7+3

MaaT Pharma Treats First Acute Myeloid Leukemia Patient in Phase 1 Clinical Trial to Evaluate Capsule Formulation of Microbiome Restoration Biotherapeutic

Retrieved on: 
Thursday, November 12, 2020
Oncology, Health, Other Science, Clinical trials, Pharmaceutical, Science, Blood disorders, Acute myeloid leukemia, Myelodysplastic syndrome, Cancer, 7+3, Clinical medicine, Leukemia, Protein kinase inhibitors, Hematology, Bemcentinib

The trial named CIMON will enroll patients with acute myeloid leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) following intensive chemotherapy.

Key Points: 
  • The trial named CIMON will enroll patients with acute myeloid leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) following intensive chemotherapy.
  • This in turn can result in multiple complications, some of them severe, especially for leukemia patients.
  • The MaaT033 capsule formulation is designed to restore the microbiome of patients that receive intensive chemotherapy and adds an important treatment modality to our portfolio of microbiome restoration therapeutics.
  • Initiating the clinical evaluation of our capsule formulation is an important milestone for MaaT Pharma, enabling us to expand our therapeutics pipeline with a complimentary product candidate to our MaaT013 biotherapeutic.

Multi-Center Evaluation of Bionano Optical Genome Mapping by Cytogenetics Thought Leaders in the US Leads to Recommendation for Bionano’s Saphyr to Replace Karyotyping as First-Line Test for Detection and Identification of Structural and Copy Number Var

Retrieved on: 
Wednesday, November 11, 2020
Acute myeloid leukemia, 7+3, Acute eosinophilic leukemia

The paper, published this week in medRxiv, describes detection and identification of structural variants and copy number variants in 100 patients with acute myeloid leukemia (AML).

Key Points: 
  • The paper, published this week in medRxiv, describes detection and identification of structural variants and copy number variants in 100 patients with acute myeloid leukemia (AML).
  • Karyotyping, which provides a whole genome analysis of single cells, has been the standard of care for AML patients for decades.
  • This study demonstrated several advantages of OGM over karyotyping with no obvious deficiencies in performance.
  • Erik Holmlin, Ph.D., CEO of Bionano Genomics commented, This study is our flagship study in the United States.

Immune-Onc Therapeutics Announces Orphan Drug Designation of IO-202 (Anti-LILRB4) for Treatment of AML and Poster Presentation at ASH 2020

Retrieved on: 
Tuesday, November 10, 2020
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical trials, Cancer, 7+3, Leukemia, Clinical medicine, Acute myeloid leukemia, Antibody-drug conjugates, Drugs, Orphan drugs, Vadastuximab talirine

Orphan Drug Designation can also convey seven years of marketing exclusivity for a drug approved to treat an orphan disease in the United States.

Key Points: 
  • Orphan Drug Designation can also convey seven years of marketing exclusivity for a drug approved to treat an orphan disease in the United States.
  • As outlined in our ASH poster presentation, IO-202 holds promise for AML patients because it demonstrates novel mechanisms of action in overcoming immune suppression.
  • Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III , on Monday, December 7, 2020, 7:00 a.m. - 3:30 p.m. Pacific Time.
  • The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation status for treatment of AML in October 2020.

Two Confirmed Responses and Five out of Six Patients with Initial Tumor Reductions from Early Dose Cohorts of SURPASS Trial, Presented at SITC

Retrieved on: 
Monday, November 9, 2020
Clinical medicine, Medicine, Branches of biology, Gene delivery, Viral vector, Virotherapy, Apheresis, Cyclophosphamide, Fludarabine, 7+3

Eligible pts undergo apheresis, Tcells are isolated, transduced with a Lentiviral vector containing the MAGE-A4c1032 TCR and CD8 coreceptor, and expanded.

