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Gritstone bio Announces Presentations from Phase 1 Studies Evaluating Next-Generation Vaccine Candidate for COVID-19 at IDWeek 2023

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수요일, 10월 4, 2023

Vaccine, Nextgen, Biomedical Advanced Research and Development Authority, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, HHS, National Institute of Allergy and Infectious Diseases, Gritstone bio, COVID-19, Infection, Messenger, Development, Infectious Disease Clinics of North America, NIAID, CORAL, BARDA, Gritstone, Pharmaceutical industry

EMERYVILLE, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced results from all three (3) Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) are to be presented at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.

Key Points:

EMERYVILLE, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced results from all three (3) Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) are to be presented at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.
Last week, Gritstone bio announced a contract with the Biomedical Advanced Research and Development Authority (BARDA) to advance the program into a 10,000 patient, randomized Phase 2b comparative study against COVID-19.
Gritstone last presented data from the CORAL-BOOST and CORAL-CEPI studies in April 2023 ( press release ).
At IDWeek, Gritstone will present further follow up from both of those studies.

Aligos Therapeutics Announces Award of an $8.5 Million NIAID Contract to Advance Development of Best-In-Class Pan-Coronavirus Protease Inhibitor, ALG-097558

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화요일, 10월 3, 2023

National Institute of Allergy and Infectious Diseases, Human, Therapy, Doctor of Philosophy, Jacob Aligo, SARS-CoV-2, Coronavirus, COVID-19, MBA, MERS-related coronavirus, SAN, Liver, NIAID, NIH, Infection, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has been awarded an $8.5 million National Institute of Allergy and Infectious Diseases (NIAID) contract to conduct nonclinical and clinical studies to advance its pan-coronavirus protease inhibitor ALG-097558 into future Phase 2/3 studies.

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SOUTH SAN FRANCISCO, Calif., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has been awarded an $8.5 million National Institute of Allergy and Infectious Diseases (NIAID) contract to conduct nonclinical and clinical studies to advance its pan-coronavirus protease inhibitor ALG-097558 into future Phase 2/3 studies.
“It is an honor to be awarded this NIAID contract, which is our second NIH-funding received for the development of novel inhibitors of the coronavirus 3CL protease,” said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics.
“Given that ALG-097558 potently inhibits all forms of coronavirus tested to date (SARS-CoV, MERS-CoV, SARS-CoV-2 and seasonal coronavirus), we believe that this compound will be important for the ongoing COVID-19 endemic as well as for the treatment of emergent novel coronavirus infections in humans in the future.
These non-dilutive external funds will enable Aligos to continue to advance the ALG-097558 program beyond the ongoing Phase 1 study, which is evaluating single and multiple doses in healthy volunteers.”

Gritstone bio Awarded BARDA Contract to Conduct Comparative Phase 2b Study Evaluating Next-Generation Vaccine Candidate for COVID-19 Valued at up to $433 Million

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수요일, 9월 27, 2023

EMERYVILLE, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, announced today that it was awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study evaluating Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate containing Spike plus other viral targets to protect against COVID-19. The agreement, which is valued at up to $433 million, was awarded as part of ‘Project NextGen,’ an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19.

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Under the contract, Gritstone bio will conduct a 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of the Gritstone next-generation COVID-19 vaccine candidate with an approved COVID-19 vaccine.
Preparations for the study are underway, and execution of the study will be fully funded by BARDA.
CORAL was designed to address these limitations by inducing durable neutralizing antibody and T cell-based immunity against current and future SARS-CoV-2 variants.
We are excited about this opportunity to work alongside BARDA and look forward to initiating the Phase 2b study (CORAL-BARDA) in the first quarter of 2024.

Chrysalis Receives FDA Approval to Initiate Clinical Trials with Chrysalin™ (TP508)

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화요일, 9월 26, 2023

Chrysalis BioTherapeutics, Inc. announced today that the US Food and Drug Administration (FDA) has given the company permission to initiate human clinical trials aimed at treating acute lung failure.

