Milatuzumab

SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias

Retrieved on: 
Monday, June 28, 2021
Leukemia, NPM1, Cancer, Clinical medicine, Acute myeloid leukemia, Antibody-drug conjugates, Branches of biology, Milatuzumab

In preclinical models of MLLr acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit.

Key Points: 
  • In preclinical models of MLLr acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit.
  • SNDX-5613 is currently being evaluated in the Company's AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias.
  • SNDX-5613 was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with AML, and Fast Track designation for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged MLLr or NPM1 mutation.
  • MLLr leukemias, which are routinely diagnosed through currently available cytogenetic or molecular diagnostic techniques, occur in approximately 80% of infant acute leukemias and up to 10% of all acute leukemias.

Transcenta Announced the Results of the Phase I Clinical Study of PD-L1 Antibody MSB2311 with Advanced Solid Tumors and Hematological Malignancies

Retrieved on: 
Thursday, May 20, 2021
Tumors of the hematopoietic and lymphoid tissues, Oncology, Clinical medicine, Medicine, Cancer, Cancer treatments, Milatuzumab, Bone metastasis

In the dose escalation Phase, MSB2311 was given at dose levels of 3, 10, and 20mg/kg intravenously every 3 weeks.

Key Points: 
  • In the dose escalation Phase, MSB2311 was given at dose levels of 3, 10, and 20mg/kg intravenously every 3 weeks.
  • "Patients with metastatic solid tumors or selected lymphoma progressed on or after standard treatments were enrolled in this Phase I study.
  • This Phase I study showed promising preliminary efficacy and tolerability of MSB2311 in patients with advanced solid tumors and hematological malignancies.
  • Transcenta is developing a panel of nine antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders.

Sutro Biopharma to Participate in Upcoming Virtual Investor Conferences

Retrieved on: 
Friday, May 14, 2021
Cancer, Clinical medicine, Drugs, South San Francisco, California, Sutro Biopharma, Antineoplastic drugs, Hodgkin lymphoma, Multiple myeloma, Orphan drugs, Milatuzumab

STRO-001 is a CD74-targeting ADC currently being investigated in a Phase 1 clinical trial of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin lymphoma.

Key Points: 
  • STRO-001 is a CD74-targeting ADC currently being investigated in a Phase 1 clinical trial of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin lymphoma.
  • STRO-001 was granted Orphan Drug Designation by the FDA for multiple myeloma in October 2018.
  • STRO-002 is a folate receptor alpha (FolR)-targeting ADC, currently being investigated in a Phase 1 clinical trial of patients with ovarian and endometrial cancers.
  • The four product candidates above being evaluated in clinical trials resulted from Sutro's XpressCFand XpressCF+ technology platforms.

Oncopeptides presents new clinical and preclinical melflufen data at the upcoming European Hematology Association meeting

Retrieved on: 
Wednesday, May 12, 2021
Drugs, Orphan drugs, Medicine, Clinical medicine, Multiple myeloma, Melphalan flufenamide, Tumors of the hematopoietic and lymphoid tissues, Hematology, Blastic plasmacytoid dendritic cell neoplasm, Milatuzumab

The clinical data presentation contains interim results from the phase 2 BRIDGE study supporting the use of melflufen in relapsed refractory multiple myeloma patients with moderately impaired renal function.

Key Points: 
  • The clinical data presentation contains interim results from the phase 2 BRIDGE study supporting the use of melflufen in relapsed refractory multiple myeloma patients with moderately impaired renal function.
  • Two preclinical data presentations show the future potential of melflufen in treatments of other hematological diseases outside multiple myeloma.
  • "In addition, our strong proprietary PDC platform makes us uniquely positioned to become a major player in other hematological malignancies.
  • In 2021 the second compound from the PDC platform, OPD5, is expected to enter clinical development.\nOncopeptides has approximately 300 coworkers.

Oncopeptides presents new clinical and preclinical melflufen data at the upcoming European Hematology Association meeting

Retrieved on: 
Wednesday, May 12, 2021
Drugs, Orphan drugs, Medicine, Clinical medicine, Multiple myeloma, Melphalan flufenamide, Tumors of the hematopoietic and lymphoid tissues, Hematology, Blastic plasmacytoid dendritic cell neoplasm, Milatuzumab

The clinical data presentation contains interim results from the phase 2 BRIDGE study supporting the use of melflufen in relapsed refractory multiple myeloma patients with moderately impaired renal function.

Key Points: 
  • The clinical data presentation contains interim results from the phase 2 BRIDGE study supporting the use of melflufen in relapsed refractory multiple myeloma patients with moderately impaired renal function.
  • Two preclinical data presentations show the future potential of melflufen in treatments of other hematological diseases outside multiple myeloma.
  • "In addition, our strong proprietary PDC platform makes us uniquely positioned to become a major player in other hematological malignancies.
  • In 2021 the second compound from the PDC platform, OPD5, is expected to enter clinical development.\nOncopeptides has approximately 300 coworkers.

Exelixis Announces U.S. FDA Accepts Investigational New Drug Application for XB002 in Patients with Advanced Solid Tumors

Retrieved on: 
Monday, April 5, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Cancer treatments, Clinical medicine, Medicine, Antineoplastic drugs, Immunology, Biotechnology, Monoclonal antibodies, Antibody-drug conjugate, Milatuzumab, Loncastuximab tesirine

Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors.
  • Considering XB002s promising preclinical data and potential differentiation from other tissue factor-targeting antibody-drug conjugates, we look forward to initiating our phase 1 trial in patients with advanced solid tumors.
  • XB002 (formerly ICON-2) is an ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent.
  • The data also demonstrated encouraging activity of XB002 in multiple solid tumor cancer models and improved tolerability compared with other tissue factor-targeting ADCs.

HUTCHMED Initiates International Phase I Trials of IDH1/2 Dual Inhibitor in Patients with Advanced Solid Tumors or Hematological Malignancies

Retrieved on: 
Monday, March 29, 2021
Monoclonal antibodies, Drugs, Clinical medicine, Milatuzumab, Palifermin

One trial is in patients with advanced solid tumors and one trial is in patients with hematological malignancies.

Key Points: 
  • One trial is in patients with advanced solid tumors and one trial is in patients with hematological malignancies.
  • The first international patient was dosed on March 25, 2021, following a Phase I trial that was initiated in China in the second half of 2020.
  • These two trials are multi-center studies to evaluate the safety, tolerability pharmacokinetics, pharmacodynamics and preliminary efficacy of HMPL-306.
  • The second stage is a dose expansion phase where patients will receive HMPL-306 to further evaluate the safety, tolerability, and clinical activity at the RP2D.

Cerecor Announces First Patient Dosed in a Phase 1b Clinical Trial of CERC-007 for the Treatment of Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Wednesday, December 16, 2020
Clinical medicine, Medicine, Medical specialties, Multiple myeloma, Monoclonal antibody, Orphan drugs, Milatuzumab, B-cell maturation antigen

CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb) being developed for patients with relapsed or refractory multiple myeloma (MM).

Key Points: 
  • CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb) being developed for patients with relapsed or refractory multiple myeloma (MM).
  • The study will determine the recommended Phase 2 dose, safety and preliminary efficacy of CERC-007.
  • The Phase 1b clinical trial is a U.S. multicenter, open-label, dose-escalation, sequential group study of CERC-007 as a monotherapy in approximately 30 patients with relapsed or refractory MM.
  • Multiple myeloma is the second most common blood cancer, with approximately 140,000 patients in the United States.2 Multiple myeloma is characterized by an excess proliferation of plasma cells.

Arch Oncology Announces First Patient Dosed in Phase 1/2 Clinical Trial of Anti-CD47 Antibody AO-176 in Multiple Myeloma

Retrieved on: 
Monday, December 7, 2020
Drugs, Medicine, Clinical medicine, Multiple myeloma, CD47, Monoclonal antibodies, Orphan drugs, Milatuzumab, Prodrugs, Carfilzomib

We are excited to begin dosing patients in our second clinical trial for AO-176, said Julie Hambleton, M.D., Interim President and Chief Executive Officer of Arch Oncology.

Key Points: 
  • We are excited to begin dosing patients in our second clinical trial for AO-176, said Julie Hambleton, M.D., Interim President and Chief Executive Officer of Arch Oncology.
  • This is an important milestone for AO-176 and for patients as this is the first dedicated trial of an anti-CD47 antibody exclusively in patients with multiple myeloma.
  • In our first clinical trial of AO-176, we saw encouraging anti-tumor activity as a single agent in patients with solid tumors and we are excited to evaluate our therapy for patients with multiple myeloma.
  • This open-label, multi-center, dose-escalation Phase 1/2 trial is evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AO-176 in patients with relapsed/refractory multiple myeloma.

Immunomedics Announces FDA Orphan Drug Designation of Trodelvy™ for Adult and Pediatric Glioblastoma

Retrieved on: 
Monday, October 12, 2020
Cancer treatments, Clinical medicine, Drugs, Antibody-drug conjugates, Immunomedics, Sacituzumab govitecan, Antibody-drug conjugate, TACSTD2, SN-38, Milatuzumab

This orphan drug designation is an important milestone for Immunomedics as we strive to broaden the clinical utility of Trodelvy, said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics.

Key Points: 
  • This orphan drug designation is an important milestone for Immunomedics as we strive to broaden the clinical utility of Trodelvy, said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics.
  • Trodelvy (sacituzumab govitecan-hziy) is the lead product and the most advanced program in Immunomedics unique antibody-drug conjugate (ADC) platform.
  • Trodelvy is an ADC that is directed against Trop-2, a cell-surface protein expressed in many solid cancers.
  • Trodelvy binds to Trop-2 and delivers the anti-cancer drug, SN-38, to kill cancer cells.