CAMBRIDGE, Mass. - Scholar Rock (NASDAQ: SRRK), a biopharmaceutical company, announced encouraging data from a Phase 1 trial of SRK-181, a drug designed to overcome resistance to certain cancer therapies. The trial results, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, showed positive response rates in patients with advanced solid tumors resistant to anti-PD-(L)1 therapies.
The study indicated objective response rates (ORR) in multiple tumor types, including clear cell renal cell carcinoma (ccRCC) and melanoma. Specifically, ccRCC patients showed a notable doubling of the ORR, suggesting a potential strategy for selecting patients likely to benefit from the treatment.
Safety data from the trial demonstrated that SRK-181, in combination with pembrolizumab, was generally well tolerated. The most common adverse events were rash, pruritis, fatigue, and diarrhea, with one Grade 4 event of generalized dermatitis exfoliative reported.
The company further highlighted biomarker analyses that could inform patient selection strategies. For ccRCC patients, a correlation was found between baseline CD8+ T-cell infiltration and response rates, indicating a potential predictive value for treatment outcomes.
Scholar Rock is planning to engage with the FDA for an end of Phase 1 meeting and is exploring partnership opportunities for the program. The company will host a conference call with Dr. Toni Choueiri to discuss the data on Tuesday, June 4th.
SRK-181 is a selective inhibitor of TGFβ1 activation, aiming to counteract the immunosuppressive environment in tumors that hinders the effectiveness of anti-PD-(L)1 therapies. The drug is still investigational, and its efficacy and safety have not been fully established.
This article is based on a press release statement from Scholar Rock.
InvestingPro Insights
As Scholar Rock (NASDAQ: SRRK) announces promising trial results for its cancer therapy SRK-181, the company's financial health and market performance provide additional context for investors. With a market capitalization of $757.66 million, Scholar Rock is a mid-sized player in the biopharmaceutical industry. The company's financial data shows a challenging landscape, as evidenced by its P/E ratio of -4.18, reflecting the high growth potential but also the risks associated with its developmental pipeline.
One of the key InvestingPro Tips for Scholar Rock is that the company holds more cash than debt on its balance sheet, which is a positive sign for its financial stability. This could be crucial for funding ongoing research and development without the immediate need for external financing. However, investors should be cautious as another InvestingPro Tip highlights that the company is quickly burning through cash, which could impact its long-term operations if not managed effectively.
From a stock performance perspective, Scholar Rock has seen significant volatility. The stock has taken a considerable hit over the last week, with a price total return of -12.0%, and has fared poorly over the last month, with a -38.83% return. This volatility is a common trait in the biopharmaceutical sector, where trial outcomes can greatly affect investor sentiment and stock prices.
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