– Highlighted R&D Strategy and Broad Pipeline of 15 Programs including 10 with Worldwide Rights
– ATG-010’s First Approval in Asia transforms Antengene into a Commercial Entity, 10 Studies in ATG-010 being Conducted in Mainland China
– Exciting ATG-008 (mTORC1/2 inhibitor) Signal, ATG-017 (ERK1/2 inhibitor) Progress, and ATG-101 (PD-L1/4-1BB bispecific antibody) SITC Data Lead off Clinical Pipeline
– Next Wave of IND Candidates Focus on Resistant Tumor Targets
SHANGHAI and HONG KONG, Nov. 19, 2021 /PRNewswire/ — Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer and other life-threatening diseases, hosted two Investor R&D meetings this week to discuss the Company’s vision and R&D philosophy, strategy, capabilities and its commercial readiness to launch Xpovio® (Selinexor) in its markets. During the meetings, members of Antengene’s senior leadership team presented a comprehensive overview of the Company’s robust discovery and early clinical development portfolio and deep clinical pipeline, as well as Xpovio® (selinexor/ATG-010) lead commercial brand.
The event was held virtually for an English speaking audience and in a live meeting in Shanghai, China with invited investors and guests.
“Antengene is pleased to highlight the excellent progress on our mission of building a research-driven cancer-focused global biopharmaceutical company since it began operations in 2017. This year marks the Company’s transition to becoming a fully-integrated company, with launch of its first commercial asset and the build-out of its core capabilities in drug discovery, clinical development, manufacturing and commercialization” said Jay Mei, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Antengene. “As of today, the Company has secured 19 IND approvals, with more approvals expected by the end of this year and Q1 2022. These achievements, coupled with the Company’s 2020 IPO and ~US$430 million cash balance as of June 30, 2021, are a testament to Antengene’s operational excellence, efficiency and robust execution.”
Dr. Mei continued, “Cancer does not wait and neither do we. Antengene is pressing forward to bring disruptive medicines to patients in a relatively short period of time. I am optimistic about Antengene’s bright future. Our bold focus on new areas of cancer biology and targets, especially in drug resistant tumors, expansive pipeline, broad internal R&D portfolio, array of value-added partnerships, strong key opinion leader relationships and highly-qualified management team will enable Antengene to deliver best-in-class, first-in-class medicines to transform cancer care. Furthermore, our plans to expand our R&D organization and build a new drug discovery and development facility for biologics in Hangzhou will provide the support we need to deliver results with excellence.”
Key highlights from the event are noted below. A complete review of the presentation and a replay of the Virtual Event (held in English on November 16, 2021, and in Chinese on November 18, 2021) can be found on Antengene’s website at: https://www.antengene.cn/en/event#investorBox
Focused Commercial Program, Starting with ATG-010 (selinexor)
Carefully Selected Target Markets – Antengene discussed its target markets (mainland China, South Korea, Taiwan, Hong Kong, Singapore, and Australia), selected based on unmet medical needs, insurance and reimbursement coverage, and GDP growth. Earlier-than-expected XPOVIO approval® in South Korea transformed Antengene into a commercial entity. Antengene reported positive receptivity in selinexor in mainland China, where an approval is anticipated around year-end 2021 or early 2022. Expectations were also outlined for additional marketing authorizations in between now and 2022.
Active ATG-010 Clinical Program to Yield Data continually based on a portfolio of 10 studies conducted by Antengene (3 with Karyopharm). Antengene noted that its expansive pipeline gives it the ability to conduct “in-house” combinations with agents from its own portfolio. Segments to highlight are:
– Bridging studies in mainland China for three FDA approved indications for R/R Multiple Myeloma and R/R DLBCL: MARCH, SEARCH, and BENCH
– Endemic Disease in Asia Underserved with Current Treatments: TOUCH:
A set of novel combinations in B-NHL were reviewed: MATCH: in-house combo ATG-010 + ATG-008 in R/R DLBCL (Novel Combo) and SWATCH: ATG-010 + Lenalidomide + Rituximab in R/R DLBCL and Indolent NHL (Combo with SoC)
– A series of global trials were outlined including potential new indications:
XPORT-DLBCL-030: Combination with Rituximab-Gemcitabine-Dexamethasone-Cisplatin (R-GDP) in R/R DLBCL patients with prior 1-2 regimens.
