Antengene Announces Full Year 2023 Financial Results, Highlights Clinical Progress Across First-in-Class, Best-in-Class Pipeline
PR Newswire
SHANGHAI and HONG KONG, March 22, 2024
-- Promising clinical activities and efficacies during dose escalations for
four lead global rights programs targeting CD24, Claudin 18.2, CD73, and
PD-L1/4-1BB
-- Positive, differentiated cervical cancer data advancing mTORC1/2
inhibitor on registrational track for APAC markets
-- RMB1.188 billion cash expected to support planned operations
SHANGHAI and HONG KONG, March 22, 2024 /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 full year results for the period ended December 31, 2023, and provided an update on the impressive progress of its clinical development pipeline over the last several months.
"2023 has been a breakout year for Antengene, with excellent pipeline momentum across multiple first/best-in-class programs marked by encouraging clinical activities and efficacies during dose escalations for our four lead global-rights programs, namely ATG-031, ATG-022, ATG-037, and ATG-101 which are designed to target CD24, Claudin 18.2, CD73, and PD-L1/4-1BB. With respect to our APAC-rights programs, our second generation mTORC1/2 inhibitor ATG-008 has made steady progress towards registrational path for the indication of cervical cancer, complemented by the inclusion of XPOVIO$(R)$ in the 2023 China National Reimbursement Drug List. Furthermore, we have entered into a partnership with Hansoh Pharma, a leading Chinese pharmaceutical company, for the commercialization of XPOVIO(R) in the Mainland of China, " said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "Looking into 2024 and beyond, we are confident that out four lead global rights programs will continue to deliver encouraging results and emerge as category leaders. Our current cash balance totaling RMB1.188 billion is expected to fund planned operations and product development. We look forward to report on our progress throughout the year, starting with the presentation of several abstracts at the American Association for Cancer Research Annual Meeting (AACR 2024)."
1. Momentous clinical development across four lead global-rights programs
-- ATG-031 (anti-CD24 monoclonal antibody): Promising Activity at Starting
Doses: ATG-031 is the first-in-class humanized anti-CD24 monoclonal
antibody to enter the clinic for cancer in the U.S. ATG-031 acts by
inhibiting the "don't eat me" signal while stimulating the "eat me"
signal and enhances macrophage-mediated phagocytosis of cancer cells.
-- Phase I "PERFORM" study: To date, a total of 5 late-stage cancer
patients have been treated with ATG-031 in the Phase I dose
escalation study. To date, no dose-limiting toxicities (DLTs) have
been observed among the 5 patients. Tumor shrinkage based on CT
scan was observed in one heavily pre-treated patient (7 prior
lines of therapy). Key study sites include four major U.S. cancer
centers: The University of Texas MD Anderson Cancer Center, the
University of California San Francisco, the University of Colorado,
and Yale University Cancer Center.
-- Next ATG-031 Milestone: Completion of the dose escalation portion
of the Phase I "PERFORM" Study in H1 2025.
-- ATG-022 (Claudin 18.2 antibody-drug conjugate, "ADC"): Potential to
Target Claudin 18.2 Low Expressors: ATG-022 is differentiated by its
potential ability to be active across a range of Claudin 18.2 expression
levels, including in low expressors. Antengene has also developed a
companion diagnostic assay to support the clinical program. The ADC has
been awarded two Orphan Drug Designations $(ODD)$ by the U.S. Food and Drug
Administration (FDA) for treatment of gastric and pancreatic cancers.
-- Phase I "CLINCH" study: To date, 7 gastric cancer patients
(without pre-screening patients' Claudin 18.2 expression levels)
have been treated with ATG-022. Antengene has observed one
complete response $(CR)$ and one partial response $(PR)$ in 2 patients
with metastatic gastric cancer. In the 2.4 mg/kg dose cohort, one
patient with extremely low expression of Claudin 18.2 achieved CR,
while one patient from the 1.8 mg/kg dose cohort achieved PR. The
study has already completed the dose escalation portion and
initiated the dose expansion portion.
-- Next ATG-022 Milestone: Clinical data readout of Phase I "CLINCH
trial", including preliminary efficacy and safety in H2 2024.
