Category Archives: Cell Therapy

Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an interdisciplinary research group at Singapore-MIT Alliance for Research and Technology (SMART), MITs research enterprise in Singapore, have been awarded Intra-CREATE grants from the National Research Foundation (NRF) Singapore to help support research on retinal biometrics for glaucoma progression and neural cell implantation therapy for spinal cord injuries. The grants are part of the NRFs initiative to bring together researchers from Campus for Research Excellence And Technological Enterprise (CREATE) partner institutions, in order to achieve greater impact from collaborative research efforts.

SMART CAMP was formed in 2019 to focus on ways to produce living cells as medicine delivered to humans to treat a range of illnesses and medical conditions, including tissue degenerative diseases, cancer, and autoimmune disorders.

Singapores well-established biopharmaceutical ecosystem brings with it a thriving research ecosystem that is supported by skilled talents and strong manufacturing capabilities. We are excited to collaborate with our partners in Singapore, bringing together an interdisciplinary group of experts from MIT and Singapore, for new research areas at SMART. In addition to our existing research on our three flagship projects, we hope to develop breakthroughs in manufacturing other cell therapy platforms that will enable better medical treatments and outcomes for society, says Krystyn Van Vliet, co-lead principal investigator at SMART CAMP, professor of materials science and engineering, and associate provost at MIT.

Understanding glaucoma progression for better-targeted treatments

Hosted by SMART CAMP, the first research project, Retinal Analytics via Machine learning aiding Physics (RAMP), brings together an interdisciplinary group of ophthalmologists, data scientists, and optical scientists from SMART, Singapore Eye Research Institute (SERI), Agency for Science, Technology and Research (A*STAR), Duke-NUS Medical School, MIT, and National University of Singapore (NUS). The team will seek to establish first principles-founded and statistically confident models of glaucoma progression in patients. Through retinal biomechanics, the models will enable rapid and reliable forecast of the rate and trajectory of glaucoma progression, leading to better-targeted treatments.

Glaucoma, an eye condition often caused by stress-induced damage over time at the optic nerve head, accounts for 5.1 million of the estimated 38 million blind in the world and 40 percent of blindness in Singapore. Currently, health practitioners face challenges forecasting glaucoma progression and its treatment strategies due to the lack of research and technology that accurately establish the relationship between its properties, such as the elasticity of the retina and optic nerve heads, blood flow, intraocular pressure and, ultimately, damage to the optic nerve head.

The research is co-led by George Barbastathis, principal investigator at SMART CAMP and professor of mechanical engineering at MIT, and Aung Tin, executive director at SERI and professor at the Department of Ophthalmology at NUS. The team includes CAMP principal investigators Nicholas Fang, also a professor of mechanical engineering at MIT; Lisa Tucker-Kellogg, assistant professor with the Cancer and Stem Biology program at Duke-NUS; and Hanry Yu, professor of physiology with the Yong Loo Lin School of Medicine, NUS and CAMPs co-lead principal investigator.

We look forward to leveraging the ideas fostered in SMART CAMP to build data analytics and optical imaging capabilities for this pressing medical challenge of glaucoma prediction, says Barbastathis.

Cell transplantation to treat irreparable spinal cord injury

Engineering Scaffold-Mediated Neural Cell Therapy for Spinal Cord Injury Treatment (ScaNCellS), the second research project, gathers an interdisciplinary group of engineers, cell biologists, and clinician scientists from SMART, Nanyang Technological University (NTU), NUS, IMCB A*STAR, A*STAR, French National Centre for Scientific Research (CNRS), the University of Cambridge, and MIT. The team will seek to design a combined scaffold and neural cell implantation therapy for spinal cord injury treatment that is safe, efficacious, and reproducible, paving the way forward for similar neural cell therapies for other neurological disorders. The project, an intersection of engineering and health, will achieve its goals through an enhanced biological understanding of the regeneration process of nerve tissue and optimized engineering methods to prepare cells and biomaterials for treatment.

Spinal cord injury (SCI), affecting between 250,00 and 500,000 people yearly, is expected to incur higher societal costs as compared to other common conditions such as dementia, multiple sclerosis, and cerebral palsy. SCI can lead to temporary or permanent changes in spinal cord function, including numbness or paralysis. Currently, even with the best possible treatment, the injury generally results in some incurable impairment.

The research is co-led by Chew Sing Yian, principal investigator at SMART CAMP and associate professor of the School of Chemical and Biomedical Engineering and Lee Kong Chian School of Medicine at NTU, and Laurent David, professor at University of Lyon (France) and leader of the Polymers for Life Sciences group at CNRS Polymer Engineering Laboratory. The team includes CAMP principal investigators Ai Ye from Singapore University of Technology and Design; Jongyoon Han and Zhao Xuanhe, both professors at MIT; as well as Shi-Yan Ng and Jonathan Loh from Institute of Molecular and Cell Biology, A*STAR.

