LAE001 / Laekna Therap, Novartis - LARVOL DELTA

A Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=33 | Terminated | Sponsor: Laekna Limited | Suspended ➔ Terminated; This is phase I/II study, phase I study completed, phase II study started and enrolled 1 patient. Company strategy consideration to terminated phase 2 study finally.

Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Preclinical development and first clinical use of a radioiodinated CYP17 inhibitor for adrenal theranostics (ESPE-ESE 2025) - "Steroid concentrations of 17- OH-progesterone, DHEA and androstenedione were measured by LC-MS in supernatant after coincubation with the respective compounds and IC50 values were calculated... Ten derivatives of the known CYP17-inhibitor CFG920 showed single-digit nanomolar inhibition of at least one target steroid... The CYP17-targeting radioiodinated compound IPIMA is a promising theranostic agent for adrenocortical tumors."

Preclinical • Adrenal Cortex Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CYP11B1

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC (clinicaltrials.gov) - P1/2 | N=49 | Completed | Sponsor: Laekna Limited | Active, not recruiting ➔ Completed | N=74 ➔ 49 | Trial completion date: Oct 2024 ➔ Mar 2024

Enrollment change • Metastases • Trial completion • Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • PIK3CA • PTEN

Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of LAE002 (Afuresertib) PLUS LAE001 for the Treatment of Prostate Cancer (PRNewswire) - "Laekna, Inc...announced that the company has received approval from the U.S. Food and Drugs Administration for the protocol of the phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) ('LAE201') in patients with metastatic castration-resistant prostate cancer (mCRPC) following standard of care (SOC) treatment."

New P3 trial • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Prostate Cancer

A Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=33 | Suspended | Sponsor: Laekna Limited | N=80 ➔ 33 | Trial completion date: Aug 2022 ➔ Jun 2025 | Unknown status ➔ Suspended | Trial primary completion date: Feb 2022 ➔ Oct 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial suspension • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase I/II efficacy and safety study of LAE001/prednisone and afuresertib in patients with metastatic castration-resistant prostate cancer (mCRPC) following 1-3 lines of standard of care (ESMO 2023) - P1/2 | "Conclusions The combination therapy demonstrated clinical benefit and a tolerable safety profile in mCRPC patients who failed multiple lines of SOC. The preliminary results warrant further evaluation in a phase III pivotal trial."

Clinical • Metastases • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Laekna, Inc. (2105.HK) Announces Interim Results 2023 (PRNewswire) - "EXPECTED UPCOMING MILESTONES: (i) Presenting Afuresertib+LAE005+nab-paclitaxel Phase I clinical study results as an oral presentation at the CSCO 2023 in Xiamen, China in September 2023; (ii) Presenting Afuresertib+LAE001 Phase I/II clinical study results as a poster presentation at the ESMO 2023 in Madrid, Spain in October 2023; (iii) Presenting Afuresertib+fulvestrant Phase Ib clinical study results in the fourth quarter of 2023."

P1 data • P1/2 data • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC (clinicaltrials.gov) - P1/2 | N=74 | Active, not recruiting | Sponsor: Laekna Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • PIK3CA • PTEN

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC (clinicaltrials.gov) - P1/2 | N=74 | Recruiting | Sponsor: Laekna Limited | Trial completion date: Oct 2022 ➔ Oct 2024 | Trial primary completion date: Sep 2022 ➔ Oct 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • PIK3CA • PTEN

[VIRTUAL] A phase I dose-escalation study of LAE001 in patients with metastatic castration-resistant prostate cancer (mCRPC) (ESMO 2021) - P1/2 | "Background: Abiraterone, a CYP17 enzyme inhibitor, blocks the synthesis of androgens but causes the hyperaldosteronism that requires long term steroid use. LAE001 monotherapy is safe and well-tolerated at 50mg BID level (RP2D). The preliminary antitumor activity of LAE001 monotherapy at RP2D level supports the potential clinical benefit of treating pts with mCRPC. Further expansion phase Ib at RP2D is ongoing."

Clinical • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] A phase I dose-escalation study of LAE001/prednisone plus afuresertib in patients with metastatic castration-resistant prostate cancer (mCRPC) following standard of care (SOC) treatment (ESMO 2021) - P1/2 | "The combination therapy of LAE001 75mg BID/prednisone 5mg BID and afuresertib 125mg QD was determined as the RP2D. The preliminary antitumor activity under the RP2D supports the potential clinical benefit for treating dr-mCRPC and moves forward this study to phase II stage."

