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Kathleen Meyer, Vice Present of Nonclinical Development, will present at this year’s Applied Pharmaceutical Toxicology 2022 Conference on the…
Kathleen Meyer, Vice Present of Nonclinical Development, will present at this year’s Applied Pharmaceutical Toxicology 2022 Conference on the…
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David Luci
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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Hung Trinh
Umoja Biopharma Announces Publication in Blood Highlighting Successful Generation of In Vivo CAR T-cells in Non-Human Primate Modeling First landmark, peer-reviewed publication of successful in vivo CAR T-cell data in an immune competent NHP model Data validate the VivoVec™ platform in a translationally relevant model and support its transition into human clinical testing, offering a potential paradigm shift in the field of CAR T-cell therapies Key Study Findings VivoVec particles (VVPs) incorporating CD80 and CD58 costimulation proteins exhibit enhanced capacity for in vivo CAR T-cell generation and produce CAR T-cells with increased antitumor functionality compared to those produced from VVPs displaying anti-CD3 scFvs alone. Combining the anti-CD3 scFv together with the ligand binding domains of CD80 and CD58 into a single multi-domain fusion (MDF) protein markedly augments the particles’ ability to bind, activate, and transduce T-cells. VVPs incorporating MDF compatible with NHP T-cell activation and costimulation potently generate anti-CD20 CAR T-cells in vivo, comprising up to 65% https://lnkd.in/eqsSTKjf
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Hung Trinh
Genentech Wins FDA Approval for First Adjuvant Therapy for ALK-Positive, Early NSCLC The FDA on Thursday greenlit the use of Genentech’s Alecensa (alectinib) for the adjuvant treatment of patients with early-stage, anaplastic lymphoma kinase-positive non-small cell lung cancer who have undergone tumor resection. With the approval, Alecensa is now the “first and only” ALK inhibitor approved for this indication and patient population, according to Genentech. Thursday’s regulatory win is backed by data from the Phase III ALINA trial, a randomized, active-controlled and open-label study comparing adjuvant Alecensa with platinum-based chemotherapy. The study enrolled 257 patients with Stage IB to IIIA tumors who had undergone resection and tested positive for anaplastic lymphoma kinase (ALK) using an FDA-approved test. Results from ALINA, which the company released in October 2023, showed that Alecensa could cut the risk of disease recurrence or death by 76% versus platinum-based chemotherapy. This treatment effect was highly significant and yielded a p-value of less than 0.0001. The ALK blocker also led to a significant improvement in central nervous system-disease-free survival, according to an exploratory analysis of ALINA. Genentech CMO Levi Garraway in a statement on Thursday called ALINA’s disease-free survival data “unprecedented,” adding that “Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer.”
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Los Angeles Biotech Networks
STAT+: Pharmalittle: We’re reading about an ‘unaffordable’ Novartis drug, a proposed patent rule, and more https://lnkd.in/g_jz7AhH In today’s Pharmalittle roundup, we’re reading about an “unaffordable” Novartis drug, a new patent office rule, and more. Click here to view original post Click Here to Publish/Feature Your Company or Product News with Biotech [...] #LosAngeles #OrangeCountyCA #Biotech #Lifescience #News
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LucidQuest
Thoughts on this? >> Ocugen Announces CSO to Present on Modifier Gene Therapy at International Society for Cell & Gene Therapy 2024 ... - Ocugen >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharmaceutical #pharma #biotech #competitivemarketing
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LucidQuest
Thoughts on this? >> Andelyn Biosciences Selected as Viral Vector Manufacturing Partner for the California Institute for Regenerative ... - Morningstar >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #competitivemarketing #pharma #healthcare #pharmaceutical
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Hung Trinh
