Top 5 Target	Count

CD18(integrin subunit beta 2)	2
CD73(5-nucleotidase)	1
PGE2(Prostaglandin E2)	1
TIGIT(T cell immunoglobulin and ITIM domains)	1
FAP(Fibroblast activation protein alpha)	1

Drugs associated with Twinpig Biolab, Inc.

TB-796

Target

IGF-1

Mechanism

IGF-1 modulators

Active Org.

Twinpig Biolab, Inc.

Originator Org.

Twinpig Biolab, Inc.

Active Indication

Sarcopenia

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

TB-511

Target

CD18

Mechanism

CD18 inhibitors [+1]

Active Org.

Twinpig Biolab, Inc. [+1]

Originator Org.

Twinpig Biolab, Inc.

Active Indication

Advanced Malignant Solid Neoplasm [+8]

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

TBR-202

Target

FAP

Mechanism

FAP modulators

Active Org.

Twinpig Biolab, Inc.

Originator Org.

Twinpig Biolab, Inc.

Active Indication-

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Twinpig Biolab, Inc.

NCT06400160

/ Not yet recruitingPhase 1/2

An Open-label, Multi-center, and Dose-escalation, Phase 1/2a Clinical Trial to Assess the Maximum Tolerated Dose(MTD), Safety, and the Anti-tumor Effect of TB511 Monotherapy in Patients With Advanced Solid Tumors Refractory or Intolerant to Standard of Care(SoC) and Pembrolizumab Combination Therapy in Patients With Advanced Solid Tumors Relapsed or Refractory

1. Study population
[TB511 Monotherapy Cohort for Phase 1 and Phase 2a Clinical Trial] Patients with advanced solid tumors who are either refractory or intolerant to standard of care (SoC).
[Immune checkpoint inhibitors (ICIs) Combination Therapy Cohort for Phase 2a Clinical Trial] Patients with advanced solid tumors who are refractory to immune checkpoint inhibitors (ICIs) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 inhibitors or who have no available standard of care.
2. Objectives of the Clinical Trial
2.1 Primary Objectives [Phase 1 Clinical Trial]
* To evaluate the safety and tolerability of TB511 monotherapy in patients with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D).
[Phase 2a Clinical Trial]
* To evaluate the Objective Response Rate (ORR) of TB511 monotherapy and TB511 in combination with Pembrolizumab in patients with advanced solid tumors (based on Response Evaluation Criteria In Solid Tumors Version 1.1, RECIST v1.1).
2.2 Secondary Objectives [Phase 1 Clinical Trial]
* To evaluate the safety of TB511 monotherapy.
* To assess the Objective Response Rate (ORR) and anti-tumor activity of TB511 monotherapy (based on RECIST v1.1).
* To characterize the pharmacokinetic (PK) profile of TB511 monotherapy.
[Phase 2a Clinical Trial]
* To evaluate the Disease Control Rate (DCR), Duration of Response (DoR), and Progression-Free Survival (PFS) of TB511 monotherapy and TB511 in combination with Pembrolizumab.
* To assess the safety and tolerability of TB511 monotherapy and TB511 in combination with Pembrolizumab.
* To characterize the pharmacokinetic (PK) profile of TB511 monotherapy and TB511 in combination with Pembrolizumab.
2.3 Exploratory Objectives
* To compare changes in biomarker levels of TB511 monotherapy.
* To assess immunogenicity of TB511 by measuring anti-drug antibodies (ADA).

Start Date01 May 2025

Sponsor / Collaborator

Twinpig Biolab, Inc.

100 Clinical Results associated with Twinpig Biolab, Inc.

0 Patents (Medical) associated with Twinpig Biolab, Inc.

Literatures (Medical) associated with Twinpig Biolab, Inc.

