We are excited to announce our latest #royaltymonetization with Agenus. This partnership gives Ligand an interest in multiple oncology products diversified across different targets and indications. Our investment team spent a significant amount of time and effort conducting diligence on each of these unique and valuable assets and we are enthusiastic about the potential of Agenus’ partnered portfolio and the company’s broad and highly differentiated botensilimab and balstilimab (BOT/BAL) clinical development program. Under the terms of the agreement, Ligand is entitled to receive royalties and milestone payments on six Agenus-partnered oncology programs and royalties on future global net sales generated by BOT/BAL. This partnership will support Agenus’ planned confirmatory Phase 3 trial in its lead indication of patients with metastatic, relapsed/refractory colorectal cancer not microsatellite instability-high or deficient mismatch repair, who are without active liver metastases, which received Fast Track Designation from the FDA in April 2023. Read the announcement here: https://bit.ly/3wAqOQF
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"But key to their success is whether ADCs can really become the new Standard of Care (SoC) across a broad range of cancers, replacing the less targeted chemotherapy “gold-standard” in first line, or whether their price tag will limit uptake and their blockbuster potential." In 2023 over 75 ADCs involving #pharma companies rocked the #oncology landscape, with Pfizer taking home the largest acquisition of Seagen for $43 BN. Additionally, standing ovations at ADC readouts and overall noise around these agents at conferences, highlight the frenzy that these potentially tumor-agnostic drugs have caused amongst practitioners and competitors. In this article, written by Solici Senior Associate Consultant Cecilia Boz, PhD, which is the first of a series on the ABC of ADCs, we will take you through the current landscape status and potential. We will further explore the questions -- have ADCs have already maxed out their potential? And where do we expect the field to go next? Read the full article here: https://lnkd.in/eHVkn28i
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My favorite oncology news of the week: 💰 Lilly ($LLY) adds one more deal to the growing list of radiopharmaceutical deals. Lilly will collaborate with Aktis oncology for target discovery with $60M upfront payment and up to $1.1B in milestone payments. https://lnkd.in/efuVrfdY 💡 Cool approach of loading L.plantarum with SN-38 (irinotecan pro-drug) to target heparan sulfate-rich nasopharyngeal carcinoma cells, with decent activity in mice. https://lnkd.in/eedjuHAJ ⬆ Merus' petosentamab is one of my most anticipated presentations for #ASCO24. Not only does the drug seem very active in HNSCC, it also has a novel target (LGR5). n=10; one complete response, five partial responses, and three instances of stable disease. https://lnkd.in/e_F4YhkA
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Therapies in the oncology space face an ever-changing market with new treatments frequently becoming available. It is vital to have brand messaging that clearly demonstrates product benefits and is memorable for physicians. To provide pharmaceutical companies with insight into messaging in their therapeutic categories (both the level of success of their own and competitive detailing), Elma Research developed SmartCall. This is a syndicated programme which provides information on cancer therapies within a given category (e.g., chronic lymphocytic leukaemia) on the key messages that are cutting through, memorable areas of brand differentiation and how messaging is impacting prescribing behaviour. Clients can then use these insights to optimise their communication strategy. To date we have used SmartCall support our clients areas such as multiple myeloma, CLL, RCC, NSCLC, SCCHN, and Ovarian Cancer. If you would like to learn more about the SmartCall projects we have upcoming, contact Kyle Haynes. #elmaresearch #leadingwithideas #marketresearch #insight #oncology
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Director Clinical Development Project Management| Project, Program and Portfolio Management| Strategy and Portfolio Planning| Strategic Alliances| Global Product Team PM Lead| Small molecule/Immunotherapy/ADCs
Clear and succinct summary of the recent ODAC regarding perioperative trial design. Going forward our asset teams need to be aware of the impact of this decision on trial design to best ensure that the clinical question is answered in the trial and the probability of regulatory success is robust.
FDA ODAC Vote: Reshaping Perioperative Trial Designs in Oncology Watch our Chief Medical Officer and former FDA oncology division director, Dr. Harpreet Singh, MD, as she breaks down the recent FDA Oncologic Drugs Advisory Committee (ODAC) vote and its significant implications for drug development. Key points covered: - Unanimous ODAC vote on future perioperative trial designs - FDA's concerns about potential overtreatment in resectable lung cancer - Implications for drug developers across multiple cancer types Dr. Singh's insights: - Need for higher standards in approving long-term post-surgery treatments - How this vote could influence trial designs beyond lung cancer - Potential requirement for additional trial arms to justify treatment phases What does this mean for patients, providers, and the future of cancer drug development? Watch to find out. 💬 How do you think these potential changes in trial design will affect the pace of drug development in oncology? #OncologyTrials #DrugDevelopment #ClinicalTrialDesign Follow Dr. Singh for more #FDAinsights and expert analysis.
