On June 1, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported the first data for casdatifan plus cabozantinib in an oral presentation by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Arcus Biosciences, JUN 1, 2025, View Source [SID1234653572]).

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"I was very encouraged to see that nearly half of patients had a confirmed response to the casdatifan plus cabozantinib combination despite short follow-up," said Toni K. Choueiri, M.D., director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber, the Jerome and Nancy Kohlberg Chair and professor of medicine at Harvard Medical School, and lead investigator of ARC-20. "Casdatifan plus cabozantinib was well tolerated, and the safety profile was consistent with that of either agent alone, supporting their potential as a combination therapy. I look forward to enrolling patients into the PEAK-1 trial as soon as it is open."

"The initial data for casdatifan plus cabozantinib in the ARC-20 study have already exceeded the historic benchmarks for either agent alone, as well as that of another HIF-2a inhibitor plus cabozantinib in the same second-line setting," said Terry Rosen, Ph.D., chief executive officer of Arcus. "These data serve as the proof of concept for PEAK-1, which will be initiated in the coming weeks and is designed to generate evidence to change the standard of care for people who have progressed on prior immunotherapy treatment."

ARC-20 is a Phase 1/1b dose-escalation and expansion study that includes a cohort evaluating once-daily 100mg of casdatifan plus 60mg of cabozantinib in patients with ccRCC who had progressed on prior immunotherapy. At the time of the data cutoff (DCO, March 14, 2025), 42 participants were evaluable for safety, and 24 reached at least 12 weeks of follow-up and were evaluable for efficacy. Among the safety-evaluable population (N=42), most participants (79%) had an International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factor of intermediate or poor. Nearly half (46%) of the efficacy-evaluable population (N=24) achieved a confirmed response per RECIST 1.1, and only one patient had primary progressive disease. The vast majority of the efficacy-evaluable population remains on treatment.

In the safety-evaluable population, no unexpected safety risks were identified at the time of DCO, and casdatifan plus cabozantinib had an acceptable safety profile with no meaningful overlapping toxicity for the two drugs. Only two patients discontinued any drug, and no patients discontinued treatment with both drugs. The incidence of treatment-emergent adverse events (TEAEs) with casdatifan, particularly anemia and hypoxia, was similar to TEAEs observed with casdatifan monotherapy, and there were no casdatifan-related Grade 4 or 5 adverse events. The incidence of TEAEs associated with each drug was consistent with what is expected for each drug alone.

A summary of the efficacy and safety results is below.

Efficacy-Evaluablea

casdatifan 100mg QD + cabozantinib 60mg QD

(n=24)

Median Follow-Up

5.3 months

Confirmed ORR (cORR) per RECIST v1.1 [95% CI]

46% (11)b

[26,67]

Best Overall Response:

Complete Response

4% (1)

Partial Response

42% (10)b

Stable Disease

50% (12)

Progressive Disease

4% (1)

CI: confidence interval; QD: daily

a All eligible patients who received any study treatment and reached a minimum of 12 weeks follow-up or discontinued due to progression or death.

b Inclusive of one patient who had partial response confirmation after March 14, 2025.

Safetya

casdatifan 100mg QD + cabozantinib 60mg QD

(n=42)

casdatifan

cabozantinib

Patients with any Treatment-Related Grade ≥3 AEb

Anemia

24% (10)

14% (6)

Hyponatremia

0

7% (3)

Hypoxia

7% (3)

0

Hypertension

0

5% (2)

Neutrophil count decrease

2% (1)

5% (2)

Patients with any AE leading to dose reductionb

Fatigue

2% (1)

12% (5)

Anemia

10% (4)

2% (1)

Hypoxia

10% (4)

0

Palmar-plantar erythrodysesthesia

0

5% (2)

Stomatitis

0

5% (2)

AE: adverse event

a Safety population included patients who received any amount of study drug and had at least one month of safety follow-up at the data cutoff date.

b Treatment-emergent adverse events (grade 3 or higher) related to casdatifan, cabozantinib, or any study drug reported in ≥3% of patients in any treatment arm.

