On June 2, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) reported longer-term efficacy and safety results from Arm A1 of the Phase 2 EDGE-Gastric study. These updated data show consistent objective response rate (ORR) and provide mature progression-free survival (PFS) in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma (upper GI cancers) (Press release, Gilead Sciences, JUN 2, 2024, View Source [SID1234643936]). The ongoing, multi-arm, global Phase 2 EDGE-Gastric study is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in this patient population. These results will be presented today during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series: Rapid Abstract Updates session by Yelena Y. Janjigian, M.D., Chief, Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center, and a principal investigator for the EDGE-Gastric study (Abstract 433248).

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"I am encouraged to see that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival beyond one year, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone," said Dr. Janjigian. "Notably, nearly 60% of patients in the EDGE-Gastric study achieved progression-free survival at 12 months. These promising results reinforce our confidence in the ongoing Phase 3 STAR-221 study, which evaluates the same regimen in the same patient population and has the potential to address a high unmet need for people with these cancers."

At data cutoff (DCO, March 12, 2024), safety and efficacy were evaluated in all patients enrolled and treated (n=41). With a median time on treatment of 49.4 weeks (range: 0.4 – 79.4 weeks), the domvanalimab plus zimberelimab and chemotherapy regimen demonstrated sustained improvement across efficacy measures, including in those patients who have low PD-L1 expression.

Summary of efficacy results:

Endpoint

Overall*

PD-L1-high

PD-L1-low

n=41

(TAP ≥5%)

(TAP <5%)

n=16

n=24

Progression-Free Survival (PFS)

Median in Months (95% CI)

12.9 mos (9.8, 13.8)

13.8 mos (11.3, NE)

11.3 mos (5.5, 13.8)

12-month PFS Rate (95% CI)

57.6% (41.7,73.5)

68.8% (46.0, 91.5)

46.8% (24.7, 68.9)

Objective Response Rate (ORR)

per RECIST v1.1

Confirmed ORR (95% CI)

58.5% (42.1, 73.7)

68.8% (41.3, 89.0)

50.0% (29.1, 70.9)

Complete Response

3 (7.3%)

1 (6.3%)

1 (4.2%)

Partial Response

21 (51.2%)

10 (62.5%)

11 (45.8%)

Stable Disease

14 (34.1%)

5 (31.3%)

9 (37.5%)

Progressive Disease Confirmed

2 (4.9%)

0

2 (8.3%)

Not Evaluable**

1 (2.4%)

0

1 (4.2%)

Median Duration of Response (DOR) in Months

12.4 mos (9.9, NE)

NE (11.5, NE)

10.2 mos (4.0, 12.4)

*One subject with no tissue available for central PD-L1 testing. From local lab results, the subject is PD-L1 low via 22-C3 assay. This subject achieved confirmed complete response.

** One subject has no post baseline scans.

CI: confidence interval

NE: not evaluable

TAP: tumor area positivity

No unexpected safety signals were observed at the time of DCO. The domvanalimab plus zimberelimab and chemotherapy regimen was generally well tolerated and showed an overall safety profile consistent with the known safety profiles of each individual molecule to date. Infusion-related reactions were observed in 19.5% of the total subjects, and the majority were related to chemotherapy.

The updated data from Arm A1 of the Phase 2 EDGE-Gastric study support the ongoing Phase 3 STAR-221 study, in unresectable or metastatic upper GI cancers, which is expected to complete enrollment mid-year 2024.

Domvanalimab and zimberelimab are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of gastrointestinal cancers have not been established.

About the EDGE-Gastric Study

The ongoing, multi-arm, multi-cohort global Phase 2 EDGE-Gastric trial (NCT05329766) is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab and the anti-PD-1 monoclonal antibody zimberelimab in patients with locally advanced unresectable or metastatic gastric (G), gastroesophageal junction (GEJ) or esophageal (E) adenocarcinoma. Patients in Arm A1, with previously untreated G/GEJ/E adenocarcinoma, received 1600 mg of domvanalimab intravenously (IV) every four weeks (Q4W) plus 480 mg of zimberelimab IV Q4W + FOLFOX (oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2 IV, fluorouracil 400 mg/m2 IV bolus + 2400 mg/m2 continuous 46-48-hour IV infusion) every two weeks.

About Domvanalimab

Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity.

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab, as well as other investigational cancer immunotherapies and A2a/A2b adenosine receptor antagonist etrumadenant, in multiple ongoing and planned early and late-stage clinical studies in various tumor types.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing and planned early and late-stage clinical studies in combination with other immunotherapies, including investigational Fc-silent anti-TIGIT monoclonal antibody domvanalimab and A2a/A2b adenosine receptor antagonist etrumadenant.

Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

On June 2, 2024 GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, reported the phase II trial data of KROCUS Study, fulzerasib (GFH925, KRAS G12C inhibitor) in combination with cetuximab for first-line non-small cell lung cancer (NSCLC) treatment，at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, GenFleet Therapeutics, JUN 2, 2024, View Source;safety-result-from-phase-ii-trial-for-first-line-nsclc-treatment-in-krocus-study-fulzerasib-kras-g12c-inhibitor-in-combination-with-cetuximab-in-a-late-breaking-abstract-at-the-oral-p-302161182.html [SID1234643952]).

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The preliminary result of the trial was accepted as a late-breaking abstract and selected for oral presentation at the clinical science symposium of lung cancer treatment, highlighting the combination therapy’s promising efficacy and its excellent safety/tolerability profile. Notably, this marks the first time that a KRAS G12C inhibitor is combined with an EGFR inhibitor as a first-line NSCLC treatment with its data presented at a global academic event.

The KROCUS Study, led by renowned lung cancer expert Dr. Rafael Rosell, is a European multi-center phase Ib/II study initiated in March 2023. As of April 19 this year, a total of 40 subjects were enrolled and 33 of them received at least one available post-treatment tumor assessment: the objective response rate (ORR) reached 81.8% and the disease control rate (DCR) reached 100%. The post-treatment evaluation revealed that most patients (27/33) exhibited tumor response: one patient achieved complete response; the other two achieved partial response with a shrinkage in their tumor size by 100%.

Additionally, the combination therapy demonstrated a favorable safety/tolerability profile, with both treatment-related adverse events (TRAEs) and TRAEs above grade 3 occurring at a lower rate than those in the fulzerasib monotherapy study in second line and above NSCLC. The data was presented by Dr. Vanesa Gregorc from Italy’s Candiolo Cancer Institute, Italy.

The new drug application for fulzerasib monotherapy in treating advanced KRAS G12C-mutant NSCLC has been accepted and granted priority review designation by China’s National Medical Products Administration (NMPA). Based on the data presented at 2023 ESMO (Free ESMO Whitepaper) Asia, the registrational phase II study of GFH925 monotherapy for NSCLC showed an ORR of 46.6% and a DCR of 90.5%; the median progression-free survival (mPFS) was 8.3 months. In addition, fulzerasib monotherapy received two breakthrough designations for advanced G12C-mutant NSCLC and metastatic colorectal cancer (CRC) patients.

"I am delighted that the preliminary data of this phase II trial was selected for oral presentation at ASCO (Free ASCO Whitepaper), an acknowledgement of this innovative combination therapy’s potential in treating NSCLC patient in a of first-line setting. Currently, there are multiple global trials exploring the combination of KRAS G12C and EGFR inhibitors for later-line CRC. However, GenFleet is propelling the validation of this synergistic mechanism further into first-line treatment for NSCLC, the cancer type with the largest G12C-mutant patient population. We eagerly anticipate the trial’s continued progress, aiming to offer more frontline options for patients worldwide. "said Dr. Rafael Rosell, the principal investigator of KROCUS study.

"The design of the KROCUS Study is based on deep research into synergistic mechanisms, animal models validation, as well as clinical data generated from the fulzerasib monotherapy in the second-line setting. We are excited to see that the preliminary data from our first-line combination study exceeding our expectation. Furthermore, this chemo- and immuno-free combination could potentially mitigate overlapped toxicities and delay drug resistance, leaving space to allow later-line immunotherapy to extend the patients’ overall survival." stated by Yu Wang, M.D.,Ph.D., Chief Medical Officer of GenFleet.

KROCUS: a Phase II study investigating the efficacy and safety of fulzerasib (GFH925) in combination with cetuximab in patients with previously untreated advanced KRAS G12C mutated NSCLC
Presenter: Dr. Vanesa Gregorc
Abstract No. : LBA8511

A total of 40 treatment naïve advanced KRAS G12C positive NSCLC patients were treated with GFH925 in combination with cetuximab (fulzerasib 600mg BID + cetuximab 500 mg/m2 Q2W) as of April 19, 2024. Most patients (95%) were diagnosed with stage IV disease and 13 (32.5%) patients with brain metastases.

Efficacy: As of cutoff date, of the 33 patients who received at least one post-treatment tumor assessment, investigator-assessed ORR was 81.8% (95% CI: 64.5, 93.0) and DCR was 100% (95% CI: 89.4, 100); ORR among patients with brain metastasis was 70%. The median duration of response (DoR) was not reached yet and 88% of patients were still on treatment with a median follow-up of 5.1 months.

