Early Signals at ASCO 2026 | How Do You Turn Next-Generation ADC Science Into Global Clinical Success?

Antibody-drug conjugates (ADCs) are transforming oncology, but scientific innovation alone isn't enough. As platforms become more sophisticated—with novel linker technologies, diversified payloads and increasingly targeted approaches—the challenge shifts from discovery to execution. How do sponsors successfully translate next-generation ADC science into global clinical development programs?

In this episode of Early Signals, Wael Harb, MD, sits down with Diana Chen, Vice President of Global Clinical Operations at MediLink Therapeutics, to discuss what it takes to operationalize innovation at scale. From building a rapidly growing ADC pipeline and managing global partnerships with leading biopharma companies to navigating cross-cultural clinical operations, Diana shares practical insights into the strategies shaping the next generation of oncology drug development.

Together, they explore how platform technologies like MediLink's TMALIN® linker are expanding the potential of ADCs, why global collaboration is becoming a competitive advantage and what operational excellence looks like in an increasingly complex development landscape.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

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Transcript

SPEAKER_00 0:00

Welcome to the Sinia's Health Podcast, Early Signals, where we explore the ideas, innovations, and emerging trends shaping the future of oncology. I'm Dr. Y. L. Harb, Head of RD and Scientific Strategy in Oncology at Synus Health. Recorded live from ASCO 2026, these conversations bring together perspective from leaders across biopharma, academia, and technology on the signals they're watching most closely, from AI-enabled drug development and real-world evidence to precision medicine. These conversations offer a snapshot of where oncology innovation is headed next. Let's tune into one of our conversations now. Antibody drug conjugates have moved from a promising idea to one of the most active frontiers in oncology, and the science is evolving fast. Noble linker chemistry, payload diversification, smarter target selection, and the operational machinery to run these programs globally and at speed. My guest today sits right at that intersection. Diana Chen is a VP of Global Clinical Operation at Middle Link Therapeutics, where she helps lead the clinical development of a pipeline built on the Tamilin platform, including YL201, which earned FDA breakthrough designation in small cell lung cancer. Diana brings a rare operational vantage point on what it actually takes to translate next generation ADC science into global trials. Diana, welcome to Early Signals.

SPEAKER_01 1:42

Thank you, Dr. Harb, for having me today. I'm very excited to be here at ASCO among all our wonderful colleagues here at Cineos and the rest of the oncology community. So thank you so much.

SPEAKER_00 1:53

We're delighted to have you. Let's start with your journey, Diana. How did you decide to get into clinical research?

SPEAKER_01 2:00

Well, as probably the case with many of us, I somewhat fell into it. So I was in Boston for grad school looking to get my PhD, but halfway through, wasn't really interested in being in a lab, experimenting with mice and rats all day long in a basement laboratory, as many of us were probably at in grad school. And a friend of mine who was also a grad student got her master's and started at a CRO, a competitor of yours. And I asked her on Deso, what is this? What is this clinical research? And then she explained what she did. So I started my career as a CRA, a monitor at a CRO, and from there my career moved on to big pharma, medical device, biotech, and never turned back. And 20 some years later, I'm now at Metalink as the head of global clinical operations.

SPEAKER_00 3:00

Amazing journey. You're leading global clinical development to one of some of the most exciting ADCs. Tell us more about Medilink.

SPEAKER_01 3:09

Metalink is a biotech company headquartered in SUTO. We are actually a very young company. We've only been in existence for about six years. Within the six years, we have have phenomenal discovery come out of our laboratories, and we currently have 14 assets, all ADCs, in the pipeline, four of which we are managing the clinical trials ourselves. The other 10 we have outlicensed to other partners, many of which you most likely work with. A lot of big pharma partners such as Pfizer, Rose Genentech, BioNTech, Estelas, Hinlis. Not only are we in clinical stage, but we also, from a discovery perspective, many large pharma companies come to us for assets.

SPEAKER_00 4:06

That's amazing. I remember when I visited Middling office in Shanghai, it was very early days. It was not too long ago, it was uh four years ago, and I think it was a small team.

SPEAKER_01 4:18

And now how many you have in the We have over, I believe, you know, the numbers change every day. We're in about 380 now. We have 20 people in the U.S., the rest of the team is in China due to the fact that we are growing. Hopefully, we'll have a product on the market next year. And so we're growing our commercial team and our CMC team, and we also have a large clinical team in China as many of our studies are in phase three in China, and quite a few of them are in source.

