ADAG Adagene Inc.

15.47
+0.04  (+0%)
Previous Close 15.43
Open 15.6
52 Week Low 11.11
52 Week High 31.83
Market Cap $673,222,006
Shares 43,517,906
Float 43,517,906
Enterprise Value $604,311,262
Volume 10,707
Av. Daily Volume 51,304
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Upcoming Catalysts

Drug Stage Catalyst Date
ADG106-2001
Solid tumors
Phase 2
Phase 2
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ADG116
Solid Tumors
Phase 1
Phase 1
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ADG126
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
ADG126 combined with KEYTRUDA (pembrolizumab)
Solid tumors
Phase 1
Phase 1
Phase 1 trial planned.
ADG116 combined with KEYTRUDA (pembrolizumab)
Solid tumors
Phase 1
Phase 1
Phase 1 trial planned.

Latest News

  1. SAN FRANCISCO, July 22, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that it has entered into the clinical trial collaboration and supply agreement with Merck (known as "MSD" outside the United States and Canada), the leader among top immuno-oncology (IO) drugs on the market. The agreement includes two open-label, dose escalation and expansion clinical studies to evaluate Adagene's anti-CTLA-4 monoclonal antibody (mAb) product candidates, ADG116 and ADG126, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced/metastatic…

    SAN FRANCISCO, July 22, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that it has entered into the clinical trial collaboration and supply agreement with Merck (known as "MSD" outside the United States and Canada), the leader among top immuno-oncology (IO) drugs on the market. The agreement includes two open-label, dose escalation and expansion clinical studies to evaluate Adagene's anti-CTLA-4 monoclonal antibody (mAb) product candidates, ADG116 and ADG126, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced/metastatic solid tumors.

    "This collaboration with Merck and the advancement of our global clinical studies represent an important milestone in our comprehensive CTLA-4 clinical development program," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "Our AI driven platforms have generated two highly differentiated CTLA-4 targeting molecules, ADG116 and ADG126. ADG116, our NEObody™ CTLA-4 candidate, is designed with strong antibody-dependent cellular cytotoxicity (ADCC) and softened T cell activation which combined, leading to increased potency with an improved safety profile. Our SAFEbody™ candidate ADG126 effectively limits on-target off-tumor toxicities in normal tissues and is designed for a superior systemic safety profile at efficacious dose levels with a significantly enhanced therapeutic window to overcome existing issues associated with current anti-CTLA-4 therapies."

    Dr. Luo continued, "Although we believe that ADG116 and ADG126 have great promise as single agents, combining with KEYTRUDA may unleash the potential of dual PD-1/CTLA-4 blockade, overcoming the safety profile limitations seen historically with this combination while also modulating different T cell populations to drive new immune functions and synergies not achievable through conventional monotherapies. Our extensive preclinical and early strong clinical data support this strategy, and we look forward to combining our anti-CTLA-4 therapeutics with anti-PD-1 checkpoint inhibitors such as KEYTRUDA to fulfill the potential of this combination therapy approach. We are fortunate to have the opportunity to explore this combination with Merck and tackle two of the most potent immunotherapy targets."

    "We are extremely pleased to partner with Merck to explore the therapeutic potential of ADG116 and ADG126 in combination with KEYTRUDA, as this collaboration represents an important milestone for Adagene, and for patients with advanced/metastatic solid tumors," said Steven Fischkoff, M.D., interim Chief Medical Officer of Adagene. "ADG116 program is at the 3 mg/kg dose level now which is where the commercial CTLA-4 therapy had been approved previously in mono and combination for specific indications. We expect to see differentiation going forward of our programs."

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    About CTLA-4 Clinical Development Program

    ADG 116-P001: The Phase 1, open-label, dose escalation and cohort expansion study of ADG116 combined with KEYTRUDA in patients with advanced/metastatic solid tumors will be conducted at multiple sites in Asia and the United States. The study will evaluate the safety, tolerability, and recommended Phase 2 dose for ADG116 in combination with KEYTRUDA with dose escalation planned for up to 10 mg/kg. The study builds on encouraging signs of pharmacodynamic (PD) markers, favorable pharmacokinetic (PK) profile, strong early clinical data of the ADG116-1003 trial, extensive preclinical and safety tolerability data and successful Safety Review Committee meetings. In the ADG116-1003 trial, ADG116 has been well tolerated in 17 patients, with no dose-limiting toxicities or unexpected safety signals. No drug related Grade 2, Grade 3 or Grade 4 toxicities have been observed. Dosing for three additional patients has been completed in the 3 mg/kg cohort, for a total of 17 patients treated to date.

