Stem Cell Clinic

Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine – GlobeNewswire

November 29, 2020 21:07 ET | Source: Telix Pharmaceuticals Limited

MELBOURNE, Australia and BAAR, Switzerland, Nov. 29, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces it has entered into an agreement with Scintec Diagnostics GmbH (Scintec) to acquire TheraPharm GmbH (TheraPharm), a Swiss-German biotechnology company developing innovative diagnostic and therapeutic solutions in the field of hematology.

The acquisition of TheraPharm provides Telix with access to a portfolio of patents, technologies, production systems, clinical data and know-how in relation to the use of Molecularly Targeted Radiation (MTR) in hematology and immunology. TheraPharm is developing antibody MTR technology against CD66, a cell surface target highly expressed by neutrophils (a type of white blood cell) and tumor-infiltrating lymphocytes. As such, the technology has potentially very broad applications in the diagnosis and treatment of hematologic diseases (e.g. blood cancers), lymphoproliferative disorders and immune-mediated diseases (e.g. lupus, and multiple sclerosis). Of particular interest is the demonstrated use of the technology to safely and effectively perform bone marrow conditioning (BMC) prior to bone marrow stem cell transplant.

Telix CEO, Dr. Christian Behrenbruch stated, Telix is committed to extending and improving the lives of patients with serious diseases. As such, the acquisition of TheraPharm and its MTR assets are uniquely aligned to Telixs mission and technical strengths in antibody engineering and radiochemistry. TheraPharms technology has a significant role to play in BMC and stem cell transplantation across a broad range of blood cancers and rare diseases. The current approach to BMC employs highly toxic drugs that have a poor morbidity and mortality profile, and for which many patients are ineligible. MTR offers an excellent safety profile that may greatly expand the number of patients able to undergo life prolonging stem cell transplantation while greatly reducing the hospitalisation burden and cost associated with such procedures.

TheraPharm co-founder and Managing Director, Dr. Klaus Bosslet added, Over the past 5 years, TheraPharm, in collaboration with Dr. Kim Orchard from the University of Southampton (UK), has made excellent progress developing 90Y-besilesomab for the treatment of hematologic cancers and several related conditions including multiple myeloma, leukemia and amyloidosis. This unique asset is a logical addition to Telixs portfolio, offering a potentially rapid development path to a first commercial indication for the treatment of patients with SALA, while at the same time having potentially broad applications for stem cell transplantation in patients with more common cancers of the blood, including multiple myeloma and leukemia. We look forward to joining the Telix team in order to expedite the development of products for this under-served field.

Full transaction details, including financial terms, can be found via the Telix website and ASX portal here.

About Hematopoietic Stem Cell Transplant (HSCT)

Bone marrow conditioning (BMC) followed by hematopoietic stem cell transplantation (HSCT) is presently performed to treat patients with hematologic malignancies (blood cancers), with the objective of extending patient survival or achieving cure. HSCT is also performed for a broad range of non-cancer conditions. HSCT is preferentially performed in countries of high income (Europe >30,000, Americas >20,000, worldwide >65,000 p.a., respectively) and is growing at around 5% annually.

About Systemic Amyloid Light-Chain Amyloidosis (SALA)

SALA is a rare, but serious protein deposition disease, caused by a protein known as amyloid that is produced by abnormal plasma cells residing in the bone marrow. As amyloid accumulates in the organs of the body, organ function will eventually deteriorate, ultimately causing organ failure. SALA has an estimated prevalence of 30,000 and 45,000 in United States and Europe, respectively and while a rare disease, SALA portends a very poor prognosis, with a median survival from diagnosis of ~11 months if untreated.

The current standard of care comprises of induction therapy (typically cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC, followed by HSCT. This approach is typically only accessible to a small proportion of patients (<20%) who are able to tolerate induction therapy and melphalan BMC.

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit http://www.telixpharma.com.

About TheraPharm GmbH

TheraPharm is a biotechnology company specialised in the research, development and manufacturing of monoclonal antibodies for targeted radiation of hematopoietic malignant and non-malignant diseases, lymphoproliferative diseases, conditioning for allogeneic stem cells as well as in diagnostics of inflammatory diseases and bone marrow metastases.

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Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine - GlobeNewswire

ONLINE: The UW Now – Isthmus

press release: Stream at the WAA YouTube channel.

Dec. 1: As multiple pharmaceutical companies announce initial positive results from vaccine clinical trials, people all over the world are beginning to ask what comes next. Have the vaccines been tested enough? With limited quantities available, who gets first priority? What factors may complicate distribution? Once we have been vaccinated, how long will we be protected?

