TIDAL-01 / Xoma - LARVOL DELTA

TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | N=15 ➔ 7 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | N=25 ➔ 17

Enrollment change • Enrollment closed • Cutaneous Melanoma • Eye Cancer • Melanoma • Mucosal Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Uveal Melanoma • BRAF • IL2

TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: May 2026 ➔ Aug 2026 | Trial primary completion date: May 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=31 | Terminated | Sponsor: Turnstone Biologics, Corp. | Recruiting ➔ Terminated | N=60 ➔ 31 | Trial completion date: Jun 2025 ➔ Feb 2025; Sponsor decision

Enrollment change • Trial completion date • Trial termination • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Eye Cancer • Head and Neck Cancer • HER2 Positive Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma

Turnstone Biologics Announces Plans to Explore Strategic Alternatives (GlobeNewswire) - "Turnstone Biologics...announced that it has completed an assessment of its business and operations, including the status of its program, resources, and capabilities. The Company has made the determination to discontinue all clinical studies evaluating TIDAL-01 and halt further development of the program....'The Company has decided to discontinue development of TIDAL-01 and to conclude all clinical studies evaluating the program in solid tumors'....Turnstone does not intend to disclose further developments unless and until it is determined that further disclosure is appropriate or legally required."

Discontinued • Solid Tumor

Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Cutaneous Melanoma • Eye Cancer • Melanoma • Mucosal Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Uveal Melanoma • BRAF • IL2

Session II: Next Generation TIL - TIDAL-01: Enriching for a More Potent TIL Population with Selected TIL Therapy (SITC 2024) - "(Luncheon), and KSQ Therapeutics, Inc. (Luncheon)."

Clinical • Oncology

Turnstone Biologics Presents Preclinical Data Highlighting Potential for Selected Tumor-Infiltrating Lymphocyte (TIL) Therapy in Solid Tumors at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Key findings from the two poster presentations follow...Turnstone’s Selected TIL clinical candidate, TIDAL-01, utilizes a novel unbiased identification and functional screening process to isolate and selectively expand the greatest breadth of the most potent tumor-reactive (neoantigen-reactive) TIL from the patient’s tumor in vitro, before infusing them into the patient for more targeted tumor killing....Although tumor-reactive TIL infused to patients are associated with clinical responses, there are currently no biomarkers that can predict whether tumor-reactive T cells can be expanded from a tumor; Using single T cell sequencing, this poster illustrates a manufacturing method tested to enrich TIL in tumor-reactive T cells, the results for which suggest that the degree of baseline TCR (T cell repertoire) overlap between blood and tumor repertoire could help identify patients from which tumor-reactive TIL can be expanded."

Preclinical • Oncology • Solid Tumor

Turnstone Biologics Announces Strategic Restructuring to Prioritize Portfolio… (GlobeNewswire) - "Turnstone Biologics Corp...announced a strategic prioritization of its pipeline...to focus resources on the continued advancement of its Phase 1 program, TIDAL-01....TIDAL-01 is currently being evaluated in multiple Phase 1 trials including patients with colorectal cancer, head and neck cancer, and uveal melanoma, and the Company expects to provide a clinical update in the first half of 2025."

P1 data • Pipeline update • Colorectal Cancer • Head and Neck Cancer • Uveal Melanoma

Turnstone Biologics Corp. Reports Positive Initial Data from Phase 1 Trial of TIDAL-01 in Metastatic Colorectal Cancer (GlobeNewswire) - P1 | N=60 | STARLING (NCT05576077) | Sponsor: Turnstone Biologics, Corp. | "Overall response rate ('ORR') of 25% and 50% disease control rate ('DCR') observed in first four evaluable patients treated with TIDAL-01 with advanced CRC; Complete response achieved in heavily pre-treated late line patient with progression free survival extending beyond one year; Favorable tolerability profile and demonstrated manufacturing success; Product characterization and translational data support biological hypothesis for Selected TILs."

P1 data • Colorectal Cancer • Gastrointestinal Cancer

Dr Kirtane on the Design of a Phase 1b Trial of Tbio4101 Plus Pembrolizumab in HNSCC (OncLive) - "...discusses the design of a phase 1b trial (NCT06236425) evaluating the tumor-infiltrating lymphocyte (TIL) Tbio-4101 plus pembrolizumab (Keytruda) in patients with PD-1 inhibitor–resistant, advanced head and neck squamous cell carcinoma (HNSCC), as well as unmet needs that this research aims to address....In this trial, the patients who progress on frontline therapy will then have the option to receive Tbio-4101 as second-line treatment, shortening their wait time between lines of therapy."