-- ATG-037 (CD73 small molecule inhibitor): Early Combination Activity Shown
Potential in Reversing Prior PD-1 Resistance: Inhibiting CD73 is intended
to stop the production of adenosine, a key immunosuppressive molecule in
the tumor microenvironment. As a small molecule inhibitor of CD73,
ATG-037 has demonstrated pre-clinically the ability to overcome the "hook
effect" that can limit efficacy and is commonly seen in anti-CD73
antibodies. Antengene entered into a global clinical collaboration with
MSD and is currently evaluating this molecule in combination with the
anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab), in patients with locally
advanced or metastatic solid tumors.
-- Phase I "STAMINA" study: In the dose escalation segment of ATG-037
combined with pembrolizumab, Antengene has observed PRs in two
patients with melanoma and one patient with non-small cell lung
cancer (NSCLC), all of whom were refractory to prior treatment
with checkpoint inhibitors (CPIs). To date, 23 patients have been
enrolled and received a first tumor assessment.
-- Next ATG-037 Milestone: Completion of Phase I dose escalation and
proceed to dose expansion in H1 2024.
-- ATG-101 (PD-L1/4-1BB bispecific antibody): Durable Responses at Low Doses
with No Off-Target Hepatotoxicity Observed and Efficacy in Cold Tumors:
ATG-101's differentiated approach to targeting PD-L1 resistant cancers
incorporates the T-cell co-stimulatory receptor 4-1BB. The bispecific
antibody utilizes high PD-L1 affinity and conditional 4-1BB activation,
to reduce the risk of hepatotoxicity.
-- Phase I "PROBE" study: Antengene has observed a PR in a patient
with metastatic colon adenocarcinoma (microsatellite stability
biomarker [MSS], liver metastasis, and three prior lines of
therapy). In addition, SD has been observed in two patients for
longer than 1 year.
-- Next ATG-101 Milestone: Completion of Phase I dose escalation and
proceed to dose expansion in H1 2025.
-- Progressing Early programs: Antengene continues to advance IND candidate,
ATG-042 (MTAPnull-selective PRMT5 Inhibitor), and the proprietary
AnTenGagerTM "2+1" T cell engager platform.
2. Steadily progressing mid/late-stage clinical programs continue to demonstrate clinical potentials
-- ATG-008 (mTORC1/2 small molecule inhibitor): Positive, Robust Cervical
Cancer Data -The mTOR complex regulates different cellular processes and
is upregulated in multiple tumors. mTORC1 and mTORC2 have to be inhibited
simultaneously to maximize efficacy and minimize the development of
resistance. ATG-008 was designed to inhibit both.
-- Phase II "TORCH-2" study: ATG-008 has demonstrated positive Phase
II results in cervical cancer that position the program to have a
competitive profile compared to other agents approved across
different global markets. The Phase II "TORCH-2" study is
currently enrolling both checkpoint inhibitor $(CPI.UK)$-naïve and
CPI-pre-treated patients. Based on the latest data review as of
March 14th, 2024, out of the 31 CPI-naïve patients who
received treatment (30 had at least one tumor assessment), the
objective response rate $(ORR.UK)$ was observed to be 53.3%, the
disease control rate (DCR) was 86.7%. Among the 30 patients with
prior CPI treatment (26 patients had at least one tumor
assessment), the ORR was 23.1%, with a DCR of 84.6%.
-- Next ATG-008 Milestone: Confirm registrational pathway in cervical
cancer with health authorities.
3. Solidifying presence in APAC markets through accelerating commercialization
-- Antengene and Hansoh Pharma entered into a collaboration for the
commercialization of XPOVIO(R) in the Mainland of China in August 2023.
-- XPOVIO(R) has been added to the NRDL (2023 Version) as announced on
December 14th, 2023. The updated NRDL, taking effect on January 1st,
2024, will significantly improve the accessibility of XPOVIO(R) in
Mainland of China.
-- As of December 2023, Antengene has successfully secured XPOVIO(R)
regulatory approvals in seven markets: Mainland of China, Taiwan China,
Hong Kong China, Macau China, Australia, South Korea, and Singapore.
National reimbursement has been secured in 3 markets: Mainland of China
(NRDL), Australia (Pharmaceutical Benefits Scheme), and Singapore (Cancer
Drug List). In June 2023, the coverage of XPOVIO(R) by the Australian
Pharmaceutical Benefits Scheme $(PBS)$ was extended from Xd to include both
XVd and Xd regimens..
4. Strong cash and bank balance enabling continuous growth
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