Chew says, Our earlier SMART and NTU scientific collaborations on progenitor cells in the central nervous system are now being extended to cell therapy translation. This helps us address SCI in a new way, and connect to the methods of quality analysis for cells developed in SMART CAMP.

Cell therapy, one of the fastest-growing areas of research, will provide patients with access to more options that will prevent and treat illnesses, some of which are currently incurable. Glaucoma and spinal cord injuries affect many. Our research will seek to plug current gaps and deliver valuable impact to cell therapy research and medical treatments for both conditions. With a good foundation to work on, we will be able to pave the way for future exciting research for further breakthroughs that will benefit the health-care industry and society, says Hanry Yu, co-lead principal investigator at SMART CAMP, professor of physiology with the Yong Loo Lin School of Medicine, NUS, and group leader of the Institute of Bioengineering and Nanotechnology at A*STAR.

The grants for both projects will commence on Oct. 1, with RAMP expected to run until Sept. 30, 2022, and ScaNCellS expected to run until Sept. 30, 2023.

SMART was. established by the MIT in partnership with the NRF in 2007. SMART is the first entity in the CREATE developed by NRF. SMART serves as an intellectual and innovation hub for research interactions between MIT and Singapore, undertaking cutting-edge research projects in areas of interest to both Singapore and MIT. SMART currently comprises an Innovation Centre and five interdisciplinary research groups (IRGs): Antimicrobial Resistance, CAMP, Disruptive and Sustainable Technologies for Agricultural Precision, Future Urban Mobility, and Low Energy Electronic Systems.

CAMP is a SMART IRG launched in June 2019. It focuses on better ways to produce living cells as medicine, or cellular therapies, to provide more patients access to promising and approved therapies. The investigators at CAMP address two key bottlenecks facing the production of a range of potential cell therapies: critical quality attributes (CQA) and process analytic technologies (PAT). Leveraging deep collaborations within Singapore and MIT in the United States, CAMP invents and demonstrates CQA/PAT capabilities from stem to immune cells. Its work addresses ailments ranging from cancer to tissue degeneration, targeting adherent and suspended cells, with and without genetic engineering.

CAMP is the R&D core of a comprehensive national effort on cell therapy manufacturing in Singapore.

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SMART researchers receive Intra-CREATE grant for personalized medicine and cell therapy - MIT News

Orgenesis has struck a deal to acquire Koligo Therapeutics. The takeover will give Orgenesis control of an autologous cell therapy treatment for respiratory disease caused by COVID-19.

Koligos business is built on technologies for developing autologous cell therapies, including a system for printing 3D cell and tissue constructs with a vascular network. In the case of the COVID-19 program KT-PC-301, Koligo is using its technologies to harvest fat from patients infected with the coronavirus and process the material into a cell therapy.

The COVID-19 therapy contains mesenchymal stem cells, vascular endothelial cells and immune cells that Koligo expects to migrate to the lung and other sites of inflammation when readministered back into the patient. By getting the cells to sites of inflammation, Koligo thinks it may be able to improve oxygenation, support antibody production and induce an anti-inflammatory effect. Those effects may help patients with acute respiratory distress syndrome caused by the pandemic coronavirus.

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Orgenesis is set to pay $15 million in stock to acquire KT-PC-301 and the rest of Koligos assets. After closing the takeover, Orgenesis will keep members of Koligos management including CEO Matthew Lehman and Chief Medical Officer Michael Hughes on to handle work related to the acquired assets. The start of a 75-subject phase 2 trial of KT-PC-301 is high on Koligos to-do list.

The deal will also give Orgenesis a commercially available treatment for chronic and recurrent acute pancreatitis and Koligos 3D-V bioprinting technology. The commercial product, Kyslecel, is made by resecting the pancreas from a patient, isolating pancreatic islet cells and infusing the minimally modified islets back into the patient.

Koligo has treated 40 patients with Kyslecel at six U.S. hospitals through a commercial pilot, generating revenues of around $2 million. Lehman expects the commercialization effort to benefit from the support of Orgenesis, which is connected to a network of hospitals and healthcare centers through its own point-of-care cell therapy platform.

Orgenesis sees its platform as complementary to the tools it is set to acquire from Koligo, leading CEO Vered Caplan to frame the takeover as a boost for his effort to implement new technologies to improve efficacy and lower the costs of cell and gene therapies. Caplan, in a statement to disclose the takeover, added that COVID-19 cell therapy KT-PC-301 may have applications in the treatment of other acute and chronic respiratory indications.

