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ImmunityBio has announced that the combination of N-803 and natural killer cells can potentially reduce viral load in people living with human immunodeficiency virus (HIV), per the Phase 1 pilot study data.

Results from this study were published in The Journal of Infectious Diseases in January 2024; researchers at the University of Minnesota Medical School gave six HIV-positive individuals infusions of healthy NK cells from close relatives, along with N-803, to boost NK cell activity. All participants in this Phase 1 study experienced a significant reduction in infection levels following treatment with N-803.

The approach was well tolerated, with no unexpected adverse events.

N-803 is a novel investigational IL-15 superagonist complex with an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its proposed mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding with the generation of memory T-cells while avoiding T-reg stimulation.

N-803 is designed to have improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

The use of N-803 is investigational. Safety and efficacy have not been established by any Health Authority or Agency, including the U.S. FDA.

Tim Schacker, MD, senior author of this paper, and colleagues are planning a follow-on study with additional participants to investigate these immunotherapies in HIV-infected individuals further.

“Antiretroviral therapies have had a profound impact on society, making it possible for those living with HIV to live longer lives with better outcomes. However, these therapies are not a cure, and still place a significant burden on people living with HIV and the healthcare system,” said Patrick Soon-Shiong, M.D., Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on March 5, 2024.

“These data preliminarily validate what we know about the benefit of enhancing NK cell function and the potential utility of N-803 in infectious diseases.”

In addition to this study, three other clinical trials are underway involving N-803 in HIV Cure-related strategies.

Two Phase 1 clinical trials are investigating N-803 in combination with bNAbs in HIV-infected individuals (ACTG A5386, NCT04340596: and NCT05245292 at the Rockefeller University), and a Phase 2 study is also underway to investigate the effect of combining N-803 with ART during acute HIV infection, sponsored by the Thai Red Cross and the U.S. Military HIV Research Program. To learn more about these studies, please visit our website.

HIV affects tens of millions globally and currently has no known cure. HIV can disable NK cells—a frontline defense against viral infections—making it difficult to clear the infection.

One current strategy for curing HIV is known as the “kick and kill” approach. N-803 is under evaluation using this strategy, given the molecule’s ability to activate viral transcription in CD4+ T cells (“kick”) and boost CD8+ and NK cells, crucial for identifying and eliminating infected cells (“kill”), directing them to viral reservoirs.

ImmunityBio’s IL-15 superagonist N-803 (also called Anktiva® and nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells.

N-803 is currently being evaluated in adult patients in two clinical NMIBC trials. QUILT-2.005 is investigating the use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease.

Vaccine Treats:

HIV

Image:

Image Caption:

ImmunityBio website 2024

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Culver City

Vaccine:

Anktiva N-803 plus BCG Vaccine Therapy

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Fact checked by Robert Carlson, MD

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A leading global vaccine developer has announced that their investigational vaccine candidate for Herpes Simplex Virus (HSV) is undergoing a phase 1/2 clinical trial for the first time in Europe, England, and the United States.

GlaxoSmithKline plc. (GSK), known for its extensive range of vaccines for various conditions, including RSV, meningitis, and shingles, is conducting an innovative study to evaluate the safety, immune response, efficacy, and reactogenicity of HSV-targeted immunotherapy (HSVTI).

This multi-country research study is recruiting 332 healthy participants aged 18-40 years or those aged 18-60 years with recurrent genital herpes.

Known as GSK3943104A, GSK Study #215336 is forecasted to conclude in May 2026.

This HSVTI study will explore different formulations and be conducted in two parts:

Part I assesses different formulations of the HSVTI in healthy participants;

Part II assesses the two formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.

In 2023, the World Health Organization estimated 3.7 billion people under the age of 50 have a HSV infection. Genital herpes is a sexually transmitted infection (STI) passed on through vaginal, anal, and oral sex.

There are approved vaccines to prevent STIs, such as mpox and HPV.

Currently, there's no cure or preventive vaccine for genital herpes.

However, in addition to GSK, companies such as Moderna Inc and BioNTech SE are conducting HSV vaccine research as of March 5, 2024.

Vaccine Treats:

Herpes

Image:

Image Caption:

GSK clinical trial map March 2024

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

London

Vaccine:

GSK Herpes Simplex Virus Targeted Immunotherapy (GSK3943104A)

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PhotonPharma, a biotechnology company that aims to revolutionize cancer treatment, announced today that it has received clearance from the U.S. Food and Drug Administration to proceed with its Phase I clinical study for the treatment of Stage III/IV ovarian cancer.

The company will use Innocell™, its groundbreaking investigational autologous cell-based vaccine therapy, for this purpose. The vaccine therapy will be manufactured at City of Hope's Los Angeles campus.

This therapy is based on the use of inactivated tumor cells prepared with a proprietary process that involves UV light and riboflavin.

These cells are isolated from a patient's tumor and inactivated and then used in a treatment that is designed to stimulate the patient's immune system to fight cancer.

Alan Rudolph, the CEO of PhotonPharma, expressed his enthusiasm about this development in a press release on March 5, 2024, stating, "We are thrilled to have reached this pivotal moment in our journey toward providing a novel treatment option for patients facing advanced ovarian cancer."

