conpelisib (CVL237) / Karus Therap, Convalife - LARVOL DELTA

Results of a First in Human, Dose Ascending, Phase I Study Examining the Safety and Tolerability of KA2237, an Oral PI3K p110β/δ Inhibitor in Patients with Relapsed/Refractory (R/R) B-Cell Lymphoma (ASH 2019) - P1; " Pts ≥ 18 years (yrs) of age, ECOG ≤ 2, with B-cell lymphoma R/R or intolerant of established therapies (including rituximab) were enrolled using a 3+3 dose escalation (50-400mg) design. KA2237 is an oral, once a day, selective dual inhibitor of PI3K β/δ with a manageable toxicity profile and promising single-agent clinical activity in heavily pretreated R/R B-cell lymphoma. The recommended phase II dose is 200mg daily. The findings of this study support the further evaluation of KA2237."

Clinical • P1 data • PTEN

Preclinical and phase I studies of KA2237, a selective and potent inhibitor of PI3K β/δ in relapsed refractory B cell lymphoma. (PubMed, Leuk Lymphoma) - P1 | "Thirty-three percent discontinued treatment due to adverse events. KA2237 induced objective responses in indolent and aggressive lymphoma (overall response rate 37%; complete response n = 4, partial response n = 3)."

Journal • P1 data • Preclinical • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Small Lymphocytic Lymphoma

Targeting phosphatidylinositol 3 kinase-β and -δ for Bruton tyrosine kinase resistance in diffuse large B-cell lymphoma. (PubMed, Blood Adv) - "In addition, combining KA2237 with currently available chemotherapeutic agents synergistically inhibited metabolic growth. This study elucidates the compensatory upregulated PI3K/AKT axis that emerges in ibrutinib-resistant cells."

Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BTK

Karus Therapeutics to announce positive new data from phase I relapsed/refractory B-cell lymphoma trial at ASH (Businesswire) - “Karus Therapeutics Ltd…announces that new data will be presented from its KA2237 Phase I study at the ASH Annual Meeting & Exposition in Orlando, Florida, 9 December 2019. The Phase I clinical trial, conducted at The University of Texas MD Anderson Cancer Center, has examined the safety, tolerability, pharmacokinetic properties and pharmacodynamic effects of KA2237 in patients with relapsed/refractory B-cell lymphoma.”

P1 data

The Safety, Pharmacokinetic and Pharmacodynamic Effect of KA2237 (PI3 Kinase p110β/δ Inhibitor) In B Cell Lymphoma (clinicaltrials.gov) - P1; N=23; Completed; Sponsor: Karus Therapeutics Limited; Recruiting ➔ Completed; N=53 ➔ 23; Trial completion date: May 2019 ➔ Dec 2018

Clinical • Enrollment change • Trial completion • Trial completion date