Advancing Delivery of AAV Vector-Based Gene Therapies Using Bispecific Antibodies (ASGCT 2024) There are several challenges that the viral vector field has been facing over the past few decades, noted Sven Moller-Tank, PhD, director of Viral Delivery Technologies, Regeneron Genetic Medicines, Regeneron, in an interview with BioPharm International® at the American Society of Gene and Cell Therapy’s (ASGCT’s) 27th Annual Meeting, which is occurring May 7–11, 2024 in Baltimore, Md. The first challenge is pre-existing immunity because people have naturally been exposed to adeno-associated virus (AAV) and have developed immune responses. This makes it a challenge to run clinical trials, when patients have pre-existing immunity, Moller-Tank stated. The second challenge has been delivery; as a whole, it has been extremely difficult to get enough virus to the peripheral tissues, as opposed to the liver, where it can cause issues with your immune response, and thirdly, there has always been an issue with cargo capacity, he explained. “AAVs can only package about 4.7 kb, and [many] therapeutic genes really don't fit into that capacity,” he said. A fourth challenge dealing with viral vectors would be sustained expression, Moller-Tank added. “The idea with AAV gene therapies generally is that it's a one-and-done therapeutic. However, there [are many] unknowns about how long it's going to express. We're now seeing [in] clinical trials [that] it can indeed last a long time, but it's really unknown for maybe more junior populations, children, where they're going to grow over time, and, after receiving a therapeutic, they may lose expression,” he observed. https://lnkd.in/eBTf8YXG
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RAS LifeScience Solutions
Amgen’s $27.8 B acquisition of Horizon Therapeutics included Uplizna, a key asset now showing promise for label expansion. In the Phase 3 MITIGATE study, Uplizna reduced the risk of disease flare in immunoglobulin G4-related disease (IgG4-RD) by 87% over 52 weeks. The study met secondary endpoints, indicating reduced flares and disease remission, with no new safety signals. This marks the first placebo-controlled trial supporting a steroid-sparing regimen for IgG4-RD. Regulatory filings in the US and other "key markets" are in the planning. Originally approved in 2020 for neuromyelitis optica spectrum disorder, Uplizna could be a significant growth driver for Amgen. Detailed News: https://lnkd.in/gYmbntaP Stay updated on the latest trends and news in the pharmaceutical industry. Follow our page for more insights: https://lnkd.in/de5zNWmK #Amgen #HorizonTherapeutics #Uplizna #IgG4RD #BiotechNews #ClinicalTrialSuccess #Trending #RASLSS
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Hung Trinh
PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™ WARREN, N.J., May 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of AADC deficiency. The application has been granted Priority Review with a target regulatory action date of November 13, 2024. "We are excited to be one step closer to bringing an approved therapy to patients with AADC deficiency in the United States," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "The data collected to date continue to support the transformative benefit of Upstaza, this highly innovative gene therapy directly infused into the brain." About Upstaza™ (eladocagene exuparvovec) Upstaza is a one-time gene replacement therapy indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L–amino acid decarboxylase (AADC) deficiency with a severe phenotype. It is a recombinant adeno-associated virus serotype 2 (AAV2) https://lnkd.in/e5EvQp7D
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SmaBio Labs
🌟 Exciting News! 🌟 We are thrilled to share that our CEO & Co-Founder, LakshmiDevi Ethirajan, will be moderating a panel at the 20th BioPharma Nexus Conference in San Diego. The panel discussion will focus on "Advancing Hit Discovery for Complex and Emerging Targets. Join us in San Diego on May 8-9 to gain insights from industry leaders and see how innovations are shaping the future of #DrugDiscovery!
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Pete Bastedo
So what's the common thread between successful biotech CEOs ? In preparing for this panel I thought doing 1-1 calls ahead of time would be a cool way to get to know a set of accomplished CEOs from the New England biotech community. The odds of getting everyone on one Teams call seemed pretty low right ? Well, let me say these calls have been an absolute highlight of the past month for me. The most important takeaway observation (if you can't make it to COG New England next week): The passion these CEOs have for the underlying patient challenges is what gets them moving each day. The fundraising and clinical data journey isn't easy. These CEOs press forward through that difficult journey because they understand they have an opportunity to help bring cures and treatments to the people that need them.
