Immunai’s Post

We are proud to share that Ichnos Sciences has dosed the first patient in our Phase 1 trial of ISB 2001, our first-in-class TREAT™ trispecific antibody targeting BCMA, CD38 and CD3, for the treatment of relapsed/refractory multiple myeloma. The first-in-human dosing of ISB 2001 marks Ichnos’ third clinical-stage asset. Learn more about ISB 2001: https://lnkd.in/eD46Aba5

At Avidity, we’re leveraging our proprietary AOC platform to redefine the delivery of RNA therapeutics and more effectively target underlying genetic drivers of disease through our clinical development programs in three distinct rare muscle diseases – DM1, DMD44 and FSHD. Building upon our knowledge of AOCs, we have made great progress in advancing our innovative AOC platform. Recently at #WMS23, we shared new positive data demonstrating improvement in additional functional measures including hand grip, muscle strength and patient reported outcomes, augmenting previously reported positive data. This data showed improvements in myotonia, muscle strength and mobility as well as favorable long-term safety in people living with DM1. Antibody oligonucleotide conjugates (AOC) therapeutics are designed to combine the proven technology of monoclonal antibodies (mAbs) with the precision and potency of oligonucleotide therapies to access previously untreatable tissue and cell types. Read our press release to learn more about our recent DM1 program data update presented at the World Muscle Society Congress at https://lnkd.in/e5bX3cQe and learn more about our science at https://lnkd.in/dH-56XKM https://lnkd.in/eNxaEU2X

Is another BCG manufacturer on the horizon?  BCG has eternally been on shortage ever since Sanofi pulled out of the market, causing clinicians to experiment with alternative therapies or different dosing schedules.  However, it appears as though Immunitybio may be attempting to enter the market.  The reason for this, it appears, is because its FDA-approved IL-15 receptor agonist, nogapendekin alfa inbakicept-pmln, must be used in combination with BCG, and has a strict dosing schedule.  As a result, any shortage in BCG would deter clinicians from using this agent in clinical practice.  It's unfortunate that it took another drug being approved in combination with BCG to get another company involved in BCG manufacturing, but at least we may no longer have to endure BCG shortages. #bladdercancer #bcg https://lnkd.in/eCJDZwGy

How do #clinicaltrials use single-cell sequencing? A valuable example: "In what we believe is one of the first clinical trials to incorporate systematic scRNAseq analysis of paired pre- and on-treatment tumor biopsies from all patients, we identified a potential mechanism underlying the cooperativity observed between BRAF/MEK inhibition and immune response." The authors of the above quote are scientists from the Massachusetts General Hospital Cancer Center and Harvard Medical School. They conducted a phase-2 trial with metastatic colorectal cancer patients in collaboration with Novartis and Stand Up To Cancer. The patients were given a new combination therapy of BRAF/MEK inhibitors and immunotherapy. The team investigated the mechanism behind the combination therapy's ostensible success with single-cell sequencing. 🦀 Metastatic Colorectal Cancer. About 10% of colorectal cancer patients harbor the BRAF-V600E mutation. It confers poor prognosis. Standard therapies do not work. Monotherapies with BRAF inhibitors, which work well on melanomas, rarely work on colorectal cancer. Combination therapies, which target BRAF together with associated molecules like MEK or EGFR (see image), do some good, but more effective treatments are much sought after. Immunotherapy drugs such as immune checkpoint inhibitors work very well on certain cancers like melanoma yet also fail to bring down metastatic colorectal cancers. However, (pre)clinical data suggests that combining BRAF and MEK inhibitors with immune checkpoint inhibitors may cooperatively produce a stronger punch. 💊 Phase-II Clinical Trial. This is what the phase-2 trial wanted to test. Results convincingly show an ~25% overall response, three times higher than seen in trials with BRAF/MEK inhibitors alone. Then, the team leveraged single-cell sequencing to uncover the mechanism behind this response rate. 🔬 Single-cell Sequencing. They employed 10x Genomics Single Cell Immune Profiling to generate the transcriptomes of the tumor cells, microenvironment, and immune repertoire. They performed sequencing on paired biopsies from patients before and on Day 15 of treatment. Then, they studied the important changes in cell-type composition and gene expression patterns before and during treatment. From the gene expression changes, they observed a more active immune program and greater pathway inhibition in tumor cells. Moreover, the single-cell data showed that tumor cells had more active immune programs in patients with longer progression-free survival. This shows a correlation between combination-therapy efficacy and tumor effects. That is how clinical trials can valuably use single-cell sequencing. 📑 More on single-cell sequencing in drug development: https://hubs.ly/Q020wkMn0 Find the full paper here: https://hubs.ly/Q020wkqQ0 Clinical trial NCT03668431 details are here: https://hubs.ly/Q020wrHq0 📷 Photo credits: National Cancer Institute/Kelly Crotty