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Chrysalis BioTherapeutics, Inc. announced today that the US Food and Drug Administration (FDA) has given the company permission to initiate human clinical trials aimed at treating acute lung failure.
Other animal studies show potential TP508 benefit in treating acute lung injury, chronic smoke inhalation, and mitigating radiation effects on brain and other tissues.
“TP508 is a natural regenerative peptide that accelerates tissue repair and revascularization while modulating the inflammatory response.
Chrysalis is using UTMB, Houston-area, and national advisors to advance TP508 for treating pulmonary indications.

Vir Biotechnology Announces First Participant Dosed in New Phase 1 Trial Evaluating VIR-1388, an Investigational T Cell Vaccine for the Prevention of HIV

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수요일, 9월 20, 2023

SAN FRANCISCO, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first participant has been dosed in a Phase 1 trial evaluating the safety, reactogenicity and immunogenicity of VIR-1388, an investigational novel T cell vaccine for the prevention of human immunodeficiency virus (HIV). The Company expects initial data from the Phase 1 trial in the second half of 2024.

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The Company expects initial data from the Phase 1 trial in the second half of 2024.
VIR-1388 was developed using applied learnings from VIR-1111, the Company’s initial investigational proof-of-concept HIV T cell vaccine based on HCMV.
The Phase 1 trial of VIR-1388 will take place in both domestic and international sites within the federally funded HIV Vaccine Trials Network (HVTN) as study HVTN 142.
The randomized, double-blind, placebo-controlled Phase 1 trial (NCT05854381) is evaluating the safety, reactogenicity and immunogenicity of three different doses of VIR-1388 compared with placebo.

ResVita Bio Receives NIH Grant to Develop Breakthrough Treatment for Severe Atopic Dermatitis

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월요일, 9월 18, 2023

National Institute of Allergy and Infectious Diseases, Synthetic biology, Infection, NIAID, FDA, Atopic dermatitis, NIH, Netherton syndrome, Doctor of Philosophy, Advisory board, SBIR, Pharmaceutical industry

BERKELEY, Calif., Sept. 18, 2023 /PRNewswire/ -- ResVita Bio, a synthetic biology startup, announces that it has been awarded a $250,000 Phase 1 Small Business Innovation Research (SBIR) grant by the National Institute of Allergy and Infectious Disease (NIAID).

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BERKELEY, Calif., Sept. 18, 2023 /PRNewswire/ -- ResVita Bio, a synthetic biology startup, announces that it has been awarded a $250,000 Phase 1 Small Business Innovation Research (SBIR) grant by the National Institute of Allergy and Infectious Disease (NIAID).
This grant will be used to develop RVB-101, a genetically engineered cell therapy for the treatment for severe atopic dermatitis.
Dr. Amin Zargar, PhD, Chief Executive Officer of ResVita Bio, expressed his excitement regarding the recent achievement.
"Within a year, we have been honored to receive two innovation grants from the NIH to develop therapies for both Netherton Syndrome, an orphan disease, and severe atopic dermatitis through our topical cell therapy approach," Dr. Zargar stated.

NDRI Receives $3.7 Million Grant from NIH to Continue the Development of NDRI’s Human Tissue and Organs for Research Resource (HTORR) Program

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수요일, 9월 6, 2023

This new three-year award for NDRI’s Human Tissue and Organs for Research Resource (HTORR) Program parent grant extends the NIH’s ongoing funding support for HTORR to 35 consecutive years.

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This new three-year award for NDRI’s Human Tissue and Organs for Research Resource (HTORR) Program parent grant extends the NIH’s ongoing funding support for HTORR to 35 consecutive years.
The HTORR Program supports investigators across the full spectrum of research with access to normal and diseased human biospecimens.
“NDRI is grateful to the NIH for the support of our expanding HTORR program,” said Bill Leinweber, President and CEO of NDRI.
This grant renewal includes multiple enhancements such as a new Pilot Program, Pathology Service Options, and a Pathology Consultant Committee.

