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FDA Approves Enhertu for Unresectable or Metastatic HER2-Low Breast Cancer

FDA Approves Enhertu for Unresectable or Metastatic HER2-Low Breast Cancer | Genetic Engineering in the Press by GEG | Scoop.it

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BigField GEG Tech's insight:

The FDA approval was based on results from the DESTINY-Breast04 study, which found that Enhertu improved both progression-free survival and overall survival in people diagnosed with previously treated metastatic HER2-low breast cancer when compared with doctors’ choice of chemotherapy.

This information is provided by Breastcancer.org.
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Novel approaches highlight potential of cell therapy for a wider array of cancers

Novel approaches highlight potential of cell therapy for a wider array of cancers | Genetic Engineering in the Press by GEG | Scoop.it
The ideal strategy to treat cancer with cell therapy can vary greatly depending on tumor type.On one hand, outcomes for patients with hematologic malignancies might be improved by modifying current chimeric antigen receptor T-cell therapy constructs.
BigField GEG Tech's insight:

The ideal strategy for treating cancer with cell therapy can vary greatly depending on the type of tumour. Three presentations at this year's annual meeting of the American Association for Cancer Research highlighted how distinct approaches can be used to improve the efficacy of cell therapies for blood cancers or solid tumours. First, younger patients with diffuse midline glioma experienced prolonged benefit after receiving an experimental GD2-directed CAR T therapy developed at Stanford University. Secondly, initial data from a phase 1/2 dose escalation trial showed encouraging clinical activity for patients with testicular cancer and ovarian cancer who received the experimental regimen. Agents used in the trial included BNT211 (BioNTech), an autologous CAR T cell therapy that targets the oncofetal antigen Claudin-6 (CLDN6) and CARVac, an mRNA-based vaccine encoding CLDN6 designed to enhance CAR T cell activity. Finally, another emerging cell therapy uses a completely different effector cell platform. Researchers have combined natural killer cells with a bispecific antibody for patients with relapsed or refractory CD30-positive lymphoma. All patients who received the recommended phase 2 dose of the experimental treatment achieved an objective response to treatment. 

 

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CAR-T demonstrates efficacy as second-line therapy for transplant-ineligible lymphoma

CAR-T demonstrates efficacy as second-line therapy for transplant-ineligible lymphoma | Genetic Engineering in the Press by GEG | Scoop.it
CHICAGO — Second-line therapy with lisocabtagene maraleucel induced initial complete remission among more than half of patients with relapsed or refractory transplant-ineligible large B-cell lymphoma, results from a phase 2 trial showed. A primary analysis from the PILOT study — presented at ASCO Annual Meeting — revealed low incidence of high-grade treatment-related cytokine
BigField GEG Tech's insight:

Maraleucel lisocabtagen is a second-line treatment for adults with relapsed or refractory diffuse large B-cell lymphoma. It is a chimeric T-cell therapy directed at the CD19 antigen receptor, commonly known as liso-cel. This therapy induced an initial complete remission in more than half of patients with relapsed or refractory large B-cell lymphoma ineligible for transplantation, results of a phase 2 PILOT trial showed. The multicenter study included 61 patients (median age 74 years; range 53-84; 61% male) with relapsed or refractory B-cell lymphoma. All study participants experienced disease progression after first-line therapy and were ineligible for high-dose chemotherapy and HSCT. Patients received lymphodepleting chemotherapy followed by a single infusion of liso-cel at a target dose of 100 × 10 6 CAR T cells. In addition, a primary analysis of the study revealed a low incidence of treatment-related high-grade cytokine release syndrome and neurotoxicity after a single dose of cell therapy.

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Exa-cel may offer functional cure for beta-thalassemia, sickle cell disease, new data show

Exa-cel may offer functional cure for beta-thalassemia, sickle cell disease, new data show | Genetic Engineering in the Press by GEG | Scoop.it
An investigational CRISPR/Cas9 gene-edited cell therapy demonstrated significant, durable efficacy among patients with transfusion-dependent beta-thalassemia and sickle cell disease, according to study results.The new data, presented during European Hematology Association Hybrid 2022 Congress, showed increases in fetal hemoglobin levels after a single dose of exagamglogene autotemcel, or exa-cel
BigField GEG Tech's insight:

An experimental gene-modified CRISPR/Cas9 cell therapy has demonstrated significant and sustained efficacy in patients with transfusion-dependent beta-thalassemia and sickle cell disease. The new data, presented at the European Association of Haematology Hybrid Congress 2022, showed an increase in fetal haemoglobin levels after a single dose of exa-cel, formerly known as CTX001. Exa-cel uses CRISPR-Cas9-mediated ex vivo editing of BCL11A to produce high levels of fetal haemoglobin in red blood cells. In patients, this treatment resulted in the elimination of transfusions in almost all of the 44 patients with beta-thalassemia and the elimination of vaso-occlusive crises in the 31 patients with sickle cell disease. The researchers also observed clinically significant increases in fetal haemoglobin and haemoglobin levels in both groups of patients, with an average proportion of fetal haemoglobin of more than 20% at month 3, rising to about 40% at month 4 and stabilising thereafter. Mean total haemoglobin levels exceeded 11 g/dL after month 3.  

