IKS03 / Light Chain Biosci, LigaChem Biosci, Iksuda Therap - LARVOL DELTA

IKS03, a Novel CD19-Targeted Antibody Drug Conjugate, Induces Target Dependent In Vivo Cell Killing of B-Cell Lymphoma Xenografts By DNA Crosslinking (ASH 2023) - P1 | "IKS03 demonstrated greater in vivo efficacy than the clinical benchmark ADCs polatuzumab vedotin and loncastuximab tesirine approved for the treatment of patients with B-cell non-Hodgkin lymphomas. This is consistent with the proposed mechanism of action of CD19-mediated delivery of a PBD payload specifically to B-cell tumors. Clinical investigation in patients with advanced B-Cell Non-Hodgkin Lymphomas is being initiated (NCT05365659)."

Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients with Advanced B-Cell Non-Hodgkin Lymphomas (NHL) (ASH 2023) - P1 | "IKS03 demonstrated greater activity than the clinical benchmark ADC loncastuximab tesirine. Secondary objectives include further evaluation of safety, tolerability, immunogenicity and PK profile of IKS03 as well as confirmation of the RP2D. Clinical trial information: NCT05365659."

Clinical • Metastases • P1 data • Burkitt Lymphoma • Cardiovascular • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia • CD19

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Iksuda Therapeutics Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

IKS03, a Next Generation CD19-Targeted Antibody Drug Conjugate, Shows Potent Activity in Preclinical Models of Aggressive B-Cell Lymphomas (ASH 2022) - "Post tumor collection, this patient was refractory to R-CHOP therapy with disease progression within 2 months. In conclusion, IKS03 is highly effective in preclinical MCL and DLBCL xenograft models that contain some of the genetic alterations commonly found in relapsed/refractory NHL patients in need of treatment. Preclinical data further demonstrates that IKS03's advanced ADC design results in specific target-dependent in vitro activity, excellent plasma stability and allows for effective targeting of B-cell tumors while sparing normal CD19-negative cells."

IO biomarker • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CCND1 • CD19 • MYC

"While at #ASH22 we were able to share our IKS03 Preclinical Poster! 👏 #Antibodydrugconjugate #ADC" (@IksudaT)

Preclinical

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Iksuda Therapeutics Ltd. | Trial completion date: Jul 2026 ➔ Jul 2027 | Initiation date: Jul 2022 ➔ Jun 2023 | Trial primary completion date: Jul 2024 ➔ Jul 2025

Trial completion date • Trial initiation date • Trial primary completion date • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Iksuda Therapeutics Ltd.

New P1 trial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

IKS03, a CD19-targeted antibody drug conjugate with enhanced efficacy and tolerability for treatment of B-cell lymphomas (AACR 2022) - "Preclinical data demonstrates that IKS03’s advanced ADC design results in an increased therapeutic margin compared to traditional ADCs with DNA-crosslinking payloads, with increased efficacy and decreased toxicity."

Clinical • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] Advanced ADC Design Shows Marked Increase in Therapeutic Index for Powerful DNA-targeting Payloads (ADC-USA 2021) - "Tumor-selective linker and prodrug technology leads to improved toxicity profiles and therapeutic margins for high potency ADC payloads Case study: Moving IKS03, a best-in-class CD19-targeting ADC with tumor-selective technology, toward the clinic"

Oncology • CD19

LegoChem Biosciences and Iksuda Therapeutics expand License Agreement for development of antibody-drug conjugates (Businesswire) - “Iksuda Therapeutics…announced that it has expanded its research collaboration and License Agreement with LegoChem Biosciences, Inc. (‘LCB’) to explore additional ADC programmes which leverage LCB’s proprietary ADC platform technology…Under this expanded Agreement, Iksuda has now been granted rights for three additional targets, bringing the total number of potential ADC programmes using LCB’s ADC platform technologies to six. Iksuda also gains access to LCB’s innovative and recently discovered novel DNA-modifying payload, supplementing LCB’s proprietary tumour-activated DNA toxins which were included in last year’s License Agreement.”

Licensing / partnership • Oncology

Iksuda Therapeutics Closes $47 Million Financing Round (Businesswire) - “Iksuda Therapeutics….announced it has completed a US $47 million (circa GB £34 million) financing round…The funding will support the advancement of Iksuda’s lead ADC assets and expansion of its payload and conjugation platform technologies…The investment will enable progression of IKS03 to first-in-human phase 1 clinical trials. It will also be used to accelerate the Company’s earlier-stage programmes including IKS04 and IKS012 to IND filing.”

Financing • Oncology

Iksuda Therapeutics raises $47m to progress ADC pipeline (PharmaTimes) - "Newcastle, UK-headquartered Iksuda Therapeutics has announced the closing of a $47m (£34m) financing round, with the funds to be used to support the advancement of its lead antibody drug conjugate (ADC) assets....This includes the company’s lead pre-clinical ADC candidate IKS03, a potentially ‘best-in-class’ CD19-targeted asset for B-cell cancers."

Financing • Hematological Malignancies • Oncology