NIAID

Ocugen Provides Business Update with Certain Financials for the Year Ending 2023

Retrieved on: 
Tuesday, April 2, 2024
Stargardt disease, Disease, Safety, Webcast, Inflammation, Patient, CGMP, Data, Inhalation, Cohort, RP, Life, Bank statement, Investment, Clinical trial, NIAID, Injection, AMD, Vaccine, Nextgen, Geographic atrophy, RHO, FDA, Lipid metabolism, Government, Oxidative stress, Pharmaceutical industry

Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively

Key Points: 
  • Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively
    MALVERN, Pa., April 02, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today provided a general business update with certain financials for the year ending 2023.
  • During the fourth quarter of 2023, the Company announced its mucosal vaccine candidate, OCU500, was chosen for the multi-billion-dollar NIAID Project NextGen initiative.
  • The first patient was dosed in the Phase 1/2 trials to assess the safety and efficacy of OCU410ST for Stargardt disease in November 2023.
  • Ocugen’s cash, cash equivalents, and investments totaled $39.5 million as of December 31, 2023, compared to $90.9 million as of December 31, 2022.

ReAlta Life Sciences Announces New Research Collaboration with the National Institute of Allergy and Infectious Diseases to Evaluate RLS-0071 as a Medical Countermeasure for Acute Radiation Syndrome

Retrieved on: 
Thursday, March 28, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Radiation, Acute radiation syndrome, Attack, ARS, Inflammation, Education, Chronic obstructive pulmonary disease, RNCP, USUHS, Virus, IND, European Medicines Agency, Outline of health sciences, Nausea, Accident, Hypoxia (medical), NIAID, Defense Threat Reduction Agency, AFRRI, HIE, Vaccine, Collection, Vomiting, Food, FDA, Defense, Infection, Peptide, Pharmaceutical industry

“We are very pleased to partner with NIAID and AFRRI to evaluate ReAlta’s lead drug candidate, RLS-0071, as a radiation countermeasure for GI-ARS,” says Dr. Ulrich Thienel, Chief Executive Officer of ReAlta.

Key Points: 
  • “We are very pleased to partner with NIAID and AFRRI to evaluate ReAlta’s lead drug candidate, RLS-0071, as a radiation countermeasure for GI-ARS,” says Dr. Ulrich Thienel, Chief Executive Officer of ReAlta.
  • AFRRI is unique and powerful radiobiological research institute, with six decades of active, robust, and outstanding support to the U.S. Department of Defense through research, reach-back, and education.
  • It is the only U. S. Department of Defense medical R&D facility dedicated solely to nuclear and radiological defense.
  • ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life threatening acute inflammatory and rare diseases.

Calico Appoints Michael Lenardo, M.D., as Chief Scientific Officer

Retrieved on: 
Thursday, March 28, 2024
Internal medicine, University, Natural science, Biomedicine, Alphabet, Calico (company), Immune system, SAN, Research, Science, Whitehead Institute, National academy, Biology, Biochemistry, Johns Hopkins University, NIAID, Most, Nobel, Bangladesh Technical Education Board, Birth, Biomedical Research, O.B.E, Infection, Ageing, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 28, 2024 /PRNewswire/ -- Calico Life Sciences LLC (Calico), a biotechnology organization focused on the biology of aging and age-related diseases, and founded by Alphabet and Arthur D. Levinson, Ph.D., today announced the appointment of Michael Lenardo, M.D., as its new Chief Scientific Officer.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 28, 2024 /PRNewswire/ -- Calico Life Sciences LLC (Calico), a biotechnology organization focused on the biology of aging and age-related diseases, and founded by Alphabet and Arthur D. Levinson, Ph.D., today announced the appointment of Michael Lenardo, M.D., as its new Chief Scientific Officer.
  • Dr. Lenardo is an accomplished molecular immunologist and geneticist whose medical research career spans four decades.
  • "Securing someone of Mike's caliber for the critical role of Chief Scientific Officer is a major achievement for Calico," said Dr. Levinson, CEO of Calico.
  • "The commitment to scientific excellence and integrity at Calico, coupled with the highly talented team, is truly impressive and reflected in the impactful progress they are making.

