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Category Archives: Stem Cell Therapy

Vertex’s Robust Pipeline is Ramping Up for Another Big Year – BioSpace

David L. Ryan/The Boston Globe via Getty

Vertex Pharmaceuticals has made significant progress in the fight against cystic fibrosis (CF) throughout the past decade, bringing onto the market four medicines that treat the genetic disorder with a predicted life expectancy of 46 years. While this worthy indication is where the Massachusetts-based company is best known, it is hardly Vertex's only offering.

The companys investment in transformative medicines continues into several other focuses, including type 1 diabetes (T1D), sickle cell disease (SCD) and pain. As stated in its presentation at the 40th Annual J.P. Morgan Healthcare Conference, Vertexs pipeline is delivering potential treatments and cures for more patients in multiple new disease areas.

Our broad and deep pipeline spans multiple diseases where we understand the causal human biology and are addressing validated targets with multiple different modalities, which maximizes our potential for success, Carmen Bozic, M.D., Vertexs EVP of global medicines development and medical affairs and chief medical officer, told BioSpace.

We have made tremendous progress across our pipeline in the last year, with four positive proof of concept readouts and four programs now in pivotal development, and a fifth program is anticipated to enter pivotal development later this year, she continued.

One of these programs will address patients living with APOL1-Mediated Kidney Disease (AMKD). The chronic disorder is caused by APOL1 gene mutations. The recently announced Phase II/III adaptive study will evaluate both the efficacy and safety of VX-147, a treatment that hopes to reduce the rate of kidney function decline in patients with AMKD. It is the first investigational therapy intended to treat the underlying cause of the chronic kidney disease.

At the time, Bozic said that VX-147 holds the potential to be a first-in-class and best-in-class treatment for patients with AMKD, based upon Phase 2 results demonstrating a 47.6% reduction in proteinuria in APOL1-mediated focal segmental glomerulosclerosis (FSGS).

She added that the company has concluded its discussions with the FDA, enabling us to initiate the pivotal development program evaluating VX-147 in the broad patient population with AMKD and to have a clear path forward for potential accelerated approval in the U.S.

In January, Vertex announced positive 150-day results from its Phase I/II study of VX-880, an investigational allogeneic human stem cell-derived islet cell therapy being developed for the treatment of T1D. The company reported that the cell therapy resulted in a 92% reduction in daily insulin use, and an HbA1c decline to 6.7%.

The study continues to dose and enroll patients, measuring the efficacy and safety of various VX-880 dosages. Vertex plans to file an Investigational New Drug (IND) approval in 2023 for a second program approach that will utilize a novel immunoprotective device with transplanted islet cells in hopes of treating an even wider range of T1D patients.

On March 31, Vertex announced positive results from a duo of Phase II proof of concept (POC) studies in acute pain treatment post bunionectomy surgery or abdominoplasty surgery. VX-548 is a selective NaV1.8 inhibitor that may provide a substitute for opioids. In both studies, the data determined that the treatment was generally well tolerated. Vertex announced that it will advance VX-548 into pivotal development in the second half of 2022.

Another intriguing program is CTX001, a CRISPR/Cas9 gene-editing therapy currently being investigated for the treatment of sickle cell disease and transfusion-dependent thalassemia (TDT). In June 2021, Vertex and partner CRISPR Therapeutics presented data from their ongoing Phase I/II clinical trials at the European Hematology Association Annual Meeting.

The data was based on 22 patients who were followed up with a minimum of three months post-treatment. At the final follow-up, all 15 TDT patients were transfusion-free. Each of the seven patients with severe SCD showed elimination of vaso-occlusive crises (VOCs) at the final follow-up.

Vertex CEO and President Reshma Kewalramani, M.D., hailed the results, saying that the data presented today in 22 patients are impressive in both the consistency and durability of effect." He added that "these results add to the growing body of evidence that CTX001 may hold the promise for a one-time functional cure for sickle cell disease and beta thalassemia.

Vertex describes itself as a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

Along these lines, the company announced that as of April 1, its blockbuster CF therapy, Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), is available to Australians with cystic fibrosis, and has been listed on the Pharmaceutical Benefits Scheme (PBS).

