Pharma’s CAR T Therapy Gets Orphan Drug Status

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https://www.zacks.com/stock/news/1781745/allogenes-allo-car-t-therapy-gets-orphan-drug-status

Allogene's (ALLO) CAR T Therapy Gets Orphan Drug Status​

Zacks Equity ResearchAugust 13, 2021

 

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Allogene Therapeutics, Inc. (ALLO - Free Report) recently announced that the FDA has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma.



ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies.



This designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the United States. ODD also include incentives including tax credits for clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity in the event of regulatory approval.

 

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In April 2021, the candidate was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA.



A phase I study, UNIVERSAL, is underway. The study is evaluating ALLO-715 as a monotherapy and in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor,



Allogene is developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells. It has a deep pipeline of allogeneic chimeric antigen receptor (CAR) T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors.

 

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The company is sponsoring a phase I study (the ALPHA trial) of ALLO-501 in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). The company continues to advance the phase I study (the TRAVERSE trial) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC).



Shares of Allogene have declined 16.1% so far this year compared with the industry’s decrease of 0.3%.

Image Source: Zacks Investment Research

While the CAR T space promises a lot of potential, competition is stiff. Earlier in the year, the FDA approved bluebird bio (BLUE - Free Report) / Bristol Myers Squibb (BMY - Free Report) ’s CAR T cell immunotherapy idecabtagenevicleucel under the brand name Abecma.



Other approved CAR T cell therapies in the United States include Gilead’s (GILD - Free Report) Yescarta and Novartis’ Kymriah.

 

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Allogene Therapeutics, Inc. (ALLO - Free Report) recently announced that the FDA has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma.

Multiple myeloma​

From Wikipedia, the free encyclopedia



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Not to be confused with Melanoma.

Multiple myeloma
Other names	Plasma cell myeloma, myelomatosis, Kahler's disease, myeloma[1]
Micrograph of a plasmacytoma, H&E stain
Specialty	Hematology and oncology
Symptoms	Bone pain, fatigue[2]:653
Complications	Amyloidosis, kidney problems, bone fractures, hyperviscosity syndrome, infections, anemia[3][2]:653
Duration	Long term[3]
Causes	Unknown[4]
Risk factors	Obesity[5]
Diagnostic method	Blood or urine tests, bone marrow biopsy, medical imaging[6]
Treatment	Steroids, chemotherapy, thalidomide, stem cell transplant, bisphosphonates, radiation therapy[3][6]
Prognosis	Five-year survival rate 54% / life expectancy 6 years (USA)[7]
Frequency	488,200 (affected during 2015)[8]
Deaths	101,100 (2015)[9]

Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies.[6] Often, no symptoms are noticed initially.[10] As it progresses, bone pain, anemia, kidney dysfunction, and infections may occur.[10]Complications may include amyloidosis.[3]
The cause of multiple myeloma is unknown.[4]Risk factors include obesity, radiationexposure, family history, and certain chemicals.[5][11][1

 

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B-cell maturation antigen (BCMA or BCM), also known as tumor necrosis factor receptor superfamily member 17(TNFRSF17), is a protein that in humans is encoded by the TNFRSF17 gene.

TNFRSF17 is a cell surface receptor of the TNF receptorsuperfamily which recognizes B-cell activating factor(BAFF).[5][6][7]

ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies.

 

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TNFRSF17 is a cell surface receptor of the TNF receptorsuperfamily which recognizes B-cell activating factor(BAFF).[5][6][7]

Cell surface receptor​

From Wikipedia, the free encyclopedia



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Main article: Receptor (biochemistry)

The seven-transmembrane α-helix structure of a G-protein-coupled receptor
Cell surface receptors(membrane receptors, transmembrane receptors) are receptorsthat are embedded in the plasma membrane of cells. They act in cell signaling by receiving (binding to) extracellular molecules. They are specialized integral membrane proteins that allow communication between the cell and the extracellular space. The extracellular molecules may be hormones, neurotransmitters, cytokines, growth factors, cell adhesion molecules, or nutrients; they react with the receptor to induce changes in the metabolism and activity of a cell. In the process of signal transduction, ligand binding affects a cascading chemical change through the cell membrane.

 

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TNFRSF17 is a cell surface receptor of the TNF receptorsuperfamily which recognizes B-cell activating factor(BAFF).[5][6][7]

TNF receptor superfamily​

From Wikipedia, the free encyclopedia
(Redirected from TNF receptor)


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Identifiers
TNFR/NGFR cysteine-rich region
Structure of the soluble human 55 kd TNF receptor-human TNF beta complex.[1]
Symbol	TNFR_c6
Pfam	PF00020
InterPro	IPR011614
PROSITE	PDOC00561
SCOP2	1tnr / SCOPe / SUPFAM
Membranome	6
The tumor necrosis factor receptor superfamily(TNFRSF) is a protein superfamily of cytokine receptors characterized by the ability to bind tumor necrosis factors (TNFs) via an extracellular cysteine-rich domain.[2][3] With the exception of nerve growth factor (NGF), all TNFs are homologous to the archetypal TNF-alpha.[4] In their active form, the majority of TNF receptors form trimeric complexes in the plasma membrane. Accordingly, most TNF receptors contain transmembrane domains (TMDs), although some can be cleaved into soluble forms (e.g. TNFR1), and some lack a TMD entirely (e.g. DcR3). In addition, most TNF receptors require specific adaptor protein such as TRADD, TRAF, RIP and FADD for downstream signalling. TNF receptors are primarily involved in apoptosis and inflammation, but they can also take part in other signal transduction pathways, such as proliferation, survival, and differentiation. TNF receptors are expressed in a wide variety of tissues in mammals, especially in leukocytes.[4] showAvailable protein structures:

 

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B-cell maturation antigen (BCMA or BCM), also known as tumor necrosis factor receptor superfamily member 17(TNFRSF17), is a protein that in humans is encoded by the TNFRSF17 gene.

TNFRSF17 is a cell surface receptor of the TNF receptorsuperfamily which recognizes B-cell activating factor(BAFF).[5][6][7]

B-cell activating factor(BAFF) also known as tumor necrosis factor ligand superfamily member 13B is a protein that in humans is encoded by the TNFSF13B gene.[5][6]BAFF is also known as B Lymphocyte Stimulator (BLyS) and TNF- and APOL-related leukocyte expressed ligand (TALL-1) and the Dendritic cell-derived TNF-like molecule (CD257 antigen; cluster of differentiation 257).

 

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B-cell activating factor(BAFF) also known as tumor necrosis factor ligand superfamily member 13B is a protein that in humans is encoded by the TNFSF13B gene.[5][6]BAFF is also known as B Lymphocyte Stimulator (BLyS) and TNF- and APOL-related leukocyte expressed ligand (TALL-1) and the Dendritic cell-derived TNF-like molecule (CD257 antigen; cluster of differentiation 257).

BAFF is a cytokine that belongs to the tumor necrosis factor (TNF) ligand family. This cytokine is a ligand for receptors TNFRSF13B/TACI, TNFRSF17/BCMA, and TNFRSF13C/BAFF-R. This cytokine is expressed in B cell lineage cells, and acts as a potent B cell activator. It has been also shown to play an important role in the proliferation and differentiation of B cells.[7]

 

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BAFF is a cytokine that belongs to the tumor necrosis factor (TNF) ligand family. This cytokine is a ligand for receptors TNFRSF13B/TACI, TNFRSF17/BCMA, and TNFRSF13C/BAFF-R. This cytokine is expressed in B cell lineage cells, and acts as a potent B cell activator. It has been also shown to play an important role in the proliferation and differentiation of B cells.[7]

B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype.[1] They function in the humoral immunity component of the adaptive immune system.[1] B cells produce antibodymolecules; however, these antibodies are not secreted. Rather, they are inserted into the plasma membrane where they serve as a part of B-cell receptors.[2] When a naïve or memory B cell is activated by an antigen, it proliferates and differentiates into an antibody-secreting effector cell, known as a plasmablast or plasma cell.[2]Additionally, B cells present antigens (they are also classified as professional antigen-presenting cells (APCs)) and secrete cytokines.[1] In mammals, B cells mature in the bone marrow, which is at the core of most bones.[3] In birds, B cells mature in the bursa of Fabricius, a lymphoid organ where they were first discovered by Chang and Glick,[3]which is why the 'B' stands for bursa and not bone marrow as commonly believed.

 

[Cottonmouth]

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