7+3

Horizon Therapeutics plc Initiates Clinical Trial to Assess Shorter Infusion Duration for KRYSTEXXA® (pegloticase injection) Concomitantly Used with Methotrexate to Treat Uncontrolled Gout

Retrieved on: 
Thursday, October 29, 2020
Biotechnology, Pharmaceutical, Health, Clinical trials, Medical specialties, Clinical medicine, Medicine, Immunosuppressants, Pegloticase, Methotrexate, 7+3, Gout, KRYSTEXXA, Horizon

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the first patient has been enrolled in the Infusion Duration Study to Assess Tolerability of Pegloticase Administered with a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate, or AGILE, clinical trial to evaluate a shorter infusion duration for KRYSTEXXA (pegloticase injection) co-prescribed with methotrexate to treat people with chronic gout refractory to conventional therapies, also known as uncontrolled gout.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the first patient has been enrolled in the Infusion Duration Study to Assess Tolerability of Pegloticase Administered with a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate, or AGILE, clinical trial to evaluate a shorter infusion duration for KRYSTEXXA (pegloticase injection) co-prescribed with methotrexate to treat people with chronic gout refractory to conventional therapies, also known as uncontrolled gout.
  • A shorter infusion duration for KRYSTEXXA could meaningfully impact the experience for patients, clinicians and sites of care.
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion.
  • Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate (AGILE).

Forma Therapeutics Announces Positive Top-line Olutasidenib Data From a Planned Interim Analysis of a Registrational Phase 2 Clinical Trial in Acute Myeloid Leukemia (AML)

Retrieved on: 
Monday, October 26, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Orphan drugs, Lactams, Cancer treatments, Chemical compounds, Cancer, Azacitidine, Nucleosides, Triazines, 7+3, Antibody-drug conjugates, Olutasidenib, Forma Therapeutics

We are pleased to announce these compelling top-line data, said Patrick Kelly, MD, chief medical officer of Forma Therapeutics.

Key Points: 
  • We are pleased to announce these compelling top-line data, said Patrick Kelly, MD, chief medical officer of Forma Therapeutics.
  • Phase 1 of the trial, FT2102-HEM-101, was an open-label, dose-escalation and expansion study of olutasidenib alone and in combination with azacitidine (AZA).
  • The pivotal Phase 2 study is an open-label, fixed-dose study of olutasidenib as a monotherapy in IDH1m AML patients.
  • Forma is currently evaluating olutasidenib in a registrational Phase 2 trial for relapsed/refractory AML and in an exploratory Phase 1 trial for glioma and other solid tumors.

Agios Announces Withdrawal of European Marketing Authorization Application for TIBSOVO® as a Treatment for Relapsed or Refractory IDH1-mutant Acute Myeloid Leukemia

Retrieved on: 
Friday, October 16, 2020
Acute myeloid leukemia, Cancer, Orphan drugs, Drugs, Ivosidenib, RTT, 7+3, Antibody-drug conjugates, CD135

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated.

Key Points: 
  • Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated.
  • In the clinical trial, 25% (7/28) of patients with newly diagnosed AML and 19% (34/179) of patients with relapsed or refractory AML treated with TIBSOVO experienced differentiation syndrome.
  • Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.
  • Of the 34 patients with relapsed or refractory AML who experienced differentiation syndrome, 27 (79%) patients recovered after treatment or after dose interruption of TIBSOVO.

Adaptimmune Provides Full Contents of its SITC Abstract for the Phase 1 SURPASS Trial

Retrieved on: 
Thursday, October 15, 2020
Clinical medicine, Medicine, Branches of biology, RTT, 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.

MacroGenics Announces Flotetuzumab Publication in Blood Advances

Retrieved on: 
Thursday, October 15, 2020
Acute myeloid leukemia, Leukemia, RTT, Flotetuzumab, 7+3, Clinical medicine, Medical specialties, Drugs, Bemcentinib, Minimally differentiated acute myeloblastic leukemia

This represents the third publication of flotetuzumab data in 2020.

Key Points: 
  • This represents the third publication of flotetuzumab data in 2020.
  • The same gene signature was shown to be associated with an increased probability of this subset of patients to respond to flotetuzumab.
  • These individuals represent approximately 40-50% of all AML patients, said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics.
  • 1 Flotetuzumab as Salvage Immunotherapy for Refractory Acute Myeloid Leukemia , Blood, 2020; and Immune Landscapes Predict Chemotherapy Resistance and Immunotherapy Response in Acute Myeloid Leukemia , Science Translational Medicine, 2020.

Kura Oncology Announces Preliminary Data for Menin Inhibitor KO-539 Accepted for Oral Presentation at ASH

Retrieved on: 
Wednesday, October 7, 2020
Acute myeloid leukemia, RTT, 7+3, Oncology, Clinical medicine

The following abstract will be posted on the ASH website at 9:00 a.m.

