Breakthrough Clinical Data for LBL-024 in First-Line Treatment of Advanced EP-NEC Unveiled at 2025 ASCO Oral Session
NANJING, China, May 31, 2025 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs") today announced the presentation of groundbreaking clinical data from a multicenter phase Ib/II clinical trial evaluating LBL-024, an anti-PD-L1/4-1BB bispecific antibody, in combination with etoposide plus platinum-based chemotherapy for treatment-naive patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). The results were featured in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
ASCO is recognized as the world's most prestigious oncology conference, serving as a global stage for unveiling transformative scientific and clinical advancements. The Oral Sessions are highly competitive, served for studies demonstrating significant clinical relevance or scientific innovation. In 2025, ASCO received a record-breaking 7,775 abstract submissions, with 32 Chinese-led studies selected for oral presentation - among them, the LBL-024 trial (NCT06157827).
The study, led by Professor Shen Lin of Peking University Cancer Hospital and conducted across multiple clinical centers, evaluates the efficacy and safety of LBL-024 combined with etoposide plus platinum-based chemotherapy as a first-line treatment for advanced EP-NEC.
Robust Anti-Tumor Activity Observed with LBL-024 Plus Chemotherapy
In 52 efficacy-evaluable patients, the overall response rate (ORR) across all dose levels was 75.0% and the disease control rate (DCR) was 92.3%, significantly outperforming historical ORR data (30%-55%) with chemotherapy alone.
The 15 mg/kg in dose optimization demonstrated the strongest anti-tumor activity, achieving an ORR of 83.3% and a DCR of 100%.
57.7% (30/52) of the patients experienced >50% tumor shrinkage.
As of April 15th, 2025, with a median follow-up of 8.2 months, progression-free survival (PFS) data remains immature, but trends indicate promising durability across all the dose groups.
In the phase Ib dose escalation stage, no dose-limiting toxicities (DLTs) were observed. Most treatment-emergent adverse events (TEAEs) were Grade 1–2 and manageable, primarily associated with chemotherapy, including hematologic toxicity and nausea. No unexpected safety signals were identified.
Leadership Perspectives
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:" We are thrilled to share these exciting clinical data, which strongly support the advancement of LBL-024 into a pivotal phase III trial as a first-line treatment for EP-NEC. Our strategy prioritizes efficient development through single-arm registrational trial in underserved indications, while also maximizing value through broad indication expansion. LBL-024 received regulatory clearance in April 2024 to initiate a single-arm pivotal trial in China, marking the first 4-1BB targeted agent globally to reach this stage. With its expanded use now demonstrated in first-line settings and active studies in cancers such as SCLC and NSCLC, LBL-024 is poised to offer promising transformative therapeutic options for more cancer patients worldwide."
Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "It is deeply encouraging to see LBL-024 featured consecutively in ASCO oral presentations. From target selection to molecular design, our R&D approach has focused on differentiated innovation to address pressing clinical challenges. The success of LBL-024 reflects our commitment to pioneering innovation at the source—breaking free from homogeneity to deliver genuinely impactful therapies. We remain dedicated to addressing unmet needs, advancing breakthrough therapeutics, and improving outcomes for patients across the globe."
About LBL-024
LBL-024 is a potential first-in-class bispecific antibody simultaneously targeting PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB-targeting bispecific antibody globally to reach the single arm pivotal trial stage as a monotherapy and holds promise to become the first approved treatment specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC), a malignancy with significant unmet medical need.
Developed using Leads Biolabs' proprietary X-Body™ bispecific platform, LBL-024 features a 2:2 format with two binding domains each for PD-L1 and 4-1BB, and an optimized affinity ratio. This design allows LBL-024 to both reverse PD-L1–mediated immune suppression and selectively enhance T cell activation, resulting in potent, synergistic anti-tumor effects.
In Phase I/II clinical trials in China, LBL-024 has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. The lack of a standard of care in EP-NEC supports the pursuit of accelerated approval through a single-arm pivotal study.
In recognition of its clinical potential, LBL-024 received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China (October 2024), and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for neuroendocrine carcinoma (November 2024).
Beyond NEC, LBL-024 has shown encouraging early activity in other tumor types, including small cell lung cancer (SCLC), ovarian cancer (OC), biliary tract cancer (BTC), and with strong potential for expansion into broader indications such as non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), and gastric cancer (GC).
About Leads Biolabs
Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally.
We are a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 12 innovative drug candidates, including six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally.
We adopt a science-driven R&D approach and have successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. We have also developed multiple proprietary technology platforms, including LeadsBodyTM platform (a CD3 T-cell engager platform), X-bodyTM platform (a 4-1BB engager platform), which serve as the cornerstone for our continued innovation and have been validated by the clinical outcomes of our bispecific antibody portfolios.
We have established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of our drug candidates, coupled with our global perspectives, proactive strategy, and efficient clinical validation, have made us an attractive partner for leading industry players and venture capitals. For more information, please visit https://en.leadsbiolabs.com/
View original content:https://www.prnewswire.com/news-releases/breakthrough-clinical-data-for-lbl-024-in-first-line-treatment-of-advanced-ep-nec-unveiled-at-2025-asco-oral-session-302466588.html
SOURCE Leads Biolabs
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
18 minutes ago
- Yahoo
Morgan Stanley: Nvidia stands out as a unique investment case
-- Morgan Stanley reiterated its Overweight rating on Nvidia (NASDAQ:NVDA), calling it a "unique opportunity" in the semiconductor space and maintaining it as the firm's top pick despite broader concerns about sector headwinds. 'This still seems like a unique opportunity to us,' Morgan Stanley analysts wrote in a note. 'The largest market cap semiconductor company in the world is making a strong case that business will accelerate from here, while there is still significant anxiety—almost consensus—that conditions will decelerate.' Nvidia's most recent results impressed across multiple fronts. 'Gross margins ahead, revenues ex-China strong, networking recovering, positive commentary on the supply chain ramp on racks,' the analysts stated. While there was limited forward guidance on the second half of 2024 or calendar year 2026, Morgan Stanley attributed that restraint to geopolitical sensitivity around China. 'Our view continues to be that we are materially undershipping demand,' the analysts wrote. A key short-term concern, namely that rack bottlenecks are leading to rising inventory among original design manufacturers (ODMs), is expected to resolve soon. 'That rack bottlenecks are causing inventory to build up at the ODMs… will soon be replaced by tight supply of those Bianca cards as rack bottlenecks are cleared and demand strengthens.' Morgan Stanley's continued conviction in Nvidia comes as part of a broader weekly review of semiconductor names. The firm said it also likes Marvell (NASDAQ:MRVL) 'a bit more given the selloff,' and is looking to 'good numbers' from Broadcom (NASDAQ:AVGO) this week. Related articles Morgan Stanley: Nvidia stands out as a unique investment case BioNTech soars 15% on cancer drug deal with Bristol Myers Campbell Soup beats Q3 estimates, reaffirms guidance
Android Authority
19 minutes ago
- Android Authority
Does it bend? Watch JerryRigEverything try to break the Galaxy S25 Edge in durability test.
TL;DR The Samsung Galaxy S25 Edge has survived a bend test by YouTube channel JerryRigEverything. The channel also put the phone through a number of other durability tests. Samsung's new phone has a titanium frame and uses Corning Gorilla Glass Ceramic 2 on the front. The Samsung Galaxy S25 Edge is finally available, and it brings a thin and light design. Does this slim and light design come at the expense of durability, though? Well, YouTube channel JerryRigEverything put the Galaxy S25 Edge through its trademark durability test. Perhaps the biggest durability-related question is whether the phone, which is made out of titanium, can withstand a bend test. Fortunately, the phone didn't catastrophically break under pressure. 'The Galaxy S25 Edge, as thin as it is, survives the bend test with flying colors,' host Zack Nelson noted during the video. The phone still seemed to function fine, although the rear panel popped off slightly. That's a pretty impressive result in light of the slim design. What else to know about the S25 Edge's durability? The Galaxy S25 Edge also features Corning Gorilla Glass Ceramic 2 on the display. The YouTuber showed that the display experiences scratches at level six of the Mohs hardness scale, followed by deeper grooves when using a pick on level seven of the scale. This lines up with most phones, including the S25 Ultra, although last year's S24 Ultra started scratching at level six and saw deep scratches at level eight. Nelson also took a knife to the phone and found the buttons could pop out somewhat easily. However, the camera housing and lenses stayed firmly attached. Furthermore, the phone's screen didn't seem seriously damaged, if at all, after a lighter was held to it for 30 seconds. This durability test is a big win for the Galaxy S25 Edge in light of its slim design. Samsung's phone does make compromises elsewhere, though, as it has a small battery and lacks a telephoto camera. Got a tip? Talk to us! Email our staff at Email our staff at news@ . You can stay anonymous or get credit for the info, it's your choice.
