Ralf Huss

#ICYMI Our CEO Sarah Howell, and Thomas Pieber from the Medical University of Graz, Austria, and Principal Investigator for the AT278 Phase I clinical trial in Type 2 diabetics with a high BMI, hosted a webinar last week to discuss the recent positive headline clinical results for AT278, our ultra-concentrated, ultra-rapid acting insulin candidate. Sarah and Thomas highlighted the significance of our latest clinical results, with AT278 demonstrating a fast and superior onset of action and glucose lowering profile, and explored the potential of the only concentrated, yet very rapid acting, insulin in development, to enable the next generation of miniaturised, longer-wear insulin pumps – ultimately reducing the burden for patients and transforming future diabetes management. To watch the full recording, click here: https://lnkd.in/eczwHZet #Arecor #insulinPumps #diabetes #biotech #drugDevelopment #webinar #KOL

25

1 Kommentar

🌟Exciting News in Breast Cancer Diagnostics! 🌟 We are thrilled to announce the latest update to the German Uniform Evaluation Standard (EBM) catalogue for the third quarter of 2024, which includes the introduction of a groundbreaking new code, 19466. This code represents a significant advancement in the fight against breast cancer. Code 19466 allows for the targeted determination of ESR1 mutations using circulating tumour #DNA. This test is crucial for postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. It provides a targeted treatment pathway for those whose disease has progressed after at least one line of endocrine therapy, including a CDK 4/6 inhibitor. 🧬 Why is this important? This new code covers the detection of activating mutations E380Q, L536H, Y537C/N/S, and D538G, along with up to four additional activating mutations in the ligand binding domain using PCR-based methods. This precision in detecting mutations ensures that patients receive the most effective, tailored treatment possible, enhancing their chances of positive outcomes. 💰 Tariff and Billing: The tariff for this test is set at €250.61 and can be billed twice if the disease persists. This makes the test not only a scientific breakthrough but also a financially viable option for ongoing patient management. 🔬 Manufactured by: This innovative diagnostic test is developed by QuantideX qPCR ESR1 Mutation Kita leader in precision medicine and diagnostic solutions. Their commitment to advancing healthcare and improving patient outcomes is evident in the introduction of this essential diagnostic tool. By integrating Code 19466 into the #EBM catalogue, Germany is taking a decisive step towards enhancing personalised medicine and providing hope to many battling #breastcancer. This development underscores the importance of continued investment in medical research and the swift adaptation of new technologies into clinical practice. #BreastCancerAwareness #MedicalInnovation #Healthcare #Diagnostics #PrecisionMedicine #Oncology #EBMUpdate #Germany #CancerTreatment #PersonalizedMedicine #HealthcareInnovation www.asuragen.com

7

📢 Pentixapharm AG Acquires Target Discovery Business of Glycotope GmbH, effective July 1st.  This strategic acquisition of the Berlin-based biotech company marks a significant milestone in their mission to develop novel targeted radiopharmaceuticals against a broad range of malignancies. 🌟 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗔𝗰𝗾𝘂𝗶𝘀𝗶𝘁𝗶𝗼𝗻: • 𝗖𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗣𝗼𝗿𝘁𝗳𝗼𝗹𝗶𝗼: The deal includes a portfolio of 𝗽𝗿𝗲𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗮𝗻𝘁𝗶𝗯𝗼𝗱𝗶𝗲𝘀 against multiple oncology targets, 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀, cell banks, a 𝘁𝘂𝗺𝗼𝗿 𝘁𝗮𝗿𝗴𝗲𝘁 𝗱𝗮𝘁𝗮𝗯𝗮𝘀𝗲, and essential equipment.    • 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗜𝗻𝘁𝗲𝗹𝗹𝗲𝗰𝘁𝘂𝗮𝗹 𝗣𝗿𝗼𝗽𝗲𝗿𝘁𝘆: This acquisition broadens the 𝗜𝗣 𝗽𝗼𝗿𝘁𝗳𝗼𝗹𝗶𝗼 beyond the CXCR4 receptor, 𝗱𝗼𝘂𝗯𝗹𝗶𝗻𝗴 the 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗽𝗶𝗽𝗲𝗹𝗶𝗻𝗲 and expanding business and clinical opportunities.    • 𝗘𝘅𝗽𝗲𝗿𝘁 𝗧𝗲𝗮𝗺: Pentixapharm welcomes an 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗲𝗱 𝘁𝗲𝗮𝗺 𝗼𝗳 𝟰𝟬 seasoned executives, R&D specialists, and administrators from Glycotope.    • 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽 𝗘𝘅𝗽𝗮𝗻𝘀𝗶𝗼𝗻: Patrik Kehler, former CSO of Glycotope, will join as Pentixapharm's 𝗖𝗦𝗢, and Henner Kollenberg, former CEO of Glycotope, will become the 𝗖𝗵𝗶𝗲𝗳 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗢𝗳𝗳𝗶𝗰𝗲𝗿.    💬 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗿𝗼𝗺 𝗣𝗲𝗻𝘁𝗶𝘅𝗮𝗽𝗵𝗮𝗿𝗺'𝘀 𝗟𝗲𝗮𝗱𝗲𝗿𝘀: “Glycotope’s pipeline comprises 𝘀𝗲𝘃𝗲𝗿𝗮𝗹 𝗰𝗮𝗻𝗱𝗶𝗱𝗮𝘁𝗲𝘀 that can be 𝘂𝘀𝗲𝗱 𝗶𝗺𝗺𝗲𝗱𝗶𝗮𝘁𝗲𝗹𝘆 for 𝗽𝗿𝗼𝗼𝗳-𝗼𝗳-𝗰𝗼𝗻𝗰𝗲𝗽𝘁 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 as next generation radiopharmaceuticals,” said Dr. Hakim Bouterfa, CEO of Pentixapharm AG. “We look forward to 𝗺𝗮𝘅𝗶𝗺𝗶𝘇𝗶𝗻𝗴 𝘁𝗵𝗲 𝘀𝘆𝗻𝗲𝗿𝗴𝘆 of Pentixapharm’s know-how and Glycotope’s target discovery for the 𝗯𝗲𝗻𝗲𝗳𝗶𝘁 𝗼𝗳 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 in both diagnostics and therapeutic applications.” “The transaction 𝘀𝘁𝗿𝗲𝗻𝗴𝘁𝗵𝗲𝗻𝘀 our 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗽𝗶𝗽𝗲𝗹𝗶𝗻𝗲 and administrative capacities, facilitating a 𝘀𝗲𝗮𝗺𝗹𝗲𝘀𝘀 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 to the 𝗙𝗿𝗮𝗻𝗸𝗳𝘂𝗿𝘁 𝗦𝘁𝗼𝗰𝗸 𝗘𝘅𝗰𝗵𝗮𝗻𝗴𝗲,” noted 𝗗𝗿. 𝗔𝗻𝗱𝗿𝗲𝗮𝘀 𝗘𝗰𝗸𝗲𝗿𝘁, Chairman of the Supervisory Board of both Pentixapharm and Eckert & Ziegler SE. This acquisition positions Pentixapharm to develop 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗿𝗮𝗱𝗶𝗼𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹𝘀 by leveraging Glycotope’s 𝘂𝗻𝗶𝗾𝘂𝗲 𝗚𝗹𝘆𝗰𝗼𝗧𝗮𝗿𝗴𝗲𝘁𝘀—tumor-associated 𝗰𝗮𝗿𝗯𝗼𝗵𝘆𝗱𝗿𝗮𝘁𝗲 𝘀𝘁𝗿𝘂𝗰𝘁𝘂𝗿𝗲𝘀 with 𝘀𝘂𝗽𝗲𝗿𝗶𝗼𝗿 𝘁𝘂𝗺𝗼𝗿-𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗶𝘁𝘆. These advancements have the potential to close the treatment gap for many solid tumors, enhancing both diagnostic and therapeutic applications. 🔗 Learn More: https://lnkd.in/eCXh35Nw #NuclearMedicine #Radiopharmaceuticals #Acquisition #PrecisionMedicine  

106

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

1

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

1

👉 Although an #RCT was submitted for #Abecma, no additional benefit was granted by the German #HTA body.   Abecma (active substance: idecabtagene vicleucel) is a #CAR-T cell therapy and authorized for treatment of patients with multiple myeloma. Initially, Abecma was authorized for treatment after at least 3 prior therapies in August 2021, after extension of indication in March 2024, Abecma can also be used after only 2 prior therapies. Initial marketing authorization is based on the single-arm study KarMMa, the extension of indication is based on the #RCT KarMMa-3, comparing Abecma to “investigator´s choice”. 🔎 Of note: KarMMa-3 is one of the first multi-comparator RCTs for CAR-T cell therapies in multiple myeloma. Abecma is available in Germany   🏆German HTA rating: To date Abecma was assessed in 2️⃣  German HTAs. First HTA rating from June 2022 resulted in a hint for a non-quantifiable additional benefit, only because of the orphan drug status of Abecma.   In June 2023 Abecma exceeded annual sales of € 30 million and reassessment started in March 2024 (📍 see previous post on #orphan drug reassessment). In the same month Abecma was granted the extension of indication. The according HTA started in April 2024. As this HTA covers also patients with 3 prior therapies, the HTA from March 2024 was suspended.    Reassessment and simultaneous assessment of the new indication was based on the RCT KarMMa-3, comparing Abecma versus “investigator´s choice. The HTA rating from September 2024 resulted in no additional benefit, because Abecma did not show significant advantages in overall survival.   💵 Launch price: € 350,000. Abecma is used as a one-time treatment. Reimbursement price: € 240,000 (so far one price reduction, price negotiation after the latest HTA is not completed, yet). Current rebate: 31 %. An arbitration award for Abecma determined the retroactive effect of the reimbursement price and an extended refund period.   📘 Special features of reimbursement: Abecma is reimbursed. Like other CAR-T cell therapies, Abecma is reimbursed via #NUB fees in hospitals, which meet all requirements of the #ATMP Quality Assurance Guideline.   💡 Orphan drug reassessment usually yields the risk of no additional benefit, due to the lack of comparative data. For Abecma direct comparative data was indeed submitted. However, there was no advantage in overall survival and therefore no additional benefit was granted.

4

Our colleague, Christian Reinhard, is attending this year's #Digestive #Disease #Week® (#DDW2024) together with our US sister company BUHLMANN Diagnostics Corp. He is presenting the latest research from BÜHLMANN Laboratories AG at this important event for  #gastroenterology experts. Join us for insightful discussions! #DDW #DDW2023 #DigestiveDiseaseWeek #gastroenterology #medicalconference #healthcare #medicine #research #immunology

46

🧐 Beyond the Average Patient: Integrating Population Diversity to Revolutionize Liver Safety in Drug Development at #IHICallDays Our Head of External Collaborations and Co-founder, Dr. Wolfgang Moritz will attend the Brokerage event for Innovative Health Initiative (IHI)’s 2025 calls from November 12 to 14 in Brussels, where he will present InSphero’s innovative approach to enhance population diversity in #preclinical research. 🔬 By using human liver microtissues from a wide range of human donors—including varying ages, sexes, races, and liver health profiles—we’re addressing gaps in #drugsafety that can lead to unexpected #livertoxicity in diverse populations. 🚀 Our approach involves testing compounds known to cause drug-induced liver injury (#DILI), applying pathology and biomarker profiling, and even developing an #AI-assisted DILI prediction scoring tool to identify high-risk profiles early. 🤩 Aligned with #IHICallDays, this initiative not only promotes patient safety but aims to create safer, more effective therapies across diverse populations. Excited to lead this next chapter in patient-centered drug development! 📅 Would you like to learn more and join our initiative? Register for the event via the link in comments 👇 Jan Lichtenberg Madhu Lal Nag, MBS PhD Paul Edgard Clémençon Arumugham (Ragoo) Raghunathan Arnab China, Ph.D. Bärbel Ulmer Christine Schwenk Sue Grepper, PhD Tina Žel Rositsa Hadzhipetrova

15

3 Kommentare

We're making strong progress! The Freiburg prospective trial is crucial for setting a gold standard for FDA submission. It provides a powerful case for the treatment process when paired with retrospective data from Markus Notter’s 2020 paper (as presented in the September 21 graphical results). The Freiburg trial focuses on key metrics and endpoints outlined in the graphic. Marianne Sarcich #BreastCancerAwareness, #BreastCancerResearch, #BreastCancerTreatment, #ClinicalTrials, #CancerCare, #BreastCancerSupport, #BreastCancerMonth, #CancerInnovation, #PatientCare, #MedicalAdvancements, #OncologyResearch, #FightingCancer, #BreastCancerHope, #BreastCancerWarriors, #BreastCancerSolutions, #LocallyRecurrentBreastCancer, #RecurrentBreastCancer, #LymphangiosisCarcinomatosa, #CancerSpread, #InflammatoryBreastCancer, #IBCawareness, #TripleNegativeBreastCancer, #TNBC, #InvasiveDuctalCarcinoma, #IDCawareness, #InvasiveLobularCarcinoma, #ILCawareness

3

⏰#timeisrunning 📣The countdown for #HUPO2024 just started! Will we see you in Dresden two weeks? ➡️ Check all details here: https://2024.hupo.org/ #HUPO2024 #Proteomics #humanproteomics #clinicalproteomics #Microbiome #cellbiology #Bioinformatics #science

5

At #ESMOBreast24, we are happy to share our #LUZERNtrial The study focuses on ER+/HER2-, locally advanced, or metastatic breast cancer patients who harbor either germline BRCA (gBRCA) mutations or wild-type BRCA with homologous recombination deficiency (HRD). Patients were treated with Niraparib (PARP inhibitor) in combination with aromatase inhibitors to evaluate the efficacy and safety of this strategy (The LUZERN Strategy). 220-P <<Niraparib Plus Aromatase Inhibitors for Luminallike(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)>> Presented by Daniel Alcalá López PhD. Download the poster here: https://lnkd.in/dSRSfcMR #ESMObreast24

82

1 Kommentar

🎗 𝗕𝗶𝗼𝗡𝗧𝗲𝗰𝗵'𝘀 𝗛𝟭 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗠𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲𝘀 📣 We are advancing our oncology pipeline with mRNA as the centerpiece of our toolbox. In the first half of 2024, we presented encouraging data from our investigational mRNA-based cancer therapies, including BNT111 and BNT122. Additionally, we have progressed the development of immunomodulatory candidates, such as BNT327, which we believe are well-suited for combination therapies. We have continued to execute our combination therapy strategy by successfully initiating a trial evaluating the antibody candidate BNT327 in combination with the investigational ADC BNT325. 🌟🧬 More news from H1/2024 in our PR (incl. forward-looking statements): https://lnkd.in/edJXDHc9 #BioNTech #mRNA #CancerTherapy #Oncology

1.141

21 Kommentare

Quantro and Boehringer Ingelheim Hit Milestone in #Cancer Treatment Development QUANTRO Therapeutics GmbH, which focuses on transcription factors targeting cancer treatments, announced that it has reached a key milestone in its joint R&D program with Boehringer Ingelheim. In successfully applying Quantro’s proprietary Quantroseq Transcriptional Fingerprint technology, all pre-set goals for technical proof-of-concept, cross-validation of HTS #screening technology, and identification of high-quality hits for a previously undruggable transcription factor were fully accomplished. Cancer, a leading global cause of death, often has limited treatment options. Transcription factors, key gene expression regulators often disrupted in cancer, are promising therapeutic targets. Despite being hard to target with drugs, the 2022 joint R&D program aims to develop innovative, first-in-class cancer treatments targeting these factors. Read more on #CMI online: https://lnkd.in/eVKrqmhv

1

🎉Congratulations to Charline Sommer & Maximilian Schinke – both were awarded the Young Scientist Travel Award #YSTA at the #EUSAAT Congress last week🎉. 🏆Maximilian received the award for his presentation titled 'Generation of Human Sensory Macrophages to Replace Animal Research in Preclinical Pharmacology and Drug Safety Applications' – a very exciting and new topic for us at Fraunhofer ITEM: 💡The use of innovative macrophages derived from induced pluripotent stem cells (#iPSC) represents a promising approach to evaluate new therapeutic strategies and conduct a comprehensive #safetyassessment of parenteral drugs. Particularly regarding this safety assessment, we could provide a promising alternative that significantly advances the Monocyte Activation Test (#MAT), making the use of rabbits or horseshoe crabs in the field of parenteral drugs unnecessary. 🏆Charline was awarded for the abstract of her poster, developed in the context of the imSAVAR project, on 'Immune-related adverse outcome pathways' (irAOPs), and this is what it was about: 💡 Immune therapies are promising but are associated with side effects – often with unresolved pathophysiological mechanisms. The #irAOP concept helps to focus on key cells and molecules inducing the adverse effects and uncovers knowledge gaps in the immunological cascade. This allows targeted generation of experiments to fill gaps and verify the irAOPs, supporting safe application of #immunetherapies. #verywelldeserved

156

7 Kommentare

+++ 𝗤𝟭 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝟮𝟬𝟮𝟰 𝗮𝗻𝗱 𝗰𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗲 𝘂𝗽𝗱𝗮𝘁𝗲 +++ We started the year with good progress across our oncology pipeline and our commercialization activities. Some key events: 🔬 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆: We and our collaboration partner Duality Biologics dosed the first patient in a Phase 3 clinical trial with our #ADC candidate BNT323/DB-1303 in breast cancer patients, advancing towards BioNTech’s goal of ten or more potentially registrational trials running by the end of 2024. 🩹 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵: We are focusing on preparing for variant-strain adaptation of our COVID-19 vaccine to be ready for a commercial launch ahead of the upcoming 2024/2025 vaccination season, pending approvals. 🌎 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀: We appointed our General Manager Fatma Ocak for the U.S. in line with our commercial preparations to drive our first expected global #oncology product launch. 𝗟𝗶𝗻𝗸 𝘁𝗼 𝗣𝗥 𝗮𝗻𝗱 𝗳𝗼𝗿𝘄𝗮𝗿𝗱-𝗹𝗼𝗼𝗸𝗶𝗻𝗴 𝘀𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁𝘀: https://lnkd.in/ePDQiHbH  

550

2 Kommentare

Next month, our own Philipp Pauli, Country Head Germany, will host the Big Data in Oncology panel discussion during the BioTechX EU conference on October 9th in Basel, Switzerland. Want to hear Philipp’s thoughts on big data and the latest in multiomic data management and personalized therapies ahead of the conference? Read his interview here: https://lnkd.in/e6CUHjeZ #BioTechX #BigDataInOncology

138

1 Kommentar

BioNTech SE has reported promising outcomes from the ongoing Phase 2 clinical trial of its #mRNA-based #immunotherapy, #BNT111, for advanced #melanoma. The randomized trial evaluates the clinical activity and safety of BNT111 in combination with #cemiplimab, and assesses the two agents separately. This breakthrough targets patients unresponsive to standard therapies, leveraging novel mRNA and lipoplex technologies. https://lnkd.in/dKkyk7i9

1

On this World Lung Day, we would like to emphasize the importance of Krebs von den Lungen-6 (#KL-6) as a key biomarker for interstitial pneumonia. KL-6, a high molecular weight glycoprotein, is a reliable serum biomarker for interstitial lung diseases (ILD). It plays a key role in diagnosis, monitoring disease activity, evaluating treatment response, and predicting clinical outcomes. Due to the complexity of ILD, patients are frequently misdiagnosed, which could lead to delays in appropriate management #WorldLungDay #Lung #laboratory #laboratoryequipment #diagnosis

37