SPEAKER_00 4:56

Diana, tell me what differentiates MIDI-link platform technology from other ADCs.

SPEAKER_01 5:03

Our ADC is what we call our platform, current platform, is called the Tamalin, which is the tumor microenvironment actable linker. What's special about this particular platform is it's got a dual cleavage mechanism. So not only does the linker cleave intracellularly at the lysosome level, but also extracellularly. So it has the ability to increase the payload efficacy against tumor cells with low antigen expression, not just high antigen expression. Most ADCs you see out there require internalization, whereas ours does not require that.

SPEAKER_00 5:44

Well, that's very important differentiation because you're able to have efficacy even that the target expression is low. Exactly. Yes. Amazing. Now you have 14 assets? We have 14 assets now, yes. That's significant growth, but you have really interesting strategies. Some of the assets you have kept in-house and you're developing, but also you have developed a global collaboration. Can you tell me about that?

SPEAKER_01 6:11

Yes, with some of the assets that we have, we are a young company, a smaller company. So with us being a small biotech, we don't have the capability of the large pharma companies. So we may have the resources to conduct phase one slash two studies, but to in order for us to take it to the finish line, we partner with large pharmaceutical companies such as Roche and BioNTech, which we have been very fortunate to have their amazing assets that they've been interested in. And so we have two assets that we partner with Roche and one that we partner with BioNTech. And these are assets where we basically have code development opportunities with some assets we completely outlicense, where others, such as these three, we start the development and they come in prior to the end of phase two to take it to the finish line.

SPEAKER_00 7:18

Tell me about Wild 2019. You have received breakthrough designation. It's a very exciting moment.

SPEAKER_01 7:24

Yes, it is a very exciting moment. Wild 201 is what we like to call our baby, our brainchild, our first asset that came out of the discovery. And we've been lucky enough, not only from a safety and equity perspective, but from a partnership perspective with Roast Genentech. This past year we went into partnership with them. This is our second asset with Roast Genentech. But this particular asset is hopefully going to be that breakthrough blockbuster, we hope, for small cell lung cancer and also other lung indications, and hopefully outside of lung, as we know, B7H3 target have been seen in other disease areas.

SPEAKER_00 8:09

What about YL202?

SPEAKER_01 8:11

Well, YL202 is our HER3 target ADC. We have partnered with BioNTech, as many people know BioNTech for the COVID vaccine. That was actually one of our first partnerships. And the team has been amazing. And what has happened with all these partnerships is that MetaLink will start the studies, we'll work on the phase one slash two studies, and then our business partners such as BioNTech and Roche will take it to the finish line. So with Wild 202, which is also called BNT 326, there are ongoing phase three studies in China, but also phase two and soon have phase three studies globally that's being managed by the BioNTech team.

SPEAKER_00 8:54

That's fantastic. It's all about getting access for patients to life-saving drugs. I'm really interested to know about the global expansion you had. You have a really unique model. You're developing the drugs in China, but you're doing the trials in the US and China and have global collaboration. I would like to take your perspective from a clinical operation. Where do you see the synergy? Where do you see the challenges?

SPEAKER_01 9:20

There's always challenges, I think, when you work in not just within each region, but also, you know, you add more complexity when you work in a global environment. For us, we have team members that are in China, but also we have one team member in Australia and team members here. And then we have CROs with team members in Europe and also US and China. So the challenge is really knowing how to communicate and communicate well. We also try to make sure that our employees are culturally aware of learning how to work across regions, knowing the nuances, having the EQ, not just the IQ of working with people, but really having that EQ and being respectful and cognizant of the cultures. I always say to everyone, they teach you this oftentimes in Mansion Coaching that when you are talking to someone or working with someone, try to mimic how their body language or how their energy level is. Oftentimes it's hard to do that over the phone, but if you can try to get them on a video call versus a phone call, getting to know them, getting to know what's in it for them and what drives them, I think that helps with working cross-culturally and dealing with some of the challenges around that.

SPEAKER_00 10:49

And how's the efficiency model here? How you decide about the trial, where to do it, whether to start in China, when to move it to the US?

SPEAKER_01 10:59

It really sometimes depends on the asset, and you're probably gonna see this at many companies. If you have an asset that's within, for instance, our Tamalan platform, we know it works. It's been utilized in thousands of patients to date. So if you have an asset that's using the same platform and a similar linker payload, the risk is may not be as high. We really strategize to look at when we do have something that's a little bit more high risk. We start it with a smaller number of sites, number of patients, and we keep a close eye in terms of close follow-up and working closely with the CRO and also with the sites to ensure patient safety is number one. But also looking at the treatment landscape too, and also the competition out there, what other companies are doing, and which sites have they gone to, which countries they have gone to. And also from a corporate strategy, what's the long-term view of where we want to register this particular asset?

