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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

Type 1 Diabetes (T1DM) Cell Therapy –Progress Towards a Functional Cure With 8.5 million people affected globally, Type 1 Diabetes continues to present significant management challenges. Recent developments in cell therapy, however, are positioning the field closer to a functional cure, reducing or eliminating reliance on daily insulin. 🔑 Lantidra (Donislecel) – The first FDA-approved islet cell therapy for T1DM, offering insulin independence for patients with recurrent severe hypoglycemia. 🔑 VX-880 (Vertex Pharmaceuticals) – A stem-cell derived therapy in Phase I/II trials with Fast Track Designation by the FDA, focused on regenerating functional β-cells. Preliminary results were exciting. 🔑 Sernova’s Cell Pouch System – Under clinical investigation, this implantable device supports islet cell function while potentially reducing insulin needs. 🔑 ViaCyte’s PEC-Direct/PEC-Encap – Stem cell-based solutions with promising clinical trial data for β-cell replacement, aimed at addressing both encapsulated and direct cell delivery. Key Innovations: 🌕 Stem cell-derived islets offer a renewable source for β-cell transplantation, though safety and efficacy remain priorities. 🌕Genetic engineering of β-cells shows promise in reducing immune rejection and enhancing resilience, but further validation is necessary. 🌕Local immunomodulation is emerging as a strategy to bypass systemic immunosuppression in transplant therapies. 🌕Preclinical data shows immunoprotected islet cell grafts could maintain normoglycaemia for over a yearwithout systemic immunosuppression. As cell therapy advances, the focus remains on creating safe, scalable, and cost-effective solutions that align with real-world healthcare systems and patient needs. #T1DM #CellTherapy #Biotech #StemCells #DiabetesCare #Mellalta

Key Catalyst Events ito Watch in September.

Investors are shifting their focus within the oncology and immunology space. Recent trends show a decreased interest in complex therapeutics like CAR-t, NK's, TCR's, and oncolytic viruses. Instead, there is a growing preference for ADCs, antibodies, and engagers due to cost-effectiveness and reduced administration times. Key highlights in the industry include: - Over 13 ADCs currently marketed, with a projected market value of 26 billion by 2028. - Seagen leads with 10+ drugs in clinical trials, followed by Merck and Daiichi Sankyo. - ADCs primarily target breast, lung, and genitourinary (GU) cancers in ongoing clinical trials. - HER2 stands out as the most favorable target for ADCs, alongside c-met, B7H3, B7H4, ROR1, and others. - Future Phase 1 trials will explore ADCs for lymphoma and other targets If you are interested in this space, feel free to reach out for more information. #Oncology #Immunology #ADCs #CancerResearch

AstraZeneca and Presage Biosciences collaborates for a “Remarkable Intratumoral Evaluation of 3 Novel Drugs (done concurrently)”: A Ground-breaking Tumor microenvironment analysis in HNSCC Antitumor efficacy in PCT models doesn't translate faithfully to patient outcomes– a fundamental problem in cancer drug development! To address this inconsistency, Presage Biosciences have developed a technology platform called CIVO (Comparative In Vivo Oncology), which enables simultaneous assessment of up to eight drugs or drug combinations within a single solid tumor in vivo. On April, 2024, Astra Zeneca in collaboration with Presage Biosciences initiated a Phase 0 trial. (Phase O studies can help identify, early in the process, promising candidates for continued development and eliminate those lacking promise). Key facts: 🚩 The purpose of this trial was to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, and sabestomig within the tumor microenvironment (TME) of HNSCC tumor when administered intratumorally in microdose quantities via the CIVO device (Based on Presage’s CIVO Platform). 🚩 AstraZeneca (AZ) is developing 3 bispecific novel monoclonal antibodies: rilvegostomig, volrustomig, and sabestomig designed to stimulate antitumor immunity. 🚩 Using Presage’s CIVO device, AZ will get to evaluate the intratumoral activity of all these 3 drugs simultaneously, by injecting their microdoses, that too, in a single patient tumor, while the tumor is still in the patient, in its native environment! 🚩 Pembrolizumab will also be injected in a single patient tumor to see how it compares with the other 3 AZ’s novel drugs. Why is this process unique?  Because microdoses of the novel drugs are injected directly in the tumor (thereby maintaining the tumor microenvironment), the results produced would be more promising than systemically administering the evaluated drug. All this while Presages CIVO platform tracks the drug exposure intratumorally and provides quantitative analysis on distinct cell populations within the intact TME.    Implications for Drug Developers  This trial represents a significant opportunity for drug developers to gain insights into tumor and microenvironment responses to multiple drug combinations. The data obtained could revolutionize the strategies for developing more effective treatments for HNSCC and potentially other cancers. Are you looking to stay ahead in oncology drug development? Contact us to learn how our market research and consultancy services can help you leverage the latest advancements, like the CIVO platform, to accelerate your drug development process and optimize your clinical trial outcomes. Email us at support@mellalta.com #Oncology #CancerResearch #HNSCC #DrugDevelopment #Pharma #Biotech #Innovation #ClinicalTrials #Phase0 #CIVOPlatform #PresageBiosciences #AstraZeneca #Consulting #MarketResearch

🏥 34% of HCPs utilize AI/ML to identify under/misdiagnosed patients–HCP Engagement and Patient Identification with Advanced Analytics In today’s data-rich environment, life science leaders are poised with more resources than ever—abundant real-world data paired with cutting-edge analytics tools. Yet, finding and engaging the right customers, whether patients or healthcare providers (HCPs), at the right time remains a challenge. Why is this, and what can be done about it? A survey conducted by Real Chemistry with studioID reveals a surprising gap: only 34% of respondents utilize AI/ML to identify undiagnosed or misdiagnosed patients, whereas 53% deploy these technologies to locate new patients for their products. There is a significant opportunity to better utilize AI and ML tools to tap into previously inaccessible patient segments. Here are some key strategies and insights: 1️⃣ Leveraging Machine Learning for Patient Discovery Most biopharma companies are adept at identifying patients within narrowly defined parameters. However, utilizing AI and ML can uncover patients who might be undiagnosed, misdiagnosed, or about to switch treatments—potentially transforming patient care in areas like rare diseases. 2️⃣ Understanding HCPs Beyond Prescriptions Traditional HCP datasets often lack depth, reducing the effectiveness of engagement strategies. By integrating AI-enhanced real-world data, companies can gain insights into HCPs as individuals, enhancing engagement strategies significantly. 3️⃣ Coordinated Omnichannel Approach Identifying potential patients and HCPs is just the start. The real challenge lies in delivering coordinated, data-driven messaging across multiple channels to activate these targets effectively. Advanced analytics platforms like Real Chemistry’s Swoop are redefining how messages are tailored and delivered, ensuring relevance and timing are optimized. 🎯 Case Study Highlight: AVEO Oncology AVEO Oncology's use of @Real chemistry IPM.ai showcases the power of targeted analytics. By predicting therapy changes 2-3 months in advance, AVEO was able to engage HCPs with timely messages, leading to a significant increase in patient conversion. Approximately 47% of new patient starts in Q1 2022 were traced back to these predictive alerts. Want to dive deeper into the companies that are using predictive analytics to transform patient engagement in oncology? Connect with us. #DataScience #MachineLearning #PatientCare #HCPengagement #RealChemistry #Analytics