Beyond Vessel Occlusion. A Porous-Microsphere Approach to Reinventing TACE in HCC

Liver cancers are one of the most common cancers worldwide and a leading cause of cancer mortality, and numbers are only rising globally. The standard treatment for intermediate-stage hepatocellular carcinoma, transarterial chemoembolization (TACE), treats approximately 40% of liver cancer patients, yet the outcomes remain grim: nearly half of those who receive TACE die within two years of diagnosis, and only about one in five survive beyond five years. This sobering prognosis highlights why TACE represents one of oncology’s most critical unmet needs.

 That’s where BDUK Therapeutics, an Israeli biotech startup poised to redefine TACE, comes into the picture. Co-founders Walter Wasser, MD and Yaron Suissa, PhD, MBA, contend that the fundamental flaw isn’t in the concept of targeting tumors by disrupting their blood supply, but rather in current methods that completely occlude vessels, inadvertently preventing the very chemotherapy they aim to deliver from reaching its cancerous target.

Their answer is EmboPore, a novel porous microsphere-based delivery technology developed by Professor Ofra Benny at Hebrew University, which is designed to maintain partial blood flow, allowing chemotherapy to be delivered directly to tumors over a sustained two-week period. Recent advancements in the field, showing improved progression-free survival when TACE is combined with targeted and immunotherapy drugs, further highlight the urgent demand for more effective TACE platforms—a need BDUK Therapeutics is uniquely positioned to address.

With approximately 900,000 new hepatocellular carcinoma diagnoses globally each year, and the TACE market alone valued at $11.8 billion in 2024 and projected to reach $16.4 billion by 2031, the moment for this innovation could not be more opportune. We recently sat down with BDUK co-founders Walter and Yaron to learn more about their approach to this immense challenge.

How did the idea for BDUK Therapeutics come together, and what made this particular approach to liver cancer stand out to you?

Walter: Yaron and I had been exploring multiple biotech opportunities, looking for something that addressed a major clinical gap. As a physician and a scientist, we were drawn to projects that could make a real difference.

After reviewing around ten technologies, we found Professor Benny’s work on porous microspheres designed to treat liver cancer especially compelling. The science was strong, the need was urgent, and it was clear this product  had the potential to change the standard of care. That’s when we decided to build BDUK Therapeutics around it.

Liver cancer accounts for more than 700,000 deaths annually worldwide, and TACE remains the standard of care for many patients. Why does TACE continue to fall short, and how does that shape the opportunity for innovation?

Walter: Liver cancer is a major global health challenge. The Lancet Commission’s July 2025 report on global hepatocellular carcinoma has already garnered significant attention, identifying liver cancer as the sixth most common cancer worldwide and third leading cause for cancer-related mortality globally. The commission projects new liver cancer cases will nearly double from 870,000 in 2022 to 1.52 million by 2050.

There are 60,000 to 70,000 new cases in the U.S. and Europe each year, with only 40% of these individuals are eligible for curative surgery. Another 20% have advanced disease with no treatment options. This leaves 40% of patients to be treated with TACE, transarterial chemoembolization.

TACE involves injecting beads mixed with chemotherapy into the hepatic artery to block blood flow and target the tumor. In theory, this starves the cancer and delivers the drug directly. But in practice, the occlusion is so complete that very little of the chemotherapy reaches the tumor. That’s the fundamental flaw.

As a result, outcomes remain deeply concerning. Nearly half of the patients who receive TACE die within two years of diagnosis, and only about one in five survive beyond five years. These are not just statistics; they reflect the limitations of current therapies and the urgent need for better options.

Your solution, EmboPore, was designed to overcome the core limitations of conventional TACE, namely, poor drug delivery and irreversible vessel occlusion. Can you explain how it works, and why it represents such a significant advance over the current standard of care?

Walter: EmboPore fundamentally reimagines how locoregional therapy is delivered. Traditional TACE uses embolic beads to block the hepatic artery and starve the tumor, but the complete occlusion means that very little of the chemotherapy actually reaches the cancer. That’s the root problem.

What Professor Benny developed is a porous microsphere that allows partial blood flow to continue, enabling embedded drugs —Doxorubicin and Tirapazamine (TPZ)—to reach the tumor over an extended two-week period. These microspheres are made of PLGA, a biodegradable polymer that rapidly breaks down in acidic environments, which are the conditions typically found in tumors. After an initial rapid degradation, the microspheres degrade in a gradual manner. This is a controlled degradation that releases the two drugs gradually and directly into the tumor microenvironment.

There is also a synergy between the two drugs: doxorubicin is a standard chemotherapeutic agent, while TPZ is only activated by hypoxia. The microspheres themselves induce localized hypoxia, activating TPZ which together with DOX provide the synergistic effect. Because EmboPore eventually dissolves, repeat treatments through the same arterial portal become a possibility—something conventional TACE doesn’t allow. The inability to re-catheterize the same hepatic artery has a significant negative impact on liver burden and on patients’ ability to undergo repeat procedures. 

