ABK Biomedical Launches First-in-Human Clinical Trial for Eye90 Microspheres After 11 Years of R&D in Yttrium-90 Radioembolization

In March 2021, Boston Scientific’s TheraSphere Y-90 glass microspheres received FDA approval, becoming the only radioembolization therapy currently approved in the United States for the treatment of unresectable liver cancer.

Six months later, on the other side of the world, China’s first specially approved yttrium-90 (90Y) resin microsphere therapy for liver cancer was successfully performed at Boao Super Hospital in the Lecheng International Medical Tourism Pilot Zone on September 28. Five months later, Grand Pharma’s flagship product, yttrium-90 (90Y) microsphere injection, was successfully launched in the Chinese market after receiving approval from the National Medical Products Administration (NMPA) for the treatment of colorectal cancer liver metastases.

In no time, news about Yttrium-90 [⁹⁰Y] resin microspheres and Yttrium-90 [⁹⁰Y] glass microspheres flooded in, with their popularity growing day by day.

In the previous article, VCBeat introduced yttrium-90 (⁹⁰Y) technology and reviewed the major domestic and international companies actively developing this technology. In this article, we will provide a detailed introduction to the Canadian company ABK Biomedical, which has recently initiated human clinical trials. By examining its key developmental milestones and product portfolio, we aim to offer some insights that may benefit Chinese pharmaceutical and medical device enterprises as well as the nuclear medicine industry.

In April 2019, medical device company ABK Biomedical announced the completion of a $30 million Series B financing round to support the research and development of its Eye90 microsphere technology. The round was led by F-Prime Capital and Varian Medical Systems. The former is one of the world’s largest asset management firms, with prior investments in well-known companies such as Alibaba, TieMu Pharmaceuticals, and Atari. The latter is Varian Medical Systems, which holds over 50% of the global market share in radiotherapy. Both are seasoned “hunters” with more than seven decades of history, deep internal strength, and extensive experience.

This financing round became one of the largest healthcare venture capital investments in Atlantic Canada that year.

Prior to this, in February 2018, ABK Biomedical received $3 million in support from the Atlantic Canada Opportunities Agency (ACOA) to commercialize its Easi-Vue embolic microspheres in-house.

ABK Biomedical, a medical device company headquartered in Nova Scotia, Canada, derives its name from the initials of its three founders: interventional radiologist Robert Abraham, physician and materials scientist Dr. Daniel Boyd, and Sharon Kehoe (A = Abraham, B = Boyd, K = Kehoe).

The Three Founders of ABK Biomedical

Since its establishment in 2012, ABK has been dedicated to innovating embolization therapies for the treatment of uterine fibroids, hypervascular tumors, and arteriovenous malformations, striving to provide better therapeutic options for patients with vascular anomalies.

Specifically, ABK Biomedical holds intellectual property rights in the key area of inorganic polymer microspheres, targeting the growing field of embolization therapy within interventional radiology and interventional oncology. The company possesses advanced intellectual capital, along with its own R&D and manufacturing facilities, for the development and commercialization of unique, breakthrough embolization therapy products.

Low-profile pragmatism is a hallmark of most technology-driven, execution-focused enterprises, and ABK Biomedical is no exception.

ABK Biomedical, a low-profile company, shuns publicity; online information and media coverage about it are scarce. Its official website features only six news items, each closely tied to its products.

However, co-founder Bob Abraham humorously remarked, “ABK’s next big news might be the U.S. FDA approval of our first product, X-ray Visible Beads (Eye90 Microspheres).”

Stephen Schwarzman once said, “The difficulty of doing big things is the same as that of doing small things. Therefore, choose an ambitious goal worth pursuing, so that the rewards match your efforts.” ABK Biomedical clearly puts this principle into practice. Although its fundraising pace and scale are not as rapid or large as those of emerging startups, it has gained an edge by choosing to do what is “difficult yet right” from the very beginning.

Microsphere therapy is characterized by high energy, short half-life, pure beta-ray emission, and limited tissue penetration depth. Clinical evidence has demonstrated that 90Y microsphere therapy for malignant liver tumors offers significant advantages, including remarkable efficacy, fewer adverse reactions, shorter hospital stays, and applicability in patients with portal vein tumor thrombus. Consequently, 90Y microspheres have become a crucial therapeutic modality for advanced malignant liver tumors, showing particularly notable efficacy in the treatment of colorectal cancer liver metastases and intermediate-to-advanced primary liver cancer.

Meanwhile, the fabrication and separation of microspheres involve interdisciplinary integration, representing one of the frontier technologies in the world today.

Despite their small size, microspheres impose exceptionally high requirements on materials and production technologies. The motion and interactions of matter within microscopic systems cannot be described by classical physics, as they follow a distinct set of principles. Consequently, conventional methods and techniques largely become ineffective when processing materials at the micro- or even nanoscale, necessitating an entirely different system and process framework.