Florencer Edwine's curator insight, July 13, 1:20 PM

 

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Researchers create first comprehensive functional map of genes expressed in human cells

Researchers create first comprehensive functional map of genes expressed in human cells | Genetic Engineering in the Press by GEG | Scoop.it
The Human Genome Project was an ambitious initiative to sequence every piece of human DNA. The project drew together collaborators from research institutions around the world, including Whitehead Institute, and was finally completed in 2003.
BigField GEG Tech's insight:

Jonathan Weissman, a member of the Whitehead Institute, and his colleagues have produced the first comprehensive functional map of genes expressed in human cells. The data from this project, published online on 9 June in Cell, associates each gene with its work in the cell. For this project, the researchers used the Perturb-seq method, which uses CRISPR/Cas9 genome editing to introduce genetic modifications into cells, and then uses single-cell RNA sequencing to capture information about the expressed RNAs resulting from a given genetic modification. Since RNAs control all aspects of cell behavior, this method can help decipher the many cellular effects of genetic modifications.  Using human blood cancer cell lines as well as non-cancerous retina-derived cells, the researchers performed a Perturb-seq on over 2.5 million cells and used the data to create a comprehensive map linking genotypes to phenotypes. Once completed, the researchers decided to use their new dataset and examine some biological questions. In the future, the researchers hope to use Perturb-seq on different cell types in addition to the cancer cell line they started with. They also hope to continue exploring their map of gene functions and hope that others will do the same. 

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News: Clinical Trial Update: Positive Initial Data for CRISPR-Edited CAR-T Therapy in Aggressive Blood Cancer

News: Clinical Trial Update: Positive Initial Data for CRISPR-Edited CAR-T Therapy in Aggressive Blood Cancer | Genetic Engineering in the Press by GEG | Scoop.it
Caribou Biosciences recently shared positive clinical data for its CRISPR-edited CAR-T cell therapy, CB-010, in patients with relapsed/refractory B cell non-Hodgkin lymphoma. CB-010 is the first allogeneic CAR-T cell candidate to achieve a clinical response in all patients evaluated.
BigField GEG Tech's insight:

Caribou Biosciences recently announced positive initial clinical trial data for its genetically engineered CAR-T cell therapy candidate CB-010. Caribou is developing CB-010 as a ready-to-use allogeneic anti-CD19 CAR-T cell therapy for relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r NHL-B). The CD19-specific CAR is inserted into the TRAC gene, which encodes the T cell receptor alpha constant. The PD-1 gene is also deleted in these cells. This gene encodes the PD-1 protein that functions as a safety switch on T cells that cancer cells activate to protect themselves from T-cell mediated immune responses. CB-010 is the first allogeneic CAR-T cell therapy with a CRISPR-mediated PD-1 deletion to be approved for clinical trial. CB-001 is being evaluated in the Phase 1 ANTLER trial, and data published to date have shown a 100% overall response rate (ORR, 5 out of 5 patients) and an 80% complete response rate (CR, 4 out of 5 patients) after a single dose at baseline in patients with aggressive r/r NHL. These data make CB-010 the first allogeneic CAR-T cell therapy to achieve a 100% ORR. 

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Trial Assessing CAR T-Cell Therapy ACLX-001 in Relapsed/Refractory Multiple Myeloma Begins

Trial Assessing CAR T-Cell Therapy ACLX-001 in Relapsed/Refractory Multiple Myeloma Begins | Genetic Engineering in the Press by GEG | Scoop.it
Investigators have initiated a phase 1 trial exploring ACLX-001, a novel CAR T-cell therapy using the ARC-SparX platform, in patients with relapsed/refractory multiple myeloma.
BigField GEG Tech's insight:

