STI-6129 / Sorrento - LARVOL DELTA

Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Trial completion date: Feb 2027 ➔ Feb 2028 | Trial primary completion date: Mar 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | N=36 ➔ 0 | Initiation date: Mar 2023 ➔ Sep 2023 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial initiation date • Trial withdrawal • Amyloidosis

Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1b/2a | N=72 | Active, not recruiting | Sponsor: Sorrento Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: M.D. Anderson Cancer Center | N=62 ➔ 0 | Trial completion date: Apr 2027 ➔ Feb 2023 | Initiation date: Feb 2023 ➔ Aug 2022 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Apr 2027 ➔ Feb 2023

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Trial withdrawal • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Amyloidosis • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Sorrento Therapeutics, Inc.

New P1 trial • Amyloidosis

Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis (clinicaltrials.gov) - P1b/2a | N=60 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Jun 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date • Amyloidosis

Study to Access Anti-CD38 Anibody Drug in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=34 | Not yet recruiting | Sponsor: Sorrento Therapeutics, Inc.

New P1 trial • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1b/2a | N=72 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Dec 2025 ➔ Jul 2026 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis (clinicaltrials.gov) - P1b/2a | N=60 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Phase classification: P1 ➔ P1b/2a

Phase classification • Amyloidosis

A Phase 1, Open-Label, Dose-Escalation Study of Safety And Efficacy of An Anti-CD38 Antibody Drug Conjugate (STI-6129) In Patients With Relapsed Or Refractory T-Acute Lymphoblastic Leukemia/Lymphoma (T-ALL) Or Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=62 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1b/2a | N=72 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Initiation date: May 2022 ➔ Sep 2022

Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1b/2a | N=72 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Phase classification: P1 ➔ P1b/2a

Phase classification • Hematological Malignancies • Multiple Myeloma • Oncology

Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Sorrento Therapeutics, Inc.

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Dec 2021 ➔ Aug 2024 | Trial primary completion date: Dec 2021 ➔ Jun 2024

Trial completion date • Trial primary completion date • Amyloidosis

A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients with Relapsed or Refractory Multiple Myeloma (ASH 2021) - "STI-6129 binds to different CD38 epitopes than daratumumab. While neurotoxicity or ocular toxicity were not observed with STI-6129 in animal models, including non-human primates, such event will be considered as adverse events of special interest (AESI) and comprehensive neurology and ocular (including slit lamp) examinations will be performed at baseline and study completion, and at any AESI. STI-6129 will be administered intravenously once in a 4-week cycle, with the intention being to treat patients until disease progression or unacceptable toxicity."

Clinical • IO biomarker • P1 data • Glaucoma • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Multiple Myeloma • Oncology • Ophthalmology • Pain • CASP3 • CASP7

Dr. Henry Ji, Sorrento Chairman and CEO, to Participate at the H.C. Wainwright 23rd Annual Global Investment Conference September 13-15, 2021 (GlobeNewswire) - “Sorrento Therapeutics...announced today that Dr. Henry Ji, Chairman and CEO, will participate in the H.C. Wainwright 23rd Global Investment Conference...The conference is being held virtually on September 13-15, 2021…Abivertinib: Phase 3 topline data in NSCLC available Q4 2021…IND for Phase 2 in Prostate Cancer to be filed Q4 2021. PD-L1 antibody: In Phase 3 for SCLC and NDA submission in China for recurrent or metastatic cervical cancer. CD38 ADC: In Phase 1 for Amyloidosis and Multiple Myeloma. CD38 DAR-T: In Phase 1 for Relapsed and Refractory Multiple Myeloma. CD47 antibody: In Phase 1 in solid tumors. SOFUSA: Lymphatic delivery of Enbrel in Phase 1b in refractory rheumatoid arthritis patients.”

Clinical data • IND • P3 data: top line • Cervical Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

Sorrento Announces First Patient Treated in Phase IB AL Amyloidosis Trial with STI-6129, an Anti-CD38 Antibody-Drug Conjugate (GlobeNewswire) - "Sorrento Therapeutics...today announced that the first patient has been treated in its Phase 1b Amyloid Light Chain (AL) Amyloidosis study of STI-6129...in patients with advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis with a primary objective to identify a Phase 2 dose for STI-6129 based on its safety, preliminary efficacy and pharmacokinetic profile."

Trial status • Amyloidosis • CNS Disorders

Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Amyloidosis

Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.; Trial completion date: Aug 2026 ➔ Dec 2021

Clinical • Trial completion date • Amyloidosis

[VIRTUAL] Preclinical development and characterization of STI-6129, an anti-CD38 antibody-drug conjugate, as a new therapeutic agent for multiple myeloma (AACR-II 2020) - "Daratumumab is the first anti-CD38 mAb drug approved by the FDA for use as single agent and in combination with standard therapies for MM. In cynomolgus monkey, the PK profiles of STI-6129 and STI-5171 were nearly identical, further confirming the stability of the ADC in monkey blood circulation.In summary, STI-6129 exhibits potent in vitro and in vivo anti-tumor activities in multiple CD38-positive hematological models. These results warrant further development of STI-6129, potentially as a better or alternative agent for treatment of multiple myeloma."

Late-breaking abstract • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • CD38

Anti-CD38-Duostatin 5.2 ADC for AL Amyloidosis (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P1 trial