S95029 / Servier - LARVOL DELTA

11 Class 1 innovative drugs were approved for clinical trials in China for the first time! From Sanofi, Hengrui Medicine and other companies [Google translation] (Sina Corp) - "The Class 1 new drug S095029 applied by Servier has been approved for clinical trials and is intended to be developed to treat locally advanced unresectable or metastatic MSI-H/dMMR gastroesophageal junction cancer/gastric cancer...The lyophilized preparation of BM230, a Class 1 new drug applied by Biomins, has been approved for clinical trials and is intended to be developed to treat HER2-related solid tumors...Hengrui Medicine 's Class 1 new drug SHR-4375 injection has been approved for clinical trials and is intended to be developed to treat solid tumors....The Class 1 new drug SCG142 autologous T cell injection submitted by Xinghand Bio has been approved for clinical trials and is intended to be developed to treat HPV16 or HPV52-related malignancies."

New trial • Cervical Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Microsatellite Instability • Oral Cancer • Penile Cancer • Solid Tumor • Vulvar Cancer • HER-2

CL1-95029-001: S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: Institut de Recherches Internationales Servier | Trial completion date: Jan 2025 ➔ Jun 2025

Combination therapy • Metastases • Monotherapy • Trial completion date • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

A phase 1 multicenter study of the safety and efficacy of the NKG2A targeting antibody S095029 as single agent and in combination with anti-PD1 in patients with advanced malignancies (SITC 2024) - P1, P1/2 | "Sym021 is an anti-PD1 IgG1 antibody. S095029 is currently investigated in combination with anti-PD1 in patients with previously untreated advanced NSCLC with high PDL1 expression (NCT06162572), and in patients with MSI-H/dMMR advanced gastric/GEJ cancer (NCT06116136). Ethics Approval Written informed consent was provided by all the patients or their legal guardians before participation in the trial, and approval from the institutional review board or independent ethics committee was obtained at each trial site."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Metastases • P1 data • Gastric Cancer • Leiomyosarcoma • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • CXCL9 • HLA-E • IFNG • KLRC1 • KLRD1 • MSI • PD-L1 • TNFA

Keynote E70: A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers. (clinicaltrials.gov) - P1/2 | N=32 | Recruiting | Sponsor: Servier Bio-Innovation LLC | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: Institut de Recherches Internationales Servier | Trial completion date: Jul 2024 ➔ Jan 2025

Combination therapy • Metastases • Monotherapy • Trial completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=176 | Recruiting | Sponsor: Servier Bio-Innovation LLC | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: Institut de Recherches Internationales Servier | Trial completion date: Feb 2024 ➔ Jul 2024

Combination therapy • Metastases • Monotherapy • Trial completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: Institut de Recherches Internationales Servier | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

Keynote E70: A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers. (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: Servier Bio-Innovation LLC | Phase classification: P1b/2 ➔ P1/2

Combination therapy • Metastases • Phase classification • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Keynote E70: A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers. (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: Servier Bio-Innovation LLC

Combination therapy • Metastases • New P1/2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=176 | Not yet recruiting | Sponsor: Servier Bio-Innovation LLC

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov) - P1 | N=41 | Recruiting | Sponsor: Institut de Recherches Internationales Servier | Phase classification: P1a/1b ➔ P1

Combination therapy • Metastases • Monotherapy • Phase classification • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov) - P1a/1b | N=39 | Recruiting | Sponsor: Institut de Recherches Internationales Servier | N=129 ➔ 39 | Trial completion date: Jul 2025 ➔ Jan 2024 | Trial primary completion date: May 2023 ➔ Jan 2024

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

S095029: a novel clinical-stage Fc-silenced NKG2A-blocking antibody with best-in-class potential (AACR 2023) - P1a/1b | "Finally, S095029 combination with PD-1 blocking agents, with or without an additional ADCC mAb component, conferred superior anti-tumor activity compared to treatments without NKG2A blockade.Overall, our in vitro and in vivo data support the clinical development of S095029 in tumor settings with adequate HLA-E expression and suggest potential differentiating characteristics compared to other anti-NKG2A mAbs. S095029 is currently being evaluated in phase 1 dose escalation studies as a single agent or in combination with anti-PD-1 therapy (NCT05162755)."

Clinical • IO biomarker • Late-breaking abstract • Oncology • HLA-E • KLRC1