Allogene Generic BCMA CAR-T Therapy Receives FDA Orphan Drug Designation

April 29, 2022/eMedClub News/--On April 27, 2022, Allogene Therapeutics announced that the U.
S.
FDA has granted its generic BCMA CAR-T therapy ALLO-605 orphan drug designation (ODD) for the treatment of Multiple Myeloma (MM)
.

 ALLO-605 is the first TurboCAR™ product candidate developed by Allogene
.

TurboCAR™ is a next-generation platform technology based on programmable cytokine signaling designed to control T cell exhaustion and improve T cell function and potency
.

These properties may enable CAR-T products to successfully treat hematological malignancies and solid tumors
.

On June 30, 2021, the FDA has granted Fast Track designation to ALLO-605 based on the product's potential to address an unmet need in patients who have failed other standard treatments for multiple myeloma
.

Preclinical findings demonstrate that ALLO-605 exhibits enhanced cytokine secretion, multifunctionality, in vitro serial killing activity, and tumor eradication in animal models of myeloma
.

A Phase 1 clinical study evaluating ALLO-605 is currently underway
.

 Rafael Amado, MD, Executive Vice President of R&D and Chief Medical Officer of Allogene, said: "Orphan drug designation marks a step toward developing an anti-BCMA portfolio for patients with multiple myeloma, as well as providing patients with an allogeneic CAR-T product.
An important step forward
.

We look forward to providing an update on our BCMA clinical assets by the end of this year, with an eye toward prioritizing strategies for the next phase of development
.

"Allogene's Allogeneic BCMA CAR-T BCMA is a proven target in multiple myeloma due to its high specificity and broad expression
.

Allogene currently has two BCMA CAR-T products in clinical development
.

 ALLO-715, the company's other BCMA-targeting allogeneic CAR-T therapy, is a potential new treatment for multiple myeloma and other BCMA-positive malignancies
.

ALLO-715 is in the UNIVERSAL trial to evaluate ALLO- Efficacy of 715 administered as monotherapy, in combination with the gamma-secretase inhibitor nirogacestat in the treatment of multiple myeloma
.

ALLO-715 received Regenerative Medicine Advanced Therapy (RMAT) designation in April 2021 and U.
S.
Food and Drug Administration in August 2021 Orphan Drug Designation (ODD) by the Drug Administration (FDA)
.

 In addition, on March 23, 2022, Allogene Therapeutics announced the publication of preclinical findings in Cancer Research Communications, a journal of the American Association for Cancer Research, demonstrating the Allogeneic BCMA CAR-T cells from healthy donors have longer-term in vitro myeloma-killing activity compared to BCMA CAR-T cells from myeloma patients
.

 Allogeneic strategies have become a major trend in allogeneic CAR-T therapy The product development time is greatly shortened and it is more cost-effective, which has successfully set off a research and development boom in the field of cell therapy
.

 On March 17, 2022, the clinical trial application of "CTA101 UCAR T cell injection" (universal CAR-T) independently developed by Nanjing Beiheng Biotech obtained the implied license of the State Food and Drug Administration (NMPA).
For the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
.

Recommended reading: The first domestic "spot type" CAR-T enters the clinic, will Beiheng Bio be the first "crab eater"? Medical Maimeng broke the news On March 15, 2022, Wugen announced that the first patient had been dosed in its Phase 1/2 trial of its allogeneic CAR-T-007, mainly for the treatment of relapsed or refractory (R /R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphocytic lymphoma (LBL)
.

Recommended reading: "Spot-type" CD7 CAR-T for the treatment of hematological tumors, completes the first patient dosingYimai Meng broke the newsOn January 5, 2022, Intellia Therapeutics and Kyverna Therapeutics announced an exclusive cooperation agreement to jointly develop and later Commercialization of allogeneic CD19 CAR-T cell therapy for the treatment of severe autoimmune diseases
.

Recommended reading: Another new type of CD19 CAR-T cell therapy enters autoimmune diseases! Nobel Prize-winning co-creation company Intellia is optimisticYimai Meng broke the news On December 11, 2021, Precision BioSciences submitted its two allogeneic CAR-T cell therapies PBCAR0191 at the 63rd American Society of Hematology (ASH) annual meeting In the latest data from the Phase 1/2a clinical study, according to the company's CEO Michael Amoroso, they observed that in patients who relapsed after treatment with autologous CAR-T, there was still a response after treatment with PBCAR0191
.

Recommended reading: "Spot" CD19 CAR-T announces latest data - still effective for patients with relapse after autologous CAR-T therapy On November 22, 2021, CRISPR Therapeutics announced that the US FDA has granted CTX110 Regenerative Medicine Advanced Therapy Designation (RMAT)
.

CTX110 is an allogeneic CAR-T cell therapy engineered with CRISPR gene editing technology for the treatment of patients with CD19-positive B-cell malignancies
.

Recommended reading: The "most" safe CAR-T has been granted regenerative medicine advanced therapy (RMAT) qualification by the US FDAYimai Meng broke the newsOn November 12, 2021, Cellectis announced its allogeneic CAR at the annual meeting of the Cancer Immunotherapy Society - First preclinical data on T-cell UCARTMESO for the treatment of solid tumors expressing mesothelin (MSLN)
.

Preclinical data demonstrate potent activity of UCARTMESO against MSLN-expressing cell lines in vitro and in vivo, as well as in vivo activity in mouse models of pancreatic and pleural mesothelioma
.

Recommended reading: "Spot" CAR-T giant Cellectis announces preclinical data and expands its universal cell therapy footprintYimai Meng broke the news to launch new autologous and allogeneic CAR-T cell therapy companies
.

Also co-founded are Intellia Therapeutics and GEMoaB GmbH, a subsidiary of Cellex Cell Professionals
.

Recommended reading: $250 million incubating cell therapy cutting-edge! Blackstone and Intellia are deploying allogeneic CAR-TYimai Meng revealed that the allogeneic strategy aims to allow more patients to receive CAR-T treatment in a cheaper, more convenient and faster way
.

This is also one of the strategies that are expected to effectively reduce the cost of CAR-T treatment in the future, in addition to the production process revolution
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At present, allogeneic CAR-T has shown great potential in treatment.
If it can solve the current safety problems such as graft-versus-host disease (GvHD) and rejection (HvG), this field is expected to gain further development
.

Reference: https:// -for-the-treatment-of-multiple-myeloma-/——List of recent popular activities——▼On May 5th, the process and regulations are parallel, analyzing the key elements of mRNA production quality control▼On May 10th, mRNA vaccine development Online Forum on Technology Application▼May 11, AAV Gene Therapy CMC Control Strategy▼May 22, 2022TIL Cell Therapy Technology Innovation Forum