from the first group of MSS CRC patients treated with ADG126 10 mg/kg every three weeks showed clinical benefits, including confirmed responses. This matters to investors because positive clinical trial results for ADG126 could significantly increase Adagene's future revenue potential and stock value, especially given the 'best-in-class' median progression-free survival of seven months in a specific patient subgroup.

Why It Matters

Positive interim clinical trial results for Adagene's ADG126 could lead to future drug approval and commercialization, directly impacting the company's financial performance and stock price.

Risk Assessment

Risk Level: medium — While the interim results are positive, this is still an early-stage clinical trial, and future trials or regulatory hurdles could still impact the drug's success.

Analyst Insight

A smart investor would monitor Adagene's future clinical trial updates for ADG126, as continued positive results could signal significant upside potential for the stock. Consider the 'best-in-class' PFS as a strong indicator.

Key Numbers

Key Players & Entities

Forward-Looking Statements

FAQ

What specific type of cancer is ADG126 being tested for in this filing?

ADG126 (muzastotug) is being tested in combination with Pembrolizumab for metastatic microsatellite-stable (MSS) colorectal cancer (CRC), as stated in the Exhibit 99.1 press release.

What was the dosing regimen for ADG126 in the first tranche of MSS CRC patients?

The first tranche of MSS CRC patients was treated with ADG126 at a dose of 10 mg/kg every three weeks (Q3W), according to the Exhibit 99.1 press release.

What clinical benefit was observed in the initial patient group?

The data showed clinical benefit, including confirmed responses, at higher, more frequent, and repeat doses of the anti-CTLA-4 therapy, as detailed in Exhibit 99.1.

What was the median progression-free survival (PFS) observed for ADG126 in a specific patient subgroup?

Preliminary survival analysis of ADG126 10 mg/kg dosing regimens in patients without liver and peritoneal metastases indicated a median progression-free survival (PFS) of seven months, as per Exhibit 99.1.

Who signed the 6-K filing on behalf of Adagene Inc.?

The 6-K filing was signed by Peter (Peizhi) Luo, Chief Executive Officer of Adagene Inc., on January 16, 2024.

From the Filing

0001104659-24-004145.txt : 20240116 0001104659-24-004145.hdr.sgml : 20240116 20240116170013 ACCESSION NUMBER: 0001104659-24-004145 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20240116 FILED AS OF DATE: 20240116 DATE AS OF CHANGE: 20240116 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: 24535819 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 tm243326d1_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 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 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 (Peizhi) Luo Name: Peter (Peizhi) Luo Title: Chief Executive Officer Date: January 16, 2024 2 EXHIBIT INDEX Exhibit Description 99.1 Press Release titled “Adagene Presents Interim Results Reinforcing Best-in-Class Profile of Masked anti-CTLA-4 SAFEbody ® ADG126 (muzastotug) in Combination with Pembrolizumab in Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC)” 3 EX-99.1 2 tm243326d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Adagene Presents Interim Results Reinforcing Best-in-Class Profile of Masked anti-CTLA-4 SAFEbody ® ADG126 (muzastotug) in Combination with Pembrolizumab in Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC) - Data from first tranche of MSS CRC patients treated with ADG126 10 mg/kg every three weeks (Q3W) in dose expansion showed clinical benefit including confirmed responses at higher, more frequent and repeat doses of the anti-CTLA-4 therapy – - Preliminary survival analysis of ADG126 10 mg/kg dosing regimens in patients without liver and peritoneal metastases indicates best-in-class median progression-free survival (PFS) of seven months – - Data from additional patients at 10 mg/kg Q3W dosing regimen expected throughout 2024 – SAN DIEGO and SUZHOU, China, January 16, 2024 – Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced data from its presentation at the American Society of Clinical Oncology (ASCO) 2024 Gastrointestinal (GI) Cancers Symposium, taking place January 18-20 in San Francisco. “The expanded therapeutic index for the masked ADG126 allows us to dose with a higher and more frequent effective dose of anti-CTLA-4 therapy than today’s options,” said Daneng Li, MD and Associate Professor Department of Medical Oncology & Therapeutics Research at the City of Hope Comprehensive Cancer Center. “ These promising data support further evaluation of this potential best-in-class anti-CTLA-4 antibody, ADG126, in combination with pembrolizumab for MSS CRC patients, including battli

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