– Best-in-class profile demonstrated with repeat dosing throughout dose ranges –
– Antitumor exercise noticed in chilly tumors with regular accumulation of activated ADG126 –
– On monitor in 2022 to report outcomes of ADG126 dose escalation together with anti-PD-1 remedy, establishing dose routine for section 2a dose growth cohorts –
SAN DIEGO and SUZHOU, China, Sept. 10, 2022 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), an organization remodeling the invention and growth of novel antibody-based therapies, at the moment introduced the publication of knowledge exhibiting the best-in-class potential of ADG126, a masked, anti-CTLA-4 SAFEbody®. Interim outcomes from the Phase 1 portion of an ongoing Phase 1b/2 trial of ADG126 are being introduced at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris, September 9 – 13, 2022.
The poster, titled “Phase 1 Results Demonstrate Highly Differentiated Safety and PK Profile of ADG126, a Masked anti-CTLA-4 SAFEbody® in Patients with Advanced Solid Tumors,” reviewed knowledge from the first-in-human, open label, section 1 dose-escalation and dose growth. The poster stories knowledge on 26 sufferers with superior metastatic stable tumors, the bulk (58%) of whom obtained three or extra traces of prior therapies and practically half (42%) of whom progressed from prior immuno-oncology (IO) remedy.
Key findings embrace:
- Safety: ADG126 monotherapy confirmed an unprecedented medical security profile at dosing ranges as much as 20 mg/kg when administered to this closely pretreated affected person inhabitants as soon as each three weeks. ADG126 was nicely tolerated, with no dose-limiting toxicities or treatment-related Grade 3 or greater antagonistic occasions noticed. The most frequent remedy associated antagonistic occasions (TRAEs) (≥10%) have been fatigue (12%), pruritis (12%), rash (12%) and diarrhea (12%). Dose escalation is accomplished at 20 mg/kg and dose growth is ongoing at 10 mg/kg.
- Antitumor Activity in Cold Tumors: With 18 cycles of remedy at 1 mg/kg, an ovarian most cancers affected person skilled vital, continued discount of a longtime ovarian most cancers biomarker, CA125, dropping 90% to inside the regular vary for full medical profit. As of cycle 16, the affected person skilled a 22% lower in goal lesions. Previously, this affected person had surgical procedure and 5 prior traces of systemic therapies. At the info cut-off of August 17, 2022, the illness management price was 39% (9/23 evaluable sufferers).
- Pharmacokinetics: ADG126 plasma pharmacokinetics (PK) have been roughly linear and activated ADG126 amassed steadily throughout repeat dosing throughout totally different dose ranges. This suggests extended exposures of activated ADG126 within the tumor microenvironment (TME), with cleaved ADG126 on common accumulating ≥3-fold throughout repeat dosing, ensuing from an roughly 1.5-fold longer half-life of whole ADG126 in contrast with its parental antibody.
“ADG126 continues to demonstrate a remarkable safety profile, highly differentiated from both the currently approved anti-CTLA-4 therapy and others in development, as well as antitumor activity in heavily pre-treated patients with cold tumors,” stated Dr. Gary Richardson, OAM, MBBS, FRACP, Group Director at Cabrini Health Research, Neil Beauglehall Endowed Chair, Medical Oncology Research, and Professor of Medicine at Monash University, Australia, stated, “An intriguing case study of our poster is the experience of a patient with ovarian cancer, whose tumor reduced by 22 percent accompanied by normalization of an established clinical biomarker, CA125, dropping by tenfold after more than one year of treatment with ADG126 administered every three weeks at only 1 mg/kg. 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.”
Trials evaluating the mix of ADG126 and anti-PD-1 therapies are ongoing in sufferers with superior, metastatic tumors within the US, China and Asia Pacific (APAC), evaluating optimized doses of ADG126 in focused tumors.
ADG126 SAFEbody applies precision-masking expertise to the parental anti-CTLA-4 antibody, ADG116, for conditional activation within the TME to develop the therapeutic index and additional tackle security issues with current CTLA-4 therapies. Binding to the identical distinctive epitope as ADG116, the masked ADG126 is designed to offer enhanced security and efficacy profiles as a result of mixture of the potent Treg depletion within the TME and partial ligand blocking by the activated ADG126, which is amassed steadily for the extended tumor killing impact in TME.
About Adagene
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology firm dedicated to remodeling the invention and growth of novel antibody-based most cancers immunotherapies. Adagene combines computational biology and synthetic intelligence to design novel antibodies that tackle unmet affected person wants. Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody®, and POWERbody™ applied sciences, Adagene’s extremely differentiated pipeline options novel immunotherapy applications. Adagene has solid strategic collaborations with respected world companions that leverage its expertise in a number of approaches at the vanguard of science.
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SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.
Safe Harbor Statement
This press launch accommodates forward-looking statements, together with statements relating to sure medical outcomes of ADG126, the potential implications of medical outcomes of the product candidate, and Adagene’s development of, and anticipated medical growth, regulatory milestones and commercialization of Adagene pipeline candidates. Actual outcomes might differ materially from these indicated within the forward-looking statements because of varied vital elements, together with however not restricted to Adagene’s potential to show the security and efficacy of its drug candidates; the medical outcomes for its drug candidates, which can not assist additional growth or regulatory approval; the content material and timing of choices made by the related regulatory authorities relating to regulatory approval of Adagene’s drug candidates; Adagene’s potential to attain industrial success for its drug candidates, if accredited; Adagene’s potential to acquire and preserve safety of mental property for its expertise and medicines; Adagene’s reliance on third events to conduct drug growth, manufacturing and different providers; Adagene’s restricted working historical past and Adagene’s potential to acquire extra funding for operations and to finish the event and commercialization of its drug candidates; Adagene’s potential to enter into extra collaboration agreements past its current strategic partnerships or collaborations, and the influence of the COVID-19 pandemic on Adagene’s medical growth, industrial and different operations, in addition to these dangers extra absolutely mentioned within the “Risk Factors” part in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based mostly on data at present out there to Adagene, and Adagene undertakes no obligation to publicly replace or revise any forward-looking statements, whether or not because of new data, future occasions or in any other case, besides as could also be required by regulation.