SIENDO: Phase 3 study to evaluate selinexor vs. placebo maintenance therapy for advanced or recurrent endometrial cancer could position this as a new standard of care.
XPORT-MF-035 (Myelofibrosis, MF) – A Phase 2 study to evaluate selinexor versus treatment of physician’s choice in patients with previously treated MF.
Expansive Clinical Pipeline
Antengene provided a detailed overview of its clinical pipeline, comprised of targeted therapy and innovative immunotherapy candidates. A review of clinical and preclinical results was provided showing the potential to convert “cold tumors” into “hot tumors” with potent activity demonstrated in aggressive murine models of resistant, relapsing or progressing tumors and limited preclinical toxicity. Further, the Company outlined its target to obtain IND approvals for two to three drug candidates or indications each year by 2025. Highlighted programs include:
– ATG-101 (PD-L1/4-1BB Bi-specific): Differentiating pre-clinical data recently presented at SITC (in vivo efficacy in anti-PD-L1 resistant, and anti-PD-L1 refractory tumor models, with no liver toxicity) were reviewed. A phase I, multicenter, dose-escalation clinical trial evaluating ATG-101 in patients with solid tumors and hematologic malignancies is ongoing in Australia and has received FDA IND approval to start in the USA.
– ATG-008 (Onatasertib MTORC1/2 inhibitor): Data from the TORCH-2 Phase I/II solid-tumor dose-finding study in combination with PD-1 antibody was reviewed. New data from 20 efficacy evaluable patients showed 1 CR, 5 PR (ORR = 30%), 9 SD (DCR = 75%). In particular, of 5 cervical efficacy evaluable patients, Antengene reported 1 CR and 3 PR (all confirmed). This promising signal warrants further exploration and Antengene noted that it will move rapidly to expand the study whilst exploring a potential accelerated regulatory path.
– ATG-037 (Oral small molecule CD73): to reverse adenosine-mediated immune-suppression: Comparative studies showing advantages for small molecule vs. other benchmark mAb programs were discussed. Preclinical results show that ATG-037 restores CD8+T cell deficit in the tumor microenvironment, demonstrating both single agent activity as well as enhanced activity in combination with other agents. Antengene indicated that it expects to complete Australian protocol submission by year end in order to evaluate this drug as mono- and combination therapy.
– ATG-017 (ERK 1 / 2 inhibitor): Antengene discussed this potential “best-in-class” program, which also has broad combinatory potential, including with checkpoint inhibitors and other inhibitors of the RAS/MAPK pathway. The Phase 1 dose escalation “ERASER” study is currently progressing through dose-escalation stages in Australia.
Broad R&D Portfolio
Antengene discussed its plan to complete 2-3 IND submissions per year and its focus on resistance to immune-oncology therapies, fast becoming one of the most challenging aspects of cancer care.
Data were presented on preclinical studies including the differentiated profiles of three programs: ATG-022 (Claudin 18.2 ADC), ATG-018 (ATR inhibitor) and ATG-012 (KRAS G12C inhibitor). IND filings are expected over the next 12 months.
Exciting Developments In Early Discovery Programs
The Company discussed its perspective that macrophages will be the next focus in immune-oncology studies and affirmed its view that the tumor microenvironment is another rich new target source.
Two new programs in these fields were unveiled, ATG-032 (mAb) targeting LILRBs, important immune-checkpoint proteins expressed by macrophages, and ATG-041 (a small molecule) with dual targeting of Axl and Mer with both tumor specific killing and modulation of the immune microenvironment as the MOA. These are two of the next wave of IND filings, starting in 2023+.
ASH, 2021 Presentations
A reminder was noted for the upcoming ASH presentations, set for Saturday, December 12th.
Antengene will present abstract# 2452 (related to the Phase 1b ATG-010/selinexor TOUCH trial) at the 2021 American Society for Hematology Meeting (ASH, https://www.hematology.org/meetings/annual-meeting) in Atlanta Georgia during the Poster Session to be held from 6:00 and 8:00 p.m.
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading clinical-stage R&D- driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for oncology 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 19 investigational new drug (IND) approvals in the APAC region and the U.S., submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor/ATG-010 in South Korea already approved through a priority review process. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and pre-clinical assets. The Company has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.
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.