Key Points: 
  • Eligible pts undergo apheresis, Tcells are isolated, transduced with a Lentiviral vector containing the MAGE-A4c1032 TCR and CD8 coreceptor, and expanded.
  • Expansion, transduction level, cellular composition and function of the manufactured product (MP) are assessed in vitro.
  • Prior to infusion, pts receive lymphodepletion with fludarabine 30mg/m2/day for 4days and cyclophosphamide 600mg/m2/day for 3 days.
  • This dose escalation trial is ongoing and updated clinical and translational data will be presented.

Sumitomo Dainippon Pharma Oncology to Present New Data Evaluating Investigational Agent Alvocidib at 62nd ASH Annual Meeting

Retrieved on: 
Friday, November 6, 2020
Clinical medicine, Sumitomo Dainippon Pharma, Economic history of Japan, Drugs, 7+3, AXL receptor tyrosine kinase, Sumitomo Group, Cytarabine

We look forward to reinforcing this commitment at the ASH Annual Meeting as we share the latest data on our diverse pipeline of investigational cancer therapeutics," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology).

Key Points: 
  • We look forward to reinforcing this commitment at the ASH Annual Meeting as we share the latest data on our diverse pipeline of investigational cancer therapeutics," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology).
  • SDP Oncology and its parent company, Sumitomo Dainippon Pharma Co. Ltd., will also be presenting Phase 1 data evaluating alvocidib in combination with cytarabine and mitoxantrone in patients with relapsed/refractory AML or cytarabine and daunorubicin in patients with newly diagnosed AML.
  • In addition, preclinical data evaluating how dubermatinib (TP-0903), an oral AXL kinase inhibitor, modulates CART19function will be presented.
  • Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide.

Rubius Therapeutics Announces Dosing of First Patient with Relapsed/Refractory Acute Myeloid Leukemia in the Ongoing Phase 1/2 Clinical Trial of RTX-240

Retrieved on: 
Thursday, November 5, 2020
Cancer treatments, Cancer, 7+3, Leukemia, Chemotherapy, Antibody-drug conjugates, Lactams, Protein kinase inhibitors, Acute myeloid leukemia, CD135

The ongoing clinical study of RTX-240 has two Phase 1 arms, one in all solid tumors and the other in relapsed/refractory AML.

Key Points: 
  • The ongoing clinical study of RTX-240 has two Phase 1 arms, one in all solid tumors and the other in relapsed/refractory AML.
  • When NK cells are restored to their full anti-tumor potential, their cytolytic activity predicts a better long-term outcome for patients with AML.
  • AML is a rare and aggressive cancer of the blood and bone marrow, and is the most common form of acute leukemia in adults.
  • Rubius Therapeutics is enrolling patients in a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study of RTX-240.

MacroGenics Announces Flotetuzumab and Tebotelimab Presentations at the ASH Annual Meeting 2020

Retrieved on: 
Wednesday, November 4, 2020
Interleukin-3 receptor, 7+3, Leukemia, Antibody-drug conjugates, Clinical medicine, Camidanlumab tesirine, Acute myeloid leukemia, Orphan drugs

We look forward to presenting clinical and biomarker results for flotetuzumab in patients with relapsed or refractory acute myeloid leukemia at the 2020 ASH annual meeting, saidScott Koenig, M.D., Ph.D., President and CEO ofMacroGenics.

Key Points: 
  • We look forward to presenting clinical and biomarker results for flotetuzumab in patients with relapsed or refractory acute myeloid leukemia at the 2020 ASH annual meeting, saidScott Koenig, M.D., Ph.D., President and CEO ofMacroGenics.
  • The first of our two oral presentations will address results of the role of immune senescence and exhaustion-related RNA profiles in predicting outcomes in AML.
  • Together with our four posters, these presentations add to the growing medical and scientific interest in the potential of flotetuzumab in AML.
  • The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells.