I am so proud that one of the final treatments listed on the PBS under my watch as Minister for Health is Trikafta, quoted Greg Hunt, Minister for Health and Aged Care in Australias Department of Health, in a recent media release. This listing will make access to treatment within reach for thousands of Australians with CF each year.

Vertex has made a point over the past decade to make research and development a priority, investing over 70% of its expenses back into it. The company plans to sustain this investment level in the future.

Offering treatments to those with serious diseases may be the highlight of these significant strides made throughout the companys robust pipeline. We are relentless in investing in scientific innovation with the goal of transforming the lives of people with serious diseases, Bozic said.

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City of Hope to present late-breaking and clinical trial data at AACR: Cell therapy and preventive medicine – EurekAlert

NEW ORLEANS Researchers at City of Hope, one of the largest cancer research and treatment organizations in the United States, will present late-breaking and clinical trial findings at this years American Association for Cancer Research Annual Meeting, which begins today. These additional presentations showcase a pilot program in tobacco use cessation and new developments in cell therapy.

Engineering natural killer cells for a new type of cell therapy (two presentations)(1) Off-the-shelf cord blood FLT3 CAR-NK cells for immunotherapy of acute myeloid leukemiaPoster Presentation LB102: Monday, April 11, 1:30 to 5 p.m. CT

Jianhua Yu, Michael Caligiuri and colleagues have developed a new cell therapy approach using natural killer cells that, in lab models, induced a greater response against acute myeloid leukemia (AML) and lengthened the survival of mice with AML without damaging healthy blood stem cells. The treatment could one day provide a viable cell therapy option for patients with AML, who traditionally have not benefited from innovative cell therapy treatments. When these patients experience relapse, it often occurs rapidly, so there is not enough time to prepare patient-derived chimeric antigen receptor (CAR) T cell therapy. City of Hope researchers believe the off-the-shelf cord blood approach they are developing will provide a breakthrough treatment option for a subpopulation of AML patients with the FLT3 gene.

(2) Tumor-reactive and anti-PD-L1 co-stimulated killer cells (TRACK-NK) for immunotherapy of non-small cell lung cancerPoster presentation LB211, Wednesday, April 13, 9 a.m. to 12:30 p.m. CT

Ting Lu, Jianhua Yu, Michael Caligiuri and colleagues have engineered off-the-shelf natural killer cells to make a protein that causes them to be 10 times more potent in killing human lung cancer cells grown in the lab. When tested in mice transplanted with human non-small cell lung cancer, the innovative cell therapy City of Hope developed worked better than un-engineered natural killer cells and did not appear to affect body weight, liver or kidney function, or blood counts, suggesting a safe and effective approach to test clinically.

Priming brain tumors with an oncolytic virus before CAR T cell therapy will soon be tested in humansOncolytic viral reshaping of the tumor microenvironment to promote CAR T cell therapy for glioblastomaPoster Presentation CT541, Wednesday, April 13, 9 a.m. to noon CT

Christine Brown will present data to support the initiation of a Phase 1 clinical trial combining CAR T cell therapy with a cancer-killing oncolytic viral therapy for the treatment of recurrent glioblastoma. This combination trial builds on interim clinical findings from City of Hope and the University of Alabama at Birmingham (UAB). A CAR T cell therapy Phase 1 trial being carried out at City of Hope for recurrent glioblastoma suggests that the more immune cells within the tumor, the longer the patients survival. The oncolytic viral clinical Phase 1 trial conducted by UAB used an oncolytic virus engineered for improved gene expression and viral replication to kill specific brain tumor cells; early findings suggest that the virus could activate immune responses in the brain. Based on these human clinical trials, the research team treated mice with brain tumors first with the oncolytic virus, then with cell therapy, and showed that together the two treatments did not cause any side effects. Based on these findings, a clinical trial under a Mustang Bio investigational new drug application will soon open to try this combination on two types of brain tumors.

