- For the Phase II pivotal trial of Afuresertib (LAE002) + Paclitaxel for platinum-resistant recurrent ovarian cancer (PROFECTOR-II), the patients were fully enrolled and the topline data is expected in the late fourth quarter of 2023

 - For the Phase Ib/III trial of Afuresertib + Fulvestrant for HR+/HER2- breast cancer (BC), the phase Ib read-outs will be disclosed in the fourth quarter of 2023. The Company is in discussion with regulatory agencies to initiate a Phase III pivotal trial

  - The first internally discovered antibody LAE102 has obtained the IND approval from FDA in May 2023. The company will further explore LAE102 in cancer indications, obesity, metabolic diseases, pulmonary arterial hypertension, etc.

 - Cash and cash equivalents were RMB 837 million as of June 30, 2023, while research and development expenses totaled RMB 102 million for the six months ended June 30, 2023

Shanghai, China and New Jersey, U.S., 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, announced today 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.

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) 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 chemotherapy.

 - 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 2023 in Madrid, Spain in October 2023.

● Presenting LAE111/LILRB1-2 bispecific antibody as a poster presentation at the Society for Immunotherapy of Cancer’s (SITC) 38th annual meeting in San Diego, California, U.S., in November 2023.

● Presenting LAE113/TIGIT/PVRIG bispecific antibody as a poster presentation at theSITC 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 RMB 837 million and total assets amounted to RMB 1,063 million. We remained committed to investing in research and development, with research and development expenses totaling RMB102million for the six months ended June 30, 2023.

—End—

For more information, please visit:

https://www.laekna.com/

or https://www.linkedin.com/company/74110713/

Contact Us

IR  ir@laekna.com

Media  communication@laekna.com

Corporate and Business Development  BD@laekna.com

About Laekna

Stock Code: 2105.HK

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapies to cancer and liver fibrosis patients worldwide.

As of June 30, 2023, Laekna has initiated six clinical trials including one pivotal trial for Afuresertib (LAE002), LAE001 and LAE005 to address unmet medical needs in cancers, such as ovarian cancer, breast cancer and prostate cancer. Among the six clinical trials, three are multi-regional clinical trials (MRCTs). 

Laekna’s internal drug discovery platform has discovered 12 drug candidates. LAE102 is our first internally discovered antibody which has obtained the IND approval from FDA in May 2023.

Laekna, Inc. was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023, the stock code is 2105.HK. 

For more information, please visit:  https://www.laekna.com/

Forward-Looking Statements

This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.