Keros Therapeutics, Inc. · NASDAQ:KROS
Keros Therapeutics — 64th Annual Congress of the American Society of Hematology 2022
27 slides from Keros Therapeutics's conference presentation, Dec 12, 2022
Slide 1: Hematology Franchise: Update of Data Presented at ASH 64th Annual Congress
Hematology Franchise: Update of Data Presented at 64th Annual Congress of the American Society of Hematology December 12, 2022
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 is Developing Differentiated Clinical Assets in Hematological, Pulmonary, and Cardiovascular Disorders
Keros is Developing Differentiated Clinical Assets in Hematological, Pulmonary, and Cardiovascular Disorders Phase of Development Program Asset Preclinical Phase 1 Phase 2 Phase 3 Status Phase 2 clinical trial Myelodysplastic syndromes ongoing KER-050 (therapeutic protein) Myelofibrosis Phase 2 clin
Slide 4: Keros' Hematology Franchise
Keros’ Hematology Franchise KER-047 (ALK2) Fe Fe Fe Fe BFU-E CFU-E Pro-E Baso-E Poly-E Ortho-E RET RBCs KER-050 • Production of red blood cells (RBCs), a process called erythropoiesis, requires cell division, differentiation and incorporation of iron into hemoglobin • A failure to produce fully matu
Slide 5: 64th American Society of Hematology Annual Meeting and Exposition
64th American Society of Hematology Annual Meeting and Exposition Preclinical Presentations • “ALK2 Inhibition and a Modified Activin Receptor Type IIA Ligand Trap Co-therapy Maximized Hematologic Improvements in a Mouse Model of Anemia of Inflammation” – Publication Number: 2338 • “RKER-050, a Nove
Slide 6: KER047-IR-201
KER047-IR-201 A Phase 2 Clinical Trial Of KER-047 For The Treatment Of Patients With Iron-Refractory Iron Deficiency Anemia (IRIDA) 6
Slide 7: Phase 2 Clinical Trial of KER-047 in IRIDA
Phase 2 Clinical Trial of KER-047 in IRIDA • KER-047 is a novel, oral, investigational small molecule ALK2 inhibitor • Ongoing two-part, open-label dose-escalation and dose-expansion Phase 2 clinical trial in patients with IRIDA (an inherited form of iron deficiency anemia) • Participants treated on
Slide 8: Phase 2 Clinical Trial of KER-047 in IRIDA – Preliminary Data
Phase 2 Clinical Trial of KER-047 in IRIDA – Preliminary Data • A dose of 25 mg once daily was generally well tolerated in one participant enrolled thus far; no serious adverse events or dose-limiting toxicities were observed during treatment Laboratory Results Before, During, and After Administrati
Slide 9: KER050-MD-201
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) 9
Slide 10: Phase 2 Clinical Trial of KER-050 in MDS
Phase 2 Clinical Trial of KER-050 in MDS • Ongoing, two-part, multicenter, open-label Phase 2 clinical trial in very low-, low- and intermediate-risk Exploratory Biomarker Clinical Update: MDS patients (LR-MDS) Analyses: Safety and Efficacy Markers of Iron Overload • KER-050 administered once every
Slide 11: Phase 2 Clinical Trial of KER-050 in MDS
Phase 2 Clinical Trial of KER-050 in MDS Key Eligibility Criteria: • MDS with very low-, low-, or intermediate-risk disease, as classified by the International Prognostic Scoring System- Revised (IPSS-R), including both patients that did not have ring sideroblasts (non-RS) and patients that have rin
Slide 12: Demographics and Baseline Characteristics of Participants Treated at the RP2D
Demographics and Baseline Characteristics of Participants Treated at the RP2D of 3.75 to 5.0 mg/kg Parameter RP2D Dataset (n=36) Age, years, median (range) 74.5 (61-88) Male, n (%) 20 (55.6) RS status, n (%) RS+ 23 (63.9) Non-RS 13 (36.1) WHO MDS classification, n (%) MDS-MLD 12 (33.3) MDS-MLD-RS 20
Slide 13: KER-050 Generally Well-Tolerated at RP2D of 3.75 to 5.0 mg/kg
KER-050 Generally Well-Tolerated at RP2D of 3.75 to 5.0 mg/kg Category Participants Reporting, n (%), n=36* Any treatment-emergent adverse event (TEAE) 33 (91.7) Any treatment-related TEAE 11 (30.6) Any serious TEAE 12 (33.3) Any treatment-related serious TEAE 1 (2.8) Any TEAE leading to death 1 (2.
