{"id":27273,"date":"2025-07-22T11:32:52","date_gmt":"2025-07-22T04:32:52","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=27273"},"modified":"2025-07-22T11:32:52","modified_gmt":"2025-07-22T04:32:52","slug":"dualitybios-next-generation-her3-adc-db-1310-granted-fda-fast-track-designation","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=27273","title":{"rendered":"DualityBio’s Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

SHANGHAI<\/span>, July 22, 2025 \/PRNewswire\/ — DualityBio (HKEX Stock Code: 9606.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310<\/b>. This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.<\/span><\/p>\n

\n<\/div>\n

DB-1310 is a novel ADC targeting HER3 developed using DualityBio’s proprietary DITAC platform. In June 2025<\/span>, Dr. Aaron E. Lisberg<\/span> from the University of California, Los Angeles<\/span> (UCLA<\/span>) presented the first-in-human Phase I\/IIa clinical trial data (NCT05785741) of DB-1310 in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.<\/p>\n

Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: “<\/span>DB-1310 demonstrated encouraging clinical efficacy and manageable safety in patients with\u00a0EGFRm nsqNSCLC and multiple solid tumors. It is noteworthy that preclinical investigations of DB-1310 in combination with EGFR TKIs and other anticancer agents have also demonstrated robust synergistic tumor suppression activity. We will spare no effort to accelerate the clinical development of DB-1310 and look forward to its potential, as a next-generation HER3 ADC, to become a novel therapeutic option for a broad population of cancer patients.”<\/p>\n

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

Duality Biotherapeutics is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADC 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, has enrolled over 2,000 patients for multiple clinical-stage ADC candidates.<\/p>\n

Additionally, DualityBio have established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing bispecific ADCs, novel-payload ADCs, and autoimmune ADCs. For more information, please visit www.dualitybiologics.com<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

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

SHANGHAI<\/span>, July 22, 2025 \/PRNewswire\/ — DualityBio (HKEX Stock Code: 9606.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310<\/b>. This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.<\/span><\/p>\n

\n<\/div>\n

DB-1310 is a novel ADC targeting HER3 developed using DualityBio’s proprietary DITAC platform. In June 2025<\/span>, Dr. Aaron E. Lisberg<\/span> from the University of California, Los Angeles<\/span> (UCLA<\/span>) presented the first-in-human Phase I\/IIa clinical trial data (NCT05785741) of DB-1310 in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.<\/p>\n

Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: “<\/span>DB-1310 demonstrated encouraging clinical efficacy and manageable safety in patients with\u00a0EGFRm nsqNSCLC and multiple solid tumors. It is noteworthy that preclinical investigations of DB-1310 in combination with EGFR TKIs and other anticancer agents have also demonstrated robust synergistic tumor suppression activity. We will spare no effort to accelerate the clinical development of DB-1310 and look forward to its potential, as a next-generation HER3 ADC, to become a novel therapeutic option for a broad population of cancer patients.”<\/p>\n

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

Duality Biotherapeutics is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADC 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, has enrolled over 2,000 patients for multiple clinical-stage ADC candidates.<\/p>\n

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

<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-27273","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/27273","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=27273"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/27273\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27273"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27273"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27273"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}