Michael Ports

<!-- Content start --> South San Francisco, CA — July 3, 2024 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (nSq NSCLC), did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes Phase II and Phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting. “These results are disappointing as it was our hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are thankful to all of the patients and healthcare professionals involved in the study, and we will leverage the learnings to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.” Ongoing Phase III studies are investigating treatment settings and indications distinct from SKYSCRAPER-06. Based on today’s results, we will evaluate any relevant changes needed to the ongoing tiragolumab program. About SKYSCRAPER-06 study SKYSCRAPER-06 is a global Phase II/III, randomized, placebo-controlled and double-blinded study evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy as an initial (first-line) treatment versus pembrolizumab and chemotherapy in 542 people with non-squamous non-small cell lung cancer. Primary endpoints are overall survival (OS) and progression-free survival (PFS). About tiragolumab Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq® (atezolizumab). The TIGIT pathway is distinct but

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Watch an #agingshort #video about this #research paper: "Cell type-dependent modulation of senescence features using Weo electrolyzed water." Weo Sutter Health https://lnkd.in/e6AGTvng #aging #trendingwithimpact #senescence #cells #openaccess #openscience #publishing #trending #meded

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🌟 Best of #ASMS2024 🌟 Fintiede Solutions is thrilled to share the groundbreaking advancements unveiled by Evosep at the #ASMS2024 conference in Anaheim! Evosep continues to push the boundaries in the field of proteomics, introducing innovations that are set to transform research and clinical diagnostics. 🔬 Key Innovations Announced: Fully Automated Workflows: - Capable of processing over 500 plasma samples per day. - Maximizes efficiency and minimizes manual intervention. - Ideal for accelerating drug discovery and supporting large-scale translational research. - Reduces cost per sample and environmental impact. Whisper™ Zoom Methods: - Enhances scalability and sensitivity for detailed and accurate proteomic analyses. - Unlocks the ability to detect low-abundant proteins and identify novel biomarkers. - Facilitates deeper biological insights into disease pathways. Evosep Biolabs: Center of Excellence for High Throughput Proteomics: - Specializes in high-throughput proteomics with automated sample preparation. - Offers access to state-of-the-art LC-MS/MS workflows and expert assay development. - Provides scalable capacity for outsourcing proteomics research projects. 🏆 Impact and Vision: Evosep's innovations are designed to make clinical proteomics 100x more robust and 10x faster, revolutionizing the landscape of proteomics research. These advancements are particularly aimed at accelerating drug discovery and enhancing proteomics-based diagnostics, ultimately improving patient care. We are proud to be part of this journey and look forward to the incredible breakthroughs these technologies will enable in the near future. #Evosep #Proteomics #ASMS2024 #ScientificInnovation #DrugDiscovery #TranslationalResearch #Biomarkers #ClinicalDiagnostics #automation #whisper

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In the Quantitative Biosciences Institute, UCSF Coronavirus Research Group (QCRG), Nevan Krogan, PhD, built a transdisciplinary, multi-lab, multi-institutional, multi-national, multi-sector open-science consortium in which over a thousand trainees and senior investigators worked together—overcoming virtually every barrier that fragments science and the science community. Read more about the challenges academic research faces when it comes to breaking down silos, and about how facilitating collaboration is the solution, in this Q&A with the UCSF SCHOOL OF MEDICINE Department of Cellular and Molecular Pharmacology faculty member. https://lnkd.in/gg4D39FB

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Scientists from the UC San Diego have taken a novel approach to #nanoparticle drug delivery to the lungs. Lung metastasis poses a formidable challenge in the realm of cancer treatment, with conventional chemotherapy often falling short due to limited targeting and low accumulation in the lungs. In this article, researches take a microrobot approach using motile algae for localized delivery of drug-loaded nanoparticles to address lung metastasis challenges. The biohybrid microrobot [denoted “algae-NP(DOX)-robot”] combines green microalgae with red blood cell membrane–coated nanoparticles containing doxorubicin, a representative chemotherapeutic drug. Microalgae provide autonomous propulsion in the lungs, leveraging controlled drug release and enhanced drug dispersion to exert antimetastatic effects. Upon intratracheal administration, algae-NP(DOX)-robots efficiently transport their drug payload deep into the lungs while maintaining continuous motility. This strategy leads to rapid drug distribution, improved tissue accumulation, and prolonged retention compared to passive drug-loaded nanoparticles and free drug controls. In a melanoma lung metastasis model, algae-NP(DOX)-robots exhibit substantial improvement in therapeutic efficacy, reducing metastatic burden and extending survival compared to control groups. Be sure to not that this was performed through intratracheal administration, opposed to nebulized delivery. https://lnkd.in/gESp_6DZ #microbots #LNP #PNP #DDS #CRS #CRS2024 #precisionmedicine #innovation #drugdevelopment #cancer #cancerresearch #chemotherapy

