Day: June 2, 2024
— 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...
Telix Completes TLX250-CDx (Zircaix™) BLA Submission for Kidney Cancer Imaging
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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...
Preliminary Analysis of Data Evaluating Investigational Epcoritamab (DuoBody® CD3xCD20) Combination Demonstrates 95% Overall Response Rate in Patients with Previously Untreated Follicular Lymphoma
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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...
Merus Presents Interim Data on MCLA-145 Monotherapy and in Combination with Pembrolizumab at the 2024 ASCO® Annual Meeting
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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...
Seer Technology Access Center Provides Unprecedented Scale and Depth of Coverage for PrognomiQ’s Early Cancer Detection Study
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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,...
ALX Oncology Presents First Evorpacept Combination Data with an Antibody-Drug Conjugate from Phase 1 ASPEN-07 Clinical Trial in Patients with Advanced Bladder Cancer
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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...
Nanobiotix Announces New Data Showing Disease Control and Tumor Response in Patients Treated With RT-Activated NBTXR3 Followed By anti-PD-1 For 2l+ R/M HNSCC Naïve or Resistant to Prior anti-PD-1 Therapy
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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,...
Celldex Therapeutics Presents Data Demonstrating Profound Improvements in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2024
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– 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...
NVIDIA Enables Real-Time Healthcare, Industrial and Scientific AI Applications at the Edge With Enterprise Software Support for NVIDIA IGX With Holoscan
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Medtronic, SETI Institute, Manufacturing Leaders and More Build NVIDIA IGX Systems to Supercharge AI at the Industrial EdgeNVIDIA IGX with HoloscanNVIDIA IGX with Holoscan used in medical, industrial robotics and scientific computing applications.TAIPEI, Taiwan, June 02, 2024 (GLOBE NEWSWIRE) — COMPUTEX — To address the increasing need for real-time AI computing at the industrial edge, NVIDIA today announced the general software availability of NVIDIA AI Enterprise-IGX with NVIDIA Holoscan on the NVIDIA IGX™ platform. Together, they empower solution providers within the medical, industrial and scientific computing sectors to develop and deploy edge AI solutions faster, with enterprise-grade software and support.
NVIDIA AI Enterprise-IGX is a new offering providing enterprises with unprecedented performance,...
NVIDIA Robotics Adopted by Industry Leaders for Development of Tens of Millions of AI-Powered Autonomous Machines
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BYD Electronics, Siemens, Teradyne Robotics and Intrinsic, an Alphabet Company, Using NVIDIA Isaac Robotics Platform for Autonomous Robot Arms, Humanoids, Mobile RobotsNVIDIA Isaac robotics platformThe NVIDIA Isaac robotics platform powers electronics, healthcare and industrial applications. Credit: Virtual Incision (center), Amazon Robotics (right)TAIPEI, Taiwan, June 02, 2024 (GLOBE NEWSWIRE) — COMPUTEX — NVIDIA today announced that the world’s leaders in robot development are adopting the NVIDIA Isaac™ robotics platform for the research, development and production of the next generation of AI-enabled autonomous machines and robots.
BYD Electronics, Siemens, Teradyne Robotics and Intrinsic, an Alphabet company, are among more than a dozen robotics industry leaders globally that are integrating NVIDIA Isaac...