SHANGHAI and HONG KONG, March 18, 2022 /PRNewswire/ — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced its financial results for the full year ended December 31, 2021 and provided corporate updates on key events and achievements since the start of 2021.
“The last 15 months have been a time of significant achievements for Antengene,” said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. “The company was founded to develop innovative cancer medicines to treat patients beyond borders, worldwide. We have delivered on our vision this year and significantly de-risked the Company. We accomplished this by securing our first regulatory approvals for our lead first-in-class/only-in-class product, XPOVIO® (selinexor), across China and 3 Asia-Pacific countries, and making the transition to a commercial organization, and by significantly advancing our portfolio with potential first-in class/best-in-class clinical programs in China, Australia and the US.”
Dr. Mei continued, “We also delivered on our mission of building a research-driven biopharmaceutical company that is developing transformational, best-in-class/first-in-class medicines for cancer, focusing on resistant or relapsing diseases with high unmet medical needs. Today, we have 8 programs in 18 clinical studies, including 5 registrational trials, utilizing our internal capabilities and platform and clinical development partnerships. We have built a team of over 350 employees across China, the US and APAC regions, and have built core capabilities in drug discovery, development, manufacturing and commercialization.”
“Looking ahead,” said Dr. Mei, “2022 is the fifth anniversary of Antengene’s founding and we believe it will be a landmark year for the Company. We expect to have regulatory approvals for selinexor in all 6 markets in Greater China and Asia Pacific markets where we have submitted new drug applications (NDAs). We are optimistic about the first launch of selinexor in Q2:22 in China, based on strong participation in the Named Patient Program (NPP) as well as the inclusion of selinexor in several important practice treatment guidelines. In addition, we expect to report data on at least 5 clinical programs and file 2 new investigational new drug (INDs), from in-house development programs.”
In conclusion, Dr. Mei said “Looking forward, we believe our strong cash, bank balances and cash management products of RMB 2.370 billion, and revenue growth will continue to fund advancement of our programs and continue to deliver additional value for investors. Since cancer are diseases that knows no borders, we are devoted and passionate in advancing our programs to treat cancer patients beyond borders, worldwide. Antengene is optimistic about this year and the future based on the excellent work of our team and collaborators, all around the world, and we look forward to updating you on our progress as the year unfolds.”
Overview of Antengene’s Products and Clinical Pipeline:
XPOVIO® (selinexor) Commercial Approvals, Bridging Studies and Inclusion in Practice Treatment Guidelines: Antengene is strategically investing in XPOVIO® (selinexor) and positioning the product for a successful commercial launch across the Asia-Pacific region based on solid registrational data and a growing body of studies to support product adoption and label expansions. In addition, Antengene has implemented a well-supported Named Patient Program, and built a highly experienced, well respected commercial team to position for market launch and revenue growth.
- XPOVIO® (selinexor) Approvals: We secured approvals for XPOVIO® (selinexor), a first-in-class, oral selective inhibitor of nuclear export (SINE), in mainland China, Australia, South Korea and Singapore for hematological cancer indications including relapsed/refractory multiple myeloma (R/R MM), refractory diffuse large B-cell lymphoma (R/R DLBCL) for use as monotherapy and as part of established multi-drug regimen.
- Further Selinexor Approvals in 2022: We expect further approvals in Hong Kong and Taiwan markets in 2022.
- Named Patient Program: We provided selinexor to patients in mainland China and Hong Kong under the Named Patient Program which generated revenue of RMB28.5 million in 2021. This program provided Antengene with the opportunity to connect with key opinion leaders on selinexor, which will pave the way for an effective commercial launch of selinexor in China, planned to begin in Q2:22.
- Selinexor Inclusion in Practice Treatment Guidelines: Use of selinexor was included in the Chinese Society of Clinical Oncology (CSCO) 2021 Diagnosis and Treatment Guidelines (CSCO Guidelines). This follows prior inclusion of multiple selinexor regimen into practice guidelines by major oncology networks, National Comprehensive Cancer Network (NCCN) in the U.S. and the European Society for Medical Oncology (ESMO) in the EU.
- Pivotal Selinexor Studies Presented at Major Medical Meetings: Positive results of the pivotal MARCH bridging study were reported at international medical meetings including the American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Annual Meeting in 2021. Results from the MARCH trial have confirmed the efficacy and manageable safety profile to be consistent with that observed in the STORM trial which supported selinexor’s accelerated approval by the U.S. Food and Drug Administration (FDA).
- Pivotal Bridging Studies, BENCH and SEARCH are registrational trials in China: The BENCH study, which evaluates selinexor in combination with bortezomib and dexamethasone, for patients with R/R MM, will serve as the confirmatory trial to support selinexor’s conditional approval. The SEARCH study evaluates selinexor as monotherapy in patients with R/R DLBCL who have received at least 2 but no more than 5 prior treatment regimens. We expect to file sNDA for SEARCH and complete patient enrollment for the BENCH study in 2022.
