Antengene Corporation Limited (HKG:6996)
Hong Kong flag Hong Kong · Delayed Price · Currency is HKD
4.980
+0.220 (4.62%)
May 7, 2026, 4:08 PM HKT
← View all transcripts

Status update

Mar 4, 2026

Donald Lung
CFO, Antengene

Good morning and good evening, everyone. Thank Thank you for joining us on such short notice. We are pleased to announce that Antengene has entered into a global license agreement with UCB for ATG-201, our CD19/CD3 bispecific T-cell engager designed for treating autoimmune diseases. During today's call, we will provide further details on the agreement, outline the strategic rationale for partnering with UCB, and highlight the differentiated features of our proprietary AnTenGager platform and TCE programs. I'm Donald Lung, CFO for Antengene, and I will be hosting the call today. Before we begin, I would like to remind everyone that during today's call, Antengene may make certain forward-looking statements. These statements may include, but are not limited to, our business plans and objectives, as well as the anticipated timing and progress of our clinical trials, regulatory submissions, and potential commercial launches.

These forward-looking statements are based on our current expectations and assumptions and are subject to a number of risks and uncertainties. They are not guarantees of future performance, and therefore you should not place undue reliance on them. Actual results may differ materially from those expressed or implied in these statements. For a discussion of the risk factors that could cause actual results to differ materially, please refer to our filings with the Hong Kong Stock Exchange. I will now turn the call over to our Founder, Chairman, and CEO, Dr. Jay Mei. Jay, please.

Jay Mei
Founder, Chairman, and CEO, Antengene

Thank you, Donald. Good morning and good evening again. Today marks an important milestone for Antengene with the announcement of our global licensing partnership with UCB for ATG-201, the first program from our AnTenGager platform to enter a global partnership. T-cell engagers are emerging as an important and potentially disruptive therapeutic modality, and this transaction reflects Antengene's commitment and growing relevance in the next-generation T-cell engager innovation and development. While AnTenGager represents a core innovation platform for us, our R&D approach remains fundamentally target-driven and modality-agnostic. We start with the biology and select the most appropriate therapeutic modality for each target, whether that is a T-cell engager, monoclonal antibody, bispecific antibody- drug conjugate, or any other next-generation novel modalities. Our focus is on advancing differentiated science and translating it into meaningful therapeutic innovations across disease areas.

As our programs advance, we evaluate the optimal developmental strategy for each asset, including strategic partnership that can maximize global impact. Since its creation, Antengene has built a solid global clinical and regulatory execution track record. We have conducted clinical trials across 5 regions, including the United States, China, and Australia. To date, we have secured 32 IND approvals in these regions and advanced 6 first-in-human programs globally, supported by approximately 70 clinical study centers collaborating on various stages of clinical trials. We have also demonstrated late-stage development capability with 29 NDA and sNDA filings, approvals in 10 markets across Asia-Pacific, and the reimbursement achieved in 5 of these markets. This experience demonstrates our ability to execute efficiently from first-in-human studies through regulatory approvals and commercialization across multiple international markets in Asia-Pacific.

I now pass the time to our Head of Pipeline Strategy, Project Leadership, and Business Development, Ariel, who will be sharing more about the transaction. Ariel.

Ariel Guo
VP of Business Development and Chief of Staff, Antengene

Thank you, Jay. For ATG-201, partnering with UCB represents the most effective pathway to accelerate its global development and fully realize its potential. This collaboration brings together Antengene's discovery and early clinical execution capabilities with UCB's established leadership in immunology, along with global development and commercialization expertise. Under the agreement, UCB receives worldwide exclusive rights to ATG-201. Antengene will receive $80 million in upfront and near-term milestone payments and is eligible for up to approximately $1.1 billion in future development and commercial milestone payments, in addition to tier royalties on net sales. The total potential deal value is approximately $1.2 billion, excluding royalties. We plan to submit clinical trial applications in the first quarter of 2026 in China and Australia, and Antengene will complete the first-in-human phase I studies in those regions.

