L&L Biopharma Co., Ltd. is a company engaged in the field of biopharmaceuticals, focusing on the preclinical research and development of new drugs in the direction of tumor immunotherapy, specializing in the innovation of monoclonal antibody new drugs, CAR-T (Chimeric Antigen Receptor T Cell) technology, and the development of combined treatment products.

Tags

Neoplasms

Digestive System Disorders

Immune System Diseases

Bispecific antibody

Trispecific antibody

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	8
Endocrinology and Metabolic Disease	1
Hemic and Lymphatic Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Bispecific antibody	5
Trispecific antibody	3

Top 5 Target	Count

CLDN18 x CLDN18.2	1
PD-1 x TIM3	1
CD8 x CLDN18.2	1

Drugs associated with L&L Biopharma Co., Ltd.

LB-4330

Target

CD8 x CLDN18.2

Mechanism

CD8 inhibitors [+1]

Active Org.

L&L Biopharma Co., Ltd.Startup

Originator Org.

L&L Biopharma Co., Ltd.Startup

Active Indication

Solid tumor [+4]

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

Recombinant PD-1/TIM3 bispecific antibody(L&L vision biopharmaceuticals)

Target

PD-1 x TIM3

Mechanism

PD-1 inhibitors [+1]

Active Org.

L&L Biopharma Co., Ltd.Startup

Originator Org.

L&L Biopharma Co., Ltd.Startup

Active Indication

Metastatic Solid Tumor [+5]

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

LNL-012

Target-

Mechanism

T lymphocytes stimulants

Active Org.

L&L Biopharma Co., Ltd.Startup

Originator Org.

L&L Biopharma Co., Ltd.Startup

Active Indication

Neoplasms

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with L&L Biopharma Co., Ltd.

CTR20241814 / RecruitingPhase 2

一项在晚期/转移性实体瘤患者中评价LB1410联合LB4330的Ib/II期、开放、剂量递增和扩展研究

[Translation] A Phase Ib/II, open-label, dose-escalation and expansion study evaluating LB1410 in combination with LB4330 in patients with advanced/metastatic solid tumors

主要目的： 1.在晚期实体瘤成人患者中，评估LB1410联合LB4330的安全性和耐受性。 2.确定剂量递增阶段LB1410联合LB4330最大耐受剂量（MTD）和/或II期推荐剂量（RP2D）。 3.评估LB1410联合LB4330的抗肿瘤疗效。次要目的： 1.评估LB1410联合LB4330在晚期实体瘤患者中的药代动力学（PK）特征。 2.评价LB1410联合LB4330的免疫原性（ADA）。 3.评价LB1410联合LB4330的ADA与PK、安全性和疗效间的关系。 4.检测基线期采集的肿瘤组织中PD-L1、TIM3、Claudin18.2（按肿瘤类型细分检测项目）。探索性目的：？LB1410联合LB4330药效学或潜在生物预测标记物：淋巴细胞亚群（含CD8+ T细胞、CD4+ T细胞等），细胞因子。

[Translation]

Primary objectives: 1. To evaluate the safety and tolerability of LB1410 combined with LB4330 in adult patients with advanced solid tumors. 2. To determine the maximum tolerated dose (MTD) and/or the recommended dose (RP2D) of LB1410 combined with LB4330 in the dose escalation phase. 3. To evaluate the anti-tumor efficacy of LB1410 combined with LB4330. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of LB1410 combined with LB4330 in patients with advanced solid tumors. 2. To evaluate the immunogenicity (ADA) of LB1410 combined with LB4330. 3. To evaluate the relationship between ADA and PK, safety and efficacy of LB1410 combined with LB4330. 4. To detect PD-L1, TIM3, and Claudin18.2 in tumor tissues collected at baseline (test items are subdivided by tumor type). Exploratory objectives: ? Pharmacodynamic or potential biological predictive markers of LB1410 combined with LB4330: lymphocyte subsets (including CD8+ T cells, CD4+ T cells, etc.), cytokines.

Start Date28 Jun 2024

Sponsor / Collaborator

L&L Biopharma Co., Ltd.Startup

NCT06468358 / RecruitingPhase 1/2

A Phase Ib/II, Open, Dose-escalation and Expansion Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors

This is a phase Ib/II, open, dose-escalation and expansion study of an anti-PD1/TIM3 bispecific antibody，LB1410 in combination with an anti-Claudin18.2/IL-10 fusion protein, LB4330 in patients with advanced or metastatic solid tumors.

