Mellalta Meets

⁉️ ❇️ 𝐓𝐡𝐞 𝐁𝐢𝐨𝐭𝐞𝐜𝐡 𝐓𝐫𝐞𝐧𝐝𝐬 𝐄𝐯𝐞𝐫𝐲𝐨𝐧𝐞’𝐬 𝐈𝐠𝐧𝐨𝐫𝐢𝐧𝐠 (𝐚𝐧𝐝 𝐭𝐡𝐞 𝐇𝐲𝐩𝐞 𝐖𝐞 𝐍𝐞𝐞𝐝 𝐭𝐨 𝐑𝐞𝐭𝐢𝐫𝐞) 𝘊𝘙𝘐𝘚𝘗𝘙 𝘤𝘶𝘳𝘦𝘴 𝘢𝘯𝘥 𝘈𝘐-𝘥𝘦𝘴𝘪𝘨𝘯𝘦𝘥 𝘥𝘳𝘶𝘨𝘴 𝘥𝘰𝘮𝘪𝘯𝘢𝘵𝘦 𝘩𝘦𝘢𝘥𝘭𝘪𝘯𝘦𝘴, 𝘣𝘶𝘵 𝘩𝘦𝘳𝘦’𝘴 𝘸𝘩𝘢𝘵 we are 𝘕𝘖𝘛 𝘴𝘦𝘦𝘪𝘯𝘨 𝘪𝘯 𝘰𝘶𝘳 𝘪𝘯𝘣𝘰𝘹. 📥 ➡️ 1. “𝐀𝐈 𝐂𝐮𝐭𝐬 𝐃𝐫𝐮𝐠 𝐃𝐢𝐬𝐜𝐨𝐯𝐞𝐫𝐲 𝐓𝐢𝐦𝐞!” (𝐁𝐮𝐭 𝐇𝐚𝐯𝐞 𝐘𝐨𝐮 𝐒𝐞𝐞𝐧 𝐭𝐡𝐞 𝐅𝐢𝐧𝐞 𝐏𝐫𝐢𝐧𝐭?) 𝐘𝐞𝐬, 𝐀𝐈 𝐬𝐥𝐚𝐬𝐡𝐞𝐝 𝐭𝐚𝐫𝐠𝐞𝐭 𝐝𝐢𝐬𝐜𝐨𝐯𝐞𝐫𝐲 (𝐟𝐢𝐧𝐝𝐢𝐧𝐠 𝐦𝐨𝐥𝐞𝐜𝐮𝐥𝐞𝐬 𝐭𝐡𝐚𝐭 𝐦𝐢𝐠𝐡𝐭 𝐰𝐨𝐫𝐤) 𝐟𝐫𝐨𝐦 5 𝐲𝐞𝐚𝐫𝐬 𝐭𝐨 6 𝐦𝐨𝐧𝐭𝐡𝐬. 𝐁𝐮𝐭 𝐯𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 𝐜𝐨𝐬𝐭𝐬 (𝐩𝐫𝐨𝐯𝐢𝐧𝐠 𝐭𝐡𝐞𝐲 𝐚𝐜𝐭𝐮𝐚𝐥𝐥𝐲 𝐰𝐨𝐫𝐤 𝐢𝐧 𝐥𝐚𝐛𝐬/𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬) 𝐝𝐨𝐮𝐛𝐥𝐞𝐝. 𝘞𝘩𝘺? 𝘈𝘐 𝘴𝘱𝘪𝘵𝘴 𝘰𝘶𝘵 100𝘒 “𝘩𝘪𝘵𝘴,” 𝘣𝘶𝘵 99.9% 𝘧𝘢𝘪𝘭 𝘪𝘯 𝘵𝘩𝘦 𝘳𝘦𝘢𝘭 𝘸𝘰𝘳𝘭𝘥. 𝘛𝘩𝘦 𝘪𝘳𝘰𝘯𝘺: 𝘞𝘦’𝘳𝘦 𝘴𝘱𝘦𝘯𝘥𝘪𝘯𝘨 $200𝘔 𝘵𝘰 𝘢𝘶𝘵𝘰𝘮𝘢𝘵𝘦 𝘵𝘩𝘦 𝘧𝘪𝘳𝘴𝘵 10% 𝘰𝘧 𝘙&𝘋… 𝘢𝘯𝘥 𝘴𝘵𝘪𝘭𝘭 𝘥𝘳𝘰𝘸𝘯𝘪𝘯𝘨 𝘪𝘯 𝘵𝘩𝘦 𝘭𝘢𝘴𝘵 90%. ➡️ 