CK1

On July 31, 2020, the Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. The efficacy of tafasitamab-cxix with lenalidomide was evaluated in L-MIND (NCT02399085), an open label, multicenter single-arm trial in 81 patients. Patients received tafasitamab-cxix 12 mg/kg intravenously with lenalidomide (25 mg orally on days 1 to 21 of each 28-day cycle) for maximum of 12 cycles, followed by tafasitamab-cxix as monotherapy. Efficacy was based on best overall response rate (ORR), defined as complete and partial responders and response duration, as assessed by an independent review committee. The best ORR in 71 patients with a diagnosis of DLBCL confirmed by central pathology was 55% (95% CI: 43%, 67%), with complete responses in 37% and partial responses in 18% of patients. Median response duration was 21.7 months (range: 0, 24). The most common adverse reactions (≥20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. The recommended tafasitamab-cxix dose is 12 mg/kg as an intravenous infusion. View full prescribing information for MONJUVI. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application one month ahead of the FDA goal date. This application was granted priority review, fast track, breakthrough, and orphan product designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. For information on the COVID-19 pandemic, see the following resources: FDA: Coronavirus Disease 2019 (COVID-19) NCI: Coronavirus: What People With Cancer Should Know CDC: Coronavirus (COVID-19) Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer. Content current as of: 08/03/2020 Regulated Product(s) Drugs Prescription Drugs 08/03/2020 Drugs Prescription Drugs Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description

HEFEI, China, June 5, 2024 /PRNewswire/ -- Kangpu Biopharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has recently approved a Phase II/III clinical trial of KPG-121 in combination with Abiraterone for a first-line treatment of metastatic castration resistant prostate cancer (mCRPC). Discovered by Kangpu Biopharmaceuticals, KPG-121 is a modulator of the Cereblon (CRBN) E3 ubiquitin ligase complex CRL4CRBN targeting rapid ubiquitination and degradation of casein kinase 1α (CK1α) and transcription factors Aiolos (IKZF3) and Ikaros (IKZF1). KPG-121 promotes anti-proliferation and anti-angiogenesis activities and enhances immunomodulatory properties. KPG-121 significantly improves anti-tumor efficacies when combined with androgen-receptor antagonists including enzalutamide, abiraterone acetate, apalutamide, or darolutamide in xenograft models when compared to the androgen-receptor antagonist therapy alone. A Phase I study to evaluate the safety, pharmacokinetics, and efficacy of KPG-121 when combined with enzalutamide, abiraterone, or apalutamide for the treatment of patients with metastatic or non-metastatic castration-resistant prostate cancer was completed in the US (NCT03569280). KPG-121 was generally well tolerated and demonstrated a favorable pharmacokinetic profile as well as promising efficacy. About Kangpu Biopharmaceuticals Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative small molecules for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein ubiquitination and degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES®, gDACs®, and X-SYNERGY®. For more information, please visit . Contact: Florence Liu [email protected] SOURCE Kangpu Biopharmaceuticals

BROOKLINE, Mass.--(BUSINESS WIRE)-- Edgewood Oncology, a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically-defined solid tumors, today announced that the first two patients with metastatic breast cancer were treated with BTX-A51, a multi-specific kinase inhibitor of casein kinase 1 alpha (CK1α) and cyclin-dependent kinases 7 and 9 (CDK7 and CDK9), that synergistically targets master regulators of cancer. BTX-A51 is being evaluated in a Phase 2a study for the treatment of estrogen receptor positive / human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer with and without GATA binding protein 3 (GATA3) mutations. GATA3 is a protein that helps maintain healthy breast cells and mutations in this protein, which are found in approximately 15% of breast cancer cases, are associated with shorter progression free (PFS) and overall survival (OS). Moreover, these mutations are almost always accompanied by a wild type (non-mutated) p53 tumor suppressor protein. Recent studies have shown that targeting MDM2, a molecule that degrades the p53 protein, could be particularly effective in treating cancers with these GATA3 mutations. Due to its ability to reduce MDM2 expression, Edgewood Oncology is testing the hypothesis that BTX-A51 may be beneficial in this breast cancer sub-population. “This represents an important milestone for both Edgewood Oncology and for patients with ER+/HER2- breast cancer, particularly those with a GATA3 mutation, who need better treatment options targeted to their underlying mutation profile,” said Zung L. Thai, M.D., Ph.D., chief medical officer of Edgewood Oncology. “Moreover, while CDK4/6 inhibitors remain a cornerstone of current treatment regimens, resistance to these therapies poses a formidable challenge. By targeting CDK7 and CDK9, key regulators of cell cycle progression, BTX-A51 not only aims to circumvent this resistance but also to transform the treatment landscape.” The ongoing Phase 2a trial of BTX-A51 is a multicenter, open-label, nonrandomized, multiple dose study evaluating the safety, toxicity, pharmacokinetics and preliminary efficacy of BTX-A51 in patients with ER+/HER2- metastatic breast cancer with and without GATA3 mutations. Multiple sites for the clinical study are open for enrollment. For more information, visit clinicaltrials.gov (NCT04872166). About Edgewood Oncology Edgewood Oncology is a clinical-stage biotechnology company that was founded to deliver on the promise of BTX-A51 for patients with hematologic malignancies and genetically-defined solid tumors. BTX-A51 is an investigational, first-in-class, small molecule, multi-selective kinase inhibitor of CK1α, CDK7 and CDK9 that synergistically co-targets master regulators of cancer to activate programmed cell death, or apoptosis. BTX-A51 holds promise in acute myeloid leukemia and genetically-defined solid tumors, which are the focus of ongoing clinical programs. For more information, please visit , and follow us on LinkedIn.