Paul Lipkin

🚀 Ginkgo Bioworks, Inc. Bioworks Sets Date for Q2 2024 Results Presentation 🚀 📅 Presentation Date: Thursday, August 8, 2024, at 5:30 PM ET. Ginkgo Bioworks Holdings, Inc. (NYSE: DNA) has announced a presentation and Q&A session to review its business performance for the second quarter ended June 30, 2024. The session will be held post-market on August 8, 2024. About Ginkgo Bioworks: Ginkgo Bioworks is a leader in cell programming and biosecurity, offering end-to-end services for various markets, including food, agriculture, pharmaceuticals, and specialty chemicals. Their biosecurity division focuses on developing infrastructure and technologies to predict and respond to biological threats. #GinkgoBioworks #Q2Results #InvestorUpdate #Biotech #Biosecurity #CellProgramming #Innovation #GinkgoResults

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Struggling to find qualified histotechnologists for your lab? You’re not alone. I just wrapped up a conversation with a laboratory director from the West Coast, and he shared some real challenges his lab is facing. Like many, he’s dealing with a shortage of histotechnologists. His lab currently relies on travelers, which creates significant issues: 1.) These travelers are expensive. 2.) They often lead to quality problems. There’s a lack of local talent; the pipeline just isn’t there. So, what's the solution? International recruitment. Here’s how it can transform their pathology department. Build Your Own Pipeline: Instead of waiting for new histotechnologist to relocate to the this city you can take control and bring your own. Imagine bringing in 3 to 4 motivated histotechnologists from the Philippines who are ready to contribute to your lab. Quick Turnaround: The process can move fast. As a nonprofit, this lab can get new staff in about six months. That’s efficient and effective. Cost Efficiency: By hiring international candidates, they can eliminate the need for temporary workers, reducing costs and training time. Plus, these new hires can stay for up to six years, providing stability and continuity. In summary, now you know you can utilize International recruitment not just for medical laboratory scientist but histotechnologist as well.

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🦠 Breaking News in Viral Surveillance! 🧬 Introducing the Viral Surveillance Panel v2 - your new ally in the fight against emerging diseases! Expand your viral surveillance capabilities with the new Viral Surveillance Panel v2, a cutting-edge NGS-based assay that: • Identifies over 200 high-risk viruses • Supports crucial genomic surveillance • Enhances zoonosis monitoring Ready to level up your viral surveillance game? Learn more at illumina.com/VSP #ViralSurveillance #PublicHealth #NGSTechnology #EmergingDiseases

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CDMO Nucleus RadioPharma reveals expansions at two sites that will "significantly improve" market access to promising cancer treatments. 🏗️ The upgrades at sites in Mesa, #Arizona and Springhouse, #Pennsylvania will give each facility research, development and commercial production capabilities, boosting capacity by 200%. The expansions are expected to be completed by the end of 2026 and will create around 100 jobs overall. 💉 The upgrades will allow more patients to receive radiopharmaceuticals, which have a limited shelf-life, according to Nucleus. 💬 "To reach their full potential as treatments for millions of patients with limited options, theranostic radiopharmaceuticals must be available close to those who need them," Nucleus RadioPharma CEO Charles Conroy, RPh, MBA said in a release. "Our expansion will significantly improve patient access to these life-saving treatments and expedite clinical trials, potentially reducing time-to-market for new therapies by up to 30%." #CDMO #Radiopharmaceuticals #Radiopharma

