Torsten Hoffmann

Xiaorong He on Boehringer Ingelheim’s Investments in AI, Broader Applications in Pharma - Genetic Engineering & Biotechnology News: Xiaorong He on Boehringer Ingelheim’s Investments in AI, Broader Applications in Pharma  Genetic Engineering & Biotechnology News http://dlvr.it/TGNBqr #ai #artificialintelligence

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📑 Sifting through lengthy research papers and articles can slow down discovery. Open Targets now uses LLM-powered summaries to tackle this challenge—helping researchers quickly uncover key insights about drug targets and therapeutic opportunities. Discover how this feature accelerates your research! ⚡https://lnkd.in/eY7pSfAH #OpenTargets #DrugDiscovery #BiomedicalResearch #LLMs #LifeSciences #AIPowered #ScientificInnovation

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The synergy between technological innovation and regulatory advancement. At the 15th Annual Drug Discovery Innovation Forum in Berlin Sept. 4-5, Karen Sayal - MD PhD consultant clinical oncologist and industry-first scientist in AI-driven Clinical Translation and Clinical Development at Recursion - will give a talk on the synergistic advancement of AI-enabled drug discovery and regulation. She'll discuss: ◾ How industrialising drug development is unveiling hidden biological complexities to propel a paradigm shift in treating human disease. ◾ How technology-driven discovery is synergistic to the needs of our evolving next-generation regulatory ecosystem. ◾ And how we can achieve seamless interoperability between the needs of developing and deploying AI technologies and the needs of regulation through pragmatic bipartisan dialogue and coordinated evolution. Learn more & register: https://lnkd.in/d8EFpTuh #ai #ddif #ddif2024 #drugdiscovery #innovation #tech #techbio #regulation

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Malte Lenders and colleagues conclude that the pharmacokinetic profile of pegunigalsidase alfa depends on the presence of neutralizing anti-AGAL antibodies, which result in reduced plasma half-life and peak enzyme activity after infusion. #pegunigalsidase #FabryDisease #Pharmacokinetics #openaccess https://lnkd.in/gt8CCkFS

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Mainz Biomed NV (NASDAQ: MYNZ), a molecular genetics diagnostic company, is making strides with its flagship product, ColoAlert®, an early detection screening test for colorectal cancer. The company has reported significant clinical successes in U.S. and European trials, with ColoAlert demonstrating sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas. These positive results have positioned Mainz Biomed for upcoming FDA clinical trials in 2025, a crucial step towards entering the U.S. market and unlocking a major revenue growth opportunity. The company has also seen increased demand for its enhanced ColoAlert product, launched in July, with existing and prospective laboratory partners transitioning to the new version. This enhancement simplifies workflow and reduces retest rates, contributing to a 26% reduction in net loss for the first half of 2024 compared to the previous year. Mainz Biomed's efforts have garnered support from brand ambassadors like Petra Smeltzer Starke, a former White House advisor, and Frankie Muniz, an actor and NASCAR driver. Muniz has highlighted the importance of early detection, especially among young people, where colorectal cancer cases have surged 500% in the past twenty-two years. Beyond ColoAlert, Mainz Biomed has a robust pipeline, including PancAlert, a next-generation detection test for pancreatic cancer developed in collaboration with Liquid Biosciences. Mainz Biomed #coloncancerawareness #earlydetection #healthtech

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Radioligand therapies (RLTs) allow for the targeted destruction of cancer cells by powerful alpha or beta particles. We review the historical use of radioisotopes in medicine, and the case study of Novartis' development of Pluvicto and Lutathera (which revived the space). We discuss technical considerations surrounding RLTs, such as choice of isotope, linker and targeting moiety, in addition to supply chain and manufacturing barriers. We also summarize recent private financings, pharma M&A and licensing deals, and close with a short investment thesis on the space. Kudos to Joseph Mekhael & Dennis Gong for creating this useful resource. #biomarker #biotech #radiopharm https://lnkd.in/ewYTB8yk

