IND

Wave Life Sciences Announces Continued Momentum in GSK Collaboration and Advancements in siRNA and RNA Editing

Retrieved on: 
星期二, 四月 23, 2024
Sequence, Small RNA, RNA editing, Potency, Durability, Health, ...Continued, RNA, MD, Doctor of Philosophy, Weight loss, IND, CNS, Obesity, Oligonucleotide, GSK, Patient, Medicinal chemistry, MBA, Liu Wei, Clinical trial, Pharmaceutical industry

CAMBRIDGE, Mass., April 23, 2024 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today provided an update on its best-in-class small interfering RNA (siRNA) and RNA editing platform capabilities.

Key Points: 
  • As part of Wave’s ongoing collaboration with GSK, GSK has selected its first two programs to advance to development candidates following achievement of target validation.
  • GSK will provide an aggregate initiation payment of $12 million to Wave for these two oligonucleotide programs.
  • Under the agreement, GSK can advance up to eight programs leveraging Wave’s PRISM™ platform and multiple RNA-targeting modalities (RNA editing, splicing, siRNA, and antisense) with target validation work ongoing across multiple therapy areas.
  • Beyond these programs, our collaboration is focusing on all Wave modalities, including RNA editing.

Silo Pharma Announces Positive Results for Intranasal PTSD Treatment

Retrieved on: 
星期二, 四月 23, 2024
FDA, Post-traumatic stress disorder, Administration, PTSD, IND, SILO, Therapy, Tmax, GLP, PIND, Anxiety, Absorption, Investigational New Drug, Pharmaceutical industry

SARASOTA, FL, April 23, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced positive data in the final validation report from the recent pharmacokinetic (PK) study

Key Points: 
  • SARASOTA, FL, April 23, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced positive data in the final validation report from the recent pharmacokinetic (PK) study
    of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD).
  • The PK study was conducted as part of non-GLP small animal dose-ranging study of SPC-15 completed in February 2024.
  • Time to peak drug concentration (Tmax) occurred between 0.5 and 2 hours following intranasal administration compared to 2 hours following oral gavage administration.
  • Silo CEO Eric Weisblum commented, “Our evaluation of the PK profile for SPC-15 indicates effective and consistent exposure from intranasal administration of the drug.

OncoC4 Announces FDA Clearance of IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors

Retrieved on: 
星期二, 四月 23, 2024
Cancer, Cell, Safety, Pharmacokinetics, Tumor microenvironment, Doctor of Philosophy, IND, Knowledge, Entrepreneurship, ADCC, Phagocytosis, Macrophage, CSO, CD16, NK, SIGLEC, TME

“SIGLEC 10 is an immune checkpoint that inhibits the activation of both innate and adaptive immune cells.

Key Points: 
  • “SIGLEC 10 is an immune checkpoint that inhibits the activation of both innate and adaptive immune cells.
  • “ONC-841 is designed to block this immune checkpoint to rejuvenate immune cell activity for tumor destruction within the TME.
  • Preclinical studies supporting the IND application demonstrated ONC-841 increased the phagocytosis of cancer cells and improved the function of tumor-infiltrating T cells.
  • Additional in vivo syngeneic and xenograft tumor models showed enhanced immune rejection of tumor cells following treatment with ONC-841.

Artelo Biosciences Announces Publication of Peer-Reviewed Article Highlighting FABP7 as a Promising Novel Target in Cancer Therapy

Retrieved on: 
星期二, 四月 23, 2024
Pain, FDA, Brain, Cancer, Food, Prognosis, Survival, Breast, Research, FABP5, Transport, Dicarboxylic acid, IND, Drug discovery, Patient, Metabolism, Neuropathic pain, FABP, FABP7, Chemotherapy-induced peripheral neuropathy, Pharmaceutical industry

Additionally, the evidence shows that both genetic and pharmacological inhibition of FABP7 led to reduced tumor cell growth, migration, and invasion in multiple studies.