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𝗛𝘂𝗴𝗲 𝗻𝗲𝘄𝘀 𝗳𝗼𝗿 𝗛𝘂𝗻𝘁𝗶𝗻𝗴𝘁𝗼𝗻'𝘀 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀! 🚨 uniQure announced alignment with the FDA on key elements of accelerated approval for its Huntington's Disease gene therapy AMT-130. 𝗔𝗠𝗧-𝟭𝟯𝟬 𝗕𝗮𝗰𝗸𝗴𝗿𝗼𝘂𝗻𝗱: 🧬 AMT-130 consists of an AAV5 vector carrying an artificial micro-RNA specifically tailored to silence the huntingtin gene to inhibit the production of the mutant protein (mHTT) 🧬 In 2018 the EMA granted AMT-130 Orphan Medicinal Product Designation 🧬 In 2019 the US FDA granted AMT‑130 Fast Track designation 🧬 In May 2024 the US FDA granted RMAT designation for AMT-130 to accelerate development and potentially facilitating earlier access - the first Huntington's Disease drug to receive RMAT designation 🧬 In July 2024, uniQure presented interim data at 24 months showing durable, dose-dependent slowing of disease progression 𝗡𝗲𝘄 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀: 👉 The FDA has agreed that ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a BLA for Accelerated Approval, avoiding the need for an additional pre-submission study 👉 The composite Unified Huntington’s Disease Rating Scale (cUHDRS) may serve as an intermediate clinical endpoint for Accelerated Approval 👉 Reductions in NfL measured in cerebrospinal fluid may serve as supportive evidence in a BLA application 👉 uniQure has initiated BLA readiness activities and will further engage with the US FDA in H1 2025 𝗪𝗵𝘆 𝗶𝘀 𝘁𝗵𝗶𝘀 𝘀𝗼 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁? 💡 Huntington’s disease is a rare, inherited neurodegenerative disorder that leads to motor symptoms including chorea, behavioral abnormalities and cognitive decline 💡 Approximately 70,000 people have been diagnosed with Huntington’s disease in the US and Europe, with hundreds of thousands of others at risk of inheriting the disease 💡 There are currently no approved therapies to delay onset or to slow Huntington disease progression Full release: https://lnkd.in/gPPH6DEz For more insights, follow the Bio-weekly 🧬 Newsletter: https://lnkd.in/gH5e-nhN

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𝗛𝘂𝗴𝗲 𝗻𝗲𝘄𝘀 𝗳𝗼𝗿 𝗛𝘂𝗻𝘁𝗶𝗻𝗴𝘁𝗼𝗻'𝘀 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀! 🚨 uniQure announced alignment with the FDA on key elements of accelerated approval for its Huntington's Disease gene therapy AMT-130. 𝗔𝗠𝗧-𝟭𝟯𝟬 𝗕𝗮𝗰𝗸𝗴𝗿𝗼𝘂𝗻𝗱: 🧬 AMT-130 consists of an AAV5 vector carrying an artificial micro-RNA specifically tailored to silence the huntingtin gene to inhibit the production of the mutant protein (mHTT) 🧬 In 2018 the EMA granted AMT-130 Orphan Medicinal Product Designation 🧬 In 2019 the US FDA granted AMT‑130 Fast Track designation 🧬 In May 2024 the US FDA granted RMAT designation for AMT-130 to accelerate development and potentially facilitating earlier access - the first Huntington's Disease drug to receive RMAT designation 🧬 In July 2024, uniQure presented interim data at 24 months showing durable, dose-dependent slowing of disease progression 𝗡𝗲𝘄 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀: 👉 The FDA has agreed that ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a BLA for Accelerated Approval, avoiding the need for an additional pre-submission study 👉 The composite Unified Huntington’s Disease Rating Scale (cUHDRS) may serve as an intermediate clinical endpoint for Accelerated Approval 👉 Reductions in NfL measured in cerebrospinal fluid may serve as supportive evidence in a BLA application 👉 uniQure has initiated BLA readiness activities and will further engage with the US FDA in H1 2025 𝗪𝗵𝘆 𝗶𝘀 𝘁𝗵𝗶𝘀 𝘀𝗼 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁? 💡 Huntington’s disease is a rare, inherited neurodegenerative disorder that leads to motor symptoms including chorea, behavioral abnormalities and cognitive decline 💡 Approximately 70,000 people have been diagnosed with Huntington’s disease in the US and Europe, with hundreds of thousands of others at risk of inheriting the disease 💡 There are currently no approved therapies to delay onset or to slow Huntington disease progression Full release: https://lnkd.in/gPPH6DEz For more insights, follow the Bio-weekly 🧬 Newsletter: https://lnkd.in/gH5e-nhN

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🎙 The BioHub Episode with Amit Kumar is LIVE! 🎙 In this episode, we sit down with Amit Kumar, Chairman, President and CEO at Anixa Biosciences, Inc. Biosciences We're excited to dive into his journey, the challenges and successes along the way, and what's next for Anixa and the broader biotech space. 👉 Catch the full episode via the link in the comments

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Happy Wednesday all! Check out this open access Cell Immunity review by Jason G. Cyster and Patrick C. Wilson, "Antibody modulation of B cell responses—Incorporating positive and negative feedback." Summary: Antibodies are powerful modulators of ongoing and future B cell responses. While the concept of antibody feedback has been appreciated for over a century, the topic has seen a surge in interest due to the evidence that the broadening of antibody responses to SARS-CoV-2 after a third mRNA vaccination is a consequence of antibody feedback. Moreover, the discovery that slow antigen delivery can lead to more robust humoral immunity has put a spotlight on the capacity for early antibodies to augment B cell responses. Here, we review the mechanisms whereby antibody feedback shapes B cell responses, integrating findings in humans and in mouse models. We consider the major influence of epitope masking and the diverse actions of complement and Fc receptors and provide a framework for conceptualizing the ways antigen-specific antibodies may influence B cell responses to any form of antigen, in conditions as diverse as infectious disease, autoimmunity, and cancer. #drugdiscovery #cancerresearch #antibodies #infectiousdisease #sarscov2 #autoimmunity #immunooncology #immunotherapy #scientificresearch

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👨‍🔬💬 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐍𝐞𝐰𝐬: 𝟏𝟎𝐭𝐡 𝐃𝐞𝐜𝐞𝐦𝐛𝐞𝐫 𝟐𝟎𝟐𝟒 👩‍🔬💬 🧬 MeiraGTx received RMAT designation from the FDA for AAV2-hAQP1, targeting Grade 2/3 radiation-induced xerostomia (RIX). The therapy showed promising results in the Phase 1 AQUAx clinical trial, demonstrating significant improvements in patient-reported outcomes and saliva production, with no treatment-related serious adverse events. 🦠 Indapta Therapeutics has partnered with Sanofi to evaluate its g-NK cell therapy, IDP-023, combined with Sarclisa (isatuximab) in relapsed/refractory multiple myeloma. This collaboration adds a new cohort to Indapta’s ongoing Phase 1 trial to explore up to three dose levels. Indapta will sponsor the trial, with Sanofi supplying Sarclisa and co-funding the study. Preclinical results suggest superior efficacy of g-NK cells versus conventional NK cells in combination with monoclonal antibodies. 🧬 VIVEbiotech has received an equity investment from Ampersand Capital Partners. The undisclosed funds will enhance VIVEbiotech’s lentiviral vector manufacturing capabilities and support its cell and gene therapy projects. The company operates a 3,000 sq. m. GMP-compliant facility and specializes in process development, manufacturing, and analytical testing for biopharma innovators focused on in vivo and ex vivo therapies. 🦠 Citryll has raised €85M in a Series B funding round led by Johnson & Johnson, Forbion, and Novartis Venture Fund to advance CIT-013, which aims to enhance Neutrophil Extracellular Trap (NET) clearance and prevent new formation, addressing chronic inflammation in disorders like rheumatoid arthritis (RA) and hidradenitis suppurativa (HS). Phase 2a trials are planned following successful Phase 1 trials. Citryll’s NET-targeting approach offers potential across immune-mediated inflammatory diseases, addressing unmet therapeutic needs. 🧬 Ori Biotech and Fresenius Kabi have partnered to integrate Ori's IRO® platform with Fresenius Kabi's Cue® and Lovo® systems, creating a streamlined, modular manufacturing process for cell and gene therapies. This collaboration enhances scalability, efficiency, and flexibility while maintaining product quality by enabling closed workflows that reduce process steps and operator handling. 🦠 Cimeio Therapeutics has partnered with Kyowa Kirin International plc. to develop novel cell therapies using Cimeio’s Shielded-Cell & Immunotherapy Pairs™ (SCIP) platform. Cimeio will receive an upfront payment, two years of research funding, and may earn up to $300 million through milestones and royalties if Kyowa Kirin exercises a commercial license option. The SCIP platform enables innovative immunotherapies targeting previously untreatable diseases, offering transformative treatments for hematologic diseases, autoimmune disorders, and genetic conditions. 🛎 My aim is to be the messenger when it comes to your CGT news. Follow #mCGT to stay updated! #celltherapy #genetherapy #ATMP

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Guardant co-CEO AmirAli Talasaz said that participating in the Vanguard study provides a "unique opportunity" for the company to engage both the NCI and the FDA. "A major outstanding question in cancer screening is the clinical utility of [MCED] testing. By working with the NCI and the FDA to define follow-up diagnostic pathways for patients post [MCED] testing, we can help ensure that these tests have the greatest benefit for healthcare providers and their patients,"

