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Overview

Tags

Neoplasms

Urogenital Diseases

Skin and Musculoskeletal Diseases

Antibody drug conjugate (ADC)

Small molecule drug

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	6
Hemic and Lymphatic Diseases	2
Endocrinology and Metabolic Disease	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Antibody drug conjugate (ADC)	5
Small molecule drug	4

Top 5 Target	Count

DNMT1(DNA (cytosine-5)-methyltransferase 1)	2
11β-HSD1(Corticosteroid 11-beta-dehydrogenase isozyme 1)	2
HER2(Receptor tyrosine-protein kinase erbB-2)	1
EGFR(Epidermal growth factor receptor erbB1)	1
Trop-2(Tumor-associated calcium signal transducer 2)	1

A Phase 1/2, Open-label, Dose-exploration and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NTX-301 Monotherapy in Advanced Solid Tumours, and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer, and in Combination With Temozolomide as Adjuvant (Maintenance) Therapy in High-grade Glioma (Optional Arm)

This is a Phase 1/2, open-label, dose-exploration, combination/expansion study, which will start by evaluating the safety and tolerability of NTX-301, an oral DNMT1 inhibitor, as a monotherapy in patients with advanced solid tumours, who have failed treatment with available therapies known to be active for treatment of their corresponding disease. It will then explore the safety and tolerability of NTX-301 in combination with platinum-based therapy in patients with ovarian and bladder cancer. Optionally, the safety and tolerability of NTX-301 in combination with Temozolomide (TMZ) in patients with Isocitrate Dehydrogenase 1 (IDH1) mutated high-grade glioma will also be assessed.

Start Date25 Aug 2021

Sponsor / Collaborator

Xennials Therapeutics, Inc.

[+1]

NCT05041543 / CompletedPhase 1

A Randomized, Double-blinded, Placebo-controlled, Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of NTX-101 in Healthy Volunteers

A double-blinded, placebo controlled, multiple dose, randomized, single site, phase 1 clinical trial to evaluate safety, tolerability, and pharmacokinetics of NTX-101 topical eye drop in Korean healthy volunteers

Start Date02 Mar 2021

Sponsor / Collaborator

Pinotbio, Inc.

100 Clinical Results associated with Pinotbio, Inc.

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0 Patents (Medical) associated with Pinotbio, Inc.

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1

Literatures (Medical) associated with Pinotbio, Inc.

22 Mar 2024·Cancer Research

Abstract 1812: Development of novel topoisomerase 1 inhibitor PBX-7 payload-based ADC including tandem cleavable linker system

Author: Park, Suhyun ; Kweon, Sohui ; Jung, Doo Young ; Cho, Hyun Yong ; Lee, Byeong Sung ; Chun, Younghwa ; Shin, Seunggun ; Han, Hyemin ; Go, Areum ; Lee, JaeHyeon

AbstractAntibody-Drug Conjugates (ADC) employing camptothecin-based payloads are gaining high interests as a new modality to treat various cancers, especially solid tumors. Among them, novel ADCs containing synthetic camptothecin-based payloads specially optimized for ADC applications (e.g., DXd) are of special interest due to their successful clinical results. Despite the remarkable success of ADCs exploiting these payloads, such as Enhertu (DS-8201a), there are still clear unmet needs, including the improvement of safety profile (minimization of ILD and neutropenia) and the development of novel ADCs with multiple MoA payloads to combat cancer heterogeneity.To address these unmet needs, we have synthesized and evaluated a series of PBX-7 payloads, derived from novel camptothecin FL118, a potent, dual inhibitor of Top 1/anti-apoptotic pathway known for its favorable safety profile. These compounds showed strong in vitro cytotoxicity across various cancer cell lines and inhibition of Top 1 comparable to DXd or other related camptothecin compounds. They had excellent safety profile in the preliminary toxicity study in mice that can be attributed to their physicochemical properties.PBX-7 series payloads-based ADC exhibited superior cellular cytotoxicity and in vivo tumor regression compared to Enhertu in Her2-positive cell line and CDX mouse model. Notably, PBX-7 payload-based ADC demonstrated remarkable efficacy in reducing tumor volume more than Enhertu in the T-DM1-resistant JIMT-1 xenograft mouse model. Furthermore, PBX-7 payload-based ADC have bystander effects similar to Enhertu, leading to reduced viability of antigen-negative cells when co-cultured with antigen-positive cell lines. In NHP toxicity study in Cynomolgus monkeys, no sign of toxicity was observed when dosed with anti-Her2 PBX-7 payload-based ADC up to 30mg/kg.As another way of addressing unmet needs, we synthesized novel linker including tandem cleavage site to reduce payload mediated toxicity. Two distinct enzyme, beta-glucuronidase and cathepsin B cleave linker sequentially. This linker system has a higher stability during circulation in the body and higher specific payload release in the tumor tissue than single cleavable linker.In conclusion, our research shows the promising potential of novel camptothecin PBX-7 payload-based ADCs and tandem cleavable linker system as potent and safe ADC candidates for cancer therapy. These advancements hold great promise in addressing the current challenges in ADC development with their enhanced safety profiles and targeted efficacy.Citation Format: Younghwa Chun, Hyun Yong Cho, Byeong Sung Lee, Areum Go, Seunggun Shin, JaeHyeon Lee, Sohui Kweon, Hyemin Han, Suhyun Park, Doo Young Jung. Development of novel topoisomerase 1 inhibitor PBX-7 payload-based ADC including tandem cleavable linker system [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 1812.

100 Deals associated with Pinotbio, Inc.

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100 Translational Medicine associated with Pinotbio, Inc.

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Pipeline

Pipeline Snapshot as of 18 Nov 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

Preclinical

7

2

Phase 2 Clinical

Other

2

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

NTX-301 ( DNMT1 )	Bladder Cancer More	Phase 2 Clinical
NTX-101 ( 11β-HSD1 )	Glaucoma More	Phase 2
PBX-002	Triple Negative Breast Cancer More	Preclinical
PBX-CT01	-	Preclinical
PBX-003 ( EGFR )	Lung Cancer More	Preclinical