{"id":63726,"date":"2026-04-22T21:34:40","date_gmt":"2026-04-22T13:34:40","guid":{"rendered":"https:\/\/flcube.com\/?p=63726"},"modified":"2026-04-22T21:34:41","modified_gmt":"2026-04-22T13:34:41","slug":"leads-biolabs-enrolls-first-patient-in-phase-ii-trial-for-gastric-cancer-drug-opamtistomig","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=63726","title":{"rendered":"Leads Biolabs Enrolls First Patient in Phase II Trial for Gastric Cancer Drug Opamtistomig"},"content":{"rendered":"\n

Nanjing Leads Biolabs Co., Ltd.<\/strong> (HKG: 9887<\/a>) announced the first patient enrollment in a Phase II clinical study<\/strong> evaluating opamtistomig (LBL-024)<\/strong> for first-line gastric or gastroesophageal junction adenocarcinoma<\/strong>, expanding the bispecific antibody’s development into a high-need oncology indication.<\/p>\n\n\n\n

Drug Profile & Clinical Progress<\/h2>\n\n\n\n
Attribute<\/th>Detail<\/th><\/tr><\/thead>
Molecule<\/strong><\/td>PD-L1\/4-1BB bispecific antibody (BsAb)<\/td><\/tr>
Development Stage<\/strong><\/td>Phase II across multiple indications<\/td><\/tr>
Key Indications<\/strong><\/td>Non-small cell lung cancer, small cell lung cancer, extrapulmonary neuroendocrine carcinoma, gastric\/gastroesophageal junction adenocarcinoma<\/td><\/tr>
Differentiation<\/strong><\/td>Demonstrated first-in-class (FIC) or best-in-class (BIC) potential in registrational trials<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Regulatory Milestones Summary<\/h2>\n\n\n\n
Designation<\/th>Authority<\/th>Indication<\/th>Date<\/th><\/tr><\/thead>
Breakthrough Therapy Designation (BTD)<\/td>China NMPA<\/td>Advanced extrapulmonary neuroendocrine carcinoma (later-line)<\/td>Oct 2024<\/td><\/tr>
Orphan Drug Designation<\/td>U.S. FDA<\/td>Neuroendocrine carcinoma<\/td>Nov 2024<\/td><\/tr>
Fast Track Designation<\/td>U.S. FDA<\/td>Extrapulmonary neuroendocrine carcinoma<\/td>Jan 2026<\/td><\/tr>
Orphan Drug Designation<\/td>European Commission<\/td>Extrapulmonary neuroendocrine carcinoma<\/td>Jan 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Significance<\/h2>\n\n\n\n

The expansion into gastric cancer represents a significant opportunity for Leads Biolabs, as gastric and gastroesophageal junction adenocarcinomas affect approximately 1.1 million patients globally each year with limited effective treatment options in the first-line setting. Opamtistomig’s dual mechanism\u2014simultaneously targeting PD-L1 to block immune checkpoint inhibition and 4-1BB to stimulate T-cell activation\u2014offers a novel approach to overcoming resistance mechanisms common in gastrointestinal malignancies.<\/p>\n\n\n\n

The company’s robust regulatory recognition across major markets (China, U.S., EU) underscores the therapeutic potential of LBL-024 and positions it as a cornerstone asset in Leads Biolabs’ emerging oncology portfolio.<\/p>\n\n\n\n

Forward-Looking Statements<\/strong>
This brief contains forward-looking statements regarding clinical development and regulatory timelines. Actual outcomes may differ based on trial results, regulatory decisions, and competitive developments.-Fineline Info & Tech<\/a><\/p>\n\n\n\n