Join fellow UW-Madison alumni and friends online for a livestream and Q & A with three UW-Madison experts about the development and distribution of COVID-19 vaccines. The talks will be moderated by Mike Knetter, president and CEO of the Wisconsin Foundation and Alumni Association.

R. Alta Charo is the Warren P. Knowles Professor of Law and Bioethics at the University of WisconsinMadison. She is an elected fellow of the National Academy of Medicine, where she serves on its board on health sciences policy and its executive council. Charo served as a member of the Obama-Biden Transition Project, where she was a member of the health and human services review team. She has served as a senior policy adviser in the Office of the Commissioner at the U.S. Food and Drug Administration as well as on several expert advisory boards of organizations with an interest in stem cell research. She is also the cochair of the National Academy of Medicine Forum on Regenerative Medicine and the Committee on Human Gene Editing. She has been a key figure in drafting regulations and guidelines concerning adult, embryonic, and induced pluripotent stem cell research.

James Conway is a pediatric infectious disease specialist and professor of pediatrics. He is the associate director of the UWs Global Health Institute, the medical director of the UW Health Immunization Program, and director of the Office of Global Health at the School of Medicine and Public Health. He is a fellow of the American Academy of Pediatrics (AAP), serving in the sections on infectious diseases and international child health, and received an AAP Special Achievement Award in 2009 for his immunization projects. He is also a member of the board of directors of the Wisconsin AAP chapter (WIAPP), where he serves as chair of the Committee on Immunizations and Infectious Diseases and represents WIAAP on the Wisconsin Council on Immunization Practice.

Jonathan Temte MD87, PhD93 is the associate dean for public health and community egagement at the UW School of Medicine and Public Health. As a family medicine physician and a professor in the Department of Family Medicine and Community Health, Temte has served as a clinician, teacher, and researcher for 25 years. His research includes investigation of the relationships between communities, primary care, and respiratory viruses. An expert in vaccines and immunization policy, Temte has served on the U.S. Advisory Committee on Immunization Practices, also acting as chair of its Evidence-Based Recommendation Work Group. Temte is chair of the Wisconsin Council on Immunization Practices and serves as medical director for Public Health Madison & Dane County. On the national level, Temte is serving an appointment to the Centers for Disease Control and Prevention Board of Scientific Counselors.

More info: https://www.allwaysforward.org/uwnow/. A recording of this livestream will be available on uwalumni.com after the event.

WFAA plans to host The UW Now Livestream weekly, featuring UWMadison faculty and staff with unique expertise.

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ONLINE: The UW Now - Isthmus

Celularity Announces Positive DMC Safety Review and Continuation of its Phase I/II CYNK-001-COVID-19 (CYNKCOVID) Study – PRNewswire

FLORHAM PARK, N.J., Dec. 1, 2020 /PRNewswire/ -- Celularity announced today that the independent Data Monitoring Committee (DMC) completed the first assessment of the ongoing Phase I/II CYNK-001-COVID-19(CYNKCOVID) study (https://clinicaltrials.gov/ct2/show/NCT04365101) with CYNK-001 off-the-shelf, allogeneic, natural killer (NK) cell therapy in adults with COVID-19. The DMC confirmed the absence of dose-limiting toxicities and recommended to move forward with the trial. Additionally, there was no evidence of worsening of inflammatory biomarkers observed. The observed clinical findings justify the continuation of the trial. Enrollment is ongoing in this multi-center clinical study with active sites in Arizona, Arkansas, California, New Jersey, and Washington.

"We are encouraged that an esteemed group of independent experts in COVID-19 and cellular therapy determined that CYNK-001 was safe in the first participants receiving the treatment on the multi-site national study. Our goal now is to rapidly complete enrollment of the study so we can determine the efficacy of this promising treatment for COVID-19 with the epidemic resurging in the United States and few good treatment options for many patients,"said the national PI for the CYNKCOVID clinical trial, Corey Casper, M.D., M.P.H.

"The administration of NK cells may have the potential to both control viral infection while also coordinating a more effective immune response that could lead to strong and lasting protection against viruses. With the increasing incidence of COVID-19 nationwide, Celularity reaffirms our commitment to the development of CYNK-001 as a potential therapeutic treatment for patients with limited treatment options. Through our collaboration with investigators, we anticipate rapid enrollment culminating in the next DMC review of safety and efficacy data," said Robert J. Hariri, M.D., Ph.D., Celularity's Founder, Chairman and Chief Executive Officer.

The Phase I/II CYNK-001-COVID-19 (CYNKCOVID) clinical trial investigating CYNK-001 is continuing to enroll to the next evaluation milestone where the external, independent DMC will review the phase I data for both safety and efficacy. Celularity continues to accumulate safety data on CYNK-001 across a broad platform of programs including COVID-19, as well as hematologic and solid tumor malignancies.

About NK Cells NK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001 CYNK-001 is an investigational cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf allogeneic cellular therapies. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post-partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Media Contact Factory PR Email: [emailprotected]

SOURCE Celularity, Inc.

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Celularity Announces Positive DMC Safety Review and Continuation of its Phase I/II CYNK-001-COVID-19 (CYNKCOVID) Study - PRNewswire

Mustang Bio to Host Key Opinion Leader Call on MB-106 for the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma – GlobeNewswire

December 01, 2020 08:00 ET | Source: Mustang Bio, Inc.

WORCESTER, Mass., Dec. 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 it will host a key opinion leader (KOL) call on MB-106 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma on Wednesday, December 9, 2020, at 1:00 p.m. EST.

The call will feature presentations by KOLs Mazyar Shadman, M.D., M.P.H., Fred Hutchinson Cancer Research Center (Fred Hutch), and Brian Till, M.D., Fred Hutch, who will discuss the interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphoma that the company is developing in collaboration with Fred Hutch. Data from this study have been selected for a poster presentation at the 62nd American Society of Hematology Annual Meeting.

During the call, Drs. Shadman and Till will also discuss the modified cell manufacturing process that was co-developed by Fred Hutch and Mustang Bio, as well as the correlative science observed in the study to date. The Mustang team will then give a corporate update on its pipeline and future plans. Following the formal presentations, the Mustang team, along with Drs. Till and Shadman, will be available for questions.

To register for the call, please click here.

About Dr. Shadman Mazyar Shadman, M.D., M.P.H., is an associate professor at the University of Washington (UW) and Fred Hutch. He is a hematologic malignancies expert who specializes in treating patients with lymphoma / chronic lymphocytic leukemia (CLL). He is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cell), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies. Dr. Shadman received his M.D. from Tehran University in Iran. He finished internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his training in hematology and medical oncology fellowships at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for National Cancer Institutes cancer research training program at Fred Hutch, where he studies cancer epidemiology.

About Dr. Till Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

About Mustang Bio Mustang 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 X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. 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 Statements This 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 Begien Mustang Bio, Inc. (781) 652-4500 ir@mustangbio.com

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

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

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Mustang Bio to Host Key Opinion Leader Call on MB-106 for the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - GlobeNewswire

Exploring the Challenges and Opportunities of Harvesting CTCs – Technology Networks

This cluster of circulating tumor cells (CTCs, shown in red) originated from the blood of a breast cancer patient. Credit: Min Yu (Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC), National Cancer Institute/USC Norris Comprehensive Cancer Center

Liquid biopsies involve sampling and analyzing bodily fluids, such as blood, urine or saliva, to look for signs of cancer or other diseases. A range of disease biomarkers can be detected, including circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), exosomes and proteins. The information gleaned from liquid biopsies could help clinicians diagnose, monitor and treatcancer more efficiently, providing insights not possible with traditional surgical biopsies.

