A Single-arm, Multi-center, Open-label Proof of Concept Safety and Efficacy Study of FCR001 Cell-based Therapy in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis at Risk for Organ Failure

This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) at risk for organ failure.

Start Date24 Nov 2021

Sponsor / Collaborator

Talaris Therapeutics, Inc.

NCT03995901 / TerminatedPhase 3

A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors

A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.

Start Date25 Oct 2019

Sponsor / Collaborator

Talaris Therapeutics, Inc.

NCT01649388 / WithdrawnPhase 2

A Single-arm, Multi-center, Exploratory Safety and Efficacy Study of FCR001 Cell-based Therapy to Induce Donor-specific Tolerance in Previously Transplanted Recipients of a Kidney From a Living Donor, and Safety in FCR001 Donors

An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.

Start Date15 Oct 2012

Sponsor / Collaborator

Talaris Therapeutics, Inc.

100 Clinical Results associated with Enriched hematopoietic stem cell (Talaris Therapeutics)

100 Translational Medicine associated with Enriched hematopoietic stem cell (Talaris Therapeutics)

100 Patents (Medical) associated with Enriched hematopoietic stem cell (Talaris Therapeutics)

Literatures (Medical) associated with Enriched hematopoietic stem cell (Talaris Therapeutics)

01 Nov 2023·Clinical Transplantation

Immune tolerance via FCR001 cell therapy compared with maintenance immunosuppression for kidney transplantation: Real‐world evidence analysis of safety and efficacy

Article

Author: Richards, Margaret ; Chodoff, Lawrence ; Leventhal, Joseph R ; Ho, Bing ; Schaumberg, Debra A ; Axelrod, David A ; Krieger, Nancy ; Ildstad, Suzanne T ; Laidlaw, Douglas

AbstractWhile kidney transplantation (KTx) has traditionally required lifelong immunosuppression, an investigational stem cell therapy, FCR001, has been demonstrated to induce tolerance and eliminate the need for immunosuppression through the establishment of persistent mixed chimerism in a phase 2 clinical study. Real‐world evidence (RWE) methods were employed to compare the safety and efficacy of non‐myeloablative conditioning with FCR001 with standard of care [SOC] immunosuppression in a retrospective single‐center analysis of outcomes among propensity score matched living‐donor KTx receiving SOC (n = 144) or FCR001 (n = 36). Among the FCR001 recipients, 26 (72%) developed persistent chimerism allowing durable elimination of all immunosuppression. There was no significant difference in the composite primary endpoint (biopsy‐proven acute rejection [BPAR], graft loss, or death) at 60 months (FCR001 27.8%, n = 10 and SOC 28.5%, n = 41; p = .9). FCR001 recipients demonstrated superior kidney function at 5 years (estimated glomerular filtration rate [eGFR] [mean ± standard deviation]: 64.1 ± 15.3) compared to SOC (51.7 ± 18.8; p = .02). At 5 years, FCR001 recipients experienced fewer complications including new‐onset diabetes post‐transplant, although two patients developed graft versus host disease. In conclusion, RWE demonstrated that KTx combined with non‐myeloablative conditioning and FCR001 resulting in superior kidney function without increasing the risk of rejection, graft loss, or death among patients off immunosuppression.

01 Apr 1990·Seminars in hematologyQ2 · MEDICINE

Treatment of cytomegalovirus disease.

Q2 · MEDICINE

Review

Author: Emanuel, D

Cytomegalovirus (CMV) infection, particularly CMV pneumonitis, continues to be an important infectious complication following allogeneic bone marrow transplantation. Most bone marrow transplant (BMT) centers have reported an overall incidence of CMV pneumonitis of 15% to 20%. Until recently, the mortality rate from CMV pneumonitis has been extremely high (greater than 80%). Historically, both single-agent therapy and combination treatments have failed to increase survival of BMT recipients with CMV pneumonia. The introduction of new antiviral agents with potent activity against CMV in vitro, such as ganciclovir and trisodium phosphonoformate, seemed to offer promise for improving survival. However, as single agents, a significant impact on mortality has not been achieved with either. The addition of high-dose intravenous immunoglobulin (IVIG) to ganciclovir appears to have a significant impact on mortality due to CMV pneumonia following bone marrow transplantation. The mechanism by which IVIG exerts its clinical effect remains to be determined, and a better understanding of the underlying process may improve this approach in the future. Bone marrow toxicity associated with ganciclovir remains a particular problem in the BMT population. Strategies to circumvent this problem, such as the use of hematopoietic stem cell growth factors or the use of an agent that is less bone marrow suppressive, such as phosphonoformate, may also increase the effectiveness of treating CMV pneumonia.

Transplantation

Evaluation of Immunocompetence and Biomarkers of Tolerance in Chimeric and Immunosuppression-free Kidney Allograft Recipients

Article

Author: Leventhal, Joseph R. ; Mathew, James M. ; Lee, John R. ; Feng, Chris Yuhsuen ; Li, Carol ; Gibson, Meg ; Ding, Ruchuang ; Suthanthiran, Manikkam ; Galvin, John ; Belshe, Dianne ; Tollerud, David J. ; Ison, Michael G. ; Ildstad, Suzanne T. ; Gallon, Lorenzo ; Gornstein, Eric

Background.Thirty-seven patients have received a living-donor kidney transplant in a phase 2 study designed to induce tolerance with facilitated allogeneic hematopoietic stem cell transplant. The study protocol is based on tolerogenic CD8+/T-cell receptor− facilitating cells (FCR001; also including hematopoietic stem cells and αβ-T-cell receptor+ T cells) and low-dose, nonmyeloablative conditioning. Persistent chimerism allowing full immunosuppression (IS) withdrawal was achieved in 26 patients (time off IS 36–123 mo).Methods.We evaluated biomarkers of tolerance through urinary cell mRNA profiling and immunocompetence to respond to vaccination in these patients. We also assessed kidney function and metabolic parameters compared with standard-of-care patients on IS.Results.Persistently chimeric patients retained chimerism after removal of IS and remained rejection free without donor HLA–specific antibody development. The presence of donor chimerism at >50% correlated with a signature of tolerance in urinary cell mRNA profiles, with a uniquely elevated increase in the ratio of cytotoxic T lymphocyte–associated protein 4 to granzyme B mRNA. Tolerance was associated with protection from recurrence of immune-mediated causes of kidney disease. Tolerant participants were safely vaccinated, developed protective immune responses, and did not lose chimerism after vaccination. When compared with kidney transplant recipients treated with standard IS, tolerant participants showed stable kidney function and reduced medication use for hypertension and hyperlipidemia.Conclusions.These results suggest that elimination of IS has distinct advantages in living-donor kidney allograft recipients.

News (Medical) associated with Enriched hematopoietic stem cell (Talaris Therapeutics)

15 Feb 2024

·www.pharmaceutical-technology.com

FDA maps out process for sponsors to charge for drugs in clinical trials

The FDA released a draft guidance, answering questions on charging for investigational drugs under an IND. Credit: Vi_L via Getty Images The US Food and Drug Administration (FDA) published a final guidance on how sponsors can charge for new drugs under an investigational new drug application (IND) during clinical trials or in expanded access programs. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will recieve your mail in sometime.So, please check your email to download the Report. Go deeper with GlobalData Reports NPVM: FCR-001 Reports NPVM: FLT190 Premium Insights The gold standard of business intelligence. Find out more The new guidance replaces a previous one issued in June 2016. If a sponsor wants to charge a trial participant for an investigational drug, the issued guidance provides a blueprint for the logistics involved in getting approvals for the same while ensuring it does not worsen any financial burden on participants. The updated document also outlines how this may work in a blinded, controlled clinical trial without compromising the study’s blind. In those cases, the FDA advised sponsors to seek out the appropriate review division in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) or get advice from the appropriate review office in the Center for Biologics Evaluation and Research (CBER) on how to maintain the blind. While the FDA allows sponsors to charge for a drug in a study after an authorisation, in terms of expanded access use, the agency mandates sponsors to give reasonable evidence that the charging would not interfere with drug development and provide documentation to justify this approach is consistent with current requirements. The FDA also made it clear that sponsors must also show that the clinical trial would not be possible without asking for the costs to be incurred due to the extraordinary cost of the drug and providing the paperwork to support its calculation for cost recovery. The FDA lists potential reasons for extraordinary drug costs as “manufacturing complexity, scarcity of a natural resource, the large quantity of the drug needed (e.g., based on the size or duration of the trial), or some combination of these or other extraordinary circumstances.” The agency clarified that the “extraordinary” status of these costs would be assessed relative to the size of financial position of a company. The FDA accepts several INDs every month in a bid to allow clinical research. Recently, the agency approved an IND from Veru for a Phase IIb trial investigating its GLP-1 RA-associated muscle loss drug Ostarine. This month, the agency also approved an IND for Acepodia’s solid tumour trial . The agency currently has a pre-IND consultation program in which sponsors can discuss any questions and concerns about the IND process with the FDA. See Also: FDA fast tracks Diamyd’s immunotherapy for managing type 1 diabetes Japan’s FY 2024 pricing reform expected to favour new listed innovative drugs Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will recieve your mail in sometime.So, please check your email to download the Report.