UCB will assume responsibility for global clinical development and commercialization. This structure provides Antengene immediate value while maintaining significant long-term participation in the global success of ATG-201 and places the program within UCB's established immunology franchise, supported by deep clinical, regulatory, and commercial capabilities. Founded in 1928, UCB has evolved into a global pharmaceutical company inspired by patients and driven by science. With nearly 100 years of history, UCB maintains a highly focused strategy centered on two core therapeutic areas: immunology and neurology. Immunology represents a primary pillar of the company, UCB is widely recognized as a global leader in immune-mediated diseases. UCB continues to invest heavily in innovation with approximately 24% of its 2025 revenue reinvested into research and development. The company employs more than 10,000 people across 36 countries, demonstrating its international presence.

UCB brings significant scale and experience into this partnership and is widely recognized as a global powerhouse in immunology. In 2025, the company generated EUR 7.7 billion in revenue, approximately $9 billion, reflecting the strength of its global franchise. The company has demonstrated strong clinical execution with a phase III success rate of approximately 86%, significantly above industry averages. This track record underscores its capability in advancing complex immunology programs through late-stage development and regulatory approval. UCB has also built a multi-product global immunology franchise supported by established commercial infrastructure and lifecycle management expertise across major markets. Together, these capabilities provide a strong foundation to advance ATG-201 globally within an experienced immunology organization. Let me turn to the broader application of AnTenGager platform.

AnTenGager was designed as a scalable next generation T-cell engager platform, integrating our proprietary CD3 sequence, bivalent target mining architecture, and a steric hindrance masking design to create differentiated T-cell engagers. As shown on this slide, we have built a robust portfolio of programs spanning autoimmune diseases, solid tumors, and hematological malignancies, targeting biological validated disease-relevant antigens across therapeutic areas. The AnTenGager platform was designed to address key limitations observed with the first- generation T-cell engagers, including suboptimal killing of the low targeting expressing cells and safety concerns related to cytokine release syndrome. Its bivalent disease-associated antigen binding enhances ability, enabling more effective targeting of low antigen-expressing cells. Unlike many existing T-cell engager platforms that rely on off-patent CD3 sequences such as OKT3 or SP34 , we have developed our own proprietary CD3 antibodies.

AnTenGager targets a unique conformational epitope on the CD3 epsilon gamma or epsilon delta complex with fast on/fast off binding kinetics. This enables potent target cell killing while reducing on-target cytokine release. The CD3 sequence is patented, supporting long-term competitive differentiation. The platform also incorporates a steric hindrance-based CD3 masking mechanism that enables target-dependent activation. The CD3 binding site is exposed only upon engagement with a disease-associated antigen. The slides presents cryo-electron microscopy images of our AnTenGager T-cell engager, visually illustrating its masking effect. As shown here, the highlighted CD3 binding region is directly shielded by the constant region of the DAA binding arm, effectively masking the CD3 site in absence of target engagement. For comparison, we also show another 2+1 T-cell engager structure as a benchmark.

In this format, the CD3 binding arm is a full-length Fab fragment, which has a relatively rigid structure, resulting in a continuous exposure of the CD3 binding site. These structural differences provide visual confirmation of the steric hindrance-based masking mechanism underlying the AnTenGager design. In another ex vivo comparison with the first- generation T-cell engagers, AnTenGager TCEs demonstrate reduced T-cell exhaustion. This finding supports the effectiveness of the masking mechanism, as AnTenGagers are activated only upon target engagement and avoid non-specific CD3 activation. By preventing continuous non-productive T-cell stimulation, AnTenGagers reduce T-cell exhaustion compared with the first- generation non-masked TCEs. In summary, AnTenGager as T-cell engager 2.0 is designed to minimize both off-target and on-target T-cell activation. The steric hindrance-based masking technology reduces off-target T-cell activation and cytokine release by enabling target-dependent CD3 activation.

This supports a wider and safer therapeutic window and helps prevent T-cell exhaustion. In contrast to peptide masking or structure locking strategies used in certain TCE platforms, which are protease dependent and rely on activation within the tumor microenvironment, AnTenGagers are activated independently of the tumor microenvironment. This enables potential applications beyond oncology, including in autoimmune indications, while still preventing uncontrolled systematic T-cell activation. In addition, the proprietary anti-CD3 sequence further mitigates on-target T-cell activation and cytokine release through its fast on, fast off binding kinetics. Together, the design features enable the development of T-cell engagers that have the potential to be safer and more effective and applicable across a broader range of therapeutic areas. With that overview of the AnTenGager platform, let me now turn to the ATG-201.

ATG-201 is the first and lead program generated with AnTenGager platform, and is the program we have licensed to UCB. It is a CD19/CD3 T-cell engager designed for the treatment of B-cell related autoimmune diseases. We conducted an in vivo comparison of ATG-201 against a first-generation CD19/CD3 T-cell engager. Following a single dose, ATG-201 achieved deep and sustained B-cell depletion across blood, bone marrow, and spleen, with no detectable B-cells up to 14 days post-treatment. Complete depletion in spleen is particularly notable given the difficulty of clearing tissue- resident B-cells. In contrast, the benchmark showed early B-cell reduction, followed by recovery within days, with incomplete depletion in bone marrow. ATG-201 also induced lower levels of key inflammatory cytokines compared with the benchmark, supporting the potential for improved safety. Now I will turn the presentation over to Dr.

Bing Hou, our Head of Discovery and Translational Science, who will run through the other T-cell engager programs generated using the AnTenGager platform.

Bing Hou
Head of Discovery Science and Translational Medicine, Antengene

Thank you, Ariel. Beyond the ATG-201, we are systemically applying the AnTenGager design principles across additional TCE programs. I would like to briefly highlight those assets. ATG-106 is a cadherin-6 CD3 T-cell engager and our lead program in the solid tumor space being developed for ovarian and kidney cancers. It is potentially first-in-class and has demonstrated a compelling preclinical profile, including cadherin-6-dependent T-cell activation, potent antitumor activity in both in vitro and in vivo models, favorable developability characteristics, and good tolerability in non-human primates. We plan to submit our IND in the first quarter of 2027. ATG-112 is an ALPPL2 CD3 T-cell engager and another novel program in the solid tumor space being developed for gynecological cancers, non-small cell lung cancer, and pancreatic cancer.

ALPP and ALPG are selectively expressed in tumors with limited expression in normal tissues, making them attractive targets for T cell engagement. ATG-112 has demonstrated a compelling preclinical profile, including ALPPL2-dependent T cell activation and potent antitumor activity in both in vitro and in vivo models. The program is also potentially first-in-class. We have nominated the preclinical candidate this quarter. In addition to ATG-106 and ATG-112, we are advancing several other AnTenGager TCE programs in solid tumors. ATG-110 is a LY6G6D CD3 TCE 2.0 for microsatellite stable colorectal cancer. LY6G6D is highly expressed in CRC, particularly in pMMR and MSS tumors that are typically resistant to immune checkpoint inhibitors with limited expression in normal tissues. ATG-110 has demonstrated strong preclinical efficacy and stability with an IND submission planned for the first half of 2027.

Beyond disclosed programs, we are also advancing additional AnTenGager TCE candidates. ATG-115 is an undisclosed tumor-associated antigen bispecific TCE for liver cancer. The target was identified using AI and bioinformatics approaches and is highly expressed in liver cancer with low normal tissue expression. In addition, we have two undisclosed tri-specific TCE programs targeting metastatic castration-resistant prostate cancer and small cell lung cancer or neuroendocrine tumors. These programs are designed with the first-in-class potential and aim to enhance efficacy while reducing toxicity. In addition to our solid tumor pipeline, we are also advancing differentiated AnTenGager TCE programs in hematologic malignancies. ATG-021 is a GPRC5D CD3 TCE 2.0 for the treatment of multiple myeloma. GPRC5D is a validated target in multiple myeloma with strong expression on malignant plasma cells and limited expression in normal tissues.

