- \n
- Boehringer Ingelheim and Zai Lab launch a clinical collaboration to evaluate a dual DLL3\u2011targeting\u00a0combination\u00a0therapy in small cell lung cancer (SCLC)\u00a0and\u00a0other\u00a0neuroendocrine carcinomas (NECs).<\/li>\n<\/ul>\n
- \n
- Phase\u00a0Ib\/II study will test the\u00a0combination\u00a0of\u00a0obrixtamig, a DLL3\/CD3 T\u2011cell engager, with\u00a0Zai Lab\u2019s\u00a0zocilurtatug\u00a0pelitecan\u00a0(zoci), a DLL3\u2011targeting\u00a0antibody\u2013drug conjugate\u00a0(ADC), to explore\u00a0safety and potential increase in clinical benefit\u00a0for patients.<\/li>\n<\/ul>\n
Boehringer Ingelheim<\/strong> and Zai Lab\u00a0(NASDAQ: ZLAB; HKEX: 9688)\u00a0today announced a clinical\u00a0collaboration\u00a0focused on\u00a0pioneering\u00a0a\u00a0dual\u00a0DLL3-targeting\u00a0combination.\u00a0The Phase\u00a0Ib\/II study will assess the safety, tolerability, and initial clinical activity of combining\u00a0obrixtamig, Boehringer Ingelheim\u2019s DLL3\/CD3\u00a0T-cell\u00a0engager, with\u00a0zocilurtatug\u00a0pelitecan\u00a0(zoci;\u00a0formerly\u00a0ZL\u20111310), Zai\u00a0Lab\u2019s\u00a0DLL3-targeting\u00a0ADC.\u00a0The study\u00a0will enroll\u00a0patients with poorly differentiated NECs and extensive stage SCLC (ES-SCLC);\u00a0diseases\u00a0where patients urgently need more effective treatment\u00a0options.<\/p>\n
\u201cThe strategy to\u00a0engage the immune system with\u00a0a\u00a0specific T\u2011cell engager\u00a0and deliver a potent cytotoxic payload with a\u00a0DLL3\u2011targeting ADC,\u00a0aligns with our immuno\u2011oncology strategy and our drive to advance smart combinations for hard\u2011to\u2011treat cancers,\u201d\u00a0said Itziar\u00a0Canamasas,\u00a0Ph.D.,\u00a0Global Head of Oncology at Boehringer Ingelheim<\/strong>.\u00a0\u201cIt\u2019s another step in our mission to expand effective options for people with DLL3\u2011expressing cancers.\u201d<\/p>\n
\u201cZoci\u00a0has shown encouraging activity and\u00a0good tolerability\u00a0in SCLC,\u201d said\u00a0Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. \u201cWe have rapidly advanced\u00a0zoci\u00a0into pivotal stage and are pursuing opportunities to explore multiple combination approaches in SCLC and other\u00a0NECs. This collaboration with Boehringer Ingelheim\u00a0offers\u00a0a compelling DLL3\u2011targeting\u00a0strategy with the potential to\u00a0benefit\u00a0patients who urgently need better treatments.\u201d<\/p>\n
Obrixtamig\u00a0is Boehringer Ingelheim\u2019s investigational bispecific DLL3\/CD3 T\u2011cell engager, designed to direct the body\u2019s own immune cells to attack DLL3\u2011expressing cancer cells, a hallmark of\u00a0SCLC\u00a0and certain\u00a0NECs.\u00a0In the global Phase\u00a0I\u00a0first\u2011line ES\u2011SCLC study DAREON\u00ae\u20118, in combination with chemotherapy and atezolizumab,\u00a0obrixtamig\u00a0showed encouraging\u00a0signs of early clinical\u00a0efficacy and a\u00a0manageable\u00a0safety profile1.\u00a0Obrixtamig\u00a0is being evaluated across multiple global studies\u00a0and\u00a0is advancing into\u00a0a\u00a0global Phase III trial\u00a0(DAREON\u00ae\u2011Lung\u20111,\u00a0NCT07472517<\/a>).\u00a0The molecule has received FDA Fast Track Designation and Orphan Drug Designation from both the FDA and the European Commission for neuroendocrine carcinomas.<\/p>\n
Zocilurtatug\u00a0pelitecan\u00a0is Zai Lab\u2019s DLL3targeting\u00a0ADC engineered to deliver a potent cytotoxic payload to DLL3positive tumor cells in\u00a0ES-SCLC. Updated global Phase\u00a0I\u00a0results\u00a0in previously treated ES-SCLC\u00a0show strong and durable responses, including in patients with brain metastases,\u00a0along\u00a0with a favorable safety profile. On this basis, the program has advanced into a global Phase\u00a0III\u00a0registrational\u00a0study.\u00a0In addition to SCLC,\u00a0zoci\u00a0is being evaluated in NECs.\u00a0Zoci\u00a0has\u00a0received FDA Orphan Drug Designation\u00a0and FDA Fast Track Designation\u00a0for the treatment of SCLC.<\/p>\n
Under the terms of the agreement, Zai Lab will supply its DLL3\u2011targeting\u00a0ADC for the study, while Boehringer Ingelheim will sponsor and oversee day\u2011to\u2011day clinical operations. Each company\u00a0retains\u00a0the rights to its respective assets.<\/p>\n
Boehringer Ingelheim<\/h2>\n
