LAE005 / Novartis, Laekna Therap - LARVOL DELTA

First-in-human study of FAZ053, an anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody, alone and in combination with spartalizumab, in patients with advanced malignancies. (PubMed, ESMO Open) - P1 | "FAZ053 monotherapy was well tolerated and effective in maintaining disease control in various tumors including ASPS and chordoma. The anticipated synergistic effect of combined programmed cell death protein 1 (PD-1) and PD-L1 inhibition was not observed. These findings contribute to the growing evidence that rare, phenotypically 'immune cold' sarcomas, such as ASPS and chordoma, can become responsive to immune checkpoint inhibitors."

IO biomarker • Journal • P1 data • Alveolar Soft Tissue Sarcoma • Chordoma • Oncology • Sarcoma • Solid Tumor

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1 | N=154 | Terminated | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Terminated; The early termination was based on a business decision that FAZ053 would no longer be formulated and was not a consequence of any safety concern.

Trial termination • Alveolar Soft Tissue Sarcoma • Breast Cancer • Chordoma • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

Phase I/II clinical trials of LAE005, afuresertib plus nab-paclitaxel in patients with advanced solid tumors, primarily in patients with triple-negative breast cancer (TNBC) (AACR 2024) - P1 | "The triplet regimen shows a manageable safety profile and encouraging preliminary activity in the drug resistant TNBC patients. This triplet regimen warrants further investigation."

Clinical • Metastases • P1/2 data • Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1 | N=154 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2024 ➔ Nov 2024 | Trial primary completion date: Jun 2024 ➔ Nov 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Alveolar Soft Tissue Sarcoma • Breast Cancer • Chordoma • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

PhI to Solid Tumors and PhII to Locally Advanced or mTNBC (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Laekna Limited | Recruiting ➔ Completed

Trial completion • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • ER • HER-2 • PD-L1 • PGR • PI3K • PTEN

Laikai Pharmaceuticals-B (02105) appeared at the 2023 SITC annual meeting with 2 achievements, and the international recognition of its innovation capabilities and configuration value were simultaneously improved. [Google translation] (Investing.com) - "On November 1, at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in San Diego, California, USA, Laika Medical-B (02105) announced the preclinical results of two independently developed new bispecific antibodies in the form of a poster. Data: LILRB1-B2 bispecific antibody (LAE111) that modulates T/NK/myeloid cell function, and TIGIT-PVRIG bispecific antibody (LAE113) that modulates T/NK cell function....When LAE113 is combined with PD-L1 monoclonal antibody (LAE005), it shows a synergistic effect in enhancing the secretion of IFN-γ by CD8+ T cells. In addition, when combined with antibodies that mediate ADCC effects, it significantly enhances the activity of NK cells and the effects of ADCC. LAE113 significantly inhibited tumor growth in the HuPBMC A375 xenograft model, outperforming clinical-stage control antibodies."

Preclinical • Oncology

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

First-in-human study of FAZ053, an anti-PD-L1 mAb, alone and in combination with spartalizumab, an anti-PD-1 mAb, in patients with advanced malignancies (SITC 2018) - P1; "Conclusions SA FAZ053 was well tolerated and the RDE was determined to be 1200 mg Q3W. Clinical activity was observed in a range of indications including chordoma, a rare tumor without standard therapy options."

Clinical • Combination therapy • IO biomarker • P1 data • PD(L)-1 Biomarker • Oncology • Sarcoma • Solid Tumor

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1 | N=154 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2023 ➔ Jun 2024 | Trial primary completion date: Mar 2023 ➔ Jun 2024

Combination therapy • Trial completion date • Trial primary completion date • Alveolar Soft Tissue Sarcoma • Breast Cancer • Chordoma • Immune Modulation • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1 | N=154 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jul 2022 ➔ Mar 2023 | Trial primary completion date: Apr 2022 ➔ Mar 2023