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Orgenesis inks Koligo buyout to gain COVID-19 cell therapy - FierceBiotech

Summary

MSK currently has a number of trials investigating the use of T cell therapies in gynecologic therapy an approach thats beginning to show promise in treating these and other solid tumors.

The American Cancer Society estimates that more than 113,000 people in the United States are diagnosed with a gynecologic cancer every year. Memorial Sloan Kettering is a leader in treating people with these cancers, which include tumors of the cervix, ovaries, and uterus.

Among the new treatments being developed for gynecologic cancers are a type of immunotherapy called T cell therapies. These are treatments in which a patients own immune cells are modified to recognize and attack cancer cells. MSK doctors and scientists were the first to develop these treatments for leukemia and lymphoma. Now, many researchers are focused on further advancing this approach to make it effective against solid tumors.

For certain blood cancers, cellular therapy can be remarkably potent, perhaps even curative, says physician-scientist Christopher Klebanoff, whose lab is focused on developing new cell therapy approaches. One challenge of immunotherapy is directing the immune cells only to tumors so they dont cause injury to healthy tissues.

The most well-known cell therapy is chimeric antigen receptor (CAR) T therapy, which has shown success in treating certain blood cancers. CAR T modifies a patients immune cells (T cells) so they can recognize a protein (called an antigen) on the outer surface of cancerous cells. These supercharged T cells then seek out and destroy the cancer. For many cancers, especially cancers originating from a solid organ, the antigen isnt quite as easy for the T cell to find, making cell therapies more challenging to develop.

This has led to a related tactic called T cell receptor (TCR) therapy, in which T cells are engineered to detect antigens on the inside of the cancer cell. The ability to do this is one of the greatest tricks in biology, Dr. Klebanoff says. That is, how can you allow an immune cell to look inside other cells to detect if the proteins inside are normal or abnormal?

As it turns out, the way this looking works is actually indirect: As part of normal cellular operations, proteins eventually get broken down and recycled to make new proteins. One step in this recycling process displays proteinfragments on the surface of cells allowing them to be seen by engineered T cells. TCR therapies are designed to take advantage of this natural process that the immune system uses to survey tissues in the body.

Some of the newest cell therapies known as TRUCKs T cells redirected for antigenunrestricted cytokineinitiated killing work by combining the antitumor abilities of CAR T or TCR therapy with a molecule called a cytokine. The cytokine recruits another wave of immune cells to the tumor.

We're building up our clinical trial program at MSK so that we will be able to offer more cellular therapies for patients with gynecologic cancers.

Medical oncologist Roisin OCearbhaill is the research director for the Gynecologic Medical Oncology Service and a leader in studying new cell therapies and immunotherapy approaches for treating gynecologic cancers, including a treatment for cervical cancer and other tumors caused by the human papillomavirus (HPV). Were building up our clinical trial program at MSK so that we will be able to offer more cellular therapies for patients with gynecologic cancers, she says.

With cell therapies, we use our knowledge about specific molecular and genomic properties of the patients cancer, Dr. OCearbhaill explains. And we may also use certain markers on their blood cells in order to get the best possible match for a targeted therapy for that individual patient.

For each of our patients, we take a very personalized approach to match the best possible medicines, including experimental medicines offered in clinical trials, with the patients disease, Dr. Klebanoff says. Im a big believer in the concept of partnership and shared purpose, and this is how we work in collaboration with our patients. We have a shared purpose to try to improve things both for them and for others with similar diseases in the future.

We have a shared purpose to try to improve things both for [our patients] and for others with similar diseases in the future.

MSK currently has a number of clinicaltrials that are examining this approach.

Dr. Klebanoffs laboratory and MSK receive research funds from Kite/Gilead, the sponsor of both TCR clinical trials. MSK receives clinical trial funding from Celgene and TCR2 Therapeutics for the CAR T cell and TRUCK studies, respectively.

Outside this work, MSK receives funding for clinical research that Dr. OCearbhaill is leading from Tesaro/GlaxoSmithKline, the Ludwig Cancer Institute, Abbvie, Regeneron, Atara Biotherapeutics, MarkerTherapeutics, Syndax Pharmaceuticals, Genmab Therapeutics, Sellas Therapeutics, Genentech, and the Gynecologic Oncology Foundation. Dr. OCearbhaill has served on advisory boards for Genmab, Regeneron, and GlaxoSmithKline.

