Delving into the Latest Updates on Shanghai Xianxiang Medical Technology Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Shanghai Xianshang Pharmaceutical Technology Co., Ltd. operates as a subsidiary under the larger umbrella of Xiansheng Pharmaceuticals. This entity was established in September 2022 and primarily concentrates on the development in areas such as oncology, neurology, autoimmune diseases, and anti-infective treatments.

Tags

Neoplasms

Immune System Diseases

Hemic and Lymphatic Diseases

Antibody drug conjugate (ADC)

Trispecific T-cell engager (TriTE)

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	4
Hemic and Lymphatic Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Antibody drug conjugate (ADC)	1
Small molecule drug	1
Fusion protein	1
Trispecific T-cell engager (TriTE)	1

Top 5 Target	Count

USP1(ubiquitin specific peptidase 1)	1
IL-15 x PDL1	1
BCMA x CD3 x GPRC5D	1
CDH6(cadherin 6)	1

This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.

Start Date24 May 2024

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

[+1]

CTR20241358 / RecruitingPhase 1

评价人源化GPRC5D-BCMA-CD3 三特异性抗体 SIM0500在复发或难治性多发性骨髓瘤受试者中的安全性、耐受性、药代动力学和初步抗肿瘤活性的首次人体 (FIH) 、开放性I期研究

[Translation] A first-in-human (FIH), open-label Phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of the humanized GPRC5D-BCMA-CD3 trispecific antibody SIM0500 in subjects with relapsed or refractory multiple myeloma

主要目的： 1、第1部分 (剂量递增) ：评价SIM0500单药治疗的安全性和耐受性，并确定最大耐受剂量 (MTD) 和/或推荐剂量 (RD) 。 2、第2部分 (剂量优化) ：评价SIM0500在拟定RD下的安全性和初步抗肿瘤活性。

[Translation]

Main objectives: 1. Part 1 (dose escalation): Evaluate the safety and tolerability of SIM0500 monotherapy and determine the maximum tolerated dose (MTD) and/or recommended dose (RD). 2. Part 2 (dose optimization): Evaluate the safety and preliminary anti-tumor activity of SIM0500 at the proposed RD.

Start Date08 May 2024

Sponsor / Collaborator

Shanghai Xianxiang Medical Technology Co., Ltd.

NCT06331559 / RecruitingPhase 1

A Phase I First-in-human, Open-label Trial to Investigate the Safety, Pharmacokinetics and Antitumor Activity of SIM0501 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated.

Start Date19 Mar 2024

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Shanghai Xianxiang Medical Technology Co., Ltd.

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0 Patents (Medical) associated with Shanghai Xianxiang Medical Technology Co., Ltd.

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1

Literatures (Medical) associated with Shanghai Xianxiang Medical Technology Co., Ltd.

10 Jun 2024·Journal of Clinical Oncology

A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES).

Author: Wu, Lingying ; Li, Jundong ; Sun, Shuguang ; Lou, Ge ; Wang, Danbo ; Liu, Xiaowei ; Li, Qingshui ; Yang, Chen ; Yuan, Guangwen ; Zhang, Jiajing

LBA5516 Background: Suvemcitug is a new-generation recombinant humanized anti-VEGF rabbit monoclonal antibody. In the previous P1b study, Suvemcitug demonstrated its favorable safety profile and efficacy signals when combo with chemotherapy in platinum-resistant ovarian cancer (PROC). SCORES is the first randomized, double-blind, placebo-controlled phase III clinical trial to confirm the efficacy of Suvemcitug combo with chemo in PROC, whether or not previously received antiangiogenic agents or PARP inhibitors. Methods: Eligible patients had progressed during platinum-based therapy or within 6 months after ≥4 cycles of platinum-based therapy with at least one measurable lesion. After the investigators chose chemotherapy (CT) (weekly paclitaxel 80 mg/ m2 d1, 8, 15 & 22 q4w, pegylated liposomal doxorubicin 40 mg/m2 d1 q4w or topotecan 4 mg/m2 d1, 8 & 15 q4w), patients were randomly assigned (2:1) to either Suvemcitug (1.5 mg/kg q2w) or placebo combine with CT until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) by blinded independent review committee (BIRC) according to the RECIST 1.1. Key secondary end point is the overall survival (OS). Results: A total of 421 patients were enrolled between June 2021 and June 2023 in China. As the data cut off of the primary efficacy analysis (8 December 2023), 197 PFS events (70.1%) in Suvemcitug arm and 111 PFS events (79.3%) in placebo arm had occurred with the median follow-up of 14.36 and 14.26 months, respectively. The median PFS by BIRC was 5.49 months in Suvemcitug arm versus 2.73 months in placebo arm (hazard ratio[HR] 0.46, p<0.0001). OS data are immature. 42.7% and 50.7% of patients are deceased in Suvemcitug arm or placebo arm respectively, and there is a trend of OS benefit trend: median OS 16.07 months vs. 14.88 months, HR 0.79, p=0.1244. Efficacy results are summarized below. Treatment-emergent adverse events (TRAEs) occurred in all patients in Suvemcitug arm, with the most common being neutrophil count decreased, white blood cell count decreased and platelet count decreased. No Suvemcitug-related grade 5 TEAE occurred. Conclusions: To the best of our knowledge, this is the first double-blinded phase III study demonstrated promising antitumor activity of anti-angiogenic agent in patients with PROC. The improvement in PFS, ORR and DCR gained by adding Suvemcitug to single-agent CT was observed with no new safety concern. Clinical trial information: NCT04908787 . [Table: see text]

100 Deals associated with Shanghai Xianxiang Medical Technology Co., Ltd.

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100 Translational Medicine associated with Shanghai Xianxiang Medical Technology 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

IND Application

1

3

IND Approval

Phase 1 Clinical

3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

SIM-0501 ( USP1 )	Advanced Malignant Solid Neoplasm More	Phase 1
SIM-0500 ( BCMA x CD3 x GPRC5D )	Multiple Myeloma More	Phase 1
SIM-237 ( IL-15 x PDL1 )	Non-Muscle Invasive Bladder Neoplasms More	Phase 1
SIM-0508 ( POLQ )	Locally Advanced Malignant Solid Neoplasm More	IND Approval
SIM-0506 ( SOS1 )	KRAS mutation-related tumors More	IND Approval