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry\u2019s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at\u00a0www.boehringer-ingelheim.com<\/a>.<\/p>\n
About\u00a0Zocilurtatug\u00a0Pelitecan\u00a0(zoci, formerly ZL-1310)<\/h2>\n
Zoci\u00a0is a novel ADC in Zai Lab\u2019s global oncology pipeline targeting DLL3, an antigen that is overexpressed in many neuroendocrine\u00a0carcinomas, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC.\u00a0Zoci\u00a0comprises a humanized anti-DLL3 monoclonal antibody linked to a novel\u00a0camptothecin\u00a0derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN\u00ae, which\u00a0leverages\u00a0the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity.<\/p>\n
Zoci\u00a0is being evaluated in a global development program, which includes DLLEVATE, a pivotal trial to further evaluate the safety and efficacy of\u00a0zoci\u00a0compared to investigator\u2019s choice single agent therapy in patients with relapsed ES-SCLC; a phase 1b\/2 trial evaluating\u00a0zoci\u00a0in selected solid tumors including extrapulmonary neuroendocrine carcinoma; and a phase 1a\/1b trial evaluating\u00a0zoci\u00a0as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of\u00a0ES-SCLC.<\/p>\n
Zoci\u2019s\u00a0potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential as a backbone ADC in first-line combination regimens, including those that reduce the burdens of chemotherapy.\u00a0Zoci\u00a0received FDA Orphan Drug Designation and FDA Fast Track Designation for the treatment of SCLC.<\/p>\n
About\u202fZai Lab<\/h2>\n
Zai Lab\u202f(NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in\u202fChina\u202fand\u202fthe United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to\u00a0leverage\u00a0our competencies and resources to positively\u00a0impact\u00a0human health.<\/p>\n
For\u00a0additional\u00a0information about\u202fZai Lab, please visit\u202fwww.zailaboratory.com<\/a>\u202for follow us at\u202fhttps:\/\/x.com\/ZaiLab_Global<\/a>.<\/p>\n
Intended Audiences Notice<\/b><\/p>\n
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.<\/p>\n
Zai Lab Forward-Looking Statements<\/b><\/p>\n
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including zocilurtatug pelitecan, the potential benefits of zocilurtatug pelitecan, and the potential treatment of SCLC and other neuroendocrine carcinomas. These forward-looking statements may contain words such as \u201caim,\u201d \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cforecast,\u201d \u201cgoal,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpossible,\u201d \u201cpotential,\u201d \u201cwill,\u201d \u201cwould,\u201d and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to 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. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.<\/p>\n
Our SEC filings can be found on our website at www.zailaboratory.com<\/a> and on the SEC\u2019s website at www.SEC.gov<\/a>.<\/p>\n
AGENCIA EFE S.A.U.,S.M.E. shall not be liable for any information contained in this message and assumes no responsibility towards third parties in relation to its contents, being expressly exempt from any liability that the author may have in relation to the information in question. Agencia EFE reserves the right to distribute the press release on the news wire, or to publish it on EFE Comunica.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
Statement issued by the company (Announcement) Boehringer Ingelheim and Zai Lab launch a clinical collaboration to evaluate a dual DLL3\u2011targeting\u00a0combination\u00a0therapy in small cell lung cancer (SCLC)\u00a0and\u00a0other\u00a0neuroendocrine carcinomas (NECs). Phase\u00a0Ib\/II study […]<\/p>\n","protected":false},"author":198164071,"featured_media":48434,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[125518],"tags":[],"class_list":["post-219196","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globenewswire-en"],"acf":[],"yoast_head":"\n
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- Phase\u00a0Ib\/II study will test the\u00a0combination\u00a0of\u00a0obrixtamig, a DLL3\/CD3 T\u2011cell engager, with\u00a0Zai Lab\u2019s\u00a0zocilurtatug\u00a0pelitecan\u00a0(zoci), a DLL3\u2011targeting\u00a0antibody\u2013drug conjugate\u00a0(ADC), to explore\u00a0safety and potential increase in clinical benefit\u00a0for patients.<\/li>\n<\/ul>\n