ADAG

Adagene Announces Clinical Trial Collaboration to Evaluate Anti-CTLA-4 SAFEbody® ADG126 in Combination with Roche’s Standard-of-Care for First-Line Advanced Liver Cancer

Retrieved on: 
Friday, December 16, 2022
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The collaboration will utilize Roche’s MORPHEUS-LIVER platform for rapid and efficient combination development.

Key Points: 
  • The collaboration will utilize Roche’s MORPHEUS-LIVER platform for rapid and efficient combination development.
  • Under the collaboration, Roche will sponsor and conduct a randomized phase 1b/2 multi-national trial to evaluate the efficacy, safety and pharmacokinetics of ADG126 in combination with bevacizumab and atezolizumab, versus atezolizumab and bevacizumab alone, initially in 60 patients.
  • Each company is supplying its respective anti-cancer agent(s) to support the trial.
  • Adagene will retain global development and commercialization rights to ADG126.

Adagene Announces Clinical Data at SITC 2022 on Anti-CTLA-4 NEObody™, ADG116, Showing Differentiated Safety and Anti-tumor Activity in Heavily Pre-treated Patients with Difficult-to-Treat Tumors

Retrieved on: 
Thursday, November 10, 2022
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SAN DIEGO and SUZHOU, China, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced clinical data from phase 1b/2 studies of its anti-CTLA-4 antibody candidate, ADG116, in two poster presentations at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting taking place in Boston.

Key Points: 
  • Combination data from dose escalation of ADG116 plus the anti-PD-1 therapy, toripalimab, were also reported from nine heavily pre-treated patients, close to half (44%) of whom received three or more lines of prior therapy.
  • Key findings as of the data cutoff date on September 19, 2022 include:
    Compelling, differentiated safety profile demonstrated with ADG116 monotherapy up to 15 mg/kg: ADG116 is well tolerated across dose levels with repeat dosing.
  • Grade 1/2 and Grade 3/4 treatment-related adverse events (TRAEs) were reported in 28 (56%) and 3 (6%) patients, respectively.
  • There were no Grade 3 or higher TRAEs reported at the 15 mg/kg dose level for ADG116 monotherapy.

Adagene Announces Poster Presentations on Anti-CTLA-4 NEObody™, ADG116, at Upcoming Society for Immunotherapy of Cancer’s (SITC) Annual Meeting in November

Retrieved on: 
Tuesday, October 11, 2022
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SAN DIEGO and SUZHOU, China, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that it will present clinical data from phase 1b/2 studies of its anti-CTLA-4 antibody candidate, ADG116, at the upcoming Society for Immunotherapy of Cancer’s (SITC) Annual Meeting taking place November 8-12 in Boston.

Key Points: 
  • The posters will summarize the comprehensive safety data for ADG116 with repeat dosing as monotherapy, as well as new data supporting its optimal dose selection in combination with two different anti-PD-1 therapies.
  • Additionally, data will show anti-tumor activity in warm and cold tumors, including details of a partial response with monotherapy and a complete response in combination therapy, which were both observed in tumor types where no anti-CTLA-4 therapy is approved.
  • Adagene Inc.(Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies.Adagenecombines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs.
  • SAFEbody is a registered trademark inthe United States,China,Australia,Japan,Singapore, and theEuropean Union.

Adagene Presents Interim Monotherapy Data at ESMO 2022 Showing Compelling Safety, Anti-Tumor Activity and Pharmacokinetics of Masked, Anti-CTLA-4 SAFEbody® ADG126 in Patients with Advanced Tumors

Retrieved on: 
Saturday, September 10, 2022
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SAN DIEGO and SUZHOU, China, Sept. 10, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced the publication of data showing the best-in-class potential of ADG126, a masked, anti-CTLA-4 SAFEbody®. Interim results from the Phase 1 portion of an ongoing Phase 1b/2 trial of ADG126 are being presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris, September 9 – 13, 2022.

Key Points: 
  • Safety: ADG126 monotherapy showed an unprecedented clinical safety profile at dosing levels up to 20 mg/kg when administered to this heavily pretreated patient population once every three weeks.
  • ADG126 was well tolerated, with no dose-limiting toxicities or treatment-related Grade 3 or higher adverse events observed.
  • Pharmacokinetics: ADG126 plasma pharmacokinetics (PK) were approximately linear and activated ADG126 accumulated steadily during repeat dosing across different dose levels.
  • These data clearly demonstrate the monotherapy activity of this novel antibody, ADG126, supporting its ongoing evaluation as both monotherapy and in combination with anti-PD-1 agents.

Adagene Announces Authorization of Share Repurchase Program up to US$10 Million

Retrieved on: 
Wednesday, June 29, 2022
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The Companys board of directors will review the 2022 Share Repurchase Program periodically and may authorize adjustments to its terms and size or suspend or discontinue the program.

Key Points: 
  • The Companys board of directors will review the 2022 Share Repurchase Program periodically and may authorize adjustments to its terms and size or suspend or discontinue the program.
  • The Company expects to utilize its existing funds to fund repurchases made under this program.
  • The Company has disclosed certain details of the repurchases made in accordance with the prior share repurchase program in its annual report for the year ended December 31, 2021 filed with the SEC.
  • The 2022 Share Repurchase Program does not obligate Adagene to acquire any particular number of American depositary shares, and the 2022 Share Repurchase Program may be modified or suspended at any time at the management's discretion.