Arcus is pursuing a broad development program in both the immuno-oncology (IO)-naive and post-IO settings with differentiated combinations to maximize the opportunity for casdatifan in ccRCC. These studies include:

Arcus’s planned Phase 3 study, PEAK-1, which will evaluate casdatifan plus cabozantinib versus cabozantinib monotherapy as a first- or second-line treatment in patients with metastatic ccRCC who have previously received anti-PD-1/PD-L1 therapy. The primary endpoint will be PFS with a key secondary endpoint of overall survival.
eVOLVE-RCC02, a Phase 1b/3 study sponsored by AstraZeneca, which will evaluate casdatifan plus volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody, as first-line treatment for participants with ccRCC.
ARC-20, which includes three cohorts evaluating casdatifan in earlier-line settings, including casdatifan plus zimberelimab in first-line ccRCC, casdatifan monotherapy in favorable risk ccRCC, and casdatifan monotherapy in immunotherapy-experienced, TKI-naive settings.
Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 446724 on Monday, June 2, 2025, at 5:00 AM PT / 7:00 AM CT. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2a, casdatifan is designed to shut down hypoxic oncogenesis and key oncogenic pathways, which leads to cancer cell death. Clear cell renal cell carcinoma is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.

On June 1, 2025 InnoCare reported latest data of robust oncology pipelines were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, involving the anti-CCR8 antibody ICP-B05 (CM369), the BCL2 inhibitor mesutoclax (ICP-248) and the pan-TRK inhibitor zurletrectinib (ICP-723) (Press release, InnoCare Pharma, JUN 1, 2025, View Source [SID1234653571]).

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Oral Presentation

Title: Preliminary results from the dose-escalation stage of a phase I trial of an anti-CCR8 antibody in patients with relapsed/refractory cutaneous T-cell lymphoma (R/R CTCL) (Abstract No.: 2514)

The current study is the first and only report on the preliminary efficacy data of anti-CCR8 targeted therapy for CTCL patients. The efficacy of ICP-B05 was supported by the PD effects in both skin lesions and peripheral blood in the depletion of CCR8+ cells. ICP-B05 is safe and well tolerated and its safety profile made it a good candidate for combo therapies for CTCL patients with lymph node and other organ involvement.

As of Jan. 6, 2025, a total of 13 patients with R/R CTCL were treated. There were 12 patients received at least one skin lesion assessment followed the mSWAT. 33.3% of patients achieved PR, and 58.3% of patients were assessed as SD with reduction in skin lesion. The 6-month PFS rate was 82.5%, and the median PFS was 11.4 months.

Among the five patients with CCR8+ levels exceeding 10%, four (80%) achieved PR. PK analysis showed that serum exposure (Cmax and AUC0-14D) increased with dose escalation. PD analysis demonstrated significant depletion of CCR8-expressing cells in CTCL skin lesions.

Poster 1:

Title: Preliminary safety and efficacy data of ICP-248, a novel BCL2 inhibitor, in patients with relapsed or refractory B-cell malignancies (Abstract No.: 7038)

The results of ICP-248 monotherapy suggests a well-tolerated safety profile and an exciting efficacy in BTK failed, heavily treated, relapsed or refractory B-cell malignancies.

As of April 15, 2025, a total of 68 patients were enrolled in the dose escalation and dose expansion study. 17 R/R CLL/SLL and 32 R/R MCL patients were treated with 125 mg of ICP-248, including 10 CLL/SLL and 25 MCL patients were previously treated with BTK inhibitors, and 70.0% of CLL/SLL patients and 100% of MCL patients were resistant to BTK inhibitors.

17 CLL/SLL and 26 MCL patients had at least one response assessment. Among the BTK naïve patients, the ORR for R/R CLL/SLL and R/R MCL patients were both 100%, and the CRR was 14.3% and 71.4% respectively, of which 43% of MCL patients reported undetectable minimal residual disease (uMRD). Among the BTK treated patients, the ORR for R/R CLL/SLL and R/R MCL patients were 100% and 78.9% respectively, and the CRR were 30.0% and 26.3% respectively, of which uMRD was reported in 20% of CLL/SLL and 16% of MCL patients.

The median PFS of R/R MCL patients who had received treatment of BTK inhibitors before was 8.3 months. The PFS was not reached among BTK naïve R/R CLL/SLL and R/R MCL patients and BTK-treated R/R CLL/SLL patients.

