DSP-107 / Kahr Medical - LARVOL DELTA

A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Kahr Bio Australia Pty Ltd

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies (clinicaltrials.gov) - P1 | N=25 | Terminated | Sponsor: Kahr Medical | N=36 ➔ 25 | Trial completion date: Jun 2025 ➔ Oct 2025 | Active, not recruiting ➔ Terminated; Slow enrolment

Enrollment change • Trial completion date • Trial termination • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Phase 2 dose expansion study of DSP107, a first-in-class bi-specific 4-1BB T-cell engager, with and without atezolizumab in metastatic MSS colorectal cancer patients. (ASCO 2025) - P1/2 | "These data suggest that the combination of DSP107 with PD(L)1 blockade has anti-tumor activity and provides clinical benefit in third line metastatic MSS CRC including in patients with liver metastases. Updated survival data will be presented at the conference. A Phase 2 randomized controlled study is currently in planning to confirm this preliminary efficacy signal."

Clinical • Metastases • P2 data • Anemia • Colorectal Cancer • Fatigue • Hepatocellular Cancer • Oncology • Solid Tumor • CD47 • SIRPA

KAHR Bio Announces Positive Phase 2 Results of DSP107 in Combination with anti-PD-L1 in Colorectal Cancer (PRNewswire) - P1/2 | N=125 | NCT04440735 | "The results were presented...at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting....Results from the completed dose expansion cohort show that DSP107 monotherapy and combination treatment with atezolizumab were well tolerated with no dose limiting toxicities. The median OS from the efficacy-evaluable patients who received DSP107 monotherapy (n=19) and combination therapy with atezolizumab (n=21) has not been reached, but currently (May 2025 cutoff) stands at 8.1 and 17 months, respectively. Disease control was demonstrated in 21% (monotherapy) and 62% (combination) of evaluable patients including a patient who achieved a complete response (> 2.5 years) and a patient with a deep (86% target lesion reduction) and durable (> 16 months) confirmed partial response and disappearance of pulmonary and hepatic metastases."

P2 data • Colorectal Cancer

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Kahr Medical | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=125 | Active, not recruiting | Sponsor: Kahr Medical | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • NTRK • ROS1

A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=125 | Recruiting | Sponsor: Kahr Medical | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • NTRK • ROS1

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients with Hematological Malignancies (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Kahr Medical | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Aug 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

#ESMOGI24 thrilled to present mature data from phase 2 #CRC expansion cohort of ongoing DSP107+atezolizumab trial. Appealing results in MSS CRC 3rd L & beyond suggesting synergy w this 1st in class trimeric fusion protein 😇✨ @UPMCHillmanCC @UPMCPhysicianEd @OncoAlert

Phase II dose expansion study of DSP107, a first-in-class fusion protein targeting CD47 and 4-1BB, in combination with atezolizumab in patients with advanced MSS colorectal cancer (ESMO-GI 2024) - P1/2 | "DSP107 demonstrated a distinct safety and efficacy profile. These phase 2 data suggest that the combination of DSP107 with PD(L)1 blockade has anti-tumor activity in MSS CRC including in patients with liver metastases and warrants further clinical investigation."

Clinical • Combination therapy • Metastases • P2 data • Anemia • Colorectal Cancer • Eosinophilia • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Oncology • Solid Tumor • BRAF • KRAS • SIRPA

Phase 1 dose escalation study of DSP107, a first-in-class CD47 and 4-1BB targeting fusion protein, in combination with atezolizumab in patients with advanced solid tumors. (ASCO 2023) - P1/2 | "DSP107 is a novel, CD47 and 4-1BB targeting fusion protein with a differentiated safety, binding and pharmacodynamic profile compared to other CD47 and 4-1BB targeting agents. These Phase 1 data suggest that the combination of DSP107 with PD(L)1 blockade may have anti-tumor activity in cold tumors such as MSS-CRC. Clinical trial information: NCT04440735."

Clinical • Combination therapy • Metastases • P1 data • Anemia • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • BRAF • CD47 • KRAS • SIRPA

KAHR Reports Dose Escalation Results from Phase I Trial of DSP107 in Combination with anti-PD-L1 in Patients with Advanced Solid Tumors (PRNewswire) - P1/2 | N=125 | NCT04440735 | Sponsor: Kahr Medical | "Results of the completed dose escalation part of the study show that DSP107 in combination with atezolizumab was well tolerated (n=19) with no dose limiting toxicities (DLT's) and no hematological or hepato-toxicities up to and including the highest dose tested (10 mg/kg)....At the highest dose (10 mg/kg) of DSP107, which was selected for the expansion cohorts, the combined treatment demonstrated a disease control rate (DCR) of 57% (4/7 patients with objective response or stable disease). Deep and durable objective responses were observed in 2 of 3 patients with MSS-CRC, with target lesion shrinkage of 73% and 83% including disappearance of pulmonary and hepatic target lesions in one patient and response durability currently standing at 10 and 9 months, respectively."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of DSP107 Alone and in Combination With Atezolizumab for Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=125 | Recruiting | Sponsor: Kahr Medical | Trial completion date: Aug 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Sep 2024

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • NTRK • ROS1

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Kahr Medical | Trial completion date: Apr 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ Aug 2024

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

[VIRTUAL] DSP107, a Novel Bi-Functional Fusion Protein That Combines Inhibition of CD47 with Targeted Activation of 4-1BB to Trigger Innate and Adaptive Anticancer Immune Responses (ASH 2020) - "The mainstay of treatment for Diffuse Large B cell Lymphoma (DLBCL) is conventional chemotherapy combined with anti-CD20 monoclonal antibody rituximab (RTX). Moreover, binding of DSP107 to CD47 enables the 4-1BBL-mediated costimulation of antitumor T cell cytotoxicity. Thus, DSP107 activates both innate and adaptive anticancer immunity and may be of use for the treatment of DLBCL alone or in combination with RTX."