Key Points: 
  • The following abstract will be posted on the ASH website at 9:00 a.m.
  • KOMET-001 (Kura Oncology Menin Inhibitor Trial) is a Phase 1/2A study to determine the safety, tolerability and recommended Phase 2 dose of KO-539 in patients with refractory or relapsed acute myeloid leukemia (AML).
  • Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer.
  • For additional information about Kura, please visit the Companys website at www.kuraoncology.com .

Apollomics, Inc. Receives China Investigational New Drug Approval for APL-106 to Initiate a Phase 3 Bridging Study in Acute Myeloid Leukemia

RTT, Cancer, Acute myeloid leukemia, Clinical medicine, Organic compounds, 7+3, Leukemia, Antibody-drug conjugates, Lactams, Orphan drugs, Devimistat, CD135

This approval enables the initiation of a Phase 1 pharmacokinetics (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory acute myeloid leukemia (AML).

Key Points: 
  • This approval enables the initiation of a Phase 1 pharmacokinetics (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory acute myeloid leukemia (AML).
  • AML is one of the most common leukemias in adults, and there is a strong demand for an effective breakthrough treatment for relapsed/refractory AML.
  • We look forward to initiating our clinical trials in China as we strive to offer a new and effective treatment option for AML patients.
  • A comprehensive Phase 3 development program in AML is currently ongoing with uproleselan in the United States by GlycoMimetics.

NuCana Presents Three Posters at the ESMO Virtual Congress 2020

Retrieved on: 
Monday, September 21, 2020
European Society for Medical Oncology, 7+3, Dat

EDINBURGH, United Kingdom, Sept. 21, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA), announced data from the ongoing NUC-3373 and NUC-7738 clinical programs, as well as a review of the ongoing Acelarin Phase III study, at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress.

Key Points: 
  • EDINBURGH, United Kingdom, Sept. 21, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA), announced data from the ongoing NUC-3373 and NUC-7738 clinical programs, as well as a review of the ongoing Acelarin Phase III study, at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress.
  • NuCana believes these data support the potential of NUC-3373 to improve progression-free survival in patients who had relapsed or were refractory to prior 5-FU containing regimens.
  • NuCana also believes these data show NUC-3373s potential to offer enhanced efficacy, an improved safety profile and a more convenient dosing regimen as compared to 5-FU.
  • Additionally, interim data from two case studies showed the significant reductions in tumor volume were maintained over time in these patients.

ORYZON Presents Efficacy and Safety Results of its CLEPSIDRA Trial with Iadademstat in ED-SCLC Patients at ESMO-2020

Retrieved on: 
Thursday, September 17, 2020
Cancer research, Response Evaluation Criteria in Solid Tumors, 7+3, Lung cancer

Results are presented as an e-poster entitled Final safety and efficacy data from CLEPSIDRA trial in 2L ED-SCLC, which includes data from the 14 patients enrolled in the study, of which 10 are evaluable for efficacy as per protocol.

Key Points: 
  • Results are presented as an e-poster entitled Final safety and efficacy data from CLEPSIDRA trial in 2L ED-SCLC, which includes data from the 14 patients enrolled in the study, of which 10 are evaluable for efficacy as per protocol.
  • Upon treatment with iadademstat + carboplatin-etoposide for 6 cycles, this patient showed an initial 78.7% of tumor reduction according to RECIST criteria.
  • Thereafter the patient received 15 additional cycles of iadademstat alone without showing any toxicity and with good overall tolerability.
  • The most prevalent toxicity of the triple combination iadademstat plus carboplatin-etoposide was severe hematological alterations in 11 of 14 patients (thrombo- and neutropenia).

Menarini Ricerche Announces Initiation of Cohort Expansion for the Clinical Study of SEL24/MEN1703 in Acute Myeloid Leukemia

Retrieved on: 
Wednesday, September 16, 2020
Menarini, 7+3, Economy of Italy

The above cohort expansion had already started in the US, with the first patient being treated as of 21 July 2020.

Key Points: 
  • The above cohort expansion had already started in the US, with the first patient being treated as of 21 July 2020.
  • DIAMOND-01 is a first-in-Human, Phase I/II dose escalation and cohort expansion trial of SEL24/MEN1703 in AML relapsed or refractory as well as previously untreated patients unsuitable for chemotherapy.
  • Through the work of Menarini Silicon Biosystems, Menarini is also developing advanced technologies and products to study rare cells with single-cell precision.
  • The Menarini Group is a leading international pharmaceutical and diagnostics company, with turnover of 3.793 billion and over 17,000 employees.