SAIT101 (rituximab biosimilar) / Archigen Biotech - LARVOL DELTA

Samsung Biologics, AZ decide to end developing Rituximab biosimilar (Korea Biomedical Review) - "Samsung Biologics recently gave up developing SAIT101, a biosimilar of follicular lymphoma treatment Rituxan (ingredient: rituximab), which it had promoted as its first product since entering the bio business....According to the Samsung Biologics’ quarterly report released on Monday, the company and AstraZeneca, a U.K. pharmaceutical company, decided in September to suspend research and development activities by their joint venture, Archigen Biotech, and liquidate the latter."

Discontinued • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

RAMO-2: A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma (clinicaltrials.gov) - P3; N=315; Completed; Sponsor: Archigen Biotech Limited; Active, not recruiting ➔ Completed; Trial completion date: May 2020 ➔ Jan 2020

Clinical • Trial completion • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CTCs

Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (clinicaltrials.gov) - P2; N=28; Recruiting; Sponsor: University of Washington; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Biosimilar • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Samsung admits it failed to develop Rituxan biosimilar (Korea Biomedical Review) - "The Samsung Group has admitted that a Samsung-affiliated company failed to develop a Rituxan (ingredient: rituximab) biosimilar. It is unclear whether Archigen Biotech, a subsidiary of Samsung BioLogics, could continue the global clinical trial on the experimental drug."

Clinical

Samsung Biotech subsidiary 'Aquenze' continues to transfuse without new development this year [Google Translation] (CEO Score Daily) - "Archigen Biotech...subsidiary of Samsung Biologics...has continued to transfuse funds from its parent company without adding new pipelines this year....Only the triple phase of the Rituxan biosimilar SAIT101, the only pipeline, will continue....SAIT101 is now under global testing in more than 30 countries."

Clinical

RAMO-2: A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma (clinicaltrials.gov) - P3; N=315; Active, not recruiting; Sponsor: Archigen Biotech Limited; Recruiting ➔ Active, not recruiting; Trial completion date: May 2019 ➔ May 2020; Trial primary completion date: Feb 2019 ➔ Feb 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date