OXS-1550 / GT Biopharma - LARVOL DELTA

Bispecific ligand-directed toxin targeting CD22 and CD19 (DT2219) for refractory B-cell malignancies: Results of phase I-II trial. (ASCO 2019) - P1/2; "We have established the biologically active dose of DT2219 at 60 μg/kg/day ×8 doses. Further development of DT2219 includes combination with rituximab (to reduce NA formation) and synergistic combinations against B-cell malignancies. Clinical trial information: NCT02370160"

P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

GT Biopharma announces preliminary clinical results from interim review of phase 1/2 clinical trial of OXS-1550, its bi-specific antibody drug conjugate (GT Biopharma Press Release) - P1/2, N=18; NCT02370160; Sponsor: Masonic Cancer Center, University of Minnesota; "GT Biopharma, Inc...announced preliminary clinical data...of the OXS-1550 [DT2219ARL] Phase 1/2 trial...At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients...The efficacy signal was most prominent in ALL patients with 75% (three of four) exhibiting clinical benefit...One patient had a grade 4 low platelet count, two patients had a grade 3 increase in liver function tests, or LFTs, and one patient had a grade 3 capillary leak....The Company currently expects final data for this trial to be available in the fourth quarter of 2018 or the first quarter of 2019."

P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Novel therapy for relapsed childhood acute lymphoblastic leukemia (EHOC 2019) - "In the more intensive re-induction British protocol (ALL-R3), Mitoxantrone and Idarubicin were compared, and it was observed that Mitoxantrone resulted in significant increases in both overall survival and progression-free survival rates due to the reduction of the relapse rate. The BFM (Berlin-FrankfurtMünster) group administered a more intensive re-induction treatment by adding medium-dose Methotrexate and high-dose Cytarabine to the 4-drug chemo combination...Although the response rate was 44% in the phase 2 Clofarabine + Cyclophosphamide study performed in the previously intensively treated group, there was no benefit in the COG study containing Clofarabine + high dose Cytarabin (Ara-C) in the second or more recurrent ALL cases...The COG group demonstrated that the addition of Nelarabine to high-risk T-ALL treatment based on the BFM treatment scheme had an acceptable toxicity (mostly peripheral neuropathy) and observed an uneventful survival rate higher in the..."

Clinical • IO Biomarker • BCL2 • CDK6

OXS-1550: End of P2a meeting with FDA for ALL and NHL in Q4 2019 (GT Biopharma) - Corporate Presentation

FDA event

GT Biopharma GTB-1550 multi-targeted bispecific drug conjugate strategically positioned in new class of ADC drugs (PRNewswire) - "To date, GTB-1550 has completed one dose escalation Phase I-II expansion clinical trial, and one fixed dose Phase I-II expansion clinical trial which collectively enrolled a combined 43 patients. Top-line Consolidated Results: Two patients exhibited a Complete Remission (CR) with one patient currently disease-free at 50 months post treatment. Five patients exhibited Stable Disease (SD) with the longest response lasting 12 months post treatment...Greater than 50% of evaluable patients receiving 60 mg/kg dose had positive clinical response defined as stable disease, partial remission, or complete remission."

Clinical data

GT Biopharma GTB-1550 phase I-II results to be published in conjunction with 2019 ASCO Meeting May 31 - June 4 in Chicago (PRNewswire) - P1/2, N=18; NCT02370160; “GT Biopharma, Inc….announced today that the results of its second Phase I-II trial (NCT02370160) for GTB-1550 (DT2219), an MTBDC targeting CD22 and CD19 for treatment of refractory B-cell malignancies, will be published…on-line in conjunction with the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 31 – June 4….All were Grade 1-2 and resolved after 3-5 days allowing day 15 GTB-1550 administration. There were no neutropenic fever or immune mediated adverse events. Four patients experienced dose limiting toxicity (DLT) at dose 80 μg/kg/day: Grade 4 capillary leak syndrome (n=1), Grade 3 liver function test (LFT) abnormalities (n=2) and Grade 4 thrombocytopenia >7 days duration (n=1).”

P1/2 data