OriginCV Accelerator

Accelerators

OriginCV-powered programs accelerating the Mays Cancer Center oncology portfolio from discovery to patients — across 5 strategic tracks aligned to the OriginCV mission.

Accelerator Tracks

48+

Molecules Accelerated

20+

Active Clinical Trials

$50M+

Funding Deployed

ORIGINCV

“An Advance for One is an Advance for All”

OriginCV is a partnership of leading research institutes and science professionals accelerating access to medical advances for patients in greatest need. Through its decentralized research platform, researcher support program, and biopharma partnerships, OriginCV bridges the critical gap between discovery and patients.

origincv.com →

500

Clinical Trials

FDA Approvals

Exits & Spinouts

M&A Transactions

Decentralized Research Platform

Network of forward-thinking research centers with integrated scientific, administrative, legal, and financial teams embedded in partner health systems.

Researcher Support Program

Financial and operational support for the most promising scientists during the vulnerable stage between discovery and traditional investment.

Biopharma Partnerships

Modernize drug development, streamline timelines, and reduce costs through faster execution and stronger coordination with pharma partners.

Accelerator Tracks

Five strategic programs mapping OriginCV missions to active Mays Cancer Center initiatives

🧬

Discovery-to-IND Accelerator

OriginCV Mission: Research Infrastructure + Entrepreneur Development

10 molecules

CIDD/IDD-powered drug discovery platform accelerating home-grown therapeutics from hit identification through IND-enabling studies. The OriginCV Researcher Support Program provides financial and operational backing for Mays scientists navigating the valley of death between discovery and clinical investment.

Tier 1 Molecules

IND Applications Filed

Active PROTAC Programs

IND-Enabling Programs

Molecules in this Track

DT2216→753B DT-MCL1 DT-KRAS SF2523 SRX3177 CIDD-0149897 CIDD99 MBD6 Amuvatinib→

Current Initiatives

DT2216 Phase 1/2 Dose Expansion

First-in-class BCL-XL PROTAC with FDA Fast Track + Orphan Drug designations advancing through dose expansion in CTCL/PTCL.

753B Dual PROTAC Preclinical Advancement

Next-generation BCL-xL/BCL-2 dual PROTAC under Dr. Zhou demonstrating enhanced selectivity in preclinical models.

DT-KRAS Degrader Hit-to-Lead

KRAS G12D targeted protein degrader in hit-to-lead optimization at CIDD, addressing the most common oncogenic driver mutation.

Chemical Endocytic Breakthrough

Dr. Hong-yu Li's Chemical Endocytic discovery published in Cell (2025) — a new mechanism for intracellular drug delivery that could transform the PROTAC platform.

Key Milestones

DT2216 Phase 1/2 initiated

completed

2022

Chemical Endocytic breakthrough published

completed

2025

DT2216 Phase 2 expansion cohort readout

upcoming

2027

753B IND filing

upcoming

2028

Key People

Dr. Daohong Zhou · Dr. Stanton McHardy · Dr. Hong-yu Li

🏥

Clinical Trial Accelerator

OriginCV Mission: Decentralized Research Platform

10 molecules

Investigator-initiated trial infrastructure enabling Mays faculty to run innovative clinical studies with integrated site activation, IRB coordination, and enrollment optimization. Part of the OriginCV decentralized research network that reduces site activation from months to weeks.

IIT Programs

NCT-Registered Trials

Therapeutic Areas

Actively Recruiting

Molecules in this Track

SG-GBM→BSI-082→Imp+Lom Avasopasem eRapa Lonca+Rofl Tisle+SX682 Treme+Durva Zanz+D+T EGCG

Current Initiatives

BSI-082 First-in-Human Phase 1a/1b

Anti-SIRPa monoclonal antibody — first patient expected Feb 2026. Novel innate immune checkpoint avoiding the RBC toxicity that derailed anti-CD47 approaches.

Sacituzumab Govitecan GBM Phase 2

ADC repurposed for recurrent glioblastoma. Phase 0 CNS PK data confirms brain penetration — first ADC to demonstrate this in GBM.

Avasopasem Phase 1 in ER+ Breast Cancer

SOD mimetic for radiation protection in ER+ breast cancer with $3.2M CPRIT funding under Dr. David Gius.

Key Milestones

Sacituzumab GBM Phase 0 completed

completed

2024

BSI-082 first patient dosed

in progress

2026

Sacituzumab GBM Phase 2 interim analysis

upcoming

2027

BSI-082 dose escalation complete

upcoming

2028

Key People

Dr. William Kelly · Dr. John Sarantopoulos · Dr. David Gius

📋

Regulatory Pathway Accelerator

OriginCV Mission: AI Integration — Accelerating Regulatory Timelines

3 molecules

Leveraging FDA designation strategies and OriginCV AI tools to compress regulatory timelines. The triple-designated 186RNL (Fast Track + Orphan Drug + RMAT) is the flagship case study for this track, demonstrating how strategic regulatory engagement can accelerate approval for breakthrough therapies.

FDA Fast Track

Orphan Drug

RMAT Designation

Commercially Approved

Molecules in this Track

186RNL→DT2216→Pluvicto→

Current Initiatives

186RNL RMAT-Enabled Accelerated Pathway

Regenerative Medicine Advanced Therapy designation enables rolling review, priority review, and potential accelerated approval. Estimated approval 2029.

DT2216 Breakthrough Therapy Designation Pursuit

Phase 2 CTCL data expected to support BTD application — would enable intensive FDA guidance and rolling review.

OriginCV AI Regulatory Intelligence

Origin AI Labs tools for regulatory submission optimization, competitive landscape monitoring, and timeline prediction.

Key Milestones

186RNL RMAT designation granted

completed

2024

186RNL Phase 2 primary endpoint readout

upcoming

2027

186RNL Rolling BLA submission

upcoming

2028

186RNL Priority Review & approval

upcoming

2029

Key People

Dr. Andrew Brenner · Plus Therapeutics · Dialectic Therapeutics

💰

Market Access & Commercialization Accelerator

OriginCV Mission: Funding & Collaboration — Financial Innovation

3 molecules

Novel financial models and payer strategies ensuring patient access to approved therapies. The OriginCV financial innovation pillar addresses the $100K–$200K per-treatment cost barrier through creative reimbursement navigation and buy-and-bill optimization. Pluvicto is the flagship commercial deployment.

$42.5K

Per Dose Managed

Coverage Policies

Only Civilian

Regional Position

$255K

Full Course Value

Molecules in this Track

Pluvicto→186RNL→DT2216→

Current Initiatives

Pluvicto Buy-and-Bill Optimization

Streamlining the complex ASP + 6% reimbursement model for Lu-177 radioligand therapy — ensuring financial sustainability as the only civilian center in South Texas.

PSMAfore Label Expansion Market Access

Preparing payer education, prior authorization protocols, and site-of-care strategies for the expanded pre-chemotherapy mCRPC indication.

186RNL Reimbursement Pathway Planning

Proactive engagement with CMS for combination product (drug + CED surgical procedure) reimbursement strategy ahead of potential approval.

Key Milestones

Pluvicto VISION approval & launch

completed

2022

Pluvicto PSMAfore label expansion

completed

2024

Second nuclear medicine suite planned

in progress

2026

186RNL CMS engagement begins

upcoming

2028

Key People

Novartis Partnership Team · Mays Nuclear Medicine · Dr. Daruka Mahadevan

🏆

Institutional Legacy & Evidence Accelerator

OriginCV Mission: Prevention & Early Detection

5 molecules

Documenting and leveraging the institutional track record of FDA-approved drugs developed through Mays to attract future partnerships, funding, and faculty. Five drugs approved between 2019–2023 demonstrate Mays' contribution to drug development and position the center for NCI Comprehensive Cancer Center designation.

FDA-Approved Drugs

Approved 2019–2023

JAK Inhibitor Approvals

>$2B

Combined Market

Molecules in this Track

Pacritinib Besremi Fedratinib Momelotinib Elacestrant

Current Initiatives

CPRIT Renewal Track Record Documentation

Compiling institutional evidence of drug development success to strengthen CPRIT grant renewal applications across all active programs.

Faculty Recruitment Leveraging Approval Portfolio

Using the 5-drug FDA approval track record as a differentiator for recruiting top oncology investigators and clinical trialists.

NCI Comprehensive Cancer Center Designation

Leveraging approval portfolio, active IIT pipeline, and CIDD discovery engine to pursue NCI Comprehensive Cancer Center designation upgrade.

MPN Center of Excellence

Three JAK inhibitor approvals (Pacritinib, Fedratinib, Momelotinib) position Mays as a national leader in myeloproliferative neoplasm treatment.

