marrow infiltrating lymphocytes / WindMIL Therap - LARVOL DELTA

[VIRTUAL] Marrow-infiltrating Lymphocytes (MILs): A Novel Adoptive Immunotherapy for Hematological and Solid Tumors (SITC 2020) - P2a | "MILs-based therapies hold therapeutic promise across a wide range of tumor indications. Ethics Approval This study was approved by each participating instituion’s IRB."

IO Biomarker • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • CD8 • IFNG

[VIRTUAL] Marrow-infiltrating Lymphocytes (MILs): A Novel Adoptive Immunotherapy for Hematological and Solid Tumors (SITC 2020) - P2a | "MILs-based therapies hold therapeutic promise across a wide range of tumor indications. Ethics Approval This study was approved by each participating instituion’s IRB."

IO Biomarker • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • CD8 • IFNG

Marrow-infiltrating lymphocytes as adoptive immunotherapy for breast cancer (SABCS 2021) - P2a | "MILs isolated from this expanded cohort of metastatic and high-risk early stage breast cancer patients demonstrated cytokine production in response to pulsed cancer cell line lysates, consistent with our experience with other solid (5) and hematological (3) malignancies. A phase II trial to evaluate MILs in combination with a checkpoint inhibitor is underway in patients with anti-PD1/PDL1-refractory NSCLC (NCT04069936). These preclinical data demonstrate that expanding MILs is feasible and could be evaluated therapeutically in breast cancer."

IO biomarker • Brain Cancer • Breast Cancer • Glioblastoma • Hematological Malignancies • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • HER-2

Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC (clinicaltrials.gov) - P2a | N=19 | Terminated | Sponsor: WindMIL Therapeutics | Trial completion date: Mar 2027 ➔ Nov 2021 | Active, not recruiting ➔ Terminated | Trial primary completion date: Aug 2022 ➔ Oct 2021; Resourcing

Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Fox Chase Cancer Center; N=40 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Combination therapy • Enrollment change • Trial withdrawal • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

[VIRTUAL] Phase IIa study of marrow infiltrating lymphocytes (MILs), an adoptive T cell therapy, alone or in combination with nivolumab in non-small cell lung cancer (NSCLC). (ASCO 2020) - P2a | "Patients will undergo lymphodepletion (fludarabine 300 mg/m2/day and cyclophosphamide 30 mg/m2/day on days -5,-4,-3) followed by infusion of MILs on day 0. The first patient was treated in December 2019. Research Funding: None"

Combination therapy • P2a data • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • CD8

Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Fox Chase Cancer Center; Trial completion date: Jun 2024 ➔ Oct 2024; Initiation date: Jun 2021 ➔ Oct 2021; Trial primary completion date: Jun 2023 ➔ Oct 2023

Clinical • Combination therapy • Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

WindMIL-001: Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma (clinicaltrials.gov) - P=N/A; N=6; Terminated; Sponsor: University of Oklahoma; N=12 ➔ 6; Trial completion date: Aug 2021 ➔ Apr 2021; Recruiting ➔ Terminated; Trial primary completion date: Aug 2021 ➔ Mar 2021; Study funding was withdrawn.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC (clinicaltrials.gov) - P2a; N=19; Active, not recruiting; Sponsor: WindMIL Therapeutics; Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Fox Chase Cancer Center; Trial completion date: Mar 2024 ➔ Jun 2024; Initiation date: Mar 2021 ➔ Jun 2021; Trial primary completion date: Mar 2023 ➔ Jun 2023

Clinical • Combination therapy • Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC (clinicaltrials.gov) - P2a; N=23; Recruiting; Sponsor: WindMIL Therapeutics; Trial completion date: Jun 2026 ➔ Mar 2027; Trial primary completion date: Mar 2022 ➔ Aug 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab in Locally Advanced and Unresectable or Metastatic NSCLC (clinicaltrials.gov) - P2a; N=23; Recruiting; Sponsor: WindMIL Therapeutics; Trial completion date: Dec 2025 ➔ Jun 2026; Trial primary completion date: Jul 2021 ➔ Mar 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • ALK • EGFR • ROS1

Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab in Locally Advanced and Unresectable or Metastatic NSCLC (clinicaltrials.gov) - P2a; N=23; Not yet recruiting; Sponsor: WindMIL Therapeutics

Clinical • Combination therapy • New P2a trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • ALK • EGFR • ROS1

Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab in Locally Advanced and Unresectable or Metastatic NSCLC (clinicaltrials.gov) - P2a; N=23; Recruiting; Sponsor: WindMIL Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • ALK • EGFR • ROS1

Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Fox Chase Cancer Center

Clinical • Combination therapy • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Fox Chase Cancer Center; Trial completion date: Oct 2023 ➔ Mar 2024; Trial primary completion date: Jan 2021 ➔ Mar 2023

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

WindMIL-001: Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma (clinicaltrials.gov) - P=N/A; N=12; Recruiting; Sponsor: University of Oklahoma; Phase classification: P1 ➔ P=N/A

Phase classification • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

WindMIL Therapeutics and Stephenson Cancer Center Announce Collaboration to Collect Bone Marrow from Patients with Renal and Urothelial Carcinomas to Develop Marrow Infiltrating Lymphocytes (MILs) (GlobeNewswire) - "WindMIL Therapeutics (WindMIL) and Stephenson Cancer Center today announced that the first patients have been identified in an investigator-sponsored study for the collection of bone marrow from patients with renal (RCC) and urothelial carcinomas (UC)....The study is being conducted at Stephenson Cancer Center at OU Medicine in Oklahoma City, OK."

Licensing / partnership • Trial status • Bladder Cancer • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Urothelial Cancer

WindMIL Therapeutics announces dosing of first patient in phase 2 clinical study of MILs - NSCLC in combination with nivolumab (Opdivo) for the treatment of non-small cell lung cancer (GlobeNewswire, WindMIL Therapeutics) - "WindMIL Therapeutics…announced that the first patient has been dosed in the combination therapy portion of its Phase 2 clinical trial to assess the safety and efficacy of MILs™ - NSCLC in patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) who are refractory to, or have relapsed on, an anti-PD-1-containing regimen. The first combination therapy dosing took place at Sarah Cannon Research Institute. 'We are excited to further explore how MILs - NSCLC can be used in combination with nivolumab to potentially strengthen immune responses in hard-to-treat cases of NSCLC,' said Melissa Johnson, MD...WindMIL plans to treat approximately 20 patients with MILs - NSCLC plus nivolumab."

Enrollment open • Media quote • Lung Cancer • Non Small Cell Lung Cancer • Oncology

WindMIL-001: Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: University of Oklahoma; Suspended ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

WindMIL Therapeutics opens combination therapy portion of its phase 2a clinical trial of Marrow-Infiltrating Lymphocytes (MILs) for treatment of patients with non-small cell lung cancer (GlobeNewswire, WindMIL Therapeutics) - “WindMIL Therapeutics…announced it has begun enrollment in the combination therapy portion of its open-label, multi-center Phase 2a clinical trial to assess the safety and efficacy of MILs in patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) who are refractory to, or have relapsed on, an anti-PD-1-containing regimen. In this part of the study, MILs will be administered in combination with nivolumab, a PD-1 immune checkpoint inhibitor….WindMIL plans to treat approximately 20 patients with MILs - NSCLC plus nivolumab in this next part of the study.”

Clinical • Enrollment open • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology

WindMIL-001: Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: University of Oklahoma

New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

WindMIL-001: Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma (clinicaltrials.gov) - P1; N=12; Suspended; Sponsor: University of Oklahoma; Not yet recruiting ➔ Suspended

Trial suspension • Bladder Cancer • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer