NEW YORK - IO Biotech (NASDAQ:IOBT), a biopharmaceutical company specializing in immune-modulating cancer vaccines, has announced encouraging data from a Phase 2 trial of its lead investigational candidate, IO102-IO103. The trial, which combined IO102-IO103 with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), showed promising activity in treating patients with metastatic non-small cell lung cancer (NSCLC).
The study, which included patients with previously untreated metastatic stage NSCLC with high PD-L1 expression, reported an overall response rate of 55% unconfirmed and 48% confirmed. Furthermore, approximately 50% of the patients showed no disease progression at 12 months, with a median progression-free survival of 8.1 months and the median duration of response not yet reached.
The safety profile of the combination treatment was consistent with prior studies, with low-grade transient injection site reactions as the most common treatment-related adverse event. The study’s principal investigator, Dr. Jonathan Riess, emphasized the need for new treatments that extend the durability of response for lung cancer patients and noted the positive signal from the trial's findings.
IO Biotech also presented pre-clinical data at the Society for Immunotherapy of Cancer’s Annual Meeting for its second vaccine candidate, IO112. This vaccine targets arginase 1, which is known to play a central role in immune suppression in the tumor microenvironment. The pre-clinical data showed that IO112 vaccination leads to robust expansion of Arg1-specific T cells, resulting in the reprogramming of immune-suppressive tumor-associated macrophages (TAMs) and tumor growth inhibition.
These results build on previous positive data from IO102-IO103 in other cancers, including squamous cell carcinoma of the head and neck (SCCHN) and melanoma. The company aims to submit an Investigational New Drug (IND) application for IO112 in 2025.
IO Biotech maintains global commercial rights to IO102-IO103 and is conducting a pivotal Phase 3 trial in advanced melanoma in collaboration with Merck (NS:PROR), which is supplying pembrolizumab for the trials. This information is based on a press release statement from IO Biotech.
In other recent news, IO Biotech has been the subject of several analyst reports. Piper Sandler reaffirmed its Overweight rating, citing recent data from the European Society for Medical (TASE:PMCN) Oncology conference. The data pertains to IO102-IO103, used in combination with pembrolizumab, for treating patients with first-line PD-L1 high squamous cell carcinoma of the head and neck. Morgan Stanley (NYSE:MS) also maintained an Overweight rating on IO Biotech, based on recent abstract data for the company's IO102-103. Jefferies, despite lowering the price target to $8.00, maintained its Buy rating, and H.C. Wainwright kept its Buy rating with a steady price target of $12.00.
Despite the company's Phase 3 trial not meeting the interim analysis objective response rate, the Independent (LON:IOG) Data Monitoring Committee recommended the continuation of the study. The primary progression-free survival analysis is expected in the first half of 2025. In governance news, Kathleen Sereda Glaub, Peter Hirth, and Mai-Britt Zocca were elected as class III directors, serving until the 2027 Annual Meeting of Stockholders, and EY Godkendt Revisionspartnerselskab was ratified as its independent registered public accounting firm for the fiscal year ending December 31, 2024. These are the recent developments for IO Biotech.
InvestingPro Insights
As IO Biotech (NASDAQ:IOBT) advances its promising cancer vaccine candidates, investors should consider some key financial metrics and insights from InvestingPro.
The company's market capitalization stands at $76.42 million, reflecting its current valuation in the biotech sector. Despite the positive clinical trial results, InvestingPro data shows that IO Biotech is not yet profitable, with an adjusted operating income of -$93.4 million over the last twelve months as of Q2 2023. This is not unusual for early-stage biotech companies investing heavily in research and development.
An InvestingPro Tip highlights that IO Biotech holds more cash than debt on its balance sheet, which is crucial for funding ongoing clinical trials and operations. However, another tip warns that the company is quickly burning through cash, a common challenge for biotech firms in the development phase.
The stock's performance has been mixed, with a 1-year price total return of 18.97% as of the latest data, but a year-to-date decline of 38.3%. This volatility is typical in the biotech sector, especially as companies approach critical milestones in their clinical trials.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips that could provide valuable insights into IO Biotech's financial health and market position. These tips, along with real-time metrics, can help investors make more informed decisions as they evaluate the company's potential in the competitive oncology market.
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