21 Apr 2025·Cancer Research

Abstract 4775: Combination therapy with TB511 and anti-nectin-4 antibody drug conjugate in a human pancreatic cancer mouse model

Author: Kim, Soyoung ; Han, Ik-Hwan ; Yun, Geumseong ; Choi, Ilseob ; Bae, Hyunsu ; Lee, Hyunju ; Lee, Heekyung ; Yang, Juwon

AbstractPancreatic cancer is a type of cancer that occurs in the pancreas and occurs in the pancreatic duct in more than 90% of cases and is known as the 10th most common cause of cancer deaths worldwide. Recently, tumor-associated macrophages (TAMs) in tumor microenvironment (TME) have been known to closely associate with progression of pancreatic cancer. Among TAMs, M2 type macrophages constitute the majority within the TME and are associated with tumor progression and drug resistance. Targeting M2 macrophages represents a promising therapeutic strategy to reprogram the TME and enhance anti-tumor immunity. In our previous study, we developed TB511, a peptide drug conjugate that preferentially binds to M2 macrophages and induces apoptosis through mitochondrial targeting by conjugating with dKLA. Furthermore, in pancreatic cancer, the nectin-4 expression has been known to contribute to tumor proliferation, angiogenesis, and patient prognosis. Nectin-4 has been considered a potential new target for the treatment of pancreatic cancer. However, therapeutic efficacy of anti-nectin-4 antibody has not been established in pancreatic cancer. This study aims to evaluate the efficacy of the combination therapy of TB511 and anti-nectin-4 antibody drug conjugate (ADC) in reducing tumor growth and modulating the immune cells of tumor microenvironment in a humanized pancreatic cancer mouse model. In this study, humanized mice bearing subcutaneous pancreatic cancer using the PANC1 cell line were treated with TB511, ADC, their combination, or PBS as a control. As a result, TB511, PADCEV, and their combination significantly reduced tumor growth and Ki67 expression. EMT marker analysis revealed increased E-cadherin and decreased vimentin expression in combination therapy groups. TB511 and combination therapy reduced M2 macrophages (CD163, CD18, Kim127, CD11b) and increased CD8 T cells in the TME, while ADC alone showed no significant immune modulation. Spatial transcriptomics highlighted decreased epithelial cancer cells, increased M1 macrophages, and elevated CD8 T and NK cells in the TB511 and combination groups. Immune checkpoint markers (CTLA4, FOXP3, LAG3) were downregulated, and cytotoxic markers (GZMB, IFNG) were upregulated with TB511 and combination therapy. No significant off-target effects were observed in the spleen, liver, lung, or brain. In conclusion, combination therapy with TB511 and ADC effectively suppresses pancreatic tumor growth and reprograms the immune microenvironment by decreasing M2 macrophages and enhancing cytotoxic T and NK cell responses, offering a promising strategy for pancreatic cancer treatment.Citation Format:Ik-Hwan Han, Ilseob Choi, Soyoung Kim, Juwon Yang, Heekyung Lee, Geumseong Yun, Hyunju Lee, Hyunsu Bae. 4775: Combination therapy with TB511 and anti-nectin-4 antibody drug conjugate in a human pancreatic cancer mouse model [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4775.

01 Apr 2025·Journal for ImmunoTherapy of Cancer

Conformation-sensitive targeting of CD18 depletes M2-like tumor-associated macrophages resulting in inhibition of solid tumor progression

Article

Author: Yang, Juwon ; Choi, Hyojung ; Kang, Seong Ho ; Hwang, Deok-Sang ; Choi, Jeongyoon ; Go, Hyemin ; Choi, Hongseo ; Kim, Soyoung ; Chae, Songah ; Shin, Jin Sun ; Jeong, Chanmi ; Bae, Hyunsu ; Yeom, Hye Duck ; Pak, Sehyun ; Choi, Ilseob ; Han, Ik-Hwan ; Cao, Yingying ; Park, Namgyeong ; Ko, Eunbin ; Lee, Eun-Ji ; Lee, Won-Jun ; Lee, Junho H ; Lee, Heekyung ; Chung, Hwan-Suck ; Cha, Nari ; Kim, Hongsung ; Lim, Se Eun ; Kwon, Minjin