Empowering cancer patients to design their own smoking cessation program increases desire to quitEmpowering tobacco-using cancer patient initiation of tobacco cessation by a personal pathway to success program during preoperative patient counseling: a feasibility studyPoster Presentation LB553, Friday, April 8, noon to 1 p.m. CT

Cary Presant, Kimlin Ashing, Steven Rosen and colleagues developed a novel Personal Pathway to Success program where cancer patients were able to choose from 27 individualized tobacco cessation services to help them quit smoking prior to surgery. The pilot program was offered to 54 patients in a preoperative anesthesia testing clinic, and 23 completed counseling. The availability of the program increased initial patient interest from less than 10% to more than 50% of patients working to quit smoking. The innovative, personalized intervention program appears to be effective, partially because it reaches cancer patients during presurgery visits, when they seem to be more receptive to a teachable moment of behavioral changes to prevent disease.

# # #

About City of HopeCity of Hope'smission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. As an independent, NationalCancerInstitute-designated comprehensive cancer center, City of Hope brings a uniquely integrated model to patients, spanning cancer care, research and development, academics and training, and innovation initiatives. Research and technology developed at City of Hope has been the basis fornumerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. A leader inbone marrow transplantationand immunotherapy, such asCAR T cell therapy, City of Hopes personalized treatment protocols help advance cancer care throughout the world.

With a goal of expanding access to the latest discoveries and leading-edge care to more patients, families and communities, City of Hopes growing national system includes its main Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, scheduled to open in 2022, andCancer Treatment Centers of America. City of Hopes affiliated family of organizations includesTranslational Genomics Research InstituteandAccessHopeTM. For more information aboutCity of Hope, follow us onFacebook,Twitter,YouTube,InstagramandLinkedIn.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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BlueSphere Bio Presents New Data Supporting the Potential of its TCXpress Platform at the 2022 AACR Meeting – Yahoo Finance

BlueSphere Bio

PITTSBURGH, April 08, 2022 (GLOBE NEWSWIRE) -- BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, today announced that it presented preclinical data demonstrating the potential of its novel high throughput TCXpress platform to efficiently identify TCRs against minor histocompatibility antigens (miHAs) for the future clinical development of adoptive TCR T-cell therapy aimed at improving the efficacy of allogeneic stem cell transplant (alloSCT) treatments for patients with hematologic malignancies, including acute myeloid leukemia (AML), during the 2022 American Association for Cancer Research (AACR) Annual Meeting on April 8 - 13, 2022.

This work enabled the discovery of BlueSpheres first clinical candidate, a TCR T-cell therapy directed against the miHA HA-1. The company anticipates filing its first IND by the end of 2022. In addition, the TCXpress platform has enabled the discovery of a TCR panel reactive against other relevant miHAs, which BlueSphere plans to soon announce this year.

Mark Shlomchik, M.D., Ph.D., co-founder and chief scientific officer of BlueSphere Bio commented that "The data from this presentation highlight the potential of our platform technology for the development of novel cellular therapies targeting miHAs that can be used to improve treatment outcomes in alloSCT. These data also demonstrate the remarkable efficiency of our high throughput discovery platform to robustly identify TCRs with potential applications that are not limited to a single class of targets or therapeutic strategy. We look forward to continuing to advance our internally developed candidates and fully realizing the potential of this platform to transform TCR discovery."

Story continues

Presentation HighlightsTitle: High throughput single-cell based cloning reveals functional diversity of T-cell receptors targeting minor histocompatibility antigenPresenter: Sawa Ito, M.D., Ph.D., hematologist/oncologist at UPMC Hillman Cancer Center and Assistant Professor, Division of Hematology-Oncology and of Immunology at the University of Pittsburgh School of Medicine.

Data Highlights:

TCXpress successfully identified a diverse set of novel TCRs with activity against the miHA, HA-1, from a single donor, naturally immunized to HA-1 through pregnancy.

TCXpress yielded this set of TCRs with a broad functional affinity from a single donor, demonstrating its rapid and efficient discovery capabilities.

When re-expressed in primary CD8-positive T-cells, a high affinity TCR against HA-1 mediated specific killing of HA-1 positive target cells.

The data also highlight the wide range of TCR affinities that can arise from a natural immune response against a single allopeptide/HLA complex, underscoring the potential to identify and characterize TCRs against other targets with this technology.

About TCXpressTCXpress is a proprietary high-throughput and efficient T-cell receptor (TCR) capture, expression and functional screening platform capable of processing thousands of single T cells directly into functionally expressed TCRs within a matter of days, thereby creating extensive libraries without the need for lengthy sequencing.