Xencor to Present Data from Phase 1 Study of Vibecotamab in Acute Myeloid Leukemia at the 2020 ASH Annual Meeting

Retrieved on: 
Wednesday, November 4, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Cancer, Medical specialties, Clinical medicine, Pediatric cancers, Acute myeloid leukemia, Acute lymphocytic leukemia, Leukemia, 7+3, Acute lymphoblastic leukemia, Oncological emergencies, Leukostasis, Childhood leukemia, Vibecotamab, Xencor, Inc.

"Data from the Phase 1 study of vibecotamab suggest that patients with AML having low baseline disease burden and specific T-cell signatures may be more likely to respond to treatment with vibecotamab.

Key Points: 
  • "Data from the Phase 1 study of vibecotamab suggest that patients with AML having low baseline disease burden and specific T-cell signatures may be more likely to respond to treatment with vibecotamab.
  • At data cut off for submitting the abstract, 104 patients with AML, one patient with B cell acute lymphoblastic leukemia and one patient with chronic myeloid leukemia had received vibecotamab.
  • Patients received doses of vibecotamab ranging from 0.003 mcg/kg to 12 mcg/kg.
  • This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Syros to Present New Data from Phase 2 Clinical Trial of SY-1425 in Oral Presentations at 62nd ASH Annual Meeting

Retrieved on: 
Wednesday, November 4, 2020
Research, Genetics, Clinical trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Orphan drugs, Lactams, Chemical compounds, Organic compounds, Drugs, Nucleosides, Triazines, Acute myeloid leukemia, 7+3, Azacitidine, Antibody-drug conjugates, Midostaurin

The oral presentations will include data on SY-1425 in combination with azacitidine from a cohort of RARA-positive patients with relapsed or refractory acute myeloid leukemia (AML) and mature data on the combination in newly diagnosed unfit AML patients who are not suitable candidates for standard chemotherapy.

Key Points: 
  • The oral presentations will include data on SY-1425 in combination with azacitidine from a cohort of RARA-positive patients with relapsed or refractory acute myeloid leukemia (AML) and mature data on the combination in newly diagnosed unfit AML patients who are not suitable candidates for standard chemotherapy.
  • Syros is advancing a robust pipeline, including SY-1425, a first-in-class oral selective RAR agonist in a Phase 2 trial in a genomically defined subset of acute myeloid leukemia patients, and SY-5609, a highly selective and potent oral CDK7 inhibitor in a Phase 1 trial in patients with select solid tumors.
  • Syros also has multiple preclinical and discovery programs in oncology and monogenic diseases.
  • For more information, visit www.syros.com and follow us on Twitter (@SyrosPharma) and LinkedIn.

American Society of Hematology (ASH) Abstract Shows Initial Anti-Leukemic Activity of UCART22 in BALLI-01 Phase 1 Study in R/R Adult B-ALL

Retrieved on: 
Wednesday, November 4, 2020
Drugs, Cancer treatments, Cancer, Cyclophosphamide, Hepatotoxins, Organochlorides, Prodrugs, Fludarabine, 7+3, Dose-ranging study, Leukemia, Chemotherapy regimen

This will be the first publicly released data from Cellectis Phase 1 dose-escalation study of UCART22 product candidate in adult patients with Relapsed/Refractory CD22+ B-ALL.

Key Points: 
  • This will be the first publicly released data from Cellectis Phase 1 dose-escalation study of UCART22 product candidate in adult patients with Relapsed/Refractory CD22+ B-ALL.
  • BALLI-01 is a Phase 1 open-label dose-escalation study designed to assess the safety, the maximum tolerated dose (MTD), and preliminary anti-leukemia activity of UCART22 in patients with R/R B-ALL.
  • The abstract includes preliminary data from the first five patients who received escalating doses of UCART22 cells after fludarabine/cyclophosphamide (FC) lymphodepletion.
  • UCART22 demonstrated preliminary signs of activity at low dose levels with fludarabine/cyclophosphamide (FC) lymphodepletion regimen, without unexpected nor significant treatment-related toxicities.