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3 Comments -
Carolyn Yong
How robust is your control of materials? Is your product allogeneic cell-based? Do you use human and/or animal derived materials in your CGT or TEMP or its manufacturing process? This week, FDA/CBER issued TWO new draft CMC guidances applicable to certain CGTs and TEMPs. Sponsors must provide adequate SAFETY and QUALITY information of materials used in manufacturing in their regulatory submissions. Bigger picture - the key considerations in these guidances are also critical to quality risk management and assurance of potency! Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products https://lnkd.in/eP-S2rYe
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Sarah A. Ziegler, Ph.D, RBP, SM(NRCM), CBSP
Curious what I do at Sitero? I lead our group in consulting services, and we function with multiple committees on different aspects of research and their compliance. So biosafety and IBC are among them. We also work with IRBs! We have our own external IRB and a whole bunch of other acronyms. I usually joke and say I'm leading the way if it's an acronym or a committee. It's fascinating to be working with so many clients in many research areas, from pre-clinical research to phase three trials and other ways to bring health to communities. #IRB #Sitero #Biosafety #IBC
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Xing Wang
In the PCA (Protein Conformational Array) technology, the screening of SHP2 conformational disruption identified compounds impacting multiple domains of the target protein, this will make mutation-driven drug resistance less likely. In our testing of the SHP2 conformational disruptors, we found that KRAS was degraded by the treatment from several compounds in cancer cell lines, indicating that the SHP2 conformational disruption could have profound impact downstream of the SHP2-KRAS-ERK pathway.
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Sword Bio
Science with John Pirro is back! This month, John discus’s what was presented at WRIB on Drug Tolerance in ADA methods and the concerns of the regulatory agencies, specifically, the concentration of the therapeutic at which you determine the DT. Watch until the end to hear the possible solutions to limit the requests from the FDA for justification or re-evaluating the ADA method. Please leave a comment with your thoughts or a topic you would like to see John present next. #Immunogenicity #wrib #scienceandsolutions
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Hung Trinh
Kite Data at EHA 2024 Demonstrate Positive Patient Outcomes and Advances in Delivery of CAR T-cell Therapy - Kite Pharma, Gilead Sciences – Analysis Comparing Real-World and Clinical Trial Data Show Yescarta® Has Higher Manufacturing Success Rates and Improved T-Cell Performance, Respectively, in Second-Line vs. Third-Line+ Treatment of Large B-cell Lymphoma – – Encore Oral Presentation from the Phase 1 Study of Anitocabtagene autoleucel (anito-cel) in Relapsed/Refractory Multiple Myeloma (R/R MM); Trial Design for Phase 3 iMMagine-3 Pivotal Study for R/R MM to be Published as E-Publication – SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced 12 abstracts from its industry-leading Chimeric Antigen Receptor (CAR) T-cell therapy portfolio at the upcoming 2024 European Hematology Association (EHA) Annual Congress, June 13-16, Madrid, Spain. Four presentations will highlight real-world experience with Yescarta (axicabtagene ciloleucel), including manufacturing experience for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in second-line versus third-line treatment and beyond. The real-world manufacturing analysis investigated potential benefits of administering Yescarta in earlier lines of therapy by assessing manufacturing success rate and product characteristics. Analyses exploring outpatient administration of Yescarta in R/R LBCL includes preliminary results of the Phase 2 ZUMA-24 study to evaluate the safety and efficacy of Yescarta outpatient administration compared to previous in-hospital clinical trials and real-world evidence. A real-world analysis on the use of Yescarta and Tecartus® (brexucabtagene autoleucel) assess safety trends and hospitalization rates following treatment to further understand the feasibility of CAR T-cell therapy administration in the outpatient setting. “Whether it’s continuing to evolve our industry-leading manufacturing capabilities or looking at different ways patients can obtain CAR T-cell therapy, such as in the outpatient setting, our goal is to improve patient outcomes and experience with our therapies,” said Ibrahim Elhoussieny, Vice President, Medical Affairs, Kite. “These data will reflect our progress in helping CAR T reach more people with complex and hard-to-treat blood cancers.” https://lnkd.in/epD74Yxj
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Drug Hunter
Drug Discovery News Roundup from May 2024 | https://lnkd.in/gKF2UZVX In May, we saw transactions worth millions and billions of dollars to advance next-generation neuroplastogens from AbbVie and Gilgamesh Pharmaceuticals, KRAS G12C inhibitors from BridgeBio Oncology Therapeutics, a potential Pompe disease treatment from Shionogi & Co., Ltd and Maze Therapeutics and molecular glues from Takeda and Degron Therapeutics. We also highlight positive clinical readouts for hot targets such as TTR stabilizers, Hedgehog pathway inhibitors, plasma kallikrein inhibitors, DPP-1 inhibitors, and PCSK9 inhibitors. Did you miss any key updates? Here's a recap of May's most notable drug discovery news highlights! Link | https://lnkd.in/gKF2UZVX
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