About Laekna

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company.

Laekna has two Core Products and 13 other pipeline product candidates. Core Product LAE002 is an adenosine triphosphate (ATP) competitive AKT inhibitor for the treatment of ovarian cancer, prostate cancer, breast cancer and PD-1/PD-L1 drug-resistant solid tumors. The other Core Product LAE001 is an androgen synthesis inhibitor that simultaneously inhibits cytochrome P450 family 17 subfamily A member 1 (CYP17A1) and cytochrome P450 family 11 subfamily B member 2(CYP11B2) for the treatment of prostate cancer.

Laekna has initiated one registrational clinical trial and another five clinical trials for our Core Products LAE002 and LAE001. Among these six clinical trials, three are multi-regional clinical trials (MRCTs) designed to address medical needs in the standard of care (SOC)-resistant cancers.

As of the Latest Practicable Date, Laekna owned 163 patents and patent applications (including in-licensed patents and patent applications with global rights).

Laekna’s internal drug discovery primarily focuses on identifying innovative immunology therapies for cancer and liver fibrosis.

Our Vision

We are committed to becoming
an innovative
biopharmaceutical company
that can bring novel therapies
to cancer and liver fibrosis
patients worldwide.

Glossary & abbreviations

MCRPC: metastatic castration-resistant prostate cancer IND: investigational new drug MRCT: multi-regional clinical trial PROC: platinum-resistant ovarian cancer TNBC: triple negative breast cancer ActRIIA: activin receptor type IIA HR+/HER2- breast cancer: the most common type of breast cancer with overexpression of HR and without overexpression of HER2

Board of Directors

Executive Directors

Dr. Chris LU （Chairman）
Dr. Chris LU is the founder, Chairman, Executive Director and CEO of Laekna, Inc. (“Laekna”).

Prior to Laekna, Dr. LU was Executive Director at Novartis AG, where he was responsible for leading the drug discovery platform and multiple disease research programs. He was previously a venture partner at Frontline BioVentures (currently 6 Dimensions Capital), a venture capital firm focusing on investment in healthcare industry.

Dr. LU was one of the first scientists to join the Novartis Institutes for BioMedical Research (“NIBR”). After working at NIBR headquarters in Cambridge, Massachusetts, USA for 4 years, he returned to Shanghai in 2007 to help establish China Novartis Institutes for BioMedical Research (“CNIBR”). He was bestowed Novartis VIVA Award with “Novartis Leading Scientist” honorary title in 2012.

Before joining Novartis, Dr. LU worked at Wyeth Research, a U.S. based pharmaceutical company (currently Pfizer) as the principal scientist and had led multiple drug discovery projects. He had worked in Ontogeny, Inc.(currently Curis), a biotechnology company, in 1998.

Dr. LU received his Bachelor of science degree and Master of science degree in biology department from Nankai University in China. He obtained the Doctor of Philosophy degree from the School of Medicine of the University of North Carolina at Chapel Hill in the United States. Dr. LU was a postdoctoral fellow at Harvard University in the United States.

Ms. Ling XIE
Ms. Xie is Co-founder, Executive Director and Senior Vice President of Laekna, Inc. (“Laekna”), responsible for overseeing global operations, including administration, human resources, finance, legal, IT and compliance. Laekna is a clinical-stage global biotechnology company, dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide.

Ms. Xie has rich experience of operations in multinational companies, such as Novartis and Boehringer-Ingelheim. Before joining Laekna, Ms. Xie served as an executive assistant at China Novartis Institutes for BioMedical Research (CNIBR), supporting the head of CNIBR.

Ms. Xie was accredited as national second-level psychological counselor by Ministry of Human Resources and Social Security of the PRC, and she was certified as Myers-Briggs Type Indicator (MBTI) practitioner by Center for Applications of Psychological Type in the United States in 2012.

Ms. Xie received her bachelor’s degree in law from East China University of Political Science and Law in China.

Dr. Justin GU
Dr. Justin GU joined Laekna, Inc. (“Laekna”) in 2020 as Chief Scientific Officer responsible for overseeing Group’s pre-clinical discovery research works. He was appointed as an executive Director in May 2022.

Dr. GU has over 20 years of experience in the biotechnology and pharmaceutical industry. Before joining Laekna, Dr. GU was a venture partner at GP Healthcare Capital Co., Ltd. in 2019.

