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Business Of Biotech

Radiotherapeutics For CNS Cancers With Plus Therapeutics' Marc Hedrick, M.D.

54 min episode · 2 min read
·
Plus Therapeutics' Marc Hedrick

Episode

54 min

Read time

2 min

Topics

Fundraising & VC, Leadership

AI-Generated Summary

Key Takeaways

  • Therapeutic index advantage: Rayovik achieves a 100-to-1 therapeutic index in CNS cancers compared to roughly 2-to-4-to-1 for alpha emitter competitors. This allows single-dose delivery of up to 740 gray versus the 30-50 gray maximum from fractionated external beam radiation, with no identified upper dose limit in two separate phase one trials.
  • Leptomeningeal disease scale: Approximately 125,000 US patients annually develop leptomeningeal metastases, roughly ten times the 15,000 annual glioblastoma cases, and the condition is likely two-to-four times underdiagnosed. Median survival with current treatment is two-to-four months, making it the higher commercial priority over glioblastoma despite glioblastoma entering trials earlier.
  • Diagnostic gap as business opportunity: Standard-of-care cytology for leptomeningeal cancer dates to 1904 and detects disease only 40% of the time. See Inside's tumor cell enumeration assay detects a single cell in five cubic centimeters of cerebrospinal fluid, has 70 million US lives covered for reimbursement, and represents an estimated $6 billion gap in the global diagnostic market.
  • Supply chain scalability via Rhenium-186: Rhenium-186's 90-hour half-life enables centralized US manufacturing at Missouri's MURR reactor, overnight shipping to hospitals, and two-to-four days of usable shelf life on arrival. The drug bypasses the radiopharmacy entirely, ships through standard radiology receiving, and allows dose recalculation if a patient misses a scheduled injection window.
  • Surrogate endpoint strategy for approval: Because no approved drugs or established clinical trial models exist for leptomeningeal cancer, Plus Therapeutics secured FDA alignment in a January 2026 Type B meeting around compartmental endpoints beyond overall survival and the potential use of See Inside tumor cell counts as a validated surrogate endpoint, accelerating the path toward a pivotal trial.

What It Covers

Marc Hedrick, CEO of Plus Therapeutics, details the development of Rhenium-186 radiotherapeutic Rayovik for CNS cancers including glioblastoma and leptomeningeal disease, explains the company's diagnostic subsidiary See Inside, and outlines why targeted radiotherapy delivers over 10 times the radiation dose of external beam treatment.

Key Questions Answered

  • Therapeutic index advantage: Rayovik achieves a 100-to-1 therapeutic index in CNS cancers compared to roughly 2-to-4-to-1 for alpha emitter competitors. This allows single-dose delivery of up to 740 gray versus the 30-50 gray maximum from fractionated external beam radiation, with no identified upper dose limit in two separate phase one trials.
  • Leptomeningeal disease scale: Approximately 125,000 US patients annually develop leptomeningeal metastases, roughly ten times the 15,000 annual glioblastoma cases, and the condition is likely two-to-four times underdiagnosed. Median survival with current treatment is two-to-four months, making it the higher commercial priority over glioblastoma despite glioblastoma entering trials earlier.
  • Diagnostic gap as business opportunity: Standard-of-care cytology for leptomeningeal cancer dates to 1904 and detects disease only 40% of the time. See Inside's tumor cell enumeration assay detects a single cell in five cubic centimeters of cerebrospinal fluid, has 70 million US lives covered for reimbursement, and represents an estimated $6 billion gap in the global diagnostic market.
  • Supply chain scalability via Rhenium-186: Rhenium-186's 90-hour half-life enables centralized US manufacturing at Missouri's MURR reactor, overnight shipping to hospitals, and two-to-four days of usable shelf life on arrival. The drug bypasses the radiopharmacy entirely, ships through standard radiology receiving, and allows dose recalculation if a patient misses a scheduled injection window.
  • Surrogate endpoint strategy for approval: Because no approved drugs or established clinical trial models exist for leptomeningeal cancer, Plus Therapeutics secured FDA alignment in a January 2026 Type B meeting around compartmental endpoints beyond overall survival and the potential use of See Inside tumor cell counts as a validated surrogate endpoint, accelerating the path toward a pivotal trial.

Notable Moment

Hedrick describes how Rhenium-186's dual beta and gamma emissions allow clinicians to place a patient in a SPECT-CT scanner post-treatment and calculate the exact absorbed radiation dose delivered to the tumor, effectively making every treated patient their own individual dosimetry trial.

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Episode Transcript

Welcome back to the business of biotech. I'm your host, Ben Comer, chief editor at Life Science Leader. And today, I'm speaking with Mark Hedrick, MD, president and CEO at Plus Therapeutics, a company developing novel radiotherapeutics for difficult to treat cancers such as glioblastoma, which has a median survival of just twelve to eighteen months. Mark is a trained general vascular and plastic surgeon who worked in academic medicine at UCLA before transitioning into life sciences as a CEO at STEMsource and Satori Therapeutics. We'll find out what Mark has learned as a biotech leader. We'll discuss Plus's lead candidate, iridium based beta emitting radiotherapy called Rayovik. We'll hear about the company's virtual development model and diagnostic subsidiary called See Inside Diagnostics, and I'll get Mark's thoughts on the current radiotherapeutics landscape and investor sentiment. Thank you so much for being here today, Mark. My pleasure, Ben. Thank you. Let's start out with your background. You were an MD. You trained as a surgeon. What what can you say about your time as a practicing surgeon and maybe the work that you did at UCLA? Yeah. You you know, the the the thing in my career that really, is responsible for making the transition from academia into therapeutic development and business was a, about a three year stint at University of California, San Francisco, where I worked on a team that was developing therapies for babies still in the womb. And so that these were these were largely, pregnant women who had, fetuses that had life threatening conditions, and the survival of the the child was kinda universally poor. However, they were there are group of diseases where if you if one intervenes kind of early in gestation with sort of intervention, then you could actually dramatically increase the odds of survival. So that that started me down a path of, innovating in, in medicine and surgery. We developed a number of procedures and and devices and therapeutic approaches as as part of that. And that really kinda got me excited and, finished my career, went on to be on the faculty at UCLA, but continue that, that interest. And then, we were early in the, the stem cell, could I I would call it sort of the bench to bedside for stem cells in the, in the 2,000 time frame and then just do a series of circumstances ended up, leaving on sabbatical and starting a company. And then, the next thing you know, I'm kinda doing it full time. Well, that with the, the program that you mentioned at UCSF, I imagine there's a diagnostic component to that too given that it's, you know, unborn children. Was that was it something that, you know, with those diseases that you're talking about, was it something that was regularly diagnosed or or was it, you know, like, you had a a genetic likelihood to have it? How how did you know, you know, that, an unborn baby had a …

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  • See InsideBy guest

    by Plus Therapeutics

    explains the company's diagnostic subsidiary See Inside, and outlines why targeted radiotherapy delivers over 10 times the radiation dose of external beam treatment.
  • RayovikBy guest

    by Plus Therapeutics

    Marc Hedrick, CEO of Plus Therapeutics, details the development of Rhenium-186 radiotherapeutic Rayovik for CNS cancers including glioblastoma and leptomeningeal disease

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