7+3

Rubius Therapeutics Reports Initial Clinical Data from Ongoing Phase 1/2 Trial of RTX-240 in Patients with Advanced Solid Tumors, Demonstrating Single-Agent Activity

Retrieved on: 
Monday, March 15, 2021
Cancer treatments, Acute myeloid leukemia, Chemotherapy, Clinical medicine, Antibody-drug conjugates, 7+3, Leukemia, Camidanlumab tesirine, Genmab

The Company also shared tumor trafficking data from one patient with relapsed/refractory acute myeloid leukemia (AML) in the second Phase 1 arm of the study.

Key Points: 
  • The Company also shared tumor trafficking data from one patient with relapsed/refractory acute myeloid leukemia (AML) in the second Phase 1 arm of the study.
  • The study will include a monotherapy dose escalation phase followed by an expansion phase in specified tumor types during the Phase 2 portion of the trial.
  • The extent to which the COVID-19 pandemic may impact Rubius ability to enroll patients in the trial will depend on future developments.
  • Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics.

Apollomics, Inc Doses First Patient in Phase 1 Clinical Trial in China of GlycoMimetics’ Uproleselan for the Treatment of AML

Retrieved on: 
Thursday, March 4, 2021
Health, FDA, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Cancer treatments, Antibody-drug conjugates, Chemotherapy, Clinical medicine, Orphan drugs, 7+3, Lactams, Antineoplastic drugs, Acute myeloid leukemia, Devimistat, Uproleselan, Apollomics, Inc., GlycoMimetics, Inc.

The Phase 1 clinical trial in China is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML.

Key Points: 
  • The Phase 1 clinical trial in China is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML.
  • In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML.
  • GlycoMimetics' drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is being evaluated across a range of patient populations including in a Company-sponsored Phase 3 trial in relapsed/refractory AML.
  • GlycoMimetics has an ongoing Phase 1b clinical trial evaluating GMI-1359, a combined CXCR4 and E-selectin antagonist, also a wholly-owned drug candidate,.

Apollomics, Inc. Announces Successful Enrollment of First Patient Into Phase 1 Clinical Trial of APL-106 (Uproleselan Injection) in China

Retrieved on: 
Thursday, March 4, 2021
Cancer treatments, Drugs, Antibody-drug conjugates, Orphan drugs, Clinical medicine, 7+3, Acute myeloid leukemia, Devimistat

The Phase 1 clinical trial is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML.

Key Points: 
  • The Phase 1 clinical trial is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML.
  • Apollomics has the rights to clinical development, production and commercial sales in the Chinese market (Mainland China, Hong Kong, Macau and Taiwan).
  • In September 2020, APL-106 received the approval of the National Medical Products Administration (NMPA) through the issuance of the Clinical Trial Drug Approval Notification.
  • The annual incidence of AML in China in 2019 is approximately 26,9002, and relapsed/refractory AML has an extremely poor prognosis.

Kronos Bio Announces Positive End-of-Phase 2 Meeting with FDA for Entospletinib in Newly Diagnosed NPM1-mutated Acute Myeloid Leukemia (AML)

Retrieved on: 
Thursday, March 4, 2021
Chemical compounds, Acute myeloid leukemia, Entospletinib, Indazoles, Morpholines, Branches of biology, Organic compounds, Leukemia, Tyrosine-protein kinase SYK, 7+3, NPM1, HOXA9

Even with current therapies, about half of patients with newly diagnosed NPM1-mutated AML will die from the disease within five years.

Key Points: 
  • Even with current therapies, about half of patients with newly diagnosed NPM1-mutated AML will die from the disease within five years.
  • Kronos Bios lead investigational therapy is entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK) in development for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML).
  • Results of a Phase 1b/2 study of entospletinib (GS-9973) monotherapy and in combination with induction chemotherapy in newly diagnosed patients with acute myeloid leukemia.
  • Entospletinib in combination with induction chemotherapy in previously untreated acute myeloid leukemia: response and predictive significance of HOXA9 and MEIS1 expression.