Safety: As of cutoff date, the combination therapy was well tolerated. Treatment-related adverse events (TRAEs) occurred in 87.5% of subjects and the majority of the TRAEs were grade 1-2. About 17.5% of subjects reported grade 3 TRAEs. There were no grade 4-5 TRAEs. No new safety signals were identified compared with fulzerasib or cetuximab as single agent.

About KROCUS Study and fulzerasib (GFH925)
The multi-center study of fulzerasib in combination with cetuximab started in scores of clinical research centers worldwide from March 2023 and sets its objectives to evaluate the safety/tolerance, efficacy and the pharmacokinetic characteristics of the combination in advanced NSCLC patients harboring KRAS G12C mutation.

Fulzerasib the first China-developed KRAS G12C inhibitor that has its NDA submission accepted and granted with Priority Review Designation by NMPA. Fulzerasib also received Breakthrough Therapy Designations this year for treating advanced KRAS G12C-mutant NSCLC patients that have received at least one systemic therapy and CRC patients who have received at least two systemic therapies.

RAS protein family can be divided into KRAS, HRAS and NRAS categories. KRAS mutations are detected in nearly 90% of pancreatic cancer, 30-40% of colon cancer, and 15-20% lung cancer patients. The occurrence of KRAS G12C mutation subset is more frequently observed than those with ALK, ROS1, RET and TRK 1/2/3 mutations combined. GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of fulzerasib towards G12C. Subsequently, fulzerasib effectively inhibits the downstream signal pathway to induce tumor cells’apoptosis and cell cycle arrest.

On June 2, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported data from its Phase 1 ASPEN-07 clinical trial in a poster presentation (abstract #4575) at the 2024 American Society of Cancer Oncology ("ASCO") Annual Meeting being held in Chicago from May 31-June 4, 2024 (Press release, ALX Oncology, JUN 2, 2024, https://ir.alxoncology.com/news-releases/news-release-details/alx-oncology-presents-first-evorpacept-combination-data-antibody [SID1234643920]). These findings represent the first evorpacept combination data with an ADC from ASPEN-07’s ongoing, open-label, single-arm, clinical trial of evorpacept in combination with PADCEV (enfortumab vedotin or "EV") in patients with locally advanced or metastatic urothelial cancer ("la/m UC"). Evorpacept is a CD47 blocker with an inactivated Fc effector domain that is designed to minimize associated toxicity.

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Key results as of the data cut-off date of April 3, 2024:

Initial patient demographics

Twenty-eight EV-naïve patients were enrolled with 29% having received three or more prior lines of therapy.
All patients had disease that progressed after platinum chemotherapy and checkpoint inhibition.
Approximately 93% of patients had metastatic disease.
The combination was generally well-tolerated in a heavily pre-treated patient population

No maximum tolerated dose was reached, and the maximum administered evorpacept dose was 30 mg/kg Q2W.
There were no treatment-related deaths in the study.
The most frequent adverse events due to any cause were low-grade fatigue, dysgeusia, nausea, diarrhea, hyperglycemia, and pruritis.
Initial activity showed tumor reduction in the majority of evaluable patients

ASCO poster presentation data-cut reported an unconfirmed overall response rate ("ORR") of 59% (n=22) with evorpacept plus EV (EV single agent ORR benchmark is 41%1).
Following the April data cut-off, four additional response evaluable patients yielded an unconfirmed ORR of 61% (n=26) including two confirmed complete responses and six confirmed partial responses.
To date, 58% of evaluable patients remain in the study.
Continued follow-up for patients who are EV-naïve on ASPEN-07 is ongoing and, enrollment of a new cohort of patients who have received prior EV has begun.
"We are encouraged by the preliminary safety data and clinical activity of evorpacept combined with PADCEV in patients with advanced bladder cancer," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology. "To our knowledge, these data are the first demonstration of anti-tumor activity with a CD47 blocker and an ADC in a heavily pre-treated patient population in the clinical setting. With these promising early results, we are evaluating clinical development options in both PADCEV-naïve and experienced patient populations."

"This emerging dataset reported favorable potential for evorpacept to be combined with an ADC in a patient population that has exhausted many treatments," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "We are especially hopeful because of the two patients with confirmed complete responses, which further exhibited this combination is active and that responses could improve over time in more patients. Heading further into the year, we will continue the momentum for ASPEN-07 as we gear up to share multiple, randomized, Phase 2 clinical data readouts where evorpacept is combined with anti-cancer antibodies and checkpoint inhibitors."