BackgroundTumor-associated macrophages (TAMs) primarily exist in the M2-like phenotype in the tumor microenvironment (TME). M2-TAMs contribute to tumor progression by establishing an immunosuppressive environment. However, TAM targeting is hindered, mainly owing to a lack of specific biomarkers for M2-TAMs. Previously, we demonstrated that a novel peptide drug conjugate (TB511) consisting of a TAM-binding peptide and the apoptosis-promoting peptide targets M2-TAMs. This was achieved through M2-TAM targeting, although the target mechanism of action remained elusive. Herein, we elucidate the anticancer efficacy of TB511 by identifying new target proteins that preferentially bind to M2-TAMs and clarifying the apoptosis-inducing mechanism in these cells.MethodsWe investigated the target proteins and binding site of TB511 using LC-MS/MS analyses, surface plasmon resonance and peptide–protein interaction 3D modeling. Activated CD18 expression in M2 TAMs was assessed using Quantibrite PE beads in PBMCs. The anticancer efficacy of TB511 was tested using colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) mouse model. The immunotherapeutic effect of TB511 was investigated through spatial transcriptomics in human pancreatic ductal adenocarcinoma (PDAC) model.ResultsActivated CD18 was highly expressed in human tumor tissues and was significantly higher in M2 TAMs than in other immune cells. TB511 showed high binding affinity to CD18 among the cell membrane proteins of M2 macrophages and appeared to bind to the cysteine-rich domain in the activated form. Moreover, TB511 specifically induced apoptosis in M2 TAMs, but its targeting ability to M2 macrophages was inhibited in CD18 blockade or knockout model. In mouse or humanized mouse models of solid tumors such as CRC, NSCLC, and PDAC, TB511 suppressed tumor growth by targeting M2-TAMs via CD18 and enhancing the presence of CD8+T cells in the TME.ConclusionsCollectively, our findings suggest that activated CD18 holds promise as a novel target protein for cancer therapy, and TB511 shows potential as a therapeutic agent for tumor treatment.

22 Mar 2024·Cancer Research

Abstract 2901: The apoptotic peptide TB511 targets activated CD18 and suppresses solid tumor progression

Author: Han, Ik-Hwan ; Kim, Jinho ; Kim, Soyoung ; Kim, Hye Yeon ; Lee, Heekyung ; Choi, Hongseo ; Bae, Hyunsu ; Shin, Jin Sun ; Park, Daehwan ; Moon, Jihwan ; Choi, Jeongyoon ; Yang, Juwon ; Choi, Ilsoeb

AbstractTumor-associated macrophages (TAMs) primarily exist in the M2-like phenotype in the tumor microenvironment (TME). M2-TAMs contribute to tumor progression by establishing an immunosuppressive environment. However, TAM targeting is hindered, mainly owing to a lack of specific biomarkers for M2-TAMs. Herein, we verified that TB511, a fusion peptide comprising a TAM-targeting peptide and the pro-apoptotic peptide dKLA, could preferentially bind to active CD18 in M2-TAMs, inducing apoptosis; it was less toxic to other tissue-resident macrophage lineages. TB511 suppressed tumor progression in various cancer models and humanized mouse models. Removal of M2-TAMs by TB511 significantly increased the infiltration of tumor-killing cells, such as granzyme B-positive CD8+ T cells and natural killer cells, in the TME. Collectively, our findings suggest that targeting CD18 in M2-TAMs using peptide drugs is a potential strategy for immunotherapy in various tumors, including non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, and prostate cancer.Citation Format: Ilsoeb Choi, Ik-Hwan Han, Soyoung Kim, Juwon Yang, Hye Yeon Kim, Daehwan Park, Hongseo Choi, Jeongyoon Choi, Heekyung Lee, Jin Sun Shin, Jinho Kim, Jihwan Moon, Hyunsu Bae. The apoptotic peptide TB511 targets activated CD18 and suppresses solid tumor progression [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2901.

100 Deals associated with Twinpig Biolab, Inc.

100 Translational Medicine associated with Twinpig Biolab, Inc.

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Pipeline

Pipeline Snapshot as of 11 May 2025

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

Preclinical

Phase 2 Clinical

Current Projects

Drug(Targets)	Indications	Global Highest Phase

TB-511 ( CD18 )	Hepatocellular Carcinoma More	Phase 2 Clinical
TB-796 ( IGF-1 )	Sarcopenia More	Phase 2
TBR-323 ( CCR8 )	-	Preclinical
TB-592 (Twinpig Biolab) ( PGE2 )	Obesity, Abdominal More	Preclinical
TBR-621 ( ROR1 )	-	Preclinical

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