James P. Crowley’s Post

🚀 Exciting News from Kyverna Therapeutics! 🌟 #FDA #FastTrack #InnovationInHealthcare #MultipleSclerosisTherapy #KyvernaTherapeutics 🔬 The FDA has just granted fast track designation to Kyverna Therapeutics' groundbreaking CAR T-cell therapy, KYV-101, specifically aimed at treating multiple sclerosis (MS). This is a major leap forward in autoimmune disease treatment, showcasing Kyverna's commitment to innovative healthcare solutions. 👩🔬KYV-101, an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell therapy, is designed to target the CD19 protein on the B cell surface - a key player in various autoimmune diseases. This therapy represents a novel approach, modifying patients' T cells to effectively identify and eliminate B cells. 🧬 Originating from a collaborative effort with the US National Institutes of Health, the CAR in KYV-101 has been engineered for enhanced tolerability and has already shown promise in a 20-subject Phase I oncology trial. 🔎 Following the FDA's fast track designation for KYV-101 in myasthenia gravis last month, this new status for MS treatment accelerates the development and review process, addressing a critical unmet medical need. 🌍 As a clinical-stage biopharmaceutical leader, Kyverna is not stopping here. Plans are underway for further trials of KYV-101 in systemic sclerosis, myasthenia gravis, and multiple sclerosis, reinforcing their dedication to transforming the treatment landscape for autoimmune diseases. 💡 Kyverna CEO Peter Maag remarks, “This marks another important milestone in our endeavor to change the treatment paradigm with KYV-101.” 🔗 Join us in celebrating this significant advancement in healthcare and stay tuned for more updates on Kyverna’s journey in revolutionizing autoimmune disease treatment! #HealthcareInnovation #CARTherapy #AutoimmuneDisease #ClinicalTrials #Biopharmaceuticals #KyvernaUpdate #HealthTech #MedicalAdvancement

📢📢Imdelltra™ by Amgen approved in the US for the treatment of extensive-stage small cell lung cancer📢📢 The US FDA has granted accelerated approval to Imdelltra™ (Tarlatamab-dlle; DLL3- targeting bispecific CD3 T-cell engager therapy) by Amgen for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The approval is based on data from Phase 2 DeLLphi-301 (https://shorturl.at/Ru7mf) clinical trial. The data demonstrated a median overall survival (mOS) of 14.3 months with an overall response rate (ORR) of 40% and a median duration of response (mDOR) of 9.7 months. The most common adverse reactions (>20%) were cytokine release syndrome (55%; predominantly confined to Gr1/ 2), fatigue (51%), pyrexia (36%), and dysgeusia (36%). Neurologic toxicities occurred in 47% of the patients in the pooled safety population, including immune effector cell-associated neurotoxicity syndrome (ICANS) in 9% of the patients. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The US label (https://shorturl.at/YKLml) has a step-up dosing schedule for the first cycle followed by every two weeks intravenous infusion. The prescribing information includes Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity including ICANS. Warning and precautions are also recommended for cytopenias, infections, hepatotoxicity, hypersensitivity and embryo-fetal toxicity. The company has announced a special investor webcast on the FDA approval on May 20, 2024 (Monday) at 4:00 PM ET. Source:https://shorturl.at/efvtN Stay tuned for more such updates. #lungcancer #amgen #oncology #cancerresearch #fda #fdaapproval #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #biotech #productmarketing #healthcare #lifesciences #lifesciencesconsulting

Imdelltra™ (tarlatamab-dlle) represents a breakthrough as the first approved T-cell engager therapy for extensive-stage small cell lung cancer (ES-SCLC). This approval, received approximately one month ahead of its PDUFA date (June 12, 2024), addresses a significant unmet medical need. Current first-line treatment for ES-SCLC typically involves platinum-based chemotherapy combined with PD-1/PD-L1 inhibitors (atezolizumab/durvalumab). However, there is a critical lack of standardized treatment options for patients whose disease progresses following this initial therapy. Imdelltra™ fills this critical gap by offering a targeted therapy specifically for this patient population. Compelling efficacy and safety data, coupled with its first-mover advantage and convenient biweekly outpatient administration, are expected to accelerate clinical adoption of this novel therapy. A recent Reuters report (https://shorturl.at/hPNtM) suggests that Amgen has set the initial US price of Imdelltra™ at $31,500 for the first cycle and $30,000 for subsequent infusions, translating to an estimated annual cost of $781,500. Beyond its current application, Amgen is actively investigating Imdelltra™ in early-stage SCLC treatment through various pivotal late-stage clinical trials. These trials explore both monotherapy and combination regimens. Additionally, a phase 1 trial is evaluating the potential of Imdelltra™ in neuroendocrine prostate cancer. #lungcancer #amgen #oncology #cancerresearch #fda #fdaapproval #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #biotech #productmarketing #healthcare #lifesciences #lifesciencesconsulting

