Eric Celidonio

🚀 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

2

1 Comment

Do you know when companion diagnostics (CDx) are needed for your cell and gene therapy programs? Or what kind of testing is required and how to choose the right lab partner for a CDx assay? In our blog, you’ll learn from Labcorp subject matter experts as they answer key questions you may have about developing CDx for your cell and gene therapy programs. Learn more: https://lnkd.in/gSChJieM #CellandGeneTherapy #CompanionDiagnostics

4

#TuesdayTip 💡 How to Attract Top Talent in Biotech 💡 Biotech is evolving at lightning speed, and so is the competition for top-tier talent. We get asked all the time what the "secret sauce" is for attracting top talent in sales, marketing, biz dev, launch teams, etc. Here are some tips to attract the best in the business: 🎯 1. Showcase your mission! Biotech professionals are drawn to companies that make a difference. Share how your team is driving innovation and impact – people want to know they’ll be part of something meaningful. 🚀 2. Be upfront about salary ranges. Transparency builds trust. Sweeten the deal with unique benefits (stock options, wellness programs, or personalized career development). 🧠 3. Long interview processes? Top candidates won’t wait around! Streamline decision-making and provide quick feedback to candidates. 🤝 4. Not every great candidate is actively job-seeking—reach out and build relationships. Share relevant industry content and thought leadership posts to position your company as a market leader. 🌐 5. Top candidates look for companies committed to building diverse teams. Create inclusive job descriptions to encourage a broad pool of applicants. And what's another way to get ahead? Partner with specialty biotech #recruiters like BlueGene Search! 💬 How do you ensure your hiring process stands out? Comment below!

10

1 Comment

Our latest blog dives into the importance of cell density, even distribution and the science behind effective seeding techniques. Learn how understanding these steps can lead to more precise evaluations of cellular reactivity. https://lnkd.in/gYhukzVr blog&utm_term=&utm_marketing_tactic=aw #CellCulture #Cytotoxicity #CellSeeding

3

BrightPath Bio and Cellistic Announce Process Development and Manufacturing Collaboration for Phase 1 Clinical Trial of iPSC-derived BCMA CAR-iNKT cell - https://lnkd.in/eUv2kfKq Brightpath Biotherapeutics (Tokyo Stock Exchange Growth 4594, “BrightPath”), a pioneer in iPS cell-derived Natural Killer T (“NKT”) cell therapy, and Cellistic, a leader in advanced iPS cell therapy manufacturing, today announced a process development and manufacturing agreement to advance BrightPath’s novel allogeneic CAR-T cell therapy platform, utilizing iPSC-derived NKT cells for clinical trials. The strategic collaboration includes the use of Cellistic’s innovative 3D bioreactor-based manufacturing platform, Echo, to enable GMP-compliant, clinical-scale manufacturing of iPSC-derived BCMA-targeting CAR-NKT cells for Phase 1 multiple myeloma trial; establishing BrightPath as a first mover in this emerging field. “The use of NKT cells as effectors in allogeneic CAR-T therapy represents a promising strategy, offering not only direct cytotoxicity but also indirect anti-tumor activity through the priming of host CD8+ T cells—a mechanism expected to evade host immune rejection and to enhance the durability of clinical responses. However, achieving clinical- scale manufacturing of such a rare subset of T cells while preserving their original functionality has conventionally been a significant challenge. Induced pluripotent stem (iPS) cell technology has overcome this barrier, making large-scale production feasible.“ stated Ken Nagai, CEO of BrightPath. “We are excited to partner with BrightPath in the development of their revolutionary iPSC-derived cell therapy,” said Gustavo Mahler, CEO of Cellistic. “Our Echo manufacturing platform is designed to meet the unique challenges of cell therapy production, ensuring scalability, quality, and regulatory compliance. Together, we can advance the therapeutic potential of BCMA CAR-NKT cells and help BrightPath to bring innovative solutions to patients in need.” #ipscells #tcells #advancedtherapies Laetitia Avanzini

35

🎙 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

18

1 Comment

🦠 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

1

Demonstrating the technical leadership of SK pharmteco! 🧬 Catch up with our team at ASGCT to discuss how SKPT can support your #cellandgene development!

9

1 Comment

The results from Arrowhead Pharmaceuticals' Phase 3 PALISADE study on plozasiran are truly impressive and could be a game-changer for patients with familial chylomicronemia syndrome (FCS). I'm excited by the potential impact this could have on a condition that currently has no approved treatments in the U.S. The involvement of experts like Gerald F. Watts and Bruce Given, M.D. adds significant weight to these findings. Their work not only showcases the power of RNAi therapeutics but also highlights how targeted innovation can meet critical, unmet medical needs. If plozasiran is approved, it could dramatically improve the quality of life for FCS patients, and it’s exciting to see this kind of progress in the field. #RNAi #FCS #research #Biotechnology

