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.
Quantum Leap Healthcare Collaborative Announce Termination of the Cyproheptadine Treatment Arm for Critically Ill COVID-19 Patients in the I-SPY COVID Trial

Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, announced that the cyproheptadine arm of the study has been terminated.
Cyproheptadine is most commonly used to alleviate allergies, headaches, and motion sickness, which was thought to improve hypoxia and clinical outcomes in patients with COVID-19.
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.
I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Reports Assessment of Narsoplimab for Treatment of Critically Ill Patients With COVID-19

Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, and Omeros Corporation (NASDAQ: OMER), developer of the investigational agent narsoplimab, announced that enrollment has been closed and data have been analyzed in the narsoplimab arm of the I-SPY COVID Trial.
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.
Quantum Leap Healthcare Collaborative Announces Termination of the Cyclosporine Treatment Arm for Critically Ill COVID-19 Patients in the I-SPY COVID Trial

Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, announces that the cyclosporine arm of the study has been terminated for futility. Cyclosporine, a calcineurin inhibitor and a well-known and commonly prescribed immunosuppressant medication, is best known for its efficacy in the prevention of solid organ transplant rejection.
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.
NEJM Authors’ Perspective cites FDA collaboration with OneSource in discussion about Real World Evidence
More than 5 years after the passage of the 21st Century Cures Act of 2016, the terms “real-world data” (RWD) and “real-world evidence” (RWE) are being used inconsistently and sometimes interchangeably. This imprecision has complicated efforts to assess the impact of such data and evidence and hindered attempts to track their use.
Quantum Leap Healthcare Collaborative™ Announces OneSource as a Grand Prize Winner in the 2022 Bio-IT World Innovative Practices Awards

Quantum Leap Healthcare Collaborative™ (QLHC) announces the award of OneSource, Quantum Leap Healthcare Collaborative’s groundbreaking clinical trial data management solution developed in collaboration with OpenClinica as the grand prize winner at the 2022 Bio-IT World Innovative Practices award in the Clinical & Health-IT category. By integrating clinical trial data systems directly with existing electronic health records, OneSource achieves new levels of efficiency and quality control for clinical trial data management.