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📚 Publication Alert: Nanovials used to optimize cell therapies! In a recent Nature Communications publication, researchers at UCLA used Nanovials to identify and isolate high EV secreting stem cells and used them as a therapeutic in mice, demonstrating improved tissue regeneration post-cardiac injury. Key Takeaways from the publication: 📌 EVs play an important role in cell-to-cell communication 💬, including tissue regeneration 📌 Traditional methods, which study EV-secreting cells in bulk, often mask this heterogeneity and typically destroy the cells, making it difficult to optimize EV therapeutics 📌 Nanovials were used to analyze and sort single cells based on EV secretion levels—cells are kept alive during this process 📌 Imaging cytometry 📸 using the Cytek Biosciences Amnis Imagestream helps distinguish different Nanovial populations 📌 Mice treated with high EV secreting populations isolated using Nanovials show increased tissue recovery after myocardial injury 🐭 🚀 Nanovials can facilitate the optimization of other EV therapies! Read the press release here: https://lnkd.in/gvf8U7ZW Read the publication here: https://lnkd.in/gGt2FTNP #CellTherapy #ExtracellularVesicles #Nanovials #Therapeutics

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Ever wonder why some CAR-T cell therapies show better efficacy than others? This week's #RayBioRead is a groundbreaking study published in @Nature focused on the role of tonic signaling in CAR-T cell function. The research, led by Chen, J., Qiu, S., Li, W. et al, identifies positively charged patches (PCPs) on CARs as drivers behind spontaneous CAR activation. By manipulating these PCPs, researchers were able to fine-tune CAR-T cell behavior, enhancing effectiveness and reducing exhaustion. This discovery opens doors for next-gen CAR-T designs. Learn more: https://lnkd.in/gxRguPwx Featured RayBiotech Product: https://lnkd.in/e7NdF3-H

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Cambridge genomics company Broken String Biosciences has teamed up with The Francis Crick Institute for a key project targeting a progressive and debilitating neurodegenerative disease. https://lnkd.in/dX7DzxiM In partnership with leading researchers at the Crick, the project aims to develop novel applications for Broken String’s proprietary DNA break-mapping platform, INDUCE-seq™, beyond its established capabilities in gene-editing. The research will be focused on leveraging the technology to investigate the impact of genomic instability in the development of amyotrophic lateral sclerosis (ALS). ALS is a progressive and debilitating neurodegenerative disease, causing gradual loss of the ability to control voluntary movements and basic bodily functions. The collaboration is focused on understanding the contribution of genome stability to ALS, combining the interests of Simon Boulton and Nishita Parnandi at the Crick focused on genome stability and DNA double-strand break (DSB), with Rickie Patani and Giulia Tyzack, interested in understanding the underlying mechanism of ALS disease mechanism. Recognising the utility of the novel INDUCE-seq platform developed by Broken String’s R & D team, led by Simon Reed, the Crick and Broken String teams aim to collaborate to demonstrate and further validate the INDUCE-seq technology in this setting. The partnership has been secured via the Francis Crick Institute’s Business Engagement Fund, an initiative supported by The Medical Research Council (MRC-UKRI), designed to encourage collaborations with SMEs and strengthen the Crick’s engagement with industry. Felix Dobbs, CEO, Broken String Biosciences, said: “This collaboration with the Crick Institute is validation of our differentiated approach to DNA break-mapping; enabling our team to support world-leading research with insights provided through our INDUCE-seq platform. “It demonstrates a fantastic opportunity to apply our expertise across other key research areas to support the advancement of human health. There is an unmet clinical need for effective ALS treatments as well as strategies for earlier diagnosis that can significantly improve patient outcomes.”

