{"id":24306,"date":"2025-05-23T13:41:04","date_gmt":"2025-05-23T06:41:04","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=24306"},"modified":"2025-05-23T13:41:04","modified_gmt":"2025-05-23T06:41:04","slug":"fda-clearance-of-investigational-new-drug-application-received-for-novel-egfr-her3-bispecific-antibody-drug-conjugate-avzo-1418-db-1418","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=24306","title":{"rendered":"FDA Clearance of Investigational New Drug Application Received for Novel EGFR\/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418\/DB-1418"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Phase 1\/2 first-in-human clinical study planned this year<\/i><\/p>\n

SHANGHAI<\/span> and SAN DIEGO<\/span><\/span>, May 23, 2025<\/span><\/span> \/PRNewswire\/ — Duality Biotherapeutics (“DualityBio”, HKEX:09606) partner Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-1418\/DB-1418, a potential best-in-class, novel EGFR\/HER3 bispecific antibody-drug conjugate (ADC).<\/p>\n

\n<\/div>\n

On January 7th, 2025<\/span>, \u00a0DualityBio and Avenzo announced that they entered into an exclusive license agreement, pursuant to which Avenzo will develop, manufacture and commercialize AVZO-1418\/DB-1418, a potential best-in-class EGFR\/HER3 bispecific ADC, globally (excluding Greater China<\/span>).<\/p>\n

Under the IND, a Phase 1\/2 first-in-human, open-label clinical study is planned to initiate later this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-1418\/DB-1418 as a single agent and in combination therapy in patients with advanced solid tumors.<\/p>\n

Preclinical data for AVZO-1418\/DB-1418 were presented for the first time at the American Association for Cancer Research (AACR) Annual Conference in April 2025<\/span> and highlighted AVZO-1418\/DB-1418’s novel design and additive binding affinity in EGFR and HER3 co-expressing tumor cells. In addition, AVZO-1418\/DB-1418 demonstrated efficacy in in vivo<\/i> xenograft models across multiple tumor types, including in an EGFR TKI-resistant NSCLC model.<\/p>\n

About DualityBio <\/b><\/p>\n

Duality Biotherapeutics (HKEX:09606) is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADCs to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries and has enrolled over 2,000 patients for multiple clinical-stage ADC candidates.<\/p>\n

Additionally, DualityBio has established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing novel ADCs, including bispecific ADC candidates, novel-payload ADC candidates, and autoimmune ADC candidates. For more information, please visit www.dualitybiologics.com<\/a>.<\/p>\n

Media Contact: <\/b>PR@dualitybiologics.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Phase 1\/2 first-in-human clinical study planned this year<\/i><\/p>\n

SHANGHAI<\/span> and SAN DIEGO<\/span><\/span>, May 23, 2025<\/span><\/span> \/PRNewswire\/ — Duality Biotherapeutics (“DualityBio”, HKEX:09606) partner Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-1418\/DB-1418, a potential best-in-class, novel EGFR\/HER3 bispecific antibody-drug conjugate (ADC).<\/p>\n

\n<\/div>\n

On January 7th, 2025<\/span>, \u00a0DualityBio and Avenzo announced that they entered into an exclusive license agreement, pursuant to which Avenzo will develop, manufacture and commercialize AVZO-1418\/DB-1418, a potential best-in-class EGFR\/HER3 bispecific ADC, globally (excluding Greater China<\/span>).<\/p>\n

Under the IND, a Phase 1\/2 first-in-human, open-label clinical study is planned to initiate later this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-1418\/DB-1418 as a single agent and in combination therapy in patients with advanced solid tumors.<\/p>\n

Preclinical data for AVZO-1418\/DB-1418 were presented for the first time at the American Association for Cancer Research (AACR) Annual Conference in April 2025<\/span> and highlighted AVZO-1418\/DB-1418’s novel design and additive binding affinity in EGFR and HER3 co-expressing tumor cells. In addition, AVZO-1418\/DB-1418 demonstrated efficacy in in vivo<\/i> xenograft models across multiple tumor types, including in an EGFR TKI-resistant NSCLC model.<\/p>\n

About DualityBio <\/b><\/p>\n

Duality Biotherapeutics (HKEX:09606) is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADCs to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries and has enrolled over 2,000 patients for multiple clinical-stage ADC candidates.<\/p>\n

Additionally, DualityBio has established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing novel ADCs, including bispecific ADC candidates, novel-payload ADC candidates, and autoimmune ADC candidates. For more information, please visit www.dualitybiologics.com<\/a>.<\/p>\n

Media Contact: <\/b>PR@dualitybiologics.com<\/a><\/p>\n

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