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💰 𝐂𝐆𝐓 𝐅𝐢𝐧𝐚𝐧𝐜𝐢𝐚𝐥 𝐑𝐨𝐮𝐧𝐝 𝐔𝐩: 𝐐𝟑 𝟐𝟎𝟐𝟒 💰 🌱 𝗦𝗘𝗘𝗗 𝗙𝗨𝗡𝗗𝗜𝗡𝗚 🌱 🧬 Amlogenyx (Ultragenyx) raised $14 million to support the development of novel gene therapies for Alzheimer's disease and other amyloid diseases 🧬 Kano Therapeutics secured $7.1M to develop its innovative non-viral DNA insertion technology using single-stranded DNA (ssDNA). 🧬 Vironexis Biotherapeutics unveiled with $26 million to advance their AAV gene therapy pipeline taking aim at blood cancers and solid tumor metastasis prevention. 💸 𝗦𝗘𝗥𝗜𝗘𝗦 𝗔 💸 🧬 AIRNA closed $90 million to advance their RNA editing therapeutics into clinical trials and further develop their pipeline. 🦠 LIfT BioSciences raised £10 million to advance its Immunomodulatory Alpha Neutrophils (IMANs) into clinical trials. 🦠 GC Therapeutics launched with $75 million to develop next-generation cell therapies using its TFome™ platform. 🦠 Shinobi Therapeutics expanded their Series A to $119 million to support development of their immune evasive iPSC-derived technology. 💸 𝗦𝗘𝗥𝗜𝗘𝗦 𝗕 💸 🧬 Beacon Therapeutics raised $170 million to support the advancement of gene therapy programs for eye diseases. 🦠 Outpace Bio raised $144 million to advance their T cell therapies for solid tumors. 💸 𝗦𝗘𝗥𝗜𝗘𝗦 𝗖 💸 🦠 Arsenal Biosciences, Inc. raised $325 million to support the development of its programmable cell therapy programs. 💵 𝗚𝗥𝗔𝗡𝗧𝗦 💵 🧬 Rejuvenate Bio received a $4M grant to advance RJB-0402, a gene therapy for desmoplakin gene variant arrhythmogenic cardiomyopathy. 🦠 The Multiple Myeloma Research Foundation - MMRF invested $1 million in novel CAR T-cell technology from Dynamic Cell Therapies, Inc. 🧬 GENEXYS BioMed received $320,000 from the NIH to advance its non-viral delivery system for delivering mRNA / DNA directly to CF patients' lungs. 🦠 Marker Therapeutics, Inc. received $2 million grant from the NIH to support a Phase 1 study of MT-601. 🤑 𝗣𝗨𝗕𝗟𝗜𝗖 𝗢𝗙𝗙𝗘𝗥𝗜𝗡𝗚 🤑 🦠 Artiva Biotherapeutics raised $167 million in an IPO centered around the promise of donor-derived cell therapies for autoimmune diseases. 🧬 Precigen raised ~$31.4 million to advance PRGN-2012 to regulatory approval and commercial readiness. 🦠 TC BioPharm closed a $2 million direct public offering to support a clinical trial for relapsed / refractory AML. 🤑 𝗣𝗢𝗦𝗧-𝗜𝗣𝗢 𝗘𝗤𝗨𝗜𝗧𝗬 🤑 🦠 Cartesian Therapeutics announced a $130 million PIPE financing deal to fund pipeline programs. 🤑 𝗣𝗥𝗜𝗩𝗔𝗧𝗘 𝗘𝗤𝗨𝗜𝗧𝗬 🤑 🦠 SmartCella Holding AB raised EUR 50 million to accelerate growth and support commercialization of the Extroducer and the company’s cell and mRNA operations. 🤑 𝗦𝗛𝗔𝗥𝗘 𝗢𝗙𝗙𝗘𝗥𝗜𝗡𝗚 🤑 🧬 MeiraGTx announced a $50 million share offering to support the development of their gene therapies. #mCGT #advancedtherapies #ATMP #funding #investment

