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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- Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
- This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
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Disclosures for Wedbush, Scholar Rock, October 31, 2023
Analyst Certification We, David Nierengarten, Martin Fan and Dennis Pak, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report.
Company Specific Disclosures This information is subject to change at any time.
1. WS makes a market in the securities of Scholar Rock.
3. WS co-managed a public offering of securities for Scholar Rock within the last 12 months.
5. WS provided Scholar Rock with investment banking services within the last 12 months.
7. WS expects to receive or intends to seek compensation for investment banking services from Scholar Rock in the next three months.
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