About BlueSphere Bio

BlueSphere Bio is the first translational sciences stand-alone company formed by UPMC Enterprises, the innovation, commercialization and venture capital arm of the Pittsburgh-based health system. The company was founded upon the unique, advanced TCR discovery platform - TCXpress, designed to isolate and functionally characterize TCRs with speed, sensitivity and efficiency. BlueSphere anticipates filing its first IND application in 2022 for a novel TCR T-cell therapy for patients with high-risk leukemias, including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS) in the context of allogeneic stem cell transplantation. Concurrent with its pursuit of hematologic cancers, BlueSphere is pursuing additional programs in solid tumors using NEOXpress, a proprietary patient-specific neoantigen discovery platform, to target patient-specific neoantigens, and anticipates additional virtual patient data from multiple tumor types on a rolling basis over the next year.

Company ContactKim JaffeVice President, Business Development & Operations+1- 609-306-7042kjaffe@bluespherebio.com

Media ContactAndrew MielachLifeSci Communications+1-646-876-5868amielach@lifescicomms.com

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Century Therapeutics to Present at the 21st Annual Needham Virtual Healthcare Conference – GlobeNewswire

PHILADELPHIA, April 06, 2022 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today announced that Lalo Flores, Ph.D., Chief Executive Officer,will present at the 21st Annual Needham Virtual Healthcare Conference on April 13, 2022, at 10:15 AM ET and participate in a panel titled Company Perspectives: Companies Discussing Key Features and Differentiators in the NK Cellular Therapeutics Space on April 14, 2022, at 11:00 AM ET.

A live webcast of the podium presentation will be available on the Events & Presentations page in the Investors section of the Companys website athttps://investors.centurytx.com/events-and-presentations. A replay of the webcast will be archived on the Companys website for 30 days following the presentation.

About Century Therapeutics

Century Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visitwww.centurytx.com.

Century Therapeutics Forward-Looking Statement

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as may, might, will, should, expect, plan, aim, seek, anticipate, could, intend, target, project, contemplate, believe, estimate, predict, forecast, potential or continue or the negative of these terms or other similar expressions. These statements are not guarantees of future performance These risks and uncertainties are described more fully in the Risk Factors section of our most recent filings with the Securities and Exchange Commission and available at http://www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

For More Information: Company: Elizabeth Krutoholow investor.relations@centurytx.comInvestors: Melissa Forst/Maghan Meyers century@argotpartners.comMedia: Joshua R. Mansbach century@argotpartners.com

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Century Therapeutics to Present at the 21st Annual Needham Virtual Healthcare Conference - GlobeNewswire

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Global 3D Cell Culture Market to be Driven by Growing Impact of Economy on Regenerative Medicine, Emerging Applications of Gene Therapy During the…

The new report by Expert Market Research titled, Global3D Cell Culture MarketReport and Forecast 2021-2026, gives an in-depth analysis of the global 3D cell culture market, assessing the market based on its segments like applications, technology type and major regions. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analyzing the market based on the SWOT and Porters Five Forces models.

Get a Free Sample Report with Table of Contents:https://www.expertmarketresearch.com/reports/3d-cell-culture-market/requestsample

The key highlights of the report include:

Market Overview (2016-2026)

Forecast Historical Market Size (2020): USD 1.29 billion

Forecast CAGR (2021-2026): 16.3%

Forecast Market Size (2026): USD 3.2 billion

The numerous uses of 3D cell culture in drug screening, regenerative medicine, stem cell therapies, cancer research, and cell biology are propelling the global market for 3D cell culture forward. The industry benefits from the increased acceptance of 3D cell culture models as an alternative to in vivo testing, research and development of expanded cell culture systems, and growing demand for organ transplantation. With the onset of the coronavirus pandemic, the demand for 3D cell culture has increased significantly for the investigation and development of COVID-19 and other respiratory illnesses. Additionally, 3D cell cultures can provide desired outputs with greater efficiency in research and development, both in terms of quality and cost. These are the key driving factors anticipated to accelerate market growth in the forecast period.

Industry Definition and Major Segments

Three-dimensional cell culture is a culture environment that is artificially developed to allow biological cells to thrive and interact with the surrounding framework in all three dimensions. Unlike standard 2D cell cultures, in which cells grow in a flat monolayer on a plate, 3D cell culture allows cells to grow in all directions within a test-tube system.