Adagene Announces Publication at ASCO of Interim Monotherapy Dose Escalation Data Showing Compelling Safety Profile of Anti-CTLA-4 SAFEbody® ADG126, with Repeat Dosing Across Dose Levels

Retrieved on: 
Thursday, May 26, 2022
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SAN DIEGO and SUZHOU, China, May 26, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced the publication of data showing the potential best-in-class safety profile of its anti-CTLA-4 monoclonal antibody (mAb), ADG126. Interim results from the Phase 1 dose escalation portion of an ongoing Phase 1b/2 trial of ADG126 are published in an abstract on the American Society of Clinical Oncology (ASCO) meeting website in conjunction with the 2022 Annual Meeting taking place in Chicago from June 3-7, 2022.

Key Points: 
  • ADG126 was administered to this heavily pretreated patient population intravenously as monotherapy once every three weeks at doses up to 10 mg/kg.
  • Plasma pharmacokinetics (PK) were approximately linear and the activated ADG126 accumulated steadily during repeat dosing across different dose levels.
  • This activity is likely due to the accumulation of activated ADG126 in the TME upon repeat dosing at 1 mg/kg.
  • Dose escalation in this trial continues at 20 mg/kg and dose expansion has started at 10 mg/kg.

Adagene to Participate in Investor Conferences in May and June

Retrieved on: 
Thursday, May 12, 2022
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Management will also participate in one-on-one investor meetings at the conference to be held in New York, the United States.

Key Points: 
  • Management will also participate in one-on-one investor meetings at the conference to be held in New York, the United States.
  • Goldman Sachs Annual Global Healthcare Conference: Adagene will participate in one-on-one investor meetings during the conference on Monday, June 13.
  • ICA 2nd Annual Asia Pacific Healthcare Conference: Adagene will participate in one-on-one investor meetings to be held virtually during May 18 - 24.
  • Berenberg Emerging Biotech Conference: Adagene will participate in one-on-one investor meetings during the virtual conference on Thursday, May 19.

Adagene Presents Data Demonstrating First and Best-in-Class Potential for Differentiated Preclinical Antibody Candidates at American Association for Cancer Research (AACR) Annual Meeting 2022

Retrieved on: 
Friday, April 8, 2022
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SAN DIEGO and SUZHOU, China, April 08, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced preclinical data showcasing the potential first and best-in-class profile of new antibody candidates. Data are being presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place in New Orleans, Louisiana from April 8-13, 2022. Posters are available in the Publications section of the company’s website at www.adagene.com.

Key Points: 
  • Data are being presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place in New Orleans, Louisiana from April 8-13, 2022.
  • We are encouraged by the preclinical data presented across four posters at AACR, showing the first and best-in-class profiles for our differentiated preclinical candidates, designed to achieve safe, potent and durable responses.
  • Preclinical data demonstrated that ADG153 IgG1 was well tolerated, did not induce human hemagglutination and significantly reduced anemia-related and antigen sink liabilities.
  • Preclinical data demonstrated the excellent safety profile of ADG138, including 100-fold greater reduction in cytokine release compared to its parental TCE.

Adagene Announces FDA Clearance to Proceed with Phase 1b/2 Trial of Anti-CTLA-4 ADG126 SAFEbody® in Combination Therapy With Anti-PD-1 Antibody Pembrolizumab

Retrieved on: 
Wednesday, March 16, 2022
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SAN DIEGO and SUZHOU, China, March 16, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced FDA clearance to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with the anti-PD-1 antibody pembrolizumab. The global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).

Key Points: 
  • The FDA clearance of this trial represents a major step forward in our wholly-owned CTLA-4 program.
  • We are excited to initiate our clinical trial evaluating combination therapy with ADG126, which leverages SAFEbody precision masking technology to address toxicity limitations.
  • This multi-regional trial of ADG126 with pembrolizumab also reflects our commitment to bringing highly differentiated therapies to cancer patients globally.
  • The trial is designed to evaluate safety and tolerability, and to determine the recommended Phase 2 dose for ADG126 in combination with pembrolizumab.

Adagene Announces SAFEbody® Multi-Target Collaboration with Sanofi for Novel Masked Immuno-Oncology Antibody Candidates

Retrieved on: 
Wednesday, March 2, 2022
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SAN DIEGO and SUZHOU, China, March 02, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of antibody-based therapies, today announced a collaboration and exclusive license agreement with Sanofi to generate masked monoclonal and bispecific antibodies for development and commercialization by Sanofi.

Key Points: 
  • Under the terms of the agreement, Adagene will be responsible for early stage research activities to develop masked versions of Sanofi candidate antibodies, using Adagenes SAFEbody technology.
  • Sanofi will make an upfront payment of $17.5 million to Adagene and will have the ability to advance two initial Sanofi antibody candidates in the collaboration, followed by an option for two additional candidates.
  • Adagene is eligible to also receive tiered royalties on global net sales of approved collaboration products.
  • These include three wholly-owned clinical assets in phase 1b/2 development by Adagene, and two product candidates outlicensed in Greater China.