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FDA ODAC Vote: Reshaping Perioperative Trial Designs in Oncology Watch our Chief Medical Officer and former FDA oncology division director, Dr. Harpreet Singh, MD, as she breaks down the recent FDA Oncologic Drugs Advisory Committee (ODAC) vote and its significant implications for drug development. Key points covered: -Unanimous ODAC vote on future perioperative trial designs -FDA's concerns about potential overtreatment in resectable lung cancer -Implications for drug developers across multiple cancer types Dr. Singh's insights: -The need for higher standards in approving long-term post-surgery treatments -How this vote could influence trial designs beyond lung cancer -Potential requirement for additional trial arms to justify treatment phases What does this mean for patients, providers, and the future of cancer drug development? Watch to find out. 💬 How do you think these potential changes in trial design will affect the pace of drug development in oncology? #OncologyTrials #DrugDevelopment #ClinicalTrialDesign Follow Dr. Singh for more #FDAinsights and expert analysis.
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Pfizer revealed its oncology business plan during the recent #ASCO2024 meeting in Chicago. The company aims to have eight #blockbuster cancer drugs by as early as 2030, coming from its focused therapeutic areas of hematology, thoracic, breast, and genitourinary cancers. Following the reworking of Pfizer’s commercial infrastructure in which oncology became a separate division, accommodating the $43 billion acquisition Seagen (antibody-drug conjugate specialist) tie-up deal, the company is at the scale ‘it needs to be’ (according to Suneet Varma). The newly merged Oncology Commercial and Medical team will utilize Pfizer’s publicist and digital tools to enhance Seagen’s products, such as the Astellas Pharma-partnered bladder cancer drug Padcev. Also, during the recent ASCO meeting, Pfizer released updated phase 3 results for the ALK inhibitor Lorbrena in newly diagnosed advanced ALK-positive non-small cell lung cancer. Results show that 60% of patients who were given Lorbrena in the CROWN trial stayed alive without disease progression, as opposed to only 8% of patients who received Pfizer’s old ALK drug Xalkori. Lorbrena also caused a 94% reduction in the progression of brain metastases or an 81% reduction in the risk of disease progression or death compared to Xalkori. More updates on what we had eyes on: https://lnkd.in/g6yiS4vt
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FDA ODAC Vote: Reshaping Perioperative Trial Designs in Oncology Watch our Chief Medical Officer and former FDA oncology division director, Dr. Harpreet Singh, MD, as she breaks down the recent FDA Oncologic Drugs Advisory Committee (ODAC) vote and its significant implications for drug development. Key points covered: - Unanimous ODAC vote on future perioperative trial designs - FDA's concerns about potential overtreatment in resectable lung cancer - Implications for drug developers across multiple cancer types Dr. Singh's insights: - Need for higher standards in approving long-term post-surgery treatments - How this vote could influence trial designs beyond lung cancer - Potential requirement for additional trial arms to justify treatment phases What does this mean for patients, providers, and the future of cancer drug development? Watch to find out. 💬 How do you think these potential changes in trial design will affect the pace of drug development in oncology? #OncologyTrials #DrugDevelopment #ClinicalTrialDesign Follow Dr. Singh for more #FDAinsights and expert analysis.
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Does the future of head and neck squamous cell carcinoma (HNSCC) run through Merus N.V.’ petosemtamab? We will be speaking with a leading #oncologist to find out. Learn more here: https://lnkd.in/dFrw4Ejj #biotechnology #cancer #clinicalresearch #medicalaffairs #Merus #pharmaceuticals
KOL Views Preview: Does the future of HNSCC run through Merus’ petosemtamab?
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💥 **New Collaboration: Sanofi, Radiomedix, Inc. , and Orano Med Join Forces to Advance AlphaMedix for Rare Cancers!** 🧬 Sanofi has partnered with RadioMedix and Orano Med to accelerate the development of AlphaMedix (212Pb-DOTAMTATE), a cutting-edge radioligand therapy (RLT) for somatostatin-receptor-expressing neuroendocrine tumors (NETs). **Key Details:** - **Orano Med** will handle manufacturing via its global platform under development. - **Sanofi** will lead the commercialization efforts worldwide. - **RadioMedix** and Orano Med will receive €100M upfront, with potential milestone payments up to €220M, plus royalties. AlphaMedix has shown promising early results, earning FDA Breakthrough Therapy Designation based on significant tumor reduction and a strong safety profile. This collaboration represents a major step forward in the fight against rare cancers, leveraging radiopharmaceutical innovation for patients with high unmet needs. #Sanofi #RadioMedix #OranoMed #RadioligandTherapy #CancerTreatment #AlphaMedix #FDAApproval #Oncology #PharmaInnovation #NeuroendocrineTumors #Healthcare
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The FDA Oncologic Drugs Advisory Committee (ODAC) vote today could have significant implications for the future of perioperative regimens and the standards we set for clinical trials. In today's video I will be sharing: - Background on today’s ODAC vote on AstraZeneca’s lung cancer trial - FDA’s concerns about trial design and patient over-treatment - Implications for future perioperative trials in oncology While providing insights into: - The importance of trial design in proving treatment efficacy - How this vote could affect drug developers across multiple cancer types - Potential changes in FDA trial designs asks for perioperative trials Emerging data suggest that more immunotherapy around surgery doesn’t necessarily lead to better outcomes, raising concerns about potential overtreatment. The FDA has recommended that future trials should isolate the effects of each treatment phase to better evaluate efficacy. 💬 What are your thoughts on the FDA’s stance? How might this impact your work in oncology drug development? --- 🔔 Follow for more #FDAinsights
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