K-NK002 / Sanofi - LARVOL DELTA

[VIRTUAL] BMT CTN 1803: Haploidentical Natural Killer Cells (K-NK002) to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (TCT-ASTCT-CIBMTR 2021) - P2 | "BMT conditioning (Day -7 to day -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy of total body irradiation...GVHD prophylaxis consists of post-transplantation cyclophosphamide with tacrolimus and mycophenolate mofetil. The primary endpoint is cumulative incidence of relapse at 1 year post haploBMT in patients receiving at least 1 infusion of K-NK002. Secondary endpoints are safety and tolerability; overall survival; non-relapse mortality; relapse-free survival; GVHD-free survival; cumulative incidence of acute GVHD and chronic GVHD; hematologic recovery; donor-cell engraftment; primary and secondary graft failure; overall incidence of toxicity; and cumulative incidence of infections including cytomegalovirus re-activation and symptomatic BK virus hemorrhagic cystitis."

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Immunology • Transplantation • IL21

[VIRTUAL] BMT CTN 1803: Haploidentical Natural Killer Cells (K-NK002) to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (TCT-ASTCT-CIBMTR 2021) - P2 | "BMT conditioning (Day -7 to day -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy of total body irradiation...GVHD prophylaxis consists of post-transplantation cyclophosphamide with tacrolimus and mycophenolate mofetil. The primary endpoint is cumulative incidence of relapse at 1 year post haploBMT in patients receiving at least 1 infusion of K-NK002. Secondary endpoints are safety and tolerability; overall survival; non-relapse mortality; relapse-free survival; GVHD-free survival; cumulative incidence of acute GVHD and chronic GVHD; hematologic recovery; donor-cell engraftment; primary and secondary graft failure; overall incidence of toxicity; and cumulative incidence of infections including cytomegalovirus re-activation and symptomatic BK virus hemorrhagic cystitis."

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Immunology • Transplantation • IL21

[VIRTUAL] BMT CTN 1803: Haploidentical Natural Killer Cells (K-NK002) to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (TCT-ASTCT-CIBMTR 2021) - P2 | "BMT conditioning (Day -7 to day -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy of total body irradiation...GVHD prophylaxis consists of post-transplantation cyclophosphamide with tacrolimus and mycophenolate mofetil. The primary endpoint is cumulative incidence of relapse at 1 year post haploBMT in patients receiving at least 1 infusion of K-NK002. Secondary endpoints are safety and tolerability; overall survival; non-relapse mortality; relapse-free survival; GVHD-free survival; cumulative incidence of acute GVHD and chronic GVHD; hematologic recovery; donor-cell engraftment; primary and secondary graft failure; overall incidence of toxicity; and cumulative incidence of infections including cytomegalovirus re-activation and symptomatic BK virus hemorrhagic cystitis."

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Immunology • Transplantation • IL21

[VIRTUAL] BMT CTN 1803: Haploidentical Natural Killer Cells (K-NK002) to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (TCT-ASTCT-CIBMTR 2021) - P2 | "BMT conditioning (Day -7 to day -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy of total body irradiation...GVHD prophylaxis consists of post-transplantation cyclophosphamide with tacrolimus and mycophenolate mofetil. The primary endpoint is cumulative incidence of relapse at 1 year post haploBMT in patients receiving at least 1 infusion of K-NK002. Secondary endpoints are safety and tolerability; overall survival; non-relapse mortality; relapse-free survival; GVHD-free survival; cumulative incidence of acute GVHD and chronic GVHD; hematologic recovery; donor-cell engraftment; primary and secondary graft failure; overall incidence of toxicity; and cumulative incidence of infections including cytomegalovirus re-activation and symptomatic BK virus hemorrhagic cystitis."

