Conference on Retroviruses and Opportunistic Infections

Atea Pharmaceuticals Presents Favorable Drug Interaction Profile of Bemnifosbuvir in Phase 1 Studies at CROI 2023

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Thursday, February 23, 2023

BOSTON, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that data from three Phase 1 studies suggest a favorable drug-drug interaction profile. No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive substrates of efflux and hepatic uptake transporters when co-administrated with bemnifosbuvir. CYP3A is an enzyme that metabolizes many classes of prescribed medicines and medicinal supplements, and efflux/hepatic uptake transporters regulate cellular trafficking of many drugs that are commonly prescribed to patients that are at high risk for severe COVID-19.

Key Points: 
  • BOSTON, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that data from three Phase 1 studies suggest a favorable drug-drug interaction profile.
  • No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive substrates of efflux and hepatic uptake transporters when co-administrated with bemnifosbuvir.
  • These results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI), which took place February 19-22, 2023 in Seattle, Washington.
  • A single dose (simultaneous or staggered) of bemnifosbuvir 1100 mg administered with ROSU slightly increased the plasma exposure of ROSU.

Immunocore announces initial Phase 1 safety and pharmacodynamic activity data with first soluble TCR therapy for people living with HIV

Retrieved on: 
Wednesday, February 22, 2023

IMC-M113V is an immunotherapeutic approach designed to specifically eliminate CD4+ cells that are persistently infected with HIV (‘reservoirs’).

Key Points: 
  • IMC-M113V is an immunotherapeutic approach designed to specifically eliminate CD4+ cells that are persistently infected with HIV (‘reservoirs’).
  • IMC-M113V targets a peptide derived from the Gag protein that is presented by HLA*A02 on the surface of HIV infected cells.
  • Although people living with HIV can control their disease with antiretroviral therapies, lifelong treatment is needed as reservoirs of HIV infected cells persist.
  • There were no serious adverse events, significant changes in hematology or chemistry, nor cytokine release syndrome or neurotoxicity.

Merck Opens Enrollment in New Phase 3 Clinical Trials with Investigational Once-Daily Islatravir in Combination with Doravirine for Treatment of HIV-1 Infection

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Wednesday, February 22, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the company has opened enrollment in its new Phase 3 clinical program with investigational once-daily islatravir 0.25 mg in combination with doravirine 100 mg (DOR/ISL) for the treatment of HIV-1 infection.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the company has opened enrollment in its new Phase 3 clinical program with investigational once-daily islatravir 0.25 mg in combination with doravirine 100 mg (DOR/ISL) for the treatment of HIV-1 infection.
  • Select Merck abstracts for islatravir at the Conference on Retroviruses and Opportunistic Infections (CROI) 2023 include:
    Switch to DOR/ISL (100/0.75MG) QD From B/F/TAF: Week 48 Results From a Phase 3 Trial.
  • For more than 35 years, Merck has been committed to scientific research and discovery (R&D) in HIV.
  • We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

Atea Pharmaceuticals to Present Data on Bemnifosbuvir Drug Interaction Profile at Conference on Retroviruses and Opportunistic Infections

Retrieved on: 
Wednesday, February 15, 2023

BOSTON, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced two upcoming poster presentations at the Conference on Retroviruses and Opportunistic Infections (CROI), which will take place February 19-22, 2023 in Seattle, Washington.

Key Points: 
  • BOSTON, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced two upcoming poster presentations at the Conference on Retroviruses and Opportunistic Infections (CROI), which will take place February 19-22, 2023 in Seattle, Washington.
  • Details for the poster presentations are as follows:
    Title: Bemnifosbuvir Has Low Potential to Inhibit P-gp, BCRP, and OATP1B1 Mediated Transport

Gilead Demonstrates Transformative Potential Impact Of Antiviral Innovation at CROI 2023

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Tuesday, February 14, 2023

At CROI 2023, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s continued pursuit of an HIV cure.

Key Points: 
  • At CROI 2023, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s continued pursuit of an HIV cure.
  • Additionally, Gilead will present data from a pre-clinical in vivo assessment of a single subcutaneous administration of lenacapavir for pre-exposure prophylaxis (PrEP).
  • Gilead will present data that reinforce the critical role Veklury® (remdesivir) plays as the antiviral standard of care for the treatment of hospitalized patients with COVID-19.
  • Additionally, Gilead will present a new in vitro analysis that evaluates the antiviral activity of Veklury against common variants of concern, and data assessing the resistance profile of Veklury and other antiviral compounds.