Poster 2:

Title: Efficacy, safety and pharmacokinetics (PK) of zurletrectinib, a next-generation pan-TRK inhibitor, in pediatric and adolescent patients with NTRK fusion-positive (NTRK+) solid tumors (Abstract No.: 10048)

The integrated analysis demonstrated that zurletrectinib had significant efficacy and good safety profile in pediatric and adolescent patients with NTRK+ solid tumors. Zurletrectinib also showed the potential to overcome the resistance to first generation TRK inhibitors. These findings support zurletrectinib is a better treatment option for NTRK+ pediatric and adolescent patients.

As of Nov. 23, 2024, 18 patients in total were enrolled, including 8 pediatric patients and 10 adolescent patients. Among the 18 patients, 6 TRK inhibitor treatment-naïve patients with central lab confirmed NTRK+ were efficacy evaluable. The confirmed ORR assessed by IRC was 100%.

All patients achieved partial response (PR) at the first tumor assessment and maintained the remission as of the cutoff date. Median time to response were 1.0 month in adolescent patients and 0.9 month in pediatric patients. It is worth noting that one pediatric patient who progressed on prior first-generation TRK inhibitor achieved complete response after receiving zurletrectinib.

Poster 3:

Title: Updated efficacy and safety of zurlectrectinib in adult patients (pts) with locally advanced or metastatic NTRK fusion-positive (NTRK+) solid tumors (Abstract No.: 3112)

In line with previously reported results, zurletrectinib continued to demonstrate a deep and durable responses in adult patients with NTRK+ advanced solid tumors with or without brain metastasis. Zurletrectinib was also well-tolerated and showed favorable safety profile in adult patients with various tumor types.

As of Nov. 23, 2024, a total of 49 TRK inhibitor naïve adult patients were evaluable for efficacy representing 12 different solid tumor types. Among the efficacy population, the distribution of NTRK1, NTRK2 and NTRK3 fusions was 53.1%, 2.0% and 44.9% respectively.

The confirmed ORR by IRC was 83.7%, with CR of 10.2%. Median duration of response (DOR) and median progression-free survival (PFS) by IRC were not reached. The DOR rate and PFS rate by IRC at 12 months was 92.0% and 90.5% respectively. Two of the three patients who had brain metastasis at the baseline achieved intracerebral ORR, which is consistent with the good brain penetration and strong intracranial activity of zurletrectinib.

The 2025 ASCO (Free ASCO Whitepaper) Annual Meeting is held from May 30 to June 3, 2025 in Chicago, U.S. The ASCO (Free ASCO Whitepaper) annual meeting is the most important and professional academic event in the global oncology field, which showcases the international cutting-edge clinical oncology research results and tumor treatment technologies.

On June 1, 2025 InxMed Co., Ltd, a clinical-stage biotechnological company, pioneering therapies to transform cancer treatment, reported latest clinical data from a Phase Ib/II clinical trial (NCT06166836; NCT05379946) to evaluate the efficacy and safety of ifebemtinib (IN10018), an oral focal adhesion kinase (FAK) inhibitor in combination with garsorasib (D-1533), an oral KRAS G12C inhibitor, in KRAS G12C mutant solid tumors (Press release, InxMed, JUN 1, 2025, View Source;kras-g12c-inhibitor-in-kras-g12c-mutant-solid-tumors-at-asco-2025-302470109.html [SID1234653570]).

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The clinical data presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #8629 | Poster Board #109) included results from two cohorts:

Durability follow-up data of the single-arm cohort in first-line KRAS G12C-mutant non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 expression, who received ifebemtinib + garsorasib treatment.
A randomized cohort in previously treated KRAS G12C-mutant colorectal cancer (CRC) patients comparing ifebemtinib+ garsorasib versus garsorasib monotherapy.
In NSCLC cohort, the combination of ifebemtinib and garsorasib, as a dual-oral, chemotherapy-free regimen, demonstrated compelling clinical benefit including high response rates and durable efficacy, regardless of PD-L1 expression, and in CRC cohort, the result showed clear add-on efficacy by ifebemtinib compared to KRAS inhibitor monotherapy.

Key Highlights in First-line NSCLC: Dual-Oral Regimen Shows Durable Efficacy and Emerging Survival Benefit

As of March 31, 2025, 33 first-line NSCLC patients, regardless of PD-L1 expression, were enrolled and received the combination of ifebemtinib and garsorasib, with a median follow-up of 16.0 months. Previously the company has reported an Objective Response rate (ORR) of 90.3% (data presented at ESMO (Free ESMO Whitepaper) 2024). The follow-up data were now summarized as follows:

Median progression-free survival (mPFS): 22.3 months
Median duration of response DOR (mDOR): 19.4 months
Median overall survival (mOS): not yet reached, with a significant uplifting and flattening survival curve indicating durable benefit.
Of note, the treatment demonstrated consistent efficacy regardless of PD-L1 expression status.