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Immunology • Transplantation • IL21

[VIRTUAL] BMT CTN 1803: Haploidentical Natural Killer Cells (K-NK002) to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (ASH 2020) - P2 | "BMT conditioning will consist of 140 mg/m2 (100 mg/m2 for patients ≥60 years old) melphalan on Day -7; 40 mg/m2 fludarabine on Days -7, -6, -5, and -4; and 2 Gy of total body irradiation on Day -3...Graft-versus-host disease (GVHD) prophylaxis consists of post-transplantation cyclophosphamide with tacrolimus and mycophenolate mofetil...Secondary endpoints are safety and tolerability of K-NK002; overall survival; non-relapse mortality; relapse-free survival; GVHD-free survival; cumulative incidence of acute GVHD and chronic GVHD; hematologic recovery; donor-cell engraftment; primary and secondary graft failure; overall incidence of toxicity; and cumulative incidence of infections including cytomegalovirus re-activation and symptomatic BK virus hemorrhagic cystitis. Exploratory endpoints are systemic immunosuppression-free survival; immune reconstitution at Days 28, 100, and 365 post haploBMT; proportion of patients with detectable minimal residual disease at Days 28..."

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • IL21

[VIRTUAL] BMT CTN 1803: Haploidentical Natural Killer Cells (K-NK002) to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (TCT-ASTCT-CIBMTR 2021) - P2 | "BMT conditioning (Day -7 to day -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy of total body irradiation...GVHD prophylaxis consists of post-transplantation cyclophosphamide with tacrolimus and mycophenolate mofetil. The primary endpoint is cumulative incidence of relapse at 1 year post haploBMT in patients receiving at least 1 infusion of K-NK002. Secondary endpoints are safety and tolerability; overall survival; non-relapse mortality; relapse-free survival; GVHD-free survival; cumulative incidence of acute GVHD and chronic GVHD; hematologic recovery; donor-cell engraftment; primary and secondary graft failure; overall incidence of toxicity; and cumulative incidence of infections including cytomegalovirus re-activation and symptomatic BK virus hemorrhagic cystitis."

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Immunology • Transplantation • IL21

Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Kiadis Pharma; N=63 ➔ 0; Active, not recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • FLT3 • HLA-DRB1

[VIRTUAL] BMT CTN 1803: HAPLOIDENTICAL NATURAL KILLER CELLS (K-NK002) TO PREVENT POST-TRANSPLANT RELAPSE IN AML AND MDS (NK-REALM) (EBMT 2021) - P2 | "Conditioning (Days -7 to -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy TBI...GVHD prophylaxis consists of cyclophosphamide, tacrolimus and mycophenolate mofetil.The primary endpoint is cumulative incidence of relapse at 1 year... This is an important study to confirm that K-NK002 given in the peri-transplant period can mediate an effective anti-leukemia response. Clinical Trial Registry: NCT04395092"

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • IL21

[VIRTUAL] BMT CTN 1803: HAPLOIDENTICAL NATURAL KILLER CELLS (K-NK002) TO PREVENT POST-TRANSPLANT RELAPSE IN AML AND MDS (NK-REALM) (EBMT 2021) - P2 | "Conditioning (Days -7 to -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy TBI...GVHD prophylaxis consists of cyclophosphamide, tacrolimus and mycophenolate mofetil.The primary endpoint is cumulative incidence of relapse at 1 year... This is an important study to confirm that K-NK002 given in the peri-transplant period can mediate an effective anti-leukemia response. Clinical Trial Registry: NCT04395092"

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • IL21

[VIRTUAL] BMT CTN 1803: HAPLOIDENTICAL NATURAL KILLER CELLS (K-NK002) TO PREVENT POST-TRANSPLANT RELAPSE IN AML AND MDS (NK-REALM) (EBMT 2021) - P2 | "Conditioning (Days -7 to -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy TBI...GVHD prophylaxis consists of cyclophosphamide, tacrolimus and mycophenolate mofetil.The primary endpoint is cumulative incidence of relapse at 1 year... This is an important study to confirm that K-NK002 given in the peri-transplant period can mediate an effective anti-leukemia response. Clinical Trial Registry: NCT04395092"

