AlloStim (bioengineered allogeneic immune cells) / Immunovative - LARVOL DELTA

AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: Mirror Biologics, Inc. | Phase classification: P2a ➔ P2

Phase classification • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS

STIMVAX: Immunotherapy for Third Line Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: Mirror Biologics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Aug 2025 | Trial primary completion date: Nov 2024 ➔ Mar 2025

Enrollment closed • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • KRAS

A phase 2, multicenter, open-label study of AlloStim combined with anti-PD-L1 immunotherapy as 4L therapy in patients with MSS/pMMR metastatic colorectal cancer. (ASCO-GI 2025) - P2 | " The study is a phase 2, multicenter, single-arm clinical trial of MSS/pMMR mCRC subjects in 4L that have been previously treated with an oxaliplatin-containing and irinotecan-containing chemotherapy regimen, anti-EGFR (RAS wt and left-sided), anti-VEGF and have progressed on 3L TAS-102 +/- bevacizumab or regorafenib or fruquinitinib...CT scans are conducted at baseline, day 56 after AlloStim priming, day 112 after combination of alternating q2w infusions of AlloStim and avelumab and day 168 in all patients...Up to 50 patients will be enrolled with an interim analysis performed to assess efficacy after 20 patients become evaluable. The study is open and has not yet enrolled any patients at time of submission."

Clinical • IO biomarker • Metastases • P2 data • Tumor mutational burden • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • IFNG • TMB

A phase 2, multicenter, open-label study of AlloStim in-situ cancer vaccine immunotherapy as 3L therapy in MSS/pMMR metastatic colorectal cancer. (ASCO-GI 2025) - P2 | " To investigate this novel in-situ vaccine mechanism, a phase 2, multicenter, single-arm clinical trial in 3L MSS/pMMR mCRC subjects that have been previously treated with oxaliplatin-containing and irinotecan-containing chemotherapy regimens, anti-EGFR (RAS wt and left-sided) and anti-VEGF was initiated. The primary end-point is overall survival. 21 evaluable patients have been enrolled and are currently being followed for maturity of the survival data."

Clinical • IO biomarker • Metastases • P2 data • Tumor mutational burden • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • IL12A • TMB

ALLOPRIME: Universal Anti-Viral Vaccine for Healthy Elderly Adults (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Mirror Biologics, Inc. | Trial completion date: Apr 2023 ➔ Nov 2024

Trial completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

Mirror Biologics Enters Clinical Collaboration with Merck KGaA, Darmstadt, Germany in Metastatic Colorectal Cancer (GlobeNewswire) - "Mirror Biologics, Inc...announces that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany. The parties will collaborate to conduct a Phase II clinical trial to evaluate the combination of an experimental immunotherapy drug, AlloStim from Mirror, and an immune checkpoint inhibitor (ICI), avelumab (BAVENCIO) from Merck KGaA, Darmstadt, Germany, in fourth-line metastatic colorectal cancer...Under the terms of the agreement, Mirror Biologics will be the sponsor of the clinical study, and Merck KGaA, Darmstadt, Germany will supply avelumab for the study."

Commercial • Colorectal Cancer • Gastrointestinal Cancer

COMUNITY: Combined AlloStim+Anti-PD-L1 in 4L MSS Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Mirror Biologics, Inc. | Trial completion date: Mar 2026 ➔ Nov 2025

Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

COMUNITY: Combined AlloStim+Anti-PD-L1 in MSS Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Mirror Biologics, Inc. | Trial primary completion date: Dec 2025 ➔ Mar 2026

Metastases • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

COMUNITY: Combined AlloStim+Anti-PD-L1 in MSS Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Mirror Biologics, Inc.

Metastases • New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

ALIVE: Immunotherapy for Advanced Liver Cancer (clinicaltrials.gov) - P2/3 | N=150 | Recruiting | Sponsor: Immunovative Therapies, Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

STIMVAX: Immunotherapy for Third Line Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Immunovative Therapies, Ltd. | Phase classification: P2b ➔ P2 | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Nov 2023 ➔ Nov 2024

Metastases • Phase classification • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

ALLOPRIME: Universal Anti-Viral Vaccine for Healthy Elderly Adults (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Immunovative Therapies, Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Apr 2023

Trial completion • Trial completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

ALIVE: Immunotherapy for Advanced Liver Cancer (clinicaltrials.gov) - P2/3 | N=150 | Not yet recruiting | Sponsor: Immunovative Therapies, Ltd. | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2024 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

STIMVAX: Immunotherapy for Third Line Metastatic Colorectal Cancer (clinicaltrials.gov) - P2b | N=24 | Recruiting | Sponsor: Immunovative Therapies, Ltd. | Trial completion date: Sep 2023 ➔ Apr 2024 | Trial primary completion date: Mar 2023 ➔ Nov 2023

Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

STIMVAX: Immunotherapy for Third Line Metastatic Colorectal Cancer (clinicaltrials.gov) - P2b | N=24 | Recruiting | Sponsor: Immunovative Therapies, Ltd. | Trial completion date: Feb 2023 ➔ Sep 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

ALLOPRIME: Universal Anti-Viral Vaccine for Healthy Elderly Adults (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Immunovative Therapies, Ltd. | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Jun 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

ALIVE: Immunotherapy for Advanced Liver Cancer (clinicaltrials.gov) - P2/3; N=150; Not yet recruiting; Sponsor: Immunovative Therapies, Ltd.

Clinical • New P2/3 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Mirror Biologics, Inc. Announces Initial Clearance for Phase II/III Clinical Trial (ALIVE) in Advanced Liver Cancer (PR.com) - “Mirror Biologics, Inc…announced today the clearance of the “ALIVE” Phase II/III randomized, controlled clinical trial for subjects with advanced, treatment-naïve, hepatocellular carcinoma (HCC) by the Malaysian Research Ethics Committee (MREC) and the Thailand Central Research Ethics Committee (CREC)....The ALIVE trial is expected to launch in early 2022.”

New P2/3 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology

STIMVAX: Immunotherapy for Third Line Metastatic Colorectal Cancer (clinicaltrials.gov) - P2b; N=24; Recruiting; Sponsor: Immunovative Therapies, Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

ALLOPRIME: Universal Anti-Viral Vaccine for Healthy Elderly Adults (clinicaltrials.gov) - P1/2; N=40; Recruiting; Sponsor: Immunovative Therapies, Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

ALLOPRIME: Universal Anti-Viral Vaccine for Healthy Elderly Adults (clinicaltrials.gov) - P1/2; N=40; Not yet recruiting; Sponsor: Immunovative Therapies, Ltd.; Initiation date: Mar 2021 ➔ Jun 2021; Trial primary completion date: Mar 2022 ➔ Jun 2022

Clinical • Trial initiation date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

STIMVAX: Immunotherapy for Third Line Metastatic Colorectal Cancer (clinicaltrials.gov) - P2b; N=24; Not yet recruiting; Sponsor: Immunovative Therapies, Ltd.; Trial primary completion date: Sep 2022 ➔ Dec 2022

Clinical • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

STIMVAX: Immunotherapy for Third Line Metastatic Colorectal Cancer (clinicaltrials.gov) - P2b; N=24; Not yet recruiting; Sponsor: Immunovative Therapies, Ltd.; Trial completion date: Dec 2021 ➔ Mar 2023; Trial primary completion date: Oct 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

ALLOPRIME: Universal Anti-Viral Vaccine for Healthy Elderly Adults (clinicaltrials.gov) - P1/2; N=40; Not yet recruiting; Sponsor: Immunovative Therapies, Ltd.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Jul 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Infectious Disease

[VIRTUAL] Novel allogeneic cell immunotherapy for advanced cancers (ESMO Asia 2020) - "Methods AlloStim®, was used on compassionate grounds AlloStim® is currently being evaluated in a phase IIB clinical trial in USA in MSI-S, chemotherapy-refractory, metastatic colorectal cancer patients, an indication known to present with “cold” lesions and to be non-responsive to ICI...Legal entity responsible for the study: Kananathan. Funding: Has not received any funding."

IO Biomarker • Breast Cancer • Colorectal Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hepatology • Immune Modulation • Inflammation • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • CD8 • IFNG • TMB