Phase 2

14 Aug 2023

·www.prnewswire.com

ImmunoFree Inc. has Acquired Talaris Therapeutics, Inc.'s Tolerance Business

GREENWICH, Conn., Aug. 14, 2023 /PRNewswire/ -- ImmunoFree, Inc. announced today that it has acquired all right to FCR001, a cellular therapy product, and the sponsorship of the FREEDOM-1 Study formerly owned by Talaris Therapeutics (TALS). ImmunoFree has assumed all financial and regulatory responsibilities related to these clinical trials. Effective immediately, ImmunoFree will oversee all remaining close-out activities and the shutdown of the remaining active FREEDOM-1 phase 3 clinical sites. ImmunoFree plans to commence a new clinical trial following modifications to the protocol including improved and precise allele level HLA matching, which will be achieved by leveraging the National Kidney Registry's matching capabilities. These protocol changes are designed to reduce the risk of graft versus host disease and improve patient outcomes. ImmunoFree's Scientific Advisory Board members and company co-founders are leading physicians in the bone marrow and solid organ transplant space. These members include Dr. Robert Montgomery, Dr. Joseph Leventhal, Dr. Ephraim Fuchs, Dr. Raja Kandaswamy, Dr. Yi-Bin Chen, Dr. Matthew Frigault, and Dr. Matt Cooper. "We are excited to carry forward this important tolerance work that will save/improve the lives of hundreds of thousands of transplant recipients worldwide and we are thrilled to be supported by the world-renowned physicians that make up our Scientific Advisory Board," said Co-founder & CEO, Garet Hil. About ImmunoFree Inc. ImmunoFree Inc. is a newly formed biotech company whose mission is to eliminate the need for lifelong immunosuppressive medications for transplant recipients, thus enabling them to live longer, healthier lives. Contact: Contact: Ryan Meehan, 917-837-2058, 362857@email4pr.com SOURCE ImmunoFree Inc.

Clinical StudyPhase 3

09 Aug 2023

·www.biospace.com

Fresenius Kabi Launches Plerixafor Injection

Expands Access to Oncology Medicines Broadens Health Care’s Most Comprehensive Portfolio of Generic Injectable Medicines for Oncology LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has introduced Plerixafor Injection, a generic equivalent to Mozobil®, available immediately in the United States in a 24 mg per 1.2 mL single dose vial. Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma and is the newest addition to the company’s generic injectable oncology medicine portfolio, the largest in U.S. health care. “Fresenius Kabi is pleased to add Plerixafor Injection to our oncology portfolio, further demonstrating our commitment to expanding access to high-quality and cost-effective oncology medicines in the United States,” said John Ducker, president and CEO of Fresenius Kabi USA. “The introduction of this generic equivalent will provide patients and clinicians with access to more choices for their cancer care.” Fresenius Kabi offers more than 30 different oncology drugs in the U.S. and introduced its first biosimilar in 2022 with the launch of Stimufend® (pegfilgrastim-fpgk), a biosimilar of Neulasta®. The company plans to bring more oncology and oncology supportive care products to U.S. patients to further support patient care and choice. Indications and Usage for Plerixafor Injection Plerixafor injection is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM). Important Safety Information Plerixafor is contraindicated in patients with a history of hypersensitivity to Plerixafor. Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Plerixafor. Observe patients for signs and symptoms of hypersensitivity during and after Plerixafor administration for at least 30 minutes and until clinically stable. Only administer Plerixafor when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Plerixafor may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Plerixafor is not intended for HSC mobilization and harvest in patients with leukemia. Plerixafor in conjunction with G-CSF increases circulating leukocytes and HSC populations. White blood cell counts should be monitored during treatment. Thrombocytopenia has been observed in patients receiving Plerixafor. Platelet counts should be monitored in patients who receive Plerixafor and then undergo apheresis. In patients treated with Plerixafor in combination with G-CSF for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied. Post marketing cases of splenic enlargement and/or rupture have been reported following the administration of Plerixafor in conjunction with growth factor G-CSF. Individuals receiving Plerixafor in combination with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity. Plerixafor can cause fetal harm when administered to a pregnant woman. Plerixafor is teratogenic in animals. Plerixafor administration to pregnant rats during organogenesis resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth at exposures approximately 10 times the exposure at the recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use an effective form of contraception during treatment with Plerixafor and for one week after the final dose. There are no data on the presence of plerixafor in human milk, the effect on the breastfed child, or the effect on milk production. Because of the potential serious adverse reactions in the breastfed child, advise females that breastfeeding is not recommended during treatment with Plerixafor and for one week after the final dose. The most common adverse reactions (≥10%) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), fatigue (27%), injection site reactions (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%). To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . This Important Safety Information does not include all the information needed to use Plerixafor Injection safely and effectively. Please see accompanying full prescribing information for Plerixafor Injection. Full prescribing information is also available at . About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn. *Mozobil® is a registered trademark of Sanofi. *Neulasta® is a registered trademark of Amgen Inc. View source version on businesswire.com: Contacts Joanie Clougherty (614) 717-5741 joan.clougherty@fresenius-kabi.com Source: Fresenius Kabi View this news release online at:

Drug Approval

100 Deals associated with Enriched hematopoietic stem cell (Talaris Therapeutics)

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Indication	Highest Phase	Country/Location	Organization	Date
Scleroderma, Diffuse	Phase 2	US	Talaris Therapeutics, Inc.	24 Nov 2021
Rejection, Psychology	Phase 2	US	Talaris Therapeutics, Inc.	25 Oct 2019
Renal transplant rejection	Phase 2	US	Talaris Therapeutics, Inc.	29 Sep 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03995901 (FREEDOM-1, Corporate Publications) Manual	Phase 3	Acute Graft Versus Host Disease \| Renal transplant rejection	22	FCR001	ikbrrfrweu(cogekfgaki) = eodgdbsyiw geqzvbzflb (jztietdfbo ) View more	Positive	30 Jun 2022
				Standard of Care	-

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Enriched hematopoietic stem cell (Talaris Therapeutics)

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