The poster can be found on the Publications section of the ALX Oncology website here.

Company Event with ASPEN-07 Principal Investigator and ALX Oncology Management

The Company is hosting a virtual event with key opinion leaders on Friday, June 7, 2024, at 1:00 PM ET. The event will feature leading ASPEN-07 principal investigator and bladder cancer expect, Samuel A. Funt, M.D., from Memorial Sloan Kettering Cancer Center, along with the management team of ALX Oncology. The discussion will cover details of the first promising initial dose escalation data from the Phase 1 ASPEN-07 clinical trial of evorpacept in combination with EV in patients with la/m UC, and how ASPEN-07 could fit into the treatment paradigm of this indication.

Samuel A. Funt, M.D., is a genitourinary oncologist at Memorial Sloan Kettering Cancer Center in New York, NY, where he is also Director of the Inpatient Genitourinary Oncology Service, Director of Bladder Cancer Clinical Trials Operations, and member of the Data Safety Monitoring Committee. Dr. Funt has practiced medicine and been involved in clinical trials for over 10 years. His top areas of clinical expertise are Bladder and Testicular Cancers. Dr. Funt has co-authored over 60 peer-reviewed articles and been awarded research grants from the National Institutes Health, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and the American Cancer Society. His research focuses on the development of more personalized and effective treatments and novel biomarkers of therapeutic response and resistance.

The event will be webcast live and can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under News and Events. To participate in the live event, please register using this link: View Source An archived webcast will be available following the event.

About the Phase 1 Clinical Trial Investigating Evorpacept plus EV in Advanced Bladder Cancer

The Phase 1 clinical trial is an ongoing, open-label, single arm is designed to evaluate the safety, tolerability, and efficacy of evorpacept in combination with EV in patients with la/m UC (NCT05524545). This dose escalation clinical trial has enrolled cohorts receiving 20 mg/kg Q2W or 30 mg/kg Q2W evorpacept plus standard EV treatment. The study is sponsored and conducted by ALX Oncology.

About Bladder Cancer and UC

As estimated by the National Cancer Institute, bladder cancer is the sixth most common cancer type in the United States. UC is the most common type of bladder cancer and accounts for approximately 90% of all bladder cancer cases. Roughly 83,000 new cases of bladder cancer will be diagnosed in the United States in 2024 with about 16,800 deaths. The five-year survival for patients with metastatic bladder cancer is less than 8%. Worldwide, over 614,000 new cases of bladder cancer and over 220,000 deaths occurred in 2022 according to The Global Cancer Observatory.

On June 1, 2024 TiumBio Co., Ltd. (Kosdaq: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, reported interim results from the Phase 1b clinical trial of TU2218 in combination with pembrolizumab at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, TiumBio, JUN 2, 2024, View Source [SID1234643955]).

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TU2218 is a novel oral dual inhibitor targeting transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2). TGF-ß and VEGF pathways in tumor microenvironment interfere with the anti-tumor activity of immune checkpoint inhibitors, so TU2218 is expected to maximize the efficacy of immuno-therapies by inhibiting them.

TiumBio’s ongoing Phase 1b clinical trial (NCT05784688) in the United States evaluates safety, pharmacokinetics, and preliminary efficacy of TU2218 in combination with Keytruda (pembrolizumab) in patients with advanced solid tumors. The study consists of three dosage groups (105 mg, 150 mg, and 195 mg/day), and the presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting included results from 12 patients across the three cohorts. Data from the full Phase 1b trial, which includes 18 patients, will be available in the second half of 2024.

In the poster released at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, five patients treated at the recommended phase 2 dose (RP2D) of 195mg/day TU2218 in combination with pembrolizumab demonstrated an ORR of 40% at PR (n=2) and 60% at SD (n=3) with a DCR of 100%. And across all dosage groups, patients (n=12) receiving the combination therapy showed PR at 16.7% (n=2), SD at 50.0% (n=6) and PD at 25.0% (n=3). In this study, TU2218 was well-tolerated as a combination therapy with pembrolizumab, showing no signs of DLTs, which is consistent with a previous monotherapy trial.

"We are encouraged by the preliminary efficacy results with a favorable safety profile in patients with advanced tumors and are looking forward to top-line data from the study, which is expected in the second half of this year," said Hun-Taek Kim, Ph.D., MBA, CEO at TiumBio. "We plan to initiate a Phase 2a clinical trial in head and neck cancer, biliary tract cancer, and colorectal cancer to develop an innovative novel drug for patients with limited treatment options," he added.