    ADG 126-P001: The Phase 1, open-label, dose escalation and cohort expansion study of ADG126 combined with KEYTRUDA in patients with advanced/metastatic solid tumors will be conducted at multiple sites in Asia and the United States. It will evaluate the safety, tolerability, and recommended Phase 2 dose for ADG126 in combination with KEYTRUDA with dose escalation planed for up to 10 mg/kg. The study builds on encouraging preclinical data, demonstrating ADG126 was well tolerated at doses up to 200 mg/kg, with an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent and in combination with anti-PD-1 and other therapies. In the ADG126-1001 trial, dose limiting toxicity (DLT) evaluation has been completed in six patients in the 0.1 and 0.3 mg/kg cohorts.

    About Adagene

    Adagene Inc. (NASDAQ:ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

    For more information, please visit: https://investor.adagene.com.

    Safe Harbor Statement

    This press release contains forward-looking statements, including statements regarding the therapeutic potential of ADG116 and/or ADG126 in combination with pembrolizumab to treat patients with advanced/metastatic solid tumors, data from the ADG116 and/or ADG126 clinical trials, clinical development plans of ADG116 and/or ADG126, the potential implications of clinical data for patients, and Adagene's advancement of, and anticipated clinical development, regulatory milestones and commercialization of ADG126. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to the potential failure of the combination of ADG116 and/or ADG126 and pembrolizumab to demonstrate safety and/or efficacy in the Phase 1 open-label, dose escalation and expansion studies; the clinical results for Adagene's drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene's drug candidates; Adagene's ability to achieve commercial success for its drug candidates, if approved; Adagene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene's reliance on third parties to conduct drug development, manufacturing and other services; Adagene's limited operating history and Adagene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene's ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in Adagene's filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    Media Contact:

    Tony Russo

    Russo Partners LLC

    212-845-4251



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  2. SAN FRANCISCO and SUZHOU, China, July 07, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that its board of directors has authorized a share repurchase program under which, Adagene may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares, subject to the relevant rules under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Company's insider trading policy.

    "I am pleased to announce this share repurchase program, which is a strong indication of the Board's confidence in Adagene's globally…

    SAN FRANCISCO and SUZHOU, China, July 07, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that its board of directors has authorized a share repurchase program under which, Adagene may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares, subject to the relevant rules under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Company's insider trading policy.

    "I am pleased to announce this share repurchase program, which is a strong indication of the Board's confidence in Adagene's globally differentiated pipeline driven by our proprietary NEObody, SAFEbody and POWERbody platforms," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "We believe this program will ultimately benefit Adagene and create value for its shareholders and investors."

    The Company's share repurchases, if any, under the share repurchase program may be made from time to time on the open market at prevailing market prices, in open-market transactions, privately negotiated transactions or block trades, and/or through other legally permissible means, depending on market conditions and in accordance with the applicable rules and regulations. The timing and conditions of the share repurchases will be subject to various factors including the requirements under Rule 10b-18 and Rule 10b5-1 of the Exchange Act. The Company's board of directors will review the 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 share repurchase program is effective upon and from the date on which a formal stock repurchase plan engagement agreement is signed with a qualified broker-dealer(s), and terminates over a twelve-month period depending upon market and economic conditions, and other factors including price, legal and regulatory requirements and capital availability. The share repurchase program does not obligate Adagene to acquire any particular number of American depositary shares, and the share repurchase program may be modified or suspended at any time at the management's discretion.

    About Adagene Inc.

    Adagene Inc. (NASDAQ:ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

    For more information, please visit: https://investor.adagene.com.

    Safe Harbor Statement

    This press release contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may," "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    Bruce Mackle

    LifeSci Advisors

    646-889-1200



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  3. SAN FRANCISCO and SUZHOU, China, June 16, 2021 (GLOBE NEWSWIRE) --  Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that it will be added to the FTSE Global Equity Index Series ("GEIS"), including the FTSE Global Total Cap Index and FTSE Emerging Total Cap Index, effective June 21, 2021.