Key Points: 
  • Additionally, the evidence shows that both genetic and pharmacological inhibition of FABP7 led to reduced tumor cell growth, migration, and invasion in multiple studies.
  • Moreover, inhibition of FABP7 improved host survival rates, particularly in brain cancers, indicating its role as a novel target in cancer.
  • In preclinical studies, ART26.12 demonstrated positive results in cancer, cancer bone pain, and painful neuropathies such as chemotherapy-induced peripheral neuropathy (CIPN).
  • For more information about Artelo Biosciences and our commitment to innovative therapies, please visit our website at www.artelobio.com

Cidara Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
星期一, 四月 22, 2024
CD73, Research, IND, Form, IO, AACR, Fungemia, Immunotherapy, Congress, Annual report, ESMO, Janssen, Tax, DFC, Therapy, SAN, Tavarua, Safety, Annual general meeting, SITC, Collaboration, Caspofungin, Society, Workplace, European, The San Diego Union-Tribune, CDTX, Patient, Bank statement, Pharmaceutical industry

“2023 included significant accomplishments throughout our business within both our Cloudbreak® drug-Fc conjugate (DFC) and our REZZAYO® (rezafungin) programs,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.

Key Points: 
  • “2023 included significant accomplishments throughout our business within both our Cloudbreak® drug-Fc conjugate (DFC) and our REZZAYO® (rezafungin) programs,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
  • Presented at IDWeek 2023: In October 2023, Cidara presented new preclinical and clinical data on Novel Cloudbreak Influenza Drug-Fc Conjugate CD388 at IDWeek 2023.
  • Net loss for the three months ended December 31, 2023 was $3.2 million, compared to a net loss of $13.6 million for the three months ended December 31, 2022.
  • Net loss for the full year ended December 31, 2023 was $22.9 million, compared to a net loss of $33.6 million for the year ended December 31, 2022.

Lexeo Therapeutics Announces License Agreement to Accelerate Development of LX2006 for the Treatment of Friedreich Ataxia Cardiomyopathy

Retrieved on: 
星期一, 四月 22, 2024
FDA, Weill Cornell Medicine, Patient, Fast Track, Phenotype, Death, Cardiomyopathy, Research, Natural history, IND, Cornell University, Senior, Friedreich's ataxia, Cardiovascular disease, Therapy, Orphan drug, Pharmaceutical industry

NEW YORK, April 22, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company, today announced an in-license agreement with Cornell University to expedite development of the investigational gene therapy candidate LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy.

Key Points: 
  • Under the license agreement, Lexeo has acquired certain rights1 including rights to current and future data generated in an ongoing investigator-initiated Phase 1A trial of AAVrh.10hFXN to treat FA cardiomyopathy ( NCT05302271 ).
  • The agreement will support Lexeo’s efforts to develop a potentially life-changing therapy for this unmet need.
  • Lexeo previously licensed know-how relating to AAVrh.10hFXN from Weill Cornell Medicine and collaborated with researchers there to further study the candidate, which Lexeo refers to as LX2006.
  • “This agreement with Lexeo Therapeutics builds upon years of collaboration between Weill Cornell Medicine and Lexeo to benefit patients with FA cardiomyopathy.

Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024

Retrieved on: 
星期一, 四月 22, 2024
Volunteering, FDA, Safety, Pharmacokinetics, Sleep, Food, CNTA, MWT, NT2, Idiopathic hypersomnia, IND, IH, SAD, POC, Patient, Narcolepsy, NT1, OX2R, Clinical trial, PD, Investigational New Drug, KSS, Pharmaceutical industry

The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects.

Key Points: 
  • The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects.
  • The Company expects to commence dosing of the Phase 1 study in healthy volunteers imminently, and proof-of-concept data are anticipated in the second half of 2024.
  • “We are excited to begin executing what we believe is an elegant, adaptive Phase 1 study aimed at generating early proof-of-concept data for ORX750 in acutely sleep-deprived healthy volunteers in the second half of this year.
  • We expect this study to enable dose selection for planned studies evaluating ORX750 in patients with NT1 and in patient populations with normal orexin levels, including NT2 and IH.”

IMUNON’s IND Application Cleared to Begin Human Testing of IMNN-101

Retrieved on: 
星期四, 四月 18, 2024
FDA, Drug discovery, Safety, SARS-CoV-2, Food, Infection, Vaccine, IND, DNA, Messenger, COVID-19

LAWRENCEVILLE, N.J., April 18, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces receipt of clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial with a seasonal COVID-19 booster vaccine. The company filed an Investigational New Drug (IND) application for IMNN-101 in late February, and pending resolution of limited comments from the FDA, expects to commence patient enrollment in the second quarter of 2024.

Key Points: 
  • The company filed an Investigational New Drug (IND) application for IMNN-101 in late February, and pending resolution of limited comments from the FDA, expects to commence patient enrollment in the second quarter of 2024.
  • Secondary objectives of the study include evaluating the ability of the IMNN-101 vaccine to elicit binding antibodies and cellular responses and their associated durability.
  • Based on reported preclinical data, durability of immune protection is expected to be superior to published mRNA vaccine data.
  • PlaCCine vaccines have advantages in T-cell responses, safety, compliance and manufacturing flexibility compared with viral or other DNA or protein vaccines.

Chemomab Reports New Peer-Reviewed Publication Reinforcing the Clinical Association of Its CCL24 Target with Disease Severity and Mortality in Patients with Systemic Sclerosis

Retrieved on: 
星期四, 四月 18, 2024
Mortality, University, Fibrosis, University of Leeds, TEL, Systemic scleroderma, Synovitis, Nature, Skin, CMMB, Primary sclerosing cholangitis, Prognosis, Communication, Serum, Vascular disease, Physiology, Doctor of Philosophy, Calcinosis, Rheumatology, History, ILD, IND, PSC, Disease, Therapy, Risk, Patient, CSO, Scleroderma, Lung, Clinical trial, CCL24, Pharmaceutical industry

TEL AVIV, Israel, April 18, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics to treat rare fibro-inflammatory diseases with high unmet need, today announced the publication of a new study that further confirms the key role of its novel soluble protein target CCL24 in systemic sclerosis (SSc). The study, “Serum CCL24 as a Biomarker of Fibrotic and Vascular Disease Severity in Systemic Sclerosis,” was published in the current edition of the journal Arthritis Care and Research.1

Key Points: 
  • It explored the relationship between serum CCL24 levels and SSc severity and prognosis.
  • One in four patients in a real-life SSc population was found to have a high CCL24 serum concentration, despite standard of care treatment with immunosuppressive therapy.
  • The analysis found that higher CCL24 levels were linked to critical clinical variables associated with the most severe forms of SSc.
  • Crucially, high serum CCL24 was predictive of lung deterioration and a higher baseline CCL24 level was associated with higher 10-year SSc-related mortality.

Derm-Biome Pharmaceuticals’ topical therapy shows positive results in preclinical skin cancer trial: drug prevents the development of precancerous skin conditions and treats existing skin cancers with no observable side effects. 

Retrieved on: 
星期三, 四月 17, 2024
University, Radiation, BC Cancer Agency, Mouse, Cell, Carcinoma, Skin, Aks, UVB, Topical medication, University of British Columbia, IND, Patient, BC Cancer Research Centre, Neoplasm, Toxicity, Medication, Pharmaceutical industry

VANCOUVER, British Columbia, April 17, 2024 (GLOBE NEWSWIRE) -- The rates of precancerous skin conditions and skin cancers are soaring in many parts of the world.

Key Points: 
  • VANCOUVER, British Columbia, April 17, 2024 (GLOBE NEWSWIRE) -- The rates of precancerous skin conditions and skin cancers are soaring in many parts of the world.
  • Treating AKs before the cells become cancerous and spread to other parts of the body is crucial.
  • For those patients with multiple AKs, common treatment options are chemotherapy creams and photodynamic therapy.
  • There is a real need for safer and more targeted topical therapies.”
    Derm-Biome expects to start topical formulation development this summer, with IND-enabling studies slated to begin in Q4.