SRK-181


Associated tags: Biotechnology, Patient, Pharmaceutical industry, Health, DRAGON, Safety, Rock, Clinical Trials, Publication, Oncology, SITC, Annual general meeting, Immunotherapy, Toxic epidermal necrolysis, Neoplasm, Pharmaceutical, Poster, Part, Neuromuscular Disorders, Clinical trial

Scholar Rock Presents New Data from Phase 1 DRAGON Trial Showing Promising Anti-Tumor Activity in Anti-PD-1 Resistant Metastatic ccRCC Patients and Supporting SRK-181 Continued Tolerability

Retrieved on: 
Friday, November 3, 2023
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The second poster focuses on preliminary biomarker data from part B of the trial in patients with multiple tumor types.

Key Points: 
  • The second poster focuses on preliminary biomarker data from part B of the trial in patients with multiple tumor types.
  • Data presented continues to support proof of concept for SRK-181 in 28 heavily pretreated patients with ccRCC resistant to anti-PD-1.
  • In the biomarker analysis for ccRCC, levels of circulating granulocytic myeloid-derived suppressor cells (gMDSC) correlated with clinical activity in ccRCC patients treated with SRK-181 in combination with pembrolizumab.
  • “The DRAGON trial has successfully delivered on its objective of demonstrating proof of concept for SRK-181 by showing promising anti-tumor activity.

Scholar Rock to Present Clinical and Biomarker Data from the Phase 1 DRAGON Trial at the SITC 38th Annual Meeting

Retrieved on: 
Thursday, October 19, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Patient, FRCP, Poster, MPH, Publication, Society for Immunotherapy of Cancer, Associate professor, Safety, Doctor of Philosophy, MBBS, Rock, Immunotherapy, SITC, DRAGON, San Diego Convention Center, Abstract, Annual general meeting, University, Part, Society, Therapy, Pharmaceutical industry, Nightclub

Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, announced today that it will present data from DRAGON, a Phase 1 study of SRK-181 in patients with advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego on November 1-5.

Key Points: 
  • Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, announced today that it will present data from DRAGON, a Phase 1 study of SRK-181 in patients with advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego on November 1-5.
  • In one poster presentation, Scholar Rock will share preliminary biomarker data from Part B of the trial, and in a second poster presentation, provide safety, efficacy, and biomarker results of SRK-181 in anti-PD-1 resistant metastatic clear cell renal cell carcinoma (ccRCC) patients from both Parts A and B.
  • “We are excited to present clinical and biomarker updates on the DRAGON study, which build upon the safety and efficacy data to date in the ccRCC cohort of the trial and support our goal of establishing the proof of mechanism of SRK-181,” said Jay Backstrom, M.D., MPH, President and Chief Executive Officer of Scholar Rock.
  • “As a selective latent TGFβ1 inhibitor, SRK-181 has the potential to transform cancer immunotherapy by helping to overcome resistance to checkpoint inhibitor therapy.

Scholar Rock to Present Data from the Phase 1 DRAGON trial at the SITC 37th Annual Meeting

Retrieved on: 
Thursday, October 6, 2022
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The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing.

Key Points: 
  • The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing.
  • Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path.
  • For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn ( https://www.linkedin.com/company/scholar-rock/ ).
  • Scholar Rock is a registered trademark of Scholar Rock, Inc.

Scholar Rock to Present at Upcoming ACCP Annual Meeting and World CB & CDx Summit

Retrieved on: 
Friday, September 16, 2022
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Specifically, the ACCP presentation will include new pharmacokinetic data from the Phase 1 dose escalation study (DRAGON Part A).

Key Points: 
  • Specifically, the ACCP presentation will include new pharmacokinetic data from the Phase 1 dose escalation study (DRAGON Part A).
  • SRK-181 is a selective inhibitor of TGF1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies.
  • Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path.
  • Scholar Rock is a registered trademark of Scholar Rock, Inc.

Scholar Rock to Present Biomarker Strategy for SRK-181 at the TGFβ for Immuno-Oncology Drug Development Summit

Retrieved on: 
Tuesday, January 25, 2022
Oncology, Health, Clinical Trials, Research, Science, Biotechnology, COVID-19, SITC, Gongshi, Fibrosis, Biomarker, U.S. Securities and Exchange Commission, Rock, Patient, Private Securities Litigation Reform Act, Clinical and Translational Science, Risk, FDA, IO, Annual general meeting, Toxic epidermal necrolysis, Proceedings of the Institution of Mechanical Engineers, Part B, PD, Intellectual property, Cancer, Immunotherapy, Neoplasm, Growth, Adult, DRAGON, Program, NASDAQ, Pharmacokinetics, LinkedIn, Clinical trial, Company, Investor, Antibody, Society for Immunotherapy of Cancer, Human, Neuromuscular Disorders, Safety, Disease, Security (finance), Pharmaceutical industry, SRK-181, Scholar Rock, SRK-181, SCHOLAR ROCK

The presentation, led by Si Tuen Lee-Hoeflich, Director, Translational Sciences at Scholar Rock, will discuss the SRK-181 biomarker strategy in relation to the DRAGON Phase 1 proof-of-concept trial (NCT04291079).

