Paul Hallenbeck

According to the latest analysis from BiopharmIQ by Amp, Pennsylvania holds the #3 position in CGT ecosystems for companies with under 50 employees. However, as these companies grow, I hope they choose to mature in Philadelphia. Recently, I've had numerous conversations about the region's shortage of leadership/ executive talent. It's intriguing considering that 80% of Big Pharma is located within 90 miles of the city. What the CGT sector needs is more experienced leadership, and Big Pharma could serve as an excellent source for it. For the latest updates on Life Science and Biotech news in the Philadelphia region, join The Informal Philadelphia Life Science Group below!

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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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The proposed Biosecure Act aims to restrict U.S. reliance on Chinese contract research organizations like WuXi AppTec and BGI Group, impacting NIH-funded institutions and biotech firms that depend on them for research. This legislation could disrupt supply chains and R&D efforts crucial for drug development, highlighting vulnerabilities in outsourcing strategies within the pharmaceutical sector. I believe that embracing digital solutions such as chemical coding languages and date repos in molecule design and manufacturing could foster resilience, transforming how the industry navigates global supply chain challenges. #Biotech

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At the American Society of Gene & Cell Therapy‘s 27th Annual Meeting in Baltimore this year, groundbreaking trials showcased the forefront of gene therapy research. Presentations highlighted innovative approaches in gene therapy, including targeted cell and gene therapies, advancements in AAV gene therapy, and the latest findings in cell therapy..... 1. Gene Therapy for Adult and Pediatric Patients with Severe Pyruvate Kinase Deficiency: Results from a Global Study of RP-L301 2. Interim Analysis of CD19 CAR-Expressing Allogeneic NKT Cells in B Cell Malignancies 3. Tumor Microenvironment Reprogramming in Glioblastoma via Genetically-Engineered Hematopoietic Stem Cell Transplantation 4. Safety and Effectiveness of AB-1002 Gene Therapy in Advanced Heart Failure: Ongoing Phase 1 Trial Results...... #ASGCT #highlights #research #celltherapy #genetherapy #clinicaltrials #cellandgenetherapy #advancedtherapies #regenerativemedicine #biotech #biotechnology #genetics #geneticmedicine #lifesciences #PKD #GBM #glioblastoma #braincancer #TME #tumormicroenvironment #heartfailure #safety #effectiveness #HSCtransplant #NKT #allogeneic #ASGCT2024

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With ASCO in the rear-view mirror and drug development capital beginning to loosen in private and public markets, please keep us in mind for any PhD or MD level engagements or hiring to help solve your preclinical & clinical development challenges. Check out this comprehensive article from our friends at #bowtiedbiotech about public and private capital allocation from Q1 2024. Let's hope the headwinds are settling and smoother sailing is ahead. https://lnkd.in/esbqmzCT

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My colleague Stephen Pyke recently had the privilege of joining Dr. Tala Fakhouri from the FDA on Episode 2 of ACRO's Good Clinical Podcast. 🎙 They discussed the immense potential of AI in clinical research, delving into topics such as FDA's evidentiary standards for AI and the crucial role of methodological transparency in submissions. Stephen also weighs in on ACRO's AI/ML Principles Statement, an initiative he spearheaded as the Chair of the AI/ML Committee.   Access the episode on Apple Podcasts or Spotify. You can also stream it directly below. Enjoy ─ and let me know what you think in the comments! #ACRO #AIinHealthcare #ArtificialIntelligence

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Value-based payment arrangements are crucial for expanding patient access to cell and gene therapies. That’s why I am in Washington, DC, to advocate for the Medicaid Value-based Payments for Patients (MVP) Act at the Alliance for Regenerative Medicine’s Cell & Gene Congressional Fly-In July 15-16. #CGFlyIn24 #MVPACT #celltherapy #genetherapy #cellandgenetherapy #advancedtherapies #regenerativemedicine #policy #valuebasedpayments #patientaccess #biotech #biotechnology #lifescience #lifesciences #advocacy #payments #congressionalsupport Erica Cischke #facilitatepatientaccess #removebarriers

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A great review of the challenges faced by ADCs in NSCLC treatment and potential solutions. As with many reviews into the use of ADCs, toxicity was one of the primary issues associated with antibody-based treatments for NSCLC. The potential for resistance and therapeutic failure was also identified as a key challenge. There's a chance that both can be overcome through the development of new treatments that target different biomarkers. However, many of these treatments are still in the early stages of development, making it difficult to determine how effective they might be. #Biotech #LungCancer #Antibodies

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IVIEW Therapeutics Inc. Announces Dosing of First Patient in Phase 1/2 Clinical Trial of IVW-1001 for Dry Eye Disease [Cranbury, New Jersey, June 25, 2024] – IVIEW Therapeutics Inc., a clinical stage biotechnology company advancing innovative treatments for ocular diseases, proudly announces the dosing of the first patient in the Phase 1/2 clinical trial of IVW-1001 Ophthalmic Eyelid Wipe. This milestone marks the initiation of the clinical evaluation of IVW-1001, a novel TRPM8 agonist designed to treat signs and symptoms of dry eye disease. The commencement of patient dosing in the Phase 1/2 trial represents a significant advancement in IVIEW Therapeutics' mission to develop innovative solutions for individuals suffering from dry eye disease, particularly those inadequately managed by artificial tears. This first-in-human (FIH) trial aims to rigorously assess the safety, tolerability, and preliminary efficacy of IVW-1001. Dry eye disease is a prevalent and burdensome condition affecting millions worldwide. IVW-1001, developed by IVIEW Therapeutics, offers promising potential as a therapeutic intervention through its TRPM8 agonist mechanism, targeting the underlying causes of dry eye. The innovative delivery route via an ophthalmic eyelid wipe further distinguishes IVW-1001 as a potentially groundbreaking treatment. Houman Hemmati, MD, PhD, Chief Medical Advisor, leading the clinical development of the IVW-1001 program, stated, "Dosing the first patient in our Phase 1/2 clinical trial is an exciting and critical step forward. Our focus remains on thoroughly evaluating the safety and potential efficacy of IVW-1001. This investigational TRPM8 agonist offers an innovative approach to treating dry eye diseases, and we are committed to advancing this program to address the unmet needs of patients worldwide." Bo Liang, PhD, MBA, Co-founder, Chairman, and CEO of IVIEW Therapeutics Inc., added, "We are thrilled to initiate the clinical development of IVW-1001 with the dosing of our first patient. This milestone underscores our commitment to pioneering treatments for dry eye diseases and highlights the potential of our novel TRPM8 activation mechanism. We look forward to the progress of this trial and the insights it will provide."

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🎤 uBriGene Presents Exclusive Sessions at SAPA 2024 @Philly CGT Annual Conference 🎤 🚀 We're thrilled to announce our participation at 2024 @Philly Cell and Gene Therapy Annual Conference with two exclusive sessions aimed at revolutionizing the field: 1️⃣ An Innovative Technology for High Yield and More Stable #CRISPR Guide RNA: Discover how our innovative approach of using in vitro transcription (IVT) in producing guide RNA (#gRNA) that can simplify the process while being more cost-effective and free of organic chemicals. Join us to delve into the future of precision gene editing. 2️⃣ How Could CDMO and Technology Innovations Make CGT Affordable: Dive into the intersection #CDMO of and technological advancements with uBriGene. Learn about our strategies to drive down costs without compromising quality or efficacy. Let's explore how cutting-edge technology can make #CellandGeneTherapy more accessible to all. 2024 @Philly Cell and Gene Therapy Annual Conference brings together the innovators and business leaders to foster collaborations and advance cell and gene therapy in the #GreaterPhiladelphia area. 💡 Join #uBriGene to be at the forefront of innovation and collaboration in the dynamic world of cell and gene therapy and let's make cutting-edge cell and gene technology more accessible!