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • IL21

[VIRTUAL] BMT CTN 1803: HAPLOIDENTICAL NATURAL KILLER CELLS (K-NK002) TO PREVENT POST-TRANSPLANT RELAPSE IN AML AND MDS (NK-REALM) (EBMT 2021) - P2 | "Conditioning (Days -7 to -3) will consist of 140 mg/m2 (100 mg/m2 if ≥60 years old) melphalan, 40 mg/m2 fludarabine, and 2 Gy TBI...GVHD prophylaxis consists of cyclophosphamide, tacrolimus and mycophenolate mofetil.The primary endpoint is cumulative incidence of relapse at 1 year... This is an important study to confirm that K-NK002 given in the peri-transplant period can mediate an effective anti-leukemia response. Clinical Trial Registry: NCT04395092"

Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • IL21

Kiadis Pharma announces annual results for the year ended December 31, 2020 (Kiadis Pharma Press Release) - "Enrolment for...NK-REALM Phase 2 clinical trial is planned to start in 2021. For its K-NK003 program, the FDA approved a Phase 1 trial in patients with relapsed/refractory acute myeloid leukemia (R/R AML) with off-the-shelf cells from universal donors and enrolment is ongoing."

Enrollment status • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (clinicaltrials.gov) - P2; N=63; Active, not recruiting; Sponsor: Kiadis Pharma; Not yet recruiting ➔ Active, not recruiting; Trial completion date: Mar 2023 ➔ Nov 2023

Enrollment closed • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • FLT3 • HLA-DRB1

Kiadis announces multiple abstracts related to its K-NK-cell therapy platform have been accepted for presentation at TCT, the Combined Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR (GlobeNewswire) - "Kiadis...today announces that four abstracts related to its K-NK-cell therapy platform were accepted for presentation at the TCT Meetings, the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR), which is being held virtually from February 8–12, 2021."

Clinical data • P1 data • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Kiadis announces new data at the 2020 ASH Annual Meeting and Exposition (GlobeNewswire) - “Kiadis Pharma N.V…announces that new data related to its K-NK cell therapy platform will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition being held virtually from December 5-8, 2020. Abstract #68 is an oral presentation with data showing that multiple infusions of ex vivo expanded haploidentical NK cells in R/R AML patients yielded unprecedented outcomes with no safety reactions or toxicities. The poster for abstract #825 presents data that demonstrate NKTR-255 significantly enhanced the ADCC of expanded NK cells with anti-CD20 type I and type II antibodies against Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma (FL), and rituximab-resistant BL cells. Three additional posters, abstracts #2151, #2341, and #2347, provide details of ongoing studies within the K-NK cell therapy programs.”

Clinical data • Acute Myelogenous Leukemia • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology

Kiadis announces presentations at the 2020 ASH Annual Meeting and Exposition (Kiadis Pharma Press Release) - "Kiadis Pharma...today announces that five abstracts related to its K-NK-cell therapy platform were accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition being held virtually from December 5-8, 2020."

P1 data • P2 data • Preclinical • Acute Myelogenous Leukemia • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Follicular Lymphoma • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology

Sanofi to buy Kiadis (PharmaTimes) - "Sanofi has entered into a deal to buy Kiadis, a clinical-stage biopharmaceutical company developing innovative ‘off the shelf’ natural killer (NK) cell based medicines for the treatment of life-threatening diseases...now also gains access to the firm's K-NK002, currently in Phase II development for the prevention of post-transplant relapse in patients with acute myeloid leukaemia (AML) and myelodysplastic syndromes, as well as other candidates for relapsed or refractory AML..."

