Subcutaneous T-cell lymphoma

Autolus Therapeutics to Present Three Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2022

Retrieved on: 
Thursday, November 3, 2022

Were looking forward to presenting follow up data from three of our clinical trials at ASH this year.

Key Points: 
  • Were looking forward to presenting follow up data from three of our clinical trials at ASH this year.
  • For both AUTO1/22 in pediatric ALL patients and for AUTO4 in peripheral T Cell Lymphoma we will present longer follow up data.
  • Overall, obe-cel has a tolerable safety profile in patients with r/r B-cell cancers despite high disease burden.
  • In collaboration with Autolus academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.

 Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan

Retrieved on: 
Wednesday, June 30, 2021

(TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter Solasia) today announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW).

Key Points: 
  • (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter Solasia) today announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW).
  • Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year.
  • If approved and launched, darinaparsin would be the third drug Solasia successfully developed and brought to market since its founding and is expected to contribute to the treatment of PTCL.
  • Solasia plans to present the results of the study at an international academic conference to be held in the near future.

Global T-Cell Lymphoma Pipeline Market Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, June 14, 2021

The "T Cell Lymphoma - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "T Cell Lymphoma - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "T cell lymphoma - Pipeline Insight, 2021," report provides comprehensive insights about 100+ companies and 120+ pipeline drugs in T cell lymphoma pipeline landscape.
  • This segment of the T cell lymphoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery.
  • In a Phase II study in the U.S. Intravenous darinaparsin demonstrated evidence of clinical activity in malignant lymphoma, and in particular peripheral T-cell lymphoma (PTCL).

2021 Pipeline Insight on Relapsed and Refractory CD5-expressing T Cell Lymphomas - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 16, 2021

The "Relapsed and Refractory CD5-expressing T cell lymphomas - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Relapsed and Refractory CD5-expressing T cell lymphomas - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about 2+ companies and 3+ pipeline drugs in Relapsed and Refractory CD5-expressing T cell lymphomas pipeline landscape.
  • The therapies under development are focused on novel approaches for Relapsed and Refractory CD5-expressing T cell lymphomas.
  • Relapsed and Refractory CD5-expressing T cell lymphomas pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Legend Biotech Announces FDA Clearance of the IND for LB1901, an Investigational Autologous Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma

Retrieved on: 
Monday, December 14, 2020

Under this IND, Legend will initiate a Phase 1 clinical study for LB1901 in the United States.

Key Points: 
  • Under this IND, Legend will initiate a Phase 1 clinical study for LB1901 in the United States.
  • A Phase 1, first-in-human, open-label, multicenter, multicohort clinical study will enroll patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) in the United States.
  • A high unmet medical need remains for patients with relapsed or refractory PTCL and CTCL.
  • Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications.

Adicet Announces FDA Clearance of IND Application for First-in-Class Allogeneic CAR Gamma-Delta T Cell Therapy

Retrieved on: 
Thursday, October 22, 2020

The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of off-the-shelf T cell products, said Chen Schor, President and Chief Executive Officer of Adicet.

Key Points: 
  • The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of off-the-shelf T cell products, said Chen Schor, President and Chief Executive Officer of Adicet.
  • We are particularly excited to advance on our goal to exploit the therapeutic potential of our first in class engineered CAR T cell therapy in NHL patients.
  • ADI-001 is an investigational allogeneic gamma delta T cell therapy being developed as a treatment for B-cell non-Hodgkins lymphoma (NHL).
  • Adicet is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases.

Precision BioSciences Receives Fast Track Disease Designation from U.S. Food and Drug Administration for PBCAR0191 Investigational Allogeneic CAR T Cell Therapy

Retrieved on: 
Wednesday, August 19, 2020

We believe the balance of safety and efficacy plus the accessibility of allogeneic cell therapies may fill a void left by autologous CAR T therapies.

Key Points: 
  • We believe the balance of safety and efficacy plus the accessibility of allogeneic cell therapies may fill a void left by autologous CAR T therapies.
  • This designation provides more flexibility as we attempt to identify the optimal patient population in which to seek regulatory approval.
  • Fast Track designation facilitates the expedited development and review of a new drug, whether alone or in combination with another drug that may address unmet medical needs and treats a serious or life-threatening disease.
  • The NHL cohort includes patients with mantle cell lymphoma, an aggressive subtype of NHL, for which the FDA previously granted Orphan Drug Designation.

Affimed Announces Abstracts on Innate Cell Engagers from its ROCK® Platform Accepted for Presentation at AACR Virtual Annual Meeting II

Retrieved on: 
Friday, May 15, 2020

Affimed will host a live teleconference today, Friday May 15th at 8am Eastern to discuss the abstracts and recent corporate developments.

Key Points: 
  • Affimed will host a live teleconference today, Friday May 15th at 8am Eastern to discuss the abstracts and recent corporate developments.
  • Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer.
  • Affimeds fit-for-purpose ROCK platform allows innate cell engagers to be designed for specific patient populations.
  • The companys initial clinical program, AFM13 for CD30-positive lymphomas, is currently enrolling patients for a registration-directed study in relapsed/refractory peripheral T cell lymphoma.

Affimed Announces FDA Granted Orphan Drug Designation for Lead Innate Cell Engager AFM13 for the Treatment of T-cell Lymphoma

Retrieved on: 
Wednesday, April 1, 2020

The granted designation includes peripheral T cell lymphoma (pTCL), a subtype of T-cell lymphoma.

Key Points: 
  • The granted designation includes peripheral T cell lymphoma (pTCL), a subtype of T-cell lymphoma.
  • AFM13 is being investigated as a monotherapy for the treatment of relapsed or refractory CD30-positive pTCL in a Phase 2 registration-directed study.
  • AFM13 is a first-in-class tetravalent, bispecific innate cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells.
  • AFM13 has been granted orphan drug designation by the U.S. Food and Drug Administration for HL.

Actinium Pharmaceuticals Announces Iomab-ACT Program Gene Therapy Collaboration with UC Davis in Ongoing Clinical Trial for Patients with HIV-Related Lymphoma

Retrieved on: 
Monday, January 13, 2020

In the trial, patients with relapsed or refractory HIV-related lymphoma are being treated with autologous stem cell gene therapy.

Key Points: 
  • In the trial, patients with relapsed or refractory HIV-related lymphoma are being treated with autologous stem cell gene therapy.
  • This is the first gene therapy clinical trial that will utilize ARC based conditioning.
  • The clinical trial will be conducted at UC Davis and may be expanded to additional sites in the future.
  • In this clinical collaboration, Actinium will provide drug product, support for its administration and certain trial costs.