Key Milestones

Fedratinib (Inrebic) FDA approval

completed

2019

Besremi FDA approval

completed

2021

Pacritinib (Vonjo) FDA approval

completed

2022

Momelotinib + Elacestrant FDA approvals

completed

2023

Key People

Dr. Daruka Mahadevan · Dr. Ruben Mesa (former) · Mays Cancer Center Leadership

Accelerator Impact Dashboard

Portfolio distribution across the drug development lifecycle

Discovery

Preclinical

Phase 1

Phase 2

Phase 3+

Approved

Industry-Sponsored Pipeline

Mays Cancer Center as a clinical trial site for industry partners (Tier 5)

Molecule	Sponsor	Phase	Indication	NCT #	Status
Pembrolizumab (Keytruda)	Merck	Phase 3	Various solid tumors	NCT02362594	Active
Nivolumab (Opdivo)	Bristol-Myers Squibb	Phase 3	Renal cell carcinoma	NCT03793166	Active
Atezolizumab (Tecentriq)	Genentech/Roche	Phase 3	NSCLC	NCT04091490	Active
Trastuzumab Deruxtecan (Enhertu)	Daiichi Sankyo/AstraZeneca	Phase 3	HER2+ breast cancer	NCT04784715	Recruiting
Sacituzumab Govitecan (Trodelvy)	Gilead Sciences	Phase 3	mTNBC	NCT04595565	Active
Olaparib (Lynparza)	AstraZeneca	Phase 3	Ovarian cancer (BRCA+)	NCT03737643	Active
Rucaparib (Rubraca)	Clovis Oncology	Phase 2	Prostate cancer (BRCA+)	NCT03533946	Active
Sotorasib (Lumakras)	Amgen	Phase 3	KRAS G12C NSCLC	NCT04303780	Active
Adagrasib (Krazati)	Mirati Therapeutics	Phase 2	KRAS G12C solid tumors	NCT04685135	Recruiting
Enfortumab Vedotin (Padcev)	Astellas/Seagen	Phase 3	Urothelial carcinoma	NCT04223856	Active
Zanubrutinib (Brukinsa)	BeiGene	Phase 3	CLL/SLL	NCT04116437	Recruiting
Pirtobrutinib (Jaypirca)	Eli Lilly	Phase 3	MCL	NCT04965493	Active
Belzutifan (Welireg)	Merck	Phase 3	RCC (VHL-driven)	NCT04586231	Active
Mirvetuximab Soravtansine (Elahere)	ImmunoGen	Phase 3	FRα+ ovarian cancer	NCT04209855	Active
Dato-DXd (Datopotamab)	Daiichi Sankyo/AstraZeneca	Phase 3	NSCLC / TNBC	NCT05104866	Recruiting
Tarlatamab (Imdelltra)	Amgen	Phase 2	Small cell lung cancer	NCT05060016	Active
Inavolisib	Genentech/Roche	Phase 3	HR+/HER2- breast cancer (PIK3CA)	NCT04191382	Active
Capivasertib (Truqap)	AstraZeneca	Phase 3	HR+/HER2- breast cancer	NCT04305496	Active
Ciltacabtagene Autoleucel (Carvykti)	J&J/Legend Biotech	Phase 3	Multiple myeloma	NCT05257083	Recruiting
Teclistamab (Tecvayli)	Janssen	Phase 3	Multiple myeloma (BCMA)	NCT05083169	Active

20 industry-sponsored trials active at Mays Cancer Center. View all trials →

OriginCV AI Partnership

Origin AI Labs integration powering decision intelligence across the portfolio

Trial Success Prediction

AI-powered probability assessment for each molecule's path to approval, factoring phase, modality, designations, and data strength.

5 molecules tracked

Competitive Intelligence

Automated monitoring of competitor trials, FDA actions, and market moves that affect the Mays portfolio positioning.

9 competitor trials tracked

Market Forces Analysis

Real-time assessment of regulatory, payer, scientific, and economic forces shaping the oncology market landscape.

10 forces monitored

Ask Origin Chat

Conversational AI interface providing instant portfolio intelligence, clinical data synthesis, and strategic analysis.

48+ molecule context

Partner with the Accelerator

Interested in collaborating with the Mays Cancer Center oncology accelerator? From clinical trial partnerships to drug development collaborations, we're accelerating advances for patients.

Contact OriginCV View Full Portfolio →