Anti CD19 Antibody Pipeline Insights - 2018 Size, Share, Industry, Forecast and outlook (2024-2031) Market -
ANTI-CD19 ANTIBODY
• CD19 is a 95-kDa transmembrane glycoprotein, which belongs to the immunoglobulin (Ig) superfamily and can act as a central positive response regulator in B cells. The CD19 has been expressed on the surface of leukemia cells in > 90% of cases with acute lymphoblastic leukemia (ALL).
• Moreover, it can be expressed on tumor cells of cases with both B-cell NHL and chronic lymphocytic leukemia (CLL).
• Thus, the CD19 antigen is an ideal target for immunotherapy of B-cell malignancies. CD19 can act as a B cell co-receptor in conjunction with both CD21 and CD81. Genetic studies show that CD19 has a role in keeping a balance between immunity and autoimmunity.
• Antibody-drug conjugates (ADCs) comprise an antibody, which is joined to a cytotoxic drug by a linker are promising new therapeutic anticancer drugs. Currently, over 30 ADCs are found that are being investigated in the early or late stage of clinical trials.
• The primary focus of these novel molecules is hematological cancers, specifically B cell malignancies, with CAR-T therapies leading the table. However, efforts are also being made to use these therapies in the treatment of other indications including certain autoimmune diseases and solid tumors.
• Post initial researches in CAR-T therapies; many non-industry players have entered into collaborations with industry stakeholders to fund the clinical and commercial development of these products. Some late-stage products that have emerged out of such partnerships include KTE-C19, CTL019, JCAR015, and JCAR017.
• The recent approval of BLINCYTO®, a CD19 targeting bsAb, and the emergence of CAR-T therapies has provided a significant boost to this market that has actively evolved in the past few years.
• During our research, we identified over 50 products in various phases of development. Of these, 70% are in the clinical phase of development (with one molecule in phase II/III trial and six molecules in phase II stage).
• – CAR-T therapies (constituting 70% of the development pipeline) are the most common, followed by bsAbs (11%), ADC (7%) and engineered antibodies (7%).
• Many anti-CD19 IgG1 antibodies with cytotoxicity-improved Fc? part and three drug conjugated antibodies including coltuximabravta-nine (SAR3419) by ImmunoGen Inc., Sanofi-aventis, lintuzumab-mandolin (SGN-CD19A) by Seattle Genetics and taplitu -momabpaptox are now in phase 1/2 trials and the most advanced is the anti-CD19/CD3 BiTE antibody blinatumomab, by Amgen, Which is in phase 1 trial in patients with NHL and was approved by FDA for precursor B-cell ALL therapy on December 3, 2014. XmAb5871, which was generated by Amgen and Xencor Inc, MDX-1342 by Medarex (Bristol-Myers Squibb), AFM11 by Affimed Therapeutics AG are in phase 1 trials of drug development. MOR-208 (XmAb5574) is in stage 2 and was developed by Xencor and MorphoSys AG as a therapeutic drug for NHL and ALL. MEDI-551 can target CD19 on B cells and entered phase 2 trials in 2011 by MedImmune.
• The factors driving the global anti-CD 19 antibody therapeutics market are high incidence rates of non-Hodgkin’s lymphoma (NHL), the rise in investment in health care by the government and private organizations, increase in demand for minimally invasive surgeries, growing awareness about health, and early diagnosis of diseases.
• However, the rise in the cost of treatment, side effects associated with treatment, and lack of reimbursement policies in developing countries such as India, Singapore, and Brazil are likely to restrain the market.
• CD19 is a 95-kDa transmembrane glycoprotein, which belongs to the immunoglobulin (Ig) superfamily and can act as a central positive response regulator in B cells. The CD19 has been expressed on the surface of leukemia cells in > 90% of cases with acute lymphoblastic leukemia (ALL).
• Moreover, it can be expressed on tumor cells of cases with both B-cell NHL and chronic lymphocytic leukemia (CLL).
• Thus, the CD19 antigen is an ideal target for immunotherapy of B-cell malignancies. CD19 can act as a B cell co-receptor in conjunction with both CD21 and CD81. Genetic studies show that CD19 has a role in keeping a balance between immunity and autoimmunity.
• Antibody-drug conjugates (ADCs) comprise an antibody, which is joined to a cytotoxic drug by a linker are promising new therapeutic anticancer drugs. Currently, over 30 ADCs are found that are being investigated in the early or late stage of clinical trials.
• The primary focus of these novel molecules is hematological cancers, specifically B cell malignancies, with CAR-T therapies leading the table. However, efforts are also being made to use these therapies in the treatment of other indications including certain autoimmune diseases and solid tumors.
• Post initial researches in CAR-T therapies; many non-industry players have entered into collaborations with industry stakeholders to fund the clinical and commercial development of these products. Some late-stage products that have emerged out of such partnerships include KTE-C19, CTL019, JCAR015, and JCAR017.
• The recent approval of BLINCYTO®, a CD19 targeting bsAb, and the emergence of CAR-T therapies has provided a significant boost to this market that has actively evolved in the past few years.
• During our research, we identified over 50 products in various phases of development. Of these, 70% are in the clinical phase of development (with one molecule in phase II/III trial and six molecules in phase II stage).
• – CAR-T therapies (constituting 70% of the development pipeline) are the most common, followed by bsAbs (11%), ADC (7%) and engineered antibodies (7%).
• Many anti-CD19 IgG1 antibodies with cytotoxicity-improved Fc? part and three drug conjugated antibodies including coltuximabravta-nine (SAR3419) by ImmunoGen Inc., Sanofi-aventis, lintuzumab-mandolin (SGN-CD19A) by Seattle Genetics and taplitu -momabpaptox are now in phase 1/2 trials and the most advanced is the anti-CD19/CD3 BiTE antibody blinatumomab, by Amgen, Which is in phase 1 trial in patients with NHL and was approved by FDA for precursor B-cell ALL therapy on December 3, 2014. XmAb5871, which was generated by Amgen and Xencor Inc, MDX-1342 by Medarex (Bristol-Myers Squibb), AFM11 by Affimed Therapeutics AG are in phase 1 trials of drug development. MOR-208 (XmAb5574) is in stage 2 and was developed by Xencor and MorphoSys AG as a therapeutic drug for NHL and ALL. MEDI-551 can target CD19 on B cells and entered phase 2 trials in 2011 by MedImmune.
• The factors driving the global anti-CD 19 antibody therapeutics market are high incidence rates of non-Hodgkin’s lymphoma (NHL), the rise in investment in health care by the government and private organizations, increase in demand for minimally invasive surgeries, growing awareness about health, and early diagnosis of diseases.
• However, the rise in the cost of treatment, side effects associated with treatment, and lack of reimbursement policies in developing countries such as India, Singapore, and Brazil are likely to restrain the market.
