Lotus Neuro PROOF OF PHARMACOLOGY CHALLENGE · 2026
Place a video background here
Open Tweaks · drop an .mp4 or paste a URL
2026 PROOF OF PHARMACOLOGY CHALLENGE · REQUEST FOR PROPOSALS

Breaking Barriers in GBM & DIPG Therapeutics

A funded opportunity for leading GBM and DIPG clinical centers to add a Focused Ultrasound arm to an existing IND trial and help establish human proof of pharmacology for the next generation of brain cancer therapies.

IndicationGBM & DIPG
ModalityFocused Ultrasound (FUS)
DeviceInsightec Exablate 220
1st patient byDecember 2026
01 — SUMMARY

A challenge for the brain-tumor field

Lotus Neuro is launching the POP Challenge to accelerate therapeutics for brain tumors. We're seeking clinical sites ready to integrate a FUS arm into an existing IND.

Our goal: establish human Proof of Pharmacology for therapeutic assets combined with Focused Ultrasound — starting with glioblastoma (GBM) and diffuse intrinsic pontine glioma (DIPG).

We're partnering with centers that already run GBM or DIPG studies under an active IND and have the operational capacity to amend protocols, add a FUS arm, and enroll patients with the precision these indications demand.

Selected sites receive scientific and regulatory guidance, funding for the FUS arm, and membership in an elite network advancing the next generation of brain cancer treatments.

If you believe your center meets the criteria, please complete the eligibility check below.

Eligibility check

Five questions. Three Minutes.

Five "yes/no" questions confirm operational fit. Sites that clear all five are invited to submit a full proposal.

02 — ELIGIBILITY

Eligibility questionnaire

Answer on behalf of your institution. A single "no" ends the session — but you're welcome to return and re-apply when circumstances change.

03 — PROPOSAL

Full proposal guidelines

Eligible centers submit four documents. Keep each tight; the review committee reads dozens of applications.

01

Study Proposal

6 pages maximum

The scientific and operational case for adding a FUS arm to your existing trial.

02

References

2 pages maximum

Citations supporting the rationale and methodology in Document #1.

03

Budget

single PDF

Itemized cost breakdown for the FUS arm — device time, staff, imaging, monitoring, regulatory.

04

Letter of Support

single PDF

From the biopharma collaborator providing the asset for the trial.

Document #1 · Study Proposal

Required information for the 6-page study proposal

01
Scientific rationale for asset + FUS combo

What is the scientific evidence to date that suggests FUS could enhance brain delivery of the specific asset?

02
Safety risk assessment of asset + FUS combo

What is the rationale to support the safety profile of asset dose + FUS?

03
Study plan

What are the study details incorporating a FUS arm into the ongoing trial?

04
Biomarker plan

How will TE, PK, and/or PD be detected and measured?

05
Patient recruitment

How many patients are required to sufficiently power the study? What are the plans and expectations for patient access and recruitment?

06
Overall logistics

What is the timeline and budget for the proposed study? What are the key logistical milestones leading up to first-patient enrollment?

Timeline

Key dates & deadlines

POP Challenge kick-off
June 5, 2026
Eligibility screening due
As soon as possible
1-page letter of intent due
June 22, 2026
Invitation to submit full proposal
By June 30, 2026
Full proposal due
August 2, 2026 · 11:59 PM ET
Notification of results
By August 15, 2026
Paperwork completion
September – November 2026
First patient enrolled
December 2026
Reference document

Download the full Request for Proposals.

The official RFP includes the complete submission timeline, evaluation criteria, and contracting framework. Review before submitting your proposal.

PDF · 194 KB
Version · 2026.1
Download RFP