Dr. GU worked at Novartis for 18 years. From 2001 to 2008, he served as a scientist and a group leader at Genomics Institute of the Novartis Research Foundation (GNF) in San Diego, USA. In 2008, Dr. GU returned to China and joined the newly established China Novartis Institute for Biomedical Research (CNIBR), first served as an investigator and then as the director of the lead discovery department.

Dr. GU received his Bachelor’s degree in biology from Nankai University in China; Master’s degree from the Institute of Botany, The Chinese Academy of Sciences; and the Doctor of Philosophy degree in biochemistry from the Ohio State University in the United States. Before entering the pharma industry, Dr. GU worked at Massachusetts Institute of Technology for three years as a postdoctoral fellow.
Non-executive Directors

Dr. David WANG
Dr. Wang was appointed as a Director in July 2019 and re-designated as a non-executive Director in May 2022.

Dr. Wang has over 20 years of experience in the medical industry. Dr. Wang is a partner and senior managing director of Asia at OrbiMed Advisors LLC, an investment fund with a focus on healthcare industry, where he has worked since August 2011.

Dr. Wang had also served or has been serving at multiple publicly listed companies. Dr. Wang received his Bachelor’s degree in medicine from Beijing Medical University (北京医科大学) (currently known as Peking University Health Science Center (北京大学医学部) in China in July 1986. He received his Doctor of Philosophy degree in developmental biology from California Institute of Technology in the United States in June 1995.

Dr. Wang is a director of Laekna Therapeutics.

Ms. Dongmei JI
Ms. Ji was appointed as a Director in April 2022 and re-designated as a non-executive Director in May 2022.

Ms. Ji has over 15 years of experience in equity investment and nearly 20 years of experience in financial institutions. She joined Haitong-Fortis Private Equity Fund Management Co., Ltd. (海富产业投资基金管理有限公司) as an investment manager in 2004, primarily responsible for project management and investment management and she left the company in 2013. From May 2013 to July 2015, she served as the managing director and member of the investment committee of GP Capital Co., Ltd. (金浦产业投资基金管理有限公司), primarily responsible for project management and investment management. Since August 2015, she has been a president, founding managing partner and chairwoman of the investment committee of GP Healthcare Capital Co., Ltd. (上海金浦医疗健康股权投资基金管理有限公司), responsible for managing the overall operation of the company and the fund.

Ms. Ji received her Bachelor’s degree in microbiology and Master’s degree in genetics from Fudan University (复旦大学) in China in July 1996 and in July 1999, respectively.

Ms. Yuan SUN
Mr. Sun was appointed as a Director in April 2022 and re-designated as a non-executive Director in May 2022.

Mr. Sun has over 8 years of experience in investment management industry. He is currently investment director of CS Capital Co., Ltd. (国投招商投资管理有限公司).

Mr. Sun received his Bachelor’s degree in computer science and technology from Tsinghua University (清华大学) in China in July 2010. He received his Master’s degree in finance from Washington University in St. Louis in the United States in December 2012. He obtained the Chartered Financial Analyst qualification in November 2017.

Milestones

2016

Laekna establised

2017

In June, we acquired global licenses of LAE001 from Novartis

2017

In June, we acquired global licenses of LAE001 from Novartis

2016

Laekna establised

2018

In January, we completed onshore Series Seed financing

In May, we completed Series A financing

In May, we acquired global licenses of LAE002 and LAE003 from Novartis

2019

In January, we received IND approval for Phase I/II clinical trial of LAE001 for mCRPC from NMPA in China

In May, we received IND approval for Phase I LAE002 and LAE001 combination MRCT study in patients with mCRPC from FDA in the United States

In November, we received IND approval for pivotal Phase II MRCT study of LAE002 plus paclitaxel versus paclitaxel in patients with PROC from FDA in the United States

2020

In February, we completed Series B financing

In February, we acquired global license of LAE005 from Novartis

In August, we received IND approval for pivotal Phase II MRCT study of LAE002 plus paclitaxel versus paclitaxel in patients with PROC from NMPA in China

In December, we received IND approval for Phase I/II clinical trial of LAE002 combined with LAE005 and nab-paclitaxel for TNBC from NMPA in China

