Delving into the Latest Updates on Novatim Immune Therapeutics (Zhejiang) Co., Ltd. with Synapse

Overview

Tags

Neoplasms

Hemic and Lymphatic Diseases

Immune System Diseases

Antibody drug conjugate (ADC)

Autologous CAR-T

Biological products

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	10
Hemic and Lymphatic Diseases	4
Immune System Diseases	2
Nervous System Diseases	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Autologous CAR-T	3
Antibody drug conjugate (ADC)	3
Biological products	1
Bispecific antibody	1
Fusion protein	1

Top 5 Target	Count

IL-2R x PD-1	1
TM4SF1(transmembrane 4 L six family member 1)	1
EGFR x c-Met	1
c-Met(Hepatocyte growth factor receptor)	1
BCMA x CD19	1

This trial is a first-in-human, multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KY-0301 as monotherapy in patients with advanced solid tumors. This trial will be conducted at approximately multi-sites nationwide, and approximately110
212 participants with unresectable locally advanced or metastatic solid tumors will be invited to participate. The study consists of three parts: Phase I dose escalation & dose expansion phases of KY-0301 as monotherapy, Phase II cohort expansion phase of KY-0301 as monotherapy.

Start Date01 May 2025

Sponsor / Collaborator

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

CTR20242409

/ RecruitingPhase 1

评价 KQ-2003 CAR-T 细胞注射液在 POEMS 综合征患者中的安全性、耐受性、初步有效性和药代动力学特征的I 期临床试验

[Translation] A Phase I clinical trial to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic characteristics of KQ-2003 CAR-T cell injection in patients with POEMS syndrome

主要目的：（1）评价 KQ-2003 CAR-T 细胞在 POEMS 综合征患者的剂量限制性毒性（DLT），确定其最大耐受剂量（MTD）或最佳剂量。次要目的：（1）评价 KQ-2003 CAR-T 细胞在 POEMS 综合征患者的初步有效性；（2）评估 KQ-2003 CAR-T 细胞在 POEMS 综合征患者体内的药代动力学（PK）；（3）评估 KQ-2003 CAR-T 细胞在 POEMS 综合征患者体内的药效动力学（PD）特征；（4）评估 KQ-2003 CAR-T 细胞在 POEMS 综合征患者体内的免疫原性。

[Translation]

Primary objectives: (1) To evaluate the dose-limiting toxicity (DLT) of KQ-2003 CAR-T cells in patients with POEMS syndrome and determine its maximum tolerated dose (MTD) or optimal dose. Secondary objectives: (1) To evaluate the preliminary efficacy of KQ-2003 CAR-T cells in patients with POEMS syndrome; (2) To evaluate the pharmacokinetics (PK) of KQ-2003 CAR-T cells in patients with POEMS syndrome; (3) To evaluate the pharmacodynamic (PD) characteristics of KQ-2003 CAR-T cells in patients with POEMS syndrome; (4) To evaluate the immunogenicity of KQ-2003 CAR-T cells in patients with POEMS syndrome.

Start Date11 Oct 2024

Sponsor / Collaborator

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

NCT06518876

/ Not yet recruitingPhase 1

A Phase 1 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Characterization of KQ-2003 for Patients With Relapsed/Refractory POEMS Syndrome

This is a multicenter, open-label, dose-escalation/expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and determine the recommended dose of KQ-2003 CAR T-cells for patients with Relapsed/Refractory POEMS Syndrome

Start Date31 Aug 2024

Sponsor / Collaborator

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

100 Clinical Results associated with Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

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0 Patents (Medical) associated with Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

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100 Deals associated with Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

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100 Translational Medicine associated with Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 26 Jun 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

Discovery

2

3

Preclinical

IND Application

1

2

Phase 1

Phase 2

2

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

KY-0301 ( EGFR x c-Met )	Advanced Malignant Solid Neoplasm More	Phase 1/2
KQ-2003 ( BCMA x CD19 )	Refractory Multiple Myeloma More	Phase 1/2
KY-0118 ( IL-2R x PD-1 )	Locally Advanced Malignant Solid Neoplasm More	Phase 1
KQ-2002 ( CD19 x CD22 )	B-cell lymphoma recurrent More	Phase 1
KQ-L6 ( TM4SF1 )	Solid tumor More	IND Application