SPEAKER_00 12:06

You have developed global partnership. You mentioned Roche and Biantic. Can you give us some insight in how to develop a model of collaboration that's effective?

SPEAKER_01 12:19

I think for me it's all about relationships. There's a saying in Chinese called Guanxi. It's really about building relationships. Even if you work together every day, I think if you really wanted to truly work, truly know that individual, truly have someone lean in, you need to build that strong foundation. And that strong foundation is getting to know the individuals and the relationships and spending time together. So what I have seen successful in the partnerships that not only here at Metalink, but the partnerships that I had previously at other companies is really being transparent, leaning in, sharing ideas. It's not just one-sided, but learning when to speak up when you need to, and knowing it's very simple what's right, what's wrong. Building that relationship, not just from a work perspective, but beyond that, and getting to know the individuals because at the end of the day, when it comes to these partnerships, you do work very, very closely with all the individuals and the decisions that are made. I always say it's okay to disagree, agree to disagree sometimes. I think that's what's great about healthy relationships and healthy partnerships.

SPEAKER_00 13:43

What does excite you about upcoming readout, upcoming trials, upcoming additional assets you bring into the clinical trials?

SPEAKER_01 13:53

What excites me about the upcoming reouts is that we can finally get our drug out there to be approved to give to patients. Right now, the only way our drugs are available to patients is through clinical trials. So once that approval happens, these patients can access these drugs more readily and easily. And not just at certain hospitals that we're working with, but other hospitals or small community centers. So that's what excites me about that. Our assets that are coming out, ADC has been around for a little while now. And everyone has been working with a Topo 1 payload. So really looking at other payloads, dual functions, buy-specifics, tri-specifics, different mechanisms of actions. So I'm really excited about those activities that are coming out of our pipeline. We recently had a couple posters that were presented at AACR, one of which is looking at POS and HER2. HER2 has been, I think, the forefront of ADC in the last two, three years, and it will be really nice to see what's coming after that.

SPEAKER_00 15:10

Yeah, it's very exciting with all of the innovation with biospecific, now tri-specific, ADC, ADC, T cell engagers, I think changing the payload targets. I think the number of ADCs we've seen coming to Chronicle Trial is really have expanded significantly this year. When you're managing new drug development, you're bringing new drug to first human trials, especially during this global trial, how you manage safety, especially when you're doing a trial in multiple continents, multiple countries?

SPEAKER_01 15:44

We're a small company, so we really need a strong partnership in managing that safety. As you know, working with the Cineos team, we have engaged you in terms of a strong safety team across the board, and really making sure that there's proper communication with the sites. Not just our team, but the CRAs are engaged and in constant communication with the sites and making sure that the sites know the guidelines around conducting clinical trials, that they're very familiar and experienced and they're trained, so that safety reporting is done on time. As we know, in early trials, safety is the most utmost importance. From our perspective, our safety team works closely with the CineOs safety team to ensure that safety reporting is done on time to the regulatory agencies.

SPEAKER_00 16:44

Any final thoughts you have you would like to share with the audience?

SPEAKER_01 16:48

I've been in the oncology world for many, many years, and I've worked in cardiology, immunology, and I oftentimes always come back to oncology, and I just the advancement that I've seen in the last 15, 20 years, it's been amazing. I hope that one day we can cure cancer, if not at this point, prolonged life for these patients. There's a lot of exciting things happening in the oncology world, and we work every day to make sure that we can get these drugs to the patients as soon as possible. And thank you to your team and to our team, always working so closely to ensure that that will happen.

SPEAKER_00 17:31

It goes both ways. Thank you for your partnership. Diana, thank you very much for very insightful discussions around what MiddleLink is doing about the world of ADC. Really wish you all the best in moving your drug to help a lot of patients.

SPEAKER_01 17:47

Thank you, Dr. Harb, for having me.

SPEAKER_00 17:50

That's all for today's episode of the Simeus Health Podcast, Early Signals. I'm your host, Dr. Y. L. Harb. If you have other topics you would like to hear on this podcast, please send us a message at podcast at seniushealth.com. For access to more future focused, actionable life science insights, please visit the insights hub at sineushealth.com.