KAND145 / Kancera - LARVOL DELTA

Evaluation of Safety, Tolerability, Pharmacokinetics, Food Effect and Interaction With Midazolam in Healthy Volunteers After Oral Single and Multiple Ascending Dosing of KAND145 (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Kancera AB | Recruiting ➔ Completed | N=88 ➔ 50 | Trial completion date: Sep 2024 ➔ Apr 2024 | Trial primary completion date: Sep 2024 ➔ Apr 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

Evaluation of Safety, Tolerability, Pharmacokinetics, Food Effect and Interaction With Midazolam in Healthy Volunteers After Oral Single and Multiple Ascending Dosing of KAND145 (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Kancera AB

Trial completion date • Oncology • Ovarian Cancer • Solid Tumor

Evaluation of Safety, Tolerability, Pharmacokinetics, Food Effect and Interaction With Midazolam in Healthy Volunteers After Oral Single and Multiple Ascending Dosing of KAND145 (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Kancera AB | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Ovarian Cancer • Solid Tumor

Kancera reports that the phase I study of KAND145 has received regulatory approval (Kancera Press Release) - "Kancera AB...reports that the Finnish regulatory agency (FIMEA) has approved Kancera’s application to conduct a phase I study of KAND145, the company’s second generation fractalkine blocking candidate drug....The application has been submitted through the new centralized EMA process for clinical studies that became mandatory on February 1, 2023. Kancera will now start enrollment of subjects and expect to present top line study results in the second quarter of 2024."

P1 data • Trial status • Oncology

Evaluation of Safety, Tolerability, Pharmacokinetics, Food Effect and Interaction With Midazolam in Healthy Volunteers After Oral Single and Multiple Ascending Dosing of KAND145 (clinicaltrials.gov) - P1 | N=88 | Not yet recruiting | Sponsor: Kancera AB

New P1 trial • Oncology • Ovarian Cancer • Solid Tumor

Kancera has submitted application to conduct First-In-Human study of KAND145 (Market Screener) - "Kancera today reports that the company has submitted the regulatory application to conduct a First-In-Human study of its Fractalkine blocker KAND145....The regulatory application has been submitted via the new central EMA process for clinical studies, that became mandatory from February 1, 2023....The review lead time is expected to be somewhat longer than the previous national processes and, as a consequence, regulatory approval and start of the study is expected in Q3 2023. Kancera is planning to report study results before the end of the year 2023. This planned timeline is well in line with Kancera’s long term development plan for ovarian cancer and the objective to switch over from KAND567 to KAND145 after the KANDOVA-study has been completed in 2024."

Clinical data • New trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

The Japan patent office has issued a patent that protects the manufacturing processes for KAND567 and KAND145 (Market Screener) - "Kancera today reports that the Japan patent office has issued a patent that protects the manufacturing processes for KAND567 and KAND145. The patent, JP7225379, is owned by Kancera and is valid until 2039....This patent concerns Kancera’s two drug candidates KAND567 and KAND145....The KANDOVA-study is a combined phase Ib/IIa study of KAND567 in combination with carboplatin therapy in ovarian cancer patients with relapsed disease. Patient recruitment is planned to start in Q2 2023 and top line results are expected to be presented during the second half of 2024. KAND145 is Kancera’s second generation Fractalkine blocking drug candidate and a phase I First-In-Human study is planned to be conducted and reported during 2023."

New P1 trial • P1/2 data • Patent • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Kancera provides operational update for its Fractalkine-blocking drug candidates KAND567 and KAND145 (Market Screener) - "Kancera AB...reports that the US patent office (USPTO) has issued a patent that protects the manufacturing processes for KAND567 and KAND145. The patent, 11,542,281, is owned by Kancera and is valid until 2039....The preparations for starting clinical development of KAND145 are on track and a phase Ia study in healthy volunteers is planned to start in Q2 2023."

New P1 trial • Patent • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Kancera reports promising preclinical results from studies of its Fractalkine axis blocking drug candidates in B-cell lymphoma (PharmiWeb) - "Kancera is hereby reporting promising results showing that its Fractalkine axis blocking candidate drugs KAND567 and KAND145; increase cell death of CLL cells taken from patients with progressive disease by blocking their nursing cells; leave non-tumor promoting healthy monocytes and B-cells functionally active."

Preclinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Kancera reports convincing preclinical results and decision to initiate clinical development of KAND567 in ovarian cancer (Kancera Press Release) - "Kancera has now confirmed in mouse studies that treatment with its Fractalkine-blocking drugs in combination with platinum-based chemotherapy reduces tumor volume, even in a cancer cell line that is platinum resistant and highly aggressive. The effect can be associated with DNA damage and cancer cell death. In addition, the new studies show that the treatment causes reduced numbers of cells in the microenvironment of the cancer cell that protects the tumor from platinum-based chemotherapy....Kancera has made the decision to conduct a fully financed phase Ib-study of KAND567 in ovarian cancer patients that have relapsed after platinum-based chemotherapy. The goal is to file a regulatory application during the fourth quarter this year and initiate the study in the first half of 2023....In parallel with the clinical studies of KAND567 in ovarian cancer, the company is advancing its development of KAND145, aiming to initiate phase Ia studies during the first half of 2023."

New P1 trial • Preclinical • Regulatory • Gynecologic Cancers • Oncology • Ovarian Cancer