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Christian Ramirez Amarilla now at #BITS2024 about how inhibiting METTL3, an important RNA methyltransferase, affects RNA structure, adenosine-to-inosine (A-to-I) editing, and the immune response in leukemia models, providing new insights into potential therapeutic approaches for leukemia. #Bioinformatics #LeukemiaResearch #BITS2024

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Biocom California recently invited Sapient to contribute an article for its Lifelines Magazine edition focused on innovations in #genetherapy and #celltherapy. https://lnkd.in/gC9YfQnM While cell- and gene-based treatments are advancing rapidly, spurred by a landmark year of FDA approvals, their development is not without challenges. We discuss how #multiomics for gene and cell therapy can deliver the novel insights needed to realize the incredible therapeutic potential represented in these pipelines today: https://lnkd.in/gC9YfQnM

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NAMI Oregon is proud to join Neurocrine Biosciences in supporting #TDAwarenessWeek, running from May 5-11. Tardive Dyskinesia (TD) is a condition characterized by persistent, involuntary movements affecting various parts of the body, such as the face, torso, limbs, and fingers or toes. These movements can vary from rapid and jerky to slow and writhing, significantly impacting those affected by TD. TD is often associated with prolonged use of antipsychotic medication, which may be necessary to treat mental illnesses like major depressive disorder and bipolar disorder. Approximately 600,000 Americans live with TD, and around 65% of them are undiagnosed. Let's raise awareness together and support those living with TD during #TDAwarenessWeek. Learn more at https://lnkd.in/g-atBE4x or www.TalkAboutTD.com.

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More than a dozen posters and podium talks were presented at the latest #AUA2024 meeting discussing the power of Veracyte, Inc.'s Decipher Prostate and Bladder tests, as well as our and Decipher GRID (Genomics Resource for Intelligent Discovery) transcriptomic database. Among these was a study discussing that patients with low and intermediate risk #ProstateCancer (GGG 1-3 on initial biopsy), the Decipher Score is a predictor of clinically significant upgrading (i.e, increase in GGG) on final radical prostatectomy pathology. Click the link below to read an overview of this presentation: https://lnkd.in/gRvB8GHv

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Part 2 of a two-part post: Advanced Therapies! We recently sat down with Head of Advanced Therapies, Kevin Hennegan, to discuss Quantum's advanced therapies support for Sponsors. Check out Kevin's responses below: 3.    What are some keys to building a successful engagement with a regulatory advisor in the Advanced Therapy space? Start by assessing whether the individual or group you are considering is a good fit with your existing team. Arrange for introductory or interview calls between the candidate and the members of your team who will be working with them directly. This shouldn’t be as involved as the interview process for an FTE role, but it may be in the same ballpark. You want to find someone who is a good fit with your company culture and the individual personalities within your team. You should also evaluate the individual’s depth of experience, but don’t be too quick to dismiss someone who doesn’t fit perfectly within your company’s niche specialty. In my experience, a broad background within the product’s therapeutic class has been more important than a precise match with a specific clinical indication. Finally, work to incorporate your advisor as an integral part of your development team. Sure, a regulatory strategist can write a memo or risk assessment for you, then ride off into the sunset until the next time you call, but they will be more effective, and you will reap greater benefits, if they are aware of and engaged in updates on the development process as they happen. 4.     Why did you decide to bring your skill sets to Quantum? I have known and worked with two of Quantum’s founders for many years now (and am really enjoying getting to know the third). Because of that shared history, I knew the kind of environment they would build within their new company, I knew the caliber of experts they would bring to the table to support product development, and most importantly for me, I knew that we had a uniquely complementary and synergistic fit of personalities, skill sets, and knowledge bases. So, when they offered me the chance to head up their Advanced Therapies practice, I jumped at it. I find the Cell & Gene Therapy space incredibly interesting and exciting. I am thrilled to be a part of the team here!

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Weekly Tech+Bio Highlights: • Building Foundation Models for Cancer Biology: NOETIK is developing self-supervised world models that learn cancer biology from primary data to discover new therapeutic insights, co-founded by Ron Alfa, MD, PhD. • Meet nach0: a New General Purpose LLM for Chemical and Biomedical Applications: Insilico Medicine and NVIDIA introduced nach0, a large language model for biological and chemical tasks, detailed in the Chemical Science Journal. Alex Zhavoronkov, CEO of Insilico Medicine, highlights the model's capabilities in integrating diverse datasets for biological and chemical applications. • Owkin, co-founded by Thomas Clozel Unveils AI-Driven Oncology and Immunology Pipeline: Owkin has unveiled an AI-driven pipeline, featuring OKN4395, a dual EP2/4 antagonist, set for Phase 1 trials in 2025. • Novel Cell Analytics Technology: Cytomos will present its advanced cell analytics technology, Celledonia™, at ISCT 2024, enhancing cell and gene therapy processes. • Quantum Computing in Biopharma: - Key companies and initiatives; - Quantum advantage in biopharma; - Challenges and future outlook. • New Discovery Potentially to Re-write Biology Textbooks: Researchers have discovered a unique bacterial enzyme that creates new genes by reading RNA templates and converting them into DNA, challenging the traditional understanding of genetic information flow. For a more detailed overview and more, check out the full article: https://lnkd.in/dxPJ5MCe

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