ATG-021 has demonstrated strong in vivo antitumor efficacy and significantly lower cytokine release compared with clinical benchmark TCEs. The molecule is designed with GPRC5D-dependent CD3 activation and a silenced Fc configuration to enhance safety. This data supports the potential for the best-in-class efficacy with an improved safety profile. ATG-102 is a biparatopic 2+1+1 LILRB4 CD3 TCE for the treatment of acute myeloid leukemia and chronic myelomonocytic leukemia. LILRB4 is highly expressed in certain hematological malignancies, particularly monocytic AML, with a limited expression in normal tissues. ATG-102 utilized a biparatopic design that recognizes two non-overlapping LILRB4 epitopes, enabling trivalent binding and enhanced targeting engagement. In preclinical models, ATG-102 demonstrated potent LILRB4-dependent T-cell activation and superior inhibition of AML tumor growth compared with the benchmark molecules.

I will give the stage back to Ariel.

Ariel Guo
VP of Business Development and Chief of Staff, Antengene

Thanks, Bing. Having outlined the differentiated profile and breadth of our AnTenGager pipeline, I'd now like to briefly share how we think about collaboration. AnTenGager is designed as a scalable platform, we see meaningful opportunities to expand its impact through strategic partnerships. We're open to both program-level and platform-level collaborations with global partners. At the program level, we're open to licensing existing assets similar to our partnership with UCB for ATG-201. At the platform level, we support multiple collaboration models. Partners can bring their own antibody against a disease-associated antigen and leverage the AnTenGager platform to generate and optimized novel T-cell engagers. we are also open to co-discovery and co-development partnerships, working together from concept to create differentiated T-cell engager programs. We believe the versatility and scalability of AnTenGager position it as a long-term collaboration engine across different therapeutic areas.

Now I will hand the presentation back to Jay Mei for the closing remarks.

Jay Mei
Founder, Chairman, and CEO, Antengene

Donald, you want to make some comments?

Donald Lung
CFO, Antengene

Sure. Let me briefly return to our broader pipeline and the milestones ahead. Firstly, ATG-022, our Claudin 18.2 ADC, has demonstrated best-in-class efficacy and safety in gastric cancer and remains the only Claudin 18.2 ADC globally to report efficacy beyond digestive system tumors. We plan to initiate first a phase III monotherapy study this year and also begin frontline combination studies with pembrolizumab and chemotherapy, which we believe we are uniquely positioned given our excellent safety profile, and together will bring us to a $5 billion peak sales opportunity. Secondly, ATG-037, our oral small molecule CD73 inhibitor, has shown encouraging efficacy in checkpoint inhibitor-resistant melanoma and non-small cell lung cancer. The ongoing phase II study continues to advance, with further updates expected later this year.

We also announced last week a clinical collaboration with Junshi to evaluate ATG-037 in combination with a PD-1 VEGF bispecific antibody, JS207, across multiple tumor types. This signal finding study is designed to explore potential synergistic activity with the objective of enhancing durability of response and improving long-term outcomes, including overall survival of PD-1 VEGF bispecific antibodies. Within the Engager platform, ATG-201 is advancing toward clinical entry this year, alongside multiple additional programs as we have showcased progressing through IND-enabling studies. Collectively, these programs demonstrate Antengene's sustained innovation and our ability to deliver differentiated therapies across disease areas and therapeutic modalities. Building on this foundation, Antengene is entering a new phase of growth, supported by expanding revenue streams, a pivotal stage pipeline, and continued scientific innovation.

Apart from commercialization revenues from 10 approved APAC markets, we now have an additional revenue stream from partnering, adding a meaningful source of long-term value creation, as demonstrated by the UCB transaction. It's just the beginning, with one out of 10 of our assets in the AnTenGager platform. ATG-022, our Claudin 18.2 ADC, ATG-037, our CD73 small molecule inhibitor, is advancing toward late-stage development. Most importantly, our discovery platform continues to generate differentiated programs across TCEs, ADCs, and other next-generation modalities. Together, these drivers position Antengene for diversified, sustainable growth and continued leadership in innovative therapeutics. With that, we will now open the floor for questions. If you would like to ask a question verbally, please use the raise hand function, and we will grant you the right to speak.

Alternatively, you may submit your question through the question box. We will read it out and address it accordingly.

