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  • ||||||||||  Real-World Outcomes of CD19-Targeted CAR T-Cell Therapy in Adult and Pediatric Patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL): Insights from the GoCART Coalition on Behalf of the PDWP, ALWP, and CTIWP of the EBMT (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_6049;    
    Results : A total of 345 patients (173 adults and 172 pediatrics) received therapy from 2016 to 2023 with tisagenlecleucel (65.2%), varnimcabtagene autoleucel (25.8%), brexucabtagene autoleucel (5.5%), and others (3.5%)...Bridging therapy was administered in 86.4% (298) of patients based on high or low intensity chemotherapy (32.1% or 26.5%, respectively), inotuzumab-ozogamicin (13.4%), TKI (8.2%), involved-site therapy (intrathecal chemotherapy, radiotherapy, orchiectomy) (3.5%), and blinatumomab (2.6%), alone or in combination...Lymphodepletion was performed in all but one patient, based on fludarabine and cyclophosphamide regimens...These findings support the continued use and further investigation of CAR T-cell therapy in diverse clinical settings, emphasizing the importance of post-infusion strategies to sustain long-term remission. This will provide deeper insights into the factors influencing outcomes and help refine treatment protocols to improve patient care.
  • ||||||||||  parsaclisib (INCB50465) / Incyte, gedatolisib (PF-05212384) / Celcuity, buparlisib (AN2025) / Novartis, Adlai Nortye
    Journal:  A Long Way to Go: A Scenario for Clinical Trials of PI3K Inhibitors in Treating Cancer. (Pubmed Central) -  Mar 22, 2024   
    Not yet recruiting --> Recruiting The establishment of development indicators based on clinical trials for cancer treatment was useful to highlight the clinical investment in 3 new PI3K drugs and the advantages of combine therapy using FDA-approved drugs.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
    Combined inhibition of CDK4/6 and signal transduction: activity beyond ER+ breast cancer (Ballroom 6 DE - Upper Level - Convention Center) -  Feb 5, 2024 - Abstract #AACR2024AACR_1213;    
    The palbociclib-binimetinib combination has recently been incorporated into the NCI Precision Medicine Initiative as part of ComboMATCH, where investigation is ongoing in low-grade serous ovarian cancer, pancreatic cancer, and other RAS-mutant tumors. Such combinations hold substantial promise for extending the use of the CDK4/6 inhibitor drug class beyond ER+ breast cancer.
  • ||||||||||  gedatolisib (PF-05212384) / Celcuity
    GEDATOLISIB ASSOCIATED ACUTE MYOCARDITIS IN A PATIENT WITH BREAST CANCER (Hall B4-5) -  Jan 26, 2024 - Abstract #ACC2024ACC_3273;    
    A high index of suspicion for cardiotoxicity is needed when evaluating patients receiving novel cancer therapies. The integration of multimodality imaging including CMR is instrumental.
  • ||||||||||  gedatolisib (PF-05212384) / Celcuity
    And gedatolisib (Twitter) -  Jul 18, 2023   
  • ||||||||||  gedatolisib (PF-05212384) / Celcuity, Hexalen (altretamine) / Ipsen, Eisai, Idhifa (enasidenib) / BMS, Servier
    Review, Journal:  Antitumor Activity of s-Triazine Derivatives: A Systematic Review. (Pubmed Central) -  Jun 14, 2023   
    The medicinal chemistry of s-triazine derivatives as anticancer agents was summarized, including discovery, structure optimization, and biological applications. This review will provide a reference to inspire new and original discoveries.
  • ||||||||||  gedatolisib (PF-05212384) / Celcuity
    Journal:  Design, Synthesis and Phenotypic Profiling of Simplified Gedatolisib Analogues. (Pubmed Central) -  Jun 1, 2023   
    Compound 5f (LASSBio-2252) stood out as the most promising of the series, showing good aqueous solubility (42.38 ?M (pH = 7.4); 39.33 ?M (pH = 5.8)), good partition coefficient (cLogP = 2.96), cytotoxic activity on human leukemia cell lines (CCRF-CEM, K562 and MOLT-4) and an excellent metabolic stability profile in rat liver microsomes (t = 462 min; Clapp = 0.058 mL/min/g). The ability of 5f to exert its cytotoxic effect through modulation of the PI3K pathway was demonstrated by flow cytometry analysis in a comparative manner to gedatolisib.
  • ||||||||||  gedatolisib (PF-05212384) / Celcuity
    Journal:  An integrative approach for exploring the nature of fibroepithelial neoplasms. (Pubmed Central) -  Feb 27, 2023   
    The enriched structure-activity relationships may be useful for further rational drug development of triazine hybrids as potential clinical candidates. This study revealed the molecular profiles of MPT that can lead to molecular classification and potential targeted therapy, and suggested that the MPT PDX model can be a useful tool for studying the pathogenesis of fibroepithelial neoplasms and for preclinical drug screening to find new therapeutic strategies for MPT.
  • ||||||||||  CAR T cell therapy / Mnemo Therap
    AUTOLOGOUS HEMATOPOIETIC CELL TRANSPLANTATION FOR MARGINAL ZONE LYMPHOMAS  (ePoster Area) -  Feb 11, 2023 - Abstract #EBMT2023EBMT_1831;    
    Auto-HCT can still be considered a valuable option for carefully selected patients with MZL or t-MZL, allowing for long-term disease control in a significant proportion of patients, including patients with POD24. The risk of SPM is within the range reported for auto-HCT.
  • ||||||||||  Journal:  Selective Eradication of Colon Cancer Cells Harboring PI3K and/or MAPK Pathway Mutations in 3D Culture by Combined PI3K/AKT/mTOR Pathway and MEK Inhibition. (Pubmed Central) -  Jan 22, 2023   
    We found profound tumor cell destruction under treatment with a combination of Torin 1 (inhibiting mTOR), MK2206 (targeting AKT) and selumetinib (inhibiting MEK) in 3D but not in 2D...Gedatolisib, a dual PI3K/mTOR inhibitor, could replace Torin1/MK2206 with similar efficiency...Here, we identified a novel, efficient therapy, which induced proliferation stop and tumor cell destruction in vitro based on the genetic background. These preclinical findings show promise to further test this combi-treatment in vivo in mice and to potentially develop a mutation specific targeted therapy for CRC patients.
  • ||||||||||  gedatolisib (PF-05212384) / Celcuity
    Journal:  BPTF promotes the progression of distinct subtypes of breast cancer and is a therapeutic target. (Pubmed Central) -  Dec 20, 2022   
    BPTF targeting with the bromodomain inhibitor bromosporine, alone or in combination with the PI3K pathway inhibitor gedatolisib, produced significant anti-tumor effects against TNBC cells in vitro and in vivo. These studies demonstrate BPTF activation in distinct breast cancer subtypes, identify pathways by which BPTF promotes breast cancer progression, and suggest BPTF as a rational target for breast cancer therapy.
  • ||||||||||  Talzenna (talazoparib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
    Enrollment change, Trial completion date, Trial primary completion date, Metastases:  BTCRC-BRE18-337: Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers (clinicaltrials.gov) -  Dec 19, 2022   
    P1/2,  N=37, Recruiting, 
    These studies demonstrate BPTF activation in distinct breast cancer subtypes, identify pathways by which BPTF promotes breast cancer progression, and suggest BPTF as a rational target for breast cancer therapy. N=54 --> 37 | Trial completion date: Dec 2023 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023