Researchers have initiated a Phase 1 trial (NCT04155749) exploring ACLX-001, a novel CAR T-cell therapy using the ARC-SparX platform, in patients with relapsed multiple myeloma. ARC-SparX is a universal cell therapy platform composed of soluble antigen-receptor X-linker (SparX) proteins designed to target BCMA to myeloma cells. This is combined with a separate dose of antigen receptor complex-T (ARC-T) cells, which are designed to activate only when engaged with a SparX protein that has bound to a myeloma cell. The combination of ARC-T cells and SparX protein forms ACLX-001. The ARC-T cells and SparX proteins use Arcellx's new synthetic binding scaffold called D-Domain. According to drugmaker Arcellx, the first patient received the study treatment in May 2022. In the clinical trial, patients may receive ARC-T cells, SparX-001 or both, and treatment may be escalated based on correlative clinical data, including SparX-00 pharmacokinetics and ARC-T expansion.The trial's primary endpoints are the incidence of treatment-related adverse events, including dose-limiting toxicities over 24 months, and the establishment of the recommended phase 2 dose. The trial is still recruiting patients. First data from the Phase 1 study are expected in 2023.   

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FDA-Approved CAR T-Cell Therapies Illuminate Advances in Multiple Myeloma

FDA-Approved CAR T-Cell Therapies Illuminate Advances in Multiple Myeloma | Genetic Engineering in the Press by GEG | Scoop.it
Noopur S. Raje, MD, discussed the presentation she gave at the 26th Annual International Congress on Hematologic Malignancies® on the CAR T-cell therapy product bb21217, other exciting myeloma treatments that were presented at ASH, and the need for increased treatment accessibility.
BigField GEG Tech's insight:

In the field of CAR T-cell therapies, there are three major unmet needs. The biggest thing that needs to be improved is access to treatment because at the moment all these drugs are only approved in the very late relapsed/refractory stage. Often there are patients waiting for these drugs who cannot get to that stage. This is one of the biggest unmet needs. Another unmet need in myeloma is product-specific treatments. With cilta-cel, for example, we are seeing extremely high response rates and durable remissions. The hope is that we will continue to see no neurotoxicity, the opposite of what was seen in CARTITUDE-1. The good news is that we have not seen neurotoxicity so far with the mitigation strategies the researchers are using, but they need to follow patients long-term to confirm this. The unmet need with ide-cel is that response rates are about 40% and PFS is about 20 months in the highly refractory patient population. Researchers need to do a better job of increasing response rates and also improving the duration of response.  

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The promise of RNA medicine is targeted and personalized

The promise of RNA medicine is targeted and personalized | Genetic Engineering in the Press by GEG | Scoop.it
The development of messenger RNA (mRNA) vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has only increased the impetus in this field.
BigField GEG Tech's insight:

Many new drug delivery models and systems have emerged in recent years, allowing scientists to consider the application of ribonucleic acid (RNA) based drugs in the treatment, prevention and diagnosis of a range of disorders. Hydrophilic anionic RNA therapeutic molecules are unable to cross the cell membrane without delivery systems or chemical modification. Biodegradable, biocompatible and low toxicity nanomaterials are now being used as RNA nanocarriers. These include polyethyleneimine (PEI) lipids, poly(lactic-coglycolic acid), magnetic nanoparticles, carbon nanotubes, gold nanoparticles and silica nanoparticles. Lipid nanoparticles (LNPs) are currently used in vaccines and nucleic acid drugs due to their easy manufacture and compliance with the above criteria. Origami-like RNA nanostructures are also promising vehicles, as are virus-like particles (VLPs). As RNA carriers develop, the use of new vehicles, including nanodots and carbon nanotubes, and functionalized systems is increasing

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Tisagenlecleucel appears less toxic among CAR-Ts for advanced follicular lymphoma

Tisagenlecleucel appears less toxic among CAR-Ts for advanced follicular lymphoma | Genetic Engineering in the Press by GEG | Scoop.it
Tisagenlecleucel may be less toxic than axicabtagene ciloleucel for patients with relapsed or refractory follicular lymphoma, study results suggested.Results of an indirect comparison study presented at Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR showed patients who received axicabtagene ciloleucel (Yescarta; Kite Pharma/Gilead Sciences) for advanced
BigField GEG Tech's insight:

Tisagenlecleucel and axicabtagen ciloleucel are autologous chimeric T cell antigen receptor therapies directed against CD19. Tisagenlecleucel may be less toxic than the axicabtagen ciloleucel for patients with relapsed or refractory follicular lymphoma, according to the study results. Patients who received the axicabtagen ciloleucel (Yescarta; Kite Pharma/Gilead Sciences) for advanced follicular lymphoma had a significantly higher incidence of cytokine release syndrome and neurotoxicity than those who received tisagenlecleucel (Kymriah, Novartis). Dickinson and colleagues conducted a matched indirect comparison study based on propensity score weighting to compare populations from different trials while adjusting for different characteristics of each patient population. The results showed similar efficacy results between the pre- and post-weighting studies, while tisagenlecleucel showed significantly lower rates of overall and high-grade CRS or neurotoxicity.  