ACTG Presents Study at CROI Demonstrating Efficacy of Long-Acting Injectable Treatment Among People Who Had Previously Been Unable to Maintain Viral Suppression on Daily Oral Medication

Retrieved on: 
Wednesday, March 6, 2024
Infection, Chair, Bangladesh Technical Education Board, Mental health, Injection (medicine), University of Alabama, Rilpivirine, Fungal infection, NIAID, Arm, CROI, PWH, Quality of life, ACTG, Johnson & Johnson, Data monitoring committee, Conference, Health, University, ART, UM1, Male, DSMB, ViiV Healthcare, HIV, Failure, University of North Carolina, Vaccine

“ACTG is thrilled to present this ground-breaking study at CROI,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles.

Key Points: 
  • “ACTG is thrilled to present this ground-breaking study at CROI,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles.
  • Participants received incentives and support to adhere to their daily oral medication to first achieve viral suppression and if successful, they were randomized to either receive long-acting injectable treatment every four weeks or continue taking daily oral medication.
  • The long-acting injectable treatment was more effective than the daily oral medication at maintaining virologic suppression and avoiding treatment-related discontinuation.
  • Twenty-eight participants receiving the long-acting injectable treatment experienced regimen failure (defined as virologic failure or treatment discontinuation), compared to 47 receiving daily oral medication.

ACTG CROI Presentation Demonstrates Superiority of HepB-CpG Vaccine Over Conventional Hepatitis B Vaccine Among People Living With HIV Who Have Not Previously Responded to Vaccination

Retrieved on: 
Wednesday, March 6, 2024
Infection, Bangladesh Technical Education Board, CD4, Superior, Hepatitis B, Headache, CpG, Fungal infection, NIAID, CROI, ACTG, University of Cincinnati, Weill Cornell Medicine, Conference, Vaccination, University, ART, Fatigue, Virus, Myalgia, White, Black, Protocol, UM1, Massachusetts General Hospital, Male, Hepatitis, HIV, University of North Carolina, Vaccine

These data demonstrated that the HepB-CpG vaccine achieved up to 99 percent protection among people living with HIV who had previously not responded to conventional hepatitis B vaccines, a noteworthy increase compared to the protection achieved by conventional vaccines.

Key Points: 
  • These data demonstrated that the HepB-CpG vaccine achieved up to 99 percent protection among people living with HIV who had previously not responded to conventional hepatitis B vaccines, a noteworthy increase compared to the protection achieved by conventional vaccines.
  • People living with HIV, especially those with lower CD4 counts, often do not develop protective antibodies after receiving conventional hepatitis B vaccines.
  • The HepB-CpG (HEPLISAV-B®) vaccine includes a TLR-9 agonist adjuvant (CpG 1018® adjuvant) and is known to achieve high protection against hepatitis B among people living with HIV, but until now there have been limited data about its protection among people living with HIV who have not responded to conventional hepatitis B vaccines.
  • “Hepatitis B remains a significant issue for people living with HIV, as having both viruses increases the likelihood of liver complications,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles.

ACTG CROI Presentations Show That Semaglutide Improves Metabolic-Associated Steatotic Liver Disease Among People Living With HIV

Retrieved on: 
Tuesday, March 5, 2024
Infection, Liver, Bangladesh Technical Education Board, Metabolism, Woman, P.T, Fungal infection, NIAID, Prediabetes, CROI, Liver injury, Inflammation, Quality of life, ACTG, ALT, Weight loss, Waist, Weight, Organ dysfunction, University of Southern California, Conference, Health, Glucagon-like peptide-1 receptor, University, SLIM, ART, Triglyceride, BMI, UM1, Insulin resistance, HIV, Non-alcoholic fatty liver disease, Research, University of North Carolina, Dietary supplement

Yesterday, the SLIM LIVER poster “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER study” was presented.

Key Points: 
  • Yesterday, the SLIM LIVER poster “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER study” was presented.
  • Together, these presentations demonstrate that semaglutide was highly effective in improving, and in some cases, resolving completely, metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as non-alcoholic fatty liver disease) among people living with HIV.
  • SLIM LIVER is the first study evaluating semaglutide as a treatment for MASLD among people living with HIV.
  • MASLD is common among people living with HIV and likely acts synergistically with HIV to accelerate liver injury and organ dysfunction.