Start Date19 Jun 2024

Sponsor / Collaborator

L&L Biopharma Co., Ltd.Startup

[+1]

CTR20222918 / RecruitingPhase 1

评价 LB4330 在晚期恶性实体瘤患者中的安全性、耐受性、药代动力学特征及免疫原性的剂量递增及剂量扩展的Ⅰ期临床试验

[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of LB4330 in patients with advanced malignant solid tumors

主要目的：评价 LB4330 在晚期恶性实体瘤患者中的安全性和耐受性，并探索 LB4330 的最大耐受剂量（MTD），确定Ⅱ期临床试验推荐剂量（RP2D）。次要目的： 1）评价 LB4330 在晚期实体瘤患者中的药代动力学（PK）和药效动力学（PD）特征。 2）评价 LB4330 在晚期实体瘤患者中的免疫原性。 3）初步评价 LB4330 在晚期实体瘤患者中的抗肿瘤疗效。 4）初步评价 LB4330 治疗晚期恶性肿瘤患者的疗效相关的生物标志物，为Ⅱ期临床试验的治疗人群选择提供依据。

[Translation]

Primary objectives: To evaluate the safety and tolerability of LB4330 in patients with advanced malignant solid tumors, explore the maximum tolerated dose (MTD) of LB4330, and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of LB4330 in patients with advanced solid tumors. 2) To evaluate the immunogenicity of LB4330 in patients with advanced solid tumors. 3) To preliminarily evaluate the anti-tumor efficacy of LB4330 in patients with advanced solid tumors. 4) To preliminarily evaluate the biomarkers related to the efficacy of LB4330 in the treatment of patients with advanced malignant tumors, and provide a basis for the selection of treatment populations for Phase II clinical trials.

Start Date30 Nov 2022

Sponsor / Collaborator

L&L Biopharma Co., Ltd.Startup

100 Clinical Results associated with L&L Biopharma Co., Ltd.

0 Patents (Medical) associated with L&L Biopharma Co., Ltd.

Literatures (Medical) associated with L&L Biopharma Co., Ltd.

01 Jun 2024·Journal of Clinical Oncology

Phase 1 study of LB1410, a bivalent TIM-3/PD-1 bispecific antibody, in patients with advanced solid tumors.

Author: Liu, Jiajian ; Li, Wei ; Zhou, Caicun

2639 Background: LB1410 is a recombinant humanized anti-PD-1/TIM-3 bispecific antibody (BsAb) developed by L&L Biopharma Co., Ltd, which blocks the immune checkpoint PD-1 and TIM-3-mediated immunosuppressive signal pathways, and showed better T/DC cell activity and in vivo anti-tumor efficacy compared to TIM-3 and PD-1 antibody combination in preclinical studies. Here we report the results of the first-in-human, multicenter, open-label, phase I trial of LB1410 monotherapy in pts with advanced solid tumors ( Keyplus-001 ). Methods: Eligible pts were ≥ 18 yr old with ECOG PS 0-1 and previous treatment. Dose escalation cohorts ranged from 0.001 mg/kg to 20 mg/kg IV Q2W: 0.001mg/kg-1mg/kg in an accelerated titration design, and 3 mg/kg-20 mg/kg using traditional 3+3 design. The primary objective is safety, including dose-limiting toxicities (DLTs). Secondary/exploratory objectives include efficacy, pharmacokinetics (PK), and immunogenicity. Data cutoffs were January 5, 2024 for safety, and January 25, 2024 for efficacy. Results: In total, 52 pts received LB1410 from 0.001 mg/kg to 20 mg/kg as of Jan 5, 2024, median age 58 yr, 69% male. All of patients enrolled had multiple organ metastases or multiple metastases in a single organ, and were heavily treated with anti-tumor treatment, 36/52 (69.2%) were resistant to or refractory to PD-1/PD-L1 inhibitors, and 16/52 (30.8%) were MSS CRC. Treatment related AEs (TRAEs) occurred in 65.4% of pts. The most common TRAE was anemia (19.2%). 2 patients developed Gr3 hypokalemia. There were no DLTs. Tumor response evaluation were available in 40 pts: 14 had stable disease, 25 had progression, and 1 was not evaluable. Target lesion shrinkage was observed in 9 pts, including one patient's sum of target lesion reduced by 48.7% from baseline. Of 14 pts who had stable disease, there were 2 pts with stable disease lasting for more than 6 months. PK was generally dose proportional within 1 mg/kg~15 mg/kg, with t1/2 ~4.12 days in 10 mg/kg, and t1/2 ~4.77 days in 15 mg/kg. Of the 22 subjects tested for ADA, only one produced ADA for LB1410, the positive rate was 4.5%. Antidrug antibodies had limited impact on PK. As of Jan 5, 2024, 39 pts remained on the study; updated data will be presented. Conclusions: LB1410 has manageable safety and shows preliminary efficacy. Additional dose and efficacy expansion study is ongoing in immunotherapy-naive pts with MSS CRC and pts who are resistant to immunotherapy. Clinical trial information: NCT05357651 .