Jay Mei
Founder, Chairman, and CEO, Antengene

While you are thinking about what questions to ask us today, I would like to take the opportunity to thank you again for spending the time with us on such a short notice. As you can hear, we're clearly very excited with this partnership with UCB, and we look forward to updating you on the progress across different stages of Antengene's broad-based pipeline as well.

Operator

Thank you, Jay. The first question comes from Arthur He. Arthur, please go ahead.

Arthur He
Equity Research Vice President, H.C. Wainwright & Co.

Hey, Jay and team. Congrats. It's very happy for you guys. I just had a couple quick question for the DOIs. First is, could you elaborate, or if you are able to, what's the specific milestone tied to the $20 million milestone payment? The second question is, for the trial you guys going to do in China and Australia, will UCB compensate the expense of trial? Thanks.

Jay Mei
Founder, Chairman, and CEO, Antengene

Excellent question, Arthur. We won't be able to dive into too much of the financial details, but what we can share with you is that, as you can imagine, at a very high level, there will be very general milestones related to a near clinical stage program such as ATG-201. I guess I can make comments on, let's say, patients being dosed, sites being initiated. We remain confident that we will be able to achieve these near-term milestones within 2026.

Now, with regard the financial coverage for the phase I trial, I wanna make it clear that Antengene will be the sponsor for the studies we're going to initiate in China and Australia, and we'll be fully responsible and for the conduct of the study. So, I think we will in due course and reporting back to you and either at the ClinicalTrials.gov or other forums and in a timely fashion and of course, together with our partner of UCB.

Arthur He
Equity Research Vice President, H.C. Wainwright & Co.

Okay. That's great. Thanks, Jay. Maybe another strategic question for Jay. When you're going forward, when you guys are thinking about additional partnership or business development wise, are you more leaned to these like single asset deal or you are more leaned towards like a multiple asset package deal? Thanks.

Jay Mei
Founder, Chairman, and CEO, Antengene

Yeah, it's another great question, Arthur. Thank you for that. We're actually quite open, as Ariel mentioned. We are open at the program level, collaboration. That could be a single asset or multiple assets. We're also open, collaboration at the platform level and the T-cell engager. You can bring, well, a potential partner can bring their own binder, the DAA, disease-associated antigen and antibody, and we will be able to create either bispecific or even trispecific and T-cell engager for your evaluation. But also that, if you have an idea just on a piece of paper with a target in mind, and we can start from scratch in co-discovery and co-development model as well. We're very much flexible.

Now, to your question about the partnership, as Ariel mentioned, clearly, as you can see here, we would like to think we have a very rich and robust pipeline across different stages of preclinical and clinical development all the way to pivotal stage asset, as Donald alluded to ATG-022. Our highly differentiated and very potent and with a superior efficacy and safety profile against the Claudin 18.2, a molecule that is gonna enter into pivotal stage this year. We also expect to report data in the frontline setting in combination with chemo plus pembrolizumab as well as data continue to report from other tumor types beyond the gastric, as a matter of fact, beyond GI tract and in a basket trial.

The short answer to your question is, we're very much open for partnership and then of course, and the number one objective is to be able to maximize the global impact of these innovative medicines or molecules and then bring value and benefits to our patients worldwide.

Arthur He
Equity Research Vice President, H.C. Wainwright & Co.

Awesome. Thanks, Jay. Congrats again.

Jay Mei
Founder, Chairman, and CEO, Antengene

Thank you, Arthur.

Operator

Thank you, Arthur. The next question is from Linhai Zhao. Linhai, please go ahead.

Linhai Zhao
Equity Research Analyst, Goldman Sachs

Hi, this is Linhai from Goldman. Congratulations on this very meaningful collaboration for RTCE platform. I think I got two questions. The first question is regarding the indications. In the company announcement, it does say that we granted the global licensing rights to UCB, targeting on autoimmune diseases. Just curious to see, have you guys ever discussed about other indications, for example, oncology? For the phase I trial that Antengene is going to conduct, will it be conducted on healthy volunteers or patients, if patients, what would be the indications? That's the first question.