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Prognostic and predictive impact of sex in locally advanced Microsatellite instability (MSI) gastric or gastroesophageal junction cancer - Prof. Dr. Arndt Vogel https://lnkd.in/gbKFj5NB #oncodaily #oncology #cancer #gastriccancer #gastroesophagealjunction #microsatelliteinstability #clinicaltrials #chemotherapy #prognosis #predictivefactors #sexdifferences

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In a paper newly published in mAbs, Merck KGaA, Darmstadt, Germany authors and Technical University of Darmstadt's Harald Kolmar highlight their progress in developing anti-EGFR allosteric antibodies. From the abstract: In this work, we report the discovery of potent anti-epidermal growth factor receptor (EGFR) allosteric heavy-chain antibodies by combining camelid immunization and fluorescence-activated cell sorting (FACS). After immunization and yeast surface display library construction, allosteric clones were obtained by introducing the labeled EGF Fc fusion protein as an additional criterion for FACS. This sorting method enabled the identification of 11 heavy-chain antibodies that did not compete with the orthosteric ligand EGF for the binding to EGFR. These antibodies bind to a triple-negative breast cancer cell line expressing EGFR with affinities in the picomolar to nanomolar range. Those camelid-derived antibodies also exhibit interesting properties by modulating EGFR affinity for EGF. Moreover, they are also able to inhibit EGF-induced downstream signaling pathways. In particular, we identified one clone that is more potent than the approved blocking antibody cetuximab in inhibiting both PI3K/AKT and MAPK/ERK pathways. Our results suggest that allosteric antibodies may be potential new modalities for therapeutics. https://lnkd.in/e7hPXsBb

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CatalYm GmbH’s lead drug candidate, visugromab, a monoclonal antibody targeting the immunosuppressant GDF-15, has demonstrated promising results in a Phase 1/2a trial for various solid tumors. Published in •Nature•, the study unveiled visugromab’s capacity to trigger significant and enduring cancer remission, particularly when paired with the PD-1 inhibitor nivolumab, in patients battling late-stage cancers resistant to anti-PD-(L)1 therapies. This research underscores the potential of GDF-15 inhibition as an innovative strategy to combat immunotherapy resistance. The breakthrough presents a hopeful outlook for cancer therapy. Existing immunotherapies, though effective for some, often encounter obstacles due to resistance mechanisms developed by tumor cells. Visugromab's ability to combat GDF-15, a pivotal player in this resistance, offers a viable solution to amplify and diversify the effectiveness of current immunotherapies like nivolumab. The profound and lasting responses observed, including complete remissions, in patients with limited treatment alternatives emphasize the potential clinical significance of this approach. Moreover, the relief of cachexia, a debilitating syndrome associated with elevated GDF-15 levels, presents a potential enhancement in the quality of life for patients. The Nature publication provides a detailed analysis from the GDFATHER Phase 1/2a trial. Findings reveal that visugromab, in conjunction with nivolumab, yielded strong responses in patients with relapsed or refractory non-small cell lung cancer, urothelial cancer, and hepatocellular cancer. Over half of the responsive patients encountered more profound remissions compared to their initial checkpoint inhibitor therapy. The study also offers substantial translational research showcasing visugromab’s mode of action: it stimulates T-cell infiltration and proliferation within the tumor microenvironment and triggers an Interferon-γ signature, both independently and when combined with nivolumab. 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞 : https://lnkd.in/d-j6MqFs Petra Fettes Felix Lichtenegger

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🌐 In the rapidly evolving field of mRNA-based therapies, ensuring the quality and stability of therapeutic products is paramount. Here are some insights from a recent study on the use of ion-pair reversed-phase liquid chromatography (IP-RPLC) for characterizing modified mRNA. 𝐊𝐞𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬: • 𝑨𝒅𝒗𝒂𝒏𝒄𝒆𝒅 𝑴𝒆𝒕𝒉𝒐𝒅𝒐𝒍𝒐𝒈𝒚: The study develops a robust IP-RPLC method tailored for large RNA molecules, crucial for pharmaceutical quality control. • 𝑶𝒑𝒕𝒊𝒎𝒊𝒛𝒂𝒕𝒊𝒐𝒏 𝑰𝒏𝒔𝒊𝒈𝒉𝒕𝒔: Through meticulous parameter optimization, including column temperature and mobile phase flow rate, the method achieves high-resolution separation of RNA fragments up to 1000 nucleotides. • 𝑺𝒕𝒓𝒆𝒔𝒔 𝑻𝒆𝒔𝒕𝒊𝒏𝒈: This method excels in monitoring the degradation of mRNA under various stress conditions like heat, hydrolysis, and enzymatic breakdown, providing critical data on mRNA stability. 𝐈𝐦𝐩𝐚𝐜𝐭 𝐨𝐧 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: 🎯 𝑷𝒓𝒆𝒄𝒊𝒔𝒊𝒐𝒏: The ability to detect and quantify degradation products offers a precise assessment of the mRNA's stability. 🛡️ 𝑸𝒖𝒂𝒍𝒊𝒕𝒚 𝑪𝒐𝒏𝒕𝒓𝒐𝒍: With this method, researchers can better understand degradation pathways and optimize mRNA drug formulations. 🚀 𝑹𝒆𝒈𝒖𝒍𝒂𝒕𝒐𝒓𝒚 𝑪𝒐𝒎𝒑𝒍𝒊𝒂𝒏𝒄𝒆: The study aligns with regulatory guidelines for mRNA stability testing, aiding in the compliance and approval process for new mRNA therapies. 𝐋𝐨𝐨𝐤𝐢𝐧𝐠 𝐀𝐡𝐞𝐚𝐝: This breakthrough provides a scientific foundation that could enhance the development and stability testing of mRNA-based drug products. It's a step forward in ensuring that these innovative therapies are both effective and safe for patient use. 🔗 https://lnkd.in/g238gaEs #Pharmaceuticals #Biotechnology #mRNA #DrugDevelopment #QualityControl #Innovation

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BioNTech SE has unveiled promising data from its PD-L1xVEGF-A bispecific antibody, BNT327, suggesting it could outperform @Merck's Keytruda in treating triple-negative breast cancer (TNBC). In a phase 1b/2 trial, BNT327 achieved an 18-month overall survival (OS) rate of 69.7%, significantly higher than Keytruda's 47.8% in a comparable population. The study involved patients with advanced TNBC receiving BNT327 and chemotherapy, showing consistent OS rates over 12 to 18 months. These results, presented at the San Antonio Breast Cancer Symposium, strengthen BioNTech's case for the therapy ahead of a planned global phase 3 trial in 2025. https://lnkd.in/eX-hwYrD #BreastCancerResearch #ImmunotherapyInnovation #TripleNegativeBreastCancer #BioNTechAdvances #CancerTreatmentBreakthrough

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🚀🔬 Discover the potential of advanced analytical techniques! A recent study explores the use of 𝐂𝐲𝐜𝐥𝐢𝐜 𝐈𝐨𝐧 𝐌𝐨𝐛𝐢𝐥𝐢𝐭𝐲 𝐌𝐚𝐬𝐬 𝐒𝐩𝐞𝐜𝐭𝐫𝐨𝐦𝐞𝐭𝐫𝐲 (𝐜𝐲𝐜𝐥𝐢𝐜 𝐈𝐌𝐒) for separating and characterizing isomer impurities in therapeutic oligonucleotides. This approach can significantly enhance our understanding of these molecules, especially in the context of gene modulation therapies like antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs). By isolating impurities that might otherwise go undetected, cyclic IMS offers a deeper insight into the quality control of these cutting-edge therapeutics. 🎯 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞-𝐀𝐰𝐚𝐲𝐬: • Cyclic IMS effectively separates oligonucleotide isomers, including n−1 and abasic impurities, providing detailed structural information. 🧬 • The technique can distinguish between complex isomer profiles, aiding in the identification of potential toxicities associated with specific isomers. ⚗️ • It provides a complementary approach to traditional methods like LC/MS, enhancing the analytical toolkit for therapeutic oligonucleotide characterization. 🧪 #Oligonucleotides #CyclicIMS #MassSpectrometry #Biotechnology #Pharmaceuticals #QualityControl #GeneTherapy Shogo Omuro, Takao Yamaguchi, Taiji Kawase, Kenji Hirose, Tokuyuki Yoshida , Takao Inoue & Satoshi Obika Osaka University, Nihon Waters K.K., Waters Corporation

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Atossa Therapeutics Modifies Breast Cancer Trial with Increased (Z)-endoxifen Dose Atossa Therapeutics has adjusted its ongoing clinical trial by augmenting the dose of (Z)-endoxifen and blending it with Eli Lilly's abemaciclib to target ER+/HER2- breast cancer. This alteration is based on favorable results from the Phase II EVANGELINE study, demonstrating a significant reduction in the cellular proliferation marker Ki-67 and the size of tumors. The updated trial will encompass about 80 participants across two cohorts, covering both pre- and post-menopausal women. Notably, premenopausal women in the second cohort will also undergo ovarian function suppression to facilitate direct outcome comparisons. Atossa's CEO, Steven Quay, expressed enthusiasm concerning the protocol update and the backing from Eli Lilly, highlighting the positive safety profile and optimal drug concentrations achieved with the increased (Z)-endoxifen dosage. # Thank you Elena Barbosa for your submission!

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Mainz BioMed (@mainzbio), a biotech firm specializing in clinical laboratory tests, is making strides in early disease detection and prevention. According to Bill Caragol, the company's CFO, their genetic and genomic tests can reveal patients' unique genetic profiles, enabling doctors to tailor treatments more effectively and ushering in an era of personalized medicine. Caragol recently shared promising data from recent trials, highlighting the potential of their tests to detect cancer and chronic conditions at an early stage. Early detection is crucial, as it allows patients to receive timely treatment and improve their chances of survival. As diagnostic technology advances, Mainz BioMed aims to save lives and reduce healthcare costs through early disease identification. Their innovative approach could revolutionize how we approach cancer and chronic condition management. #biotechnology #cancerprevention #personalmedicine

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#RegenerativeMedicine landscape is rapidly evolving, with 2024 shaping up to be a pivotal year for cell therapy. While #oncology remains the primary clinical focus, there’s a new wave of interest in leveraging cell therapies to treat autoimmune diseases. 🔬 Pioneering research from the University Hospital Erlangen in 2023 showed that 15 patients with autoimmune disorders went into remission after receiving CAR-T cell therapy. Earlier studies by Mogrify demonstrated the potential of regulatory T-cells in suppressing the body’s immune response for therapeutic effects. Current clinical trials are expanding to target conditions like lupus, type 1 diabetes, myasthenia gravis, and multiple sclerosis—and this list is only expected to grow. 🔹Cas9 (Vertex Pharmaceuticals & CRISPR Therapeutics): Approved in the US and EU for sickle cell disease and beta-thalassemia. 🔹Lifileucel (Iovance Biotherapeutics, Inc.): Approved for metastatic melanoma, with further global expansion on the horizon. 🔹Libmeldy (Orchard Therapeutics - U.S.): Approved for US in March 2024, targeting metachromatic leukodystrophy. 🌍 Global Snapshot: North America leads with 1,184 developers and 978 clinical trials. Asia-Pacific and Europe are also seeing significant growth. With increased effectiveness in treating blood cancers, accelerated progress against solid tumors, and breakthroughs in autoimmune diseases, 2024 is set to revolutionize how we approach chronic treatments. Get in-depth data reports about Regenerative Medicine Markets here >>https://lnkd.in/dUnjrVhX #RegenerativeMedicine #CellTherapy #GeneTherapy #AutoimmuneDiseases #Biotech #ClinicalTrials #Innovation #HealthcareTransformation #dataINSIGHTS

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