M&A • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (clinicaltrials.gov) - P2; N=63; Not yet recruiting; Sponsor: Kiadis Pharma; Initiation date: Jul 2020 ➔ Nov 2020

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • FLT3 • HLA-DRB1

Sanofi offers to acquire Kiadis, a clinical-stage company developing cell-based immunotherapy products (GlobeNewswire) - "Sanofi and Kiadis...entered into a definitive agreement under which Sanofi will make a public offer (subject to satisfaction of certain customary conditions) to acquire the entire share capital of Kiadis for EUR 5.45 per share, representing an aggregate adjusted equity value of €308m....K-NK002 is in a Phase 2 clinical study evaluating NK cells to prevent post-transplant relapse in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes. The Phase 2 trial will be conducted in collaboration with premier U.S. transplant ce nters....Kiadis plans to initiate a phase 1/2a clinical trial evaluating use of K-NK cells to treat COVID-19 patients with government grant funding."

Licensing / partnership • New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (clinicaltrials.gov) - P2; N=63; Not yet recruiting; Sponsor: Kiadis Pharma

New P2 trial • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

Kiadis announces new data validating and enhancing its PM21 K-NK-cell platform presented today at the ASGCT virtual annual meeting (GlobeNewswire) - "The first set of data (abstract #427) demonstrates similarity between K-NK cells produced using Kiadis’ feeder cell technology (FC21) and K-NK cells produced using Kiadis’ membrane particle technology (PM21). The second set of data (abstract #765) relate to an enhanced K-NK cell production platform called PM21.Fc. The data in the second poster show that K-NK cell production using feeder cells or particles with an added Fc domain not only increases K-NK cell expansion, but also improves cytotoxicity and antibody-dependent cell-mediated cytotoxicity...The bridging data presented today supported the recent U.S. Food and Drug Administration’s approval of Kiadis’ investigational new drug application, enabling the Company to proceed directly into a Phase 2 study (called the NK-REALM study) of K-NK002..."

New P2 trial • Preclinical • Oncology

Kiadis Pharma announces €12 million private placement with a U.S. healthcare investor (GlobeNewswire) - "'...we expect to provide updates at upcoming medical meetings, including the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA)'...The proceeds from this private placement will be used to fund the development of Kiadis’ K-NK cell therapy programs, including the clinical development of K-NK002 as an adjunctive therapy for patients with blood cancer undergoing a hematopoietic stem cell transplant, the development of K-NK003 for the treatment of acute myeloid leukemia..."

Clinical data • Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Kiadis Pharma announces €5 million private placement with Life Sciences Partners (GlobeNewswire) - "The proceeds from this private placement will be used to fund the development of Kiadis’ K-NK cell therapy programs, including the clinical development of K-NK002 as an adjunctive therapy for patients with blood cancer undergoing a hematopoietic stem cell transplant, the development of K-NK003 for the treatment of acute myeloid leukemia, and the research and development of the company’s K-NK platform for solid tumor indications."

Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Kiadis Pharma announces U.S. FDA approval to start NK-REALM Phase 2 clinical trial for natural killer (NK) cell therapy produced with PM21 (GlobeNewswire) - "Kiadis Pharma N.V...announced that it has received approval from the U.S. Food and Drug Administration (FDA) to start its NK-REALM phase 2 clinical trial, which the Company submitted through an investigational new drug (IND) application in April 2020...The study... will enroll 63 patients..."

IND • New P2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Kiadis Pharma files first investigational new drug application with the U.S. FDA for natural killer (NK) cell therapy produced with PM21 (GlobeNewswire) - "Kiadis Pharma N.V...announced that is has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the Company’s natural killer cell therapy product K-NK002...The Company plans to initiate a Phase 1/2 study with leading transplant centers in the U.S. to evaluate K-NK002 once it receives FDA approval for the IND....The Phase 1/2 study, called NK-REALM (haploidentical NK-cells to prevent post-transplant RElapse in AML and MDS), will evaluate the use of K-NK002 as an adjunctive therapy for blood cancer patients undergoing a haploidentical HSCT with the current standard of care, post-transplant cyclophosphamide (PTCy) protocol."

IND • New P1/2 trial