    "We believe that inclusion in the FTSE Russell indexes will meaningfully increase our visibility to the investment community and reflects the market's acceptance of Adagene Inc. as a publicly traded company," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "Driven…

    SAN FRANCISCO and SUZHOU, China, June 16, 2021 (GLOBE NEWSWIRE) --  Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that it will be added to the FTSE Global Equity Index Series ("GEIS"), including the FTSE Global Total Cap Index and FTSE Emerging Total Cap Index, effective June 21, 2021.

    "We believe that inclusion in the FTSE Russell indexes will meaningfully increase our visibility to the investment community and reflects the market's acceptance of Adagene Inc. as a publicly traded company," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "Driven by our proprietary NEObody, SAFEbody and POWERbody platforms, we look forward to continuing the design and development of novel antibodies that address unmet medical needs."

    FTSE Russell indexes are widely used by global institutional investors to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives.

    About FTSE Russell

    FTSE Russell is a leading global provider of benchmarks, analytics and data solutions with multi-asset capabilities, offering a precise view of the markets relevant to any investment process. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell is wholly owned by London Stock Exchange Group.

    About Adagene

    Adagene Inc. (NASDAQ:ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

    For more information, please visit: https://investor.adagene.com.

    Safe Harbor Statement

    This press release contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may," "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170



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  4. SAN FRANCISCO, Calif. and SUZHOU, China, May 25, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that Adagene's Co-founder, Chief Executive Officer and Chairman, Peter Luo, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Virtual Healthcare Conference to be held June 1-4, 2021 and the Goldman Sachs 42nd Annual Global Healthcare Conference to be held June 8-11, 2021.

    Details on the presentations can be found below.

    Jefferies Virtual Healthcare Conference
    Date: Friday, June 4, 2021
    Presentation Time…

    SAN FRANCISCO, Calif. and SUZHOU, China, May 25, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that Adagene's Co-founder, Chief Executive Officer and Chairman, Peter Luo, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Virtual Healthcare Conference to be held June 1-4, 2021 and the Goldman Sachs 42nd Annual Global Healthcare Conference to be held June 8-11, 2021.

    Details on the presentations can be found below.

    Jefferies Virtual Healthcare Conference

    Date: Friday, June 4, 2021

    Presentation Time: 10:00 AM ET

    Webcast: Click Here

    Goldman Sachs 42nd Annual Global Healthcare Conference

    Date: Thursday, June 10, 2021

    Presentation Time: 5:30 PM ET

    Webcast: Click Here

    About Adagene

    Adagene Inc. (NASDAQ:ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

    For more information, please visit: https://investor.adagene.com.

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170



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  5. -Identified a predictive biomarker and two pharmacodynamic biomarkers that correlate with clinical efficacy and target engagement

    -ADG106, a fully human, ligand-blocking, agonistic anti-CD137 antibody demonstrated a favorable safety profile

    SAN FRANCISCO and SUZHOU, China, May 19, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced clinical data from its ADG106 NEObody™ program. Results from Phase I, open-label, dose-escalation, single center (NCT03802955) and multicenter (NCT03707093) studies of ADG106 in subjects with advanced or metastatic solid tumors…

    -Identified a predictive biomarker and two pharmacodynamic biomarkers that correlate with clinical efficacy and target engagement

    -ADG106, a fully human, ligand-blocking, agonistic anti-CD137 antibody demonstrated a favorable safety profile

    SAN FRANCISCO and SUZHOU, China, May 19, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced clinical data from its ADG106 NEObody™ program. Results from Phase I, open-label, dose-escalation, single center (NCT03802955) and multicenter (NCT03707093) studies of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma were presented in an abstract at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting. In these Phase I trials, ADG106 monotherapy exhibited a favorable safety profile and demonstrated promising clinical efficacy in biomarker positive patients. ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 IgG4 antibody (mAb) engineered using Adagene's proprietary NEObody platform technology.

    "We are very pleased with the original finding of a predictive biomarker for our anti-CD137 agonist and its association with tumor shrinkage," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "ADG106 has been well tolerated in dose escalation and extensive expansion cohorts at dosage of up to 5 mg/kg, which exceeds that of other anti-CD137 agonists. Further, this clinical data demonstrates the power of our proprietary NEObody platform designed to generate antibodies with novel mechanisms of action by targeting unique and highly conserved epitopes. We believe these results, together with analyses of PK and PD data from around 100 patient population, support the recommended dose regimen for ongoing clinical development of ADG106 as monotherapy and in combination with anti-PD-1 and other therapies. We look forward to multiple upcoming studies as we continue to advance our ADG106 clinical program."

