Turnstone Biologics Reports 50% Disease Control Rate with TIDAL-01 in Phase I Trial for Metastatic Colorectal Cancer
Turnstone Biologics
Oncolytic Virus Immunotherapy Researcher
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August 17, 2024
eMedClub News
On August 15 local time, Turnstone Biologics (hereinafter referred to as "Turnstone") announced that itsTIDAL-01In treatmentMetastatic Colorectal CancerPreliminary positive data were obtained in the Phase I clinical trial.
It is reported that the Phase I STARLING trial initiated by Turnstone Biologics is an ongoing, multi-center, first-in-human, non-randomized, open-label, single-dose study aimed at evaluating the safety, tolerability, and clinical activity of TIDAL-01. The trial is currently recruiting patients with colorectal cancer (CRC), squamous cell carcinoma of the head and neck, and uveal melanoma.
CRC is one of the most common malignant tumors worldwide., with its incidence and mortality ranking as the 3rd and 2nd respectively among major malignant tumors. Approximately half of the patients are already in the advanced stage at the time of diagnosis, and its treatment has always faced significant challenges.The liver is the most common metastatic organ in CRC.. Metastatic advanced CRC has a complex condition and is difficult to treat,The treatment options are very limited, with a response rate of less than 5%.。
TIDAL-01 is a next-generation tumor-infiltrating lymphocyte (TIL) therapy. By identifying, selecting, and expanding the most effective subpopulation of patient-specific tumor-reactive T cells, TIDAL-01 aims to improve and broaden the clinical efficacy of TILs and overcome the limitations of current TIL-based therapies.
In Phase I clinical trials, TIDAL-01 demonstrated good tolerability in terms of safety.No serious adverse events were observed.. Preliminary evaluation results showed that, out of 4 evaluable patients,The overall response rate (ORR) was 25%, and the disease control rate (DCR) was 50%., among whichA patient exhibited durable complete response (CR).. In terms of efficacy,50%Patients demonstrated sustained clinical benefit.，Patients with sustained complete remission have a progression-free survival exceedingOne Year, while another patient whose condition stabilized had a duration of 6 months.
"Dr. Sammy Farah, President and CEO of Turnstone Biologics, stated, 'The preliminary clinical data from the STARLING Phase I trial is encouraging, indicating that TIDAL-01 has potential in the treatment of metastatic CRC and other solid tumors. The data presented in the trial (25% ORR with durable responses, 50% DCR) show a clear advantage compared to the efficacy data of current standard treatments for this patient population, which have an ORR of only 1-6% and a median progression-free survival (mPFS) of 2.0-5.6 months. Additionally, TIDAL-01 demonstrates good tolerability. These data provide a strong foundation for further development of TIDAL-01 for this high-need patient population.'"
Turnstone’s Interim Chief Medical Officer Mike Burgess stated: “CRC is one of the leading causes of cancer-related deaths in the United States. Early clinical benefit data shows that TIDAL-01 is a potentially viable option for the treatment of metastatic CRC. We are thrilled that the patient who achieved complete remission remains in remission and in good condition more than a year after treatment. Through our STARLING trial, we will continue to evaluate the efficacy of TIDAL-01 in CRC as well as in tumor types with limited or no available treatment options, including uveal melanoma and head and neck cancer.”
It is worth mentioning that Turnstone Biologics, upon its establishment in 2015, did not initially focus on the TIL therapy pipeline but instead dedicated itself to the development of oncolytic virus therapies for the treatment of malignant tumors.Collaborated with AbbVie and Takeda in 2017 and 2019, but due to a bumpy R&D journey and the influence of multiple factors, relevant collaborations were successively terminated in 2021 and 2022. Afterwards, Turnstone Biologics shifted the focus of the company's future business to TIL (Tumor-Infiltrating Lymphocytes) and attempted to differentiate itself in autologous TIL rather than concentrating on the "majority of TILs" that only show benefits in limited tumor types. Turnstone’s proprietary technology platform combines methods for discovering tumor-associated T cells in TIL with advanced cell screening and culture techniques.Can rapidly enrich T cells that eliminate tumors, preserve the diversity of T cell-targeted antigens, and reduce the manufacturing time of TIL therapy.。
In 2023, Turnstone Biologics successfully completed its IPO on Nasdaq despite a cash flow crisis, raising funds.$80 million, and is expected to continue until the third quarter of 2025. The preliminary positive clinical data exhibited by TIDAL-01 will hopefully increase Turnstone's market attention and attract investors' favor, laying a foundation for the smooth advancement of subsequent research and commercialization processes.
References:
1.https://pipelinereview.com/turnstone-biologics-corp-reports-positive-initial-data-from-phase-1-trial-of-tidal-01-in-metastatic-colorectal-cancer/
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