ANNOUNCEMENTS
TCR and MimiVax: SURVIVE Phase 2b Results
FOR IMMEDIATE RELEASE
TradeCraft Clinical Research Delivers Biostatistics and Programming for MimiVax's Phase 2b SURVIVE Trial of SurVaxM in Newly Diagnosed Glioblastoma
TCR's team produced the analyses behind the SURVIVE results announced by MimiVax and Roswell Park Comprehensive Cancer Center
Key Points:
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MimiVax reported that SurVaxM extended median overall survival by 2.5 months across all 233 evaluable patients
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In the prespecified group of patients aged 65 and under, the overall survival benefit was statistically significant
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TradeCraft Clinical Research (TCR) provided biostatistics and statistical programming for the trial, including the topline analysis
Wayne, PA, Oct. 7, 2026 — TradeCraft TradeCraft Clinical Research (TCR), a sponsor-specialization contract research organization focused on biostatistics and statistical programming, today announced its role on SURVIVE (NCT05163080), MimiVax Inc.'s Phase 2b randomized, double-blind, placebo-controlled trial of the cancer vaccine SurVaxM in patients with newly diagnosed glioblastoma.
MimiVax, in collaboration with Roswell Park Comprehensive Cancer Center, announced the trial's first reportable results on Oct. 7, 2026. TCR provided biostatistics and statistical programming for the study, including the topline analysis of overall survival, progression-free survival and safety.
SURVIVE results
Across all 233 evaluable patients at 11 U.S. cancer centers, SurVaxM improved median overall survival (OS), the primary endpoint, to 22.8 months versus 20.3 months for placebo (HR 0.75; 95% CI 0.54 to 1.03; log-rank p=0.076 adjusted for MGMT and KPS stratification). MimiVax described this as a clinically meaningful result that did not quite reach the traditional threshold for statistical significance (p=0.05).
In the prespecified key subpopulation of patients aged 65 and under, SurVaxM showed a statistically significant benefit: median OS of 24.2 months versus 20.2 months (HR 0.64; 95% CI 0.44 to 0.93; p=0.019). The same group saw a significant progression-free survival benefit (HR 0.64; p=0.018), with 12-month progression-free survival of 44% versus 24% for placebo.
About 42% of SurVaxM-treated patients aged 65 and under were alive at 30 months or longer, compared with 18% on placebo. SurVaxM was well tolerated, with mostly Grade 1 or 2 injection-site reactions, similar rates of Grade 3 or higher adverse events between arms (48% versus 46%) and no treatment-related deaths.
SURVIVE has been underway since 2022 and evaluates SurVaxM in combination with standard of care. MimiVax plans to discuss the data and potential expedited regulatory pathways with the U.S. Food and Drug Administration (FDA).
TradeCraft's role
TCR's biostatistics and programming team took on the SURVIVE analysis work in early 2026 and delivered the topline results MimiVax reported. The team built the trial's CDISC ADaM analysis datasets, produced the tables, listings and figures, and ran statistical review on each output, including complex progression-free survival derivations.
MimiVax followed the work through DataVIEWS, TCR's data-visualization platform, giving its team direct visibility into the analysis data as results took shape. TCR delivered the topline analysis within 9weeks of taking on the work.
"Patients with glioblastoma and their families can't afford to wait on data. Our job was to give MimiVax total control of its SURVIVE data, with traceable analyses delivered on the timeline the program needed. We congratulate MimiVax, the Roswell Park investigators and every patient who took part in this trial."
— Mike Willis | TradeCraft Clinical Research, CEO
“TradeCraft's expertise and exceptional quality of work have been integral to advancing our program. They've been a true partner in our success to date, and we look forward to continuing that collaboration as we move into the next phase of development”
— Michael Ciesielski, Ph.D., Chief Executive Officer and Co-Founder of MimiVax
In MimiVax's announcement, Dr. Ciesielski said: "These initial results from the SURVIVE trial give us a clear and coherent picture. SurVaxM showed a consistent survival signal, with a substantial group of patients living well past what we typically see in this disease."
About TradeCraft Clinical Research
TradeCraft Clinical Research (TCR), founded in 2014 by a team of programming and biostatistics executives, is a sponsor-specialization contract research organization. TCR provides biostatistics, statistical programming and proactive project management to biotechnology and pharmaceutical sponsors, giving them Total Control of the Data. Its fully U.S.-based team pairs that work with DataVIEWS, TCR's proprietary data-visualization platform. TCR is headquartered in Wayne, Pennsylvania.
Learn more at www.tradecraftclinical.com.
About SurVaxM
SurVaxM is a first-in-class, patented peptide-mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in approximately 95% of glioblastomas and many other cancers. It holds FDA Orphan and Fast Track Designations for newly diagnosed glioblastoma. SurVaxM is for investigational use only and has not yet been approved by the FDA or any other regulatory authority for any indication.
About MimiVax
MimiVax Inc. is a clinical-stage biotechnology company formed as a spinoff from Roswell Park Comprehensive Cancer Center in Buffalo, New York. The company develops immunotherapies designed to improve survival for patients with cancer. Learn more at www.mimivax.com.
Clinical results and regulatory plans in this release are as reported by MimiVax in its Oct. 7, 2026 announcement.