Enochian BioSciences Announces Findings From A Rigorous Internal Review of Scientific Data

Retrieved on: 
Friday, July 1, 2022

LOS ANGELES, July 01, 2022 (GLOBE NEWSWIRE) -- (NASDAQ: ENOB)In recent days, Enochian BioSciences (the Company) has conducted a rigorous internal review of scientific data to give partners and investors a clear understanding of the Companys pipelines.

Key Points: 
  • LOS ANGELES, July 01, 2022 (GLOBE NEWSWIRE) -- (NASDAQ: ENOB)In recent days, Enochian BioSciences (the Company) has conducted a rigorous internal review of scientific data to give partners and investors a clear understanding of the Companys pipelines.
  • These data, combined with similar promising data for the treatment of Hepatitis B Virus (HBV), were the basis for the Companys acquisition of the COVID-19 and influenza intellectual property.
  • However, during the review, the Company discovered that former scientific advisor Serhat Gumruku altered two different sets of animal data generated by third-party research institutions before Enochians scientists had a chance to review.
  • The Company is evaluating its internal controls regarding the review and verification of external scientific data and will modify as appropriate.

Emmes Supports Groundbreaking Anal Cancer Study Sponsored by the National Cancer Institute

Retrieved on: 
Thursday, June 16, 2022

ROCKVILLE, Md., June 16, 2022 /PRNewswire/ -- Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that a team of its researchers contributed to a successful AIDS Malignancy Consortium (AMC) study. Results of the study, which demonstrated that treating and removing anal cancer precursor lesions reduced the cancer risk for HIV-infected men and women, were published in the New England Journal of Medicine. The Phase 3 trial results included 4,446 participants at 21 clinical sites across the U.S. and Puerto Rico.

Key Points: 
  • Results of the study , which demonstrated that treating and removing anal cancer precursor lesions reduced the cancer risk for HIV-infected men and women, were published in the New England Journal of Medicine.
  • The study enrolled people living with HIV aged 35 years and older who had at least one precursor lesion for anal cancer, called high-grade squamous intraepithelial lesions (HSIL).
  • According to Dr. Palefsky, "Anal cancer is the fourth most common cancer among people living with HIV.
  • For these individuals, the ANCHOR study shows for the first time that secondary prevention of anal cancer is possible through treatment of anal HSIL.

Navidea Biopharmaceuticals Reports Fourth Quarter 2021 Financial Results

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Wednesday, March 23, 2022

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (Navidea or the Company), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the fourth quarter and year-to-date for the period ended December 31, 2021.

Key Points: 
  • Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (Navidea or the Company), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the fourth quarter and year-to-date for the period ended December 31, 2021.
  • Total net revenues for the fourth quarter of 2021 were $50,000, compared to $219,000 for the same period in 2020.
  • Research and development (R&D) expenses for the fourth quarter of 2021 were $1.4 million, compared to $1.3 million in the same period in 2020.
  • Navidea ended the fourth quarter of 2021 with $4.2 million in cash and cash equivalents.

Primmune Therapeutics Presents Interim Analysis of Clinical Data from Phase 1 Study Evaluating PRTX007 at the Conference on Retroviruses and Opportunistic Infections (CROI 2022)

Retrieved on: 
Monday, February 14, 2022

Oral administration of PRTX007 in this first-in-human study of healthy volunteers exhibited a favorable safety profile, rapid absorption and conversion to TLR7 agonist PRX034, and activation of the innate immune system, without causing inflammation.

Key Points: 
  • Oral administration of PRTX007 in this first-in-human study of healthy volunteers exhibited a favorable safety profile, rapid absorption and conversion to TLR7 agonist PRX034, and activation of the innate immune system, without causing inflammation.
  • We look forward to continuing the development of PRTX007 to address current unmet needs of patients with cancers and viral infections.
  • PRTX007 uniquely engages TLR7 and targeted immune cells without increasing levels of proinflammatory factors like IL-6, TNF and IL-1 via NF-B.
  • PRTX007 is being rapidly advanced towards clinical trials for cancer and viral diseases.

Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Naïve Adults

Retrieved on: 
Friday, February 11, 2022

Confidence in the efficacy and robustness of Biktarvy as a complete regimen helps me advance the conversation around what long-term treatment success may look like.

Key Points: 
  • Confidence in the efficacy and robustness of Biktarvy as a complete regimen helps me advance the conversation around what long-term treatment success may look like.
  • Among study participants, median change in weight from baseline through Week 240 was 6.1 kg, consistent with previously presented data.
  • Mean percentage changes in hip and spine BMD through Week 240 in Biktarvy participants were -0.29% and -0.23%, respectively.
  • Beyond week 144, participants were able to receive Biktarvy in an active open-label extension phase for up to 96 weeks.