Read Full Report with Table of Contents:https://www.expertmarketresearch.com/reports/3d-cell-culture-market

By technology, the market is divided into:

By application, the market is divided into:

By end users, the market is divided into:

By region, the industry is categorized into:

Market Trends

Globally increasing prevalence of chronic medical conditions is one of the primary reasons driving the markets growth. The industry is also benefiting from the growing preference for tailored medicines among healthcare professionals and patients. Three-dimensional cell cultures are widely employed in cancer research, stem cell research, drug discovery, toxicology testing, and tissue engineering. As the coronavirus disease (COVID-19) continues to spread around the globe, the use of scaffold-based 3D cell cultures for the development and bio-fabrication of antiviral medicines and new therapies has increased significantly. Furthermore, the development of advanced microfluidic-based three-dimensional cell cultures with enhanced cell viability, morphology, proliferation, and differentiation is assisting in the markets expansion. Additional factors, such as intensive research and development (R&D) in the realm of biotechnology, as well as the growing demand for effective alternatives to animal testing, are expected to propel the market forward.

North America is projected to remain dominant in the 3D cell culture market over the forecast period. This is because the government and commercial funding businesses in the region are willing to develop superior 3D cell culture models. Additionally, the sector is strengthened by the presence of multiple colleges and research organizations exploring various stem cell-based technologies throughout North America. Due to the increase of infrastructure development to expedite stem cell research in the regions growing economies such as India, China, Asia Pacific is expected to have the highest growth rate during the forecast period. The Chinese government has given grants for many R&D initiatives on human embryonic stem cells research, encouraging scientists to investigate the cells clinical potential. These factors are expected to boost the market during the forecast period as well.

Key Market Players

The major players in the market are 3D Biotek LLC, Advanced Biomatrix Inc., Avantor Inc., CN Bio Innovations Limited, Corning Incorporated, Emulate Inc., InSphero AG, Lonza Group AG, Merck KGaA, Promocell GmbH, and Synthecon Inc., among Others. The report covers the market shares, capacities, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

About Us:

Expert Market Research is a leading business intelligence firm, providing custom and syndicated market reports along with consultancy services for our clients. We serve a wide client base ranging from Fortune 1000 companies to small and medium enterprises. Our reports cover over 100 industries across established and emerging markets researched by our skilled analysts who track the latest economic, demographic, trade and market data globally.

At Expert Market Research, we tailor our approach according to our clients needs and preferences, providing them with valuable, actionable and up-to-date insights into the market, thus, helping them realize their optimum growth potential. We offer market intelligence across a range of industry verticals which include Pharmaceuticals, Food and Beverage, Technology, Retail, Chemical and Materials, Energy and Mining, Packaging and Agriculture.

Media Contact

Company Name: EMR Inc.Contact Person:-Ian Bell, Business ConsultantEmail:sales@expertmarketresearch.comToll Free Number: US +1-415-325-5166 | UK +44-702-402-5790Address: 30 North Gould Street, Sheridan, WY 82801, USACity: SheridanState: WyomingCountry: United StatesWebsite:https://www.expertmarketresearch.com

Explore more onProcurement Intelligenceservices of EMR Inc.

**We at Expert Market Research always thrive to give you the latest information. The numbers in the article are only indicative and may be different from the actual report.

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Pregene Enters into Innovative Partnership with CellPoint to Develop anti-BCMA CAR-T Cell Therapy in Europe and the US – PR Newswire

SHENZHEN, China and LEIDEN, Netherlands, April 6, 2022 /PRNewswire/ --Shenzhen Pregene Biopharma, a clinical-stage biopharmaceutical company engaged in discovering, developing, manufacturing and commercializes innovative medicines and CellPoint, a cell therapy company developing CAR-T therapeutics for use at the point-of-care (POC), today announce an exclusive license agreement for the development and commercialization of PRG-1801, Pregene's single domain antibody-based anti-BCMA chimeric antigen receptor T cell (CAR-T) program, for the treatment of hematological indications in Europe and the United States.

