Month: June 2024

Updated subgroup efficacy and quality of life data were also presented on June 1 at ASCO 2024 HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 03, 2024 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that results from FRUTIGA, HUTCHMED’s Phase III trial of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer in China, were published in Nature Medicine. Updated efficacy data in key subgroups and data on quality of life (QoL) within this publication were also presented on June 1 at the American Society of Clinical Oncology (“ASCO”) 2024 Annual Meeting. Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFRs”) 1, 2 and 3. It works as an anti-cancer therapy by blocking tumor angiogenesis,...

NEW YORK, June 02, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), Chief Executive Silviu Itescu provided a corporate update at the Bell Potter Emerging Leaders Conference. Dr. Itescu reiterated that the Company expects to file this quarter the Biologics License Application (BLA) resubmission with the United States Food and Drug Administration (FDA) for its lead product candidate Ryoncil®(remestemcel-L) in the treatment of steroid-refractory acute graft versus host disease, with potential approval in the second half of CY2024. Dr. Itescu additionally highlighted the heart failure and back pain programs in Phase 3, and the recent feedback from FDA regarding an accelerated approval pathway for the heart failure product Revascor® (rexlemestrocel). The presentation also highlighted Mesoblast’s strong United States...

— CB-010 allogeneic CAR-T cell therapy with partial HLA matching has potential to rival efficacy and safety profile of approved autologous CAR-T cell therapies — — 14.4 months median PFS in ANTLER patients with partial HLA matching (≥4 alleles) — — Plan to enroll ~20 additional 2L LBCL patients in ANTLER to confirm that partial HLA matching improves patient outcomes; initial data expected in H1 2025 — — Caribou expects to initiate a pivotal trial for CB-010 in H2 2025, upon confirmation of improved outcomes in partially HLA matched cohort — — Off-the-shelf CB-010 is partially HLA matched to patient within current screening timelines — — KOL webcast discussion of data from 46 ANTLER patients scheduled for today at 7:00 pm CDT — BERKELEY, Calif., June 02, 2024 (GLOBE...

MELBOURNE, Australia, June 03, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has completed the submission of a Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational radiodiagnostic PET1 agent, TLX250-CDx (Zircaix™2, 89Zr-DFO-girentuximab), for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC). The rolling BLA submission, initiated in December 20233 with timelines pre-agreed with the FDA, was based on Telix’s successful global Phase III ZIRCON4 study in ccRCC. The clear cell variant of renal cancer is the most common and aggressive sub-type of kidney cancer. The ZIRCON study met all co-primary and secondary endpoints, demonstrating a sensitivity of 86%, specificity...

Media Release COPENHAGEN, Denmark; June 2, 2024Preliminary analysis of data from the EPCORE™ NHL-2 study demonstrates patients with previously untreated follicular lymphoma (FL) who received epcoritamab in combination with rituximab-lenalidomide (R2) experienced a 95% overall response rate (ORR) Results from the optimization cohort of the EPCORE™ NHL- 1 study show that mitigation strategies led to a clinically significant reduction in rate of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in patients with relapsed/refractory (R/R) FL treated with epcoritamabGenmab A/S (Nasdaq: GMAB) today announced new efficacy and safety data from two ongoing Phase 1/2 clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in adult...

UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 02, 2024 (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 updated interim clinical data on MCLA-145 monotherapy and in combination with pembrolizumab were presented at the 2024 American Society of Clinical Oncology® (ASCO®) Annual Meeting taking place in Chicago May 31-June 4, 2024. “MCLA-145 as monotherapy or with pembrolizumab appears to have a manageable safety profile and early clinical activity in these difficult to treat cancers. Our biomarker data suggest that both dose and less frequent administration may be important determinants of clinical activity, and we are encouraged by the progress we are making...

Combined Workflow of Proteograph™ XT Assay and Thermo Scientific™ Orbitrap™ Astral™ Mass Spectrometer Robustly Identifies over 13,000 Protein Groups Across a Study of 2,840 Subjects REDWOOD CITY, Calif., June 02, 2024 (GLOBE NEWSWIRE) — Seer, Inc. (Nasdaq: SEER), a leading life sciences company commercializing a disruptive new platform for proteomics, announced today that PrognomiQ has completed the largest and deepest unbiased mass spectrometry plasma biomarker study to date utilizing the Seer Proteograph™ Product Suite and Thermo Fisher Scientific’s Thermo Scientific™ Orbitrap™ Astral™ mass spectrometer. This pioneering research involved a multi-cancer case-control cohort of 2,840 subjects, achieving the detection of over 13,000 protein groups in plasma across the study,...

Evorpacept in combination with PADCEV®, an approved antibody-drug conjugate (“ADC”), demonstrated promising activity and was generally well tolerated Company to host conference call and webcast with Samuel A. Funt, M.D., of Memorial Sloan Kettering Cancer Center on Friday, June 7, 2024, at 1:00 PM ETSOUTH SAN FRANCISCO, Calif., June 02, 2024 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today presented data from its Phase 1 ASPEN-07 clinical trial in a poster presentation (abstract #4575) at the 2024 American Society of Cancer Oncology (“ASCO”) Annual Meeting being held in Chicago from May 31-June 4, 2024. These findings represent the first evorpacept combination data with an ADC from...

Figure 1Best Change in All Target Lesions Diameter Sum from BaselineFigure 2Best Change in All Target Lesions Diameter Sum from BaselineData show favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; “ITT”) who received RT-activated NBTXR3 followed by anti-PD-1 as a second-or-later line treatment 48% ORR in evaluable anti-PD-1 naïve patients (n=25); 28% ORR in evaluable anti-PD-1 resistant patients (n=25) as per RECIST 1.1 76% DCR in evaluable naïve patients; 68% DCR in evaluable resistant patients as per RECIST 1.1 Preliminary review of survival data in ITT anti-PD-1 naïve patients (n=33) showed mPFS of 7.3 months and mOS of 26.2 months ITT anti-PD-1 resistant patients (n=35) showed mPFS of 4.2 months and mOS of 7.8 months Following the ASCO presentation,...

– Clinically meaningful and statistically significant improvements across multiple angioedema measurements and barzolvolimab dose groups –– Sustained activity with rapid onset within 2 weeks –– Data further support barzolvolimab clinical benefit to patients with CSU – HAMPTON, N.J., June 02, 2024 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data demonstrating that barzolvolimab profoundly improves angioedema at 12 weeks in the Company’s Phase 2 clinical trial in chronic spontaneous urticaria (CSU). Angioedema, characterized by swelling of the deeper dermal layers of the skin and mucous membranes, is a painful, debilitating symptom of CSU that has significant impact on quality of life. It commonly affects the face (lips and eyelids), hands, feet, and genitalia but...