APOLLOMICS, INC ANNOUNCES SUCCESSFUL ENROLLMENT OF FIRST PATIENT INTO PHASE 1 CLINICAL TRIAL OF APL-106 (UPROLESELAN INJECTION) IN CHINA

Retrieved on: 
Thursday, March 4, 2021
Cancer treatments, Drugs, Antibody-drug conjugates, Orphan drugs, Clinical medicine, 7+3, Acute myeloid leukemia, Devimistat

The Phase 1 clinical trial is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML.

Key Points: 
  • The Phase 1 clinical trial is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML.
  • Apollomics has the rights to clinical development, production and commercial sales in the Chinese market (Mainland China, Hong Kong, Macau and Taiwan).
  • In September 2020, APL-106 received the approval of the National Medical Products Administration (NMPA) through the issuance of the "Clinical Trial Drug Approval Notification".
  • The annual incidence of AML in China in 2019 is approximately 26,9002, and relapsed/refractory AML has an extremely poor prognosis.

Marker Therapeutics Announces Completion of New Manufacturing Facility to Support Clinical Development of MultiTAA-Specific T Cell Therapy Product Candidates

Retrieved on: 
Wednesday, January 13, 2021
Branches of biology, Medical specialties, Biology, Immune system, Immunology, Leukemia, Stem cells, Cell biology, Chimeric antigen receptor T cell, T cell, Cell therapy, 7+3

The Company has initiated the technology transfer process and expects the cGMP manufacturing facility to be fully operational in the first half of 2021.

Key Points: 
  • The Company has initiated the technology transfer process and expects the cGMP manufacturing facility to be fully operational in the first half of 2021.
  • "With the recent initiation of our Phase 2 study in post-transplant AML, this new facility will assist with the timely manufacture of MT-401.
  • The manufacturing of Marker's MultiTAA-specific T cell therapy for AML begins with collecting T cells from healthy donors.
  • As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Medivir presents MIV-818 data at ASCO Gastrointestinal Cancers Symposium

Retrieved on: 
Tuesday, January 12, 2021
Medivir, Life sciences, Health sciences, Dose, 7+3, Health care

The presentation will be given on January 15, 2021, at 2 pm CET during the Hepatobiliary Cancer session (presentation number 309).

Key Points: 
  • The presentation will be given on January 15, 2021, at 2 pm CET during the Hepatobiliary Cancer session (presentation number 309).
  • The inter-patient dose escalation phase Ib part is currently ongoing at a dose of 40 mg for 5 days in 21-day cycles.
  • Details of all presentations for the 2021 ASCO GI Symposium are available at the conference website: LINK
    MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects.
  • Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership.

APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia

Retrieved on: 
Thursday, January 7, 2021
Acute myeloid leukemia, Cancer treatments, Clinical medicine, Leukemia, Cancer, 7+3, CD135, Devimistat

The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China.

Key Points: 
  • The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China.
  • In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML.
  • Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow.
  • Rivipansel, a pan-selectin antagonist, is being explored for use in treatment of acute VOC in sickle cell disease.

APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia

Cancer treatments, Acute myeloid leukemia, Leukemia, 7+3, Clinical medicine, Chemotherapy, Antibody-drug conjugates, CD135, Ivosidenib

Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin.

Key Points: 
  • Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin.
  • In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML.
  • Apollomics licensed APL-106 from GlycoMimetics in January 2020 to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.
  • Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow.

Preliminary Results from NexImmune’s Phase 1/2 Trial of NEXI-001 in AML Presented at 62nd ASH Annual Meeting and Exposition

Retrieved on: 
Monday, December 7, 2020
Branches of biology, Clinical medicine, Medicine, Stem cells, Biotechnology, Transplantation medicine, Hematology, Hematopoietic stem cell transplantation, Lymphology, Biomarker, Cell therapy, 7+3

Biomarker data characterizing initial immunologic responses for the first three patients analyzed were also shared.

Key Points: 
  • Biomarker data characterizing initial immunologic responses for the first three patients analyzed were also shared.
  • Relapse after allo-HSCT is the leading cause of death in patients with AML and represents a significant challenge for treating physicians.
  • The initial Safety Evaluation Phase determines the safety and tolerability of a single infusion of NEXI-001 at escalating dose levels.
  • The modular design of the AIM platform enables rapid expansion across multiple therapeutic areas, with both cell therapy and injectable products.