Industry News

Element Biosciences and Jumpcode Genomics Partner to Validate Jumpcode’s CRISPRclean® Technology on Element’s AVITI™ System for a Broad Set of Genomic Applications

03/07/2022

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, today announced a collaboration and co-marketing partnership with Jumpcode Genomics that validates Jumpcode’s CRISPRclean technology on Element’s AVITI System. The partnership has already demonstrated the value of pairing the technologies, promising improved data quality and cost…

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Regulus Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of Lademirsen for Alport Syndrome

03/07/2022

–Final data and potential for $25m milestone anticipated in H1 2023– Excerpt from the Press Release: SAN DIEGO, Feb. 24, 2022 /PRNewswire/ — Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the “Company” or “Regulus”), today announced the completion of enrollment in the Phase 2 HERA clinical study…

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Vaxcyte Doses First Participants in Phase 1/2 Clinical Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

03/03/2022

— Company Expects to Announce Topline Results from the Phase 1/2 Study by the End of 2022 — — Proof-of-Concept Study Will Evaluate the Safety, Tolerability and Immunogenicity of VAX-24 — — VAX-24 is a 24-Valent Pneumococcal Conjugate Vaccine Designed to Deliver Broad-Spectrum Protection — Excerpt from the Press Release: SAN CARLOS, Calif., Feb. 23, 2022…

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Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma

03/02/2022

Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma If approved by the European Medicines Agency, KIMMTRAK will be the first and only treatment option approved in Europe to treat patients with unresectable or metastatic uveal melanoma KIMMTRAK demonstrated statistically and clinically meaningful overall survival (OS) benefit, hazard ratio of 0.51, with median OS of almost 22 months Excerpt from the…

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Merlin Test reduces unnecessary surgeries and associated complications for melanoma patients

03/01/2022

Excerpt from the Press Release: ROTTERDAM, Netherlands and SAN DIEGO, Feb. 24, 2022 /PRNewswire/ — Today, SkylineDx announced that their Merlin Test for melanoma patients would have been able to reduce over 59% of surgery-related complications by means of deselecting patients for surgery [2]. The commercially available Merlin Test identifies melanoma patients that can safely forgo a sentinel lymph node…

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EPIC SCIENCES AND FULGENT GENETICS COLLABORATE TO DELIVER DefineMBC™ RESULTS FOR METASTATIC BREAST CANCER PATIENTS

03/01/2022

Epic Sciences scales its workflow for ctDNA testing with Next Generation Sequencing Leader Fulgent Fulgent Genetics’ expertise in high-volume testing powers Epic’s Comprehensive Cancer Profiling Excerpt from the Press Release: SAN DIEGO, Feb. 24, 2022 /PRNewswire/ –Epic Sciences, Inc. today announced it has partnered with Fulgent Genetics (NASDAQ:FLGT) to deliver DefineMBC comprehensive profiling results for metastatic breast…

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Pliant Therapeutics Announces Positive DSMB Safety Review and Commencement of Enrollment of Phase 2a Trial of PLN-74809 at 320 mg Dose in Idiopathic Pulmonary Fibrosis

03/01/2022

Recent independent Data Safety Monitoring Board (DSMB) review recommended the INTEGRIS-IPF Phase 2a trial continue without modification and proceed to evaluate dosing at 320mg Trial initiation follows the FDA authorization of evaluation of long-term dosing of PLN-74809 at doses up to 320 mg in IPF patients Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Feb.…

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Long-Term Follow-Up Data Reinforce Continued Overall Survival Benefit of BAVENCIO® (avelumab) First-Line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma

02/28/2022

38-month median follow-up data from the Phase III JAVELIN Bladder 100 trial demonstrated prolonged median OS of 23.8 months with BAVENCIO plus best supportive care (BSC) in the first-line maintenance setting versus a median OS of 15.0 months with BSC alone BAVENCIO continues to be the first and only immunotherapy to improve survival in the…

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Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

02/25/2022

OVATION 2 Study is Over 75% Enrolled; Full Enrollment Expected by Mid-2022 Novel Gene-Mediated Immunotherapy is Safe and Demonstrates an Acceptable Risk/Benefit When Administered Over a Six-Month Period Excerpt from the Press Release: LAWRENCEVILLE, N.J., Feb. 17, 2022 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that following a pre-planned interim safety review of 81 as treated patients…

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PureTech Founded Entity Akili Announces PLOS ONE Publication of Clinical Study Results and EEG Data Showing Akili Digital Therapeutic EndeavorRx® Activates Systems in Brain Key to Attentional Functioning

02/25/2022

Electroencephalography data (EEG) demonstrate enhancement of brain activity specific to attention function in children 8-12 with ADHD following AKL-T01 (EndeavorRx) treatment Data show correlation between targeted activity in the brain and objective improvements in attention function Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics…

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