As part of its efforts in the liquid biopsy space, ANGLE has developed the Parsortix system. The technology captures CTCs from a blood sample and enables a variety of downstream analyses to be completed. In a recent study from the University Medical Centre Hamburg-Eppendorf, Parsortix was used to successfully harvest CTCs to investigate the causes of brain metastasis in non-small cell lung cancer (NSCLC) patients. We spoke to Andrew Newland, CEO, ANGLE, to learn more about the study, the challenges of harvesting CTCs and how the Parsortix system overcomes some of these challenges.Andrew also discussed the value of characterizing CTCs in clinical trials for new drugs. Anna MacDonald (AM): What advantages do liquid biopsies offer over traditional surgical biopsies? Andrew Newland (AN): Liquid biopsies are based on a blood test. This has multiple advantages but in particular: firstly they are non-invasive requiring only a simple blood draw and do not require an invasive surgical procedure, with the associated costs and potential complications. Secondly they can be repeated often to check on current status of the disease, and response to treatment, whereas the tissue biopsy can only be done once for a given cancer site. This enables personalized medicine with treatment tailored to the patients current condition. AM: Can you explain what circulating tumor cells are, how they can be used to detect and monitor cancers, and why they are so challenging to isolate? AN: CTCs are cancer cells that have left the primary site (or the secondary sites) and are circulating in the blood stream as seeds to spread the cancer in the metastasis process. If they can be captured and harvested for analysis, they can be investigated to determine the current status of the cancer. This provides the information needed for personalized treatment tailored to the patients current condition the right drug at the right time. The CTCs are challenging to isolate because they are very few in number, generally around one CTC for one billion blood cells. AM: Can you give an overview of how the Parsortix system works to capture and harvest CTCs? How does this approach compare to other methods? AN: The Parsortix system captures CTCs using a patented microfluidic structure which separates the CTCs based on their larger size and lack of deformability. Key advantages of the Parsortix system compared to alternative CTC approaches are that it is epitope-independent (does not rely on antibodies to capture CTCs) and captures all types of CTCs including those that are mesenchymal. It also allows easy harvest of the CTCs (recovery from the system) for analysis unlike filtration systems, which have the added problems of clogging up and lack of purity in addition to problems of harvesting the cells for analysis. AM: What benefits does it offer over biological affinity-based methods of CTC isolation? AN: The affinity-based systems are based on binding antibody-coated magnetic beads to the CTCs. These systems fail to capture the clinically significant EMTing and mesenchymal CTCs as they do not express the cell surface markers targeted by the antibodies. In addition, the antibody capture process kills the cells negating the ability to culture the CTCs and potentially changing the RNA and protein expression of the cells. AM: Parsortix was used in a recent study that investigated the causes of brain metastasis in NSCLC patients. Can you tell us more about the study and the significance of the findings? AN: Brain metastasis is where the primary cancer has spread to the brain. Treatment is difficult because it is not known how the cancer is developing in the brain and a surgical tissue biopsy to investigate this is too dangerous. It had been thought not to be possible to harvest CTCs from brain metastasis due to the blood-brain barrier. However University of Hamburg-Eppendorf demonstrated that this was possible using the Parsortix system. AM: ANGLE has recently applied for FDA clearance for Parsortix, for use in metastatic breast cancer. If approved, what difference could this make to patients and clinicians? AN: This would be the first ever FDA cleared platform for harvesting CTCs from patient blood for subsequent analysis. It would open up a whole range of possible diagnostic uses to tailor treatment for metastatic breast cancer patients, that can be validated with additional clinical studies. Despite being recommended in the US National Cancer Guidelines, 50% of MBC patients are too sick, the tumor too inaccessible or insufficient tissue is available for a successful tissue biopsy of the metastatic site. For these patients there is no current information on the cancer to guide treatment. A liquid biopsy would open up alternatives for these patients based on a simple blood test. All MBC patients would benefit from the potential to have repeat biopsies using the Parsortix system to tailor their treatment more effectively. The liquid biopsies can be used to determine whether a drug is being effective, to select which drugs would be effective and to monitor patients in remission to determine, in advance, whether there are signs indicating a risk of relapse. Such early detection may allow treatment to reduce relapse. AM: What value can the characterization of CTCs bring to clinical trials? AN: Analysis of CTCs in clinical trials for new drugs, may allow the identification of likely patient responders so that drugs can be targeted. CTCs enable DNA, RNA and protein analysis providing a more complete picture of the cancer than DNA analysis alone. CTCs may also reduce the time and costs of drug trials by providing early information on drug effectiveness as well as enabling faster enrolment. Liquid biopsies allow serial monitoring of patients over different time periods, which is not possible with tissue biopsies as these cannot be repeated. This longitudinal monitoring may provide more accurate and more timely information of the performance of the drug facilitating clinical trials. AM: In what areas do you envisage liquid biopsies are likely to make the most impact? Will there still be a place for surgical biopsies? AN: The Parsortix liquid biopsy is intended to be additive to surgical tissue biopsies. Tissue biopsies are the current gold standard and will likely continue where the tissue is accessible and the procedure not overly invasive. There is no expectation that liquid biopsy will replace tissue biopsy. Liquid biopsies will be used for repeat biopsies, which is not possible with a tissue biopsy (you cannot cut out the same tissue twice), to provide up-to-date information and where the tissue is inaccessible and/or the biopsy is overly invasive (such as brain metastasis). Andrew Newland was speaking to Anna MacDonald, Science Writer, Technology Networks.

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Exploring the Challenges and Opportunities of Harvesting CTCs - Technology Networks