Day: October 15, 2023

Zeno interim clinical data continues to show robust efficacy in NRG1+ NSCLC and PDAC: Sufficient clinical data expected in 1H24 to support potential BLA submissionsPetosemtamab 2L+ HNSCC phase 3 trial design supported by INTERLINK-1 control arm Clinical data update on petosemtamab monotherapy in 2L+ HNSCC planned 2024 MCLA-129 abstracts accepted at ESMO Asia Investor call on Monday, October 16 at 7:30 a.m. ETUTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 15, 2023 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that it will host a conference call to discuss a business update on Monday, October 16, 2023 at 7:30 a.m. ET. Zenocutuzumab (Zeno or MCLA-128:...

GUANGZHOU, China, Oct. 15, 2023 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA. OverC™ MCDBT is intended for early detection of multiple cancer types in adults of either sex, aged 50-75 years old, at average risk for cancer. OverC™ MCDBT demonstrated a 69.1% of sensitivity and 98.9% of specificity...

NEW HAVEN, Conn., Oct. 15, 2023 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced it will present updated Phase 1/2 trial data for bavdegalutamide (ARV-110) at the 2023 European Society for Medical Oncology (ESMO) Annual Congress. Bavdegalutamide is an investigational orally bioavailable PROTAC® androgen receptor (AR) degrader and is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). This update will be presented during a poster session at the annual congress being held from October 20-24, 2023, in Madrid, Spain. Poster session details are as follows: Date: Sunday, October 22, 2023Time: 12:00 – 1:00 p.m. CEST / 6:00 – 7:00 a.m. EDTPresentation Number:...

NEW HAVEN, Conn. and NEW YORK, Oct. 15, 2023 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced they will present updated Phase 1/2 data for vepdegestrant (ARV-471) at the 2023 European Society for Medical Oncology (ESMO) Annual Congress. Vepdegestrant is a novel oral PROTAC® estrogen receptor (ER) degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. This update will be presented during a poster session at the annual congress being held from October 20-24, 2023, in Madrid, Spain. Poster session details are as follows: Date: Saturday, October 21, 2023Time: 12:00 – 1:00 p.m. CEST / 6:00 – 7:00 a.m. EDTPresentation Number:...

Event-free survival of investigational use of Libtayo® (cemiplimab) in neoadjuvant cutaneous squamous cell carcinoma (CSCC) from Phase 2 trial to be featured in oral presentation First data for the investigational combination of Libtayo and ubamatamab (MUC16xCD3) in recurrent ovarian cancer also to be presented Additional presentations on outcomes of Libtayo-based therapy in advanced non-small cell lung cancer, including PD-L1 expression and histology specific subgroups TARRYTOWN, N.Y., Oct. 15, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the latest clinical data in early- and late-stage cancers from its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 from October 20 to 24 in Madrid, Spain. The presentations demonstrate the role of...

MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for Hidradenitis Suppurativa (HS)Maintenance treatment with sonelokimab dosed every 4 weeks (Q4W), demonstrated that 57% of patients achieved HiSCR75 at week 24, increasing the landmark week 12 responses (primary endpoint) by over 10 ppt (percentage points) The depth of responses continued to increase from week 12 to week 24 across several scores, including over 14 ppt increases in HiSCR90 and IHS4-90 (to approximately 40% of patients) – 1 in every 4 patients reached inflammatory remission with IHS4-100, reflecting 100% reduction in abscesses, nodules and draining tunnels Rates of complete resolution of inflammatory nodules and abscesses (AN 100)...