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T Cell Therapies Offer a New Way to Treat Gynecologic Cancers - On Cancer - Memorial Sloan Kettering

Researchers at the University of Florida College of Nursing have been awarded a $2.6 million grant to determine whether relaxation therapy can help reduce pain and manage stress for patients with sickle cell disease, negating the need for opioids.

The National Institute of Nursing Research awarded the grant to Miriam O. Ezenwa, an associate professor in the college of nursing. Ezenwa and other researchers will use video clips of cloud-like formations and soothing audio that instructs the participants to concentrate on deep breathing to reduce stress.

Stress releases certain hormones that can intensify pain response. Conversely, relaxation exercises can release endorphins that reduce inflammation and pain from sickle cell disease, a rare and painful blood disorder that mainly appears in the Black population.

Stress from sickle cell disease symptoms and social factors have been magnified by the public health crisis related to the opioid overdose epidemic in the United States. Studies indicate as many as 100,000 people could be living with sickle cell disease in the United States. According to a June 2019 report from the federal Centers for Medicare & Medicaid Services Office of Minority Health, 55,349 Medicaid beneficiaries nationwide had sickle cell disease in 2012, the latest available data. With 5,395 Medicaid beneficiaries with the once-fatal disease, Florida had the second largest sickle-cell Medicaid population behind New York.

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University of Florida researchers get sickle cell therapy grant - Orlando Weekly

NEW YORK, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeutics an emerging biopharmaceutical company developing Natural Killer Cell Therapeutics, today announced that it will participate in three key conferences in October 2020.

The Jefferies Cell Therapy Virtual Summit will take place on October 5-6, 2020.Cytovia CEO Dr. Daniel Teper will present on October 6th at 5.30 PM EDT. Webcast link

The BIO Investor Forum will take place on October 13-15, 2020.Cytovia will have an on-demand company presentation during the Bio Investor Forum Digital.

The New York Stem Cell Foundation Conference will take place on October 20-21, 2020.Dr. Wei Li, Cytovia Executive Vice President, R&D and Chief Scientific Officer, will present during the Stem Cell Application in Therapeutics session, on October 21st at 11.15 AM EDT.

The webcast links will be available on the company website and social media pages.

On-demand interview opportunities with Cytovia Therapeutics spokespersons:Daniel Teper, CEO Wei Li, Chief Scientific Officer

ABOUT CYTOVIA THERAPEUTICS:Cytovia Therapeutics Inc is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, and CytoImmune Therapeutics. Learn more at http://www.cytoviatx.com and Follow Cytovia on Social Media Facebook, LinkedIn, Twitter.

For more information please contact:Cytovia Therapeutics, IncSophie Badr, Vice President, Corporate Affairs1 (929) 317 1565 sophie.badre@cytoviatx.com

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Cytovia Therapeutics to present at Jefferies Cell Therapy Virtual Summit, BIO Investor Forum and New York Stem Cell Foundation Conference in October...

With its acquisition of FloDesign Sonics earlier this month, Merck/MilliporeSigma has become the first company to introduce acoustic technology in cell therapy manufacturing. The acquisition of FloDesign Sonics is a strategic fit for Merck, strengthening its ability alongside to manufacture cell-based therapies for patients.

Get a complete list of the presentations,here.

What is Acoustic Cell Processing: Acoustic cell processing is a disruptive technology that allows for the manipulation of cells with ultrasonic waves. FloDesign Sonics acoustic cell processing platform allows enhanced cell washing and concentration for manufacturing cell therapies. As per an interview with FloDesign Sonics CEO, the platform leverages a patented 3D acoustic wave to manipulate cells and particles in suspension. This gentle, non-invasive technology effectively suspends target cells within standing waves in a chamber while material continuously passes through the chamber.

Advantage of Acoustic Cell Processing Over Traditional Approaches: The technology helps the manufacturers to achieve in one process that is traditional achieved separately through filtration, centrifugation, and cell selection. This helps in significantly reducing the time required in training and technology transfer.

What Other Companies are Using This Technology: FloDesign Sonics technology is currently being used by Pall Biotech, which offers a portfolio of scalable single-use technologies for continuous bioprocessing. The companys platform is based on acoustic wave separation that can be used either for clarification of fed-batch cell culture or cell retention in perfusion cell culture.

Last year, FloDesign Sonics signed a technology development collaboration agreement with Cognate BioServices, a leading, CDMO, to advance the accessibility of life-saving therapeutics. The aim of the collaboration was to advance the development of life-saving therapeutics by improving manufacturing efficiencies using FloDesign Sonics Acoustic Cell Processing (ACP) platform.

