Pipeline


By leveraging its technology platform, ACEA has discovered and developed a robust pipeline of clinical and preclinical small molecule programs for the treatment of cancer and autoimmune diseases.

|Pre-Clinical|Phase I|Phase II|Phase III

AC0010

EGFR T790M+ (2nd Line)

EGFRmut + (1st Line)

Lymphomas

AC0058

Autoimmune Diseases

AC0246 (Anti-microtubule)

Cancer

AC0010 – EGFR Inhibitor


AC0010 is a potent, small molecule irreversible third generation tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of epidermal growth factor receptor (EGFR). ACEA is developing AC0010 as a therapeutic agent to be administered orally to patients with mutant EGFR non-small cell lung cancer (NSCLC). AC0010 inhibits the gatekeeper mutation of EGFR (T790M), as well as the common activating mutations (L858R, del19), and has minimal inhibitory activity towards the wild-type (WT) receptor. The T790M mutation of the EGFR is the major cause (approximately 50-60%) of the acquired resistance after treatment with first generation EGFR TKIs such as Tarceva (erlotinib) and Iressa (gefitinib)1.

The proposed initial indication for AC0010 is for the treatment of patients with mutant EGFR NSCLC who have failed prior EGFR-directed therapy due to the emergence of the T790M mutation. ACEA is also evaluating the use of AC0010 as first-line therapy for NSCLC patients with confirmed EGFR mutational status.


For more information on our clinical trials, please visit clinicaltrials.gov.


Source:
1 – Yu HA, Arcila ME, Rekhtman N, Sima CS, Zakowski MF, Pao W, Kris MG, Miller VA, Ladanyi M, Riely GJ. Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers. Clin Cancer Res. 2013 Apr 15;19(8):2240-7.

AC0058 – BTK Inhibitor


AC0058 is a small molecule compound that potently, selectively and irreversibly inhibits Bruton’s tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte activation (predominantly B-cell activation).

The nonclinical program has demonstrated that AC0058 has the potential to interfere with signaling functions mediated by tyrosine kinases and may be useful for controlling excessive or aberrant T- and B-cell activation in autoimmune diseases.


AC0058 was successfully evaluated in a recently completed Phase I clinical trial in the US in healthy volunteers. A total of 56 subjects participated in the 2-part study designed to evaluate the effects of AC0058 in single ascending dose and multiple ascending dose regimens. AC0058 was safe and well-tolerated at all tested doses up to 600 mg total daily dose.


Based on these encouraging results, ACEA is exploring multiple strategic paths forward for the continued global development of AC0058 for the treatment of autoimmune diseases.


For more information on our clinical trials, please visit clinicaltrials.gov.

Management Team


Xiao Xu, MD, President and CEO
Co-founder, UCSF, Scripps, CDC


Li Xu, MD, Chief Medical Officer
Hengri Medicine, Pfizer, Merck


Roger (Feng) Luo, Vice President, Global Clin. Dev.
Janseen, Daiichi Sankyo, BMS, Roche


Xiaobo Wang, Ph.D.
Vice President and Chief Technology Officer
U. of Texas, MDACC, AVIVA


Lei Lu, MBA, CPA
Vice President, Finance
Alfa Romeo, Rockwell, Nokia, BirdRock Bio


Boris Shen
Vice President, China Comm. Ops.
Glaxo, Roche, Betta


Andre Basbaum, MBA
Vice President, Business Development
VentiRx, Valeant, Anadys, Pfizer


Wei Tang, Ph.D.
Vice President, Research
Bioduro, UT Southwestern Medical Center


Wallson Xu, M.S.
General Manager, ACEA China
ACON Biotech


Clinical Advisors


Tony Mok, MD
Professor, Department of Clinical Oncology at the Chinese University of Hong Kong.


Heather Wakelee, MD
Associate Professor of Medicine (Oncology) at Stanford University Medical Center


Pasi Janny, MD
Director, Lowe Center for Thoracic Oncology;
Scientific Director, Belfer Instit.ute for Applied Cancer Science; Professor of Medicine, Harvard Medical School


Dong-Wan Kim, MD
Professor, Seoul National University Hospital


Yi-Long Wu, MD
Vice President, Guangdong General Hospital & Guangdong Academy of Medical Sciences and Director of Guangdong Lung Cancer Institute;
Professor and President of CSCO


Jean-Charles Soria
Professor of Medicine and Medical Oncology at South-Paris University


Investors



Lilly Asia Ventures


Lilly Asia Ventures, founded in 2008, is dedicated to venture capital investments in the life sciences and healthcare sectors in Asia, particularly in China. Its investors include Eli Lilly & Co., a Fortune 500 company and one of the most globalized and innovative pharmaceutical companies in the world. As a leading biomedical venture fund in China, Lilly Asia Ventures provides wise capital, industry expertise, and global resources to its portfolio companies to accelerate their growth.

Qiming


Founded in 2006, Qiming is a leading China venture capital firm with offices in Shanghai, Beijing, Suzhou and Hong Kong. In 2016, Qiming raised a US healthcare fund, and set up Qiming US office in Seattle. Currently Qiming manages five US Dollar funds and four RMB funds with US $2.7 billion assets under management.

Contact Us


Media &
Investor Relations

For inquiries regarding media and investors relations, please contact:

XIAO XU
Chief Executive Officer
Email: xxu@aceabio.com


Business
Development

For inquiries regarding in-and out-licensing opportunities, contact:

ANDRE BASBAUM
Vice President, Business Development
Email: abasbaum@aceabio.com

 

 

ACEA Biosciences Headquarters


6779 Mesa Ridge Rd #100
San Diego, CA 92121
Phone: 858.724.0928
Email: info@aceabio.com

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