Forbes
27 minutes ago
- Forbes
Natural Fibers, Lasting Impact: Armadillo's Challenge To Industrial Design
In India and Nepal, Armadillo Rugs supports its artisans not only through fair wages and dignified ... More labor conditions but also by funding schools and housing for their families. In an era marked by fast fashion and disposable design, the interiors industry faces increasing scrutiny over its environmental and social footprint. Many home goods rely on fossil fuel-based synthetics like polyester and nylon, which take centuries to decompose and account for around 35% of ocean microplastics. Textile production contributes to 20% of global clean water pollution from dyeing and finishing. More broadly, household consumption is responsible for 72% of global greenhouse gas emissions. Against this backdrop, Armadillo Rugs offers a compelling alternative: a design philosophy rooted in craftsmanship, sustainability, and deep respect for the human hands behind every product. Founded in 2009, Armadillo has challenged the dominant model by anchoring its operations in ethical sourcing, natural materials, and handwoven production. In contrast to mass production's speed and scale, Armadillo embraces the nuance of process and place. Using undyed, renewable fibers like wool, jute, and linen, the company reduces chemical inputs and highlights the raw beauty of nature in every finished piece. Armadillo co-founder Jodie Fried told me that what distinguishes Armadillo most is its long-term investment in the communities it works with. In India and Nepal, the company supports its artisans not only through fair wages and dignified labor conditions but also by funding schools and housing for their families. Education, especially for girls, is a central focus, exemplified by the KVM School, which Armadillo fully supports. These efforts reflect a broader belief that good design must contribute positively to the lives it touches, both materially and socially. As the first Australian and American rug company to achieve B Corp certification, Armadillo has formalized its sustainability efforts across governance, carbon footprint, and material circularity. With ongoing goals like deepening supply chain transparency and supporting regenerative farming, the company demonstrates that accountability in design is not static but evolving. Perhaps most notably, Armadillo reframes what 'luxury' means. In its view, luxury is not the abundance of resources, but the care with which they are used; not speed, but story; not excess, but intention. This ethic challenges consumers to consider not only the aesthetic value of what they bring into their homes, but the systems of labor, ecology, and legacy they are participating in. As businesses across sectors grapple with their impact, Armadillo offers a model of how design can serve as both aesthetic expression and social commitment. In doing so, it illuminates a path forward for companies seeking to merge beauty with justice. Christopher Marquis: Can you first discuss how Armadillo's methods differ from conventional rug manufacturingtechniques? Jodie Fried, Armadillo Rugs co-founder Jodie Fried: At Armadillo, we believe true luxury lies in authenticity – which is why every rug we create is made by hand using traditional weaving techniques passed down through generations. Our process is intentionally slow and deeply human, grounded in care, intention and a respect for craft. We work exclusively with natural fibers such as wool, jute, linen and silk, choosing quality over quantity in every facet of creation. The result is a product that honors both the artisan and the environment, with a soulfulness that simply can't be replicated by machines. Our methods may take longer, but we believe beauty that is consciously made will always endure. In a world that often prioritizes speed and convenience, we're proud to stand for something more considered — something lasting. Marquis: Can you say a bit more about the significance of using undyed, natural materials in your products, particularly how this benefits both the environment and the end-product quality? Fried: Using undyed, natural materials is one of the most meaningful choices we've made as a brand. These fibers are not only biodegradable and renewable, but they also allow us to dramatically reduce our environmental impact by avoiding the energy and water-intensive processes associated with chemical dyes. Beyond sustainability, there's a raw beauty and integrity to these materials – the tonal variations in undyed wool, for example, add a depth and richness that can't be replicated in synthetic alternatives. They give each piece a sense of place and personality. At the same time, our customers can feel confident that they are bringing something into their homes that is safe, healthy and entirely free from toxins. It's a win for the planet, the maker and the home. Marquis: How does Armadillo support the artisans and communities behind its handmade rugs? Fried: Supporting our artisan communities is intrinsic to who we are – it's a relationship built on care, transparency and mutual respect. Many of our weavers have been with us since the beginning, and we remain deeply committed to ensuring fair wages, safe working conditions and dignified livelihoods for all. But our support doesn't stop at the loom. We support a network of philanthropic initiatives in the regions where our rugs are made, with a strong focus on education - especially for girls. In India, we fully fund the KVM School, which provides free schooling for the children of our artisans. In Nepal, we support long-term education and safe housing for vulnerable youth through partnerships with Sunrise Children's Foundation and Shree Mangal Dvip Boarding School. For us, giving isn't a side project but a fundamental expression of our belief that good design should also do good in the world. Marquis: How has Armadillo's sustainability efforts evolved since its inception? What are some sustainability goals Armadillo hopes to achieve in the next few years? Fried: When we founded Armadillo in 2009, sustainability was a foundational value. We began with a simple belief: that it's possible to create something beautiful without compromising the wellbeing of the planet or its people. Over the years, that belief has grown into a comprehensive sustainability strategy, including becoming the first Australian and American rug company to achieve B Corp certification in 2021 - and most recently, recertifying with one of the highest scores in the furniture category. We've achieved carbon neutrality across all our showrooms, publish an annual Impact Report and aligned our long-term goals with the UN's Sustainable Development Goals. Looking ahead, our priorities include deepening supply chain transparency, supporting regenerative farming practices, and expanding programs like rug recycling and material circularity. Sustainability isn't a finish line for us – it's a journey of continuous improvement and responsibility. Marquis: What inspired Armadillo to pursue a B Corp certification? How has it shaped your operations and values since? Fried: Pursuing B Corp certification was a natural step for us – not just to affirm our values externally, but to hold ourselves accountable internally. From day one, we wanted to build a brand that stood for something more than just aesthetics – one that cared deeply about people, the planet and legacy. The B Corp framework gave us the structure to formalize those intentions and push ourselves to do better across every aspect of the business, from supply chains to governance. It has also become a powerful symbol to our customers, collaborators and team – a way of signaling that we're part of a growing community of businesses committed to using commerce as a force for good. Being a B Corp doesn't mean we've arrived; it means we're committed to learning, evolving and being radically transparent about where we go next.
