On August 24, 2023 Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company dedicated to bringing novel therapies to cancer and liver fibrosis patients worldwide, reported the interim results for the six months ended June 30, 2023, and provided the latest updates on the clinical and preclinical development of its drug candidates (Press release, Laekna Therapeutics, AUG 24, 2023, View Source [SID1234634703]).
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Dr. Chris LU, the Chairman and CEO of Laekna, Inc. said, "The first half of 2023 has been extraordinary for us. Laekna has become a publicly listed company, and our innovative product pipeline has gained recognition from investors and the capital market.
In the second half of 2023, we expect to achieve more milestones and present read-outs of several key clinical trials in major international conferences.
We truly believe that, with our innovation and persistent drive, we can bring hope to patients and create value for the market."
BUSINESS HIGHLIGHTS
– Advancing clinical trials
Afuresertib (LAE002) +Paclitaxel for PROC (PROFECTOR-II), Phase II pivotal
The patients have been fully enrolled and the topline data is expected to be available in the late fourth quarter of 2023. We will discuss with FDA and NMPA for NDA submission in the U.S. and in China, respectively, should the topline data meet the NDA criteria.
Afuresertib +Fulvestrant in HR+/HER2-breast cancer, Phase Ib/III
The patient enrollment has been completed for Phase Ib trial in April 2023. The study has showed promising early results and the results will be presented in the fourth quarter of 2023 in an academic cancer conference. We are currently in discussion with the regulatory agencies to initiate a Phase III pivotal trial.
Afuresertib +LAE001/prednisone in mCRPC, Phase II
We have completed the patient enrollment in the U.S. and in South Korea in March 2023. The study demonstrated promising treatment benefit for mCRPC patients. The study readouts will be presented in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. A following pivotal trial design will be discussed with the regulatory agencies.
Afuresertib +LAE005+nab-paclitaxel in TNBC, Phase I
We have completed the dose escalation phase and determined RP2D. The study demonstrated promising treatment benefit for TNBC patients, and the detailed results will be orally presented in the Chinese Society of Clinical Oncology (CSCO) 2023.
Afuresertib +Sintilimab+paclitaxel in CC and EC, Phase I
We have completed three out of four cohorts of the dose escalation study and have observed high response rate in cervical cancer (CC) and endometrial cancer (EC) patients who have been treated up to 3 lines of SOCs including PD-1 drugs and/or chemotherpy.
– Discovery of preclinical candidates
LAE102 IND approval
LAE102 is our first internally discovered antibody. We have obtained the IND approval from FDA in May 2023. We will first investigate LAE102 in cancer indications, and will explore LAE102 late on in other disease indications, such as obesity and metabolic diseases, pulmonary arterial hypertension, etc.
Pre-clinical candidates (PCC) declaration
We have advanced three PCC drug candidates from our internal discovery platform: LAE111, a LILRB1 and LILRB2 bispecific antibody; LAE113, a TIGIT-PVRIG bispecific antibody; and LAE112, a FGFR2b monoclonal antibody.
EXPECTED UPCOMING MILESTONES
Presenting Afuresertib+LAE005+nab-paclitaxel Phase I clinical study results as an oral presentation at the CSCO 2023 in Xiamen, China in September 2023.
Presenting Afuresertib+LAE001 Phase I/II clinical study results as a poster presentation at the ESMO (Free ESMO Whitepaper) 2023 in Madrid, Spain in October 2023.
Presenting LAE111/LILRB1-2 bispecific antibody as a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th annual meeting in San Diego, California, U.S., in November 2023.
Presenting LAE113/TIGIT/PVRIG bispecific antibody as a poster presentation at the SITC (Free SITC Whitepaper) 38th annual meeting in San Diego, California, U.S., in November 2023.
Presenting Afuresertib+fulvestrant Phase Ib clinical study results in the fourth quarter of 2023.
FINANCIAL HIGHLIGHTS
As of June 30, 2023, the Company’s cash and cash equivalents amounted to RMB837million and total assets amounted to RMB1,063million. We remained committed to investing in research and development, with research and development expenses totaling RMB102million for the six months ended June 30, 2023.