PhotonPharma anticipates initiating patient enrollment for this study shortly to profile the therapeutic potential of this innovative autologous vaccine therapy.

Vaccine Treats:

Ovarian cancer

Image:

Image Caption:

Innocell™ Personalized Vaccine Therapy

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Colorado

GSK Herpes Simplex Virus Targeted Immunotherapy (GSK3943104A)

GSK Herpes Simplex Virus Immunotherapy (GSK3943104A)

GlaxoSmithKline plc. (GSK) Herpes Simplex Virus (HSV) targeted immunotherapy (HSVTI) is conducting a phase 1/2 clinical study (GSK Study ID: 215336) of a targeted immunotherapy (GSK3943104A) against HSV. This study's phases are being undertaken in the United States and Europe and include healthy participants aged 18-40 years or participants aged 18-60 years with recurrent genital herpes. This first-time-in-human (FTiH) study, involving 332 participants, aims to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational HSV-targeted immunotherapy (TI).

A trial is a combined phase I/II proof-of-concept study to assess the potential clinical efficacy of GSK3943104. Results show that GSK3943104 did not meet the study's primary efficacy objective. This vaccine candidate will therefore not progress to phase III studies. No safety concern was observed. The TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up data that could offer valuable insights into recurrent genital herpes. GSK is working closely with investigators to inform trial participants. The GSK study was terminated in September 2024.

GSK terminated a SAM-based herpes vaccine approach, GSK4108771A, in 2021.

GlaxoSmithKline plc. is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. GSK is headquartered in Brentford, Middlesex, the UK.

GSK Herpes Simplex Virus Immunotherapy (GSK3943104A) Indication

Genital herpes is a sexually transmitted infection (STI) passed on through vaginal, anal, and oral sex. There's no cure for genital herpes. Symptoms typically clear up on their own, but the blisters can recur (resulting in an outbreak or recurrence).

GlobalData Assesses GSK-3943104A

The GlobalData report assesses how GSK-3943104A's drug-specific phase transition success rate and Likelihood of Approval scores compare to the indication benchmarks. The Likelihood of Approval data is updated regularly in response to events that affect the clinical development process and regulatory considerations.

GSK Herpes Simplex Virus Targeted Immunotherapy Clinical Studies

GSK Study ID: 215336; March 2022 to May 2026 - Phase 1/2 clinical trial: EudraCT Number: 2021-003586-35; ClinicalTrials.gov Identifier: NCT05298254.

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Manufacturer:

GlaxoSmithKline plc.

Reviewer:

Robert Carlson, MD

Vaccine:

GSK Herpes Simplex Virus Targeted Immunotherapy (GSK3943104A)

VIS:

PDF

Availability:

N/A

Generic:

GSK3943104A

Drug Class:

Immunotherapy

Clinical Trial Phase I:

Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent G

Clinical Trial Phase II:

Clinical trials for 2021-003586-35

Condition:

Herpes

Last Reviewed:

Friday, December 12, 2025 - 09:55

Status:

Canceled

Manufacturer Country ID:

FDA First In Class:

Yes

Location tags:

United States of America

London

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Vaxcyte, Inc. today announced it has completed enrollment for its Infant Phase 2 clinical study evaluating VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) engineered to prevent invasive pneumococcal disease (IPD).

The primary three-dose immunization series is expected to produce topline safety, tolerability, and immunogenicity data by the end of the first quarter of 2025. And the booster dose results will be announced by the end of 2025.

These results will be crucial in demonstrating the effectiveness of VAX-24 and its potential to protect humankind from bacterial diseases.

"Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under," said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte, in a press release on March 4, 2024.

Vaxcyte's carrier-sparing PCV franchise candidates include VAX-24 and VAX-31, the Company's next-generation 31-valent PCV currently being evaluated in a Phase 1/2 study, are being studied to prevent IPD.

Vaccine Treats:

Pneumococcal

Image:

Image Caption:

by Sally Wynn

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

San Carlos

Vaccine:

Vaxcyte Pneumococcal Conjugate Vaccines

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As the northern hemisphere prepares for Spring Break 2024, government officials alert travelers to protect themselves from measles outbreaks.

As of March 3, 2024, both Canada and the United States have confirmed measles outbreaks this year, generally related to unvaccinated travelers.

Canada's Chief Public Health Officer recently commented measles cases can still occur here when an individual who is not fully vaccinated has traveled to or from a country where measles is circulating.

There are about eight measles cases in Canada in 2024, in cities such as Montreal and Toronto.

In the U.S., the Centers for Disease Control and Prevention (CDC) updated its report indicating 41 measles cases in sixteen jurisdictions this year. Broward County, Florida; Detroit, Michigan; and Philadelphia, Pennsylvania, have recently reported measles cases.

At this pace, the U.S. may exceed 2023, when 20 jurisdictions reported 58 measles cases.

Last year, the CDC published a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice identifying measles outbreaks in 47 countries.

Additionally, since measles is a vaccine-preventable disease, the CDC offers people access to a digital app to help travelers determine whether or not they need MMR vaccination before departure.

The CDC says MMR vaccines are offered at health clinics and community pharmacies in 2024.

Vaccine Treats:

Measles

Image:

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Ottawa

Vaccine:

Priorix Vaccine