T-cell lymphoma

Adicet Bio Highlights Preclinical Data Supporting IND Readiness for ADI-270 in an Oral Presentation at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting

Retrieved on:

Monday, April 22, 2024

Oncology, Health, Stem Cells, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Cancer, Cell, T-cell lymphoma, IND, Renal cell carcinoma, Neoplasm, CD70, Annual general meeting, Lung cancer, Vaccine

“ADI-270 is a next-generation CAR T cell therapy candidate designed to capitalize on potent tumor infiltration associated with the gamma delta T cell platform.

Key Points:

“ADI-270 is a next-generation CAR T cell therapy candidate designed to capitalize on potent tumor infiltration associated with the gamma delta T cell platform.
ADI-270 is further enhanced with armoring to address suppressive tumor microenvironments and to address clearance by host T cells.
In preclinical studies, ADI-270 demonstrated enhanced functional persistence and potency, including unique contribution of innate anti-tumor immunity, compared to multiple clinically relevant benchmarks in cancers expressing CD70.
The preclinical findings indicate:
ADI-270 demonstrated potent in vitro cytotoxicity against multiple CD70 positive tumor cell lines expressing varying levels of CD70.

Vidac Pharma receives Japanese Patent Office Notice of Allowance for VDA-1275 cancer drug candidate

Retrieved on:

Wednesday, March 27, 2024

Cell proliferation, Apoptosis, Survival, Patent, Colorectal cancer, T-cell lymphoma, Neoplasm, Guard cell, Mitochondrion, IC50, Cisplatin, HK2, Sorafenib

(Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments, today announces it has received a Notice of Allowance from the Japanese Patent Office for the composition and methods of use for its VDA-1275 drug candidate, which has shown multiple promising effects in preclinical studies.

Key Points:

(Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments, today announces it has received a Notice of Allowance from the Japanese Patent Office for the composition and methods of use for its VDA-1275 drug candidate, which has shown multiple promising effects in preclinical studies.
“Receiving this notice from the Japanese authorities adds to our excitement about VDA-1275, Vidac’s next and powerful anti-cancer drug candidate.
Cancer cells overexpress HK2, which catalyzes the first step of the glucose metabolism necessary to fuel tumor growth.
Clinical data for Vidac’s first-generation metabolic checkpoint modulator candidates have shown powerful effects in halting cancer cell proliferation and restoring immune-sensitivity and apoptosis.

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on:

Tuesday, March 19, 2024

BURLINGAME, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points:

ET / 1:30 p.m. PT
BURLINGAME, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2023.
We have several exciting opportunities in immunology, including plans for a randomized, placebo controlled clinical trial of soquelitinib in atopic dermatitis.
Mr. Arcara previously served as senior vice president, head global marketing & portfolio and strategy for the innovative medicines and biosimilars business at Teva Pharmaceuticals.
ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2023 financial results.

Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on:

Tuesday, March 19, 2024

Research, Mutation, T-cell lymphoma, PD, ARID1A, Webcast, Patient, Lung, CDK, PLK1, Medicine, Clinical trial, CYCC, Cancer, Safety, Cyclacel, Lymphoma

BERKELEY HEIGHTS, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced fourth quarter and full year 2023 financial results and provided a business update.

Key Points:

BERKELEY HEIGHTS, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced fourth quarter and full year 2023 financial results and provided a business update.
These include pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation part of the 065-101 Phase 1/2 study.
"We expect to report final Phase 1 results including details on patient genomic profiles at an upcoming medical conference.
( Webcast link )
For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com .

GC Cell to Present Multiple Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024

Retrieved on:

Tuesday, April 2, 2024

Patient, Research, Abstract, CD5, AACR, T-cell lymphoma, Division, CSO, Hematology, Vaccine

"We are looking forward to sharing data that GL205 (GCC2005) effectively targets CD5 in malignant T-cell lymphomas, suggesting it as a new treatment option for patients with limited choices from current approved therapies.

Key Points:

"We are looking forward to sharing data that GL205 (GCC2005) effectively targets CD5 in malignant T-cell lymphomas, suggesting it as a new treatment option for patients with limited choices from current approved therapies.
Presenting at AACR offers a significant opportunity to globally disseminate our research findings, creating anticipation for the forthcoming clinical trials of GL205 (GCC2005) slated for IND submission this year."
said Sungyong Won, CSO of GC Cell.
Details for the AACR 2024 abstracts are as follows:
Title: Superior anti-tumor activity of GL205, an allogeneic anti-CD5 CAR-NK for treating T-cell malignancies
Lead Author: Jong Gwon Choi, Division of Oncology and Hematology, Konyang University Hospital, Daejeon, Korea

Citius Pharmaceuticals Announces FDA Acceptance of the BLA Resubmission of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Retrieved on:

Monday, March 18, 2024

T-cell lymphoma, PDUFA, Symantec Endpoint Protection, Letter, Disease, Patient, CRL, CTCL, Drug development, Safety, FDA, BLA, Food, Pharmaceutical industry

CRANFORD, N.J., March 18, 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 that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) 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. The FDA has assigned a PDUFA goal date of August 13, 2024.

Key Points:

"The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL.
"We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative.
We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL," added Mazur.
The resubmission follows dialog with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.

Vittoria Therapeutics Announces Appointment of Life Sciences Veteran Rosemary Mazanet, M.D., Ph.D. as Chief Medical Officer

Retrieved on:

Tuesday, February 27, 2024

Therapy, Oracle, Research, Amgen, Drug development, T-cell lymphoma, University, CD5, Patient, Internal medicine, Drug, Disease, Biology, Infection, Nursing

PHILADELPHIA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vittoria Biotherapeutics, a clinical-stage cell therapy company, has announced today that accomplished life sciences leader, Rosemary Mazanet, M.D., Ph.D., has joined the Company as Chief Medical Officer.

Key Points:

PHILADELPHIA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vittoria Biotherapeutics, a clinical-stage cell therapy company, has announced today that accomplished life sciences leader, Rosemary Mazanet, M.D., Ph.D., has joined the Company as Chief Medical Officer.
“Drawing on her extensive expertise in the oncology and hematology drug development ecosystem, Dr. Mazanet will be an invaluable asset to Vittoria’s executive team as we enter first-in-human studies for our lead program,” said Nicholas Siciliano, Ph.D., Vittoria’s Chief Executive Officer.
Vittoria’s innovative approach to CAR-T development could change the treatment paradigm for T-cell lymphoma patients struggling with this debilitating disease.
Dr. Mazanet received her clinical training in internal medicine and oncology at Harvard Hospitals.

Corvus Pharmaceuticals Announces Orphan Drug Designation Granted to Soquelitinib for the Treatment of T Cell Lymphoma

Retrieved on:

Thursday, February 8, 2024

Lymphoma, Food, T-cell lymphoma, PTCL, ITK, Toxicity, Patient, FDA, Pharmaceutical industry

BURLINGAME, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma.

Key Points:

BURLINGAME, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma.
Soquelitinib, the Company’s lead ITK inhibitor candidate, is expected to advance into a Phase 3 registrational clinical trial in patients with relapsed peripheral T cell lymphoma (PTCL) in the second quarter 2024.
“Peripheral T cell lymphoma is an aggressive subset of non-Hodgkin’s lymphoma typically associated with a poor prognosis,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus.
The orphan drug designation is an important milestone in the development of soquelitinib that reinforces the unmet need for patients with T cell lymphoma.”
FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States.

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024

Retrieved on:

Saturday, January 13, 2024

EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.

Key Points:

EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.
A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine…, Ongoing referralsProcedureStatusUpdateHydroxyprogesterone-containing medicinal products – Article-31 referralUnder evaluationPRAC continued its assessment

Cyclacel Pharmaceuticals Reports Fadraciclib Phase 1 Data Suggesting Efficacy Against Tumors With CDKN2A, CDKN2B and MTAP Deletions

Retrieved on:

Monday, December 18, 2023

Patient, Immunotherapy, NGS, Neoplasm, PR, CDKN2B, CDK2, Histology, Glioma, DLT, CYCC, Lung, CDK9, PLK1, Metformin, Half-life, Melanoma, Hyperglycemia, Blood, Cyclacel, Cancer, Endometrial cancer, T-cell lymphoma, Mesothelioma, Head, Laboratory, Pancreatic cancer, MTAP, Biomarker, Tablet, Lymphoma, NSCLC, Deletion, PRMT5, Neck

BERKELEY HEIGHTS, N.J., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today interim results from its Phase 1, dose escalation 065-101 study of fadraciclib (“fadra”) in patients with advanced solid tumors and lymphoma.

Key Points:

“The data suggest tumor sensitivity in patients with one or more of three abnormalities, CDKN2A, CDKN2B and/or MTAP deletion subject to confirmation in further studies.
The Phase 2 part of 065-101 is designed to evaluate fadra safety and efficacy in cohorts defined by histology and/or next generation sequencing (NGS).
“After retrospectively analyzing a subset of previously treated Phase 1 patients who experienced clinical benefit with fadra, we found four patients with CDKN2A, CDKN2B and/or MTAP deletions.
CDKN2B deletions occur in over 30% of several solid tumors, including bladder, glioma, pancreatic, esophageal, lung (incl.