Calithera Biosciences, Inc. · OTC:CALA
Calithera Biosciences — ASH 2020
8 slides from Calithera Biosciences's conference presentation, December 2020
Slide 1: AZA + Glutaminase Inhibition with Telaglenastat (CB-839) for Advanced MDS: An Updated Interim Analysis
AZA + Glutaminase Inhibition with Telaglenastat (CB-839) for Advanced MDS: An Updated Interim Analysis Kapil Saxena, Marina Konopleva, Tushar D Bhagat, Veronica A Guerra, Rita Maduike, Stefano Tiziani, Gautam Borthakur, Elias Jabbour, Naveen Pemmaraju, Tapan M. Kadia, Nicholas J. Short, Jan A. Burge
Slide 2: Disclosures
Disclosures Konopleva:Agios: Research Funding; Ablynx: Research Funding; Calithera: Research Funding; Cellectis: Research Funding; Eli Lilly: Research Funding; Kisoji: Consultancy; Amgen: Consultancy; Forty-Seven: Consultancy, Research Funding; Stemline Therapeutics: Consultancy, Research Funding; F
Slide 3: Background
Background • Malignant myeloid cells can utilize glutamine as an energy source [1] • Glutamine is metabolized by glutaminase into glutamate in mitochondria • Glutamate is a precursor to multiple intracellular molecules including: • alpha-ketoglutarate in the citric acid cycle • the intracellular ant
Slide 4: Trial design
Trial design • Single arm, phase Ib/II trial of CB-839 + AZA in patients with: • IPSS Int-1 risk MDS with high-risk mutation (ASXL1, TP53, RUNX1, EZH2) • IPSS Int-2 or high risk MDS • Prior HMA therapy permitted • Primary outcomes • Phase Ib – safety and RP2D -> CB-839 600mg bid + standard 7d AZA •
Slide 5: Patient characteristics
Patient characteristics Characteristic (N=23) N (%); Prior therapy _- a 34.8% Median [Range] | Diagnosis MDS-MLD 13.0% Age, years 71 [49-83] MDS-RS-MLD | | 4.3% Sex Mps-EB-1 [i i | i | 13.0% Female 5 (22) MDS-EB-2 13.0% Male 18 (78) t-MDS Ef 8 HH BRSe 34.8% Prior treatment(s) CMML i | ~ 4 21.7% Fron
Slide 6: Outcomes
Outcomes Best response attained on study N (%) (N=23) Objective response 15 (65) CR 5 (22) mCR +/- HI 10 (43) HI 0 No response 8 (35) Proceeded to allogeneic SCT 5 (22) Early mortality 30-day 0 60-day 1 (4.3) Objective response rate N (%) Previously-treated 5/8 (63) TP53-mutated 5/8 (63) Complex cyt
Slide 7: Safety
Safety 100 Treatment-related adverse events occuring in > 10% of patients eo i Any grade OF Grade > 3 60 40 20 0 0.0 0.0 Ib 0.0 v4 0.0 cle io 0.0 Nausea Constipation Neutropenia Thrombocytopenia Generalized Anorexia Transaminitis Diarrhea weakness
Slide 8: Conclusions
Conclusions • AZA + CB-839 is a safe combination for patients with MDS • Most common grade > 3 non-hematologic treatment-related AE was transaminitis (13%), which could be effectively managed with dose- reduction of CB-839 from 600mg bid to 400mg bid • AZA + CB-839 displays clinical efficacy, includ