6

Jonathan Montagu, CEO of MassBio member HotSpot Therapeutics, Inc., writes on the #LifeSCiVC blog about hopes around an immuno-oncology spring this year, aligning with the emergence of #biotech from its own long winter. Jonathan points out that after the #lifesciences industry dove headfirst into I-O “to address the substantial need that still persists for many cancer patients with a range of tumor types,” much of the second-generation agents fell short. He writes about why he’s optimistic that new approaches have started to turn the tide. What are your thoughts on the I-O space right now? https://lnkd.in/eMh62Z8j #immunooncology #oncology #patientdriven

28

Eli Lilly and Company Secures FDA Nod for Eczema Therapy, Eyes Launch in ‘Coming Weeks’ - BioSpace Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns. The FDA on Friday signed off on Eli Lilly’s therapeutic antibody lebrikizumab for the treatment of moderate-to-severe atopic dermatitis. Lilly will market the therapy under the brand name Ebglyss. Ebglyss is administered via a subcutaneous injection that can be given with or without topical corticosteroids, and is indicated for adults or children aged 12 years and above who weigh at least 40 kg. Lilly expects to make Ebglyss available in the U.S. in the “coming weeks,” according to its news release, and will work with insurers and health providers to ensure patient access to the treatment. Lilly also has available support programs, including co-pay assistance, for eligible insured patients. Daniel Skovronsky, CSO and president of Lilly Research Laboratories, said in a statement that Ebgylss’ approval can help patients mitigate some of the unpredictability of symptoms. “Ebglyss offers a targeted approach to reduce a main cause of eczema inflammation,” he said, adding that the treatment provides long-lasting symptom relief with a convenient once-monthly maintenance dose. Designed to selectively target and neutralize IL-13, Ebglyss is a monoclonal antibody that disrupts the type 2 inflammation cascade in the skin, in turn effectively addressing an underlying disease pathway in eczema. Ebglyss has high binding affinity for IL-13 and a slow dissociation rate. Lilly backed Ebglyss’ application with data from the Phase III ADvocate 1 and ADvocate 2 studies, which together showed that around 38% of patients on the drug achieved clear or almost-clear skin at 16 weeks. In the placebo arm, only 12% of patients reached this endpoint. For 10% of responders, treatment effects were apparent as early as four weeks. https://lnkd.in/e7pPtGiz

33

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

9

#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.

49

1 Comment

I'll be attending the AIRR Community Meeting VII (Adaptive Immune Receptor Repertoire) - Let me know if you're planning to attend so that we can chat. Infinity Bio, Inc. CSO, Dr. Ben Larman, will be giving a talk on "Antibody reactome profiling via self-assembling libraries of DNA barcoded antigens". This is an incredible tool for the detailed characterization of #serum #antibodies at cohort scale, allowing for novel #biomarker, therapeutic targets and #MoA discoveries. #immunology #airrc7

17

Latus Bio Launches with State-of-the-Art Gene Therapy Development Technologies, Two Lead Product Candidates, and an Initial $54 Million in Series A Financing PHILADELPHIA--(BUSINESS WIRE)--Latus Bio, Inc. (“Latus”), a biotechnology company developing novel gene therapy candidates for disorders of the central nervous system (CNS), today announced its launch and an initial close of $54 million in Series A financing. The funding round is being led by 8VC and DCVC Bio. To date, Samsung Life Science Fund (created by Samsung C&T, Samsung Biologics, Samsung Bioepis and Samsung Venture Investment Corporation), The Children’s Hospital of Philadelphia Foundation, Benjamin Franklin Technology Partners, Modi Ventures, and Gaingels have joined as syndicate partners. “With this initial close of our Series A financing, we are poised to accelerate the development of our innovative candidates for CLN2 disease - with first-in-human dosing planned in late 2025 - and for Huntington’s disease, as we seek to address these challenging conditions.” AAV-mediated gene therapy has long held promise for the treatment of genetically-defined CNS disorders; but, until now, it has been limited by its inability to transduce specific CNS substructures and cell types with requisite specificity. These limitations have led to the reliance on high-dose injections that cause off-target toxicity and difficulties in scalable manufacturing. Latus’s proprietary technologies aim to directly address these challenges by enabling massively paralleled and unbiased screening of novel AAV capsids directly in non-human primates (“NHP”). In these preclinical NHP models, Latus’s capsid variants demonstrated high gene expression in precise CNS locations with target cell specificity and minimal-to-no off-tissue activity. Based on these preclinical data, Latus plans to administer low doses of its product candidates in clinical studies, with the goal of improving safety and enabling successful manufacturing. https://lnkd.in/eb2BmbMw

