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, Inc. (NASDAQ: XLO) had its price target lowered by analysts at Raymond James from $6.00 to $4.00. They now have an "outperform" rating on the stock.MarketBeat
- Xilio Therapeutics Announces Initial Clinical Trial Data from Phase 1C Dose Escalation for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Advanced Solid TumorsGlobeNewswire
- Xilio Therapeutics Announces Pipeline and Business Updates and Third Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Xilio Therapeutics Announces Pipeline and Business Updates and Third Quarter 2024 Financial ResultsGlobeNewswire
- Xilio Therapeutics to Present Initial Phase 1C Dose Escalation Data for XTX101 (Vilastobart) in Combination with Atezolizumab in a Late-Breaker Poster at the Society for Immunotherapy of Cancer (SITC) 39th Annual MeetingGlobeNewswire
XLO
Sec Filings
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- 11/12/24 - Form SC
- XLO's page on the SEC website