The second question is a little bit more on the financials, given that you have a very high visibility of getting the $60 million up front and also the $20 million near-term payments, how confident are you going to get the fund within the year of 2026? Also, how would the strengths and the cash position would help you maybe give you more room in terms of strategically planning for ATG-022, the Claudin 18.2 ADC? Thank you.

Jay Mei
Founder, Chairman, and CEO, Antengene

Great. Thank you, Linhai . Great questions. I will start with the second one first. We, as I mentioned earlier in response to Arthur's question, we remain confident we will be able to deliver on the near-term milestones within 2026. With regard our cash position, we have been executing very efficiently in terms of capital expenditure. We are very well-funded. Just remind everybody that Antengene is a commercial stage company with revenue generating that is ramping up across multiple Asia Pacific markets, as I mentioned earlier, where we received the reimbursement for XPOVIO in mainland China, in South Korea, in Australia and other markets. That revenue is continue to increase.

Now we have a second stream of revenue, if you will, and from the partnership. As we just discussed, ATG-201 is the very first of at least nine programs we have disclosed under AnTenGager platform. We have multiple programs that are being reviewed and shared by our head of discovery and translational medicine, Dr. Bing Hou , just moments ago, against the solid tumor as well as hematological malignancies. We remain confident and then moving forward, the company will be very well-funded. But of course, and we continue to exercise our discipline in investment or expenses. We'll prioritize certain programs, including ATG-022 that is entering into pivotal stage.

We think that given that pretty much everybody has published the phase I or phase II data against the Claudin 18.2, that is either monoclonal, bispecific or antibody-drug conjugate or even including CAR-T programs. ATG-022 is differentiated in its activity across the broad spectrum of Claudin 18.2 expression, not only to high, ultra high, also to low and ultra low gastric cancer patients. The excellent safety profile we presented at our R&D day in November last year, at the J.P. Morgan Healthcare Conference in January in San Francisco, at 1.8 mg/kg, ATG-022 so far have shown less than 20% and grade 3 or higher adverse events.

This is a bit unusual, but this is something we would like to achieve for any antibody-drug conjugates. Our desire is to basically make these toxic agents to more behave like a targeted therapy. We think ATG-022 is emerging its safety profile and also its efficacy profile. Single agent activity around the 46% in later line gastric cancer with less than 20% of grade 3 or higher adverse events, efficacy in a gynecologic tumor. Outside of GI tract, we think that bodes well for the asset moving forward and position not only across the entire spectrum of Claudin 18.2 expression gastric cancer, but also other tumor types in the frontline setting as well.

I think we're very well-funded at least for the first pivotal study and, other studies, of course, we're actively seeking partnership. Your first question, to the extent, I think I can address, maybe I'll ask Ariel speak to it before I get into trouble.

Ariel Guo
VP of Business Development and Chief of Staff, Antengene

Thanks, Jay. Yeah. I think for the phase I study, we'll stay laser focused to autoimmune diseases. Given it's the T-cell engaging nature, we'll start to enroll patients for the phase I study. The protocol is still under finalization, but we definitely take into consideration other diseases with high unmet medical needs like lupus.

Linhai Zhao
Equity Research Analyst, Goldman Sachs

Got it.

Operator

Thank you.

Linhai Zhao
Equity Research Analyst, Goldman Sachs

Thank you.

Operator

Go ahead. Do you have a follow-up question?

Linhai Zhao
Equity Research Analyst, Goldman Sachs

Yeah. Yeah, just curious, have you guys ever talked about oncology for this particular asset?

Jay Mei
Founder, Chairman, and CEO, Antengene

UCB has now global rights to this program. It's up to their decision, and we will support them in any form and that is possible. At the moment and the targeted therapeutic area remains on autoimmune diseases.

Linhai Zhao
Equity Research Analyst, Goldman Sachs

Got it. Makes sense. Thank you, Dr. Mei.

Jay Mei
Founder, Chairman, and CEO, Antengene

Thank you, Linhai.

Operator

Thank you, Linhai. The next question is from Frederick Gomez. Frederick, please go ahead. Frederick?

