CARsgen Therapeutics’ Post

Another important step for the scientific innovation in the hematology space

Daratumumab is increasingly incorporated into the standard treatment regimens for patients with plasma cell dyscrasias in Asia, especially with cost-containment measures implemented by various regional health authorities. This analysis aimed to study daratumumab’s tolerability amongst Asian patients. This is a retrospective medical records review of patients who received daratumumab between November 2016 and August 2021 as part of routine clinical care. Sixty-two patients were included in the study: 62.9% had renal impairment, and 27.4% had creatinine clearance (CrCl) <30ml/min. Forty-five patients (72.6%) received daratumumab combination therapy, with a median 1 line of prior therapy. The median duration of follow-up was 12.4 months, and the median duration patients were on treatment with daratumumab was 12.3 months. Twenty-one of 62 (33.9%) patients experienced infusion-related reactions (IRRs) after the first dose of intravenous daratumumab. Seven developed mostly grades 1 and 2 respiratory events, and 14 showed grades 1 and 2 non-respiratory IRRs. Only one patient experienced a grade 1 IRR with the second infusion, with none developing any IRRs in the third or subsequent infusions. Eight (12.9%) patients were affected by hematological adverse events (AEs), mostly grades 2 and 3, with one experiencing grade-4 neutropenia without sepsis. Six (9.7%) patients experienced non-hematological AEs, the commonest being pneumonia and other infections, with one developing Nocardia pneumonia (grade 4) 14 months after the initiation of daratumumab. In conclusion, daratumumab is tolerable amongst Asian patients, including the elderly, and patients with severe renal impairment and chronic lung diseases.

Every year, the Mission Bio team looks forward to attending the American Society of Hematology (ASH) annual meeting. This year’s ASH annual meeting featured an impressive number of presentations from pharma and academic leaders, utilizing the Tapestri Platform for a great number of indications and applications in hematology. In our latest blog, we highlight several of these poster and oral presentations featuring Mission Bio technology that made #ASH23 such a success! Read it here ➡ https://lnkd.in/gtm36XAQ #singlecell #singlecellanalysis #multiomics #hematology

Moving towards A Complete solution for Oncology starting from Hematology, Digital morphology, Clinical Flow cytometry, FISH (Fluorescence In Situ Hybridization and NGS reagents.

Roche’s IL-6 Blocker Clears Phase III Bar, Still Falls Short of Expectations Roche subsidiary Chugai Pharmaceutical on Thursday unveiled results from the Phase III LUMINESCE study, showing that its IL-6 inhibitor Enspryng (satralizumab) could significantly improve generalized myasthenia gravis symptoms that affect daily life. However, the biotech was unsatisfied with the magnitude of Enspryng’s effects, noting in the announcement that “the results did not reach our expectations on the degree of clinical benefit.” In terms of safety, LUMINESCE found that Enspryng was well-tolerated when used to treat generalized myasthenia gravis (gMG), with an adverse event profile that was consistent with what had been established in trials in neuromyelitis optica spectrum disorder (NMOSD). Roche and Chugai did not provide specific data in their announcement but promised to present detailed results at the upcoming American Academy of Neurology Annual Meeting on April 15 in Denver, Colorado. The companies also did not detail their future plans for Enspryng in gMG, a chronic autoimmune disorder in which antibodies destroy communication between nerves and muscle, causing weakness of the skeletal muscles. Designed to be delivered via subcutaneous Injections, Enspryng is a recombinant humanized monoclonal antibody that targets the IL-6 cytokine. According to its label, Enspryng’s exact mechanism of action is still unknown, though it is thought to Interfere with IL-6 signaling and the inflammatory cascade. https://lnkd.in/eV9RYq5Z

Latest Healthcare News & Updates: Boehringer Ingelheim Announces Promising Findings From Groundbreaking Study on Diabetic Macular Ischemia  Novartis Expands Radioligand Therapy Portfolio With Acquisition of Mariana Oncology Astellas Pharma Partners with Poseida Therapeutics, Inc. to Pioneer Novel Allogeneic Cell Therapies in Cancer Research Prime Medicine, Inc. Secures FDA Clearance for IND Application of PM359 in Treating Chronic Granulomatous Disease TIVDAK Receives Full FDA Approval for Treating Recurrent or Metastatic Cervical Cancer Get more detailed analysis, at: https://lnkd.in/gN9he4hp #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #pharmanews #clinicaltrials #clinicalresearch

Clinical Trials Updates: Aurion Biotech receives Breakthrough Therapy and Regenerative Medicine Advanced Therapy Designation in the same day for their ophthalmologic allogeneic Cell therapy Aurion Biotech achieved a significant milestone for its allogeneic cell therapy, AURN001. The FDA granted AURN001 both Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) Designation for treating corneal edema secondary to corneal endothelial disease. This marks a first for AURN001, becoming the first allogeneic cell therapy to receive both BTD and RMAT designations for this specific condition. These designations are crucial as they expedite the development and review process for drugs with promising potential to address unmet medical needs. Corneal transplants, the current treatment option, face limitations due to a shortage of donor corneas and require complex procedures. AURN001 offers a potentially more accessible treatment approach for millions of patients suffering from corneal endothelial disease. The safety and efficacy of AURN001 are currently being evaluated in a Phase 1/2 clinical trial: a multi-centre trial enrolling 97 subjects across the US and Canada. Building on its existing regulatory approval in Japan, Aurion Biotech will leverage these designations to work closely with the FDA and accelerate the development of AURN011. #celltherapy #ophthalmology #raredisease #FDA https://lnkd.in/esTyddGh