9

Phio Pharmaceuticals Presenting Data on Its INSTAYL Compound PH-894 at ASGCT's 2024 Advancing Gene and Cell Therapies for Cancer Conference Phio's presentation will focus on how its INTASYL compound PH-894 provides a promising approach for improving the functionality and cytotoxicity of Natural Killer (NK) cells, the body's first line of defense against cancer: PH-894 treatment leads to potent and specific silencing of BRD4 in NK cells, without affecting cell viability. Incorporation of PH-894 during ex vivo NK cell expansion protocols boosts NK cell numbers by enhancing their proliferation, potentially yielding more effective therapeutic doses. PH-894 treatment decreases the expression of CD94, an inhibitory receptor, allowing for improved cytotoxic potential by limiting NK cell inhibition. PH-894 may improve NK cell efficacy in adoptive cell therapies by boosting their immune capabilities. The INTASYL compound PH-894 serves as a foundation for future NK cell-based immunotherapies and supports further exploration of BRD4 as a target in NK cell-based immunotherapies. https://lnkd.in/e2VRxw-c

8

🌟 iBio, Inc. is proud to attend the Antibody Engineering & Therapeutics Conference in our hometown of San Diego this week! 🌟 Our leaders, Kristi Sarno, SVP of Business Development, and Cory Schwartz, Director of Drug Discovery, are on the ground representing iBio’s cutting-edge advancements in AI-driven antibody discovery and development. This event is pivotal for showcasing how iBio's Machine Learning Antibody Discovery Engine and technologies like Epitope Steering, ShieldTx™, and EngageTx™ are accelerating the creation of first-in-class and best-in-class therapeutics. By addressing hard-to-drug targets and reducing preclinical timelines, we're shaping the future of cardio-metabolic therapeutics and immuno-oncology drugs. As San Diego continues to thrive as a biotech hub, our presence reflects iBio's commitment to innovation and collaboration within this vibrant #biotech ecosystem. Conferences like these are where strategic partnerships form, groundbreaking ideas emerge, and the future of antibody engineering takes shape. 💡 Let’s connect! If you’re at the conference, we’d love to discuss how #iBio can support your pipeline goals or explore partnership opportunities. #AntibodyEngineering #MachineLearning #ImmunoOncology #SanDiegoBiotech #Collaboration #iBio

41

🚀 Inocras Inc. and Watchmaker Genomics have teamed up to push the boundaries of clinical whole-genome sequencing assays! 🧬🔬 This thrilling collaboration marks a significant advancement in the field of genomic diagnostics. 🌟 🔬 Collaboration Highlights: -Adopting Advanced Technology: Inocras has integrated Watchmaker’s DNA library prep kits with fragmentation into its CancerVision assay. -Target-Enhanced Sequencing: The CancerVision assay is a state-of-the-art, target-enhanced whole-genome sequencing test designed specifically for solid tumors. -Driving Genomic Innovation: This partnership is set to revolutionize whole-genome sequencing and analytics, paving the way for more precise and advanced diagnostic products. 🗣 Stephanie Ferguson, Chief Clinical Operations Officer at Inocras, says: "We’re proud to demonstrate the power of whole-genome sequencing and analytics through our diagnostics products. Our collaboration with Watchmaker has been important in driving this innovation, and we are excited to continue our partnership on upcoming laboratory-developed assays." 📍 About Inocras: Formerly Genome Insight, Inocras is a San Diego-based spinout from the Korea Advanced Institute of Science and Technology (KAIST). The company excels in developing whole-genome sequencing assays and data curation pipelines focused on cancer and rare diseases. #Genomics #WholeGenomeSequencing #Inocras #WatchmakerGenomics #CancerResearch #BiotechInnovation #HealthcareAdvancements #GenomicAssays #PrecisionMedicine #Biotechnology

3

1 Comment

Mustang Bio Bio Announces Favorable Efficacy and Safety Data from Complete Waldenstrom Macroglobulinemia Cohort of Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR-T Therapy WORCESTER, Mass., June 17, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced that updated data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T-cell therapy, show a favorable safety and efficacy profile in patients with Waldenstrom macroglobulinemia (“WM”), a rare form of blood cancer. MB-106 is being developed in a collaboration between Mustang and Fred Hutch Cancer Center (“Fred Hutch”) to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHLs”) and chronic lymphocytic leukemia (“CLL”). The updated results from the single-institution Phase 1/2 clinical trial were presented during a poster session at the European Hematology Association 2024 Hybrid Congress (“EHA2024”) by Brian Till, M.D., Associate Professor and physician at Fred Hutch and University of Washington. All ten patients in the study were previously treated with Bruton's tyrosine kinase inhibitors (“BTKi”), and their disease continued to progress while on BTKi. Overall, 90% (9/10) of the patients treated with MB-106 responded to treatment, including 3 complete responses, 2 very good partial responses and 4 partial responses. In addition, 1 patient experienced stable disease. One of the patients who achieved a complete response has remained in remission for 31 months, with an immunoglobulin M (IgM) level that decreased rapidly to the normal range after treatment with MB-106 and has remained normal since. Patients had a median of nine prior lines of therapy and only one patient has started additional anti-WM treatment after being treated with MB-106. https://lnkd.in/eRSu7Msk

11