Applikon Biotechnology is another company that is using acoustic technology. According to the company, the Applikon BioSep system is a unique, cell retention device for high-density perfusion processes. The device uses high frequency resonant ultrasonic waves to separate cells instead of a physical mesh or membrane. It, therefore, offers all the benefits of traditional devices but without their inherent problems and limitations. There are a few other companies that claim to be using acoustic technology.

How Does this Impact the Overall Cell Therapy Manufacturing Market? According to a report by Roots Analysis, the novel technologies being developed for cell therapies have the capability to save significant cost in the manufacturing of these therapies.

For further information, check out the report here

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Cell Therapy Manufacturing Update: Merck Becomes the First to Introduce Acoustic Technology | Roots Analysis - Crypto Daily

WORCESTER, Mass., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that the first patient has been dosed in a Mustang-sponsored, open label, multicenter Phase 1/2 clinical trial to evaluate the safety and efficacy of MB-102 (CD123-targeted CAR T cell therapy) in patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (hrMDS). Study sites include City of Hope, where the CAR T cell therapy was initially developed and where the clinical data were generated to support Mustangs current multicenter trial, Dana-Farber Cancer Institute, Duke University and MD Anderson Cancer Center.

The Phase 1 portion of the trial will determine the maximum tolerated dose of MB-102 for the Phase 2 portion of the trial. Safety will be assessed at each dose level before proceeding to the next. The Phase 2 portion of the trial may be divided into as many as three arms to evaluate the efficacy of MB-102 in relapsed or refractory BPDCN (Arm 1), relapsed or refractory AML (Arm 2) and demethylation resistant hrMDS (Arm 3). The primary outcome that will be studied is the response rate at day 28 post infusion in all arms. Secondary outcome measures include duration of response, progression-free survival, overall survival and incidence of treatment-emergent adverse events, which will be followed for up to three years.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, This is a momentous occasion for Mustang, as it is the first clinical trial under Mustangs investigational new drug application (IND) in which a patient was dosed with cells processed in our own manufacturing facility. We look forward to advancing the development of MB-102 and providing updates on the trial as we seek to help address the needs of patients suffering from the devastating diseases of BPDCN, AML and hrMDS.

Additional information about the trial can be found on http://www.clinicaltrials.gov using the identifier NCT04109482.

About MB-102 (CD123-targeted CAR T Cell Therapy)MB-102 is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with myelodysplastic syndromes, as well as in hematologic malignancies, including AML, and BPDCN.

In the first-in-human clinical trial at City of Hope (NCT02159495), MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities, as reported at the American Society of Hematology (ASH) Annual Meeting in December 2017 and the American Association for Cancer Research (AACR) Special Conference on Tumor Immunology and Immunotherapy in November 2018. Dose escalation continues at City of Hope in both indications. MB-102 has received Orphan Drug Designations from the U.S. Food and Drug Administration for AML and BPDCN.

About Mustang BioMustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for XSCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission (SEC). Mustang was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit http://www.mustangbio.com.

ForwardLooking StatementsThis press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on managements current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Company Contacts:Jaclyn Jaffe and William BegienMustang Bio, Inc.(781) 652-4500ir@mustangbio.com

Investor Relations Contact:Daniel FerryLifeSci Advisors, LLC(617) 430-7576daniel@lifesciadvisors.com

Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com

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Mustang Bio Announces First Patient Dosed in Multicenter Phase 1/2 Clinical Trial of MB-102 (CD123-targeted CAR T Cell Therapy) - GlobeNewswire

HOUSTON--(BUSINESS WIRE)--Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid malignancies, today announced the treatment of the first patients in its ANCHOR phase 1 study of KUR-502, an allogeneic CAR-NKT therapy.

This is an important day, as the initiation and dosing of the first patients in the ANCHOR phase 1 clinical study marks the first time that patients have been treated with an allogeneic engineered CAR-NKT cell therapy, said Dr. Carlos Ramos, Principal Investigator of the ANCHOR study, Professor of Medicine in the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center. CAR-NKT cells have the potential to offer a distinct set of advantages over other lymphocytes commonly used for cell therapy, such as T cells. We are pleased to be advancing this ground-breaking first-in-human clinical study and anticipate that CAR-NKT cells could be an important treatment option for patients with both hematological and solid tumors in the future.

With the initiation of the ANCHOR study of KUR-502 in CD19 positive hematological malignancies, we are able to turn our focus to exploring the effects of off-the-shelf CAR-NKT cells, said Kevin S. Boyle, Sr., Kuurs Chief Executive Officer. This study will allow us to evaluate our platform technology with a validated target in CD19 and validated indications, generating critical data to advance our allogeneic efforts. Together with the results from our proof of concept GINAKIT2 study of KUR-501 in neuroblastoma, the forthcoming data from the ANCHOR study will guide future development of our next generation platform technology.