2. “𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐟𝐨𝐫 𝐀𝐥𝐥!” (𝐔𝐧𝐥𝐞𝐬𝐬 𝐘𝐨𝐮’𝐫𝐞 𝐍𝐨𝐭 𝐔𝐥𝐭𝐫𝐚-𝐑𝐚𝐫𝐞) 80% 𝐨𝐟 𝐠𝐞𝐧𝐞 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬 𝐭𝐚𝐫𝐠𝐞𝐭 𝐝𝐢𝐬𝐞𝐚𝐬𝐞𝐬 𝐚𝐟𝐟𝐞𝐜𝐭𝐢𝐧𝐠 <1,000 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬. 𝐖𝐡𝐲? 𝘙𝘖𝘐 𝘮𝘢𝘵𝘩: 𝘊𝘶𝘳𝘦 500 𝘱𝘦𝘰𝘱𝘭𝘦 𝘢𝘵 3𝘔𝘱𝘦𝘳𝘥𝘰𝘴𝘦=1.5𝘉 𝘳𝘦𝘷𝘦𝘯𝘶𝘦. 𝘊𝘶𝘳𝘦 5𝘔 𝘥𝘪𝘢𝘣𝘦𝘵𝘪𝘤𝘴? 𝘠𝘰𝘶’𝘭𝘭 𝘯𝘦𝘷𝘦𝘳 𝘱𝘳𝘪𝘤𝘦 𝘪𝘵 𝘩𝘪𝘨𝘩 𝘦𝘯𝘰𝘶𝘨𝘩 𝘵𝘰 𝘳𝘦𝘤𝘰𝘶𝘱 𝘙&𝘋. ➡️ 3. “𝐎𝐮𝐭𝐬𝐨𝐮𝐫𝐜𝐞 𝐭𝐨 𝐈𝐧𝐝𝐢𝐚/𝐂𝐡𝐢𝐧𝐚!” (𝐄𝐱𝐜𝐞𝐩𝐭 𝐓𝐡𝐞𝐢𝐫 𝐂𝐨𝐬𝐭𝐬 𝐀𝐫𝐞 𝐄𝐱𝐩𝐥𝐨𝐝𝐢𝐧𝐠) 𝐈𝐧𝐝𝐢𝐚’𝐬 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥 𝐜𝐨𝐬𝐭𝐬 𝐫𝐨𝐬𝐞 12% 𝐘𝐨𝐘 (𝐭𝐡𝐚𝐧𝐤𝐬 𝐭𝐨 𝐭𝐚𝐥𝐞𝐧𝐭 𝐰𝐚𝐫𝐬 𝐚𝐧𝐝 𝐬𝐭𝐫𝐢𝐜𝐭𝐞𝐫 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐬). 𝐂𝐡𝐢𝐧𝐚’𝐬 “𝐜𝐡𝐞𝐚𝐩 𝐥𝐚𝐛𝐬”? 𝐓𝐚𝐫𝐢𝐟𝐟𝐬 𝐚𝐧𝐝 𝐈𝐏 𝐩𝐚𝐫𝐚𝐧𝐨𝐢𝐚 𝐡𝐚𝐯𝐞 𝐁𝐢𝐠 𝐏𝐡𝐚𝐫𝐦𝐚 𝐩𝐮𝐥𝐥𝐢𝐧𝐠 𝐛𝐚𝐜𝐤. 🔥 𝐂𝐚𝐥𝐥 𝐭𝐨 𝐃𝐞𝐛𝐚𝐭𝐞 #𝐁𝐢𝐨𝐭𝐞𝐜𝐡𝐑𝐞𝐚𝐥𝐢𝐭𝐲𝐂𝐡𝐞𝐜𝐤 #𝐏𝐡𝐚𝐫𝐦𝐚𝐓𝐫𝐮𝐭𝐡𝐬 #𝐀𝐈𝐁𝐢𝐚𝐬

