Artiva Biotherapeutics’ Post

Monoclonal antibodies are used in various therapeutic research areas, including oncology, infectious diseases, cardiovascular diseases, and autoimmune conditions like rheumatoid arthritis and Crohn’s disease. Learn more on the ProSci blog! https://lnkd.in/gitUw4s7

🔬First-ever IND clearance of an allogeneic off-the-shelf NK cell therapy for an autoimmune disease🔬 Artiva Biotherapeutics Biotherapeutics' pioneering AlloNK® cell therapy has crossed a pivotal milestone with the FDA's Fast Track designation for lupus nephritis, especially when used in conjunction with rituximab. It's a testimony to the potential synergy between novel therapies and established treatments. AlloNK® stands out as the first-ever allogeneic, off-the-shelf Natural Killer (NK) cell therapy designed specifically for autoimmune diseases. It's not just a beacon of hope for those suffering from lupus nephritis; AlloNK® addresses this by potentially reducing the risk of secondary malignancies, a concern often associated with existing immunosuppressive therapies. The convenience of an off-the-shelf solution means that AlloNK® could significantly reduce the time between diagnosis and treatment, a critical factor in managing progressive conditions like lupus nephritis. The promise of a new dawn in the treatment of #autoimmunediseases is on the horizon! #NKCell #CellTherapy #Autoimmune #Immunology #Rituximab #obinutuzumab #AlloNK #LupusNephritis #InnovationInMedicine #Biotechnology #ClinicalDevelopment

We are intrigued by NextCure, Inc.'s agonist anti-VSTM-1 monoclonal antibody, which is in preclinical development. VSTM-1 is a cell-surface inhibitory receptor highly expressed on granulocytes, including neutrophils, and pulmonary monocytes. The company, which presented data at the Keystone Symposium for Inhibitory Receptors in Immune Homeostasis, Disease and Therapy, is pursuing VSTM-1 as a promising novel therapeutic target for COPD. We are not aware of any anti-VSTM-1 mAbs in clinical development, and look forward to hearing more about NextCure's program in the future. https://lnkd.in/eR4fwi5x

CD19 CAR-T treatment for lupus? 🔬 Exciting advancements in lupus and other autoimmune disease treatment are on the horizon, with CD19 CAR-T cell therapy on the front. Caribou Biosciences has recently expanded its clinical trials for CB-010 with an FDA IND clearance and targets both B-cell non-Hodgkin lymphoma and lupus. In parallel, Kyverna Therapeutics and Cabaletta Bio are innovating in the space by repurposing CAR-T therapies for autoimmune diseases, showcasing a robust international effort to leverage this transformative technology. 🧬 Targeting CD19 cells by therapies like CB-010 reduces disease-causing cells, but it also risks long-term effects, such as potential increased susceptibility to infections. However, these therapies are designed to enable the regeneration of healthy B cells, striving for a balance in immune recovery. This groundbreaking approach offers hope for lupus patients, aiming for sustained remission. #Biotech #CRISPR #LupusResearch #FDAApproval #CaribouBiosciences https://lnkd.in/eu533rEf

Diabetes drugs like Ozempic lower cancer risks: Study " [...]Published in the journal JAMA, the study compared patients with Type 2 diabetes who were treated with insulin versus patients who were given a class of drug known as GLP-1 agonists, like Ozempic, between 2005 and 2018. The researchers found that the patients who received GLP-1 agonists had a significantly lower risk of developing 10 out of 13 cancers studied, including kidney, pancreatic, esophageal, ovarian, liver and colorectal cancer. Among the cancers which saw no significant change in risk were thyroid cancer and breast cancer in postmenopausal women. [...]" "More information: Lindsey Wang et al, Glucagon-Like Peptide 1 Receptor Agonists and 13 Obesity-Associated Cancers in Patients With Type 2 Diabetes, JAMA Network Open (2024). DOI: 10.1001/jamanetworkopen.2024.21305 Journal information: Journal of the American Medical Association , JAMA Network Open " https://lnkd.in/gApGDePz