IO Biomarker • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of DSP107 Alone and in Combination With Atezolizumab for Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=100; Recruiting; Sponsor: Kahr Medical; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Myeloma Investment Fund Invests in KAHR to Explore Potential of KAHR's Lead Immunotherapy Drug Candidate for the Treatment of Multiple Myeloma (PRNewswire) - "KAHR...and the Myeloma Investment Fund (MIF)...announced that the MIF has invested in KAHR to explore the potential of DSP107, KAHR's lead immunotherapy drug candidate, for the treatment of multiple myeloma. 'We are thrilled to partner with KAHR to help advance DSP107 as a potential drug candidate for multiple myeloma'....Together with the current investment, KAHR has raised a total of $59 million since June 2021 in private placements...."

Financing • Hematological Malignancies • Multiple Myeloma • Oncology

Phase 1 dose escalation study of DSP107, a first-in-class CD47 and 4-1BB targeting multifunctional immune-recruitment protein, in patients with advanced solid tumors. (ASCO 2022) - P1/2 | "DSP107 is a novel, CD47 and 4-1BB targeting fusion protein with a differentiated safety, binding and pharmacodynamic profile compared to other CD47 and 4-1BB targeting agents."

Clinical • P1 data • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Oncology • Solid Tumor • CD47 • SIRPA

DSP107 combines inhibition of CD47/SIRPα axis with activation of 4-1BB to trigger anticancer immunity. (PubMed, J Exp Clin Cancer Res) - "DSP107 effectively (re)activated innate and adaptive anticancer immune responses and may be of therapeutic use alone and in combination with rituximab for the treatment of DLBCL patients."

Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD47 • SIRPA

KAHR Announces Publication of Preclinical Data Indicating Monotherapy and Combination Treatment Potential of its Investigational Anti-CD47 Fusion Protein (PRNewswire) - "KAHR...announced publication of preclinical data supporting the development of DSP107...The preclinical studies were designed to evaluate the potential for clinical development of DSP107 as monotherapy and in combination with standard of care anti-CD20 monoclonal antibody, rituximab, for Diffuse Large B Cell Lymphoma (DLBCL) patients. In these studies, it was demonstrated that: DSP107 alone or in combination with rituximab significantly increased macrophage- and PMN-mediated phagocytosis and trogocytosis, respectively, of DLBCL cells in culture; DSP107 increased T cell activation by 4-1BB costimulatory signaling only upon concomitant binding to CD47, which supports the targeted dual mechanism of action of DSP107; In a DLBCL mouse model, treatment with DSP107 significantly inhibited tumor growth..."

Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

KAHR and Cancer Focus Fund Announce First Patient Dosed in Phase 1b Clinical Trial of Anti-CD47 Product Candidate DSP107 in Blood Cancers (PRNewswire) - "KAHR...announced that the first patient has been dosed in a Phase 1b clinical trial of DSP107, KAHR's CD47x41BB targeting fusion protein, in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The clinical trial is being funded by a previously announced investment from Cancer Focus Fund...The two-part open label, dose escalation study is being conducted at MD Anderson and... evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of DSP107 as monotherapy and in combination with azacitidine or with azacitidine plus venetoclax in patients with relapsed/refractory AML or in MDS patients..."

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

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Kahr Medical | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Kahr Medical; Initiation date: Oct 2021 ➔ Jan 2022

Clinical • Trial initiation date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

KAHR to Host Key Opinion Leader Webinar on the Potential of CD47 Therapeutics for the Treatment of Solid Tumor and Hematologic Malignancies (GlobeNewswire) - "Chief Medical Officer, Dr. Adam Foley-Comer, MD will discuss clinical data from the ongoing Phase I/II study in advanced solid tumors evaluating DSP107, KAHR’s lead anti-CD47 candidate. DSP107 targets CD47-overexpressing tumors, simultaneously blocking macrophage inhibitory signals and delivering an immune costimulatory signal to activate tumor antigen-specific T-cells."

P1/2 data • Hematological Malignancies • Oncology • Solid Tumor

KAHR Announces FDA Clearance of IND Application for Phase 1b Trial of its Lead Anti-CD47 Candidate in Blood Cancers (PRNewswire) - “KAHR…announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for KAHR's Phase 1b clinical trial of DSP107, a first-in-class CD47x41BB targeting fusion protein, in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)…The Company intends to initiate a Phase 1b open label, dose escalation study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of DSP107 as monotherapy and in combination with azacytidine or with azacytidine plus venetoclax in patients with AML and MDS. The trial, expected to commence in the fourth quarter of 2021...”

IND • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology