Peter Mueller

Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results for CDI at Scientific Conference   • Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) • Results consistent with those shown in earlier human volunteer studies and Phase 2a studies • Preservation and increased concentrations of beneficial Firmicute (Bacilotta) phylum known to be involved in bile acid homeostasis and short chain fatty acid metabolism was demonstrated  • Actinobacteria and Bacteroides preservation also confirmed using quantitative analysis   https://lnkd.in/eseFt8GZ   #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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I am looking forward to moderating this cutting edge discussion with a panel of experts in the field of #AI in #medicalaffairs Luca Dezzani Herson Quiñones Sanjeev Welling Michael Vinegra #MASSEast #FierceMASS #MedicalAffairs #Technology #AI #GenerativeLangauge #FutureOfHealthcare #LifeSciences #Biotech #Pharma #FierceLifeSciences #WeAreFierce

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Biosimilars and the first MFP We will soon learn a lot about the effect on biosimilars from the transparent 2026 MFP re Stelara “Amgen will likely launch first on Jan. 1, 2025, while Samsung Bioepis, Sandoz, Fresenius Kabi (working with Formycon), and Biocon can launch their respective biosimilars in the US on Feb. 22. Reminder: Stelara had an estimated 25% absolute difference from net price for the MFP which is a larger gap than the first biosimilar (although we don't have much of a history for pharmacy brands). Source: Hernandez net price estimate Note J and J missed the MFP delay period for biosimilar entry (defined by time on market) by a whisker. #Stelara

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We started out Q1 with cautious optimism and the numbers continue to show the confidence was warranted. Biopharma M&A activity more than doubled nationally during the year’s first three months, coinciding with a rebound in venture capital deals as well as a flurry of IPOs. These are all good signs that the drug development cycle is normalizing and should translate into additional funding being available at the seed and Series A stages. Certain to be on the minds of funders and startups attending #AlignSummit24 on Thursday! https://lnkd.in/erEiJm6S  

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Please add CellReady™ to the CGT list. CellReady™ is the only CGT CDMO that is solely dedicated to G-Rex-centric manufacturing. We also believe that CellReady™ is the only CGT CDMO that has an ownership structure that is absent venture funding or any other form of ownership structure that imposes a need to generate significant financial profit. Why is this important? It frees CellReady™ to provide CGT entities what they need most and have least. TIME and MONEY How is that possible? CellReady™ is playing the Infinite Game and has a mindset of abundance. It is willing and able to run close to breakeven with minimal profit. No quarterly financial targets, no need to drive towards a lucrative financial exit, no need to do anything that makes its clients become viewed as a source of money. Where does this lead? CellReady™ is likely the only CDMO with the sole goal of openly sharing its operational and technical approaches to manufacturing efficiency with the entire field of CGT, including competitive CDMOs. By doing that, CellReady™ intends to revolutionize the business model of CGT by democratizing the information that sets it apart from others. That will help set the field free of the existing time and money trap which has caused investment to dry up. With a mindset of abundance, one initiative that CellReady™ is helping to fund is a $20 million G-Rex Grant Program available at ScaleReady which provides every recipient with up to $300,000 of free products and services to accelerate their clinical enabling manufacturing work or to make manufacturing advancements for programs that are already in the clinical. Please check it out.

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Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) to Discuss Second Quarter 2024 Financial Results on August 9, 2024 Conference Call and Provide Business Update   Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP), a clinical stage #biopharmaceutical company focused on developing new #antibiotics for difficult-to-treat #bacterial infections, has announced a conference call to discuss its second quarter 2024 financial results. The call is scheduled for August 9, 2024, at 8:00 am ET, before the U.S. financial markets open.   The company's President and CEO, David Luci, along with CFO Robert Shawah, will host the call to present the #financial results and provide a business update. #Investors and interested parties can join the call using the provided toll-free number for U.S. participants or international access numbers.   https://lnkd.in/esMuCywW #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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𝐁𝐢𝐨𝐭𝐞𝐜𝐡 𝐚𝐧𝐝 𝐏𝐡𝐚𝐫𝐦𝐚 𝐔𝐩𝐝𝐚𝐭𝐞𝐬: September 18 - 19, 2024 • GC Therapeutics launches with $75M to revolutionize cell therapy • Roche’s positive antiviral Ph3 data • Tanai Therapeutics’ obesity endeavours further fuelled by Novo Nordisk • Upstream Bio files for IPO • Basilea Pharmaceutica extends BARDA partnership • Vanda Pharmaceuticals' gastroparesis small molecule rejected by FDA • Biotech small-cap market goes “meh” on US Fed rate cut • Achilles Therapeutics plc axes TIL-based therapy program • Study finds new-gen migraine meds not much better than OTC regulars (eg. tylenol, aspirin) More in today's TLDR Biotech newsletter: https://lnkd.in/g5XN9hre #biotech #pharma #pharmanews #biotechnews #tldrbiotech

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#BigPharma's growing interest in the #cellandgenetherapy space has the potential to reshape the industry's future. At this year's Cell & Gene #MeetingontheMesa, industry leaders highlighted that large pharma companies' significant resources and expertise are uniquely positioned to address the complex challenges of developing and commercializing these therapies. From high #manufacturing costs to navigating #regulatory hurdles, Big Pharma is playing an essential role in scaling innovations that smaller biotechs often struggle to bring to market. Their partnerships will prove critical to bringing life saving treatments to patients who need them most. As the sector continues to evolve, collaboration between Big Pharma and biotech can help shape the future of cell and gene therapies.

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Roche's three discontinued MAGE-A4 programs appear to have been based on TCR domain molecules. Could CDR-Life Inc.'s CDR404 - a bispecific and bivalent antibody fragment-based T-cell engager (TCE) targeting MAGE-A4 - yield different results? While antibody-based approaches may exhibit higher affinity for their targets than TCR-based approaches, it's important to note that higher affinity doesn't necessarily translate to improved efficacy. CDR404 is currently undergoing Phase 1 clinical trials (NCT06402201). https://lnkd.in/gQw5ziHF

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A step-by-step guide on how to accelerate your vaccine trial milestones through: * Customization * Simplification * Navigation * Integration https://lnkd.in/eefXgjAt

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TRIO Pharmaceuticals Completes $3.1 Million Financing Round to Advance Cancer Therapeutics Pipeline San Diego, CA — November 2024 — TRIO Pharmaceuticals, Inc., a biotechnology company pioneering bispecific antibodies for the treatment of cancer with unprecedented potency and selectivity, announced the successful completion of a $3.1 million financing round. Trio’s pre-Series A financing was led by San Diego based Friedman Bioventure Fund (FBVF). “The Trio team has demonstrated impressive bio-activity for both their Trailbody and TIE-ADC bi-specific antibody architectures, and we believe these potential medicines warrant accelerated development” said Dr. Jeff Friedman of FBVF.  Additional significant support came from the Multiple Myeloma Research Foundation (MMRF), through its venture philanthropy arm, the Myeloma Investment Fund (MIF), underscoring the potential of TRIO’s work to impact cancers with high unmet needs. Further investors included NuFund Venture Group, Life Science Angels and others. Friedman Bioventure brings expertise in supporting innovative biotech startups, aiming to accelerate breakthrough therapies to market. The Myeloma Investment Fund focuses on advancing treatments for cancers affecting blood and bone marrow, notably multiple myeloma. The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit in the world solely focused on accelerating a cure for each and every multiple myeloma patient. MMRF has committed raised over $600 million for research, opened nearly 100 clinical trials, and helped bring 15+ FDA-approved therapies to market. “TRIO’s innovative approach aligns with our mission to drive breakthrough treatments for the myeloma community,” said Dr. Stephanie Oestreich, Managing Director, Myeloma Investment Fund. “This investment underscores our commitment to accelerating therapeutic options for myeloma patients.” TRIO Pharmaceuticals’ proprietary platforms, TRAILBody™ and TIE-ADC™, are advancing next-generation immunotherapies for cancers with high mortality rates, such as Multiple Myeloma, Acute Myeloid Leukemia, ovarian, endometrial, and triple-negative breast cancers. These therapies combine targeted tumor growth inhibition with immune system modulation to offer potent, less toxic options compared to conventional treatments. “This financing round empowers us to expand our preclinical activities and advance our programs towards clinical development,” said Dr. Reiner Laus, CEO of TRIO Pharmaceuticals. “The support from organizations like Friedman Bioventure and the Myeloma Investment Fund is invaluable as we work to bring our transformative therapies closer to patients in need.” TRIO Pharmaceuticals is dedicated to reimagining cancer care through the application of novel antibody therapeutics. This funding will accelerate TRIO’s journey towards clinical trials, offering new hope for patients facing cancers that resist standard therapies. Full press release to come out next week!

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What a fascinating and productive workshop we are having at Cold Spring Harbor Laboratory in New York from June 3 to 6th, titled "Using Cell-free Systems to Synthesize and Express Bacteriophage Genomes: Practical Biomanufacturing for Bioscience Educators." This event, held at the DNA Learning Center NYC at City Tech, Brooklyn, is empowering bioscience educators with the tools and knowledge to introduce students to innovative biomanufacturing techniques. Under the guidance of Vincent Noireaux, participants are exploring a cell-free transcription-translation (TXTL) system to manufacture bacteriophages with new host specificities. This workshop not only honors the legacy of pioneering bacteriophage research at Cold Spring Harbor but also highlights the contemporary applications of phages in tackling multi-drug resistant bacterial infections, improving food safety, and advancing biotechnological innovations. Through hands-on experiments, attendees are engineering T7 phages to infect new E. coli hosts, conducting PCR mutagenesis, and utilizing nanopore DNA sequencing to investigate phage infectivity, making this a truly transformative experience for all involved. Bacteriophages, once again at the forefront of biotechnology, offer solutions to critical challenges in pharmaceuticals, agriculture, and food safety. By equipping educators with cutting-edge techniques to manufacture phages with new host specificities.

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Looking forward to Dr. Dan DeAngelo’s comprehensive review of the pivotal, Phase 3 results investigating standard salvage CT +/- Uproleselan in relapsed and refractory AML. This is a large, multi-national, placebo-controlled dataset (N=388) that may help address many important questions in the management of R/R AML.

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🔊 Stay ahead with latest updates on ADC in Oncology Exhibit #1: News by different category and phase of development Exhibit #2: A key recent update with insights 🔬 Immunome, Inc.’s IM-1021 (ROR1 ADC) demonstrates superior preclinical efficacy against zilovertamab vedotin in MCL and TNBC models, along with enhanced ADME properties over deruxtecan. IND filing expected Q1 2025. 🧪 Daiichi Sankyo US Sankyo and AstraZeneca initiate dosing in three global Phase 3 trials—TROPION-Lung10, TROPION-Lung14, and TROPION-Lung15—testing Datopotamab Deruxtecan (TROP2 ADC) combinations in advanced/metastatic non-squamous NSCLC. 🧪 Sutro Biopharma, Inc. Biopharma begins enrolling in the REFRαME-P1 trial to assess luvelta (FRα ADC) for pediatric patients with CBF/GLIS AML. 🎯 Hansoh Bio’s HS-20093 (B7-H3 ADC) receives Breakthrough Therapy Designation from NMPA for extensive-stage SCLC treatment. 🎯 Kelun-Biotech's NDA for sacituzumab tirumotecan (TROP2 ADC) accepted by NMPA for EGFR-mutant NSCLC, after Phase 3 OptiTROP-Lung04 results showed notable PFS improvement. 💡 Crescent Biopharma acquires GlycoMimetics, expanding its pipeline with novel ADCs CR-002 and CR-003. 🏗️ MilliporeSigma invests $76M to expand ADC manufacturing by 34,000 sq. ft. in St. Louis, adding 170 jobs and solidifying its position as North America's first approved ADC CDMO. 🤝 Ryvu Therapeutics and nCage Therapeutics partner to advance ADCs using TRAP cage technology for improved efficacy and safety. 💰 Sterling Pharma Solutions allocates £10M to double GMP bio-conjugation capacity at its UK site for ADC development. 💰 CrossBridge Bio secures $10M in seed funding led by TMC Venture Fund and CE-Ventures to advance CBB-120 (TROP-2 ADC) and expand its ADC pipeline. 🤝 Lonza’s Synaffix licenses ADC technology to BigHat Biosciences, combining ADC and AI-driven antibody design to enhance its ADC pipeline. 📅 Sutro Biopharma, Inc. will present five sessions on its cutting-edge ADCs at the 15th Annual World ADC Conference in San Diego, November 4-6, 2024.

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At Sonnet BioTherapeutics, we have a variety of publications to provide readers with more information on our current research efforts in #Immunotherapy. https://bit.ly/3Wh8WTR #SONN #Oncology #SolidTumors #PancCancer #Immunotherapy

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We will present two sets of data at the upcoming AACR Special Conference in Cancer Research: Liquid Biopsy: From Discovery to Clinical Implementation, November 13-16, 2024, San Diego, California. 1. A cost-effective two-step approach for multi-cancer early detection in general population. 2. A Blood-Based Multi-Omics Test for Early Evaluation of Lymphoma Treatment Effectiveness.

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#SITC24 This approach's crux lies in leveraging erythrocytes' splenic accumulation properties. The Erythrocyte-αPD-1 conjugate efficiently activates CD8+ T cells within the spleen, prompting these activated T cells to migrate to tumors and exert their anti-cancer effects.

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