Clinical • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Laekna Announces First Patient Dosed in South Korea in LAE201INT2101 Phase 1/2 Study (PRNewswire) - "Laekna...announced yesterday that the first patient recently received a dose in the LAE201INT2101 phase I/II study at Seoul National University Hospital. The company's multi-regional clinical trials (MRCTs) now cover China, the United States and South Korea...LAE201INT2101 is a multi-center, open-label, phase I/II dose-escalation and efficacy study of the LAE001 and LAE002 (afuresertib) combination in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression or intolerability following standard of care (SOC) treatment. Laekna has finished the phase I dose-escalation stage and is starting the phase II stage of the Proof-of-Concept study now....In addition to Seoul National University Hospital, Laekna has already initiated trials in four other clinical sites in South Korea. The study is also ongoing in more than 10 sites across the United States."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

Laekna Therapeutics Raises $61 Million in Series D financing (PRNewswire) - "Laekna Therapeutics...announced that it has raised $61 million in Series D financing led by CS Capital with support from Worldstar, and Infinity Capital. Yanchuang Capital as the existing investor continued to support the company with additional funding....Proceeds from the Series D financing will be used to accelerate the clinical development of Laekna's two core product candidates, AKT kinase inhibitor afuresertib (LAE002) and the world's first clinical-stage CYP17/CYP11B2 dual inhibitor (LAE001)."

Financing • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC (clinicaltrials.gov) - P1/2; N=74; Recruiting; Sponsor: Laekna Limited; Trial completion date: Oct 2021 ➔ Oct 2022; Trial primary completion date: Sep 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • PIK3CA • PTEN

Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress (PRNewswire) - P1/2, N=74; NCT04060394; Sponsor: Laekna Limited; “Results: As of 06/29/2021, 14 pts (8 in cohort 1 and 6 in cohort 2) received study treatment with median 12.5 months follow up. The dose of LAE001 75 mg BID/prednisone 5 mg BID and afuresertib 125 mg QD was determined as the RP2D. 2 DLTs were reported in cohort 1 (thrombocytopenia) and cohort 2 (skin rash), respectively, and only one non-DLT grade >= 3 treatment-emergent adverse events (TEAE) (skin rash) in cohort 2 (RP2D). 2 pts had a PSA response (2/10, 20%). Among 5 pts who have measurable lesions, 1 PR and 2 SDs were reported. The 10 evaluable pts on average had failed 3.3 lines of SOC.”

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer

Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress (PRNewswire) - P1/2, N=80; NCT03843918; Sponsor: Laekna Limited; “Phase I dose-escalation and expansion study of LAE001 monotherapy without steroid, in patients with metastatic castration-resistant prostate cancer (mCRPC). LAE001 is the first CYP17A1/CYP11B2 dual inhibitor globally. Results: As of May 25, 2021, 27 pts (16, 5, 3, 3 pts in the 50, 75, 100 and 125 mg BID cohorts, respectively) enrolled in the phase Ia & Ib part and had a median 7.3 months follow up (1-25 months). Based on safety data, 50mg BID of LAE001 was selected as the RP2D; no DLT nor AE leading to discontinuation was reported under the RP2D, and the related serious adverse event (SAE) in the RP2D cohort was 6%. Out of 15 patients treated in 50mg bid cohort, 11 pts (73%) had a >50% best PSA decline from baseline, among whom 6 pts (40%) had >90% PSA decline from baseline. 2 pts (50mg bid) had a PSA response that sustained for >52 weeks; 81% patients are ongoing treatment at the cut-off date.”

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer

Laekna Therapeutics will present two clinical study results in ESMO 2021 (PRNewswire) - "Laekna Therapeutics...announced today that it will present the results from two clinical studies on the treatment of prostate cancer at the European Society for Medical Oncology (ESMO) Congress 2021...a phase I monotherapy dose-escalation study of LAE001, in patients with metastatic castration-resistant prostate cancer (mCRPC)...a phase I combination dose-escalation study of LAE001/prednisone plus afuresertib in patients with metastatic castration-resistant prostate cancer (mCRPC)..."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC (clinicaltrials.gov) - P1/2; N=74; Not yet recruiting; Sponsor: Laekna Limited

Clinical • New P1/2 trial

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC (clinicaltrials.gov) - P1/2; N=74; Recruiting; Sponsor: Laekna Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2; N=80; Recruiting; Sponsor: Laekna Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2; N=80; Not yet recruiting; Sponsor: Laekna Limited

Clinical • New P1/2 trial