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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

Thank you for meeting us at Bio-Japan. We’re Mellalta Meets – where innovation meets strategy. We’re excited to explore new synergies and build transformative solutions together. #biojapan2024 Mellalta Meets