CTCL

Citius Pharmaceuticals Resubmits the Biologics License Application of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Retrieved on: 
Wednesday, February 14, 2024
Symantec Endpoint Protection, FDA, Food, Safety, BLA, CRL, PDUFA, CTCL, Letter, Patient

CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Key Points: 
  • The resubmission follows ongoing engagement with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.
  • Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter.
  • There were no safety or efficacy issues cited and no additional trials required.
  • Based on Center for Drug Evaluation and Research timelines, FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act (PDUFA) date is expected within 30 days of resubmission.

Kymera Therapeutics Presents Interim Results from STAT3 Degrader Phase 1 Clinical Trial at American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Patient, STAT3, Montefiore Medical Center, Cholangiocarcinoma, Stomatitis, Neoplasm, Constipation, Tumor microenvironment, PRS, SOCS3, Relapse, Leukemia, Anemia, Fatigue, Nausea, Blood, Carcinoma, Society, Therapy, CTCL, Infrared spectroscopy correlation table, PD, Head, ASH, T-PLL, Cancer, Biomarker, Poster, Peripheral T-cell lymphoma, TPD, Safety, Arthralgia, Cutaneous T-cell lymphoma, PTCL, T-cell prolymphocytic leukemia, Lymphoma, Bone marrow, Pharmaceutical industry

WATERTOWN, Mass., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today shared new data from its ongoing KT-333 Phase 1 trial. KT-333, a first-in-class, potent, highly selective, heterobifunctional small molecule degrader of STAT3, demonstrated early signs of antitumor activity at doses that were generally well-tolerated and associated with substantial STAT3 knockdown in blood and tumor. The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.

Key Points: 
  • The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.
  • The poster provides an interim update with a data cut-off as of October 18, 2023.
  • Dr. Aditi Shastri from Montefiore Medical Center and Albert Einstein College of Medicine, a lead investigator in the study, presented the interim Phase 1 findings.
  • Preclinical data demonstrating the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia was also presented at the meeting.

New Post Hoc Analysis from MAVORIC Trial Sheds Light on the Burden of Cutaneous T-Cell Lymphoma on Health-Related Quality of Life

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Well, Mycosis fungoides, Organ, Neuropsychological test, CTCL, Cutaneous T-cell lymphoma, Central Statistics Office (India), Disease, Skin, Eastern Cooperative Oncology Group, Modified, Patient, Itch, Bivariate, Lymph, KKI, Neoplasm, Blood, ECOG, Cancer, ANOVA, Erythroderma, Female, Quality of life, Children's Oncology Group, Nursing, Medical imaging

Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical,” said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.

Key Points: 
  • Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical,” said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.
  • Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL.
  • LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.
  • In multivariate analysis, worse HRQL was associated with being younger, female, moderate or severe pruritus and impaired function (as measured by ECOG PS).

Innate Pharma to Host Virtual KOL Event on Lacutamab

Retrieved on: 
Monday, November 27, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Euronext Paris, Annual general meeting, CTCL, Bone marrow, Progression-free survival, ASH, Cutaneous T-cell lymphoma, Cutaneous lymphoma, Patient, Hematopoietic stem cell transplantation, Division, IPH, Blood, Lymphoma, ORR, Doctor of Philosophy, Society, Skin, IPHA, KOL, PTCL, ITT, Education, Pharmaceutical industry

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that it will host a virtual KOL (Key Opinion Leader) event on lacutamab, a first-in-class anti-KIR3DL2 antibody currently in development for cutaneous T-cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL), on Tuesday, December 12, 2023, at 7:00AM PST (4:00PM CET).

Key Points: 
  • Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that it will host a virtual KOL (Key Opinion Leader) event on lacutamab, a first-in-class anti-KIR3DL2 antibody currently in development for cutaneous T-cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL), on Tuesday, December 12, 2023, at 7:00AM PST (4:00PM CET).
  • Prof. Porcu is a Lymphoma-focused hematologic oncologist with a long track record of advocacy and education for patients with cutaneous lymphoma.
  • Sonia Quaratino, M.D., PhD, Chief Medical Officer of Innate Pharma, will host the call.
  • In the Intention to treat population (ITT), the global confirmed objective response rate (ORR) was 37.5% (21/56).

New Post Hoc Analysis from MAVORIC Trial Sheds Light on Burden of Cutaneous T-cell Lymphoma on Health-related Quality of Life

Retrieved on: 
Monday, December 11, 2023
Well, American Society of Hematology, Mycosis fungoides, Organ, Neuropsychological test, CTCL, Cutaneous T-cell lymphoma, Central Statistics Office (India), Disease, Skin, Eastern Cooperative Oncology Group, Modified, Patient, Itch, Bivariate, Lymph, Neoplasm, TSE, Blood, ECOG, Cancer, ANOVA, Erythroderma, Society, Female, Quality of life, Children's Oncology Group, Kyowa Kirin, B-cell lymphoma

PRINCETON, N.J., Dec. 11, 2023 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company based in Japan, today announced health-related quality of life (HRQL) findings from a post hoc analysis of the MAVORIC trial in patients with mycosis fungoides (MF) or Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL). Researchers analyzed baseline data collected prior to initiation of study treatments and found the symptoms of advanced MF/SS affected HRQL across all domains, with poorer HRQL associated with being younger in age, female, having moderate or severe itching, and impaired function as measured by the Eastern Cooperative Oncology Group performance status (ECOG PS).

Key Points: 
  • Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical," said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.
  • Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL.
  • LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.
  • Researchers concluded that assessing a patient's disease concerns may help guide treatment goals and therapeutic choice.

