Firm To Present Trial Results Update at SITC Meeting
Source: Dr. David Nierengarten
November 3, 2023 (Investorideas.com Newswire) Data will be reviewed from Part B, the dose expansion portion, of the Phase 1 study of a new TGF-β1 isoform inhibitor in advanced cancer, noted a Wedbush report.
Scholar Rock Holding Group (SRRK:NASDAQ) will present updated safety, efficacy, and biomarker data on its investigational therapeutic, SRK-181, this week at the annual meeting of the Society for Immunotherapy of Cancer (SITC), reported Wedbush analyst Dr. David Nierengarten in an October 31 research note.
These new data are from Part B, the dose expansion component, of the DRAGON Phase 1 clinical trial evaluating SRK-181, the company's selective inhibitor of TGFβ1, or transforming growth factor beta one, activation in combination with an anti-PD-(L)1 checkpoint inhibitor in patients with anti-PD-1-resistant metastatic clear cell resistant renal cell carcinoma.
Referring to already-released data, Nierengarten wrote: "Early data confirm preclinical findings that suggest that SRK-181 is able to combat the immunosuppressive conditions associated with resistance to checkpoint inhibitors."
This is positive, given Scholar Rock is developing SRK-181 to overcome resistance to checkpoint therapy in patients with advanced cancer.
Attractive Return, Upcoming Catalyst
At the time of the report, Massachusetts-based Scholar Rock was at about US$6.85 per share, noted Nierengarten. In comparison, Wedbush's target price on it is about US$23 per share. The difference between these two prices implies a significant return for investors of 236%.
Wedbush rates the biopharma Outperform.
The analyst indicated the primary near-term stock catalyst is topline data from the Phase 3 SAPPHIRE trial of Scholar Rock's lead drug candidate apitegromab in spinal muscular dystrophy, due out in Q4/24.
Also, next year, SRRK will commence a Phase 2 proof-of-concept study evaluating the same therapeutic in combination with a GLP-1 receptor.
Signs of Efficacy
In his report, Nierengarten summarized the results of the DRAGON Phase 1 trial's Part A. Data were for 16 evaluable patients out of 20, all of whom had a median of three prior lines of treatment. None of the patients had previously responded to anti-PD-1 checkpoint inhibitor therapy.
Among the 16 evaluable patients, the overall response rate was 25%; four patients had confirmed partial responses. Tumor reductions of 50−84% were observed in responders who were treated for five-plus to 14-plus months.
Seven patients had stable disease. Four of them remained on treatment for two-plus to eight-plus months.
"Combination treatment with SRK-181 and anti-PD-1 was associated with increased CD8+ T-cell infiltration in tumors and decreased circulatory immunosuppressive myeloid-derived suppressor cell levels," Pantginis wrote.
As far as safety, patients tolerated the combination therapy well. Only Grade 3 or lower treatment-related adverse effects (TRAEs) were reported. The most common were pruritus and maculopapular rash, each reported in 15% of patients, and rash, reported in 10% of patients.
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