2021

In February, we completed Phase I LAE002 and LAE001 combination study in patients with mCRPC in the United States, and entered Phase II stage

In March, we completed Series C financing

In May, we declared the first internally discovered pre-clinical candidate, ActRIIA antibody for immunotherapy of cancers and advanced it to IND-enabling studies

In June, we received IND approval for Phase Ib/III study of LAE002 plus fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer from FDA in the United States

In July, we entered into a collaboration agreement with Innovent to develop a combination therapy of LAE002 with sintilimab, targeting patients with solid tumors with prior PD-1/PD-L1 treatments

In August, we received IND approval for Phase Ib/III study of LAE002 plus fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer from NMPA in China

In September, we completed Phase I clinical trial of LAE001 for mCRPC in China, and entered Phase II stage

2022

In January, we received IND approval for Phase I/II combination therapy of LAE002 with sintilimab, targeting patients with solid tumors with prior PD-1/PD-L1 treatments from NMPA in China

In March, we received IND approval for Phase II LAE002 and LAE001 combination study in patients with mCRPC in South Korea

In April, we completed Series D financing

2016

Laekna establised

2017

In June, we acquired global licenses of LAE001 from Novartis

2017

In June, we acquired global licenses of LAE001 from Novartis

2016

Laekna establised

2018

In January, we completed onshore Series Seed financing

In May, we completed Series A financing

In May, we acquired global licenses of LAE002 and LAE003 from Novartis

2019

In January, we received IND approval for Phase I/II clinical trial of LAE001 for mCRPC from NMPA in China

In May, we received IND approval for Phase I LAE002 and LAE001 combination MRCT study in patients with mCRPC from FDA in the United States

In November, we received IND approval for pivotal Phase II MRCT study of LAE002 plus paclitaxel versus paclitaxel in patients with PROC from FDA in the United States

2020

In February, we completed Series B financing

In February, we acquired global license of LAE005 from Novartis

In August, we received IND approval for pivotal Phase II MRCT study of LAE002 plus paclitaxel versus paclitaxel in patients with PROC from NMPA in China

In December, we received IND approval for Phase I/II clinical trial of LAE002 combined with LAE005 and nab-paclitaxel for TNBC from NMPA in China

2021

In February, we completed Phase I LAE002 and LAE001 combination study in patients with mCRPC in the United States, and entered Phase II stage

In March, we completed Series C financing

In May, we declared the first internally discovered pre-clinical candidate, ActRIIA antibody for immunotherapy of cancers and advanced it to IND-enabling studies

In June, we received IND approval for Phase Ib/III study of LAE002 plus fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer from FDA in the United States

In July, we entered into a collaboration agreement with Innovent to develop a combination therapy of LAE002 with sintilimab, targeting patients with solid tumors with prior PD-1/PD-L1 treatments

In August, we received IND approval for Phase Ib/III study of LAE002 plus fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer from NMPA in China

In September, we completed Phase I clinical trial of LAE001 for mCRPC in China, and entered Phase II stage

2022

In January, we received IND approval for Phase I/II combination therapy of LAE002 with sintilimab, targeting patients with solid tumors with prior PD-1/PD-L1 treatments from NMPA in China

In March, we received IND approval for Phase II LAE002 and LAE001 combination study in patients with mCRPC in South Korea

In April, we completed Series D financing

Glossary & abbreviations

Scientific Advisory Board

Jeff Porter Ph.D.

Chairman/Advisor

Advisor

Jeff Porter, Ph.D. was appointed as Chairman of Scientific Advisory Board of Laekna in March 2022. He has over 25 years of global R&D leadership and strategic expertise, having most recently served as Vice President, Global Head of Chemical Biology & Therapeutics for the Novartis Institutes for BioMedical Research (NIBR).

As a senior member of the Leadership team at the NIBR from its inception, Jeff developed an enabling target and lead discovery approach focused on biological pathways, a fundamental tool for the success of NIBR. The diverse research group he led developed a dynamic multidisciplinary platform that merged pathway biology and disease area expertise with enabling technology. Their efforts led to numerous seminal discoveries, from fundamental insights to novel targets and clinical candidates that showed benefits in early proof of concept human trials and beyond. Examples include the discovery of multiple key targets/drug candidates in the core pathways of Developmental biology as well as the ‘drug-ability’ of RNA splicing.

Prior to Novartis, Jeff worked with Ontogeny (now Curis, Inc.) for over 5 years, starting as a staff scientist and advancing to serve as its Vice President of Research. He received a Ph.D. in Biochemistry at the Johns Hopkins University School of Medicine and performed postdoctoral work in the Department of Molecular Biology and Genetics in the Howard Hughes Medical Institute at Johns Hopkins.

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Peter ten Dijke Ph.D.

Advisor

PROFESSOR | Molecular Cell Biology Leiden University

Dr. Peter ten Dijke was appointed as advisor of Scientific Advisory Board of Laekna in 2021. He is the professor of molecular cell biology at Leiden University. His laboratory studies how subverted TGF family signaling is involved in cancer, vascular and bone diseases. They combine chemistry with biology to develop novel synthetic molecules for therapeutic gain.

He received his Ph.D. degree in 1991 from Wageningen University, The Netherlands based on his research on the identification of the third isoform of TGF-β performed at Oncogene Science, Inc., New York, USA. He did his postgraduate studies with Kohei Miyazono and Carl-Henrik Heldin at the Ludwig Institute for Cancer Research (LICR), Uppsala, Sweden. In 1994, he became group leader at LICR and in 1999 he moved to the Netherlands Cancer Institute, Amsterdam, The Netherlands. In 2005 he moved to the Leiden University Medical Center, Leiden, The Netherlands.

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Scott L Friedman M.D.

Advisor

DEAN FOR THERAPEUTIC DISCOVERY PROFESSOR | Medicine, Liver Diseases PROFESSOR | Pharmacological Sciences Specialties: Liver Medicine, Gastroenterology

Dr. Scott L. Friedman was appointed as advisor of Scientific Advisory Board of Laekna in 2022. He is the Dean for Therapeutic Discovery and Chief of the Division of Liver Diseases, at the Icahn School of Medicine at Mount Sinai. He has performed pioneering research into the underlying causes of scarring, or fibrosis associated with chronic liver disease, affecting millions worldwide. Dr. Friedman was among the first to isolate and characterize the hepatic stellate cell, the key cell type responsible for scar production in liver. His work has spawned an entire field that is now realizing its translational and therapeutic potential, with new anti-fibrotic therapies for liver disease reaching clinical trials.

He is widely recognized as a dynamic and a respected author, with over 300 peer-reviewed publications. He has mentored over 85 postdoctoral fellows and students. He has been a member of the American Society of Clinical Investigation, the Association of American Physicians, and was elected as a Fellow of the American Gastroenterological Association, the Am. College of Physicians, the American Assn. for the Study of Liver Diseases and the American Association for the Advancement for Science.

Dr. Scott L. Friedman was recognized with the Distinguished Achievement Awards from both the American Assn for the Study of Liver Diseases and the American Liver Foundation. In 2013 he was awarded the Shanghai Magnolia Gold Award by the Mayor of Shanghai and the China Friendship Award from the Premier of China in 2014 in recognition of his efforts to improve the health of the residents of Shanghai and China through his research achievements.

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Counde Oyang Ph.D.

Advisor

Dr. Oyang was appointed as advisor of Scientific Advisory Board of Laekna in 2021. He has had over 40 years of experience in drug discovery. From 2013 to 2018, he was with the Novartis Institutes for BioMedical Research (China) where he served as Head of Global Discovery Chemistry (China) and managed chemistry portfolio in drug and target discovery for various disease areas. From 2010 to 2013, he was with BioDuro where he served as Vice President of Chemistry. At BioDuro, he oversaw all programs in synthetic chemistry, medicinal chemistry and provided integrated services to clients. From 1982 to 2010, Dr. Oyang worked at Roche – in Palo Alto and at Syntex (acquired by Roche) where he served in roles of increasing responsibility including Director of Medicinal Chemistry. At Roche, he led multiple small molecule programs that advanced to the clinic. Dr. Oyang is an author of over 60 publications and patents.

Dr. Oyang obtained his Ph.D. in Chemistry from Loyola University of Chicago (with Professor James W. Wilt) and pursued postdoctoral research at Massachusetts Institute of Technology (with Professor Frederick D. Greene) and the University of Chicago (with Professor Josef Fried).

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