60 Degrees Pharmaceuticals Study Results Published by New Microbes and New Infections Demonstrate Tafenoquine Exhibits Broad Spectrum Antifungal Activity

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수요일, 8월 30, 2023

Effective treatment of drug-resistant Candida infections is an unmet need in U.S. market

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Effective treatment of drug-resistant Candida infections is an unmet need in U.S. market
WASHINGTON, Aug. 30, 2023 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals , Inc. (“60P”) (NASDAQ: SXTP), specialists in developing and marketing medicines for infectious diseases, today announced the journal, New Microbes and New Infections , has published non-clinical study results showing tafenoquine exhibits broad spectrum antifungal activity, including against Candida spp.
in cell culture, and decreases fungal burden in the lungs in an invasive pulmonary model of Rhizopus in mice.
60P was recently awarded a U.S. patent covering tafenoquine for treatment of COVID-19 and other lung infections.
“A substantial unmet need exists for clinical therapies that treat and prevent life-threatening fungal infections,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoffrey Dow.

IMUNON Enters into CRADA for Preclinical Studies of PlaCCine Modality in Preventive Vaccines Against Lassa Virus

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목요일, 8월 24, 2023

National Institute of Allergy and Infectious Diseases, CRADA, Research, Lassa mammarenavirus, Development, Death, Incidence, Cooperative research and development agreement, Developed country, Risk, Lassa fever, NIAID, Laboratory, Infection, World Health Organization, Vaccine, Virology

LAWRENCEVILLE, N.J., Aug. 24, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, announces it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the immunogenicity and efficacy of two IMUNON DNA-based Lassa virus vaccine candidates. Under the three-year agreement, the NIAID will assess the efficacy of PlaCCine DNA constructs against Lassa virus in guinea pig and non-human primate disease models, including both prime and prime-boost vaccine strategies.

Key Points:

Under the three-year agreement, the NIAID will assess the efficacy of PlaCCine DNA constructs against Lassa virus in guinea pig and non-human primate disease models, including both prime and prime-boost vaccine strategies.
Lassa virus is typically spread by rodents and can cause Lassa fever, a viral hemorrhagic-fever disease that is a significant and growing public health concern with approximately 5,000 deaths annually.
Nearly 60 million people throughout West Africa are estimated to be at risk of contracting Lassa fever.
Because of its lethality and increasing incidence, NIAID and the World Health Organization have categorized Lassa virus as a Category A Priority Pathogen.

Ceramedix Awarded Phase 2B NIH SBIR Grant to Evaluate the Non-Clinical Pharmacology of Its Lead Candidate to Support IND Submission

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목요일, 8월 24, 2023

NEW YORK, Aug. 24, 2023 /PRNewswire/ -- Ceramedix Holding, LLC (Ceramedix), a privately-held biotherapeutics company developing a new class of antibody-based drugs designed with the aim to address novel disease targets involving the microvasculature, today announced it was awarded a $3,007,043 Phase 2B National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant to evaluate the non-clinical pharmacology of its lead drug candidate. Specifically, the anti-ceramide antibody that disrupts cell death signaling is in development through the NIH as a potential therapeutic to mitigate and/or treat illness due to radiation exposure. The grant was issued by the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH, a part of the U.S. Department of Health and Human Services.

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Specifically, the anti-ceramide antibody that disrupts cell death signaling is in development through the NIH as a potential therapeutic to mitigate and/or treat illness due to radiation exposure.
The grant was issued by the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH, a part of the U.S. Department of Health and Human Services.
The grant will specifically fund the establishment of independent potency assay capabilities within Ceramedix, as well as in vitro studies to better understand the pharmacology of the antibody.
"The award of this NIH SBIR grant reflects potential of the antibody to prevent and treat lethal gastrointestinal (GI) acute radiation syndrome (ARS)," stated Charles L. Dimmler, III, Managing Member of Ceramedix.