Keros Therapeutics, Inc. · NASDAQ:KROS
Keros Therapeutics — 28th Annual Congress of the European Hematology Association (June 2023)
22 slides from Keros Therapeutics's conference presentation, Jun 9, 2023
Slide 1: Hematology Franchise: Program Updates and Summary of Data Presented at EHA 2023
June 9, 2023 Hematology Franchise: Program Updates and Summary of Data Presented at 28th Annual Congress of the European Hematology Association
Slide 2: Disclaimer
Disclaimer Statements contained in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “poten
Slide 3: Keros Hematology Franchise
Keros Hematology Franchise • Keros is harnessing the powerful biology of the TGF-b superfamily to develop product candidates with the potential to address the multiple mechanisms leading to ineffective erythropoiesis • KER-050: Designed to inhibit signaling by activin A, activin B, GDF8 and GDF11 to
Slide 4: 28th Annual Congress of the European Hematology Association
28th Annual Congress of the European Hematology Association Clinical Presentation “KER-050 treatment improved markers of erythropoietic activity and hematopoiesis over six months which resulted in hematological responses across a broad, lower-risk MDS population” • Abstract Code: S166 Preclinical Pr
Slide 5: Myelofibrosis is Characterized by Ineffective Hematopoiesis
Myelofibrosis is Characterized by Ineffective Hematopoiesis • Myelofibrosis (MF) is a group of rare cancers of the bone marrow in which the marrow is replaced by scar tissue and is not able to produce healthy blood cells • MF is characterized by ineffective hematopoiesis, an enlarged spleen, bone ma
Slide 6: RKER-050 Treatment Restored Hematopoiesis in the Bone Marrow in the Mouse Model of MF
RKER-050 Treatment Restored Hematopoiesis in the Bone Marrow, Reversing Anemia and Normalizing Megakaryocyte Precursor Number in the Mouse Model of MF Treatment of GATA1low mice with RKER-050 restored erythropoiesis to the bone marrow and reversed anemia RKER-050 also reduced the MK hyperproliferati
Slide 7: KER050-MD-201: Phase 2 Clinical Trial in Myelodysplastic Syndromes
KER050-MD-201 A Phase 2 Clinical Trial Of KER-050 For The Treatment Of Anemia In Patients With Very Low, Low Or Intermediate Risk Myelodysplastic Syndromes (MDS) 7
Slide 8: MD-201 Design and Dose Levels
RP2D = Recommended Part 2 Dose • Primary Objective: • Assess safety and tolerability of KER-050 • Secondary Endpoints include: • Hematological Improvement- Erythroid (HI-E) • Transfusion Independence (TI) ≥8 weeks • Ongoing Trial: Status as of April 3, 2023: • Part 1 Dose Escalation (N=31; completed
Slide 9: Enrolled Patient Population Included Difficult-to-Treat Patients With High Disease Burden
Enrolled Patient Population Included Difficult-to-Treat Patients With High Disease Burden • Most required transfusions at baseline • Over half were high transfusion burden (HTB; ≥4 RBC units/8 wks) • Among HTB patients, 12/31 (38.7%) received ≥8 RBC units/8 wks • Majority were ring sideroblast posit
Slide 10: Opportunity to Evaluate Longer-Term Exposure to KER-050
Opportunity to Evaluate Longer-Term Exposure to KER-050 Exposure of overall MDS RP2D Population as of the data cutoff date: • 59 patients received ≥1 dose of KER-050 (included in safety population) • Median duration of treatment = 225 days (≈32 weeks) • Range 6 to 649 days (≈1 to 93 weeks) • Median
Slide 11: KER-050 Was Generally Well-Tolerated
KER-050 Was Generally Well-Tolerated • Most TEAEs were Grades 1 or 2 (51%) • Most frequent TEAEs (in ≥15% of patients) regardless of causality were: • Fatigue, n=13 (22%) • Nausea, n=11 (18.6%) • Diarrhea, n=11 (18.6%) • Epistaxis, n=10 (16.9%) • COVID-19, n=9 (15.3%) • Dyspnea, n=9 (15.3%) • Of the
