cybolise (SHC014748M) / Nanjing Sanhome Pharma - LARVOL DELTA

Mass balance, metabolic disposition, and pharmacokinetics of a novel selective inhibitor of PI3Kδ [C] SHC014748M in healthy Chinese subjects following oral administration. (PubMed, Cancer Chemother Pharmacol) - "SHC014748M was absorbed, metabolized and excreted with unchanged SHC014748M as its main circulating component in plasma following oral administration. In addition, it was speculated that fecal excretion was the principal excretion pathway; meanwhile, monohydroxy, glucuronide conjugation, oxygen, and hydrogenation were the major clearance pathways of SHC014748M through urine and/or feces."

Journal • PK/PD data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • PIK3CD

[VIRTUAL] A phase I study of SHC014748M capsules in patients with relapsed or refractory indolent B-cell malignancies (ESMO-IO 2020) - P1 | "Conclusions Oral administration of SHC014748M capsules in Patients with iNHL were highly effective and safe in Chinese patients. And the results of phase I study suggested patients with FL administered at 200mg should be explored in additional studies."

Clinical • P1 data • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom’s Macroglobulinaemia

Preliminary Results from a Phase I Study of SHC014748M in Patients with Relapsed or Refractory Indolent B-Cell Lymphomas (ASH 2019) - P1; "The average number of prior therapies was 2.2 (range 1-8), and 84 percent of patients had received rituximab before. SHC014748M was well tolerated and demonstrated promising clinical activity in patients with relapsed or refractory indolent B-cell lymphomas."

Clinical • P1 data • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia

Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma (clinicaltrials.gov) - P2; N=122; Recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

SHC014748M, a novel selective inhi-bitor of PI3Kδ, demonstrates promising preclinical antitumor activity in B cell lymphomas and chronic lymphocytic leukemia. (PubMed, Neoplasia) - "CCL4, CCL17, CCL22 and CXCL13 in patient serum decreased sharply after SHC014748M treatment. According to the results, SHC014748M appeared to be a novel promising compound in the treatment of B cell lymphomas and CLL."

Journal • Preclinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCL2 • CCL22 • CCL4 • CCL7 • CXCL13

A Study of SHC014748M in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (clinicaltrials.gov) - P2; N=130; Not yet recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma (clinicaltrials.gov) - P2; N=122; Not yet recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P2 trial • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Food-Effect Study of SHC014748M in Healthy Subjects (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P1 trial