Acute leukemia

Terns Pharmaceuticals Announces Orphan Drug Designation Granted to TERN-701 for the Treatment of Chronic Myeloid Leukemia

Retrieved on: 
Monday, March 11, 2024
BCR-ABL, MD, Obesity, FDA, Food, Acute leukemia, Safety, Leukemia, CML, TKI, Pharmaceutical industry

FOSTER CITY, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of chronic myeloid leukemia (CML).

Key Points: 
  • FOSTER CITY, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of chronic myeloid leukemia (CML).
  • “CML is a serious leukemia that requires chronic, life-long treatment,” said Emil Kuriakose, MD, chief medical officer of Terns.
  • Orphan drug designation for TERN-701 underscores the FDA’s recognition of the unmet need for people living with CML and Terns’ commitment to developing new treatment options.”
    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.
  • Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

FibroGen Appoints Deyaa Adib, M.D. as Chief Medical Officer

Retrieved on: 
Monday, March 11, 2024
Therapy, Breast cancer, SAN, Pharmacology, ARIAD Pharmaceuticals, Biotechnology, Baxalta, Bone marrow, Drug development, Prostate, Acute leukemia, Acting, Stomach, Sanofi, Oxaliplatin, Astellas Pharma, Patient, Oncology, Qasr El Eyni Hospital, Stromal cell, Pancreatic cancer, IND, Head, Colorectal cancer, Cancer, Prostate cancer, Medical imaging

SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities.

Key Points: 
  • SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities.
  • “Deyaa’s leadership and expertise in oncology research and clinical development, particularly in bringing oncology therapeutics to market, will be key to accelerating our oncology pipeline and bringing novel cancer therapies to patients in need,” said Thane Wettig, Chief Executive Officer of FibroGen.
  • “We will benefit immensely from Deyaa’s broad and deep experience in oncology drug development, including his experiences in both pancreatic and prostate cancers.”
    “I am excited to join FibroGen and lead the clinical development organization at this important time for our company,” commented Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
  • Prior to joining FibroGen, he was the Chief Medical Officer of Triumvira Immunologics Inc. where he led the transition of two novel cell therapy programs into clinical development.

GeoVax Reports 2023 Year-End Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024
Research, Smallpox, GeoVax, Matrix (biology), Neoplasm, Vaccine, Virus-like particle, ABL, COVID-19, Biotechnology, NIH, Hospital, Security (finance), Congress, Immunity, CGMP, DNA, Therapy, Pfizer, Acute leukemia, AACR, MUC-1, Conference, Vaccination, Safety, Chronic lymphocytic leukemia, Antigen, Patent, Clinical trial, Infection, MVA, SARS-CoV-2, Messenger, Cancer, CLL, Immunodeficiency, Risk, VP40, Death, Patient, HIV, Travel

ATLANTA, GA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.

Key Points: 
  • ET
    ATLANTA, GA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.
  • Results to date have demonstrated safety of this therapy and consistent reduction in treated tumors.
  • Cash Position: GeoVax reported cash balances of $6.5 million on December 31, 2023, as compared to $27.6 on December 31, 2022.
  • ET today, February 29, 2024, to review financial results and provide an update on corporate developments.

TScan Therapeutics Presents Promising Updated Phase 1 Clinical Results on TSC-100 and TSC-101 at the 2024 Tandem Meetings of ASTCT and CIBMTR

Retrieved on: 
Monday, February 26, 2024
AML, ALL, Chimera, Syndrome, HCT, Quality of life, Safety, Society, MDS, Therapy, Immunosuppression, Patient, Acute leukemia, MRD, TCR, Transplant, Acute myeloid leukemia, KOL, DNA, Cancer, Medical device

“We are excited to report updated data from our heme program, with eight patients across our treatment arms and six patients in our control arm.

Key Points: 
  • “We are excited to report updated data from our heme program, with eight patients across our treatment arms and six patients in our control arm.
  • We remain encouraged to see that no relapses have occurred to date in treated patients, four of whom have been on the study for over ten months.
  • Unfortunately, roughly 40% of patients relapse following HCT, at which point there are limited treatment options and a poor prognosis.
  • A replay will be made available on the “ Events and Presentations ” section of the Company’s investor relations website at ir.tscan.com .

City of Hope Research Featuring the Successful Treatment of the Oldest Patient to Achieve Remission for Leukemia and HIV Published in The New England Journal of Medicine (NEJM)

Retrieved on: 
Wednesday, February 14, 2024
Oncology, AIDS, Health, Infectious Diseases, Hospitals, Research, Science, Infection, Bone marrow, Cancer, Division, Immune system, Multimedia, Syndrome, Graft-versus-host disease, Acute leukemia, Blood, CCR5, Haematopoietic system, Transplant, Government, BMT, National Cancer Institute, Laboratory, B cell, Gene therapy, Medicare, Patient, Mutation, HIV, Dentistry

View the full release here: https://www.businesswire.com/news/home/20240214747351/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240214747351/en/
    "City of Hope Patient" Paul Edmonds with City of Hope doctors, Jana K. Dickter, M.D., and Monzr Al Malki, M.D.
  • Edmonds is also the person who had HIV the longest — for over 31 years — among these five patients.
  • Known as the “City of Hope patient” among these five patients, Edmonds received a transplant at City of Hope on Feb. 6, 2019, and is now considered to be cured of leukemia.
  • City of Hope has exceptional transplant outcomes year after year, according to the Center for International Blood & Marrow Transplant Research.

