Charmaine Lykins

Next‑generation NLRP3 Inhibitors: The Future GLP‑1 Blockbuster? New article out today. Bottom line for pharma leadership: * NLRP3 is emerging as a franchise‑scale “master switch” for chronic disease and healthy longevity—and a competitive * NLRP3 program is now a strategic necessity. What’s changed: • Human validation is unequivocal (CAPS GOF mutations → IL‑1β biology; downstream IL‑1 blockade already disease‑modifying). • Research/funding inflected: NIH projects mentioning “NLRP3” grew from 392 (FY2020) to 1,326 (FY2024). Publications exploded across neurology, cardiology, and metabolism over the last decade. • Big‑pharma votes of confidence: Roche acquired Inflazome (≈€380M upfront, 2020); Novartis acquired IFM Tre ($310M upfront + up to $1.265B, 2019); Novo Nordisk licensed Ventus’ peripherally‑restricted inhibitor (deal value up to $700M, 2022). • Chemistry is maturing beyond early scaffolds (e.g., MCC950/GDC‑2394 toxicity attributed to scaffold, not target). Multiple next‑gen series now showing cleaner early safety. Why executives should care: • Pipeline‑in‑a‑product: addressable indications span Alzheimer’s, Parkinson’s, gout, IBD, CKD, NASH, atherosclerosis, osteoarthritis, COPD/IPF, obesity, and aging biology itself (“inflammaging”). • Synergy with GLP‑1s: CNS‑penetrant NLRP3 inhibitors can reduce hypothalamic inflammation; preclinical data show additive/synergistic weight loss and durability—positioned as a must‑have combination for a $100B+ category. • Differentiation vectors that matter: brain penetration vs peripheral restriction, long‑term safety, selectivity vs other inflammasomes, scaffold liability, DDI profile, oxidation risk, and once‑daily oral convenience. • IP tail: several best‑in‑class candidates carry 2023–2024 priority‑date composition‑of‑matter claims—~16–17 years fresher than some first‑gen assets. Competitive landscape highlights (from the piece): • >20 companies and >25 inhibitors across stages; class de‑risked yet still wide open for genuine best‑in‑class chemistry. • Insilico Medicine: ISM8969 (AI‑designed, brain‑penetrant) built for high potency, selectivity, and long‑term safety; broad indication strategy. Operator checklist for BD/R&D: • Prioritize scaffolds with proven translatability, clear CNS/peripheral knobs, and clean liver/safety margins. • Optimize for durability, once‑daily oral dosing, and scalable manufacturing. If GLP‑1s defined the last decade, targeted anti‑inflammasome therapy can define the next. The companies that win will pair iron‑clad chemistry with disciplined clinical and IP strategy. Read the full analysis: “Next‑generation NLRP3 Inhibitors: The Future GLP‑1 Blockbuster? A Potential Longevity Therapeutic Targeting Inflammaging.”  https://lnkd.in/gTD_5DGd

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🔎 Novo Nordisk + GoodRx: GLP-1 Pricing Reset 💊 Novo Nordisk will now offer Ozempic® and Wegovy® at $499/month for self-pay patients. 📦 Distribution runs through NovoCare and GoodRx’s 70,000-pharmacy network. ��️ This is not a pilot. It is a structural shift in access. 📌 Observed Facts • Ozempic list price ~$936/month → $499 nearly halves cost • NovoCare, built for Wegovy, now extended to Ozempic • GoodRx adds scale with 30M+ active consumers • GoodRx stock +29% on announcement; Novo Nordisk +5% (also lifted by Wegovy’s FDA MASH approval) 🌐 Market Context • GLP-1 generics and compounded alternatives accelerating • Consumer health platforms (Hims & Hers, Ro, telehealth clinics) expanding into weight loss • PBM and insurer restrictions uneven → widening cash-pay gap 📊 Implications for Competitive Dynamics • Novo aligns branded GLP-1 pricing across channels to curb leakage to off-label and compounded use • $499 is now the consumer anchor price for branded GLP-1s in the U.S. • Competitors must either match affordability or risk losing share among cash-pay and uninsured segments 🧭 Molekule Assessment Cash pay is now codified as a formal channel. The $499 anchor sets a reference price that investors, competitors, and policymakers will use to value the GLP-1 market. #GLP1 #DrugPricing #MarketAccess #PharmaStrategy #Biopharma

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This article captures an inflection point in vaccine development, the growing recognition that vulnerable populations need more than what first-generation single-antigen vaccines can provide. GeoVax Labs, Inc.’s GEO-CM04S1 data demonstrates that a multi-antigen MVA approach can generate both robust antibody and durable T-cell responses in immunocompromised patients. The Phase 2 results in CLL patients, where our vaccine succeeded while the mRNA comparator was halted, underscore why broader immune engagement matters for these populations. Worth reading for perspective on the evolving vaccine landscape and the shift toward next-generation platforms. Read the article: https://lnkd.in/esniG85d #Vaccines

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𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐍𝐞𝐰𝐬: Corvus Pharmaceuticals CEO Richard Miller, MD fields follow-up questions about last week's atopic dermatitis data for the ITK inhibitor soquelitinib. Full video: https://lnkd.in/eNDiQZSx He discusses learnings about durability, dosing, biomarkers, and more for this first-in-class target. BiotechTV is brought to you by: Mispro | Breakthrough Properties | HSBC Innovation Banking | Allucent | NYSE | Klein Hersh | Savills North America | Genezen | Orchestra | Evaluate Ltd

