Fast track (FDA)

Bio-Path Holdings Provides 2024 Clinical and Operational Update

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화요일, 4월 2, 2024
Toxicity, Obesity, Drug discovery, Chronic lymphocytic leukemia, Survival, CLL, AML, Fast track (FDA), Insulin, Patient, New York Medical College, Biomarker, Cancer, Leukemia, IND, University, Lymphoma, Pancreatic cancer, Clinical trial, Paclitaxel, Potential, Breast cancer, Safety, RNA interference, GRB2, Holding, Leptin, Probability, FDA, STAT3, Stage 4, Food, Pharmaceutical industry

HOUSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides a clinical development and operational update for 2024.

Key Points: 
  • HOUSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides a clinical development and operational update for 2024.
  • Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients.
  • Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing.
  • In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial.

Genelux Corporation Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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월요일, 4월 1, 2024
Research, Lung cancer, Medical school, Shanghai Jiao Tong University, Carcinoma, Fast track (FDA), Form, Patient, G&A, School, IPO, Hope, Security (finance), Guggenheim Partners, Investment, Platinum, Interim, Genelux Corporation, FDA, Pharmaceutical industry

WESTLAKE VILLAGE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2023 financial results and business updates.

Key Points: 
  • – $23.2 million in cash, cash equivalents and short-term investments –
    WESTLAKE VILLAGE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2023 financial results and business updates.
  • Currently, 21 sites have been activated to enroll patients with additional sites identified and in various stages of activation ( NCT05281471 ).
  • Genelux and our partner Newsoara co-sponsor the trial, which is being conducted by Newsoara in greater China.
  • Cash, cash equivalents and short-term investments were $23.2 million as of December 31, 2023 compared to $0.4 million on December 31, 2022.

Candel Therapeutics Announces Oral Presentation During the 5th Glioblastoma Drug Development Summit with Update on Phase 1b Clinical Trial of CAN-3110 in Recurrent High-Grade Glioma

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목요일, 3월 28, 2024
SOC, Survival, Fast track (FDA), Safety, Patient, Food and Drug Administration, Standard of care, Doctor of Philosophy, MD, Clinical trial, Therapy, Injection, FDA, Drug development, CADL, Food, Serology, Pharmaceutical industry

“Dosing patients with multiple injections represents the next step forward in the development of CAN-3110 for rHGG,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “The observed data suggest that repeated injections of CAN-3110 are well tolerated, supporting the design of a future phase 2 clinical trial in this indication. We’re excited by our recent progress -- as illustrated by the publication in Nature, CAN-3110’s recent FDA Fast Track designation, and the collaboration with Batavia Biosciences -- to accelerate the development and production of CAN-3110, along with our update presented today. Together, we hope this will help to accelerate the development of a better treatment for patients with high unmet need.”

Key Points: 
  • The first cohort of patients were treated with multiple injections of CAN-3110 in the ongoing phase 1b clinical trial.
  • A second cohort is being planned for enrollment in the ongoing phase 1b clinical trial of CAN-3110.
  • The data were presented today during the 5th Glioblastoma Drug Development Summit in Boston, Massachusetts.
  • Results from the ongoing phase 1b clinical trial were published in Nature in Q4 2023.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

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목요일, 3월 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

Candel Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Highlights

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목요일, 3월 28, 2024
OS, Lung cancer, Research, Administration, Conference, Development, Prostate cancer, Survival, Immunotherapy, Fast track (FDA), HGG, Patient, Brain, Standard of care, MD, Society, Insurance, Pancreatic cancer, Clinical trial, Therapy, Breast cancer, SITC, FDA, CADL, Pharmaceutical industry

Research and Development Expenses: Research and development expenses were $7.3 million for the fourth quarter of 2023 compared to $5.0 million for the fourth quarter of 2022, and $24.5 million for the full year 2023 compared to $20.8 million for the full year 2022.

Key Points: 
  • Research and Development Expenses: Research and development expenses were $7.3 million for the fourth quarter of 2023 compared to $5.0 million for the fourth quarter of 2022, and $24.5 million for the full year 2023 compared to $20.8 million for the full year 2022.
  • General and Administrative Expenses: General and administrative expenses were $3.1 million for the fourth quarter of 2023 compared to $3.2 million for the fourth quarter of 2022, and $13.9 million for the full year 2023 compared to $14.1 million for the full year 2022.
  • The change from net other income in the fourth quarter of 2022 to net other expense in the fourth quarter of 2023 was primarily related to the change in the fair value of the Company’s warrant liability.
  • Cash Position: Cash and cash equivalents as of December 31, 2023 were $35.4 million, as compared to $70.1 million as of December 31, 2022.

Tenaya Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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월요일, 3월 18, 2024
PKP2, Biopsy, ARV, Administration, Fast track (FDA), Gene editing, Patient, SAN, CGMP, BlackRock, HDAC6, Column, G&A, IND, Research and development, Clinical trial, HCM, Investment, Therapy, Antibody, MYBPC3, Safety, FDA, ARVC, Heart failure, LP, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • “Tenaya had a successful year of sustained execution in 2023 that meaningfully advanced our portfolio of genetic medicines for heart disease.
  • Research & Development (R&D) Expenses: R&D expenses were $22.9 million for the fourth quarter and $98.0 million for the full year ended December 31, 2023.
  • General & Administrative (G&A) Expenses: G&A expenses were $8.6 million for the fourth quarter and $33.2 million for the full year ended December 31, 2023.
  • Net Loss: Net loss was $29.9 million, or $0.40 per share for the fourth quarter ended December 31, 2023.

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

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수요일, 3월 13, 2024
Neurology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Fast track (FDA), Psoriasis, Cell, Disease, Risk, Patient, Megakaryocyte, Immunoglobulin G, ITP, B cell, Quality of life, Platelet, Autoantibody, Gastrointestinal tract, CD38, Bleeding, Safety, Dravet syndrome, Blood, Lennox–Gastaut syndrome, Fatigue, Fiscal, Food, Autoimmune disease, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).
  • An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results.
  • Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.
  • Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

Genprex Receives Notice of Patent Grant for Korean Patent Claiming Reqorsa® Immunogene Therapy with PD-1 and PD-L1 Antibodies to Treat Cancers

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화요일, 3월 12, 2024
Toxicity, NSCLC, Genentech, Disease, Fast track (FDA), Diabetes, Patient, Merck, Pembrolizumab, Cancer, Senior, Clinical trial, Intellectual property, Patent, PD-L1, FDA, PD-1, Pharmaceutical industry

AUSTIN, Texas, March 12, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the Korean Patent Office has issued a Notice of Patent Grant for a broad patent that covers the use of Genprex's lead drug candidate, Reqorsa® Immunogene Therapy, in combination with anti-PD-1 and PD-L1 antibodies through 2037.

Key Points: 
  • These patents are applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials.
  • Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study in the second half of 2024.
  • The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion.
  • Genprex was granted FDA Fast Track Designation and Orphan Drug Designation for the Acclaim-3 patient population.

PRISM MarketView Highlights Work of Emerging Companies on Rare Disease Day

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목요일, 2월 29, 2024
Rare disease, Therapy, Regenerative Medicine Advanced Therapy, FAP, Concha bullosa, Sulindac, Chemistry, Fast track (FDA), Muscular dystrophy, FDA, Sensation, News, Eflornithine, DMD, Prader–Willi syndrome, BLA, Chromosome, RDEB, PDUFA, Skin, Voyager, PRISM, Duchenne muscular dystrophy, Safety, Neurocrine Biosciences, Rare Disease Day, Genetics, Fatigue, Walking, PWS, Patient, DSM-IV codes, Medicine, Disease, Exosome, FA, CMC, Priority review, Pharmaceutical industry

All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders.

Key Points: 
  • All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders.
  • Today on Rare Disease Day, PRISM MarketView highlights emerging companies working to deliver life changing treatments for those living with rare diseases.
  • RDEB is a severe rare disease characterized by extremely fragile, and extensive blistering and wounds.
  • Capricor is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases.

Imugene Highlights Recent Achievements and Looks Ahead to Key Upcoming Immuno-oncology Catalysts

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목요일, 2월 22, 2024
Allotransplantation, Skin cancer, Cholangiocarcinoma, Fast track (FDA), NHL, Melanoma, FDA, Pembrolizumab, CD19, Rupture, Lung, Epidemiology, Breast, Safety, Neoplasm, ASX, Bone marrow, Patient, RECIST, MAST, National library, IMU, Blinatumomab, DLBCL, Cancer, BTC, Vaccine

Imugene Managing Director & CEO Leslie Chong said: “We are encouraged by the initial safety and efficacy signals seen to date.

Key Points: 
  • Imugene Managing Director & CEO Leslie Chong said: “We are encouraged by the initial safety and efficacy signals seen to date.
  • Notably, in our Phase 1 MAST CF33 oncolytic virus trial, we’ve seen encouraging response rates during dose escalation, including one complete response in a patient with cholangiocarcinoma, and two partial responses in melanoma as we continue to dose escalate with no safety issues.
  • Importantly, two out of three of these responses were achieved with CF33 monotherapy.
  • onCARlytics uses an antigen/target-armed CF33, followed by treatment with a CD19 targeting therapy directed against that antigen or target.