Adagene Inc. develops antibody-based cancer immunotherapies as a Nasdaq-listed foreign issuer whose securities trade as ADSs under ADAG. The company uses computational biology and artificial intelligence through its proprietary Dynamic Precision Library platform, including NEObody, SAFEbody and POWERbody technologies, to design masked and engineered antibody programs.
Recurring company updates center on muzastotug (ADG126), a masked anti-CTLA-4 SAFEbody, clinical data in microsatellite stable colorectal cancer and hepatocellular carcinoma, combination studies with checkpoint and bispecific therapies, and FDA Fast Track designation in MSS metastatic colorectal cancer. Other developments include scientific meeting presentations, SAFEbody collaborations and licensing, advisory board changes, financial results and ADS capital offerings.
Adagene Inc. (Nasdaq: ADAG) announces the appointment of Professor Aurélien Marabelle to its Scientific and Strategic Advisory Board. Professor Marabelle, an expert in oncology and immunology, has significant experience in early-phase clinical trials of cancer immunotherapies. His research focuses on targeting tumor-specific regulatory T-cells (Tregs) using Adagene’s SAFEbody technology for effective systemic delivery of anti-CTLA-4 therapies. This strategic addition is expected to enhance Adagene’s understanding of tumor-specific Treg depletion, further strengthening its pipeline of innovative immunotherapy programs.
Adagene Inc. (Nasdaq: ADAG) announced positive data for its anti-CTLA-4 SAFEbody, ADG126, in combination with anti-PD-1 therapy for advanced solid tumors. In a study of 14 patients, no dose-limiting toxicities were observed with ADG126, demonstrating a compelling safety profile. The trial also showed confirmed partial responses and ongoing tumor shrinkage in multiple tumor types, including resistant variants. The company is expanding dose optimization strategies in line with the FDA's Project Optimus initiative, looking to enhance therapeutic efficacy while minimizing toxicity.
Adagene Inc. (Nasdaq: ADAG) announces that CEO Peter Luo will present a corporate update at the Biotech Showcase™ 2023 on January 9-11 in San Francisco, coinciding with the J.P. Morgan Healthcare Conference. The presentation is scheduled for 11:30 a.m. Pacific time at the Hilton San Francisco, Union Square. A live webcast will be available on Adagene's investor website, with a replay accessible for 30 days. Adagene focuses on developing novel antibody-based cancer immunotherapies using advanced technologies like its Dynamic Precision Library.
Adagene Inc. (Nasdaq: ADAG) announced a collaboration with Roche to evaluate its ADG126 in combination with Roche's atezolizumab and bevacizumab for treating advanced hepatocellular carcinoma (HCC). The trial will be a randomized phase 1b/2 study, initially involving 60 patients. Adagene retains global rights for ADG126. This collaboration seeks to improve treatment efficacy in a disease with a high mortality rate, leveraging Adagene's SAFEbody technology to enhance safety and efficacy while addressing the challenges of combining therapies.
Adagene Inc. (Nasdaq: ADAG) announced interim phase 1b/2 clinical data for its anti-CTLA-4 antibody ADG116, showcased at the Society for Immunotherapy of Cancer Annual Meeting. Significant findings include: two partial responses in Kaposi’s sarcoma and renal cell carcinoma as monotherapy, and a confirmed durable complete response in head and neck cancer when combined with toripalimab. Additionally, ADG116 demonstrated a potent activity in microsatellite-stable colorectal cancer, with no dose-limiting toxicities reported. The overall disease control rate reached 33% across monotherapy dose levels.
Adagene Inc. (Nasdaq: ADAG) has announced the presentation of clinical data for its anti-CTLA-4 antibody candidate, ADG116, at the SITC Annual Meeting on November 10, 2022. The phase 1b/2 studies demonstrate a differentiated safety profile across dosing levels, including monotherapy and combination with anti-PD-1 therapies. Notably, the data highlights anti-tumor activity in both warm and cold tumors, as well as objective responses in tumor types lacking approved anti-CTLA-4 treatments. The findings will be available on Adagene's website post-presentation.
Adagene Inc. (Nasdaq: ADAG) has showcased the promising results of its drug ADG126 at the ESMO Congress 2022. Interim data from an ongoing Phase 1/2 trial indicates that ADG126, an innovative anti-CTLA-4 SAFEbody®, demonstrates a solid safety profile with no significant adverse effects reported at doses up to 20 mg/kg. Notably, antitumor activity was observed in cold tumors, highlighted by a patient with ovarian cancer showing a 90% drop in the biomarker CA125. Ongoing trials aim to further evaluate ADG126 in combination with anti-PD-1 therapies.
Adagene Inc. (Nasdaq: ADAG) reported positive topline results for its anti-CTLA-4 antibody, ADG116, showing safety and clinical responses in combination with anti-PD-1 therapy. Regulatory filing for ADG206's clinical trial is underway, with patient dosing planned for early 2023. Financially, the company holds US$168 million in cash, sufficient to support operations into late 2024. Notably, net revenue increased to US$3.9 million for H1 2022, rising from US$1.4 million in 2021, aided by collaborations with Sanofi and Exelixis.
Adagene Inc. (Nasdaq: ADAG) announced a share repurchase program allowing up to US$10 million in buybacks of its ordinary shares. This 2022 Share Repurchase Program enables Adagene to repurchase shares at prevailing market prices through various means, subject to market conditions and regulatory requirements. The program will commence upon agreement with a broker-dealer and lasts for twelve months. Adagene aims to utilize existing funds for this initiative, signaling confidence in its share value and long-term market strategy.
Adagene Inc. (Nasdaq: ADAG) announced promising interim results for its anti-CTLA-4 monoclonal antibody, ADG126, at the ASCO 2022 meeting. The ongoing Phase 1 trial shows no dose-limiting toxicities and only mild treatment-related adverse events in 16 heavily pretreated patients. Two patients demonstrated significant tumor reduction, with one experiencing a 77% decrease in CA-125 levels. Adagene aims to confirm ADG126's safety in combination with anti-PD-1 therapies in upcoming analyses while continuing dose escalation and expansion in the study.