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16July: How does Orum Therapeutics plan to replace chemo with the targeted conditioning agents for gene editing therapies that it will work to develop with Vertex Pharmaceuticals? Read about the collaboration in my latest for Genetic Engineering & Biotechnology News: https://lnkd.in/epKWDUbZ

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With over 200 bispecific antibodies currently in development, key areas of opportunity are beginning to emerge. A promising area of interest lies in drug resistance. Bi- and multispecific antibodies that target two or more pathways may be able to reduce the risk of drug resistance, creating an opportunity to develop more effective therapies later down the line. At evitria, we recognise the potential of bispecific antibodies and offer rapid expression services to researchers looking to unlock their therapy potential. Get in touch to learn more. #Biotech #DrugResistance #BispecificAntibodies #Antibodies

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Ab-ilityTM is very relevant due diligence for any antibody asset transactions and supply chain planning. I wouldn't buy a house without a survey, I wouldn't acquire an antibody without Ab-ilityTM.

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A simple but interesting discussion of Sernova (David) and Vertex Pharmaceuticals (Goliath) in the pursuit of #celltherapy for #T1D. https://lnkd.in/ghMH7n9b #diabetes #advancedtherapies

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In 1L G/GEJC, Osemitamab plus Nivolumab /Chemotherapy produced Claudin18.2 expression dependent increase in both objective response rate and medium progression survival, regardless of PD-L1 status, as we presented at ASCO 2024 (abstract 4048). This is very encouraging news to first-line G/GEJC patients with Claudin18.2 expression!!

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If you are interested in the #Duchenne and/or rare disease landscape, please take the time to listwn in to this conversation! NeurologyLive #duchennemusculardystrophy

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Learn more out AAV Process Development and Optimization using cloud-connected bioreactors. Come visit the Culture Biosciences Team at ASGCT. #processdevelopment #processoptimization #cloudconnectivity #aav #bioprocess

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Since 2015, Dana-Farber researchers have been participating in clinical trials that evaluate the use of bispecific antibodies for patients with non-Hodgkin lymphoma. Three bispecific antibody therapies have been FDA approved with more on the horizon. These are exciting new medicines that rally the immune system in a powerful way to fight blood cancers. But rolling out a new type of medicine is a project of its own. The experts at Dana-Farber who have been treating patients with these new medicines are now working on expanding their use. Philippe Armand, MD, PhD, chief of the Lymphoma Program, and Jennifer Crombie, MD, Reid Merryman, MD, and Christine Ryan, MD, physicians and clinical investigators in the Lymphoma Program, are using what they have learned as clinical investigators to run new trials to determine if these medicines could have benefits earlier in treatment, in combination with other therapies, or in other types of lymphoma. “The hope is that these drugs will help improve outcomes for patients with lymphoma,” says Crombie, who has been the principal investigator of a bispecific antibody trial for the past few years. Monoclonal antibodies treat cancer by binding to markers on cancer cells and rallying the immune system to destroy them. Bispecific antibodies are designed to recognize and bind to more than one cell marker. The bispecific antibodies approved for the treatment of B-cell non-Hodgkin lymphoma recognize CD20, a marker known to be on B cells, and CD3, a marker known to be on T cells, which are immune cells that can attack cancer cells. By binding to both, the bispecific antibody pulls the T cells closer to the cancerous B cells, increasing the chances that the T cells will recognize and kill the cancer. “Bispecific antibodies can be a powerful immune-based mechanism because of their dual binding properties,” says Crombie. These medicines are currently approved for use alone in patients with follicular lymphoma or diffuse large-cell lymphoma who have received three lines of treatment and need a new therapeutic option. Some patients may choose to try bispecific antibody therapy after CAR T-cell therapy. Others may opt to try bispecific antibodies before trying, or in lieu of, CAR T-cell therapy. Recommendations will vary depending on the type of lymphoma and other individual factors. These new therapies are administered via infusion or an injection under the skin. However, these immunotherapies can cause side effects that many centers are learning how best to manage. In clinical trials of bispecific antibodies, investigators noted side effects that are like those experienced by patients receiving CAR T-cell therapy. The reactions, however, are often less frequent and less severe. Learn more: https://lnkd.in/e4D8T2GG

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