Shanghai, China and New Jersey, U.S., July 26, 2021 — Laekna Therapeutics, an emerging innovative pharma company based in China’s “Zhangjiang Pharma Valley” and New Jersey in the U.S. and focused on developing new groundbreaking innovative therapies to treat cancer and liver diseases, 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.

ePoster

A Phase I Dose-Escalation Study Of LAE001 In Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Presentation Number:597P

Speakers:Dingwei Ye (Shanghai, China)

This ClinicalTrials NCT03843918 is a phase I monotherapy dose-escalation study of LAE001, in patients with metastatic castration-resistant prostate cancer (mCRPC).  LAE001 is the first CYP17/CYP11B2 dual inhibitor globally. It is a novel, potent, non-steroidal, reversible dual inhibitor of CYP17 and CYP11B2 (aldosterone synthase) that blocks both androgen and aldosterone synthesis, Therefore, unlike abiraterone acetate, LAE001 does not need a co-medication of prednisone. Laekna plan to further develop LAE001 to treat patients with mCSPC, who usually have a much longer treatment duration, and would benefit more from using LAE001.

ePoster

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

Presentation Number: 599P

Speakers: Alberto Bessudo (Encinitas, CA, United States of America)

This ClinicalTrials NCT04060394 is a phase I combination dose-escalation study of LAE001/prednisone plus afuresertib in patients with metastatic castration-resistant prostate cancer (mCRPC) following multiple lines of prior treatments including at least one line of new anti-androgen or AR (NAAR). Afuresertib (LAE002) is an oral, small molecule pan-AKT kinase inhibitor, that has been investigated in over 10 clinical trials, including ovarian cancer, gastric cancer, multiple myeloma, and melanoma, and demonstrated strong anti-cancer activities and a tolerable safety profile. The combination therapy of LAE001 plus afuresertib is expected to provide treatment benefit for patients with PTEN/PIK3CA/AKT alterations.

Abstract titles are available at the link Below: https://cslide.ctimeetingtech.com/esmo2021/attendee/confcal_4/presentation/list?q=LAE001

Further information will be available when posters are released on 13 September 2021 00:05 CEST (Central European Summer Time) on ESMO website.

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 About European Society for Medical Oncology (ESMO) Congress 2021

The ESMO Congress is one of the most influential oncology forums, where participants present the latest advances in the treatment of cancer and have cross-discipline exchanges and discussions. In response to the COVID-19 pandemic, the congress will be held virtually September 16-21, 2021.

About CYP17A1/CYP11B2 dual inhibitor (LAE001)

LAE001 is the first CYP17/CYP11B2 dual inhibitor globally. It is a novel, potent, non-steroidal, reversible dual inhibitor of CYP17 and CYP11B2 (aldosterone synthase) that blocks both androgen and aldosterone synthesis. It will be used as a treatment option for metastatic prostate cancer.

Compared to Abiraterone acetate, a CYP17 enzyme inhibitor that causes hyperaldosteronism, which requires long-term use of corticosteroids and may cause serious side effects, LAE001 has demonstrated similar therapeutic efficacy and improved safety profile in patients with mCRPC. Due to its dual inhibition of both CYP17 and CYP11B2, two critical enzymes for testosterone and aldosterone synthesis, LAE001 does not increase aldosterone level, therefore reduces the risk of cardiovascular toxicity and hepatotoxicity.

About Afuresertib（LAE002）

Afuresertib (LAE002) is a differentiated oral, small molecule pan-AKT kinase inhibitor that has been investigated in over 10 Phase 1/2 clinical trials, including ovarian cancer, gastric cancer, multiple myeloma, and melanoma. These studies have demonstrated that afuresertib has strong anti-cancer activities and a tolerable safety profile. The global randomized, open-label, multi-center Phase 2 PROFECTA-II clinical trial of afuresertib is the world’s first registration-directed clinical study of a pan-AKT kinase inhibitor to treat platinum-resistant ovarian cancer.

In recent years, AKT (a serine/threonine-protein kinase) has emerged as an important mechanism in oncology, as it plays an important role in regulating various cell functions such as metabolism, survival, proliferation, tissue invasion, and chemotherapy resistance. PTEN deletion and AKT/PIK3CA alteration may lead to excessive activation of the AKT signaling pathways, which is one of the key drivers for cancer growth. The increased activation of the AKT signaling pathway is particularly common in recurrent ovarian cancer, breast cancer, and prostate cancer.

About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is an emerging innovative pharma company based in China’s “Zhangjiang Pharma Valley” and New Jersey in the US, focusing on developing new ground-breaking innovative therapies to treat cancer and liver diseases.

Laekna Therapeutics has adopted a two-pronged strategy in new drug development. On  one hand, it continues to enrich its portfolio by introducing global new drugs with the clinical Proof of Concept. The company has obtained the global exclusive rights of four new drug candidates from Novartis. On the other hand, the company’s self-developed innovative drugs will soon enter clinical development stage.

Laekna has set up a team of top global pharmaceutical talent. Its leadership team members each have over 20 years of experience in new drug development in China and the US, with an exceptional track record in R&D, new drug approvals and commercialization. Laekna is committed to a science-based, innovation-driven approach to create an international leading clinical research and development platform for the development of first-in-class and best-in-class innovative drugs.

The detail Laekna Therapeutics information can be found from the website: http://www.laeknatp.com

Contact Laekna Therapeutics

ir@laeknatp.com

Corporate and Business Development

Guy Rosenthal (US)

bd@laeknatp.com