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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

Flu Season Focuses on Heartland States

Influenza infections in remain high in Arkansas, Oklahoma, Wyoming, Nebraska

March 4, 2024

Fact checked by Holly Lutmer PharmD

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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

Pharmacists Deliver Far More RSV Vaccines Than Doctors, Leading to Burn-Out

mRNA-1345 RSV vaccine candidate for adults may become available in 2024

March 3, 2024

Fact checked by Robert Carlson, MD

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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

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Escherichia coli (E. coli) is a harmful bacteria that poses a severe threat to newborns, causing neonatal sepsis infections that can be life-threatening. Given the underdeveloped immune systems of newborns, they are particularly vulnerable to such infections.

The risk of death from neonatal sepsis increases by 7.6% every hour a treatment is delayed.

However, there is currently no vaccine available for pregnant women to prevent this medical issue.

In an attempt to fill this void, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has taken an assertive stance by announcing $467k funding for GlyProVac to develop a maternal vaccine (GPV02) that targets E. coli.

This strategic move will help combat this bacterial species and save the lives of many newborns at risk of these severe infections.

GPV02 uses a selected bacterial protein, naturally decorated with small sugar molecules, to trigger an immune response for protection. This approach differs from previous attempts to develop protein-based bacterial vaccines since it involves specific natural sugar modifications previously undiscovered.

GlyProVac uses BEMAP technology to ensure that GPV02 correctly imitates E. coli, thus preparing the immune system to recognize the bacterium when an infection occurs.

Erin Duffy, Ph.D., R&D Chief of CARB-X, commented in a press release on February 29, 2024, "Because newborns at risk for neonatal sepsis are too young to be immunized, the vaccine would be administered to expectant mothers and target bacteria that cause neonatal bloodstream infections in babies."

"The vaccinated mothers would pass antibodies on to their babies in utero and through breastmilk after birth to strengthen their newborns' immune systems, helping them ward off infections."

The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the most significant burden in low- and middle-income countries. Since neonatal sepsis progresses rapidly, it requires immediate treatment with IV fluids and antibiotics.

GlyProVac is a research and development company from the University of Southern Denmark in Odense committed to reducing bacterial infections and antimicrobial resistance worldwide.

Vaccine Treats:

Sepsis

Image:

Image Caption:

from Pixabay

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Boston

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CytoDyn Inc., a biotechnology company developing leronlimab, a CCR5 antagonist, announced that the U.S. Food and Drug Administration (FDA) has lifted its clinical hold on leronlimab.

According to a press release on February 29, 2024, the Company is now free to proceed with its proposed HIV clinical trial exploring leronlimab and its effects on chronic inflammation.

The FDA placed a partial clinical hold on the Company's HIV program on March 30, 2022.

CytoDyn's CEO, Dr. Jacob Lalezari, commented, "CytoDyn is grateful for the FDA's guidance on our (HIV) protocol, and we are excited to open a new chapter in the development of leronlimab as a therapy that provides clinical benefit by modulating chronic inflammation."

Leronlimab is a humanized monoclonal antibody that is a once-a-week subcutaneous injection that can also be administered intravenously.

However, it is not a traditional HIV vaccine candidate.

It is a competitive rather than allosteric inhibitor of the CCR5 receptor. This mechanism of action of binding competitively to the CCR5 receptor differentiates leronlimab from all other CCR5 antagonists.

The CCR5 receptor is a protein located on the surface of various cells, including white blood cells, stellate cells that produce scar tissue in the liver, and cells that undergo malignant transformation. It is the predominant co-receptor needed for certain strains of HIV to infect healthy T-cells.

The CCR5 receptor serves as a receptor for chemical attractants called chemokines. Chemokines are the key orchestrators of leukocyte trafficking by attracting immune cells to the sites of inflammation.

For HIV, leronlimab is a viral-entry inhibitor, protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.

Dr. Lalezari plans to host a webcast on Tuesday, March 5, 2024, to provide a Company update. The update will include discussing the Company's clinical trial goals and expectations, upcoming publications, and overall development strategy.

Vaccine Treats:

HIV

Image:

Image Caption:

from Pixabay

Live Blog Update Author:

Don Hackett

Location Tags:

Vancouver

Vaccine:

Vyrologix (Leronlimab) Antibody

18 Vacation Destinations Listed as Dengue Hot-Spots

US CDC warns travelers dengue fever is a health risk in 2024

March 1, 2024

Fact checked by Robert Carlson, MD

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The global measles outbreak continued to impact people in England during late February 2024. Over the past decade, the uptake levels of childhood vaccines offered in England have been falling across all vaccines, including measles.

Data show more than 3.4 million children in England are either unprotected or not fully protected and at risk of catching completely preventable diseases.

According to the UK Health Security Agency, 69 additional laboratory-confirmed measles cases have been confirmed in England since one week ago.

As of March 1, 2024, the total number of measles cases confirmed since October 2023 is now 650.

Sixty-three percent (410 of 650) of these measles cases have been in the West Midlands, 15% in London, and 7% in Yorkshire and The Humber. The remaining cases were reported in other regions of England.

To change the trajectory of this measles outbreak, the UKHSA is launching a Childhood Immunisations national marketing campaign on March 4, 2024.

Professor Dame Jenny Harries, Chief Executive of UKHSA, said in a media release, "We need an urgent reversal of the decline in the uptake of childhood vaccinations to protect our communities. Through this campaign, we particularly appeal to parents to check their children's vaccination status and book appointments if their children have missed any immunizations."

"The ongoing measles outbreak we are seeing is a reminder of the very present threat."

"Unless uptake improves, we will start to see the diseases vaccines protect against re-emerging and causing more serious illness."

The UKHSA is co-ordinating its national marketing campaign with an operational measles, mumps, and rubella (MMR) catch-up campaign to counter this decline.

Areas with low uptake will be a focus for support and parents of children aged six to 11 years will be contacted directly and urged to make an appointment with their child's GP practice for any missed MMR vaccines.

In 2023, two million texts, emails, and letters were sent to parents and carers of 1-5-year-olds who were unvaccinated, and thanks to those efforts, 165,000 doses of MMR vaccine were delivered.

Vaccine Treats:

Measles

Image:

Image Caption:

from Pixabay

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

London

Vaccine:

Priorix Vaccine