In the biotech industry, advancing cell-based therapies is not just about innovation. It's about solving real gaps where conventional treatments fall short, especially against complex, aggressive tumors.

In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Jun Yung Woo, Co-Founder of AGEM Bio, who offers an in-depth look at the science and strategy behind engineered mesenchymal stem cells (MSCs), with a focus on why glioblastoma is the right proving ground for the platform.

Topics discussed:

• Why glioblastoma is the right Phase I indication: infiltrative growth, immunosuppression, and STING pathway deficiencies that make GBM uniquely suited to the platform (02:43)
• The surgical workflow: intracavity MSC delivery during tumor resection, oral 5-FC administration, and how engineered cells act as local bioreactors in the resection cavity (04:05)
• Mechanisms by which engineered MSCs target heterogeneous and invasive tumors through shared vulnerabilities rather than antigen recognition (05:58)
• Overcoming immune rejection with allogeneic therapies and the unique immunological profile of MSCs (07:32)
• Manufacturing and scale-up: addressing donor variability, GMP production, and building a reproducible process (09:16)
• Why GMP manufacturing should be designed in from the earliest stages of research (10:50)
• Beyond glioblastoma: expanding the platform to other solid tumors, regenerative medicine, and chronic inflammatory disease (11:27)
• Strategies for international trial expansion and partnerships beyond Singapore (12:41)
• Reframing MSCs from stem cell therapy to programmable delivery platform: the MSC 2.0 thesis (14:10)

Smart insight: The shift Jun Yung articulates is from treating stem cells as the therapy to treating them as programmable therapeutic vehicles. Once you can reliably engineer, manufacture, and preserve their function, the limitation is no longer what the cell naturally does. It becomes what biology you can encode into it. Glioblastoma is the proving ground, and the platform's reach extends to liver cancers, sarcomas, peritoneal malignancies, and chronic inflammatory disease.

These episodes expand on the same themes of MSC biology, cell engineering, and the challenges of scaling consistent, functional cell therapies:

• Episodes 179 - 180 : How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies
• Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee
• Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei
• Episodes 129 - 130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster

Connect with Jun Yung Woo:

LinkedIn: www.linkedin.com/in/junyungwoo

AGEM Bio website: www.agem.bio

Email: yung@agem.bio

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What if the answer to solid tumor therapy isn’t about making immune cells smarter—but about rethinking what a therapeutic cell can do For years, mesenchymal stem cells (MSCs) have turned heads for their ability to home in on damaged tissue, yet their clinical utility has lagged behind the hype. What would it take to transform MSCs from passive healers into precision vehicles for next-generation cancer treatment?

This week, David Brühlmann sits down with Jun Yung Woo, Co-Founder of AGEM Bio, who’s devoted nearly two decades to decoding and reimagining the potential of MSCs. From engineering stress-resilient cells to pioneering dual-payload therapeutic platforms, Jun Yung Woo bridges fundamental biology and real-world clinical translation.

Topics discussed:

• The case for understanding cell biology before focusing on process scale-up in bioprocessing (02:38)
• Jun Yung Woo's personal and scientific journey toward developing engineered MSC therapeutics (04:36)
• How MSCs sense their environment and exert therapeutic effects via secreted factors, rather than tissue replacement (08:28)
• Key differences between MSC therapies and immune cell therapies like CAR T cells (10:35)
• Overview of non-viral engineering platforms, and the importance of intracellular trafficking for modifying MSCs (12:23)
• Design of AGEM Bio's dual-payload MSC product (cytosine deaminase and interferon beta) to induce highly localized tumor stress and immune activation (14:10)
• Strategies for controlling MSC targeting and minimizing off-target effects, including the use of prodrug activation and localized cell delivery (17:23)
• Study results from treating companion animals with engineered MSCs, and observations of tumor regression and possible signs of immune memory (20:29)
• Open questions about the durability of antitumor responses and future directions for clinical research (22:34)

Smart insight: Jun Yung Woo challenges the rush toward bioprocess scale-up, arguing that a deeper understanding of cellular biology should come before manufacturing cells at scale. This episode explores how scaling the wrong biology can derail entire therapeutic platforms—and why aligning process development with cellular function may be critical for clinical success.

These episodes expand on the same themes of MSC biology, cell engineering, and the challenges of scaling consistent, functional cell therapies:

• Episodes 179 - 180 : How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies
• Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee
• Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei
• Episodes 129 - 130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster

Connect with Jun Yung Woo:

LinkedIn: www.linkedin.com/in/junyungwoo

AGEM Bio website: www.agem.bio

Email: yung@agem.bio

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Why does life-saving insulin cost hundreds of dollars a month for patients, when manufacturing costs are just a fraction of that price? What if the nonprofit model could change everything for affordable access?

In the pharmaceutical industry, affordability and access remain two of the biggest hurdles for patients, especially when the economics of essential medicines seem stacked against them.

Eric Moyal, founder of Project Insulin, is rewriting the rules of biosimilar development. Coming from a fundraising and nonprofit background rather than the pharma inside track, Eric built Project Insulin not to chase profits, but to deliver an essential therapy at a price real people can afford.

Topics covered:

• Key differences between nonprofit and for-profit models in biotech, especially around fundraising, incentives, and revenue (00:02)
• The intricate balance between development costs, operating expenses, and setting an affordable price point (00:06)
• Innovative distribution models to eliminate price inflation by middlemen, including direct-to-patient and clinic partnerships (00:08)
• Major roadblocks in reinventing drug distribution and the importance of building the right partnerships early on (00:10)
• Advice for founders and scientists exploring solutions to drug affordability, including corporate structure, fundraising, and perseverance (00:12)
• Lessons learned after five years building Project Insulin, emphasizing the value of assembling the right team and listening to feedback (00:13)
• Realistic expectations for Project Insulin’s next five years and the primary goals on the horizon (00:16)
• The broader need for affordable generic drugs and the broken promise of the current patent system (00:17)
• How to connect with Project Insulin and support its mission (00:18)

Smart insight: Generic medicines should be affordable. Ensuring low-cost, accessible generics is essential to restoring the original balance between pharmaceutical innovation and public access, and it requires collective effort beyond any single player.

If you enjoyed this episode, you might want to listen to these within a broader set of discussions on biologics affordability, CMC strategy, and bioprocessing realities — from the economic barriers blocking patient access and regulatory decision-making for biosimilars, to CDMO selection for resource-constrained teams:

• Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)
• Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
• Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa

Connect with Eric Moyal:

• Email: emoyal@projectinsulin.org
• Website: www.projectinsulin.org
• Instagram: www.instagram.com/projectinsulin
• LinkedIn: www.linkedin.com/company/82500193
• TikTok: www.tiktok.com/@project.insulin
• YouTube: www.youtube.com/@ProjectInsulin

Next step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.

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