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

Overview

Tags

Neoplasms

Hemic and Lymphatic Diseases

Other Diseases

Autologous CAR-T

Bispecific antibody

Fusion protein

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
Endocrinology and Metabolic Disease	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Autologous CAR-T	3
Fusion protein	2
Bispecific antibody	2
Antibody drug conjugate (ADC)	2
Biological products	1

Top 5 Target	Count

TM4SF1(transmembrane 4 L six family member 1)	1
IL-2 x PD-1	1
IL-2R x PD-1	1
BCMA x CD19	1
EGFR(Epidermal growth factor receptor erbB1)	1

e14505 Background: KY-0118 is an anti-PD1 and IL-2v(variant) fusion protein for advanced solid tumors. The non-α biased design reduces the binding to IL2-Raβγ and enhanced binding to PD-1 & IL2-Rβγ positive TILs to drive increased proliferation and activation of NK and CD8+ T cells without unwanted expansion of Tregs. KY-0118 adopts specific single design, only 67kDa MW thus obtains excellent tumor penetration activity. The preclinical data shows higher antitumor activity in several CDX models compared with nivolumab and IL2wt. KY-0118 monotherapy is currently in Phase I escalation. Methods: The phase I dose escalation is a traditional 3+3 design, KY-0118 on Days 1, 8 and 15, 21-day treatment cycle, 9 dose levels (0.3μg/kg-64μg/kg) or higher doses of 3 to 6 patients are planned. The dose expansion cohort is currently enrolling. The primary endpoint was to evaluate the safety, tolerability, and determine the DLT, MTD, RP2D of KY 0118 when given alone. Secondary objectives are PK/PD characteristics and preliminary evidence of efficacy via ORR per RECIST v1.1 and iRECIST. Results: Up to Jan 31, 2024, 21 patients have been treated, the median number of prior lines of systemic therapy was 2. The dose level 8 (48µg/kg) of DLT observation period is ongoing, no DLT was observed in the administered dose groups. Most of TEAEs are transient grade 1-2, no TEAE led to withdrawal from this study. The most common nonhematologic TRAEs were pyrexia, flu-like symptoms, nausea, fatigue. 2 patients had grade 3 hematologic toxicity. Treatment-related sAEs were observed in one patient (include nausea, vomiting, and pulmonary embolism, now recovered and continuing treatment). No patients experienced complete or partial response, but several showed evidence of antitumor activity, at the dose of 36 ug/kg, 21% shrinkage of target lesions in a patient with RCC, the DCR for the 12, 24, and 36μg/kg dose levels are 33%, 75%, and 67%, respectively. Conclusions: These preliminary data suggest that KY-0118 demonstrated a manageable safety profile and encouraging early evidence of activity has been observed in locally advanced and/or metastatic solid tumors. Enrollment is ongoing, further results are forthcoming. Pts: 21; AEs: 399; TEAEs: 289 (100%); AESI: 13; sAEs: 8. Clinical trial information: NCT06175780 .

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 07 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

Discovery

4

3

Preclinical

IND Application

1

2

Phase 1 Clinical

Phase 2 Clinical

1

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

KQ-2003 ( BCMA x CD19 )	Multiple Myeloma More	Phase 2 Clinical
KQ-2002 ( CD19 x CD22 )	B-cell lymphoma refractory More	Phase 1
KY-0118 ( IL-2R x PD-1 )	Non-Small Cell Lung Cancer More	Phase 1
KQ-L6 ( TM4SF1 )	Solid tumor More	IND Application
KY-0301 ( EGFR )	Solid tumor More	Preclinical