Frederick Gomez
Senior Equity Research Analyst, Jefferies

Yes. Can you hear me now?

Donald Lung
CFO, Antengene

Yep, we can hear you.

Frederick Gomez
Senior Equity Research Analyst, Jefferies

Perfect. Thanks, Donald, and congratulations to all the team. It's a fantastic, amazing news. Just a quick follow-up on the phase I. Thank you for the clarification. Can you maybe give us more colors on the duration of this phase I, and when could we expect the total transfer of the clinical development to UCB because you will stay in charge of the phase I? Maybe additional colors on the expected duration of this phase I and maybe the number of patients that will be included?

Ariel Guo
VP of Business Development and Chief of Staff, Antengene

Thank you for the question. From a phase I perspective, we're planning for filing the IND on order equivalent in the first quarter of this year. Given the typical design of such study, I think a typical follow-up period will be 48 week. However, we set up multiple early stage observation points like week 12, week 24 to get early data from both efficacy and safety perspective.

Frederick Gomez
Senior Equity Research Analyst, Jefferies

Okay. Thank you.

Donald Lung
CFO, Antengene

Thank you. Again, if you have a question, please raise your hand, if you wish to ask the question verbally. If not, you can enter your question into the Q&A box. I will start to read out a few pipeline questions in the Q&A box. First is, can you further elaborate how ATG-201 is distinct from other CD19 targeting TCEs in development?

Jay Mei
Founder, Chairman, and CEO, Antengene

I will start. Pretty much all the CD19/CD3 TCEs for autoimmune diseases were repurposed from hematological malignancies. In other words that, they were initially designed for liquid tumors. I think as we spend a great deal amount of time to discuss AnTenGager, the key feature is the tumor microenvironment independent steric hindrance-masking. That is basically enables antigen with target engagement dependent activation of T-cells, reduces the uncontrolled and unproductive overstimulation of T-cells, which of course leads to, as we know that clinically, CRS and CRS associated severe infections as well as inevitable T-cell exhaustions.

Couple that with the 2+1 bivalent format would allow us to deplete the relatively lower expression of target cells. In this case, for example, autoreactive and CD19 B-cells are much lower in quantity compared to malignant and a CD19-positive in, let's say, lymphoma. The 2+1 feature and will allow us to reach a deeper depletion and more robust immune onset as illustrated in multiple animal models in clinical trial. I mean, the preclinical studies and including the CD34 and a fully humanized mouse model, the CD19/CD3 double knockin, and the other studies we have conducted.

Again, the key feature is, we would expect ATG-201 to achieve a deeper B-cell depletion, more durable response, and a safer safety profile in terms of the occurrence of CRS or any CRS-associated severe infections. We know that they have been reported with other drugs. Of course, as I mentioned with the fast on, fast off and kinetics would also reduce the on target and cytokine release as well as T-cell exhaustion. I don't know if I addressed your question, and I would like to see if my colleagues have anything else to add.

Donald Lung
CFO, Antengene

I'll address the next online question. Can you confirm how you see the potential use of ATG-201 in monotherapy or in combination therapy? Do you have any particular initial autoimmune targets that would be most appropriate to be targeted?

Ariel Guo
VP of Business Development and Chief of Staff, Antengene

For the first-in-human study, we definitely will test the monotherapy, later on, we also will definitely include combination therapy so we can capture different line setting of patients. From target perspective, as mentioned, we're still working on finalization the protocol, definitely taking into consideration of the unmet medical needs, disease types like lupus. There are some other, disease types we're also taking into consideration, want to capture the vast regulatory pathway as well.

Jay Mei
Founder, Chairman, and CEO, Antengene

With regard, clinical combination, of course, and UCB has a wealth of experience, clinical expertise and then also a very rich pipeline in autoimmune diseases. Each disease will be unique and the combination will be different. Of course, and then that will be, the development strategy that UCB will continually to carry on. Antengene will be remain supportive as much and to the extent as possible.

Donald Lung
CFO, Antengene

I'll continue to address the offline questions. What are the key differentiators of your proprietary CD3 sequence?

