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Jay Hartenbach, President & COO, Diakonos Oncology on Reprogramming Cancer Immunity Breakthrough

28 min episode · 2 min read
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Episode

28 min

Read time

2 min

Topics

Software Development

AI-Generated Summary

Key Takeaways

  • Dual-loading mechanism: Diakonos loads tumor antigens onto both MHC class one and MHC class two simultaneously, mimicking an active viral infection signal inside the dendritic cell. This triggers a cytotoxic T-cell response roughly 11 times stronger than single-loading methods, while also converting dendritic cells into cDC1 subtypes through gene expression changes.
  • Phase one GBM results: Early glioblastoma data shows 88% twelve-month survival versus an expected 55-60% benchmark, with multiple complete responses in unmethylated GBM patients — historically the hardest subgroup to treat. The trial also accepted patients who progressed between surgery and treatment, a deliberately inclusive design that strengthens future randomized trial comparability.
  • DSMB scheduling compression: Diakonos cut months from its dose-escalation timeline by replacing standard two-to-three month DSMB scheduling windows with rapid Friday calls. This moved patients into higher-dose cohorts faster, accelerating data generation without additional cost — a replicable tactic for any biotech running sequential cohort studies on constrained budgets.
  • Site budget negotiation: Clinical site budgets were compressed by up to 75% by reviewing every line item directly with sites and leveraging demand from multiple willing institutions. Sites accepted lower budgets to maintain trial participation, demonstrating that early-stage biotechs can negotiate aggressively on site costs when the science generates genuine investigator interest.
  • Non-traditional fundraising structure: Unable to secure traditional biotech VC backing due to GBM and dendritic cell skepticism, Diakonos raised a $5M convertible note from 83 individual investors, followed by a $20M SAFE round from family offices, and opened a $40M round in October 2024. Targeting investors without prior GBM losses produced more objective science-based evaluation.

What It Covers

Jay Hartenbach, President & COO of Diakonos Oncology, explains how the company's dual-loading dendritic cell platform produces exponentially stronger anti-tumor immune responses than prior approaches, while detailing capital-efficient clinical trial execution across glioblastoma, pancreatic cancer, and refractory melanoma programs.

Key Questions Answered

  • Dual-loading mechanism: Diakonos loads tumor antigens onto both MHC class one and MHC class two simultaneously, mimicking an active viral infection signal inside the dendritic cell. This triggers a cytotoxic T-cell response roughly 11 times stronger than single-loading methods, while also converting dendritic cells into cDC1 subtypes through gene expression changes.
  • Phase one GBM results: Early glioblastoma data shows 88% twelve-month survival versus an expected 55-60% benchmark, with multiple complete responses in unmethylated GBM patients — historically the hardest subgroup to treat. The trial also accepted patients who progressed between surgery and treatment, a deliberately inclusive design that strengthens future randomized trial comparability.
  • DSMB scheduling compression: Diakonos cut months from its dose-escalation timeline by replacing standard two-to-three month DSMB scheduling windows with rapid Friday calls. This moved patients into higher-dose cohorts faster, accelerating data generation without additional cost — a replicable tactic for any biotech running sequential cohort studies on constrained budgets.
  • Site budget negotiation: Clinical site budgets were compressed by up to 75% by reviewing every line item directly with sites and leveraging demand from multiple willing institutions. Sites accepted lower budgets to maintain trial participation, demonstrating that early-stage biotechs can negotiate aggressively on site costs when the science generates genuine investigator interest.
  • Non-traditional fundraising structure: Unable to secure traditional biotech VC backing due to GBM and dendritic cell skepticism, Diakonos raised a $5M convertible note from 83 individual investors, followed by a $20M SAFE round from family offices, and opened a $40M round in October 2024. Targeting investors without prior GBM losses produced more objective science-based evaluation.

Notable Moment

Diakonos deliberately chose glioblastoma and pancreatic cancer — two indications most companies avoid — as its first clinical targets, reasoning that success in the hardest cases would validate the platform faster. That contrarian bet appears to be paying off, with refractory melanoma now added as a faster-readout confirmation study.

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