CARsgen Therapeutics’ Post

The FDA has granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for the treatment of patients with SCLC that has progressed on or after platinum-based chemotherapy, making it the first BiTE approved for a major solid tumor and the first therapeutic option for the third-line treatment of advanced SCLC. In October 2023, tarlatamab was granted breakthrough therapy designation. In December 2023, the FDA granted priority review to the biologics license application of tarlatamab. Tarlatamab is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient's own T cells to attack DLL3-expressing tumor cells. #cancertreatment #SCLC #FDA #acceleratedapproval #BTD #priorityreview #tarlatamab #imdelltra #BiTe #TCE #bispecificantibody #antiDLL3 #amgen https://lnkd.in/d2SmZ_i4

Sirius begins patient dosing in phase 1 trial of next─generation, long─acting factor XI siRNA anticoagulant to treat thromboembolic disorders

SystImmune, Bristol Myers Squibb The concentration-time curves of BL-B01D1's antibody-drug conjugate and total antibody are nearly identical, indicating the linker-payload's stability in the bloodstream. However, the hematological toxicity is significantly higher compared to other ADC drugs. The study attributes this high hematological toxicity to the following reasons: 🤔 ✅The payload used in BL-B01D1 has stronger cytotoxicity and a more significant bystander effect than existing topo1 inhibitors. ✅The patient cohort's extensive exposure to multiple systemic anticancer therapies may make them more susceptible to cytotoxic drugs. ✅This clinical study was conducted entirely on Asian patients, who generally exhibit higher rates of hematological toxicity compared to non-Asian patients.

Phase 3 Trial of Pembrolizumab with Olaparib Did Not Meet Endpoints Among Individuals with NSCLC: Pembrolizumab in combination with chemotherapy followed by maintenance olaparib did not meet its pre-specified statistical criteria of overall survival or progression free survival. #finance #pharmacy #lifesciences

CAR-T therapy targets over 80% of human tumours Leucid Bio has been granted clinical trial authorisation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I/II clinical trial evaluating autologous NKG2D-targeted CAR-T cell therapy, LEU011, in patients with relapsed or refractory solid tumours. The open-label, single patient cohort ascending dose design aims to rapidly identify the maximum tolerated dose for LEU011. This trial’s design was influenced by promising preclinical data for LEU011 in a spectrum of solid tumour models. The primary and secondary objectives include monitoring for dose-related toxicities, gauging the drug’s efficacy against tumours, and understanding its behaviour within the body. https://lnkd.in/eX-ksjz5

📢 FDA approved the first denosumab biosimilars. They approved: 1- Jubbonti (denosumab-bbdz, 60 mg/1 mL injection), as an interchangeable biosimilar to Prolia (denosumab) 2- Wyost (denosumab-bbdz, 120 mg/1.7 mL [70 mg/mL] injection), as an interchangeable biosimilar to Xgeva (denosumab). ✏ Wyost is approved to: 🔶 Prevent skeletal-related events (SREs) in patients with multiple myeloma & in patients with bone metastases from solid tumors. 🔷 Treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. 🔶 Treat hypercalcemia of malignancy refractory to bisphosphonate therapy. 🖊 Jubbonti is approved to: 🔵 Treat postmenopausal women with osteoporosis at high risk for fracture. 🔴 Increase bone mass in men with osteoporosis at high risk for fracture. ⚫ Treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture. 🔵 Increase bone mass in men at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer. 🔴 Increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. https://lnkd.in/e4eExVhU

Frontline Use of Pembrolizumab with Lenvatinib Supported in Non-clear Cell Renal Cell Carcinoma (NccRCC) The KEYNOTE-B61 trial showcases the enduring effectiveness of the pembrolizumab/lenvatinib combination against non-clear cell renal cell carcinoma (nccRCC), with a confirmed objective response rate of 49% and promising median progression-free survival of 18 months. Safety profile consistent with previous studies. Results encourage further exploration. The largest trial of its kind in this context, demonstrating activity across subgroups and maintaining a known safety profile. The pembrolizumab/lenvatinib combination could potentially provide a valuable first-line treatment for nccRCC patients. If you're interested in continuing to read the full story and want to stay updated with the Latest Pharma News in USA, visit Pharmtales. #pharma #pharmaceutical #pharmatles #latestnews #pharmanews #pharmaceuticalindustry #nccrcc #pharmaceuticalcompanies https://lnkd.in/d69n59nR

Aldeyra Therapeutics Plans to Submit IND Application for ADX-248, a RASP Modulator, Targeting Dry Age-Related Macular Degeneration Patients Exciting News from Aldeyra Therapeutics: The company is making significant strides in its RASP modulator platform, with the latest update highlighting the forthcoming submission of an IND application for ADX-248. ADX-248 is a RASP modulator currently undergoing intravitreal development to address immune-mediated diseases affecting the retina. This includes conditions such as the dry form of age-related macular degeneration, geographic atrophy, and related diseases. This marks a pivotal step toward a Phase 1/2 clinical trial targeting patients with AMD and dark adaptation deficit. Stay tuned for innovative developments in the pursuit of advancements in AMD treatment. #Innovation #MedicalAdvancements #AMD