01 Jun 2024·Journal of Clinical Oncology

A phase 1 study of LB4330, a peptide fused to CLDN18.2 antibody targeting the tumor antigen associated (TAA) CD8+T cells in patients with advanced solid tumors.

Author: Zhang, Jian ; Yu, Xianjun ; Liu, Jiajian

e15074 Background: PD-1/PD-L1-targeted immunotherapies have become critical in the treatment for many tumors. However, there has been limited progress in low immunogenic cancers such as pancreatic ductal adenocarcinoma (PDAC) or CRC. LB4330 is a novel, bi-functional molecule targeting Claudin18.2 and IL-10 with high affinity anti-CLDN18.2 (14pM). It may activate TAA CD8+ T cells in the tumor microenvironment (TME) and has potential alone or in combination with immunotherapeutic agents, including PD-1/PD-L1 mAbs, for the treatment of advanced solid tumors. A FIH, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of LB4330 in patients with advanced solid tumors (MEETCD8-001) is ongoing in China. Methods: Eligible patients were ≥ 18 years old with ECOG PS 0-1. Dose cohorts ranged from 0.001 mg/kg to1 mg/kg IV QW: 0.001mg/kg-0.05mg/kg in an accelerated titration design, and 0.2mg/kg-1 mg/kg using traditional 3+3 design. The primary objective is safety, including dose-limiting toxicities (DLTs). The secondary/exploratory objectives include efficacy, pharmacokinetics (PK), and immunogenicity. Results: As of January 5, 2024, 30 patients with advanced solid tumors who have failed standard treatments or who did not have standard treatments available or applicable at this stage were recruited, including 17 PDAC, 6 GC, 3 CRC and 4 other solid tumor patients. All patients enrolled had multiple organ metastases. Treatment emergent AEs (TEAEs) occurred in 90.3% of patients. The most common Treatment related AEs (TRAE) were thrombocytopenia, anemia, fever, rash/itching, and fatigue. 7 patients (23.3%) had grade 3 TRAE which were infusion reaction, skin itching, rash, fever, abdominal distension, anemia, and thrombocytopenia. 1 patient (3.2%) had grade 4 AE, thrombocytopenia. On-treatment scan for efficacy was available for 20 patients, and 7 had stable disease. Target lesion shrinkage was observed in 2 pts, including one PDAC patient whose sum of target lesion reduced by 32.9% from baseline. PK was generally dose proportional, with t½ ~2 days. The immune activating Th1 cytokine IL-18 was elevated in 77.8% of patients treated with LB4330. Updated data will be presented. Conclusions: LB4330 has manageable safety and shows preliminary efficacy at tolerable doses. Dose and efficacy expansion study is ongoing in more PDACs and other solid tumors. In the meantime, Phase I study of LB4330 in combination with PD1/TIM-3 bispecific antibody LB1410 has been initiated in different tumor types as well. Clinical trial information: NCT05707676 .

