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Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-Cell Therapy

Retrieved on: 
Monday, August 2, 2021

SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced today that the first patient has been treated with FT819, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies. FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, a renewable cell source that enables mass production of high quality, allogeneic CAR T cells with greater product consistency, off-the-shelf availability, and broader patient accessibility. FT819 is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy.

Key Points: 
  • FT819 is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy.
  • Treatment of the first-ever patient with FT819 ushers in a new era for off-the-shelf CAR T-cell therapy, with the potential to overcome the real-world limitations of existing patient- and donor-derived therapeutic approaches and unlock the full potential of CAR T-cell therapy.
  • FT819 was designed to specifically address several limitations associated with the current generation of patient- and donor-derived CAR T-cell therapies.
  • The first patient with relapsed / refractory ALL was enrolled in Regimen A and received a dose of 90 million cells.

Kronos Bio Announces FDA Clearance of Investigational New Drug Application for Lanraplenib (LANRA) for Treatment of Patients with Acute Myeloid Leukemia (AML)

Retrieved on: 
Tuesday, July 27, 2021

SAN MATEO, Calif. and CAMBRIDGE, Mass., July 27, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for lanraplenib (LANRA), allowing the company to proceed with a Phase 1/2 clinical trial of LANRA in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with gilteritinib. Kronos Bio expects to initiate the trial in the fourth quarter of this year. The company is developing LANRA as a next-generation spleen tyrosine kinase (SYK) inhibitor, with improved pharmacokinetic (PK) and pharmacologic properties compared with entospletinib (ENTO), the company’s lead program. ENTO will be evaluated in combination with standard chemotherapy in a planned Phase 3 clinical trial in patients newly diagnosed with NPM1-mutated AML.

Key Points: 
  • Previously, LANRA demonstrated an acceptable safety profile in clinical trials of more than 250 healthy volunteers and patients with autoimmune diseases.
  • Kronos Bio is developing ENTO for the treatment of patients who are newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) and eligible for intensive induction chemotherapy.
  • 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.

Trial Launches to Evaluate GlycoMimetics’ Uproleselan Added to Cladribine Plus Low-Dose Cytarabine in AML Patients

Retrieved on: 
Thursday, July 22, 2021

GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that clinicians have treated the first patient in a Phase 1b/2 study evaluating the companys lead drug candidate, uproleselan, added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary AML (ts-AML).

Key Points: 
  • GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that clinicians have treated the first patient in a Phase 1b/2 study evaluating the companys lead drug candidate, uproleselan, added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary AML (ts-AML).
  • According to Eric Feldman, M.D., GlycoMimetics Chief Medical Officer, Patients with treated secondary AML have an extremely poor prognosis.
  • Our previous preclinical and clinical research supports the potential for these patients to benefit from the addition of uproleselan.
  • The Phase 1b/2 single-arm trial is enrolling patients 18 years or older, with a diagnosis of ts-AML who have not received therapy for their AML.

Aprea Therapeutics Announces Positive Results from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML

Retrieved on: 
Wednesday, July 21, 2021

In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.

Key Points: 
  • In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.
  • The post-transplant RFS and OS data with eprenetapopt and azacitidine maintenance therapy in these very difficult-to-treat TP53 mutant MDS and AML patients are incredibly exciting, said trial principal investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer Center and Research Institute.
  • Post-transplant maintenance therapy with eprenetapopt and azacitidine could, if approved, represent a new treatment paradigm that meaningfully improves outcomes for these patients with limited treatment options.
  • A Phase 1/2 clinical trial of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML met the primary efficacy endpoint of complete remission.

Flatiron Health Real-World Data Support FDA Approval of New Dosing Regimen for ERBITUX® (cetuximab)

Retrieved on: 
Tuesday, July 20, 2021

This alternate dosing regimen to the previously approved weekly dosing regimen allows ERBITUX infusions to be scheduled alongside other biweekly treatments, significantly reducing the frequency of patient visits to an infusion center.

Key Points: 
  • This alternate dosing regimen to the previously approved weekly dosing regimen allows ERBITUX infusions to be scheduled alongside other biweekly treatments, significantly reducing the frequency of patient visits to an infusion center.
  • We are proud that Flatiron RWD brings the evidence we gather from patients real-life experiences to bear directly on improvements to their care.
  • It is encouraging to see the innovative use of real-world data and regulatory pathways that made this label change a reality.
  • Flatiron Health is a healthtech company dedicated to helping cancer centers thrive and deliver better care for patients today and tomorrow.