Enterprise Therapeutics has dosed the first patient in its pivotal Phase IIa clinical trial, which is investigating the efficacy and safety of ETD001 — an epithelial sodium channel (#ENaC) inhibitor designed to enhance hydration and mucus clearance in patients with cystic fibrosis. The study is also focusing on the suitability of such a treatment for the 10% of cystic fibrosis patients who are ineligible for CFTR modulators. #cysticfibrosis #clinicaltrials #CFTRmodulators #ENaCinhibitors https://lnkd.in/env3Jv_N

InCarda Therapeutics showcases promising results with FlecIH-103, an inhaled solution for converting paroxysmal atrial fibrillation (PAF) to sinus rhythm. The Phase 3 RESTORE-1 trial demonstrated a 31% cardioversion rate with inhaled flecainide, achieving normal sinus rhythm in approximately 13 minutes, significantly outperforming the placebo. Despite low enrollment, the study highlighted substantial pharmacoeconomic benefits, with patients experiencing quicker discharge and symptom resolution post-conversion. Notably, the need for electrical cardioversion decreased in the treatment arm, showcasing the efficacy of FlecIH-103. InCarda is now shifting towards a new drug-delivery platform backed by promising Phase 1 clinical data. These positive results support the continuation of the study, potentially propelling FlecIH-103 into registrational trials. The findings from the RESTORE-1 trial underscore the safety and effectiveness of inhaled flecainide as a rapid and non-invasive therapy for PAF patients, reducing the reliance on invasive procedures. Explore more: https://lnkd.in/dGwkjpmb Meisa Propst Prashanti Madhavapeddi - PhD

New, Emerging Treatment Options for Patients With Multiple Myeloma: In addition to emerging treatment options, the speakers addressed the importance of individualized decision-making when treating patients with multiple myeloma. #finance #pharmacy #lifesciences

Congratulations to Daiichi Sankyo on its Enhertu's new key indications approved by FDA! The pioneering new-gen ADC drug by Daiichi Sankyo US was just accelerated approved by FDA for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Enhertu is now the first and only tumour-agnostic approval of a HER2-directed therapy and ADC by FDA. ADC is one of topics of Chinese Antibody Society's 2024 Annual Conference which will take place in Cambridge, MA, USA, on Saturday, May 11, 2024. You are welcome to register for the conference right NOW via the following link. https://lnkd.in/ecmFPA4v #antibodies #antibody #antibodytherapeutics #mabs #mab #antibodydiscovery #adc #adcs #antibodydrugconjugate # #antibodydrugconjugates #annualmeeting #annualconference

Idiopathic Pulmonary Fibrosis (IPF) is an irreversible and progressive disease that causes scarring of the lungs. Current IPF treatment options are limited but new data from Aileron Therapeutics' Phase Ib clinical trial indicates that receiving an inhaled dose of LTI-03 could improve lung function and even reverse the course of IPF. Read the full article here: https://hubs.la/Q02xmyXY0

CAR-T Therapy is addressing the unmet medical need in multiple myeloma 📌 This is a momentous event for the multiple myeloma treatment market. Bristol Myer Squibb/2seventy Bio's ABECMA and J&J/Legend Biotech's CARVYKTI are two key value-driving programs with multi-billion-dollar potential in earlier lines of treatment setting. Both CAR-T therapies target the B-cell maturation antigen (BCMA), a cell surface protein that is highly expressed on malignant plasma cells. In fact, BCMA is the most selectively expressed cell surface receptor on both MM cell lines and MM patient cells. 📌 CAR-T therapy presents a new and promising opportunity to address the unmet medical needs in the crowded multiple myeloma market. With the potential to raise the efficacy bar higher, this innovative therapy boasts a survival rate of up to five years after treatment. 📌 Other BCMA CAR T programs are also in development. Poseida Therapeutics is evaluating an Allogeneic BCMA CAR-T program in a phase 2 study in patients with multiple myeloma. Additionally, Celgene acquired JCARH125 through a definitive merger agreement with Juno Therapeutics in January 2018. An open-label Phase 1/2 EVOLVE study (NCT03430011) has completed recruitment of patients to evaluate JCARH125 in RRMM patients who have received at least three prior lines of therapy, including an anti-CD38 antibody and ASCT. Stay tuned for further updates on the exciting progress in the multiple myeloma treatment market! #advancedtherapies #celltherapy #carttherapy #regenerativemedicine #biotech #biotechnology #eosintelligence #perspectives #pharmaceuticals #leadership #strategy #healthcare #mangement #consulting #marketaccess Poseida Therapeutics, Inc. Bristol Myers Squibb 2seventy bio Johnson & Johnson

Another day, another life-changing scientific break through. Parkinson's particularly hits a raw nerve. Anyone who's seen a senior citizen suffering from this terrible affliction has got to feel some joy today. The bizarre paradox of America: The world's best medical innovation ecosystem coupled with the world's worst care delivery system. And "system" is being generous. The better word is probably "situation." #Biotech #Biotechnology #Bigpharma #Pharmaceutical #Parkinsons #Neurology