- Well-Prepared for Commercialization across China and Asia-Pacific Countries: Antengene has carefully invested in a commercial team of 170 with a proven track record of commercial success in China and APAC for a successful launch of XPOVIO® (selinexor).
Business Development: focused on partnerships to facilitate clinical collaborations, in-license novel programs or enable access to novel platform/drug development technologies to complement and enrich our in-house capabilities.
- ATG-037 (CD73 small molecule inhibitor): In May 2021, we entered into an exclusive, worldwide license agreement with Calithera Biosciences, Inc. for the development and commercialization of CB-708 (ATG-037), Calithera Biosciences, Inc.’s small molecule inhibitor of CD73. The Phase 1 STAMINA trial has secured HREC approval in Australia and is planned to begin enrollment in H1:22.
- LegoChem Deal for New ADCs: In October 2021, we entered into a Research Collaboration and License Option Agreement with LegoChem Biosciences, Inc. (“LCB”, KOSDAQ: 141080) for new antibody-drug conjugates (ADCs). Under this agreement, the two parties will jointly generate and evaluate ADC candidates using Antengene’s antibodies and LCB’s next generation ADC technology platform.
- Bristol Myers Squibb Clinical Collaboration for ATG-017 (ERK1/2 inhibitor) and Opdivo® (nivolumab): In December 2021, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety, pharmacokinetics and preliminary efficacy of ATG-017 in an open-label, Phase 1/2 combination trial with Bristol Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo® (nivolumab) for patients with advanced solid tumors.
Clinical Program Poised to Deliver Multiple Data Readouts in 2022 and 2023 (originated in-house/through partners): The Antengene pipeline has been developed with a special focus on key mechanisms linked to relapsing/resistant disease including metabolic changes, genetic alterations, the tumor microenvironment and immune suppression/down-regulation. With a robust R&D portfolio, Antengene is well-positioned to evaluate proprietary combinations, further differentiating its programs.
Mid to Late-Stage Programs: (Antengene has certain Asia-Pacific rights): Antengene is exploring two members of the novel XPO1 family plus a novel mTOR cell growth inhibitor.
Selinexor (ATG-010, first-in-class XPO1 inhibitor): Antengene has developed a robust program to maximize the clinical utility for selinexor and the XPO1 class. The drug is being evaluated for new cancer indications, including maintenance treatment of endometrial cancer, and in combination with standard therapy for MM and DLBCL. The objective of these programs is to potentially improve response rates, maintain disease control, and expand the clinical utility of the drug.
- Phase 2 MF-035 Myelofibrosis Trial designed to evaluate the safety and efficacy of selinexor in the treatment of patients with myelofibrosis in China (Global study).
- Phase 2/3 XPORT-DLBCL-030 Trial designed to evaluate selinexor in combination with rituximab, gemcitabine, dexamethasone and platinum (SR-GDP) for patients with rr-DLBCL in China (Global study).
- Phase 1b MATCH Trial designed to evaluate selinexor in combination with ATG-008 (onatasertib) for the treatment of R/R DLBCL (sponsored by Antengene).
- Phase 1/2 SWATCH Trial designed to evaluate selinexor in combination with lenalidomide plus rituximab (“S-R2“) for the treatment of relapsed/refractory indolent non-Hodgkin lymphoma (“rriNHL“) (sponsored by Antengene).
Selinexor Data Presentations:
- Phase 1b TOUCH Results: At the 2021 American Society of Hematology Annual Meeting (ASH 2021), we published positive results from the open-label Phase 1b TOUCH trial of selinexor plus gemcitabine-oxaliplatin (“GemOx”) for the treatment of Chinese patients with relapsed/refractory (R/R) T and NK-Cell lymphoma. The combination demonstrated an Overall Response Rate (ORR) of 46.2%, a Complete Response Rate (CRR) of 26.9% and a Duration of Response (DOR) of 3.1 months. ORR for peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and extranodal NK/T-cell lymphoma (ENKTL) subgroups reached 53.8% and 57.1%, CRR of 30.8% and 28.6%, and median Progression-Free Survival (PFS) of 4.4 months and 4.7 months, respectively (sponsored by Antengene).
Eltanexor (ATG-016, second generation XPO1 inhibitor): An expansive program to evaluate ATG-016 monotherapy in:
- Phase 1/2 HATCH Trial in patients with high-risk myelodysplastic syndrome (MDS). Enrollment in China is underway (sponsored by Antengene).
- Phase 1/2 REACH in patients with solid tumors. Enrollment in China is underway (sponsored by Antengene).
- Phase 2 segment of the Solid Tumor/Hematologic Cancer trial. Enrollment in patients with high-risk MDS in China is underway (Global Study).
Eltanexor Data Presentations:
- Phase 1/2 MDS Results: At the American Society of Hematology Annual Meeting (ASH 2021), Karyopharm published Phase 1/2 data with eltanexor in patients with MDS showing that single agent eltanexor was active in patients with high-risk, refractory disease. Of the 15 patients evaluable for efficacy, Karyopharm reported that 47% of patients achieved a bone marrow complete response and 33% had stable disease (SD) for a total disease control rate (DCR) of 80%.
