Slide 1: Updated Bisantrene Phase II Data Presentation
For personal use only Updated Bisantrene Phase II Data Presentation June 2020
Slide 2: Trial highlights | Chair Clinical Advisory Board, Professor Borje Andersson
For personal use only Trial highlights | Chair Clinical Advisory Board, Professor Borje Andersson June 2020
Slide 3: About Bisantrene
About Bisantrene For personal use only Bisantrene is a cancer chemotherapy that was previously approved for AML in France 1988 and then shelved. Race Oncology is returning this drug back into clinical development Bisantrene (Xantrene®) is an anthracene with anthracycline-like activity and was shown
Slide 4: Bisantrene remains an excellent cancer drug with great potential
For personal use only Bisantrene remains an excellent cancer drug with great potential in modern cancer treatment for AML and other cancers
Slide 5: Current AML Treatment
Current AML For personal use only Treatment General overview Complete Intensive Chemotherapy Response (CR) Stem Cell Transplant AML (Induction and consolidation) (HSCT) Cure This trial This trial Relapsed and/or Salvage chemotherapy Refractory AML Bisantrene IV Management of R/R AML represents a sig
Slide 6: Phase II Bisantrene monotherapy in relapsed/refractory AML
For personal use only Phase II Bisantrene monotherapy in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML)
Slide 7: Bisantrene is active, safe and effective in Adult R/R AML
Bisantrene is active, safe and effective in For personal use only Adult R/R AML after multiple prior therapies ORR = 40% (4/10 patients Bisantrene * 4 Responses reported (1 CR + 3 PR) 7 day (single IV course) treatment Favourable safety and tolerability 10 patients enrolled *4/4 responses in high-ri
Slide 8: Study design
Study design For personal use only - Phase II open-label single arm single center study (NCT03820908) - Site: Chaim Sheba Medical Center, Tel Aviv, Israel - Principal investigator. Professor Arnon Nagler
Slide 9: Study design: Criteria
Study design For personal use only Criteria Inclusion Criteria Exclusion Criteria Patients with Relapsed/Refractory AML Active pulmonary disease, diffusing capacity for carbon monoxide(DCFO) < 30% Aged 18 years or older Symptomatic heart failure (NYHA Grade 2 or higher) Eastern Cooperative Oncology
Slide 10: Study design: Treatments and assessments
Study design Treatments and assessments For personal use only Treatment Bisantrene 250mg/m2 over 2-hour, one infusion daily for 7 days, one course only. Patients achieving CR may receive one 3-day consolidation course with the same daily dose and schedule. Salvage therapy - predominantly as 4th line
Slide 11: Study design: Assessments
Study design Assessments For personal use only ? $ Safety Response Disease mutations • Vital signs & physical • Blast cells in bone marrow and • Next generation • Clinical lab tests and bone marrow in blood sequencing (NGS) studies examination • According to 2003 on patient bone marrow • ECG Interna
Slide 12: Patient Demographics
Patient Demographics For personal use only Characteristic N=10 Characteristic N=10 Median age MRC Cytogenetic risk Years (range) 43 (22-80) Favourable 0 Intermediate 7 (70%) Gender Advanced 3 (30%) Male 6 ELN 2017 risk category Female 4 Favourable 2 (20%) ECOG performance status at screening Interme
Slide 13: Safety
Safety For personal use only All-cause adverse events Adverse events attributed to bisantrene Most frequently reported Grade 1-2 Grade 3 Grade 4 Grade 5 Grade 1-2 Grade 3 Grade 4 serious adverse events: Anemia 1 (10%) 1 (10%) 1 (10%) 1 (10%) Neutropenia 2 (20%) 2 (20%) 2 (20%) 2 (20%) • thrombocytop
Slide 14: Outcomes
Outcomes For personal use only - Of the 10 patients, one patient (10%) achieved a complete remission and three patients achieved a partial remission → Overall Response Rate of 40% - All 4 responders had high-risk extramedullary disease: • Patient with leukaemia cutis (skin) achieved CR and was bridg
Slide 15: Conclusion
Conclusion For personal use only Established safety and tolerability of current Bisantrene formulation Confirmed previously recorded anti-leukeamic activity The Dose and Schedule (250mg/m2 once daily for 7 days) maintains effectiveness in R/R AML Bisantrene is safe and its efficacy confirmed in the
Slide 16: So where, henceforth ……….
So where, henceforth ……….. For personal use only 6/19/2020 B.S. Andersson
Slide 17: Other Activities | CSO Daniel Tillett
For personal use only Other Activities | CSO Daniel Tillett June 2020
Slide 18: The MRD opportunity
The MRD For personal use only 2-year survival and residual disease opportunity status at transplant 100 Up to 80% of AML patients who are fit enough for induction 90 chemotherapy (3+7) with enter remission (CR) and may then be candidates for a human stem cell transplant (HSCT) 80 Whether the transpl
Slide 19: Bisantrene in AML treatment for MRD
Bisantrene in AML treatment For personal use only for MRD Bisantrene could transform cure rates by changing MRD status MRD(+) MRD(-) Complete Bisantrene Response Fit patients 3+7 Induction (CR) Stem Cell Chemotherapy Cure MRD(-) Transplant (HSCT) Newly Diagnosed Non- responders AML Various salvage c
Slide 20: Phase II MRD trial
1 Phase II MRD trial For personal use only Phase II study of Bisantrene treatment after (7+3) induction chemotherapy to change MRD status Aim to run trial in USA and/or Israel in partnership with a leading US cancer center Eligibility Transplant eligible MRD(+) patients in CR after induction chemoth
Slide 21: Breast cancer combination trial
4 Breast cancer For personal use only combination trial Phase I/II proof-of-concept (POC) trial in breast cancer Will use drug combinations which preclinical data show synergise with Bisantrene (preclinical studies underway with U. Newcastle) Use optimal dosing, administration and combination of Bis
Slide 22: Ovarian cancer combination trial
5 Ovarian cancer For personal use only combination trial Phase I/II proof of concept (POC) trial in ovarian or other cancer Preclinical trials to be performed to identify those cancers that respond most to Bisantrene and which drug combinations show synergy Use optimal dosing, administration & combi
Slide 23: For personal use only
For personal use only L40 140 William St, Melbourne, VIC 3000 info@raceoncology.com +61 3 9098 8750