ACTG Presents Study at CROI Elucidating Mechanism of CMV on Aging-Related Pathways in HIV

Retrieved on: 
Monday, March 4, 2024
Infection, Chairperson, Bangladesh Technical Education Board, Diabetes, CMV, Metabolism, Merck, Cancer, Endothelial dysfunction, Fungal infection, NIAID, CROI, Inflammation, Blood, IL-6, Ageing, ACTG, Splenic infarction, Risk, Conference, Cytomegalovirus, University, ART, Biomarker, Merck & Co., University of California, UM1, Insulin resistance, Poster, Letermovir, Probability, Atherosclerosis, Plasma, TNF, HIV, University of North Carolina, Immune system, Brain

CMV is a chronic and usually asymptomatic virus carried by 60 percent of adults in the general population and more than 95 percent of people living with HIV.

Key Points: 
  • CMV is a chronic and usually asymptomatic virus carried by 60 percent of adults in the general population and more than 95 percent of people living with HIV.
  • Prior to the availability of effective antiretroviral therapy (ART) for HIV, CMV caused life-threatening infections in the eyes, brain, and gut in people with compromised immune systems due to advanced HIV.
  • “Investigators have found associations between CMV and heart disease, cancer, and other aging-related complications among people living with HIV,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles.
  • ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice-Chair).

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

Retrieved on: 
Thursday, February 29, 2024
Vaccine, Project, Webcast, Exosome, Protein, Poster, Mouse, Infection, Liver, Bangladesh Technical Education Board, Biotechnology, NIAID, Marketing, File, BLA, Therapy, Congress, PPMD, PUL, WMS, CMC, Distribution, International, Regenerative medicine, ID, Duchenne muscular dystrophy, Safety, Dicarboxylic acid, Biologics license application, IND, Commercialization, SARS-CoV-2, Lipid, Messenger, MicroRNA, Inflammation, FDA, Food, DMD, Priority review, Cell, COVID-19, Report, Patient, Oligonucleotide, PRV, Kidney, Tissue, Pharmaceutical industry

Further, Capricor will receive a meaningful mid-range double-digit revenue share of product revenue under the terms of this Agreement.

Key Points: 
  • Further, Capricor will receive a meaningful mid-range double-digit revenue share of product revenue under the terms of this Agreement.
  • Next steps for Cohort A: plan to report top-line data in the fourth quarter of 2024.
  • Revenues for the fourth quarter of 2023 were approximately $12.1 million compared with approximately $1.0 million for the fourth quarter of 2022.
  • Operating expenses: Total operating expenses for the fourth quarter of 2023 were approximately $13.2 million compared with approximately $9.0 million for the fourth quarter of 2022.

Pluri’s Innovation Across Various Industries: CEO Updates on Recent Achievements & 2024 Goals

Retrieved on: 
Wednesday, February 28, 2024
Infection, Therapy, Bangladesh Technical Education Board, Parity, AFRRI, USUHS, Cocaine, Medicine, NIAID, NIH, Bar-Ilan University, PLUR, World War II, FDA, PLX, Partnership, 3D, Food, Ageing, GMP, Hope, BIRAD, Plural, Meat, Risk, Outline of health sciences, CDMO, Climate, Climate change, Health, Water, Food and Drug Administration, Coffee, Knowledge, Agriculture, Food security, Negotiation, Good manufacturing practice, Pharmaceutical industry

Leveraging our proprietary 3D technology platform, our new vertical PluriAgtech can create high-quality cell-based coffee with 98% less water than traditional coffee production.

Key Points: 
  • Leveraging our proprietary 3D technology platform, our new vertical PluriAgtech can create high-quality cell-based coffee with 98% less water than traditional coffee production.
  • We also estimate that our innovative new production process will reduce the amount of growing area by 95%, potentially preventing deforestation.
  • By creating novel cell-based products both independently and through partnerships, Pluri is showing what’s possible when we all work together.
  • As such, our transformative technology is not only creating long-term value for our shareholders; it’s also making the world a better place.

Tonix Pharmaceuticals to Participate in the 2024 BIO CEO & Investor Conference

Retrieved on: 
Tuesday, February 20, 2024
Infection, Therapy, Fibromyalgia, TNX-102, Tonix Pharmaceuticals, Orphan drug, Smallpox, NIAID, Research, Annual report, NIH, CD40L, FDA, BIO, Prader–Willi syndrome, Sumatriptan, Government, Upsher-Smith Laboratories, Conference, Disease, Autoimmunity, University, COVID-19, PWS, Patient, Acute stress disorder, Security (finance), Long, Breakthrough therapy, Risk, IND, NDA, Failure, Long COVID, Cancer, Pharmaceutical industry

CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m.

Key Points: 
  • CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m.
  • Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering.
  • Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024.
  • A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024.