Key Points: 
  • The presentation, led by Si Tuen Lee-Hoeflich, Director, Translational Sciences at Scholar Rock, will discuss the SRK-181 biomarker strategy in relation to the DRAGON Phase 1 proof-of-concept trial (NCT04291079).
  • We are excited to be presenting at the TGF for Immuno-Oncology Drug Development Summit on our biomarker strategy for SRK-181 in support of DRAGON, said Gregory Carven, Ph.D., Chief Scientific Officer.
  • Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path.
  • Scholar Rock is a registered trademark of Scholar Rock, Inc.

 Scholar Rock Announces Issuance of U.S. Patent Protecting SRK-181, an Inhibitor of TGFβ1 Activation

Retrieved on: 
Tuesday, September 28, 2021
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This US patent includes composition-of-matter claims, providing product protection for SRK-181, a selective inhibitor of TGF1 activation that avoids binding to latent TGF2, latent TGF3, or any of the three active TGF growth factors.

Key Points: 
  • This US patent includes composition-of-matter claims, providing product protection for SRK-181, a selective inhibitor of TGF1 activation that avoids binding to latent TGF2, latent TGF3, or any of the three active TGF growth factors.
  • SRK-181 is a selective inhibitor of TGF1 activation and is an investigational product candidate being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies.
  • Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path.
  • Scholar Rock is a registered trademark of Scholar Rock, Inc.

Scholar Rock to Present Trials in Progress Poster for SRK-181 DRAGON Phase 1 Clinical Trial at the American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Endoglin, Signal transduction, SRK-181, Scholar Rock, SRK-181, SCHOLAR ROCK

TGF\xce\xb21 is the predominant TGF\xce\xb2 isoform expressed in many human tumor types.

Key Points: 
  • TGF\xce\xb21 is the predominant TGF\xce\xb2 isoform expressed in many human tumor types.
  • The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing.
  • Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path.
  • Any forward-looking statements represent Scholar Rock\xe2\x80\x99s views only as of today and should not be relied upon as representing its views as of any subsequent date.

Scholar Rock Announces Publication of Preclinical Pharmacology, Pharmacokinetics, and Safety Profile of SRK-181 in the International Journal of Toxicology

Retrieved on: 
Monday, March 22, 2021
Research, Infectious diseases, FDA, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Drug discovery, Pharmaceutical industry, Life sciences, Preclinical development, Pharmacology, Natural sciences, Biotechnology, the Preclinical Data, SRK-181, Scholar Rock

This publication provides a comprehensive preclinical assessment of the pharmacology, pharmacokinetics, and safety of SRK-181, which support its evaluation in the DRAGON Phase 1 trial, said Gregory Carven, Ph.D., Chief Scientific Officer of Scholar Rock.

Key Points: 
  • This publication provides a comprehensive preclinical assessment of the pharmacology, pharmacokinetics, and safety of SRK-181, which support its evaluation in the DRAGON Phase 1 trial, said Gregory Carven, Ph.D., Chief Scientific Officer of Scholar Rock.
  • Examples of dose-limiting toxicities observed nonclinically for nonselective anti-TGF therapies include cardiovascular abnormalities, skin lesions, epithelial oral hyperplasia, and gingival bleeding.
  • Based on preclinical evaluations of SRK-181s pharmacologic and safety profiles across multiple animal species, SRK-181 may offer an improved safety profile and a wider therapeutic window than non-selective TGF inhibitors.
  • The International Journal of Toxicology publication, Nonclinical Development of SRK-181: An Anti-latent TGF1 Monoclonal Antibody for the Treatment of Locally Advanced or Metastatic Solid Tumors, provides a comprehensive preclinical assessment of the pharmacology, pharmacokinetics, and safety of SRK-181.

Scholar Rock Presents Preclinical Data for SRK-181 at the TGFβ for Immuno-Oncology Drug Development Summit

Retrieved on: 
Wednesday, January 27, 2021
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Scholar Rock will also be participating in a panel discussion titled Debating the Best Approach to Target TGF- on January 27th, 2021 at 10:45 am EST.

Key Points: 
  • Scholar Rock will also be participating in a panel discussion titled Debating the Best Approach to Target TGF- on January 27th, 2021 at 10:45 am EST.
  • TGF1 is the predominant TGF isoform expressed in many human tumors, particularly for those tumors where checkpoint therapies are currently approved.
  • Scholar Rock believes SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy.
  • Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path.

Scholar Rock Announces First Patient Dosed in Part A2 of DRAGON Phase 1 Proof-of-Concept Trial of SRK-181 to Overcome Primary Resistance to Anti-PD-(L)1 Therapy

Retrieved on: 
Wednesday, September 9, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, SRK-181, Scholar Rock

Part A1 of the DRAGON trial has successfully progressed dose escalation of SRK-181 monotherapy through 800 mg and continues to advance dose escalation.

Key Points: 
  • Part A1 of the DRAGON trial has successfully progressed dose escalation of SRK-181 monotherapy through 800 mg and continues to advance dose escalation.
  • It is our belief that SRK-181 could help overcome this immune exclusion and has the potential to increase the therapeutic benefit of this class of drugs.
  • The Part A dose escalation portion of the trial is evaluating SRK-181 as both a single agent (Part A1) and in combination with approved anti-PD-(L)1 therapy (Part A2).
  • Scholar Rock believes SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy.