cafelkibart (LM-108) / Sino Biopharm - LARVOL DELTA

Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=78 | Completed | Sponsor: LaNova Australia Pty Limited | Recruiting ➔ Completed | N=60 ➔ 78

Enrollment change • First-in-human • Trial completion • Solid Tumor

Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=392 | Active, not recruiting | Sponsor: LaNova Medicines Limited | Enrolling by invitation ➔ Active, not recruiting | Trial primary completion date: Jul 2025 ➔ Dec 2025

Enrollment closed • Trial primary completion date • Solid Tumor

NEW INDICATION OF LM-108 (“CCR8 MONOCLONAL ANTIBODY”) INCLUDED IN BREAKTHROUGH THERAPY DESIGNATION PROCESS (HKEXnews) - "The board of directors (the 'Board') of Sino Biopharmaceutical Limited...announces that LM-108, a 'CCR8 monoclonal antibody' jointly developed by the Group and LaNova Medicines Limited ('LaNova Medicines'), has been included in the Breakthrough Therapy Designation (BTD) process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China. The drug is intended for use in combination with toripalimab for the treatment of CCR8-positive advanced gastric/gastroesophageal junction (G/ GEJ) adenocarcinoma in patients who have failed first-line standard therapy. Previously, in February 2025, LM-108 was included in the BTD process by the CDE for the treatment of advanced solid tumors with microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) that have progressed following treatment with immune checkpoint inhibitors."

Breakthrough therapy • dMMR • MSI-H • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Microsatellite Instability • Solid Tumor

Efficacy and safety of cafelkibart (LM-108), an anti-CCR8 monoclonal antibody, in combination with anti-PD-1 therapy in patients with pancreatic cancer: Results from phase 1/2 studies. (ASCO 2025) - P1/2 | "Treatment regimens included LM-108 at doses of 3 mg/kg Q3W, 3 mg/kg Q2W, 10 mg/kg Q3W, or 10 mg/kg Q2W, in combination with pembrolizumab (400 mg Q6W) or toripalimab (240 mg Q3W)... LM-108 in combination with anti-PD-1 therapy demonstrated encouraging antitumor activity and a manageable safety profile in patients with pancreatic cancer who had progressed on or after prior systemic therapies. These findings support further investigation of LM-108 in combination with anti-PD-1 therapy as a potential treatment option for pancreatic cancer."

Clinical • Combination therapy • IO biomarker • P1/2 data • Anemia • Gastrointestinal Disorder • Oncology • Pancreatic Cancer • Solid Tumor • CCR8

Clinical Studies for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=134 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: LaNova Medicines Limited

IO biomarker • Mismatch repair • New P2 trial • Oncology • Solid Tumor

LaNova Medicines Announces…Completion of $42 Million Series C1 Financing (PRNewswire) - "LaNova has recently initiated its Series C2 financing round. Proceeds will be primarily used to advance the clinical development of the Company's pipeline, including lead candidates: LM-302 (anti-CLDN 18.2 ADC): ongoing Phase III registrational clinical trial in China for gastric cancers, making it one of the top three candidates globally in terms of development progress for this target; US Phase II trial expected to start in H2 2025; LM-108 (anti-CCR8 mAb): ongoing Phase II clinical trials in China for multiple solid tumors, making it one of the top three most advanced projects worldwide targeting CCR8; US Phase II trial expected to start in H2 2024; LM-299 (anti-PD-1/VEGF BsAb): Phase I clinical trial in China is currently enrolling patients for advanced solid tumors."

Financing • New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=392 | Enrolling by invitation | Sponsor: LaNova Medicines Limited | Recruiting ➔ Enrolling by invitation

Combination therapy • Enrollment status • Metastases • Oncology • Solid Tumor

Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: LaNova Australia Pty Limited | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Efficacy and safety of LM-108, an anti-CCR8 monoclonal antibody, in combination with an anti-PD-1 antibody in patients with gastric cancer: Results from phase 1/2 studies. (ASCO 2024) - P1/2 | "Patients received intravenous LM-108 at dose levels of 3 mg/kg Q2W, 6 mg/kg Q3W, or 10 mg/kg Q3W plus an anti-PD-1 antibody (intravenous pembrolizumab 200 mg Q3W or 400 mg Q6W or toripalimab 240 mg Q3W). LM-108 in combination with an anti-PD-1 antibody showed promising antitumor activity in patients with gastric cancer that was resistance to anti-PD-1 therapy. The combination therapy was well tolerated. These results support further evaluation of LM-108 in CCR8 positive gastric cancer."

Clinical • Combination therapy • IO biomarker • P1/2 data • Anemia • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Oncology • Solid Tumor • CCR8

Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: LaNova Medicines Limited | Trial completion date: Sep 2024 ➔ Dec 2023 | Trial primary completion date: Jul 2024 ➔ Nov 2023

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=24 | Terminated | Sponsor: LaNova Medicines Limited | N=54 ➔ 24 | Trial completion date: Dec 2023 ➔ Aug 2023 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2023 ➔ Aug 2023; Completed primary objective.

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=392 | Recruiting | Sponsor: LaNova Medicines Limited | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Solid Tumor

Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=392 | Not yet recruiting | Sponsor: LaNova Medicines Limited

Combination therapy • New P1/2 trial • Oncology • Solid Tumor

Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: LaNova Medicines Limited | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Solid Tumor

Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: LaNova Australia Pty Limited | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Solid Tumor

Effective depletion of tumor-infiltrating Tregs by a novel anti-CCR8 antibody (LM-108): Addressing resistance associated with immune checkpoint inhibitors (AACR 2022) - "To conclude, LM-108 is a novel Fc-optimized CCR8 antibody that selectively depletes tumor infiltrating Tregs thereby improving anti-tumor immune response either as monotherapy or combination therapy. Thus, LM-108 can be a promising therapeutic approach to overcome ICI resistance in cancer patients."

Checkpoint inhibition • IO biomarker • Breast Cancer • Oncology • Solid Tumor • CCR4 • CCR8 • CD8 • FOXP3

Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: LaNova Medicines Limited

Combination therapy • New P1/2 trial • Oncology • Solid Tumor