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FDA grants orphan drug designation to off-the-shelf CAR-T for advanced multiple myeloma

FDA grants orphan drug designation to off-the-shelf CAR-T for advanced multiple myeloma | Genetic Engineering in the Press by GEG | Scoop.it

The FDA granted orphan drug designation to ALLO-605, a chimeric antigen receptor T-cell therapy for adults with relapsed or refractory multiple myeloma.ALLO-605 (Allogene Therapeutics) is an allogeneic, gene-edited CAR T-cell therapy that targets the B-cell maturation antigen (BCMA) on the surface of cancer cells. The investigational agent was previously given fast track designation by the FDA.

BigField GEG Tech's insight:

The FDA has granted orphan drug designation to ALLO-605, a CAR T-cell therapy for adults with relapsed or refractory multiple myeloma that targets the B-cell maturation antigen on the surface of cancer cells. The ready-to-use CAR T-cell therapy is derived from healthy donor-induced pluripotent stem cells and has been developed using Allogene's proprietary TurboCAR platform to enhance their potency and function. ALLO-605 is currently being evaluated in the IGNITE Phase 1 trial. The dose escalation study is designed to evaluate the safety, feasibility and recommended Phase 2 dose of ALLO-605 for patients with relapsed or refractory multiple myeloma or other BCMA-positive malignancies. The trial uses CAR T-cell therapy in combination with ALLO-647, a monoclonal antibody to CD52, in the study's lymphodepletion regimen prior to ALLO-605 infusion.   

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CAR T-cell Therapy Demonstrates Efficacy Without Increased Risk of CRS or ICANS in CNS-Involved LBCL

CAR T-cell Therapy Demonstrates Efficacy Without Increased Risk of CRS or ICANS in CNS-Involved LBCL | Genetic Engineering in the Press by GEG | Scoop.it
The CAR T-cell therapies axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel evoked responses without increased risk of cytokine release syndrome or immune effector cell–associated neurotoxicity syndrome in patients with primary or secondary central nervous system large B-cell lymphoma.
BigField GEG Tech's insight:

The CAR T-cell therapies axicabtagene ciloleucel (axi-cel; Yescarta), tisagenlecleucel (Kymriah) and lisocabtagene maraleucel (liso-cel; Breyanzi) are all FDA-approved for the treatment of patients with DLBCL. However, patients with primary and secondary CNS lymphoma have been excluded from clinical trials using these agents due to the risk of toxicities such as CRS and ICANS. According to a systematic review and analysis of published data presented at the 2022 Transplantation and Cell Therapy Meetings, Axicabtagene ciloleucel, Tisagenlecleucel and liso-cel elicited responses without increased risk of cytokine release syndrome or effector immune cell-associated neurotoxicity in patients with primary or secondary central nervous system (CNS) large B-cell lymphoma (LBCL). In the study, 47.6% of the patients evaluated were male. In addition, 28.3% of patients had primary CNS lymphoma and 71.8% of patients had secondary CNS lymphoma. Of these patients, 53.5% achieved CR, 14.1% had PR and 36.6% had progressive disease. The PFS rates at 1 month, 3 months, 6 months and 12 months were 72.1%, 57%, 44.2% and 37.5%, respectively. 

 

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FDA grants fast track designation to CD33-directed CAR-T for acute myeloid leukemia

FDA grants fast track designation to CD33-directed CAR-T for acute myeloid leukemia | Genetic Engineering in the Press by GEG | Scoop.it
The FDA granted fast track designation to PRGN-3006 for the treatment of adults with relapsed or refractory acute myeloid leukemia.PRGN-3006 (Precigen Inc.) is an autologous, gene-edited chimeric antigen receptor T-cell therapy that targets the CD33 protein on the surface of cancer cells.
BigField GEG Tech's insight:

The FDA has granted accelerated designation to PRGN-3006 for the treatment of adults with relapsed or refractory acute myeloid leukemia. PRGN-3006 (Precigen Inc.) is a CAR T cell therapy that targets the CD33 protein on the surface of cancer cells. This investigational therapy, designed to reduce manufacturing time to 1 day, is based on Precigen's UltraCAR-T therapeutic platform. The therapy uses the Sleeping Beauty non-viral gene editing system to simultaneously express CD33-targeted CAR, membrane-bound interleukin-15 and a therapeutic "kill switch" that conditionally eliminates CAR T cells for increased safety. PRGN-3006 is being evaluated in a single-center Phase 1/phase 1B dose escalation/extension study to determine safety and recommended Phase 2 dose for adults with relapsed or refractory AML, high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Study participants will receive a single IV dose of the treatment with or without prior lymphodepletion. Interim results from the study, presented last year at the ASH Annual Meeting, showed an overall response rate of 50% in the first six patients in the lymphodepletion cohort. Safety results showed no dose-limiting toxicities. One of the 15 patients developed a grade 3 cytokine release syndrome. 