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Merry Christmas, everyone! For some holiday fun, I asked ChatGPT to write a Christmas post on-brand for me, and here’s what it came up with: ==== It’s Christmas, and like many of you, I’m taking a moment to pause and reflect. One of the things I love most about working in life sciences and biotech is that the industry itself feels like a gift. Every new therapy, every innovative platform, every piece of software we use to accelerate research is the result of people pushing boundaries, taking risks, and solving problems that, at first glance, seem unsolvable. I’m incredibly grateful for the conversations I’ve had this year—whether it was learning about someone’s data platform journey, digging into a new technology at an event, or simply sharing ideas here on LinkedIn. Those moments remind me why I do what I do. As we look toward 2025, I hope we all keep this momentum. Let’s continue to build, innovate, and—most importantly—support one another in our shared mission to improve lives. Wishing you all a joyful holiday season! ==== Not too shabby, I think! 😀 P.S. I hope you all take time to pause and reflect today, away from screens But if you are sneaking a peek, take a moment to register for the next Data Driven Pharma event 👇 https://lnkd.in/gwuBPnpx

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LumaCyte Unveils Predictive CAR T Donor Analytics to Revolutionize Cell Therapy Manufacturing CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--LumaCyte, a leader in advanced cellular analysis and precision bioanalytics, proudly announces the launch of its groundbreaking cell therapy application for predictive CAR T donor analytics. Leveraging its novel Laser Force Cytology™ (LFC™) technology and Radiance® instrument, LumaCyte uncovers deep data insights into highly variable and complex patient and donor cellular starting material, enabling cell therapy developers to predict manufacturing success for specific donors or patients. To ensure that all interested partners can benefit from this powerful new application, LumaCyte has introduced a new donor qualification service where customers can ship donor or patient samples to LumaCyte for analysis and qualification. This service aims to revolutionize the cell therapy landscape by minimizing manufacturing risks due to variability in cellular starting material, enhancing production consistency, and increasing production yields. The industry has long sought to understand the innate variability across donors and patients and how to predict manufacturing and clinical success based on biomarkers in the cellular starting material. The ability to predict the outcome prior to the start of manufacturing with near real-time analytical insights is considered the holy grail for donor selection. Combining advanced in-process analytics with the ability to enable adaptive manufacturing would be a quantum leap for the immunotherapy industry; Reducing manufacturing failures and compressing time and costs for delivering these lifesaving treatments. “The biopharmaceutical industry is advancing scientific breakthroughs into the clinic faster than any other time in its history. Developers must think differently from the start to be able to meet the clinical and commercial manufacturing scale required to serve the hundreds of thousands of advanced therapy patients expected by 2030. “We are honored to do our part in providing valuable real-time data insights that have the power to accelerate the time to patient as well as improve the cost and effectiveness of these lifesaving treatments,” says Dr. Sean Hart, LumaCyte CEO and CSO. https://lnkd.in/eQvfBi4E

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The ability to inherently co-register fluorescent signal with anatomy at depth, with no signal attenuation, is a powerful tool that enhances the researcher's decision confidence. #Immunotherapy #ViroTherapy #AAV's #NanoParticles

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Up to 60% of clinical trials require biomarker info for patients to participate, but recommendations for biomarker testing to determine eligibility for clinical trials remains inconsistent. Why? We’re exploring this in an abstract and more at #ASCO24.

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Become a donor and support cellular therapies. 🙌 Your help goes a long way in advancing medical research and saving lives. Learn how to get involved at Cellular Life Solutions by clicking the link in our bio. #GetInvolved #SupportResearch #CellularTherapies #CellularLifeSolutions

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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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Agios Pharmaceuticals will receive $1.1 billion following FDA approval of vorasidenib for Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations. This includes $905 million from Royalty Pharma and $200 million from Servier. Cecilia Jones, CFO at Agios Pharmaceuticals, noted this approval, the first for Grade 2 glioma in over 20 years, enhances Agios' cash position. This will support PYRUKYND (mitapivat) launches in 2025 and 2026 and drive pipeline progress. In 2021, Agios sold its oncology business to Servier for $1.8 billion, plus $200 million upon FDA approval of vorasidenib and 15% royalties on U.S. sales. In 2024, Agios sold these royalties to Royalty Pharma for $905 million. Royalty Pharma now receives 15% royalties on U.S. sales up to $1 billion and 12% on sales over $1 billion, with Agios retaining a 3% royalty on sales over $1 billion. Agios' strategic moves strengthen its financial foundation for continued innovation in rare disease therapies. #FDAApproval #Biotech #Pharmaceuticals #RareDiseases #Innovation #Oncology #Investment #HealthcareLeadership

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Going back into production to offer autologous angiogenic cell precursors to no option cardiovascular disease patients, including chronic limb threatening Ischemia. HEM:TSXV is a buy. https://lnkd.in/gBAQaqpX

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