Bing Hou
Head of Discovery Science and Translational Medicine, Antengene

I will address this question. Thank you for this excellent question. Our CD3 sequences are proprietary and patented, not based on commonly used of patent antibodies, such as OKT3 or SP34. They bind to a unique conformational epitope on CD3 complex, specifically, the epsilon gamma or epsilon delta heteromer rather than the epsilon monomer. This binding epitope, combined with fast on, fast off binding kinetics, enables strong and transient T-cell dependent cytotoxicity while minimizing excessive cytokine release and reducing the risk of T-cell exhaustion. This kinetic characteristics allow for potent yet controlled immune activation, which is critical for both safety and efficacy. In addition, the CD3 binding arm in our antigen structure has a very unique CDR sequence. It remains partially concealed by the antigen binding Fab arm until antigen dependent cross-linking occurs.

This direct masking ensures that T-cell activation is target dependent.

Donald Lung
CFO, Antengene

The next question is also a scientific question. Can the Antengene architecture support trispecific or next-generation formats?

Jay Mei
Founder, Chairman, and CEO, Antengene

The short answer is yes. I would like ask Bing to elaborate.

Bing Hou
Head of Discovery Science and Translational Medicine, Antengene

Yes, the Antengene architecture is modular and flexible, allowing the design of trispecific and other next-generation antibody formats. We currently have several undisclosed trispecific antibody programs in preclinical development for oncology and autoimmune indications. In addition to combining different Antengene targets, the platform also enables a structural innovation. For example, one approach is to introduce an additional single chain scFv at the C-terminal of the antibody to enhance binding diversity. We have successfully explored this concept in our ATG-102, the LILRB4 CD3 program for AML, where the molecule features three binding arms that directed at LILRB4 that recognize two distinct epitopes. This demonstrates the flexibility and expandability of Antengene platform design

Donald Lung
CFO, Antengene

The next question is more strategic related to the deal. Why did Antengene choose to grant global rights for ATG-201 instead of retaining China rights? This seems atypical compared with other BD deals. How should we think about this decision?

Jay Mei
Founder, Chairman, and CEO, Antengene

It's a good question. I think that UCB clearly is a global company. It's operating in 34 countries, it has a strategic position with regard to not only its global clinical development commercial strategy, but also with regard to China as well. I think it's public knowledge UCB has made some strategic transaction over I think about two years ago or one year ago, more than one year ago. Clearly, our understanding is to basically remain more focused on innovative drugs and medicines for the China market. We fully understand that desire and that strategy. As a matter of fact, we are supportive as well.

To be frank, Antengene started as oncology company, our, as you can see, appreciated our pipeline and also our clinical development expertise and everything, are still overwhelmingly oncology-focused. There's a lot for us to learn from our partner. To be able to partner with UCB but also allow Antengene to continue to carry on the phase I trials in China and Australia, I think this is a very good opportunity for our team to grow, to learn as well. To the extent and that UCB will be able to bring a wealth of knowledge and expertise, and also it's a commitment to the market and the patients in China, along with the rest of the world.

I don't know if Ariel has any additional comments.

Ariel Guo
VP of Business Development and Chief of Staff, Antengene

No, I think you covered all. Thank you, Jay.

Donald Lung
CFO, Antengene

Thank you, Jay and Ariel. I see that there are no further questions. Let's conclude the call. I'll see if Jay has any closing remarks.

Jay Mei
Founder, Chairman, and CEO, Antengene

Again, we appreciated your support over the years. We are very again, very excited to enter our first global partnership from Antengene's pipeline. We will continue to remain focused in discovering and developing innovative medicines for patients around the world. We'll have continued dialogue with you all and the investors, researchers, analysts. We operate in multiple countries. As a matter of fact, now in North America as well as across the entire Asia-Pacific. I know that most of you have the coverage or reach globally, we would very much like to hear from you.

We would like to take an opportunity and to thank you again for your continuing support. again and, for you spending your precious time and, this morning hour. Thank you.

Donald Lung
CFO, Antengene

Thank you very much. This concludes our conference call. Thank you. Have a good day.

Powered by