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MaxCyte signs strategic platform license with LG Chem to advance its allogeneic CAR-T programs

MaxCyte signs strategic platform license with LG Chem to advance its allogeneic CAR-T programs | Genetic Engineering in the Press by GEG | Scoop.it
MaxCyte, Inc., a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announces the signing of a strategic platform license (SPL) with LG Chem Ltd., a globally diversified chemical company established in petrochemical, advanced materials and bio-technology, aiming to create new value for its customers based on science.
BigField GEG Tech's insight:

MaxCyte, Inc, a commercial cell engineering company specializing in the provision of platform technologies has a portfolio of instruments that are the next generation of advanced, clinically validated electroporation technology for complex and scalable cell engineering. Offering high transfection efficiency, seamless scalability and enhanced functionality, their ExPERT™ platform notably delivers the high-end performance essential to enable the next wave of biological and cell-based therapies. The company announced the signing of a strategic platform licence (SPL) with LG Chem Ltd. This company obtains non-exclusive clinical and commercial rights to use MaxCyte's flow electroporation technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing rights and revenues related to the programme. LG Chem is thereby strengthening its anti-cancer business through the advanced construction of cellular drug platform technologies. LR19023, its next-generation CAR-T cell therapy, is currently in preclinical stage and under development as a solid anti-cancer therapeutic.

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Dual-target CAR-T ‘very promising’ for advanced multiple myeloma

Dual-target CAR-T ‘very promising’ for advanced multiple myeloma | Genetic Engineering in the Press by GEG | Scoop.it
BigField GEG Tech's insight:

GC012F (Gracell Biotechnologies) is an autologous, genetically engineered, bispecific CAR-T that targets B cell maturation antigen (BCMA) and CD19 proteins on the surface of cancer cells. BCMA is universally expressed on malignant plasma cells and is a well-established target for multiple myeloma, while CD19 is expressed on both myeloma cells and their progenitor cells. The new cell therapy, which previously received FDA orphan drug designation, is manufactured within 24 hours of apheresis using Gracell's proprietary FasT CAR platform. The investigators chose to use a dual-targeted CAR-T manufactured in one day or less for this study population of heavily pre-treated multiple myeloma patients to reduce the risk of disease progression prior to CAR-T infusion. Twenty-five (89.3%) of 28 patients achieved objective treatment responses after a single infusion of GC0-12F, including 21 (75%) with a negative complete response to minimal residual disease (MRD) or a strict complete response to treatment. Twenty-four (86%) patients had a very good partial response or better.

 

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CRISPR trial: Children with sickle cell disease and beta thalassemia to get gene-editing treatment

CRISPR trial: Children with sickle cell disease and beta thalassemia to get gene-editing treatment | Genetic Engineering in the Press by GEG | Scoop.it
CRISPR gene-editing trials for treating beta thalassaemia and sickle cell disease are being extended to include people under the age of 12 after positive results in older people
BigField GEG Tech's insight:

Beta thalassaemia and sickle cell disease are caused by genetic mutations that affect the adult form of haemoglobin. However, some people have few or no symptoms despite having one of the mutations that normally cause these disorders, because their bodies continue to produce foetal haemoglobin into adulthood. A CRISPR-based treatment, called exa-cel, has therefore been developed that aims to mimic this by extracting blood-producing stem cells from people's bone marrow, using CRISPR gene editing to deactivate the gene that disables fetal haemoglobin production, and then reintroducing the edited cells into each person. Initial promising results for the first people to be treated have recently been published. Results from phase II trials testing the effectiveness of the approach in 75 people have also been announced. In addition, clinical trials are being expanded to include children under 12 years of age after the therapies proved effective in ongoing trials involving people aged 12 to 35. The aim is to treat children early enough to prevent them from developing lasting damage from these inherited disorders. 

