SAN DIEGO - Turnstone Biologics Corp. (NASDAQ:TSBX), a clinical-stage biotechnology company, announced positive preliminary data from its Phase 1 STARLING trial evaluating TIDAL-01, a novel therapy for metastatic colorectal cancer (CRC). The trial, which focuses on microsatellite stable colorectal cancer (MSS mCRC), has shown promising early results.
The STARLING trial, a multi-site, first-in-human study, has reported an overall response rate (ORR) of 25% and a disease control rate (DCR) of 50% among the first four evaluable patients treated with TIDAL-01. Notably, one patient achieved a complete response with progression-free survival extending beyond one year.
TIDAL-01's production process has been successful in generating tumor-reactive T cells, with a manufacturing success rate of 80% for patients with sufficient starting material. The therapy has been generally well-tolerated, with safety events consistent with known adverse effects associated with the lymphodepletion regimen, and IL-2 and pembrolizumab administration.
Turnstone's President and CEO, Sammy Farah, M.B.A., Ph.D., stated that the initial data from the trial compares favorably to the standard of care for this patient population, which typically reports a 1-6% ORR and median progression-free survival of 2.0-5.6 months. The company believes these results provide a strong foundation for the continued development of TIDAL-01 in metastatic CRC, a disease with high unmet medical needs.
CRC is the third most commonly diagnosed cancer in the United States and the second leading cause of cancer-related deaths. The five-year survival rate for all colorectal cancer is approximately 65%, but this drops below 20% if the cancer has metastasized. Current treatment options include surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy. However, advanced MSS mCRC typically exhibits resistance to chemotherapy and lacks actionable mutations for targeted therapies.
The STARLING trial is ongoing, and Turnstone is continuing to evaluate TIDAL-01's benefits in CRC and other tumor types with limited treatment options, such as uveal melanoma and head and neck cancer.
In other recent news, Turnstone Biologics has disclosed its first-quarter earnings for 2024, alongside updates on its pipeline. The company is set to present a clinical update on its leading program, TIDAL-01, expected to align with its second-quarter 2024 earnings report.
The forthcoming update will focus on late-stage colorectal cancer patients, a group for which current treatments have shown limited effectiveness. Turnstone Biologics plans to highlight the potential of its therapy in this area, where other tumor-infiltrating lymphocyte therapies have had minimal success.
The company also reported a cash reserve of $78 million, sufficient to support operations into the latter half of 2025. This financial position enables Turnstone Biologics to achieve initial clinical proof-of-concept for its tumor-selective TIL platform.
The TIDAL-01 program update is crucial as it underscores the company's dedication to advancing its lead program and potentially addressing unmet needs in the treatment of colorectal cancer and other cancers.
Piper Sandler has reaffirmed its Overweight rating on shares of Turnstone Biologics, maintaining a price target of $20.00. The company's strategic focus on colorectal cancer, head and neck, and uveal melanoma demonstrates its intent to establish its treatment's uniqueness in the oncology market.
InvestingPro Insights
As Turnstone Biologics Corp. (NASDAQ:TSBX) shares encouraging results from its Phase 1 STARLING trial for metastatic colorectal cancer, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, TSBX holds a market capitalization of $52.04 million, reflecting its size in the biotech industry. The company's price to book ratio as of the last twelve months stands at 0.63, indicating that the stock may be undervalued relative to its assets.
However, the company's financial challenges are apparent. TSBX has experienced a significant revenue decline, with a revenue growth rate of -100% in the last twelve months. This is coupled with a gross profit of -$61.12 million, highlighting the company's struggle to maintain profitability amidst its growth efforts. The negative return on assets of -80.25% further underscores the financial hurdles the company faces.
InvestingPro Tips suggest that while TSBX has more cash than debt on its balance sheet, it is rapidly burning through its cash reserves and suffers from weak gross profit margins. In addition, analysts do not expect the company to be profitable this year, with net income projected to decrease. These factors are critical for investors to consider, especially when evaluating the company's long-term potential in the competitive biotech space.
For those looking to delve deeper into the financial nuances of Turnstone Biologics Corp., InvestingPro provides additional insights. Currently, there are 9 more InvestingPro Tips available on the platform, which can offer investors a comprehensive analysis of TSBX's financial standing and future outlook. Interested readers can find these valuable tips at: InvestingPro.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.