TBio-6517 / Turnstone Biologics - LARVOL DELTA

RAPTOR: Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Terminated | Sponsor: Turnstone Biologics, Corp. | Phase classification: P1/2 ➔ P1

Phase classification • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Mesothelioma • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • BRAF

RAPTOR: Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1/2 | N=27 | Terminated | Sponsor: Turnstone Biologics, Corp. | Trial completion date: Dec 2023 ➔ Jan 2023 | Active, not recruiting ➔ Terminated; Sponsor decision

Trial completion date • Trial termination • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Non-melanoma Skin Cancer • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • BRAF

RAPTOR: Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1/2 | N=27 | Active, not recruiting | Sponsor: Turnstone Biologics, Corp. | Recruiting ➔ Active, not recruiting | N=138 ➔ 27 | Trial completion date: Jul 2025 ➔ Dec 2023 | Trial primary completion date: Dec 2024 ➔ Jun 2023

Combination therapy • Enrollment change • Enrollment closed • Metastases • Oncolytic virus • Trial completion date • Trial primary completion date • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Non-melanoma Skin Cancer • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • BRAF

RAPTOR: Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Turnstone Biologics, Corp. | Trial completion date: Dec 2022 ➔ Jul 2025 | Trial primary completion date: Aug 2022 ➔ Dec 2024

Combination therapy • Oncolytic virus • Trial completion date • Trial primary completion date • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Non-melanoma Skin Cancer • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • BRAF

Turnstone Biologics Raises $80 Million Series D Financing (Businesswire) - “Proceeds from the financing will be used to advance Turnstone’s pipeline of programs from its oncolytic virus and TIL therapy platforms. Turnstone’s lead oncolytic virus candidate, RIVAL-01/TAK-605, is currently in the dose escalation stage of a Phase 1/2a clinical study in solid tumors conducted in collaboration with Takeda Pharmaceutical Company Limited (‘Takeda’)….Turnstone’s lead TIL therapy candidate, TIDAL-01, is expected to enter clinical development by early next year.”

Financing • New trial • Oncology • Solid Tumor

".@TurnstoneBio to advance #immunooncology portfolio after oversubscribed $80M #SeriesD #financing round Focused on #TIL #immunotherapy & #OncolyticViruses, incl RIVAL-01 in Ph1/2a #ClinicalTrials in solid #tumors https://t.co/UfYqnqCOd5 #cancers @TakedaOncology" (@DDNewsOnline)

Clinical • Oncolytic virus • Oncology • Solid Tumor

RAPTOR: Study of TBio-6517, Given Intratumorally, Alone or in Combination With Pembrolizumab, in Solid Tumors (clinicaltrials.gov) - P1/2; N=114; Recruiting; Sponsor: Turnstone Biologics, Corp.; N=84 ➔ 114

Clinical • Combination therapy • Enrollment change • Oncolytic virus • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Turnstone Biologics Announces First Patients Enrolled in Phase 1/2 Clinical Trial Evaluating RIVAL-01 For the Treatment of Solid Tumors (Businesswire) - “Turnstone Biologics Corp…announced enrollment of the first patients in a Phase 1/2a clinical trial (RAPTOR) of its RIVAL-01/TAK-605 candidate in patients with solid tumors, conducted in collaboration with Takeda Pharmaceutical Company Limited…The RAPTOR trial will evaluate the safety and efficacy of RIVAL-01 (formerly known as TBio-6517) administered intratumorally as a single agent and in combination with Keytruda® (pembrolizumab) in patients with solid tumors, including triple negative breast cancer, microsatellite stable colorectal cancer, melanoma and cholangiocarcinoma.”

Trial status • Biliary Tract Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

RAPTOR: Study of TBio-6517, Given Intratumorally, Alone or in Combination With Pembrolizumab, in Solid Tumors (clinicaltrials.gov) - P1/2; N=84; Recruiting; Sponsor: Turnstone Biologics, Corp.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Oncolytic Virus • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

RAPTOR: Study of TBio-6517, Given Intratumorally, Alone or in Combination With Pembrolizumab, in Solid Tumors (clinicaltrials.gov) - P1/2; N=84; Not yet recruiting; Sponsor: Turnstone Biologics, Corp.

Clinical • Combination therapy • New P1/2 trial • Oncolytic Virus • PD-L1

Utilizing novel oncolytic vaccinia virus for selective expression of immunotherapeutic payloads in metastatic tumors (SITC 2019) - "Various immunocompetent syngeneic mouse tumor models and human xenograft tumor models were used to characterize this engineered virus, TBio-6517... Our new best-in-class recombinant VACV robustly stimulates systemic anti-tumor immunity and has a substantially improved pre-clinical safety profile compared to other VACV clinical candidates. Additional ongoing toxicity and efficacy studies are being conducted prior to clinical evaluation of the novel virus construct."

IO Biomarker • Oncolytic Virus