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Dual-target CAR-T ‘very promising’ for advanced multiple myeloma

Dual-target CAR-T ‘very promising’ for advanced multiple myeloma | Genetic Engineering in the Press by GEG | Scoop.it
CHICAGO — A single dose of an investigational chimeric antigen receptor T-cell therapy induced an objective response in nearly 90% of patients with relapsed or refractory multiple myeloma, phase 1 study results showed. Data from the trial — presented at ASCO Annual Meeting — indicated the agent exhibited a manageable safety profile. Researchers reported few cases of high-grade
BigField GEG Tech's insight:

GC012F is an autologous, genetically engineered, bispecific CAR-T that targets B-cell maturation antigen and CD19 proteins on the surface of cancer cells. The new cell therapy, which has previously received FDA orphan drug designation, is manufactured within 24 hours of apheresis using Gracell's proprietary FasT CAR platform. A single dose of an investigational chimeric antigen receptor T-cell therapy induced an objective response in up to 90% of patients with relapsed or refractory multiple myeloma, results from the Phase 1 study showed. Data from the trial, presented at the ASCO Annual Meeting, indicated that the agent had a manageable safety profile. Twenty-five (89.3%) of the 28 patients achieved objective treatment responses after a single infusion of GC0-12F, including 21 (75%) with a negative complete response to minimal residual disease or a strict complete response to treatment. Twenty-four (86%) patients had a very good partial response or better. Researchers reported few cases of high-grade cytokine release syndrome and no treatment-related neurotoxicity.   

Florencer Edwine's curator insight, July 13, 1:19 PM

 

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CT041 CAR T-cell Therapy Elicits Manageable Toxicity and Durable Response in Gastric/GEJ Cancer

CT041 CAR T-cell Therapy Elicits Manageable Toxicity and Durable Response in Gastric/GEJ Cancer | Genetic Engineering in the Press by GEG | Scoop.it
CT041, a Claudin18.2–specific CAR T-cell therapy, demonstrated a manageable safety profile in patients with previously treated, CLDN18.2-positive advanced gastric/gastroesophageal junction cancer, with a majority of patients achieving partial response or stable disease.
BigField GEG Tech's insight:

CT041, a Claudin18.2-specific CAR T-cell therapy (CLDN18.2), demonstrated a manageable safety profile in patients with previously treated advanced gastric/gastroesophageal junction (GJ) cancer, CLDN18.2-positive, with a majority of patients achieving a partial response or stable disease, according to results from a Phase 1b study (NCT04404595) that were presented at the 2022 ASCO Annual Meeting. In the single-arm study, the objective response rate with CT041 was 33% in the evaluable efficacy patients included in the study (n=12), which included 1 complete response in a patient with metastatic gastric cancer. Including stable disease, disease control was observed in two-thirds of patients. No dose-limiting toxicities were observed and there were no cases of grade 3 or higher cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), gastrointestinal bleeding or acute gastric mucosal injury. The Phase 1b study continues to enrol participants in the dose escalation portion of the trial. Once a dose is identified, an expansion cohort will open to further evaluate the cell therapy at that dose level. Overall, the study plans to recruit 110 participants in total and is expected to end in June 2025. 

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UH experts in cloning and stem cell science take the first step toward unraveling cystic fibrosis

UH experts in cloning and stem cell science take the first step toward unraveling cystic fibrosis | Genetic Engineering in the Press by GEG | Scoop.it
Two nationally recognized experts in cloning and stem cell science from the University of Houston are taking the first step toward limiting the consequences of chronic inflammation in cystic fibrosis (CF) by identifying the source of this persistent and enigmatic inflammation in CF lungs.
BigField GEG Tech's insight:

Cystic fibrosis is caused by a defect in a gene called cystic fibrosis transmembrane conductance regulator (CFTR) and affects more than 30,000 people in the US. This defect directs the body to produce abnormally sticky, thick mucus that clogs organs, particularly the lungs, causing chronic lung disease marked by infection and inflammation. The Xian-McKeon laboratory received a $2.7 million grant from the National Heart, Lung, and Blood Institute to examine pro-inflammatory stem cell variants in cystic fibrosis. Using technology that clones stem cells from normal lungs, the Xian-McKeon lab found that the chronic obstructive pulmonary disease (COPD) lung is dominated by three stem cell variants that drive all of the pathology of COPD, including inflammation, fibrosis and mucin hypersecretion. The team hypothesizes that these cystic fibrosis stem cell variants play a key role in the progression of cystic fibrosis and represent CFTR-triggered yet CFTR-independent pathogens. To identify the key inflammatory drivers in the three variants, McKeon and Xian will use CRISPR-Cas9 gene editing, which allows them to rapidly create cell models. The Xian-McKeon studies are the first step towards a new class of cystic fibrosis drugs that restore CFTR activity in these patients. 

