We are a global clinical-stage biotechnology company focused on the discovery and development of innovative cancer therapies for patients across the spectrum of tumor types. (Incorporated in the Cayman Islands)
Our mission is to transform deadly cancer into a chronic and eventually curable disease. We are now developing multiple innovative antitumor drug candidates by leveraging our deep knowledge in cancer biology, as well as significant global R&D and clinical execution capabilities. These drug candidates are currently undergoing clinical trials, and in many cases, in collaboration with multinational pharmaceutical companies to fully realize their commercialization potential on a global scale. Our combination therapy strategy is directed towards systematically activating the immune system through a combination of multiple drugs, aiming to enhance the clinical benefit by achieving superior efficacy and safety while overcoming drug resistance.
We have identified seven drug candidates and have developed a robust pipeline of drug candidates. Currently, our pipeline includes three clinical-stage drug candidates, buparlisib (AN2025), palupiprant (AN0025), and AN4005, as well as four preclinical candidates. Our most advanced program is our lead product AN2025, a pan-phosphoinositide 3-kinase (“PI3K”) inhibitor that is designed to act against solid tumors. AN2025 is currently undergoing a Phase III, multi-regional, randomized, open-label clinical trial for the treatment of recurrent or metastatic head and neck squamous cell carcinomas (“HNSCC”) after anti-programmed death-1 (“PD-1”) or its ligand (“PD-L1”) treatment in more than 180 sites in 18 jurisdictions covering North America, Europe, Asia, and South America. We believe that AN2025, if approved, has the potential to be first-to-market, and is currently the only drug candidate in active Phase III clinical trial targeting recurrent or metastatic HNSCC patients after progression on prior anti-PD-1/PD-L1 therapy, potentially addressing a global unmet medical need.
We are collaborating with MSD International GmbH, or MSD, to evaluate AN0025, a small molecule prostaglandin E receptor 4 (“EP4”) antagonist. It is currently being developed to modulate the tumor microenvironment in combination with Keytruda or pembrolizumab, in a Phase Ib clinical trial for the treatment of recurrent non-small cell lung cancer (“NSCLC”) and urothelial cancer after anti-PD-1/PD-L1 treatments, recurrent triple-negative breast cancer (“TNBC”), microsatellite stable colorectal cancer (“MSS CRC”) and cervical cancer after standard of care treatments. In addition, a Phase I clinical trial has been initiated in collaboration with F. Hoffmann-La Roche Ltd or Roche for a combination therapy consisting of AN2025, AN0025, and Tecentriq or atezolizumab targeting a variety of PIK3CA mutant solid tumors. This triple combination is expected to target the PI3K mediated tumorigenesis while inhibiting the immunosuppressive tumor microenvironment through multiple non-overlapping mechanisms, leading to synergistic action for tumor regression. AN4005, which is currently being studied in a Phase I clinical trial, is an internally discovered oral small molecule PD-L1 inhibitor in development to induce and stabilize PD-L1 dimerization and thereby disrupt the interaction between PD-1 and PD-L1.
Additionally, we continue to advance four in-house preclinical programs considered to have high global commercial viability. We are performing investigational new drug (“IND”) enabling studies for AN3025, an immune-stimulatory anti-tumor necrosis factor receptor 2 (“TNFR2”) antibody, with a goal to submit an IND application in the second half of 2023. Our earlier preclinical candidates are: AN1025, an oral small molecule degrader of β-catenin; AN8025, a multifunctional antibody as T cell and antigen-presenting cell (“APC”) modulator; and AN6025, an oral small molecule hematopoietic progenitor kinase 1 (“HPK1”) inhibitor. We anticipate nominating preclinical candidates in the fourth quarter of 2022 for AN1025 and AN8025 and the second quarter of 2023 for AN6025.
We believe the next frontier in cancer immunotherapy lies in the category of combination therapies. Our drug candidates combine an immune checkpoint inhibitor with two or more additional cancer therapies in effort to elicit synergistic anti-cancer effects and improved tolerability relative to monotherapies. As we endeavor to engender complementary and synergistic results across our portfolio, our primary consideration is the potential interaction with our other pipeline candidates and/or currently available treatments. We strive to develop innovative antitumor candidates focusing on druggability as well as combinational strength to be leveraged in the next wave of immuno-oncology treatments, ultimately helping to shape the next-generation of cancer therapy.
Through our multi-national R&D centers established in New Jersey and Hangzhou, we execute on our global vision for drug development innovation. The geographic span of our R&D footprint empowers us to more effectively identify and develop novel early-stage programs, as well as recruit top R&D talent from the U.S. and China. We have assembled a management team and a scientific advisory board with industry leaders and influential scientists, who provide international and strategic guidance to our R&D, business development, and operational teams. In addition to building our own R&D capabilities, we continue to seek and secure partnerships with leading multi-national pharmaceutical companies such as Eisai Co., Ltd. or Eisai, MSD, Novartis Pharma AG or Novartis, and Roche, to fully realize the potential of our pipeline programs. We believe our partnerships validate our clinical expertise and reflect belief in our ability to deliver on our development and commercialization capabilities across a versatile pipeline.
**Note: Revenue and net loss figures are in U.S. dollars for the 12 months that ended June 30, 2023.
(Adlai Nortye Ltd. priced its IPO on Sept. 28, 2023, in sync with the terms in its prospectus: 2.5 million American Depositary Shares (ADS) at the IPO price of $23.00 each to raise $57.5 million.)
(Note: Adlai Nortye Ltd. filed an F-1/A on Sept. 27, 2023, in which it disclosed the terms for its revived IPO: 2.5 million ADS at $23.00 to raise $57.5 million.)
(Note: Adlai Nortye Ltd. filed an F-1/A on Sept. 12, 2023, to revive its IPO, which was postponed on Aug. 28, 2023, without setting any terms. In the new F-1/A filing. Adlai Nortye disclosed that Cantor was the sole book-runner and CLSA (Citic Securities) was no longer involved in the deal. Adlai Nortye also filed updated financial statements through June 30, 2023. Background: Adlai Nortye Ltd. has postponed its IPO, effective Aug. 28, 2023. Adlai Nortye filed an F-1/A dated Aug. 10, 2023, and disclosed terms for its IPO: The company plans to offer 3.0 million American Depositary Shares (ADS) at a price range of $22.00 to $26.00 to raise $72.0 million. Each ADS represents three ordinary shares. The IPO was initially set for pricing in mid-August and then delayed just hours ahead of pricing. Adlai Nortye Ltd. filed its F-1 on July 27, 2023. The company submitted confidential IPO documents on Dec. 21, 2022. )