I-SPY 2.2 is working. Why aren’t others replicating the design?
PRODUCT DEVELOPMENT | REPRINT FROM OCT. 04, 2024 BY LAUREN MARTZ, EXECUTIVE DIRECTOR, BIOPHARMA INTELLIGENCE The I-SPY clinical trials are creating a roadmap for a new clinical research vision that cuts inefficiencies, puts patients first, and defines a viable pathway for precision-based drug development. The question now is whether others will replicate the approach outside […]
Quantum Leap Healthcare Collaborative Initiates Landmark Phase 2 RECAST DCIS Platform Trial to Evaluate Alternative DCIS Treatments with Atossa Therapeutics, Havah Therapeutics, and the Menarini Group
40-site U.S. trial enrolling more than 300 patients could significantly change the way DCIS is treated and reduce possibly unnecessary surgery
Arvinas and Quantum Leap Healthcare Announce Clinical Study to Evaluate Vepdegestrant (ARV-471) in I-SPY-2 Endocrine Optimization Platform (EOP) Clinical Trial
Quantum Leap Healthcare Collaborative™ today announced that Arvinas’ vepdegestrant (ARV-471), a novel PROTAC® estrogen receptor (ER) protein degrader being co-developed with Pfizer Inc. will be evaluated in the ongoing I-SPY TRIAL endocrine program sponsored by Quantum Leap.
Exai Bio and Quantum Leap Healthcare Collaborative Announce Expanded Participation in I-SPY 2 Trial to Advance Exai’s Novel RNA-based Liquid Biopsy Platform in Breast Cancer
Exai Bio today announced a collaboration agreement with Quantum Leap Healthcare Collaborative™ (QLHC) to expand the use of Exai’s novel, RNA-based liquid biopsy platform to monitor patients’ treatment response and disease burden in the I-SPY 2 TRIAL. I-SPY2 is the largest and longest-running ‘platform’ trial that provides a regulatory framework to study multiple novel therapeutic treatment arms for women with newly diagnosed, locally advanced breast cancer.
Atossa Therapeutics and Quantum Leap Healthcare Announce New Study Arm to Evaluate (Z)-Endoxifen in the Ongoing I-SPY 2 Clinical Trial
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology, and Quantum Leap Healthcare Collaborative™ today announce that Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM),(Z)-endoxifen, will be evaluated in a new study arm of the ongoing I-SPY 2clinical trial.
ALX Oncology and Quantum Leap Healthcare CollaborativeTM Announce First Patient Dosed in the I-SPY-P1 TRIAL in Breast Cancer
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative (“Quantum Leap”) today announced that the first patient has been dosed in the I-SPY-P1-TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.
Sermonix Pharmaceuticals and Quantum Leap Healthcare Announce New Study Arm to Evaluate Lasofoxifene in Ongoing I-SPY 2 Clinical Trial
Sermonix Pharmaceuticals Inc. and Quantum Leap Healthcare Collaborative™ today announced that Sermonix’s investigational next-generation targeted endocrine therapy, lasofoxifene, will be evaluated in a new study arm of the ongoing I-SPY endocrine program sponsored by Quantum Leap.
Delphi Diagnostics™ Inc and Quantum Leap Healthcare Collaborative™ Announce the Inclusion of Delphi’s Proprietary Test, SET2,3™, into the Adaptive Randomization Process for the Ongoing I-SPY 2 TRIAL™
Delphi Diagnostics, Inc and Quantum Leap Healthcare Collaborative™(QLHC) announce the inclusion of Delphi’s SET2,3™ test for use in the I-SPY 2 TRIAL for patients with locally advanced breast cancer. The SET2,3™ test helps to determine which patients with HR+ tumors will benefit from endocrine therapy.
ALX Oncology and Quantum Leap Healthcare Collaborative™ Announce the Selection of Evorpacept in the I-SPY-P1 TRIAL in Combination with Enhertu® in Breast Cancer
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative™ (“Quantum Leap”) today announced that ALX Oncology’s next generation CD47 blocker, evorpacept, has been selected for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.
UCSF and I-SPY 2 Breast Cancer Researchers Develop Newly Redefined Breast Cancer Response Subtypes
Research scientists and statisticians from UC San Francisco have developed improved biomarker classifications as part of their research results in the I-SPY 2 trial for high-risk breast cancer patients. The new cancer response subtypes reflect responsiveness to drug treatments and are intended to help clinicians be more precise in how they target therapies.