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News: Gene-Edited T Cells Treat Leukaemia and Solid Tumours

News: Gene-Edited T Cells Treat Leukaemia and Solid Tumours | Genetic Engineering in the Press by GEG | Scoop.it
Researchers from Italy’s Ospedale San Raffaele Scientific Institute, in collaboration with Intellia Therapeutics, have used CRISPR to introduce multiple genomic edits to T cells, creating a T cell receptor therapy candidate with potent activity against haematological and solid tumours.
BigField GEG Tech's insight:

Professor Chiara Bonini and her team at the Ospedale San Raffaele Scientific Institute, in collaboration with Intellia Therapeutics, recently discovered a TCR specific to Wilm's tumour antigen 1 (WT1), a transcription factor involved in cell differentiation and growth, the expression of which is strongly linked to cancer development. The group explained that the WT1-specific TCR could be introduced into the patient's T cells to target a variety of cancers. In a paper published in Science Translational Medicine, the researchers describe the use of CRISPR-Cas9 technology to create several modifications in T cells to test various WT1-targeting TCRs, with promising results on tumour destruction in a range of cancer types. To create a TCR therapy capable of treating various types of cancer, the researchers had to find TCRs capable of recognising several WT1-derived epitopes with different HLA class I restrictions and with high avidity. The chosen receptor also had to be specific for WT1 epitopes that are naturally processed by the standard proteasome rather than the immunoproteasome, meaning that they are present in many cancers. Using CRISPR to introduce several genomic modifications into T cells, we have therefore created a candidate for T cell receptor therapy with potent activity against haematological and solid tumours.  

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News: CRISPR Ameliorates Disc Degeneration and Reduces Pain Signals in Mouse Model of Back Disc Injury

News: CRISPR Ameliorates Disc Degeneration and Reduces Pain Signals in Mouse Model of Back Disc Injury | Genetic Engineering in the Press by GEG | Scoop.it
Researchers have developed a CRISPR-Cas9-based method to target β-catenin in disc cells. Using a mouse model of disc injury, they show that CRISPR-mediated targeting of β-catenin in disc cells ameliorates disc degeneration and attenuates pain-related neural events.
BigField GEG Tech's insight:

Despite numerous efforts to reverse intervertebral disc degeneration and alleviate back pain using cell therapy, biomaterial-based disc repair and gene therapy, surgery remains the mainstay of treatment for disc degeneration. In a recent study, researchers from the Department of Orthopaedic Surgery at Rush University Medical Center developed a new CRISPR-Cas9-based method to treat disc degeneration by targeting β-catenin, a key signalling molecule that has been implicated in disc degeneration. After inducing lesions in the caudal discs of mice, the team turned to a CRISPR-Cas9 editing strategy that would specifically target β-catenin. Exposure of mouse mesenchymal cells to AAV vectors expressing SaCas9 and two sgRNAs targeting Ctnnb1 successfully reduced β-catenin expression levels in vitro. In a proof-of-concept study, they showed that targeting β-catenin using CRISPR-Cas9 significantly attenuated multiple pathological changes of disc degeneration in a mouse model of disc injury. In addition to restoring disc matrix structure, silencing β-catenin also attenuated pain-related neural events in a mouse model of disc degeneration.   

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CAR-T ‘highly cost-effective’ as second-line treatment for large B-cell lymphoma

CAR-T ‘highly cost-effective’ as second-line treatment for large B-cell lymphoma | Genetic Engineering in the Press by GEG | Scoop.it
Despite a high upfront price, treatment with axicabtagene ciloleucel appeared more cost-effective as second-line therapy than standard treatment for relapsed or refractory large B-cell lymphoma, according to study results.Treatment with axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead Sciences) — a CD19-directed chimeric antigen receptor T-cell therapy — improved survival
BigField GEG Tech's insight:

Treatment with axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead Sciences), a CD19-directed chimeric antigen receptor T-cell therapy, improved survival outcomes at an incremental price difference well below the typical threshold that third-party payers often use to determine insurance coverage. Perales and colleagues conducted an estimated cost-effectiveness study of axi-cel as a second-line treatment for adults with relapsed or refractory large B-cell lymphoma. The researchers projected a median OS of 59 months for patients who received axi-cel, compared with 25 months for those who received standard therapy. This translated into a gain of 1.34 years of life and 1.37 QALYs for patients treated with axi-cel compared to standard treatment. Seventy-four per cent of the predicted additional QALYs in the axi-cel group occurred during their EFS state. The analysis yielded an ICER of $75,890/QALY for axi-cel compared to the reference treatment taking into account the additional costs and the QALY difference. A subsequent sensitivity analysis showed that axi-cel has a 72% probability of being cost-effective compared to standard treatment at a willingness-to-pay threshold of $150,000/QALY.  