KUR-502 is built on Kuurs next-generation CAR-NKT platform, with novel engineering capabilities that harness and enhance the unique tumor-homing properties of NKT cells. This NKT platform technology was developed in the CAGT Lab of Dr. Leonid Metelitsa, Professor of Pediatrics-Oncology at Baylor College of Medicine and Texas Childrens Hospital and member of the Dan L Duncan Comprehensive Cancer Center, and KUR-502 was produced by the CAGT cGMP facility. One of the challenges with allogeneic therapies is that infusing a patient with donor-derived lymphocytes can induce graft versus host disease (GvHD), a potentially life-threatening condition in which the infused cells recognize the patients tissues as foreign. The NKT cells used in Kuurs CAR-NKT platform have an invariant T cell receptor that does not distinguish between self- and non-self tissues, making the cells unlikely to induce GvHD when given to another person. Preclinical data generated by Baylor College of Medicine indicate that while human CAR-T cells cause severe GvHD, CAR-NKT cells from the same donor do not.

The ANCHOR (NCT03774654) study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies, including B cell lymphomas, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). The single arm study will evaluate three dose levels, with patients receiving lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502.

Patients with R/R CD19 positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by delays to get treatment, a requirement for patient leukapheresis, and issues with inferior quality leukapheresis starting material due to prior treatment. Off-the-shelf KUR-502 is designed to overcome these limitations.

The ANCHOR study is being sponsored and conducted by Kuurs collaborator, Baylor College of Medicine.

About KUR-502

KUR-502 is an innovative allogeneic (off-the-shelf) product in which natural killer T cells are engineered with a chimeric antigen receptor targeting CD19. KUR-502 is engineered with a CD19-specific CAR construct that is additionally designed to secrete the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. In addition, the CAR-NKT cells express short hairpin RNA (shRNA) designed to downregulate HLA class I and class II expression, which may minimize rejection by the patients immune system and further enhance persistence. The CAR, IL-15 and shRNAs are effectively expressed in NKT cells via a single gammaretroviral vector, allowing for one-hit generation of off-the-shelf CAR-NKT cells. In contrast to off-the-shelf CAR therapy with conventional alpha-beta T cells, gene editing to remove the TCR to prevent GvHD is not required for off-the-shelf CAR-NKT therapy. KUR-502 is manufactured from healthy donors, from whom cell therapy products can be prepared in large quantities from a single procedure and used to treat many different patients.

About Kuur Therapeutics

Kuur Therapeutics is a clinical-stage biopharmaceutical company focused on the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid malignancies. The companys revolutionary platform engineers CARs expressed by invariant NKT cells, a subset of T lymphocytes, and is being developed in partnership with Baylor College of Medicine and Texas Childrens Hospital. Allogeneic cell therapy has the potential to be much faster and less expensive than patient-specific autologous products, and NKT cells offer several advantages over other cell types for allogeneic immunotherapy applications. NKT cells have the cytotoxic and anti-tumor properties of conventional T cells, but with other biological attributes that are expected to improve their ability to attack hematological and solid tumors. These include innate tissue and solid tumor homing properties, as well as endogenous anti-tumor activity based on the ability to eliminate immune suppressive cells and activate host immune cells within the tumor microenvironment.

Kuurs CAR-NKT platform is currently being explored in two phase 1 clinical studies, the proof of concept GINAKIT2 study of autologous therapy KUR-501, in patients with high risk, relapsed/refractory neuroblastoma, and the phase 1 ANCHOR study of allogeneic therapy KUR-502, in adult patients with relapsed/refractory CD19 positive malignancies.

About Baylor College of Medicine

Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 21st among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Lukes Medical Center, part of CHI St. Lukes Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook (http://www.facebook.com/BaylorCollegeOfMedicine) and Twitter (http://twitter.com/BCMHouston).

About Baylor College of Medicine Ventures

Baylor College of Medicine Ventures (www.bcm.edu/about-us/bcm-ventures) is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. To learn more about partnering with BCM Ventures and accessing our available technologies, contact bcmventures@bcm.edu.

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Kuur Therapeutics Announces First Patients Dosed with Allogeneic CAR-NKT Cell Therapy - Business Wire

The global Cell Therapy Processing market is segregated on the basis of Process as Cell Processing, Cell Preservation, Distribution, and Handling, and Process Monitoring and Quality Control. Based on Product Type the global Cell Therapy Processing market is segmented in Equipment, 1 Cell Processing Equipment, 2 Single-Use Equipment, 3 Other Equipment, Systems & Software, and Consumables. Based on End User the global Cell Therapy Processing market is segmented in Life Science Research Companies and Research Institutes.

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The global Cell Therapy Processing market report provides geographic analysis covering regions, such as North America, Europe, Asia-Pacific, and Rest of the World. The Cell Therapy Processing market for each region is further segmented for major countries including the U.S., Canada, Germany, the U.K., France, Italy, China, India, Japan, Brazil, South Africa, and others.

Cell therapy is the therapeutic application of cells despite cell kind or clinical indication a platform technology. Regenerative drugs is an approach to treating patients and so definitely not a platform technology. Its nearest to a hospital specialty, for example, medicine, medical specialty or palliative drugs, in alternative words platform technology independent. Its goals are ultimately to cure and so a paradigm shift away from typical symptom management and pain management. While its true that some cell therapies are regenerative, the bulk are not. Even as regenerative drugs is much larger than regenerative cell therapies alone, cell therapies collectively represent a market opportunity several orders of magnitude bigger than regenerative drugs. Equating one with the other is therefore not advantageous however instead will each a major disservice.

The global Cell Therapy Processing market is expected to exceed more than US$ 11.5 Billion by 2024, at a CAGR of 16.2% in the given forecast period.

Market Insights

Based on Cell Type, the global Cell Therapy Processing market is segmented in Human Cells, 1 Stem Cells, 2 Differentiated Cells, and Animal Cells.

Competitive Rivalry

Stemcell Technologies, Miltenyi Biotec GmbH, Beckman Coulter, Inc, Becton, Dickinson and Company, Ge Healthcare, Sartorius, Merck KGaA, Lonza Group, Thermo Fisher Scientific, Inc., Terumo Bct, Inc, and others are among the major players in the global Cell Therapy Processing market. The companies are involved in several growth and expansion strategies to gain a competitive advantage. Industry participants also follow value chain integration with business operations in multiple stages of the value chain.

The Cell Therapy Processing Market has been segmented as below:

The Cell Therapy Processing Market is segmented on the lines of Cell Therapy Processing Market, By Process, Cell Therapy Processing Market, By Product Type, Cell Therapy Processing Market, By End User, Cell Therapy Processing Market, By Cell Type, Cell Therapy Processing Market, By Region and Cell Therapy Processing Market, By Company.

Cell Therapy Processing Market, By Process this market is segmented on the basis of Cell Processing, Cell Preservation, Distribution, and Handling and Process Monitoring and Quality Control. Cell Therapy Processing Market, By Product Type this market is segmented on the basis of Equipment its covers 1 Cell Processing Equipment, 2 Single-Use Equipment & 3 Other Equipment. Systems & Software and Consumables. Cell Therapy Processing Market, By End User this market is segmented on the basis of Life Science Research Companies and Research Institutes. Cell Therapy Processing Market, By Cell Type this market is segmented on the basis of Human Cells its covers 1 Stem Cells & 2 Differentiated Cells. And Animal Cells. Cell Therapy Processing Market, By Region this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World. Cell Therapy Processing Market, By Company this market is segmented on the basis of Stem cell Technologies, Miltenyi Biotec GmbH, Beckman Coulter, Inc, Becton, Dickinson and Company, Ge Healthcare, Sartorius, Merck KGaA, Lonza Group, Thermo Fisher Scientific, Inc. and Terumo Bct, Inc.

The report covers:

Report Scope:

The global Cell Therapy Processing market report scope includes detailed study covering underlying factors influencing the industry trends.

The report covers analysis on regional and country level market dynamics. The scope also covers competitive overview providing company market shares along with company profiles for major revenue contributing companies.

The report scope includes detailed competitive outlook covering market shares and profiles key participants in the global Cell Therapy Processing market share. Major industry players with significant revenue share include Stem cell Technologies, Miltenyi Biotec GmbH , Beckman Coulter, Inc, Becton, Dickinson and Company, Ge Healthcare, Sartorius , Merck KGaA, , Lonza Group , Thermo Fisher Scientific, Inc., Terumo Bct, Inc, and others.

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Table of Contents:

5. Cell Therapy Processing Market, By Process

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Cell Therapy Processing Market COVID 19 Status, Growth Rate by Applications, and Future Forecast 2026 - The Daily Chronicle

ROCKVILLE, Md. and BEIJING, Sept. 29, 2020 /PRNewswire/ --CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced a restructuring of its partnership with Juventas Cell Therapy Ltd. relating to CNCT19, an investigational CD19 CAR-T Cell therapy.Juventas is currently developing CNCT19 for the treatment of patients with relapsed B-cell Non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia, and expects to initiate registration trials in early 2021.

Larry Zhang, CASI's President, commented, "We continue to be very enthusiastic about the innovative work Juventas is doing in the hematological malignancy space and look forward to our continued partnership with Juventas as we build a stronger and more integrated team. With the restructuring in place, Juventas now can attract new capital to help fund its upcoming trials and build out a world-class GMP manufacturing facility for commercial production of CNCT19.At the same time, we are reducing CASI's exposure to Juventas' future financial needs while ensuring that CNCT19 clinical development remains on track. CASI is committed to the commercial success of this program."

Mr. Zhang continued, "Importantly, we are also pleased to increase our equity position in Juventas which we believe will have significant upside potential for its shareholders in the China financial marketplace.As one of its major shareholders and with rights to designate a seat on the board of directors, we will continue to ensure the financial success of our investment."

Under the terms of the original licensing agreement between CASI and Juventas, CASI obtained a worldwide license for the commercialization of CNCT19 and Juventas was responsible for the clinical development, manufacturing and supply of CNCT19.As part of the original agreement, CASI Biopharmaceuticals (Wuxi) Co., Ltd ("CASI Wuxi Bio") invested in Juventas' Series A financing.The original agreement also provided that CASI would be responsible for payment of certain sales royalties and a development milestone in the amount of RMB 70 million upon the initiation of the registration trials.

Effective as of September 22, 2020, Juventas and its shareholders (including CASI Wuxi Bio) agreed to certain terms and conditions in connection with Juventas' Series B financing.In order to facilitate the Series B financing, CASI agreed to restructure its partnership with Juventas by amending and supplementing its original licensing agreement (the "Supplementary Agreement"). Under the Supplementary Agreement, CASI and Juventas will partner to co-commercialize CNCT19 and jointly be responsible for forming an integrated marketing team to carry out marketing activities, and CASI will continue to be responsible for recruiting and establishing a sales team to commercialize CNCT19.In addition, the Supplementary Agreement provides CASI with co-commercial rights to a second pipeline product from Juventas, subject to certain terms and conditions.

As part of this transaction, Juventas will waive the RMB 70 million milestone payment due from CASI in connection with the upcoming start of registration trials for CNCT19.CASI and Juventas will share a percentage of total net profits, with CASI receiving a tiered percentage of up to 50% of the net profit from commercial sales of CNCT19 depending on annual net sales, with a specified minimum annual target net profit to be distributed to Juventas as a percentage of net profit from commercial sales.In addition, CASI will be responsible for single digit royalty fee equal to a percentage of net sales that varies by region.

As part of this transaction, CASI Wuxi Bio will invest RMB 70 million in Juventas' Series A Plus equity, resulting in equity ownership of approximately 19.65% (post-Juventas Series B financing) and entitling it to appoint a director to the Juventas' board of directors.

Dr. Wei-Wu He, CASI's Chairman and CEO, is the chairman and a founding shareholder of Juventas. James Huang, CASI's director, is a managing partner of an existing shareholder of Juventas. A committee of independent directors of CASI negotiated and approved the terms of this transaction.Dr. He and Mr. Huang did not participate in the committee's deliberations or the approval of this transaction.

About Juventas

Juventas Cell Therapy Ltd. is an innovative cell therapy company with headquarters located in Tianjin City, China. The company's lead product, CNCT19 (CD19 CAR-T), was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.Juventas' pipeline also includes a pre-IND CD19/CD20 CAR-T that is currently in pre-IND development for non-Hodgkin lymphoma, along with other cellular-based products in preclinical and exploratory studies.

About CASI Biopharmaceuticals (Wuxi) Co., Ltd

CASI Biopharmaceuticals (Wuxi) Co., Ltd ("CASI Wuxi Bio") is a wholly-owned China subsidiary of CASI Pharmaceuticals (Wuxi) Co, Ltd., an 80%/20% China joint venture between CASI Pharmaceuticals (China) Co., Ltd. ("CASI China") and Wuxi Huicheng Yuanda Investment Enterprise (LP).CASI China is a wholly-owned subsidiary of the Company.

About CASI Pharmaceuticals

CASI Pharmaceuticals, Inc. ("CASI" or the "Company") is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater China market leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd. ("CASI China"), which is located in Beijing, China. The Company has built a commercial team of over 70 hematology and oncology sales and marketing specialists based in China. More information on CASI is available at http://www.casipharmaceuticals.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, revenue growth, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and we assume no duty to update forward-looking statements. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of factors.

SOURCE CASI Pharmaceuticals, Inc.

http://www.casipharmaceuticals.com

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CASI Pharmaceuticals Announces Restructuring of Partnership with Juventas Cell Therapy Ltd - PRNewswire