Kymera Therapeutics Announces Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, November 2, 2023
First grade, Research, HS, AD, PD, Food, Safety, Dana–Farber Cancer Institute, Disease, Abstract, Immunology, Cutaneous T-cell lymphoma, Uveal melanoma, STAT3, International, Physician, GDF15, Webcast, Atopic dermatitis, Therapy, Investment, CTCL, Patient, Administration, Cash, Plasma, Lymphoma, Conference, IRAK4, Development, TPD, ASH, Growth, DL2, Hypotension, DL, Solar cycle 4, Arm, AACR, Thrombocytopenia, Fast Track, PTCL, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, Society, SD, Hidradenitis suppurativa, MDM2, Recurrence, Blood, Peripheral T-cell lymphoma, Neutropenia, AML, Merkel-cell carcinoma, Pharmaceutical industry, Vaccine, Fine chemical, Medical device, Angela Merkel, Sanofi, Black Majesty

ET

Key Points: 
  • ET
    WATERTOWN, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today reported financial results for the third quarter ended September 30, 2023, and provided business updates on its pipeline of protein degraders.
  • Collaboration Revenues: Collaboration revenues were $4.7 million for the third quarter of 2023 compared to $9.6 million for the third quarter of 2022.
  • Net Loss: Net loss was $52.9 million for the third quarter of 2023 compared to a net loss of $43.0 million for the third quarter of 2022.
  • Cash and Cash Equivalents: As of September 30, 2023, Kymera had $435 million in cash, cash equivalents, and investments.

Kymera Therapeutics to Present New Clinical Data from the Phase 1 Trial of STAT3 Degrader KT-333 at the ASH Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Cutaneous T-cell lymphoma, Patient, STAT3, PD, Fatigue, Human, PTCL, Factorization of polynomials, Nausea, Society, ASH, DL2, Relapse, Blood, Anemia, Peripheral T-cell lymphoma, Exposition, DL, Safety, Therapy, CTCL, Toxicity, Pharmaceutical industry, Vaccine, Pharmacokinetics

WATERTOWN, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation, today announced that new KT-333 Phase 1 data highlighting safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical responses will be presented at the ASH 65th Annual Meeting and Exposition, taking place from December 9-12, 2023, in San Diego, California. Results released in an ASH abstract today include data as of a July 10, 2023 cut-off. The poster presentation is expected to include additional data, including PK/PD, safety and results of disease response assessments from additional patients subsequent to the abstract cut-off date. In addition, preclinical data will be presented supporting the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia.

Key Points: 
  • Results released in an ASH abstract today include data as of a July 10, 2023 cut-off.
  • The poster presentation is expected to include additional data, including PK/PD, safety and results of disease response assessments from additional patients subsequent to the abstract cut-off date.
  • In addition, preclinical data will be presented supporting the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia.
  • Title: Preliminary Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of KT-333, a Targeted Protein Degrader of STAT3, in Patients with Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia, and Solid Tumors

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

Retrieved on: 
Tuesday, October 24, 2023
TenX, READ, Suite, Food, Medication, Lexington Avenue, Auxiliary routes of Arkansas Highway 18, SPAC, Sale, Form, Acquisition, ONCE, CTCL, Patient, Person, Commerce, PD-1, Newbridge, Non-Hodgkin lymphoma, FDA, Biologics license application, Regulation of tobacco by the U.S. Food and Drug Administration, Prospectus, Peripheral T-cell lymphoma, Annual report, BLA, Security (finance), Pharmaceutical industry, Bank, Cryptocurrency, Citius, Altius, Fortius

CRANFORD, N.J. and NEW YORK, N.Y., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Citius Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition (“TenX”) (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma’s wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024.

Key Points: 
  • The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”).
  • Our majority ownership position and shared services agreement ensures that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology.
  • “We are very pleased to announce the proposed merger with Citius Oncology,” said Mr. Xiaofeng Yuan, Chairman and CEO of TenX.
  • In the transaction, all shares of Citius Pharma’s wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology.

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

Retrieved on: 
Tuesday, October 24, 2023
TenX, READ, Suite, Food, Medication, Lexington Avenue, Auxiliary routes of Arkansas Highway 18, SPAC, Sale, Form, Acquisition, ONCE, CTCL, Patient, Person, Commerce, PD-1, Newbridge, Non-Hodgkin lymphoma, FDA, Biologics license application, Regulation of tobacco by the U.S. Food and Drug Administration, Prospectus, Peripheral T-cell lymphoma, Annual report, BLA, Security (finance), Pharmaceutical industry, Bank, Generic drug, Citius, Altius, Fortius

CRANFORD, N.J. and NEW YORK, Oct. 24, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition ("TenX") (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma's wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology"). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024. 

Key Points: 
  • The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology").
  • "We are very pleased to announce the proposed merger with Citius Oncology," said Mr. Xiaofeng Yuan, Chairman and CEO of TenX.
  • Pursuant to the proposed agreement, TenX will acquire Citius Pharma's wholly owned subsidiary via a merger, with the newly combined publicly traded company to be named Citius Oncology, Inc.
  • In the transaction, all shares of Citius Pharma's wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology.

Innate Pharma Provides Update on Lacutamab Clinical Program

Retrieved on: 
Thursday, October 5, 2023
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Food, PTCL, IND, Safety, Patient, IPHA, Cutaneous T-cell lymphoma, Hemophagocytic lymphohistiocytosis, HLH, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Euronext Paris, CTCL, IPH, Pharmaceutical industry, Innate Immunotherapeutics

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL).

Key Points: 
  • Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL).
  • The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder.
  • TELLOMAK, Innate Pharma’s ongoing Phase 2 trial of lacutamab in cutaneous T-cell lymphoma (CTCL), completed enrollment in Q2 2023 (n=170 patients).
  • Innate Pharma is on track for final data from the Phase 2 TELLOMAK trial and preliminary data on PTCL in Q4 2023.