Media Contacts
TradeCraft Clinical Research
Kanan Sawyer, Sr. Director of Communications and Marketing
info@tradecraftclinical.com | (610) 935-5754
MimiVax
Patrick Brady, Communications
pbrady@brickhousecomms.com | (202) 256-7824
Partnership with DeepkinetiX
FOR IMMEDIATE RELEASE
DeepkinetiX and TradeCraft Clinical Research Partner to Deliver the Industry’s First System of Record for PK Execution
Joint offering pairs deterministic pharmacokinetic execution with a Regulatory Agency data compliance guarantee, enabling Phase I sponsors to run PK trials with audit-ready rigor from raw data to regulatory artifact.
Philadelphia, May 15, 2026 — TradeCraft Clinical Research, the sponsor-specialization CRO known for its regulatory agency data compliance guarantee, and DeepkinetiX, PK execution infrastructure company behind the KinetixFlow™ platform, today announced a partnership that will give clinical trial sponsors an integrated path for running Phase I PK studies with end-to-end confidence from execution through regulatory submission.
Pharmacokinetics (PK) execution represents only 5–15% of the cost of a Phase I study, but it controls 100% of the regulatory narrative. In complex molecule and oncology programs, fragmented data handoffs between PK analysis and biometrics are not merely operational friction—they are a regulatory risk. A single manual error in the modeling layer can derail an entire submission.
The TradeCraft–DeepkinetiX partnership eliminates that risk by combining deterministic, benchmarked PK execution with a CRO who can boast a 100% submission rate for data packages accepted by the regulatory agency. Together, the companies are delivering the industry’s first System of Record for PK Execution.
Sponsors adopting the joint model gain:
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Deterministic PK Execution—audit-ready PK/NCA benchmarked against industry standards for total numerical equivalence.
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Execution Memory—modeling logic and assumptions that accumulate across programs, eliminating start-from-scratch analyses.
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Audit-Ready Artifacts—automated, structured Word and PDF reports built to inspection standards.
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Submission-Grade Rigor—100% double-programmed, CDISC-compliant SDTM/ADaM datasets and TLFs.
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End-to-End Traceability—full lineage from raw data through to the final regulatory report artifact.
“PK/NCA may represent only a small portion of total study cost, but it sits directly in the path of review, reporting, and regulatory delivery. DeepkinetiX’s execution layer paired with TradeCraft’s total control of the data creates a fully connected workflow from PK execution through downstream study delivery.”
— Mike Willis | TradeCraft Clinical Research, CEO
“Selecting TradeCraft Clinical Research as our partner means that DeepkinetiX can now assure our clients of zero breaks in handoffs, accurate biometrics and traceability within a submission-grade delivery infrastructure needed to carry that work forward into regulatory-ready study execution.”
— Ali Ghayoor, Ph.D. | DeepkinetiX CEO
Sponsors don't buy PK analysis. They buy the confidence that their PK story will hold up months from now, when an FDA reviewer comes back with a question. The DeepkinetiX and TradeCraft Clinical Research partnership is built around that confidence.
About TradeCraft Clinical Research
Founded in 2014 by a team of programming and biostatistician executives, TradeCraft Clinical Research is a sponsor-specialization CRO offering solutions in biostatistics, programming, and proactive project management designed to function as an extension of the sponsor’s team. TradeCraft provides clients a Regulatory Agency Submission Data Compliance Guarantee, giving sponsors Total Control of their data and a clear view of trial strategy and status at every stage—so teams can stay ahead of issues and lead with confidence. Learn more at https://www.tradecraftclinical.com.
About DeepkinetiX
DeepkinetiX builds execution infrastructure for pharmacokinetic and translational modeling workflows. By grounding governed mechanistic models in human-relevant biological evidence, and full decision traceability, DeepkinetiX reduces uncertainty in model-informed decisions. Its KinetixFlow™ platform is built for regulatory scrutiny and reuse across programs. Learn more at https://deepkinetix.com.
Media Contacts
TradeCraft Clinical Research
Kanan Sawyer, Head of Communications and Marketing
kanan.sawyer@tradecraftclinical.com | (610) 935-5754
DeepkinetiX
Eduardo Aponte, Business Development Manager
eaponte@deepkinetix.com | (347) 972-0721
Congratulations...
To our very own Mike Willis (TradeCraft Clinical Research CEO) who was honored for his inclusion in the PharmaVOICE 100. These awards recognize the most inspiring people in the life-sciences industry and include leaders in research and development, marketing, technology, creativity, strategy, and medicine. They acknowledge individuals who positively impact their peers, their colleagues, their companies, their communities, as well as the industry at large through their actions.
CASE STUDIES
CDISC SEND Compliant Data for FDA Submission
The CDISC Standard for the Exchange of NonClinical Data (SEND) is required by the FDA for the submission of nonclinical (animal) data. This case study illustrates how TradeCraft Clinical Research helped a client meet a strict submission deadline by producing CDISC SEND compliant data deliverables.
For teams who are preparing for a major regulatory submission, the CDISC requirements for the data components of the submission can be quite overwhelming. Producing compliant output can be challenging when dealing with legacy studies as well as ongoing trials. Tight timelines often add pressure on teams that are already working at capacity.
Sponsor teams routinely find themselves in difficult situations when they receive clinical data from their contract research organizations (CROs) that is not submission-ready. The data is often received late in the process, leaving little or no time for the team to identify, assess, and correct the issues. Depending on the issues, the output may require minimal rework or extensive reprogramming.
Data Support for Conference Poster
Presenting relevant research data at a conference can help to communicate a sponsor's most recent findings and share the information with broader audiences. However, it can be challenging to present the data in a digestible way that is concise, yet detailed enough for audiences to understand your message.