Slide 12: KER-050 Treatment Resulted in Hematological Response Across Lower-Risk MDS
KER-050 Treatment Resulted in Hematological Response Across a Broad Population of Patients with Lower-Risk MDS • Similar rates of HI-E and TI observed regardless of transfusion burden or RS status • 44.1%* of patients show a ≥30 x 109/L increase from baseline in platelet count sustained over at leas
Slide 13: Data Suggest KER-050 Elicited a Durable Response
Data Suggest KER-050 Elicited a Durable Response Data presented as of a data cutoff date April 3, 2023. • 19 achieved HI-E or TI* • Median duration of response = 42.4 weeks • 10/19 (52.6%) had ongoing response** * During weeks 0-24 in RP2D patients with ≥24wk of treatment or who discontinued **Patie
Slide 14: Sustained Increases in Hemoglobin Observed Over Months of KER-050 Treatment
Sustained Increases in Hemoglobin Observed Over 6 Months of KER-050 Treatment 8/15 (53.3%) NT and LTB patients with ≥6 months of treatment (or discontinued) achieved HI-E response in first 24 weeks of treatment Observed sustained increases in hemoglobin support durable response with KER-050 Observed
Slide 15: Reductions in Transfusion Burden Observed with KER-050 Treatment
Reductions in Transfusion Burden Observed with KER-050 Treatment • Reduced transfusion burden observed in majority of LTB and HTB patients • TI observed in both RS+ and non-RS patients • TI achieved in patients with baseline transfusion burden ranging from 2 to 11 units/8 weeks 2 2 9 9 4 3 4 3 8 6 7
Slide 16: Data Suggest Enhanced Erythropoiesis and Potential to Reduce Iron Overload
Data Suggest Enhanced Erythropoiesis and Potential to Reduce Iron Overload M e an ± SE M ( n g/ m L) Observed Change from Baseline In Ferritin Weeks 0 4 8 12 16 20 24 -500 -250 0 250 500 Responder Non-Responder 18 17 14 13 13 11 9 17 17 17 1719 18 16 N= 0 4 8 12 16 20 24 -500 -250 0 250 500 Responde
Slide 17: Observed Reductions in Serum Ferritin with KER-050 Treatment
Observed Reductions in Serum Ferritin with KER-050 Treatment 1A. Waszczuk-Gajda et al. 2016 Adv Clin Exp Med 25(4): 633-641 Data are presented as of a data cutoff date of April 3, 2023. Observed Maximum Mean Change Over 12 Weeks (Patients with baseline ferritin ≥500 ng/mL) M e an R e d u ct io n O v
Slide 18: Summary of KER-050 MDS Data
Summary of KER-050 MDS Data • KER-050 was generally well-tolerated; safety profile consistent to that previously reported for this trial • Durable hematological responses were observed in a broad, lower-risk MDS population, including those with HTB and/or non-RS disease • Observed decreases in serum
Slide 19: Phase 2 MDS Trial Amended to Evaluate KER-050 in Patients with Iron Overload
Phase 2 MDS Trial Amended to Evaluate KER-050 in Patients with Iron Overload • In lower-risk MDS patients, severe anemia and lack of effective treatment options leads to blood transfusions, often resulting in iron overload • This transfusional iron overload has negative consequences on hematopoiesis
Slide 20: KER-050 Myelofibrosis and KER-047 IRIDA Trial Updates
• KER-050: Myelofibrosis • This open label, two-part, multiple ascending dose Phase 2 clinical trial to evaluate KER-050 as a monotherapy and in combination with ruxolitinib in patients with myelofibrosis-associated cytopenias is ongoing • Following Safety Review Committee recommendation, dosing for
Slide 21: Keros Anticipated Key Milestones
Keros Anticipated Key Milestones KER-050 • Complete enrollment in transfusion-dependent cohorts in Phase 2 MDS trial H2 2023 • Announce additional data from Part 2 of Phase 2 MDS trial H2 2023 • Announce dose escalation data from Phase 2 MF trial H2 2023 • Initiate Part 2 of Phase 2 MF trial H2 2023
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