Moleculin Receives Approval to Extend Dose Escalation in Phase 1/2 European Clinical Trial Evaluating Annamycin for the Treatment of Acute Myeloid Leukemia

Retrieved on: 
Tuesday, July 13, 2021

Annamycin is the Company's next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML.

Key Points: 
  • Annamycin is the Company's next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML.
  • Additionally, Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin.
  • This amendment will allow us to continue dose escalation in the Phase 1 portion of the trial and establish the maximum tolerated dose as we work toward the recommended dose for the Phase 2 portion of the study.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

Acute Myeloid Leukemia (AML) Epidemiology Forecast to 2030 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 7, 2021

The "Acute Myeloid Leukemia (AML) - Epidemiology Forecast to 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Acute Myeloid Leukemia (AML) - Epidemiology Forecast to 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This 'Acute Myeloid Leukemia (AML) - Epidemiology Forecast - 2030' report delivers an in-depth understanding of Acute Myeloid Leukemia (AML), historical and forecasted epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
  • The Acute Myeloid Leukemia (AML) Epidemiology Report and Model provide an overview of Acute Myeloid Leukemia (AML) 's risk factors and global trends in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan).
  • What are the key findings of the Acute Myeloid Leukemia (AML) epidemiology across 7MM, and which country will have the highest number of patients during the forecast period (2018-2030)?

Trillium Therapeutics Announces Dosing of First Patient in Phase 1b/2 Study of TTI-622 in Combination With Azacitidine and Venetoclax in TP53-Wild Type Acute Myeloid Leukemia

Retrieved on: 
Tuesday, July 6, 2021

Preclinical studies have shown that TTI-622 exhibits anti-tumor activity against AML cells as a monotherapy that is enhanced when combined with azacitidine or venetoclax.

Key Points: 
  • Preclinical studies have shown that TTI-622 exhibits anti-tumor activity against AML cells as a monotherapy that is enhanced when combined with azacitidine or venetoclax.
  • The dosing of this patient marks the second combination cohort that has been initiated with TTI-622, commented Dr. Ingmar Bruns, Trilliums Chief Medical Officer.
  • The combination of TTI-622 and azacitidine and venetoclax is being assessed as part of the ongoing, open-label study (NCT03530683).
  • Significant unmet medical need remains for elderly AML patients or those who are unfit for intensive chemotherapy, added Dr. Bruns.

HealthTree® Foundation Announces the Launch of "HealthTree for Acute Myeloid Leukemia" (AML)

Retrieved on: 
Thursday, July 1, 2021

SALT LAKE CITY, July 1, 2021 /PRNewswire/ -- HealthTree Foundation, a patient-driven, 501(c)(3) non-profit organization that empowers patients at each step of their disease journey, today announced the launch of HealthTree for Acute Myeloid Leukemia (AML).

Key Points: 
  • SALT LAKE CITY, July 1, 2021 /PRNewswire/ -- HealthTree Foundation, a patient-driven, 501(c)(3) non-profit organization that empowers patients at each step of their disease journey, today announced the launch of HealthTree for Acute Myeloid Leukemia (AML).
  • This announcement marks a milestone toward founder Jenny Ahlstrom's vision for the HealthTree platform to accelerate a cure for cancers and terminal diseases.
  • The creation of this new resource makes AML the second disease HealthTree has targeted to create and support communities that can contribute to a cure.
  • The HealthTree Foundation is a patient-driven, 501(c)(3) non-profit organization that empowers patients at each step of their disease journey.

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

Retrieved on: 
Wednesday, June 30, 2021

"Today's approval may provide a consistently sourced alternative to a pivotal component of potentially curative therapy for children and adults with this type of leukemia."

Key Points: 
  • "Today's approval may provide a consistently sourced alternative to a pivotal component of potentially curative therapy for children and adults with this type of leukemia."
  • It is the most common type of childhood cancer.
  • One component of the chemotherapy regimen is an enzyme called asparaginase that kills cancer cells by depriving them of substances needed to survive.
  • The most common side effects of Rylaze include hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage and liver toxicity.