FDA clamps partial hold on Phase III trial of BioNTech & OncoC4's NSCLC therapy [Yahoo! Finance]
Xilio Therapeutics, Inc. (XLO)
Company Research
Source: Yahoo! Finance
the registrational Phase III PRESERVE-003 trial of BioNTech and OncoC4's gotistobart. The study was placed on partial hold after the therapy showed “varying results between the squamous and non-squamous non-small cell lung cancer (NSCLC) patient populations”, as per an SEC filing by BioNTech. The companies have also “proactively” paused the enrolment of new patients and have informed the US regulator “of the possible variance for further alignment.” The companies were adamant that clinical hold does not affect other gotistobart trials, including a Phase II trial (NCT05446298) in ovarian cancer indication, a Phase I/II trial (NCT05682443) in prostate cancer and a Phase I/II trial (NCT04140526) of gotistobart and MSD's Keytruda (pembrolizumab) in advanced solid tumours. Additionally, whilst the companies are not enrolling new patients in the Phase III PRESERVE-003 study , the ones that have already enrolled in the trial will continue to receive treatment. The trial was expected to
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XLO
News
- Xilio Therapeutics to Present Initial Phase 2 Data for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI [Yahoo! Finance]Yahoo! Finance
- Xilio Therapeutics to Present Initial Phase 2 Data for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI GlobeNewswire
- Xilio Therapeutics Appoints Caroline Hensley as Chief Legal Officer [Yahoo! Finance]Yahoo! Finance
- Xilio Therapeutics Appoints Caroline Hensley as Chief Legal OfficerGlobeNewswire
- After Golden Cross, Xilio Therapeutics, Inc. (XLO)'s Technical Outlook is Bright [Yahoo! Finance]Yahoo! Finance
XLO
Sec Filings
- 12/19/24 - Form 4
- 12/19/24 - Form SCHEDULE
- 12/19/24 - Form 8-K
- XLO's page on the SEC website