Onatasertib (ATG-008, dual mTORC1/2 inhibitor) targets multiple key mTOR cell growth pathways. Data from the TORCH-2 Phase 1/2 solid-tumor dose-finding study in combination with PD-1 antibody was reviewed at Antengene’s 2021 R&D Day in November 2021. This promising signal warrants further exploration and Antengene will move rapidly to expand the study whilst exploring a potential accelerated regulatory path (sponsored by Antengene).
Early-Stage Clinical Programs (Antengene has global rights)
- ATG-017 (ERK1/2 inhibitor) has potential synergy with checkpoint inhibitors and KRAS inhibitors. The Phase 1 ERASER dose escalation for the treatment of advanced solid tumors and hematologic malignancies is well advanced in Australia (sponsored by Antengene). Antengene will also be collaborating clinically with Bristol Myers Squibb in the ERASER study to evaluate ATG-017 in combination with Opdivo® (nivolumab) in advanced solid tumors.
- ATG-101 (PD-L1/4-1BB bispecific antibody) designed to block the binding of immunosuppressive PD-1/PD-L1 and activate immune effectors via 4-1BB co-stimulation. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also showed an excellent safety profile in GLP toxicology studies. The Phase 1 PROBE multicenter, dose-escalation clinical trial, in patients metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL), is ongoing in the US and Australia and the Investigative New Drug (IND) application has been approved in China.
- ATG-037 (CD73 small molecule inhibitor) has the potential to reverse immunosuppression in the tumor microenvironment. Enrollment in the Phase 1 STAMINA trial, in patients with locally advanced or metastatic solid tumors, is planned to begin in Australia in H1: 22 (sponsored by Antengene).
Planning 2 INDs per Year (Antengene has global rights): Antengene has developed a vibrant, productive R&D team.
- 2022 IND Candidates: Antengene plans to submit an IND application for ATG-018 (ATR inhibitor) in H1:22. In addition, preclinical studies are also underway to support IND/CTA applications of ATG-022 (Claudin 18.2 antibody-drug conjugate) in 2022.
- 2023 Potential IND/CTA Filings: ATG-031 (CD24 antibody) and ATG-027 (B7H3/PD-L1 bispecific antibody)
- Early Stage, IND Track Programs: ATG-032 (LILRB antibody) and ATG-041 (Axl-Mer inhibitor)
Corporate Updates: Corporate milestones related to development of critical research and development and manufacturing infrastructure to support biological and small molecule programs highlight Antengene’s transition to a fully-integrated biopharmaceutical company are exemplified by opening and development of two major manufacturing and R&D centers. These resources help Antengene stand out in the industry.
Antengene’s selection as a constituent stock in highlights the Company’s significant progress since its November, 2020 IPO.
- Manufacturing Center in Shaoxing: In May 2021, the Company hosted an inauguration ceremony for our manufacturing center at the Binhai Life Science and Healthcare Industrial Zone in Shaoxing. Completion of the manufacturing center prepares for future production of oral medicines and provides Antengene with integrated capabilities in discovery, development, manufacturing, and commercialization. Antengene plans to initiate the manufacturing of selinexor at this site.
- Agreement with Hangzhou Qiantang New Area Administrative Committee: In May 2021, we entered into a framework agreement with the Hangzhou Qiantang New Area Administrative Committee to build a drug discovery and manufacturing center for antibody biologics.
- Selection in Major Stock Indexes: Antengene was selected as a constituent stock in three major, well-respected family market indexes, the Hang Seng Index Family, the FTSE Russell Index Family, and the MSCI Global Small Cap Indexes.
Cash, bank balances and cash management products: Cash, bank balances and cash management products at December 31, 2021 were RMB2,370.5 million as compared to RMB3,109.8 million at December 31, 2020.
Research and development costs: Research and development costs for the year ended December 31, 2021 were RMB405.0 million as compared to RMB347.7 million for the comparable period in 2020.
The increase relates to increased drug development expenses and expansion of R&D personnel.
Selling and distribution expenses: Selling and distribution expenses for 2021 were RMB67.9 million compared to RMB0.5 million for 2020.
The increase is primarily attributable to increased employee head count and professional fees related to preparations for the planned launch of our lead product, XPOVIO® (selinexor) in 2022.
Administrative expenses: Administrative expenses for 2021 were RMB169.5 million compared to RMB154.2 million for 2020.
The increase is attributable to increased professional fees and headcount related to costs of operating as a public company and in support of commercial operations.
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for cancer and other life-threatening diseases. Driven by its vision of “Treating Patients Beyond Borders“, Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since initiating operations in 2017, Antengene has obtained 22 investigational new drug (IND) approvals in the US and in Asia, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor/ATG-010/XPOVIO® in China, South Korea, Singapore and Australia approved. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and pre-clinical assets. Antengene has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.
Forward Looking Statement
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Hong Kong Stock Exchange and the other risks and uncertainties described in the Company’s Annual Report for year-end December 31, 2020, and subsequent filings with the Hong Kong Stock Exchange.
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