2025 Stifel Performance Trends in Pharma and Biotech Easy to digest. 📘 Download the full report here: https://lnkd.in/gGuV4Jjh 💡 What This Report Adds ✔ Strategic frameworks to guide decision-making. ✔ Market opportunities to identify growth areas. ✔ Insights tailored for investors, executives, and entrepreneurs. #Pharma #Biotech Mellalta Meets

🌟 Merus’ Petosemtamab: A Game-changer for R/M, 2L/2L+ HNSCC, post PD(L)1  🌟 R/M, 2L/2L+ HNSCC is a high unmet need patient segment with very limited therapeutic options for the patients and their families. The only approved targeted therapy for this patient segment is Keytruda as a monotherapy which has limited ORR efficacy rate of 16% as per the registrational KEYNOTE-012 trial, where serious adverse reactions occurred in 45 percent of patients. And this was way back in 2016. Post that, for the past 8 years there has not been any monotherapy or targeted therapy approved for this segment. Ironically in these 8 years, a problem arose that is PD(L)1 resistance which makes the patients more prone to disease progression or relapse or resistant to further lines of therapies. In the light of these events, Merus, a Netherlands based Biotech company announced in December 2024, that their drug Petosemtamab demonstrated the ORR of 36% for this patient group, a remarkable 125% increase over Keytruda (ORR:16%) with manageable safety profile. Petosemtamab has ability to impact Tumor microenvironment and potentially could provide a great option for PD1 resistant patients for Solid tumors. We at Mellalta are extremely proud of this Merus’ achievement as we support Merus in Market evaluation of HNSCC especially for R/M, 2L/2L+ HNSCC patient segment. To learn more reach out to us: support@mellalta.com #HNSCC #CancerResearch #Immunotherapy #Petosemtamab #TumorMicroenvironment MSD Merus N.V. Mellalta Meets

We wish you lovely holidays 😊 Thank you for the trust and collaborations throughout this year. We look forward to more engagements in 2025. 🥂Cheers to Mellalta Team, our Partners and Clients!! Mellalta Meets

🚀 Top Pharma Companies by Country 🌍 A recent survey highlights the top-ranked pharma leaders across 13 key markets,participants rated the 34 largest pharmaceutical companies globally based on Trust & Like Scores (TLS)–a highly rated brand and reputation attributes. Here’s a quick snapshot: 🇺🇸 US – Bayer, J&J, Eli Lilly 🇬🇧 UK – Bayer, GSK, Moderna 🇯🇵 Japan – Astellas, Daiichi Sankyo, J&J 🇨🇳 China – Bayer, Novo Nordisk, Roche 🇧🇷 Brazil – J&J, Roche, Bayer 🇩🇪 Germany – Boehringer, Novartis, Roche 🇫🇷 France – Roche, Sanofi, Merck #top2024pharma #FDA #MHRA #HealthCanada #TGA #EMA #PMDA #NMPA #CDSCO #ANVISA #MFDS #Roszdravnadzor #COFEPRIS #SAHPRA

Systemic Gene Therapy- The Promise, The Progress, and The Bottlenecks Systemic gene therapy is revolutionizing rare disease treatment, offering curative potential where traditional therapies have fallen short. But despite approved therapies paving the way, significant bottlenecks remain before the full promise of gene therapy can be realized. 🔬 Curative Intent: Curative Intent definition has changed overtime 🦠 Duchenne Muscular Dystrophy (~20,000 patients): Halt muscle degeneration with functional dystrophin genes. 🦠 Spinal Muscular Atrophy (~30,000 patients): Prevent motor neuron loss by restoring SMN protein levels. 🦠 Hemophilia A (~40,000 patients): Eliminate the need for lifelong factor VIII infusions through sustained gene expression. 🦠 Wilson Disease (~40,000 patients): Restore copper metabolism and prevent organ damage by correcting ATP7B gene function. ⚠️ Bottlenecks Holding Us Back: 1️⃣ Immune Responses: Pre-existing neutralizing antibodies (NAbs) and immune reactions to AAV vectors limit the possibility of redosing and reduce efficacy over time. 2️⃣Durability Issues: Therapies like Zolgensma and Hemgenix show promise but struggle with sustained gene expression, especially in older patient populations. 3️⃣Tissue-Specific Delivery: Diseases like Wilson’s (~40,000 patients) and Fabry (~9,000 patients) highlight the need for targeted therapies that reach key organs like the liver, heart, and kidneys. 4️⃣ CNS Penetration: Disorders such as Hunter Syndrome (~6,000 patients) face the challenge of delivering therapies across the blood-brain barrier (BBB), leaving neurological symptoms largely unaddressed. 5️⃣ Cost & Scalability: With therapies priced in the millions, like Zolgensma ($2.1M), accessibility remains a significant hurdle for patients and healthcare systems. 📊 What are your thoughts on systemic gene therapy’s challenges and opportunities? Also, comment for the PDF. Source: Mellalta Meets #Duchenne #MuscularDystrophy #SMA #SpinalMuscularAtrophy #HemophiliaA #HemophiliaB #WilsonDisease #GaucherDisease #PompeDisease #HunterSyndrome #FabryDisease #OTCDeficiency #HAE #PKU #CriglerNajjar #DM1 #MyotonicDystrophy #NeuromuscularDisorders #BleedingDisorders #LysosomalStorageDisorders #MetabolicDisorders #UreaCycleDisorders #RareDiseases #GeneTherapy #TherapeuticInnovation #RareDiseaseAwareness #GeneTherapyInnovation #RareDiseaseCommunity #PatientCare #GeneTherapyBreakthrough #LysosomalDisorders #NeuromuscularTherapy #MetabolicTherapy #BilirubinMetabolism

Comparative Results of Mutant-Selective PI3Kα Inhibitors PI3Kα Inhibitors are showing exciting results, with high selectivity for PI3Kα mutations like H1047R. Breast and gynaecological cancers remain key areas of focus, but expanding into CNS tumors, rare cancers, and combination regimens could broaden their therapeutic potential. Key Highlights 1) OKI-219 is being tested in phase 1. Robust selectivity for PI3Kα H1047R (~80-100x) and brain penetration, making it a strong contender. Toxicities manageable, with zero discontinuations so far. 2) STX-478, shows tumor reduction in 23% of breast cancer patients and 44% of gynecological cancer patients with fewer side effects. High selectivity (~14x) for PI3K mutants. No brain penetration. 3) LOXO-783 (Loxo oncology was discontinued due to non-favourable results). 4) RLy-2608 is the pan-mutant approach (H1047X, E542X, E545X) with impressive IC50 data (48 nM). Relay is setting expectations. 5) CGT6297 (Eli Lilly) is an ultra-selective (IC50 <5 nM for H1047R) but still in preclinical phases. IND-enabling studies in 2025 will determine if it can compete with advanced candidates. 6) Brain penetration remains a barrier for most candidates except OKI-219 Let me know your thoughts and comments for the PDF. #breastcancer #PI3KαInhibitors #gynecologicalcancer Follow Mellalta Meets

Semaglutide is redefining chronic care. The numbers speak for themselves. Semaglutide’s eligibility spans 136.8 million U.S. adults, reflecting an unprecedented shift in chronic disease treatment. The drug’s broad applicability across weight management (94.5%, 129.2M), diabetes (35M), and cardiovascular disease (8.9M) positions it as a cornerstone therapy in the GLP-1 landscape. Strategic Observations: 1️⃣ Weight Management Drives Market Leadership: With 129.2M eligible adults, semaglutide extends far beyond its origins as a diabetes therapy, dominating cardiometabolic health management. 2️⃣ Overlapping Indications Enhance Utility: The 39.3M adults qualifying across multiple indications (diabetes, CVD, weight management) highlight a rare synergy that strengthens its commercial viability. 3️⃣ Future Potential in CVD Expansion: While CVD eligibility is smaller (8.9M), a high overlap with metabolic conditions creates strategic opportunities for adjacent indications like chronic kidney disease. Challenges Ahead: Scaling affordability and access will be critical, especially with 40.6M eligible individuals covered by Medicare and Medicaid. Scalable pricing strategies must balance payer sensitivity with maintaining margins. Let me know if there are other points you'd highlight or if you'd frame these differently! And feel free to comment for the PDF. #semaglutide #GLP1landscape #CVD Mellalta Meets

