Last reviewed 2026-06-02 · How we verify

AlloStim8 or AlloStim-9

Mirror Biologics, Inc. · Phase 1 active Biologic ✓ Verified Jun 2026 Quality 0/100

AlloStim8 or AlloStim-9 is a Biologic drug developed by Mirror Biologics, Inc.. It is currently in Phase 1 development. Also known as: Immune activation phase.

AlloStim8 or AlloStim-9 is being studied in a Phase I/II clinical trial for the treatment of metastatic cancer. The trial combines AlloStim8 or AlloStim-9 with percutaneous tumor cryoablation as part of an in-situ therapeutic cancer vaccine.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	AlloStim8 or AlloStim-9
Also known as	Immune activation phase
Sponsor	Mirror Biologics, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

In-Situ Therapeutic Cancer Vaccine for Metastatic Cancer Combining AlloStim With Tumor Cryoablation (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

AlloStim8 or AlloStim-9 CI brief — competitive landscape report
AlloStim8 or AlloStim-9 updates RSS · CI watch RSS
Mirror Biologics, Inc. portfolio CI

Frequently asked questions about AlloStim8 or AlloStim-9

What is AlloStim8 or AlloStim-9?

AlloStim8 or AlloStim-9 is a Biologic drug developed by Mirror Biologics, Inc..

Who makes AlloStim8 or AlloStim-9?

AlloStim8 or AlloStim-9 is developed by Mirror Biologics, Inc. (see full Mirror Biologics, Inc. pipeline at /company/mirror-biologics-inc).

Is AlloStim8 or AlloStim-9 also known as anything else?

AlloStim8 or AlloStim-9 is also known as Immune activation phase.

What development phase is AlloStim8 or AlloStim-9 in?

AlloStim8 or AlloStim-9 is in Phase 1.

Manufacturer: Mirror Biologics, Inc. — full pipeline
Also known as: Immune activation phase

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing