Immunai’s Post

And if you want to read a bit more, here is the formal post

✨ Stay at the forefront of #Oncology advancements! Today’s Pharma Daily Digest delivers essential insights and trends shaping the future of #cancer treatments.   📌 Merck's Phase 3 Trial Success: Subcutaneous Pembrolizumab (Keytruda) Meets Primary Endpoints in Lung Cancer Treatment 📌 Amid strategic rebranding to BeOne Medicines, BeiGene Settles Patent Litigation, Secures BRUKINSA's Market Exclusivity Until 2037. This milestone ensures BeiGene's exclusive market rights for BRUKINSA®, a leading treatment for blood cancers such as mantle cell lymphoma and chronic lymphocytic leukemia, through 2037. 📌 Lindis Biotech GmbH and Pharmanovia Partner to Commercialize Catumaxomab, Pioneering Treatment for Malignant #Ascites, with EMA’s Positive Opinion Paving the Way for EU Approval 📌 Lunit Oncology and AstraZeneca Partner to Revolutionize NSCLC Diagnosis and Treatment with AI-Powered Tools, Advancing Precision Medicine and Improving Patient Outcomes 📌 Novartis and Ratio Therapeutics Forge $745M Partnership to Develop Innovative Radiopharmaceuticals for Cancer Treatment 📌 FDA Approves FoundationOne®Liquid CDx as First Companion Diagnostic for TEPMETKO® in #LungCancer 📌 AbbVie Secures European Commission Approval for ELAHERE® in Ovarian Cancer Treatment. In a strategic move, AbbVie has partnered with Roche Diagnostics USA diagnostics to enhance personalized cancer care through the VENTANA® FOLR1 RxDx Assay 📌 Avenzo Therapeutics Secures Exclusive Option with VelaVigo for Groundbreaking Cancer Treatment, Bolstered by $386M in Series A Funding 📌 Syndax Pharmaceuticals' Revuforj Wins FDA Approval as Novel Treatment for Aggressive #Leukemia ----- 💡 Don't forget to sign up for daily updates within the pharma and biotech industry. #PharmaDailyDigest #Pharmaceuticals #Biotech #CompetitiveIntelligence #AtacanaGroup #abbvie #Astrazeneca #BeiGene #rochediagnostics #AstraZeneca

OncoC4, Inc. has announced #FDA clearance of the IND application for AI-081, a potentially best-in-class PD-1/VEGF bispecific antibody, for the treatment of advanced solid tumors. This marks a major milestone in the fight against cancer! AI-081 is designed to harness robust cooperative interactions between PD-1 and VEGF, enabling superior anti-tumor activity as demonstrated in preclinical studies. The innovative therapy will soon begin its journey into clinical development, with the first patient dosing in the BIPAVE-001 Phase 1/2 trial expected in Q1 2025. This trial aims to evaluate the safety, pharmacokinetics, and efficacy of AI-081, potentially offering a groundbreaking new treatment option for patients battling advanced solid tumors. 📍 Based in Rockville, MD, OncoC4 continues to advance its pipeline of first-in-class and best-in-class therapies, building on its mission to transform the landscape of cancer treatment. #Oncology #ClinicalTrials #Innovation #Biopharma #CancerResearch #PD1VEGF https://lnkd.in/eaRUhpM6

I didn't realize just how many oncology stories we write regularly across Fierce Pharma and Fierce Biotech until we started the Fierce Oncology newsletter a few days ago. To compile our next biweekly collection of 30~ stories, I had to leave out 20~ articles. It is stories such as Roche's SKY-01-fall and $1.5B Poseida Therapeutics, Inc. buyout, as well as Merck's and BioNTech SE's PD-(L)1xVEGF bispecific acquisitions, that keep reminding us that cancer drugs remain a top focus among biopharma companies. In case you didn't receive our inaugural issue, you can register for all our free newsletters from the Fierce Life Sciences universe here: https://lnkd.in/eSqk8nxK See you every other Wednesday. #cancerdrugs #cancertreatments #cancertherapies #oncology #Roche #Merck #BioNTech #acquisition #bispecific #cancer #FierceOncology #mergersandacquisitions #productlaunch #newsletter

In the oncology space, drug developers are keen to develop cutting-edge solutions—and lay claim to a piece of a market estimated to hit $359.1 billion by 2028. However, most Phase III trials fail to present significant clinical improvements on the standard of care. Attached is a brief article from BioSpace that highlights five trials with game-changing potential for oncology and the potential to influence the current market. 

💡 Revolutionizing Cancer Treatment: A New Era in Solid Tumor Drug Development! 💡 The U.S. FDA has just released an insightful Guidance for Industry on using circulating tumor DNA (ctDNA) for curative-intent solid tumor drug development. This document is a monumental step forward in precision oncology, offering a beacon of hope for patients and an innovative roadmap for researchers and pharmaceutical developers. 🔬 What is ctDNA? Circulating tumor DNA refers to fragments of DNA shed by tumors into the bloodstream. This cutting-edge biomarker has immense potential to transform cancer diagnosis, treatment, and monitoring. 💉 Key Applications Highlighted in the Guidance: 1️⃣ Patient Selection: Leveraging molecular alterations for tailored treatments. 2️⃣ Molecular Residual Disease (MRD): Detecting minimal disease to refine therapy strategies. 3️⃣ Measuring Drug Response: Assessing efficacy in real-time during clinical trials. 4️⃣ Early Endpoints: Using ctDNA as a surrogate for survival outcomes in trials. 📋 Why This Matters: The incorporation of ctDNA into drug development for early-stage solid tumors could dramatically accelerate the approval of life-saving therapies while reducing invasive procedures for patients. This document also outlines assay considerations and investigational device frameworks to ensure clinical and regulatory success. 🔥 A Call to Action: Researchers: Dive into the guidance and innovate! Let's harness ctDNA to bring game-changing therapies to the forefront. Pharmaceutical Developers: Align with these FDA recommendations to streamline regulatory pathways. Healthcare Professionals: Stay informed on how this technology can enhance patient care. Together, we can shape the future of oncology! 💪 Let’s discuss: How do you see ctDNA transforming cancer treatment in the coming years? Share your thoughts below! 👇 #PrecisionOncology #DrugDevelopment #ctDNA #CancerTreatment #FDA #Innovation #Healthcare

#CDK2 is a promising target for many therapeutic indications, including cancer. While first-generation inhibitors faced challenges with tolerability, new candidates from Pfizer, Blueprint Medicines, Incyte, AstraZeneca, and Incyclix Bio are advancing in clinical trials. 🔬 What future CDK2 inhibitors await discovery? We're proud to work with a leading computational drug discovery company leveraging #computersimulations, #machinelearning and #AI to speed-up the discovery of new CDK2 targets, among others. ➡ In a recent project, they were able to screen 18 million fragment-size molecules, identified 10 compounds within 3 weeks, achieving a 20% hit rate with two promising hits. Refinement and testing of the top 12 compounds in 4 weeks led to a remarkable 92% hit rate! In 2 months, they discovered 13 effective hits from testing just 22 compounds, showcasing the efficiency of their approach. 🚀 Want to learn more? #CDK2Inhibitors #CancerResearch #DrugDiscovery #Cdk2 #ComputationalChemistry #MachineLearning #PrecisionMedicine https://lnkd.in/dvmn6N8D

Recent advances in cancer treatment using CDK inhibition have focused on targeting CDK4/6, an approach limited by drug resistance. Our #client Incyclix Bio is developing a potent and selective #CDK2 inhibitor to treat patients whose tumors are insensitive to CDK4/6 inhibition. Read more about what's next in #CDK inhibition: https://lnkd.in/dvmn6N8D

📢 New Insights: Oncology's Research Boom and Our Role in Transforming Clinical Trials 📢 We are excited to share insights from a recent article on the oncology research boom, highlighting the dynamic advancements and challenges in cancer treatment development. 🦖 The dinosaur age of clinical trial methods is officially extinct, and we're at the forefront of this transformation! 🔬 Article Highlights: Since 2015, the FDA has approved over nine dozen new cancer drugs, reflecting the rise of cancer immunotherapy and progress in genetic-based treatments. Many new drugs are reaching the market, emphasizing the need for more precise and targeted clinical trials. At Clinical Trial Scan, our innovative approaches align perfectly with these industry shifts: 🧬 Enhanced Targeting: Our patient-centric methodologies and advanced hyper-targeting algorithms ensure that the right patients are matched with the right trials, improving recruitment efficiency and trial outcomes. 📈 Streamlined Processes: We leverage cutting-edge technologies to accelerate patient enrollment and enhance retention rates, ensuring robust data integrity and reliable results. 📊 Impactful Outcomes: Our commitment to personalized outreach and comprehensive support systems leads to more meaningful trial results, supporting the development of groundbreaking cancer therapies. Read the full article on the oncology research boom here: https://lnkd.in/e8dRWG2M Join us as we continue to advance healthcare by revolutionizing clinical trial recruitment and engagement. Schedule a call with us today to discover how we can support your research and drive success: https://lnkd.in/e_7UZBmi #ClinicalTrials #PatientEngagement #MedicalResearch #HealthcareInnovation #ClinicalResearch #Pharma #Biotech #HealthTech #PatientRecruitment #OncologyResearch #CancerResearch #PatientCentricity #DigitalHealth

AbbVie and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies, today announced a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology. The discovery partnership will leverage EvolveImmune's T-cell engager platform to develop novel antibody-based therapies for solid and hematologic malignancies. EvolveImmune's proprietary EVOLVE platform is designed to deliver potent, selective and integrated T-cell co-stimulation to amplify and sustain the tumor killing capacity of the T-cells. This approach aims to bypass low tumor immunogenicity, conditionally activate adaptive immunity and reduce T-cell dysfunction to overcome therapeutic challenges in solid and hematologic tumors. "AbbVie is dedicated to advancing the understanding of devastating diseases like cancer and investing in groundbreaking technologies and therapeutic platforms, to deliver novel treatments for patients with high unmet needs," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "We are excited to collaborate with the talented team at EvolveImmune to further advance their novel T-cell engager platform technology." "This collaboration with AbbVie, a global leader in oncology, offers tremendous validation of the EVOLVE platform and the dedicated and creative work of the EvolveImmune team," said Stephen Bloch, MD, chief executive officer of EvolveImmune. "We believe that EVOLVE, with its differentiated CD2 co-stimulation strategy, represents a potential next-generation, best-in-class T-cell engager platform and that our technology may offer clinically meaningful benefits for patients." Under terms of the agreement, EvolveImmune will receive $65 million in aggregate upfront fees and equity investment from AbbVie and is eligible for up to $1.4 billion in aggregate option fees and milestones, as well as tiered royalty payments on net sales. #oncology #immunooncology #collaboration #EvolveImmune #AbbVie