TScan Therapeutics to Host Virtual KOL Event to Discuss Updated Results from Phase 1 Heme Malignancies Study Presented at the 2024 Tandem Meetings of ASTCT and CIBMTR

Retrieved on: 
Wednesday, February 14, 2024
Translational medicine, Senior, AML, ALL, Medicine, Syndrome, HCT, Risk, Society, MDS, Therapy, Patient, Acute leukemia, TCR, Transplant, Acute myeloid leukemia, KOL, Cancer

WALTHAM, Mass., Feb. 14, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the Company will host a virtual key opinion leader (KOL) event to discuss updated results from its Phase 1 heme malignancies study and highlights from its oral presentation at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®) on Monday, February 26, 2024, at 8:00 a.m. ET.

Key Points: 
  • ET.
  • The event will provide an in-depth review of the oral presentation related to TScan’s ongoing Phase 1 multi-arm clinical trial evaluating TSC-100 and TSC-101, which are designed to treat residual disease and prevent relapse following hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL) ( NCT05473910 ).
  • The Company will also discuss the potential implications of initial data from a large prospective clinical trial assessing the relationship between donor chimerism and risk of relapse.
  • Shrikanta Chattopadhyay, M.D., M.M.Sc., Senior Vice President of Medical and Translational Medicine, TScan Therapeutics

FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July 2024

Retrieved on: 
Monday, February 12, 2024
Oncology, Health, FDA, Other Science, Science, Pharmaceutical, Biotechnology, Dasatinib, CRL, Food, Acute leukemia, PDUFA, Bristol Myers Squibb, BMS, Symantec Endpoint Protection, Patent, Patient, PKI, NDA, CML, Cancer, Pharmaceutical industry

The FDA has now assigned a Prescription Drug User Fee Act (PDUFA) date to 31st of July, 2024.

Key Points: 
  • The FDA has now assigned a Prescription Drug User Fee Act (PDUFA) date to 31st of July, 2024.
  • This is the FDA’s deadline for completing the approval process, marking a significant milestone for Dasynoc®, Xspray’s innovative protein kinase inhibitor (PKI) product candidate for CML treatment.
  • With an established PDUFA date set to 31st of July, Xspray Pharma continues to strategically plan for the commercial launch of Dasynoc® on September 1, 2024.
  • As the PDUFA date approaches, the company remains focused on its goal to improve the lives of those affected by CML with this novel therapy.

BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs  

Retrieved on: 
Thursday, February 8, 2024
Acute leukemia, Therapy, BNTX, Patient, BioNTech, Entrepreneurship, CLDN6, American depositary receipt, Cooley LLP, Cancer, LLP, Pharmaceutical industry

In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

Key Points: 
  • In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.
  • “The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way.
  • "Furthermore, this collaboration grants us access to Autolus' precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates."
  • “We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies,” said Dr. Christian Itin, Chief Executive Officer of Autolus.

BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs 

Retrieved on: 
Thursday, February 8, 2024
Acute leukemia, Therapy, BNTX, Patient, BioNTech, Entrepreneurship, CLDN6, American depositary receipt, Cancer, Pharmaceutical industry

In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

Key Points: 
  • In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.
  • “The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way.
  • “Furthermore, this collaboration grants us access to Autolus' precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates."
  • “We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies,” said Dr. Christian Itin, CEO of Autolus.

Exscientia Initiates Clinical Study to Further Evaluate Functional Precision Medicine Platform in Cancer Patients

Retrieved on: 
Wednesday, February 7, 2024
Oncology, Health, Technology, Clinical Trials, Artificial Intelligence, Pharmaceutical, Biotechnology, Personalized medicine, Bone marrow, Acute leukemia, EVP, Patient, Ovarian cancer, AML, Blood, Deep learning, Medicine, Pharmaceutical industry

The EXCYTE-2 study will collect blood and bone marrow samples from first-line patients with AML, with an option to expand to second-line patients.

Key Points: 
  • The EXCYTE-2 study will collect blood and bone marrow samples from first-line patients with AML, with an option to expand to second-line patients.
  • The EXCYTE-2 study builds on other previously initiated precision medicine focused studies, including EXALT-1 and EXCYTE-1.
  • EXCYTE-2 will leverage the progress the company has made on its AI-driven precision medicine platform since the EXALT-1 trial was completed and will specifically evaluate earlier stage patient populations.
  • “A robust correlation between our platform’s results and clinical outcomes has the potential to change clinical practice for the benefit of AML patients.”