Combining yttrium-90 (⁹⁰Y) with microspheres presents even greater challenges in terms of difficulty and precision, making the process exceedingly complex.

High-barrier technologies serve as a company’s moat; every step forward in exploration translates into proprietary momentum and competitive barriers, further fortifying this moat.

Currently, in addition to Boston Scientific, which collaborates with Neurat, ABK Biomedical also possesses the technology for yttrium-90 (⁹⁰Y) glass microspheres.

ABK Biomedical’s flagship product is Yttrium-90 (⁹⁰Y) glass microspheres. Delivered via a catheter inserted into the artery, millions of tiny glass beads containing radioactive Yttrium-90 are precisely targeted to cancerous tissue in the liver. The radiation emitted by Yttrium-90 helps eradicate tumors while minimizing radiation exposure to surrounding healthy tissues.

Forging Technological Barriers Over Time, the Fruits on the Technology Tree Become Increasingly Abundant—ABK Biomedical Initiates First-in-Human Clinical Study of Eye90 Microspheres for the Treatment of Liver Tumors.

Eye90 microspheres utilize a proprietary radiopaque glass composition, with diameters finer than a human hair and nearly invisible to the naked eye. They are used for internal radiation brachytherapy in the treatment of liver tumors. The procedure is visualized using fluoroscopy, X-ray, CT, and cone-beam CT imaging modalities.

Meanwhile, the microspheres contain yttrium-90 (⁹⁰Y) as a radiation source to kill cancer cells and shrink tumors. The microspheres are also radiopaque, meaning they can be visualized during imaging procedures. This visibility enables physicians to confirm precise delivery of the microspheres to the tumor, thereby helping to improve treatment outcomes.

Furthermore, this product can also provide prognostic dosimetry for the treatment of liver tumors.

Eye90 Microsphere Administration Protocol

ABK Biomedical’s product portfolio is not complex; in addition to the aforementioned Eye90 microspheres, it also includes the Easi-Vue embolization microspheres.

Product Introduction of ABK Biomedical

However, there is scant information available online about Easi-Vue embolic microspheres. For this somewhat enigmatic product, we can currently only identify it by the green-and-white logo on the homepage of its official website.

While strengthening its core capabilities, ABK Biomedical is also actively expanding its external boundaries.

ABK Biomedical Actively Pursues External Expansion

In February 2019, ABK Biomedical established a new strategic partnership with the University of Missouri Research Reactor Center (MURR®). As a global leader in research reactor excellence, MURR possesses extensive experience in providing medical isotopes and irradiation services for medical devices. MURR is a key partner for ABK in establishing seamless manufacturing, supply, and distribution networks for critical cancer centers worldwide, serving as the primary irradiation partner for ABK’s radioembolization products.

In March 2020, a partnership with CNIC was established to enhance patient care. CNIC is an independent organization composed of representatives from the Canadian health sector, nuclear industry, and leading research groups, dedicated to providing patients with innovative cancer treatments. This collaboration also laid the foundation for the subsequent first-in-human clinical study of Eye90 microspheres.

Interestingly, the company has also partnered with the University of Missouri Veterinary Health Center to enroll canine patients in clinical trials aimed at evaluating the efficacy of yttrium-90 radioembolization for treating liver cancer in dogs.

Every step taken by ABK Biomedical has been guided by the leadership of its core team.

ABK Biomedical’s core leadership team is deeply rooted in the healthcare sector, with each member boasting over 25 years of professional experience and management expertise at world-renowned healthcare companies such as Boston Scientific, Allergan, and Abbott.

President and CEO, Michael, has over 25 years of experience in the medical device industry. He previously served as CEO of ReShape Medical and later as President of the Americas for Sirtex Medical, an interventional oncology medical device manufacturer. During his six-year tenure in that role, he successfully grew the company’s revenue from $34 million to over $130 million.

Prior to joining Sirtex Medical, he spent 15 years at Boston Scientific, holding numerous key positions. With extensive experience in marketing management, product development, strategic planning, international business, mergers and acquisitions, project management, and business model development, Michael will bring pragmatic leadership to ABK Biomedical, helping the company reach new heights.

Dr. Bob, Co-Founder and Chief Medical Officer, has served as a practicing clinician and interventional radiologist (IR) at the QEII Health Sciences Centre for over 25 years. He established the IWK Uterine Fibroid Embolization (UFE) program in 2001 and the QEII Y-90 radioembolization program in 2013. He has also served as Chair of the Diagnostic Radiology examinations for the Royal College of Physicians and Surgeons of Canada and as President of the Canadian Association for Interventional Radiology (CAIR/CIRA). He is a Fellow of the Royal College of Physicians and Surgeons of Canada (FRCPC) and is certified by the American Board of Radiology. In 2016, he was awarded Fellowship status by the Society of Interventional Radiology (FSIR) and the Cardiovascular and Interventional Radiological Society of Europe (FCIRSE).