Oncology Licensing Deals Dominance in 2023/2024 1. Phase 2 is the sweet spot. Mid-stage deals now dominate, accounting for 60.2% of dollar volume in 2023/2024—a sharp rise from 15.4% in 2008–2015. This shift reflects growing confidence in programs that offer clinical validation and commercial readiness while balancing risk and reward. 2. Early-stage deals are losing momentum. Preclinical deals dropped from 14.2% to 5.6%, and Phase 1 fell from 53.3% to 24.9%. The market is steering away from unproven pathways and focusing on assets with clearer outcomes and lower development risk. There are some patterns emerging that are worth noting: 1. Partnerships amplify potential. Aligning with partners who complement your strengths—whether in manufacturing, regulatory expertise, or market access—can reduce risks and speed up development timelines. 2. Finding untapped patient segments or specific differentiation points (e.g., genomic profiles, mutations, prior treatments) helps secure a solid foothold. This not only builds a niche position but also creates leverage for broader market penetration. 3. Competitive intelligence is important. Understanding competing assets, their design decisions, and how they differ from yours is critical. Modeling commercial and clinical outcomes at scale can help refine your strategy and uncover growth opportunities in a crowded market. Let me know if there are other points you'd highlight or if you'd frame these differently! And feel free to comment for the PDF. #oncologydeals #keytakeaways #licensingdeals

🌐 Attending CPhI India 2024 – Insights from the Pharma Connect Congress We’re honored to attend Pharma Connect Congress 2024 in Delhi NCR, a gathering of top leaders and visionaries in pharma and biopharma. This year’s congress is set to explore the pivotal industry trends that will shape the future of healthcare, focusing on sustainable innovation, agile manufacturing, digital transformation and sustainability. 2024 Key Industry Trends & Leadership Discussions: Day 1: Leadership Panels 🔹 Continuous Innovation in Therapeutics: Leaders discuss strategies for dynamic portfolio selection, agile manufacturing, and AI-driven process development to meet emerging therapeutic needs. 🔹 Digital Transformation: Addressing the integration of Industry 4.0 technologies, from IoT to digital twins, to elevate manufacturing and streamline value chain operations. 🔹 Positioning India as the "Pharmacy of the World": Strengthening cost-effective production in generics and biosimilars, with a core focus on government-backed R&D and compliance. 🔹 Biosimilars & Cost-Effective Manufacturing: Expanding biosimilar potential in emerging economies and ensuring compliance with quality standards. 🔹 Quality and Compliance: Emphasizing proactive Quality by Design (QbD) and strong regulatory compliance through digitalized quality management systems. Day 2: Sustainability & Compliance Focus 🌍 ESG & Net Zero Goals: Delving into actionable ESG strategies, waste management, and lifecycle assessments to drive industry-wide sustainability. 🌱 Green Chemistry & Packaging Innovations: Exploring sustainable drug discovery processes and eco-friendly packaging solutions to reduce carbon footprint and support a circular economy. 🔋 Supply Chain Decarbonization: Initiatives like Schneider Electric’s Energise program to drive renewable energy adoption in pharma, with a focus on reducing Scope 3 emissions. 📦 Sustainable Packaging: Shifting toward a circular economy and efficient cold-chain logistics for lower carbon footprints, especially in advanced biopharma. Find the agenda link in the comments section Let’s connect at CPhI India to discuss how we can leverage these insights to drive sustainable growth and innovation in the pharma landscape! 📅 Date: November 26-27, 2024 📍 Location: India Expo Centre, Delhi NCR, India Mridhu Verma Mellalta Meets #CPhIIndia2024 #Sustainability #NetZero #GreenChemistry #CPHI