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🚀 Exciting Asset Acquisition News 🚀 Today we announce our acquisition of two new clinical assets. These assets struggled in clinical trials with safety issues after $10m’s of investment - but we know why, and how they can be fixed. This is another key step towards Ignota Labs’ mission: turning around failing drugs and bringing fresh hope to the patients waiting for these life-saving treatments. These assets were purchased from Kronos Bio, formerly a public company once valued at $3.5bn, now dissolved. Find out more about how we are turning them around to get them to patients faster here: https://lnkd.in/eWu_YZ7K #DrugDiscovery #AI #pharma #drugturnaround #pipeline

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RxLightning offers pharma manufacturers affordability options and integrations, like integrated PAP, copay assistance and foundation options that support patient affordability and access - while integrations for RTBC and ePA streamline the onboarding process.

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🚀 Weekly ADC Insights: Regulatory, Clinical & Corporate Updates. The ADC pipeline is deeper and more diverse than ever. With expanding indications, advanced platforms, and fresh capital—2025 may redefine. Here are the latest highlights you shouldn't miss 👇 Exhibit#1: Companies with ADC and latest updates 🎯 Regulatory Milestones 🏅 Daiichi Sankyo US: ENHERTU sNDA filed in Japan for HER2+ metastatic solid tumors (4 pivotal Ph2 trials). 🧪 Kelun-Biotech: FDA cleared IND for SKB518 in the U.S.; Ph1 ongoing in China. 🧪 Keymed Biosciences: NMPA approved IND for CDH17 ADC (GI cancers); strong preclinical safety & efficacy. 💼 Corporate Developments 💰 Daiichi Sankyo US / AstraZeneca: DATROWAY off to a solid start—¥1.4B (~$10M) sales in HR+/HER2– mBC. 💰 Synthetic Design Lab: Raised $20M to scale SYNTHBODY™, enabling 10x improved payload delivery. 🤝 1STBIO x Ligachembio Sciences: Strategic R&D/licensing deal for 2–4 novel ADC payloads. 🏭 LOTTE BIOLOGICS: Opened $100M ADC CDMO facility in NY; first clinical contract secured. 📅 AACR 2025 Highlights 🔬 Innovent Biologics: IBI3010, IBI3014, and IBI3022 data in solid and gynecologic tumors. 🔬 Pfizer/Nona Biosciences: Presented PF-08052666 (TOP1i ADC) with strong preclinical activity in solid tumor models. Ph1 ongoing 🔬 NextPoint Therapeutics, Inc.: Unveiled NPX125 (B7H7 ADC) showing potent tumor regression; IND expected mid-2026. 🔬 Cantargia AB: Highlighted anti-IL1RAP ADC with robust tumor inhibition. 🔬 Zai Lab: ZL-6201 (LRRC15 ADC) showed strong tumor suppression; IND planned for 2025. 🔬 Zymeworks Inc.: Shared preclinical results on ZW327 (Ly6E ADC) and a biparatopic PTK7 ADC with strong internalization and activity. 🔬 Elevation Oncology: EO-1022 (HER3 ADC) demonstrated improved stability and reduced toxicity 🔬 ADC Therapeutics: Highlighted three exatecan-based ADCs (CLDN6, PSMA, ASCT2) potent and well tolerated. 🔬 Mythic Therapeutics, Inc.: MYTX-011 (cMET ADC) showed efficacy across multiple xenograft models. 🔬 Innate Pharma: IPH4502 (Nectin-4 ADC) outperformed EV in resistant UC. 🔬 SOTIO Biotech: Presented SOT109 (CDH17 ADC) and SOT106 (LRRC15 ADC) with potential across CRC and sarcomas. 🔬 Acepodia: Introduced dual-payload ADC platform (AD2C) targeting GPC3 in HCC. 🔬 Kowa Pharma: Demonstrated superior efficacy of K-679 (ultra-high-DAR ADUC) in EGFR+ tumors. 🔬 Debiopharm: Showcased Debio 1562M (CD37 ADC) with potency in AML/MDS and AbYlink™ conjugate platform. 🔬 GlycoNex Inc. : GNX1021 (branched Lewis B/Y ADC) exhibited activity in gastric ca with high tumor selectivity. 🔬 Alphamab Oncology: Presented bispecific ADCs — JSKN021 (EGFR/HER3) and JSKN022 (PD-L1/ITGB6/8) — strong tumor inhibition. 🔬 Precision Biologics, Inc. : PB-223 ADC (core 2 O-glycan target) demonstrated preclinical efficacy. 💬 Which ADCs do you think are poised for breakout success in 2025? Let’s explore together! ⬇️ #ADCs #Oncology #Biotech #PrecisionMedicine #PhenomiqsInsights #WeeklyUpdate #AACR2025

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GLP-1 receptor agonists have taken center stage in metabolic and obesity research. With its rapid growth in the industry, how do you ensure accurate, reliable analysis of these peptides? This LCGC International article featuring Market Development Manager Sean Orlowicz breaks down the essential tools and techniques for GLP-1 analysis, helping labs stay ahead in an evolving therapeutic space. 👉 Read more: https://bit.ly/3SOTBbR #DanaherNews #GLP1 #Pharmaceutical

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