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News: CRISPR Therapy for Beta Thalassemia Obtains FDA Rare Paediatric Disease Designation

News: CRISPR Therapy for Beta Thalassemia Obtains FDA Rare Paediatric Disease Designation | Genetic Engineering in the Press by GEG | Scoop.it
This week's clinical update features news from Editas Medicine, which recently announced that the U.S. Food and Drug Administration (FDA) has granted Rare Paediatric Disease Designation to EDIT-301 for the treatment of beta thalassemia in children.
BigField GEG Tech's insight:

 

Editas Medicine announced that the FDA has granted rare pediatric disease designation to EDIT-301 for the treatment of beta-thalassemia in children. EDIT-301 is a CRISPR-edited cell therapy in development for the treatment of transfusion-dependent beta-thalassemia and sickle cell disease. EDIT-301 is a patient-derived CRISPR-Cas12a-modified cell therapy designed to compensate for the lack of adult haemoglobin in beta-thalassaemia by reactivating the expression of foetal haemoglobin (HbF). This therapy is being developed using the ribonucleoprotein CRISPR-Cas12a to make modifications that enhance the HBG1/2 promoter region in the beta-globin locus of patient-derived blood stem cells. This strategy is envisaged to mimic the hereditary persistence of HbF that is observed in some individuals who produce HbF into adulthood. 

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UCSF researchers hope to cure sickle cell disease through CRISPR gene editing

UCSF researchers hope to cure sickle cell disease through CRISPR gene editing | Genetic Engineering in the Press by GEG | Scoop.it
With the aid of $17 million in grant funding, UCSF Benioff Children’s Hospital Oakland will initiate a 4-year trial evaluating CRISPR/Cas9 gene editing as a potential cure for sickle cell disease.Researchers at the institution have received a grant of $8.4 million from the California Institute for Regenerative Medicine and one of $8.6 million from the NIH Cure Sickle Cell Initiative, which
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With a $17 million grant, UCSF Benioff Children's Hospital in Oakland will launch a four-year trial evaluating CRISPR/Cas9 gene editing as a potential cure for sickle cell disease. The trial is the first to evaluate the use of non-viral CRISPR gene editing tools to correct a harmful mutation in the beta-globin gene in a patient's own cells. The trial is part of a UC Research consortium led by UCSF in collaboration with UCLA and UC Berkeley. It will initially enroll up to six adults with sickle cell disease at sites in Oakland and Los Angeles and, after meeting safety and efficacy criteria, will expand to include three adolescents aged 12 to 17 years. Seven patients will be treated in Oakland and two in Los Angeles.  During the trial, researchers will extract stem cells from a patient's blood and send them to UCLA's gene manufacturing lab for processing. The trial will use CRISPR technology from the Innovative Genomics Institute (IGI), a UC Berkley-UCSF collaboration founded by Doudna. They will use electrical pulses to create temporary pores in the cell membranes. This will facilitate the entry of the CRISPR/Cas9 platform into the cells and ultimately into the nucleus, where it corrects the cell mutation before being returned to the patient.   

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Preliminary data from clinical trial reveals safety, efficacy of new CAR T-cell therapy for solid tumors

Preliminary data from clinical trial reveals safety, efficacy of new CAR T-cell therapy for solid tumors | Genetic Engineering in the Press by GEG | Scoop.it
A new chimeric antigen receptor (CAR) T-cell product had an acceptable safety profile and showed early signs of efficacy as a monotherapy and in combination with an mRNA vaccine in patients with solid tumors, according to preliminary data from a phase I/II clinical trial presented during the AACR Annual Meeting 2022, held April 8-13.
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One of the main limitations of CAR-T cells for solid tumours is that most of the proteins present on these tumours that could be used as targets are also found at low levels on normal cells, making it difficult to specifically direct CAR T cells against tumour cells and spare healthy cells. However, Haanen and colleagues are conducting a first multi-centre, open-label human clinical trial to assess the safety and preliminary efficacy of a previously developed CAR T-cell product that targets CLDN6, a tumour-specific antigen widely expressed in various solid tumours but silenced in healthy adult tissues. This therapy has been tested in preclinical models in combination with an mRNA vaccine encoding CLDN6 that promotes CAR T-cell expansion. Of the 14 patients with evaluable efficacy, six weeks after infusion, four patients with testicular cancer and two with ovarian cancer showed a partial response, with an overall response rate of nearly 43%. However, Haanen cautioned that these data are very early, with few patients having been treated, so no major conclusions can be drawn at this time. 

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