    "Predictive biomarkers for patient stratification are critical to advances in precision immuno-oncology. It's compelling to identify a predictive biomarker for anti-CD137 agonism that shows a strong correlation between ADG106 treatment and tumor shrinkage," said Hua Gong, M.D. Ph.D., Chief Operating Officer and Head of Precision Medicine of Adagene. "In an upcoming global Phase Ib/II trial (ADG106-2001), we plan to enrich for populations expressing our predictive biomarker in order to demonstrate a clinical benefit to ADG106 therapy. Our predictive biomarker has the potential to optimize favorable treatment options and enable oncologists to preselect cancer patients who are likely to benefit from ADG106 treatment. In our continuing commitment to the development of precision immunotherapies, Adagene has established a center of excellence for precision medicine in San Diego with cutting-edge technologies to support biomarker-guided clinical trials."

    Interim data for the ongoing Phase 1 clinical trial includes:

    • Biomarker studies: In a retrospective analysis, 75% of biomarker positive patients demonstrated more than 30% tumor shrinkage after ADG106 treatment.



      • Tumor shrinkage was not significant among biomarker negative patients. There was a strong negative correlation (100%) between biomarker absence and clinical response.

      • A tissue microarray study confirmed biomarker expression in a variety of tumor types suggesting a broad indication for ADG106 therapy.
    • Target engagement: Target engagement upon ADG106 treatment was demonstrated with dose-dependent increases in NK cells in ADG106-mediated anti-tumor activities and in dose-dependent induction of soluble CD137 over baseline.



    • Safety and efficacy: ADG106 demonstrated a disease control rate of 56% and exhibited a favorable safety profile at 3mg/kg and 5mg/kg with dose escalation up to 10mg/kg.

    ADG106-1001 and ADG106-1002 Phase I trials have successfully completed enrollment of nearly 100 patients with advanced solid tumors and/or non-Hodgkin's lymphoma in the US and China, respectively. Limited TEAEs, i.e., liver toxicity or hematologic abnormalities, were observed. Following a productive end-of-phase I (EOP1) meeting about our ADG106 biomarker-stratified trial design with the FDA, Adagene made a new submission (ADG106-2001) to stratify patients using the predictive biomarker prior to treatment with ADG106 as monotherapy and its combination with anti-PD-1 therapy. In March 2021, Adagene initiated patient enrollment in China for ADG106-1008 (NCT04775680) a multicenter, open-label, Phase Ib/II study of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma. Preparations are underway for the ADG106-1003 trial in Australia to evaluate ADG106 in combination with other therapies in advanced solid tumors and hematological malignancies.

    About Adagene

    Adagene Inc. (NASDAQ:ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody™, SAFEbody™, and POWERbody™ technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

    For more information, please visit: https://investor.adagene.com.

    About ADG106

    ADG106, is a fully human ligand-blocking, agonistic anti-CD137 Immunoglobulin G4, or IgG4, mAb, being developed for the treatment of advanced solid tumors and non-Hodgkin's lymphoma, or NHL. CD137 stimulates the immune system to attack cancer cells and is a key driver for long-lasting T-cell proliferation and survival. In preclinical studies, we observed that ADG106 had robust antitumor activity and was well tolerated as a single agent and in combination with the existing standard-of-care and other immuno-oncology therapies. ADG106 activates CD137 in a native ligand-like fashion, blocks reverse signaling of CD137 ligand, and has potent cross-linking via Fc receptor. Because of this novel mechanism of action, ADG106 was observed to favorably balance CD137-induced toxicity and CD137 agonism, which we believe has potential to address the limitations of other existing anti-CD137 therapies.

    Safe Harbor Statement

    This press release contains forward-looking statements, including statements regarding data from the ADG106 Phase I clinical trial, the potential implications of clinical data for patients, and Adagene's advancement of, and anticipated clinical development, regulatory milestones and commercialization of ADG106. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene's drug candidates; Adagene's ability to achieve commercial success for its drug candidates, if approved; Adagene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene's reliance on third parties to conduct drug development, manufacturing and other services; Adagene's limited operating history and Adagene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene's ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in Adagene's filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170



    Primary Logo

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