PRG-1801 is a single domain antibody anti-BCMA CAR-T cell therapy in development for the treatment of relapsed/refractory multiple myeloma that has demonstrated strong signs of efficacy and an excellent safety profile in its initial investigator-initiated trial and Phase I/II clinical trials.

Under the terms of the collaboration, Pregene will receive over 20 million of upfront and near-term consideration, and is eligible to receive additional development, commercial milestone and royalty payments. CellPoint will be responsible for the development and commercialization of the anti-BCMA CAR-T therapy in Europe and the US. As part of this partnership, Pregene will also provide translational and lentivirus manufacturing services to be reimbursed by Cellpoint.

"We are excited to partner with Cellpoint to develop CAR-T cell therapies via a POC platform," said Jishuai Zhang, Chief Technology Officer and Co-founder of Pregene. "The potential of our single domain antibody fully human BCMA CAR-T to treat patients with relapsed/refractory multiple myeloma has been validated in clinical trials of our BCMA autologous CAR-T product candidate. We expect the POC modality to enable faster treatment for broader patients using our differentiated CAR-T therapy, and we look forward to working with the team at CellPoint as they seek to develop and commercialize PRG-1801."

Tol Trimborn, Chief Executive Officer of CellPoint, said: "We are very pleased to add Pregene's novel anti-BCMA CAR-T therapy to our CAR-T portfolio and look forward to develop it using our decentralised, POC manufacturing model. This is our second clinical stage program and we have demonstrated we can provide cell therapy to cancer patients in only 6 days vein-to-vein, from apheresis to infusion. We are excited to work closely alongside Pregene to bring this to patients with a convenient, readily available treatment alternative."

About PRG-1801 (anti-BCMA CAR-T)

PRG-1801 is an anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. The lentivirus vectors are produced by Pregene using a proprietary serum free suspension production system with gene-therapy-grade quality and a high transduction unit yield. This CAR-T therapy has already demonstrated strong signs of efficacy and an excellent safety profile in an investigator initiated trial and Phase I/II clinical trials. In addition to multiple myeloma, Pregeneis investigating PRG-1801in patients with autoimmune diseases. In May of 2021, Pregene and Dr. Reddy's Laboratories announced a license agreement whereby Dr Reddy's acquired the exclusive rights in India for PRG-1801.

Clinical trials of PRG-1801 include:

About Pregene

Pregene is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies with industry-leading cell and lentivirus manufacturing processes and technology. Leveraging its proprietary fully human single domain antibody discovery platform, high-throughput CAR-T drug priority platform, and proprietary cell and lentivirus manufacturing processes, Pregene is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T,CAR-NK, TCR-T, stem cell and biologics product candidates, including Pregene's leading asset, PRG-1801, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory multiple myeloma (RRMM)., has obtained NMPA IND clearance as the Class I new drug, and Phase I/II clinical trials are now ongoing. Find more at http://www.pregene.com.

About CellPoint

CellPoint B.V. is a Dutch (EU) company founded to provide affordable and readily available CAR-T therapies for all patients in need. CellPoint has initiated 2 clinical trials with CD19 CAR in NHL and CLL. The CellPoint CAR-T treatment workflow is designed for quality and patient safety, while driving down the time-to-treatment and costs by automation at the POC. Clinical centers of excellence have been selected that have experienced hematology teams and a local cell processing facility. These centers are equipped with a device, Cocoon (by Lonza), that allows automated manufacturing and receive full training and support to manufacture CAR-T therapies and to treat patients. Clinicians are enabled to schedule and perform CAR-T treatments within 1 week, without complex logistics. CellPoint's secure online xCellit platformis used to facilitate scheduling and monitoring of the CAR-T treatment workflow for the various stakeholders. In 2020, CellPoint raised series A funding from +ND Capital, the Dutch government (RVO) and has an exclusive license from Lonza to use the Cocoon at the point of care. Find out more at http://www.cellpoint.bio.

For further information

Pregene:Xueying Fan, Media/Investor Contact[emailprotected]

CellPoint:Maarten Zandvliet, CDO[emailprotected]

SOURCE Shenzhen Pregene Biopharma Co. Ltd

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Pregene Enters into Innovative Partnership with CellPoint to Develop anti-BCMA CAR-T Cell Therapy in Europe and the US - PR Newswire

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