Celebrating the first year, the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) marks a milestone with an expanded partnership with the FDA! This critical addition embodies the commitment to exploring engineered cell therapies in lupus. With CBER on board, the collective focus sharpens on advanced therapeutic avenues, especially CAR-T/Treg cell therapies. Just under a year since its inception, Lupus ABC has rallied a robust network of 40 member groups and launched pivotal projects shaping the future of lupus interventions. And now, with CBER's expertise, the fourth project on CAR-T cells takes a promising leap forward. 🧬✨ Spearheading a collaborative drive, they are blending the voices of lupus drug makers, mapping out novel pathways and clinical insights for personalised therapies - together, fostering hope for a breakthrough in lupus care. 👏👏Lupus Research Alliance 👏👏 #LupusResearch #Autoimmune #SystemicLupusErythematosus #SLE #Inflammation #Immunology #Autoimmunity #GVHD #Hidradenitissuppurativa

Alecensa by Roche Slashes Disease Recurrence Risk by Unprecedented 76% in ALK-Positive Early-Stage Lung Cancer Roche's Alecensa significantly reduces the risk of disease recurrence or death in early-stage ALK-positive non-small cell lung cancer, demonstrating potential to redefine treatment options. The drug improves disease-free survival and central nervous system DFS without unexpected safety concerns. Alecensa could benefit younger patients at high risk of brain metastases and may alter the course of the disease. Roche aims for expedited availability of Alecensa and has presented the data at ESMO Congress. This achievement shows Roche's commitment to addressing unmet medical needs. For more details please click the link! https://lnkd.in/dRE7wXiN #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

AbbVie and Genmab’s Epkinly (epcoritamab-bysp) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL). The regulator’s decision, which specifically applies to patients who have received at least two lines of prior therapy, makes Epkinly the first and only subcutaneous T-cell engaging bispecific antibody to be approved for this patient population. Approximately 15,000 people develop FL, the second most common form of non-Hodgkin lymphoma, every year in the US. The disease is considered incurable, with patients frequently relapsing and the prognosis worsening after each subsequent relapse. Epkinly, which is already approved in the US to treat certain cases of diffuse large B-cell lymphoma (DLBCL), is an IgG1-bispecific antibody designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induce T-cell-mediated killing of CD20-positive cells. The FDA’s latest decision on the therapy was supported by results from the phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Epkinly in more than 120 adults with R/R FL who had received a median of three lines of therapy, 70% of whom had double refractory disease. Results demonstrated an overall response rate of 82%, a complete response rate of 60% and a partial response rate of 22%, with more than half of patients who responded to treatment remaining responsive at a median follow-up of 14.8 months. Mariana Cota Stirner, vice president, therapeutic area head for haematology at AbbVie, said: “The FDA approval of Epkinly offers a new treatment option for R/R FL, particularly following [the] failure of other therapies… Subcutaneous dosing offers convenience, and Epkinly can be given to patients without mandatory hospitalisation using a three-step-up dosing regimen.” Read more: https://lnkd.in/eQNmMWHb If you are seeking LinkedIn groups that best match your requirements, you can find an A-Z list of LinkedIn groups covering pharmaceutical, medical and life science groups here: https://bit.ly/4caKquL

𝐅𝐃𝐀 𝐃𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐍𝐞𝐰𝐬! The FDA has granted a priority review for Roche's inavolisib, in combination with fulvestrant and Pfizer’s Ibrance (palbociclib), for treating PIK3CA-mutated, HR-positive, HER2-negative breast cancer. This decision sets a date of 27 November for the FDA to evaluate the therapy. The therapy targets adult patients with locally advanced or metastatic breast cancer, especially those experiencing recurrence within 12 months of adjuvant endocrine treatment. Inavolisib, an oral PI3 kinase inhibitor, disrupts PI3K/Akt/mTOR pathway signaling, crucial for cell growth and survival. It also recently received breakthrough therapy designation. The priority review is based on promising results from the Phase III INAVO120 trial, where the combination therapy showed a progression-free survival of 15 months compared to 7.3 months with the standard fulvestrant and Ibrance regimen. Roche is also pursuing regulatory approval in other regions, including with the European Medicines Agency. More detailed data will be presented at the upcoming ASCO Annual Meeting in Chicago from 31 May to 4 June. in other FDA news, Eli Lilly and Company have secured accelerated approval for Retevmo, their treatment for pediatric cancers. Follow Warman O'Brien for all the latest news in life sciences! #oncology #goodnews #fdaapproval #nextsteps