Key Findings in Previously Treated CRC: Randomized Trial Validates Synergy with KRAS G12Ci

As of Apr 21, 2025, 36 previously treated CRC patients were randomized 1:1 to receive the combination of ifebemtinib + garsorasib or garsorasib alone. All patients were radiologically evaluable and the antitumor responses were assessed and summarized as follows:

ORR: 44.4% (combo) vs. 16.7% (mono)
Disease control rate (DCR): 100.0% (combo) vs. 77.8% (mono)
mPFS: 7.7 months (combo) vs. 4.0 months (mono)
mOS: not yet reached in the combination arm; early separation observed in the survival curves
"These results validate ifebemtinib as an ideal combination partner for RAS inhibitors in RAS-driven malignancies to boost efficacy of RASi significantly," said Dr. Zaiqi Wang, Chief Executive Officer of InxMed. "The unprecedented 19-month DOR and 22-month median PFS in front-line NSCLC in all comers and near doubling of response rate in CRC position this dual-oral regimen as a potential paradigm shift treatment in KRAS G12C-mutant cancers. Its favorable safety profile further supports the potential for a cytotoxic chemotherapy-free regimen in winning front-line in the future."

InxMed has initiated a randomized Phase III pivotal trial in first-line KRAS G12C-mutant NSCLC. Additionally, the company is actively exploring combinations of ifebemtinib with other KRAS-targeted agents, including KRAS G12D inhibitors and multi-RAS inhibitors, supported by promising preclinical synergy data.

About Ifebemtinib (IN10018)

Ifebemtinib (IN10018) is a highly selective, orally administered, small molecule inhibitor against FAK, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, it has demonstrated therapeutic synergies with chemotherapy, targeted therapies, and immunotherapies. To date, over 600 patients have been treated with a favorable safety and tolerability profile.

Ifebemtinib has been granted Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track Designation from the U.S. Food and Drug Administration (FDA). A New Drug Application submission to the NMPA is planned for 2025.

On June 1, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the results of the pivotal Phase II clinical trial in China (CT041-ST-01, NCT04581473) investigating satricabtagene autoleucel ("satri-cel", CT041) (a Claudin18.2-specific autologous CAR T-cell product candidate) in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment, have been published in The Lancet and were orally presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Carsgen Therapeutics, JUN 1, 2025, View Source [SID1234653569]). Further details have been posted on the corporate website View Source

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The article in The Lancet was titled "Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician’s choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial". Full article available at: View Source(25)00860-8.

The oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract 4003) was titled "Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician’s choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01)".

Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of this study, said, "The CT041-ST-01 trial represents the world’s first randomized controlled clinical study of CAR-T cell therapy for solid tumors. In patients with heavily pretreated, advanced gastric/gastroesophageal junction cancer who have extremely limited treatment options and poor prognosis, satri-cel has demonstrated breakthrough efficacy with significant clinical benefits, including much improved progression-free survival (PFS), overall survival (OS), and tumor response rates. This brings new hope to patients with otherwise medically untreatable conditions. We are further exploring satri-cel’s potential in adjuvant settings and as first-line sequential therapies, aiming to intervene earlier in the disease course, extend patients’ survival, and ultimately pursue potential cures."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are honored that the CT041-ST-01 study results were published in The Lancet—a premier, global medical journal—and presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The positive result of this randomized controlled trial marks a major milestone in solid tumor CAR-T therapy. These achievements are a testament to the whole research team’s years of dedication, and we extend our deepest gratitude to patients and their families for their trust and participation. This year, satri-cel has been granted Breakthrough Therapy Designation and Priority Review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. We plan to submit a New Drug Application (NDA) for satri-cel to the NMPA this month and anticipate its approval as the world’s first commercially available CAR-T product for solid tumors, bringing benefits to patients."

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595).

Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA.

On June 1, 2025 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs") reported 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) (Press release, Nanjing Leads Biolabs, JUN 1, 2025, View Source [SID1234653568]). The results were featured in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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).