Inflammation

HCW Biologics Reports Third Quarter 2023 Financial Results And Recent Business Highlights

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Tuesday, November 14, 2023
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MIRAMAR, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2023.

Key Points: 
  • MIRAMAR, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2023.
  • We are pleased to see the consistency of results in humans with those that we saw in our preclinical animal studies.
  • Third Quarter 2023 Financial Results:
    Revenues: Revenues for the quarter ended September 30, 2022 and 2023 were $1.8 million and $853,102, respectively.
  • Revenues for the nine months ended September 30, 2022 and 2023 were $5.4 million and $1.5 million, respectively.

Progress on GeoVax’s Universal Coronavirus Vaccine Candidate, GEO-CM02, Presented at Vaccines Summit 2023

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Tuesday, November 14, 2023
Pfizer, Antigen, Associate professor, Immune system, GeoVax, Animal, Immunodeficiency, Biotechnology, Protein, Capsid, MVA, Georgia State University, Patient, Vaccine, Immunization, Dihydrolipoyllysine-residue (2-methylpropanoyl)transferase, Infection, Messenger, COVID-19, Monoclonal antibody, Chronic lymphocytic leukemia, Death, Antibody, Alpha, Doctor of Philosophy, Protein structure, SARS-CoV-2, Cancer, CLL, Inflammation, Pharmaceutical industry, Moderna, Boston, Omicron

ATLANTA, GA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of preclinical vaccine efficacy data for GEO-CM02, a multi-antigen investigational SARS-CoV-2 vaccine. The data were presented during the Vaccines Summit 2023 conference, being held in Boston, MA on November 13-15, 2023. The presentation, titled “MVA-vectored multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models,” was delivered by Mukesh Kumar, PhD, Associate Professor, Department of Biology, Georgia State University.

Key Points: 
  • The data were presented during the Vaccines Summit 2023 conference, being held in Boston, MA on November 13-15, 2023.
  • To address this limitation, GeoVax is currently evaluating its dual antigen COVID-19 vaccine, GEO-CM04S1 in three Phase 2 clinical trials.
  • Data highlights from the Vaccine Summit 2023 presentation are as follows:
    The GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
  • As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine.

MoonLake Immunotherapeutics Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, November 14, 2023
IL-17A, Moonlake, Safety, MIRA, Psoriatic arthritis, Patient, Inflammation, Research, Calendar, HS, Conference, Antibody, Hidradenitis suppurativa, Skin, PASI, ARGO, Pharmaceutical industry, Security (finance), Vaccine

During the quarter and post period, MoonLake announced significant new positive clinical data from two global Phase 2 trials of sonelokimab: “MIRA”, in moderate-to-severe hidradenitis suppurativa (HS) and “ARGO”, in active psoriatic arthritis (PsA).

Key Points: 
  • During the quarter and post period, MoonLake announced significant new positive clinical data from two global Phase 2 trials of sonelokimab: “MIRA”, in moderate-to-severe hidradenitis suppurativa (HS) and “ARGO”, in active psoriatic arthritis (PsA).
  • The Nanobody’s® smaller size versus traditional antibodies and its albumin-binding domain provide an opportunity for further efficacy.
  • Research and development expenses for the quarter ended September 30, 2023, were $7.6 million, compared to $8.7 million in the previous quarter.
  • General and administrative expenses for the quarter ended September 30, 2023, were $5.4 million, compared to $4.5 million in the previous quarter.

Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update

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Monday, November 13, 2023
CNS, Acquisition, Mydriasis, Audit committee, Telecanthus, Visual acuity, CFO, Headache, Net, Patient, Presbyopia, Research, Element, Tropicamide, Lomb, Growth, Inflammation, Vomiting, Intraocular pressure, ACE, ADT Inc., American Academy, Abnormal psychology, New Drug Application, Nausea, Tachycardia, Mouth, Hypersensitivity, NDA, Allied health professions, International Joint Commission, Photophobia, Psychotic Reaction, Cholinergic, Pilocarpine, Pallor, Reader's Digest, Blood pressure, Bausch, Carbachol, Near-sightedness, Allergy, FDA, Contact, Central nervous system, PDUFA, Hypertonia, Pharmaceutical industry, Management, Nursing, Telescopic sight, Video game, Euronext, Ophthalmology

NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage, topical ophthalmic company leveraging its Optejet® dispensing technology for both internally developed and acquired programs as well as out-licensing for additional indications, today announced its financial and operating results for the third quarter ended September 30, 2023.

Key Points: 
  • Advanced its Gen-2 Optejet device and anticipates shipping to MicroPine partners Bausch and Lomb and Arctic Vision by year-end 2023.
  • Research and development expenses totaled approximately $3.6 million for the third quarter of 2023 as compared to $3.9 million for the third quarter of 2022.
  • For the third quarter of 2023, general and administrative expenses were approximately $2.9 million, compared to $3.4 million for the third quarter of 2022.
  • Total operating expenses for the third quarter of 2023 were approximately $6.5 million compared to $7.2 million for the third quarter of 2022.

Kymera Therapeutics Announces Publication of Phase 1 Trial Results for KT-474 (SAR444656), a First-in-Class IRAK4 Degrader, in Nature Medicine

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Monday, November 13, 2023
Safety, Therapy, SAD, Clinical trial, Sanofi, Fed, Patient, Inflammation, Pharmacokinetics, Atopic dermatitis, HS, Blood, Venereology, Biomarker, Hidradenitis suppurativa, Skin, Manuscript, TPD, Pharmaceutical industry, HV, IRAK4, Dermatology, Nature Medicine

WATERTOWN, Mass., Nov. 13, 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 announced that results from the positive Phase 1 clinical trial from its lead program, KT-474 (SAR444656), a potent, highly selective, orally bioavailable IRAK4 degrader, were published in Nature Medicine. The results showed a reduction of disease-relevant inflammatory biomarkers in the blood and skin of HS and AD patients associated with improvement in skin lesions and symptoms. The full manuscript, “IRAK4 degrader in hidradenitis suppurativa and atopic dermatitis: a phase 1 trial,” was published online on November 13, 2023, on the Nature Medicine website.

Key Points: 
  • The results showed a reduction of disease-relevant inflammatory biomarkers in the blood and skin of HS and AD patients associated with improvement in skin lesions and symptoms.
  • The full manuscript, “IRAK4 degrader in hidradenitis suppurativa and atopic dermatitis: a phase 1 trial,” was published online on November 13, 2023, on the Nature Medicine website.
  • The Company previously reported Phase 1 results in December 2022 and at the European Academy of Dermatology and Venereology Symposium in May 2023.
  • The publication also highlights preclinical data on KT-474, including the first publication of the compound’s chemical structure.

Annexon Reports Significant Progress with its Priority Programs and Third Quarter 2023 Financial Results

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Monday, November 13, 2023
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EMA orphan drug designation requires that a novel rare disease therapeutic demonstrates the potential for significant benefit over available therapies.

Key Points: 
  • EMA orphan drug designation requires that a novel rare disease therapeutic demonstrates the potential for significant benefit over available therapies.
  • Importantly, Annexon also announced that it has achieved target enrollment of 225 patients in the randomized, double-blind, placebo-controlled Phase 3 trial of ANX005 in patients with GBS.
  • Research and development (R&D) expenses: R&D expenses were $27.9 million for the quarter ended September 30, 2023, reflecting the advancement of the company’s priority programs, including GBS, GA and ANX1502, compared to $27.9 million for the quarter ended September 30, 2022.
  • General and administrative (G&A) expenses: G&A expenses were $6.9 million for the quarter ended September 30, 2023, compared to $8.2 million for the quarter ended September 30, 2022.

Omega Therapeutics Showcases Bidirectional and Multiplexed Epigenomic Control of Gene Expression in Preclinical Models of Liver Inflammation and Fibrosis

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Monday, November 13, 2023
Therapy, CXCL10, CXCL11, Cirrhosis, AASLD, ECS, Mouse, CXCL9, Liver, Gene expression, Messenger, Hepatocyte, FRG, Chemokine, Cell, Inflammation, Fibrosis, Vaccine, Boston

CAMBRIDGE, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, today announced the presentation of new preclinical data from two different programs that demonstrated sustained upregulation of gene expression and coordinated pre-transcriptional downregulation of multiple genes in models of liver fibrosis and inflammation, respectively, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® 2023, taking place in Boston, Massachusetts, November 10 – 14.

Key Points: 
  • However, to extend their reach, we need to bidirectionally control the expression of multiple genes simultaneously,” said Thomas McCauley, Ph.D., Chief Scientific Officer of Omega Therapeutics.
  • “We believe that these new data demonstrate the power of our programmable epigenomic mRNA development candidates to control gene expression with unmatched flexibility.
  • To our knowledge, these are the first results to show how site-specific epigenomic modulation can durably upregulate the expression of a master liver regeneration gene.
  • EC-mediated induction of HNF4α expression in vivo in a mouse model of liver fibrosis led to decreased collagen deposition, a key marker of fibrosis.