On June 2, 2024 Nanjing leads Biolab reported that after rigorous evaluation by Scientific Program Committee and ASCO (Free ASCO Whitepaper) Leadership, LBL-024, a bispecific antibody independently developed by Leads Biolabs with global intellectual property rights, was selected for an oral presentation (Press release, Nanjing Leads Biolabs, JUN 2, 2024, View Source [SID1234643940]). Today, Dr. Panpan Zhang, the investigator of LBL-024, presented the outstanding clinical data during the Clinical Science Symposium-Building Novel Antibody-Based Approaches in Gastrointestinal Cancers.

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This is a phase I/II first in human, open-label, multicenter, dose escalation/expansion study that evaluates the safety and efficacy of LBL-024 monotherapy in patients with advanced malignant tumors and neuroendocrine carcinoma. The study results demonstrated good safety profile and very promising antitumor effects as a monotherapy in patients with advanced malignant tumors, particularly extrapulmonary neuroendocrine carcinomas (EP-NEC) patients who failed at least one line of chemotherapy.

EP-NEC is a rare disease that typically occurs in the stomach, intestines, and pancreas. Most patients are diagnosed at a later stage when the cancer has already metastasized to other areas in the body. By then, the disease has progressed rapidly and the prognosis is extremely poor. No drug has been approved by the Regulatory Agencies for this lethal malignancy so far and the recommended treatment options for the advanced EP-NEC are very limited, especially for those who progress beyond first-line platinum-based chemotherapy. These underscore the urgency to develop novel therapeutic approaches.

According to results in the oral presentation, LBL-024 monotherapy showed good safety profile, especially mild liver toxicity in advanced solid tumors. The severity of AEs was mostly grade 1-2, no unexpected AEs were observed. At the dose of 15 mg/kg, ORR was 37.5% and DCR was 50.0% in 2nd line EP-NEC, and robust anti-tumor activities were observed in wide therapeutic dose range (0.8-15mg/kg) in EP-NEC. Median follow-up was 8.5 months, Median DoR was 5.3 months, mOS was not reached, 6-months OS rate of the overall, 2nd line, and ≥3rd line were 61.7%, 72.7% and 52.0%，respectively. 54.5% ORR in 22 patients with PD-L1 negative expression (CPS<1) were observed, which indicate patients can benefit from treatment with LBL-024 regardless of PD-L1 expression in tumor tissue.

The promising efficacy data of the LBL-024 monotherapy support continued development of LBL-024 in patients with EP-NEC. A single-arm pivotal study of LBL-024 monotherapy in EP-NEC was approved on April 30, 2024, which will help accelerate the listing process of LBL-024 (Click to view details). Currently, there are no 4-1BB-targeting drugs available both domestically and internationally. LBL-024 has First-in-Class potential and is expected to become the first approved standard treatment for EP-NEC after progression on second-line therapy, offering a more effective treatment option and providing hope for survival to patients with advanced EP-NEC.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "ASCO has very strict selection criteria, and abstracts selected for oral presentation must be among the most representative studies in the field of cancer that are significant for patient treatment. Leads Biolabs adopted a differentiated, innovative, and efficient development strategy in the clinical development of LBL-024. In patients with advanced malignant tumors, particularly EP-NEC patients who failed at least one line of chemotherapy, LBL-024 has demonstrated good safety and strong efficacy signals and was recently approved to conduct an accelerated development of single-arm pivotal clinical study by China Regulatory Authority, CDE."

Dr. Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said" Leads Biolabs has always been committed to differentiated innovation, encompassing the development of new targets, the design of drug molecules, and clinical development strategies. From the very beginning of the project, we evaluate whether our technology and products are scientifically sound, whether they can overcome obstacles and challenges of current products, and whether they can bring better therapeutic benefits. It is this persistence that ensures our products have potential advantages, enabling them to stand out from numerous competitors. These innovative achievements, in turn, have verified the feasibility of our R&D strategy. In the future, Leads Biolabs will continue to focus on unmet medical need, persist in innovation, and look forward to innovative drugs with clinical value bringing benefits to patients as soon as possible."

About LBL-024

LBL-024 is a uniquely designed bispecific antibody composed of an anti-Programmed Cell Death Ligand-1 (PD-L1) and an anti-4-1BB (CD137) antibody. It binds to PD-L1 with high affinity, blocks the immunosuppressive pathway of tumor cells by targeting PD-L1 and effectively localizes 4-1BB co-stimulation to the tumor microenvironment. This activation of T cells exerts a powerful immune response, resulting in a potentially stronger antitumor effect than anti-PD-1/PD-L1 monoclonal antibodies alone.