CAR-T Killer! CD19 target new Fc-optimized immuno-enhanced monotafasitamab EU entry review, the treatment of B cell tumor efficacy is strong!

May 25, 2020 /
BiovalleyBIOON/ -- MorphoSys and Incyte recently jointly announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) of Tafasitamab (MOR208), the MA A seeks approval of tafasitamab combined with nala, used to treat adult patients with recurrent or incurable diffuse large B cell lymphoma (r/r DLBCL) that is not suitable for self-
stem celltransplant (ASCT), including DLBCL from low-grade lymphomaEMA has confirmed the integrity of the MAA and has initiated a formal review processIn the U.Sregulatory side, tafasitamab's biological product licensing application (BLA) for the treatment of r/r DLBCL is under FDA priority review with a target date of August 30, 2020In 2017, theFDAhas granted tafasitamab a breakthrough drug qualification (BTD) for the treatment of r/r DLBCLtafasitamab is a new type of humanized Fc domain-optimized immuno-enhanced monoclonal antibody targeting CD19, which is a clearbiomarkerof a variety of B-cell malignanciesTafasitamab is currently under clinical development to treat a variety of B-cell malignanttumorIn 2010, MorphoSys acquired exclusive rights to develop and commercialize tafasitamab worldwide under an authorization from Xencor in January, Morpho Sys signed a $2 billion global partnership and licensing agreement with Incyte to further develop and commercialize tafasitamab Under the agreement, Incyte will pay a $750 million advance and invest $150 million in MorphoSys to buy its U.S depositary shares MorphoSys will also be eligible for milestone payments of up to $1.1 billion based on the achievement of specific development, regulatory, and commercialization milestones if approved, Incyte will have a marketing license and exclusive commercialization rights outside the United States, including Europe cd19 expression and tafasitamab mechanism of CD19 at each stage of development of B cells
tafasitamab is a new type of humanized Fc-enhanced monoclonal antibody that targets CD19, and its Fc domain is modified (including 2 amino acids to replace S239D and I 332E), by increasing the affinity for the active-acting fc-riiia on the effect cells, significantly enhances antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP), thereby improving the critical mechanism of tumor cell killing In preclinical model studies, tafasitamab has been shown to induce cancer cells to direct apoptosis by combining CD19 currently, tafasitamab is being developed for use in two types of B-cell malignant tumor , including DLBCL and chronic lymphocytic leukemia (CLL) Globally, DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) in adults, accounting for 40% of all cases, an aggressive disease that affects the immune system's B-cells, and 30-40% of patients do not respond to initial treatment or subsequent recurrence, with significantly unmet medical needs for effective treatments CLL is the most common type of leukemia in adults tafasitamab treatment of B-cell malignant tumor - DLBCL showed strong efficacy
in the United States and the European Union, BLA and MAA were based on preliminary results from the L-MIND study of tafasitamab in the treatment of r/r DLBCL patients, as well as the results of retrospective observational study of the efficacy of patients with the treatment of r/r DLBCL - L-MIND: A single-arm, open-label Phase II study that is evaluating R/RDCL LB LLb patients who have previously received at least one but no more than three treatments for tafasitamab combined with nalaa (including an anti-CD20 targeted therapy, such as ritoxiania), ineligible for high-dose chemotherapy (HDC), and subsequent self-
stem cell transplantation (ASCT) May 2019, the L-MIND study reached its main endpoint: the total remission rate (ORR) for tafasitamab and rhiamine treatment was 60%, the total remission rate (CR) was 43%; At 19.6 months of median follow-up, the median total lifetime (OS) had not yet reached (95% CI: 18.3 months -NR), and the 12-month survival rate was 73.3% - Re-MIND: An observational, retrospective study of real-world data designed to isolate the contribution of tafasitamab to the combined drug regimen and demonstrate the effectiveness of combination therapy The study compared real-world response data from patients with r/r DLBCL who received the treatment of nala monotherapy with the efficacy of patients who satasitamab in L-MIND study in combination with rhamine treatment r/r DLBCL The study collected data on 490 patients who were ineligible for transplantation in the real world in the United States and Europe, 76 of whom matched 76 patients in the L-MIND study with a 1:1 ratio of key baseline characteristics analysis showed that the study reached its main end: tafasitamab-to-la-nado's combination therapy had a clinical advantage over the amymine monotherapy The specific data are: compared to the amine monotherapy, tafasitamab and nalaamy combination therapy has a statistically significant advantage in the main endpoint ORR (ORR: 67.1% vs 34.2%, p 0.0001), in all Consistent advantages were also observed at secondary endpoints, including a full mitigation rate (CR:39.5% vs 11.8%, p 0.0001), and total lifetime (median OS: not reached vs 9.3 months, p 0.0008) "CAR-T Killer": Tafasitamab will challenge two CD19 CAR-T therapies listed analysts say that tafasitamab will directly challenge the market for the r/R DLBCL's two anti-CD19 CAR-T therapies - Novartis
Kymriah and Gilead Yescarta Unlike conventional small molecule or biotherapy, CAR-T therapy is a live T-cell therapy product Both Kymriah and Yescarta were treated to isolate the patient's T-cells and genetically modify them in vitro to express a chimeric antigen receptor (CAR) designed to target CD19, and then return the modified T-cells to the patient's body in search of cancer cells that express CD19 to play a therapeutic role in terms of efficacy, tafasitamab is comparable to Kymriah and Yescarta In terms of medication, Kymriah and Yescarta are both prepared individually for each patient and take time, while tafasitamab is an industrially produced ready-to-use monoantigen, which is readily available In terms of treatment costs, Kymriah and Yescarta are priced in the hundreds of thousands of dollars, while tafasitamab can control very little Some analysts liken tafasitamab to a "CAR-T cell therapy killer" that, if successfully launched, would have a huge impact on Kymriah and Yescarta (biovalleybioon.com) original source: Morpho Sys and Incyte Announce the Validation Marketing the lication for Tafasitamab