RAPT Therapeutics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
RAPT, Research, Therapy, SAN, Patient, Inflammation, Lung cancer, Atopic dermatitis, SITC, Nine Months, Asthma, Pharmaceutical industry, Clothing, Airline, Cryptocurrency

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today reported financial results for the third quarter and the nine months ended September 30, 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today reported financial results for the third quarter and the nine months ended September 30, 2023.
  • Our current cash balance remains strong and we expect it to support our planned operations through mid-2025.”
    Financial Results for the Third Quarter and the Nine Months Ended September 30, 2023
    Third Quarter Ended September 30, 2023
    Net loss for the third quarter of 2023 was $31.4 million, compared to $21.2 million for the third quarter of 2022.
  • Research and development expenses for the third quarter of 2023 were $27.0 million, compared to $16.6 million for the same period in 2022.
  • General and administrative expenses for the third quarter of 2023 were $6.9 million, compared to $5.1 million for the same period in 2022.

BioVie Presents Positive Clinical Safety Data from Phase 2b Trial of BIV201 in Refractory Ascites at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2023

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Monday, November 13, 2023
Hepatology, Cirrhosis, Safety, Randomness, Insulin resistance, Food, TIPS, Incidence, AASLD, Liver, Ascites, Abdomen, Hyponatremia, Patient, Confirmatory trial, Liver transplantation, Control, Survival rate, Inflammation, Liver support system, Terlipressin, Dementia, Standard of care, Acceleration, Orphan, SOC, Poster, Pharmaceutical industry, Medical imaging, Boston

CARSON CITY, Nev., Nov. 13, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced positive clinical safety data from the Company’s Phase 2b open-label study evaluating the efficacy and safety of BIV201, terlipressin administered as a continuous infusion, with standard of care (SOC) in patients with refractory ascites due to cirrhosis. The data will be highlighted today in a late-breaking poster presentation titled “Safety and Tolerability of Continuous Infusion Terlipressin (BIV201) In Patients with Decompensated Cirrhosis and Refractory Ascites: A Phase 2, Randomized, Controlled, Open-Label Study” at The American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023 in Boston, MA.

Key Points: 
  • The incidence of treatment emergent adverse events (TEAEs), including serious TEAEs, was similar in both treatment groups.
  • Two patients who received BIV201 experienced hyponatremia that developed gradually, was asymptomatic, and was resolved upon discontinuation of the study drug.
  • Primary endpoints were safety and tolerability, and incidence of certain complications (Grade ≥2) during the 180 days following randomization.
  • BIV201, a continuous infusion of terlipressin, received Orphan Drug Designation for treatment of ascites from the U.S. Food and Drug Administration in 2017.

Enterome to Present Updated Data From Phase 1/2 ROSALIE Trial of its Peptide-Based Immunotherapy EO2401 in Recurrent Glioblastoma at SNO 2023

Retrieved on: 
Monday, November 13, 2023
Dana–Farber Cancer Institute, Bevacizumab, Glioblastoma, Patient, Inflammation, Pakistan Society of Neuro-Oncology, Neuro-Oncology (journal), Harvard Medical School, Nivolumab, Immunotherapy, Society, SNO, Official Journal, Pharmaceutical industry, Medicine

PARIS, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced it will present updated efficacy data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (the EOGBM1-18/ROSALIE study), in an oral presentation at the Society for Neuro-Oncology (SNO) 28th Annual Meeting which will be held in Vancouver, British Columbia, Canada on November 15-19, 2023.

Key Points: 
  • PARIS, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced it will present updated efficacy data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (the EOGBM1-18/ROSALIE study), in an oral presentation at the Society for Neuro-Oncology (SNO) 28th Annual Meeting which will be held in Vancouver, British Columbia, Canada on November 15-19, 2023.
  • Title: EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in first recurrent glioblastoma: the phase 1/2 EOGBM1-18/ROSALIE study (NCT04116658)
    Presenting Author: Prof. David Reardon, M.D., Professor of Medicine at Harvard Medical School, and Clinical Director for Dana Farber Cancer Institute
    Link to abstract published in a supplement to Neuro-Oncology, the Official Journal of the Society for Neuro-Oncology, can be found here .
  • The slides from the oral presentation will be available on Enterome’s website after the Meeting.