Combination therapy • Trial completion date • Trial primary completion date • Alveolar Soft Tissue Sarcoma • Breast Cancer • Chordoma • Immune Modulation • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1; N=154; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Apr 2022 ➔ Jul 2022

Clinical • Combination therapy • Trial completion date • Alveolar Soft Tissue Sarcoma • Breast Cancer • Chordoma • Immune Modulation • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

IMMUNE CHECKPOINT INHIBITORS PROVIDE FAVORABLE RESPONSES IN PATIENTS WITH RECURRENT CHORDOMA (CTOS 2021) - "Regarding the types of ICI, the majority received pembrolizumab (n=9, 53%), with others receiving durvalumab/tremelimumab (n=5, 29%), FAZ053 (n=2, 12%), and nivolumab/bempegaldesleukin (n=1, 6%). Preliminary data suggest ICI are an effective treatment for recurrent chordoma. Nearly all patients had some clinical benefit to ICI with limited toxicities, and responses were relatively durable, though longer among patients achieving a CR/PR compared to SD. These promising data provide support for the prospective evaluation of ICI in patients with Chordoma."

Checkpoint inhibition • Clinical • Cardiovascular • Chordoma • Gastroenterology • Gastrointestinal Disorder • Immune Modulation • Immunology • Inflammation • Oncology

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1; N=154; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Trial primary completion date: Jun 2021 ➔ Apr 2022

Clinical • Combination therapy • Trial primary completion date • Breast Cancer • Chordoma • Immune Modulation • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1; N=154; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Jun 2021 ➔ Apr 2022

Clinical • Combination therapy • Trial completion date • Breast Cancer • Chordoma • Immune Modulation • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

CMAB Biopharma and Laekna Therapeutics Enter Strategic Agreement for LAE005 Global Development and Commercialization Partnership (PRNewswire) - "CMAB Biopharma…announced a strategic collaboration agreement in Suzhou BioBAY for speedup of Immune Checkpoint Inhibitor (ICI) drug candidate to the clinical trial and future commercialization. According to the agreement, CMAB will provide a full spectrum of CMC services based on the recognized global quality standards for Laekna Therapeutics' anti-PD-L1 antibody (LAE005). Services to be provided by CMAB include technology transfer, process development, GMP clinical drug substance and drug product manufacturing to support IND filing in China and in the US. These services will facilitate the global development and future commercialization of LAE005."

Licensing / partnership • Oncology

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1; N=154; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Nov 2020 ➔ Jun 2021; Trial primary completion date: Nov 2020 ➔ Jun 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Immune Modulation • Oncology • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1; N=315; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting; Trial primary completion date: Feb 2019 ➔ Oct 2019

Enrollment open • Trial primary completion date • Biosimilar • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Non Small Cell Lung Cancer • Oncology • Thyroid Cancer • Triple Negative Breast Cancer • Uterine Cancer

Laekna acquires exclusive global rights to clinical-stage cancer asset (Businesswire) - “Laekna Therapeutics Shanghai Co., Ltd. (Laekna) today announced a new agreement with Novartis giving the China-based biotech company exclusive global rights to Novartis’ anti-PD-L1 Antibody (FAZ053)….As part of this agreement, Novartis will receive an upfront payment, with additional payments at key development milestones as well as royalties on future sales.”

M&A

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1; N=154; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Recruiting ➔ Active, not recruiting; Trial completion date: Nov 2019 ➔ Feb 2020; Trial primary completion date: Nov 2019 ➔ Feb 2020

Clinical • Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1; N=154; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Feb 2020 ➔ Nov 2020; Trial primary completion date: Feb 2020 ➔ Nov 2020

Clinical • Combination therapy • Trial completion date • Trial primary completion date

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (clinicaltrials.gov) - P1; N=155; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Feb 2020 ➔ Nov 2019; Trial primary completion date: Feb 2020 ➔ Nov 2019

Clinical • Combination therapy • Trial completion date • Trial primary completion date