EMERYVILLE, Calif. - Gritstone bio, Inc. (NASDAQ:GRTS), a clinical-stage biotechnology company, announced preliminary data today from a Phase 2 study of its personalized neoantigen cancer vaccine, GRANITE, in patients with metastatic microsatellite stable colorectal cancer (MSS-CRC).
The study found early signs of progression-free survival (PFS) benefit in patients treated with GRANITE, particularly in a high-risk subgroup.
Patients in the overall population showed a hazard ratio of 0.82 for PFS, while those in the high-risk group demonstrated a more significant PFS benefit with a hazard ratio of 0.52, indicating a 48% relative risk reduction of progression or death compared to the control group. Notably, over 90% of high-risk patients had liver metastases.
The study also assessed circulating tumor DNA (ctDNA) responses, which aligned with PFS trends and favored patients treated with GRANITE. Although short-term molecular responses were uninformative due to an unexpected continuation of ctDNA decrease beyond induction chemotherapy, long-term ctDNA responses supported the vaccine's potential efficacy.
GRANITE was reported to be generally well-tolerated, with manageable adverse events and no discontinuations due to adverse reactions. Gritstone bio achieved a 100% vaccine manufacturing success rate for eligible patients.
The company expects to present mature PFS data in the third quarter of 2024 and overall survival data in the first half of 2025. These preliminary findings suggest that GRANITE could potentially offer a new treatment option for MSS-CRC, a condition that has not typically responded to standard immunotherapies.
The results, based on a press release statement, indicate that the vaccine could induce a significant immune response in a disease previously considered immunologically 'cold.' This development is particularly noteworthy for MSS colorectal cancer, which represents a large majority of metastatic colorectal cancer cases and is the second most common cause of cancer death.
Gritstone bio's approach to developing potent vaccines for various diseases continues as the company prepares for further clinical trials and regulatory discussions. The findings from this study may pave the way for expanded immunotherapy options for cancer patients.
InvestingPro Insights
Gritstone bio, Inc. (NASDAQ:GRTS) has shown promising preliminary data in its latest clinical study, which may excite investors about the company's potential. However, it's important to consider the financial health and market performance of Gritstone as part of the overall evaluation.
According to InvestingPro data, Gritstone has a market capitalization of approximately $230.45 million, indicating a relatively small-cap biotech company. Despite the clinical advancements, analysts have raised concerns about the company's financials, particularly noting that Gritstone is quickly burning through cash and that it has not been profitable over the last twelve months.
From a market perspective, Gritstone has experienced a large price uptick over the last six months, with a 49.42% total return, which may signal growing investor confidence or speculative interest. This is further supported by a strong 27.23% return in the past month. Yet, the company's revenue has declined by 18.05% in the last twelve months as of Q4 2023, which could be a point of caution for investors looking at the company's growth prospects.
Two InvestingPro Tips that stand out for Gritstone are the analysts' anticipation of a sales decline in the current year and the expectation that the company will not be profitable this year. These insights suggest that while the clinical results are promising, the financial outlook may present challenges. For investors seeking a more comprehensive analysis, there are additional tips available on InvestingPro, offering a deeper dive into Gritstone's financials and market performance. To access these insights, consider using the coupon code PRONEWS24 to get an extra 10% off a yearly or biyearly Pro and Pro+ subscription.
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