SAL008 / Shenzhen Salubris - LARVOL DELTA

Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=263 | Active, not recruiting | Sponsor: Salubris Biotherapeutics Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Monotherapy • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Adenocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Endocrine Cancer • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Papillary Renal Cell Carcinoma • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • Thyroid Gland Papillary Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer • BRAF • HER-2

Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=263 | Recruiting | Sponsor: Salubris Biotherapeutics Inc | N=149 ➔ 263

Enrollment change • Metastases • Monotherapy • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Adenocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Endocrine Cancer • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • Thyroid Gland Papillary Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer • BRAF • HER-2

Salubris Biotherapeutics Announces $35 Million in Financing and Provides Pipeline Progress Update (Businesswire) - "Salubris Biotherapeutics, Inc...announced a new capital infusion of $35 million to fund continued research and development of clinical and pre-clinical programs....The ongoing Phase 1b/2, open label, dose escalation and cohort expansion study (NCT05620134) is designed to evaluate the safety and preliminary anti-tumor activity of JK08 in patients with unresectable locally, advanced or metastatic cancer....SalubrisBio plans to report additional data from this study in the second half of 2024. JK06 is positioned to be the first biparatopic ADC targeting a known tumor antigen for which no approved therapies currently exist. Given limited expression and internalization, this antigen is ideally suited for the biparatopic design intended to overcome both limitations, and JK06 has demonstrated low picomolar affinity and robust internalization of the target."

Financing • P1/2 data • Preclinical • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Gastric Adenocarcinoma • Hepatocellular Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Xinlitai (002294.SZ): The current phase I clinical trial of JK08 is progressing smoothly and there is a chance to enter the phase II clinical trial next year. [Google translation] (163.com) - "Xinlitai...held an investor relations event on November 15, 2023. Regarding 'JK08 has been in operation for a year, what is the overall effect of the first phase of data? What is the company's opinion? ? When can it enter the second phase?', the company replied that JK08 is currently progressing smoothly in the first phase of clinical trials and has the opportunity to enter the second phase of clinical trials next year. The final announcement will be subject to the company's announcement."

Trial status • Oncology • Solid Tumor

A phase 1/2 study of JK08, an IL-15 antibody fusion protein targeting CTLA-4, in patients with advanced solid tumors (SITC 2023) - "Response will be assessed every 9 weeks per RECIST v1. 1."

Clinical • IO biomarker • Metastases • P1/2 data • Oncology • Solid Tumor • CD8 • IL15

Phase I/II Study of JK08, an IL-15 antibody fusion protein targeting CTLA-4, with unresectable locally advanced or metastatic cancer (ESMO 2023) - "Conclusions At the dose levels evaluated to date, JK08 has been well tolerated, demonstrating preliminary disease stability & anticipated modulation of target immune cell populations in aggressive heavily pre-treated solid tumors. These results provide an initial characterization of JK08 biology & activity."

IO biomarker • Metastases • P1/2 data • Oncology • Solid Tumor • CD8 • IL15

Salubris Biotherapeutics Presents Positive Initial Data from Phase 1b/2 Clinical Trial of JK08 at the European Society for Medical Oncology Annual Congress 2023 (Businesswire) - P1b/2 | N=149 | NCT05620134 | Sponsor: Salubris Biotherapeutics Inc | "Salubris Biotherapeutics...announced that positive initial data from the first-in-human study evaluating JK08 in adults with solid tumors were presented in a poster session during the European Society of Medical Oncology Annual Congress 2023. The presentation included safety data from 32 patients with relapsed or refractory solid tumors who received subcutaneous JK08 monotherapy once weekly in this Phase 1b/2 dose escalation study. At the dose levels evaluated to date, JK08 has been well tolerated, demonstrating preliminary disease stability and anticipated modulation of target immune cell populations in heavily pre-treated patients."

P1/2 data • Solid Tumor

A phase 1 / 2 study of JK08, an IL-15 antibody fusion protein targeting CTLA-4, in patients with advanced solid tumors (AACR 2023) - "Four tumor specific expansion cohorts will be initiated once dose and schedule are established from dose escalation and include melanoma, breast cancer, colorectal cancer, and a basket of advanced solid tumors. Response will be assessed every 9 weeks per RECIST v1.1."

Clinical • IO biomarker • Metastases • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • CD8 • IL15

Salubris Biotherapeutics Announces $35 Million Financing to Advance Development Activities and Provides Pipeline Updates (Businesswire) - "Salubris Biotherapeutics, Inc...announced it received $35 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment will be used to advance and accelerate lead candidate JK07, including the planned initiation of the first Phase 2 study in HFrEF, the continuation of the ongoing Phase 1b clinical trial in heart failure with preserved ejection fraction (HFpEF), and the launch of the Company’s first neurology clinical trial with JK07. The financing will also support the ongoing Phase 1/2 trial of JK08 in solid tumors and advance JK06, a pre-clinical biparatopic antibody-drug conjugate, into an initial Phase 1/2 study."

Financing • New P1/2 trial • Trial status • Breast Cancer • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Heart Failure • Melanoma • Oncology • Solid Tumor

Salubris Biotherapeutics Announces $35 Million Financing to Advance Development Activities and Provides Pipeline Updates (Businesswire) - "We look forward to multiple additional milestones across our pipeline in the year ahead, including interim data readouts from JK07 in HFpEF and JK08 in solid tumors, and initiation of an initial clinical trial evaluating JK07 in neurodegenerative disease."

New trial • P1 data • P1/2 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Heart Failure • Melanoma • Oncology • Solid Tumor

A Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=149 | Recruiting | Sponsor: Salubris Biotherapeutics Inc

New P1/2 trial • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • Thyroid Gland Papillary Carcinoma • Triple Negative Breast Cancer • BRAF • HER-2