Our Chief Executive Officer Nikolai Kley, Ph.D., will be presenting on our approach to cytokine-based drug development at Hanson Wade Group’s 3rd Annual Induced Proximity-Based Drug Discovery Summit.   In his talk, titled “Using Modified Cytokines to Target Immune Receptors for Selective Response Towards Cancer,” he will cover: - Designing modified cytokines that have low affinity/activity towards their natural receptors - How to use induced proximity to restore/drive interactions between the modified cytokine and its natural receptor(s) - Optimizing selectivity/pharmacology of the modified cytokine by focusing on localizing activity to clinically relevant targets for alleviating disease   Dr. Kley is set to speak at 5:15pm ET at the Logan Airport Hilton in Boston, MA. You can learn more about the presentation and event here: https://lnkd.in/e635MQXk   #cytokines #cancerresearch #drugdevelopment

A new paper from Genentech authors describes the preclinical characterization and phase 1 trial results for DHES0815A, a HER2-directed antibody-drug conjugate that was terminated recently due to safety concerns. From the introduction: The data herein describe design of DHES0815A, mechanisms of action, efficacy in HER2+ and HER2-low xenograft models, safety studies in non-human primates, and phase 1 safety and efficacy data. In this work we show that, despite strong and compelling preclinical data and early signs of anti-tumor activity in patients, a number of persistent safety findings resulted in termination of the phase 1 study. #mabs https://lnkd.in/efZ8i6_v

Every week, we have dozens of conversations with drug development experts from various corners of the industry. This helps us keep our fingers on the pulse of the industry, so we can identify the best talking points for you at our MicroSummits. This week's highlights were particularly enlightening: 👉 There's an ongoing debate about the shift of Cell Therapies to allogeneic approaches, particularly evident as the CART field moves in this direction. Currently, Gamida Cell's Omisirge stands out as the first FDA-approved allogeneic treatment in this evolving landscape. 👉 Have we overdone the multiplicity of combinations? Is there something to be said about going back to basics and not burning out modes of action in triplets, quadruplets, etc and rather reserve them for future development? 👉 We learned about the pivotal role of costimulatory molecules (costims) in elevating the efficacy of CAR-T therapies, indicating their significance as a next-generation concept within the field of CAR-T therapy. Interested in being a facilitator at one of our events? Get in touch! What we have coming up: 📅 The Blood Cancer Drug Development Summit (Oct 2023) 📅 Immuno-Oncology MicroSummit (August 22, 1pm Eastern) 📅 Liquid Biopsy MicroSummit (August 24, 1pm Eastern) Join the conversation! #CellTherapy #Biotech #Innovation #liquidbiopsy #immunooncology

We're proud to announce the collaboration with #Janssen (Janssen Pharmaceutica NV, a Johnson & Johnson company) on the landmark companion diagnostics (#CDx) development — PredicineCARE™, the first urine-based cfDNA NGS assay of its kind. This revolutionary assay underscores Predicine's commitment to leading the charge in precision medicine. PredicineCARE™ is more than just an assay; it's a transformative approach that reshapes how we target and treat localized bladder cancer. By harnessing the power of urine cfDNA analysis, we're providing clinicians and patients with a non-invasive, yet highly precise tool for identifying suitable candidates for targeted therapies. This first-in-class CDx assay not only cements Predicine's role as an innovator in the diagnostic field but also marks our maiden foray into the CDx space. It's a testament to our vision of integrating sophisticated diagnostics into patient care, enabling more personalized and effective treatment strategies. Join us as we celebrate this pioneering step in healthcare. Together, we're not just following the science; we're creating it. Read full press release: https://lnkd.in/gnrgdx7i #bladdercancer #cdx #cfDNA #NGS #liquidbiopsy

Refreshing break from the herd mentality… JPM2024: The advantage of using RLT for both diagnostic(imaging)and treatment sets it apart form ADCs and Novartis is showing the way in adopting a new asset - would be interesting to see if rest of Big Pharma players would follow through