24 Jul 2023·Antibody Therapeutics

A BIVALENT TIM-3/PD-1 BISPECIFIC ANTIBODY FOR THE TREATMENT OF PD-1 ANTIBODY RESISTANT OR REFRACTORY SOLID TUMORS

Author: Wang, Cuihui ; Deng, Hongyuan ; Wang, Fengpo ; Zhang, Zhen ; Liu, Jiajian ; Liu, Xun ; Luan, Yan ; Abuduwaili, Kahaerjiang

AbstractBackgroundImmune checkpoint inhibitors (ICI) PD-1/PD-L1 antibody are key drugs for the treatment of cancer. Bispecific antibody is one of the strategies aimed to meet the clinical needs for cancer patients who are resistant to or refractory from ICI treatment. TIM-3, one of the next generation of ICI targets, co-expressed on exhausted T cells with PD-1. It is also expressed by innate immune populations, including NK and DC. Dual blocking PD-1 and TIM-3 not only on T cells but also on DC, NK cells may achieve better clinical benefit for patients who are resistant to or refractory from ICI treatment.MethodA bivalent TIM-3 and PD-1 bispecific antibody (Bis5) was developed, a series of in vitro and in vivo efficacy, preclinical pharmacokinetic and toxicity studies were conducted. A Phase I, multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of Bis5 in patients with advanced and/or metastatic solid tumors is ongoing in China.ResultsBis5 showed affinity of 5-8 nM to both TIM-3 and PD-1, with better cell activity than TIM-3 and PD-1 mAb combination to activated T cell as well as NK and DC, over the other clinical stage reference BsAb. In huPD-1/TIM-3 double knock in mice-CT26 tumor model, Bis5 showed significant tumor inhibition activity and doubled the survival rate, while neither PD-1 mAb, TIM-3 mAb nor PD-1 and TIM-3 antibody combination showed activity. The highest non-severe toxicity dose (HNSTD) was 200mg/kg in monkeys. Nine cohorts (0.001-15 mg/kg) are planned to be enrolled sequentially in the dose escalation part in the Phase I study, as of April 2023, seven cohorts enrollment have completed. No dose limiting toxicity was observed, and the optimal effective dose was not reached. No TRAE higher than grade 2 was observed. The TRAE with ≥10% Incidence was anemia. SD >4 or 2 months were shown in the suboptimal dose levels in NSCLC and CRC (0.3mg/kg, 1mg/kg). The Part 2 dose expansion will further characterize the safety profile and preliminary tumor response in several cohorts including NSCLC, CRC, ESCC etc.ConclusionBis5 showed good preclinical efficacy and safety profile, its clinical performance is expected. Clinical trial information: NCT05357651.

News (Medical) associated with L&L Biopharma Co., Ltd.

29 Sep 2023

·www.compositesworld.com

L&L Products expands Michigan production facility

Photo Credit: L&L Products L&L Products Inc. (Romeo, Mich., U.S.), a family-owned business-to-business company offering solutions for applications requiring static sealing, better acoustics, reduced vibration, structural reinforcement and composite components, announces the grand opening of its expanded production facilities in the Village of Romeo to accommodate automotive growth and diversification. A ribbon-cutting ceremony was attended by L&L shareholders, the L&L executive team, employees and special guests from the local community. The facility has grown from 322,974 square feet to 464,528 square feet, completing the four-phase site plan that was established when L&L purchased the 26-acre site in 1993. The completed facility now features a main aisle that stretches for nearly a quarter mile (1,194 feet), connecting the warehouse to manufacturing areas for greater flexibility. The additional warehouse space was designed to maximize manufacturing, improve material flow and increase flexibility for future growth in both manufacturing and warehousing. “This expansion will allow us to continue to delight and grow with our customer partners and invest in our future with new exciting products,” John Babi, director of operations at L&L Products Romeo, says. “Our shareholders believe in the L&L team, the community supports us and our employees make it happen daily. Without this, the expansion would not be possible.” Supported by a $450,000 Michigan Business Development Program performance-based grant, the project brings an approximate $25 million capital investment to the region and will help ensure the company’s continued growth in Michigan with approximately 65 new jobs to be associated with the expansion. L&L Products was founded in Almont, Mich., U.S. in 1958 and has production facilities around the world. The company currently employs approximately 550 Michiganders.

100 Deals associated with L&L Biopharma Co., Ltd.

100 Translational Medicine associated with L&L Biopharma Co., Ltd.

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Pipeline

Pipeline Snapshot as of 20 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Recombinant PD-1/TIM3 bispecific antibody(L&L vision biopharmaceuticals) ( PD-1 x TIM3 )	Metastatic Solid Tumor More	Phase 2 Clinical
LB-4330 ( CD8 x CLDN18.2 )	Solid tumor More	Phase 2
LNL-012	Neoplasms More	Phase 1
Bis94	Neoplasms More	Preclinical
LNL021	Neoplasms More	Preclinical

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