You can think of it like a drug-eluting stent, but for liver tumors: precise, sustained drug delivery at the site of disease with minimal systemic toxicity while enabling the required environment for optimal anti-tumor drug impact. In preclinical models, this resulted in Significantly higher drug concentrations within tumors, with minimal drug exposure in the surrounding liver tissue.

From a pharma R&D and business development perspective, what makes this platform fundamentally different from other attempts to improve TACE?

Yaron: The key limitation in TACE is the complete blockage of blood vessels, which not only prevents drug penetration but also limits the potential for repeat dosing. The field has optimized everything about the beads—size, material, drug binding—except the main problem: they completely occlude the vessel.

Our product solves that. The porous structure of the microsphere allows some blood to continue flowing through, improving drug exposure to the tumor and preserving vessel patency. It degrades faster in acidic environments like the tumor microenvironment, which further enhances drug release at the right time and place. It’s a delivery solution that works with the biology, not against it.

The TACE market is estimated at billions of dollars—how do you evaluate commercial potential and how does orphan drug designation factor into your strategy?

Yaron: The commercial potential is substantial. In 2023, the TACE market reached $11 billion globally, with over 1.3 million patients eligible for treatment. While the largest patient populations are in Asia, there are still 60,000 to 70,000 eligible patients each in the U.S. and Europe.

Given the patient population size for this condition, we anticipate qualifying for orphan drug designation in both the U.S. and Europe, which would unlock significant incentives such as market exclusivity, fee reductions, and development support.

We also believe we may be eligible to receive FDA breakthrough therapy designation (BTD), and PRIME status in Europe, which can accelerate regulatory review and potentially enable commercializing the drug before completing Phase 3 trials. From a business perspective, the market average for orphan drug ROI is compelling—even under conservative models the return is projected to reach 7x.

Additionally, we are currently observing a significant change in market trends. Whereas in the past startup interactions with big pharma were initiated only towards the end, or after completion of, a phase-2 clinical trial, it’s been reported that leading pharma companies are now investigating M&A deals much earlier, even after phase-1 studies with positive readout.

What’s your current funding timeline and how are you structuring the path to clinical trials?

Yaron: We’re in the process of raising funds to start Phase 1 over the next 18 months. That includes completing GLP-compliant large animal studies and initiating first-in-human trials with secondary efficacy endpoints. We’ve already started some preparatory work.

Interestingly, two of our three components, PLGA and Doxorubicin, are FDA approved, while the third, TPZ, is well known and previously tested. The vast existing safety data may allow us to expedite traditional preclinical steps and skip non-rodent toxicity studies or run them in parallel with the clinical study to save time.

While your lead indication is liver cancer, do you see broader applications for this platform beyond hepatocellular carcinoma (HCC)?

Yaron: Absolutely. While our initial focus is on primary liver cancer, EmboPore is equally relevant for secondary liver tumors—cancers that metastasize to the liver. These include colorectal, pancreatic, breast, and uveal melanoma, which often spread preferentially to the liver and are difficult to treat systemically.

The strength of EmboPore lies in its ability to deliver various chemotherapy locally, directly into the tumor’s blood supply, while preserving vessel patency. This allows for sustained drug exposure, reduced systemic toxicity, and the possibility of repeat treatment, thereby overcoming major limitations of conventional TACE.

Looking ahead, we also see potential applications in other solid tumors beyond the liver. Any cancer accessible through the arterial system—like kidney, prostate, or even brain tumors such as glioblastoma—could benefit from a targeted, locoregional drug delivery approach. While we’re not currently targeting non-oncology indications, the underlying technology may also have future relevance in areas like arterial inflammation or vascular diseases.

You’ve received some strong early interest from key clinical opinion leaders. How is that helping to shape your path forward?

Yaron: It’s been a strong indicator that we’re solving the right problem. Usually, it takes months to get KOLs to engage meaningfully, but we’ve had experts in the field want to get involved almost immediately.

We had a leading senior hepatologist interested in collaboration after presenting our supporting scientific data. We’ve also had interest from a translational oncology expert at a leading cancer center in New York as well as leading senior interventional radiologists both in Israel and the US. That kind of engagement, from individuals with deep experience in liver-directed therapies, confirms that we’re addressing a significant clinical gap.

We are confident that our mission to transform the treatment paradigm for individuals with intermediate-stage liver cancer will have far-reaching implications for patients worldwide, offering new hope and meaningful advances in care.

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For BDUK Therapeutics Ltd., the path ahead means proving their porous microsphere technology can succeed where standard TACE has failed, and clinical trials will provide the answer. With high liver cancer mortality rates and a clear market waiting, BDUK Therapeutics offers both hope for patients and potentially a blueprint for how academic research can be translated into life-saving therapies.

ADRES Bio is actively supporting BDUK Therapeutics on their regulatory path, including with CDMO selection, CMC activities, preclinical plans, grants, investor meetings, and regulatory discussions.