Slide 14: Summary of 8- and 12-Week Efficacy Endpoints in MDS Patients with RP2D Experience
Summary of 8- and 12-Week Efficacy Endpoints in MDS Patients with RP2D Experience Response Rate, n/m (%) Response Summary All evaluable patients HTB evaluable patients Overall Erythroid Response (HI-E or TI) 15/29 (51.7%) 10/16 (62.5%) IWG 2006 HI-E 15/29 (51.7%) 10/16 (62.5%) TI ≥8 weeks 9/18 (50%)
Slide 15: KER-050 Treatment Resulted in HI-E and TI in Transfusion-Dependent Participants
KER-050 Treatment Resulted in HI-E and TI in Transfusion-Dependent Non-RS and RS+ Participants with Sustained Increase in Platelets RS+ Non-RS Responders n = 14 12 11 14 13 8 12 7 11 5 10 6 9 8 Nonresponders n = 14 14 12 11 12 7 10 6 6 5 5 5 6 5 Altered visit schedules for participants re-baselined
Slide 16: Case Study: Long-term Transfusion Independence Achieved in Participant Dosed at RP2D
Case Study: Long-term Transfusion Independence Achieved in Participant Dosed at RP2D Part 1 Base Study, 1.5 mg/kg, HI-E responder + + + + Part 1 Extension, 2.5 mg/kg up + + + + + + + + + + + + to 3.75 mg/kg, TI responder -8 -4 0 4 8 12 16 20 24 28 32 36 40 44 48 Study Weeks + Dose 1.5 mg/kg 2.5 mg/k
Slide 17: KER-050 Impact on Iron Overload
KER-050 Impact on Iron Overload Analysis of Biomarkers from Part 1 Dose Escalation 17
Slide 18: Treatment With KER-050 Resulted in Reduction in Serum Ferritin
Treatment With KER-050 Resulted in Reduction in Serum Ferritin Following 16 Weeks of Treatment (Data from Part 1 Cohorts) Reduction in Transfusion Burden* Associated With Reduction in Serum Ferritin • Short-term treatment with KER-050 reduced • In general, reductions in transfusion burden were serum
Slide 19: Summary: Safety and Efficacy Update From Long-Term Evaluation of Participants Receiving RP2D
Summary: Safety and Efficacy Update From Long-Term Evaluation of Participants Receiving RP2D • KER-050 continued to be generally well tolerated in participants receiving long-term treatment at the RP2D as of the data cutoff date • HI-E ≥8 weeks was achieved by 51.7% of all evaluable participants an
Slide 20: KER050-MF-301
KER050-MF-301 A Phase 2 Open-label Study to Evaluate the Safety and Efficacy of KER-050 as Monotherapy or in Combination with Ruxolitinib in Participants with Myelofibrosis (MF) 20
Slide 21: Phase 2 Clinical Trial of KER-050 in MF
Phase 2 Clinical Trial of KER-050 in MF Part 1: Dose Escalation Part 2: Dose Expansion • Ongoing, two-part, open-label Phase 2 Arm 1A: KER-050 Monotherapy clinical trial evaluating KER-050 Anemia, relapsed/refractory/intolerant n=18-30 administered with or without ruxolitinib to JAK inhibitor(s) or
Slide 22: Baseline Characteristics
Baseline Characteristics KER-050 KER-050 Total Parameters 0.75 mg/kg 0.75 mg/kg + ruxolitinib N=12 N=6 N=6 Median age, years (range) 72.0 (60-85) 75.5 (69-86) 75.0 (60-86) Male sex, n (%) 3 (50.0) 6 (100.0) 9 (75.0) RBC transfusion status Transfusion Dependent (TD),a n (%) 1 (16.7) 4 (66.7) 5 (41.7)
Slide 23: KER-050 Was Generally Well-Tolerated as Monotherapy and in Combination with Ruxolitinib
KER-050 Was Generally Well-Tolerated as Monotherapy and in Combination with Ruxolitinib Monotherapy Combination Total KER-050 0.75 mg/kg KER-050, 0.75 mg/kg + (N=12) n (%) (N=6) n (%) ruxolitinib (N=6) n (%) TEAE, any grade 4 (66.7) 5 (83.3) 9 (75.0) Grade 1 1 (16.7) 0 1 (8.3) Grade 2 2 (33.3) 2 (33
Slide 24: KER-050 Treatment Increased Reticulocytes and Platelets
KER-050 Treatment Increased Reticulocytes and Platelets Change by Study Arm Change by Transfusion Status NTD: Non–transfusion dependent potential for KER-050 to promote differentiation of erythroid and megakaryocytic precursors and ameliorate anemia and thrombocytopenia in patients wit • Although va
Slide 25: Case Study: Observed Increases in Erythropoiesis and Thrombopoiesis in Patient with KER-050
Case Study: Observed Increases in Erythropoiesis and Thrombopoiesis in Patient with KER-050 Treatment (Monotherapy) Case Study of Participant on KER-050 Monotherapy Treatment at 0.75mg/kg Q4W • 60-year-old non-transfusion dependent female with primary MF • Treatment with KER-050 increased hematopoie
Slide 26: Conclusions
Conclusions • Multiple poster presentations at the 64th American Society of Hematology Annual Meeting and Exposition demonstrating continued advancement of Keros’ hematology franchise • KER-047 treatment demonstrated translation of ALK2 biology to one IRIDA patient in our ongoing Phase 2 clinical tr
Slide 27: PLL
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