Trial status • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

A phase 1b study of tbio-4101 (autologous selected and expanded tumor-infiltrating lymphocytes [TILs]) with pembrolizumab in patients with anti-PD-1–resistant, advanced head and neck squamous cell carcinoma (aHNSCC). (ASCO 2024) - P1 | "Non-tumor-reactive bystander T cells, which may negatively impact treatment efficacy via product dilution, and typically account for ≥90% of bulk TIL, are substantially reduced by this process. Thereafter, patients receive ≤6 doses of IL-2 (600,000 IU/kg) every 8h, and pembrolizumab (200 mg) every 3 weeks until disease progression. The trial is currently open, with a target enrollment of 15 patients (NCT06236425)."

Clinical • IO biomarker • Metastases • P1 data • Tumor-infiltrating lymphocyte • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • CD8

Turnstone Biologics Corp. Reports First Quarter 2024 Financial Results and Provides Recent Business Highlights (GlobeNewswire) - "Turnstone recently secured additional dedicated cleanroom capacity at Moffitt’s on-site cGMP facility for manufacturing of TIDAL-01 for the STARLING trial with IND clearance from the FDA."

Commercial • Solid Tumor

Turnstone Biologics Appoints William Waddill to its Board of Directors (GlobeNewswire) - "Turnstone Biologics Corp...today announced the appointment of industry veteran William Waddill to the Company’s Board of Directors. The Company also announced that Patrick Machado has stepped down as a member of its Board of Directors. These changes became effective as of April 15, 2024....'We look forward to working with Will as we continue to advance our next-generation Selected TIL therapies, including our lead clinical program, TIDAL-01, for patients with a broad range of solid tumors.'"

Clinical • Oncology • Solid Tumor

Turnstone Biologics Corp. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Recent Business Highlights (GlobeNewswire) - "Advancing TIDAL-01 in Multiple Phase 1 Clinical Trials and Expanding of Targeted Solid Tumor Indications....The multi-site STARLING trial protocol has been amended to cover head and neck squamous cell carcinoma (HNSCC), and the H. Lee Moffitt Cancer Center and Research Institute sponsored trial has been expanded to include colorectal cancer (CRC) and HNSCC. Turnstone expects to provide an initial clinical update across these trials in mid-2024."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Jan 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Cutaneous Melanoma • Eye Cancer • Melanoma • Mucosal Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Uveal Melanoma • BRAF • IL2

TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Turnstone Biologics, Corp. | Phase classification: P1b ➔ P1

Phase classification • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Eye Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma

Turnstone Biologics Corp. Reports Third Quarter 2023 Financial Results and Provides Recent Business Highlights (GlobeNewswire) - "Initial Clinical Data for TIDAL-01. Turnstone’s lead Selected TIL program, TIDAL-01, is currently being evaluated in two Phase 1 clinical trials, including STARLING, a multi-site trial for the treatment of breast cancer, colorectal cancer and uveal melanoma, and an investigator-sponsored trial with H. Lee Moffitt Cancer Center and Research Institute in both cutaneous and non-cutaneous melanomas. Turnstone expects to provide an initial clinical update across these two trials in mid-2024...R&D expenses for the three months ended September 30, 2023, were $14.2 million, compared to $21.3 million for the same period in 2022. The decrease was due primarily to decreases in clinical and regulatory costs, personnel-related costs, and manufacturing expenses due to the termination of the discovery, collaboration and license agreement entered into on November 7, 2019, with Takeda Oncology for...offset by an increase due to ramp up of TIDAL-01 activities."

Commercial • P1 data • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Eye Cancer • Gastrointestinal Cancer • Melanoma • Ocular Melanoma • Oncology • Skin Cancer • Solid Tumor • Uveal Melanoma

Turnstone Biologics Presents Preclinical Data Highlighting Potential for Selected Tumor-Infiltrating Lymphocyte (TIL) Therapy in Solid Tumors at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Turnstone Biologics Corp...announced it will be presenting four posters highlighting preclinical data from its pipeline of programs, including the lead clinical candidate, TIDAL-01, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting being held November 1-5, 2023 in San Diego, California....This poster demonstrates that TIL from metastatic colorectal cancer and gastric cancer patient samples were successfully expanded from multiple disease sites in vitro....In this poster, Turnstone presents TBio BFX 4101, a bioinformatics pipeline, which provides a comprehensive and efficient approach to identifying and ranking these neoantigens, with encouraging results from a variety of solid tumor samples, including melanoma, colon, and breast cancers."

Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor

Turnstone Biologics to Present Preclinical Data for Selected Tumor-Infiltrating Lymphocyte (TIL) Therapy at Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting (GlobeNewswire) - "Turnstone Biologics Corp...today announced four posters reporting preclinical data for Turnstone’s Selected TIL therapies will be presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The SITC 38th Annual Meeting will be held from November 1-5, 2023, in San Diego, California."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=60 | Recruiting | Sponsor: Turnstone Biologics, Corp. | N=30 ➔ 60

Enrollment change • Metastases • Tumor mutational burden • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Eye Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma

STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Turnstone Biologics, Corp. | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Tumor mutational burden • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Eye Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • Uveal Melanoma

STARLING: A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Turnstone Biologics, Corp. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Tumor mutational burden • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Eye Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • Uveal Melanoma