Cancer Vaccine Breaking News

Transgene today announced that new data confirm the ability of this novel investigational therapeutic cancer vaccine to induce immune responses against human papillomavirus (HPV) 16 antigens that are associated with antitumor response.

TG4001 is an investigational viral vector-based therapeutic cancer vaccine.

It is being evaluated in a randomized controlled Phase II clinical study comparing TG4001 with avelumab to avelumab alone in patients with HPV16-positive anogenital tumors. 

The data presented on June 5, 2023, were generated from 46 patients in both trial arms.

• TG4001 induced the priming of adaptive immunity
• 58% of patients receiving TG4001 + avelumab showed an increase of immune responses against HPV antigens versus 9% in the avelumab arm. At baseline, immune responses against HPV antigens were limited to 4/46 patients.
• An immune response was detected at day 43 and tended to increase intensity at day 85.
• These data demonstrate that Transgene's TG4001 could induce a specific immune response against the antigens vectorized within this vaccine.
• 11 of the 13 patients with an immune response had either stable disease, partial or complete tumor response according to RECIST criteria.
• Remarkably, two case studies are presented, with patients exhibiting a strong E6 and E7 immune response while showing a complete clinical response.
• Transgene anticipates that the last patient will be randomized in the current Phase II clinical study in the first half of 2024. The final results will be communicated in 2024.

Dr. Alessandro Riva, MD, Chairman and CEO of Transgene, commented in a press release, "These data further confirm that our therapeutic vaccine TG4001 can induce clinically meaningful immune responses that are associated with antitumor response."

The abstract and poster can be accessed on the ASCO and Transgene websites.

TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector, which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2).

TG4001 was designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens that can be found in HPV16-related tumors and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). 

HPV is a group of more than 200 related viruses, some of which are spread through sex. Researchers previously confirmed that infection with HPV16 precedes the development of some head and neck cancers. 

Other HPV cancer vaccine news is posted by Precision Vaccinations.

When it comes to immunotherapy, a tumor’s classification as hot or cold is essential. Hot refers to tumors showing signs of inflammation, meaning the immune cells have recognized and responded to the malignant cells, wrote Kim Polacek, APR, CPRC, on June 4, 2023.

These tumors respond well to immunotherapy because the immune system is already activated.

Cold tumors, on the other hand, contain immune suppressive cells and are more challenging to treat.

Breast cancer was once regarded as a cold tumor disease and therefore difficult to treat with immunotherapy, but that is changing thanks to research happening at Moffitt Cancer Center.

A new clinical trial led by Dr. Heather Han is evaluating a combination therapy utilizing two immunotherapies (dendritic cell vaccine and pepinemab), along with trastuzumab, followed by adoptive T cell therapy, for patients with metastatic HER2 positive breast cancer.

“The goal of this therapy is to activate the immune system and create a hot tumor environment so we can collect those immune cells to create a specific cellular immunotherapy to better target their cancer,” said Dr. Han, clinical research director in the Department of Breast Oncology at Moffitt.

Information about this phase 1 clinical trial is being presented at the American Society of Clinical Oncology Annual Meeting. The clinical trial is ongoing. Han says this combination therapy could provide a new option for HER2-positive breast cancer patients with metastatic disease.

The U.S. Department of State updated its Travel Advisory for the Republic of Peru regarding civil unrest.

On June 1, 2023, the State Department's Level 2: Exercise Increased Caution advisory confirmed visitors should not travel to:

• The Colombian-Peruvian border area in the Loreto Region.
• The Valley of the Apurímac, Ene, and Mantaro Rivers, including areas within the Departments of Ayacucho, Cusco, Huancavelica, and Junin.
• The Puno Region, including the Peruvian side of Lake Titicaca, and the Apurimac Region.

And the U.S. Embassy in Lima recently reported a 24-hour strike is expected to affect the Puno region on May 31, 2023. In addition, roadblocks could disrupt travel within the area and the city of Puno.

Furthermore, U.S. travelers participating in Ayahuasca and Kambo ceremonies should be aware that numerous persons, including U.S. citizens, have reported that while under the influence of these substances, they have witnessed or been victims of sexual assault, rape, theft, serious health problems and injuries, and even death.

Previously, Machu Picchu reopened to visitors in late February 2023 after a short closure.

If you visit Peru, the State Department suggests enrolling in the Smart Traveler Enrollment Program to receive alerts in an emergency.

From a health perspective, the U.S. CDC included Peru in its recent dengue outbreak advisory.

The U.S. Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Update CDCHAN-00492 to supplement the HAN issued on May 17, 2023, offering updates on the ongoing fungal meningitis outbreak.

As of June 1, 2023, a multistate outbreak of fungal meningitis is ongoing among patients who underwent procedures under epidural anesthesia in the city of Matamoros, Tamaulipas, Mexico, at two clinics: River Side Surgical Center and Clinica K-3.

A total of 212 residents in 25 U.S. states and jurisdictions have been identified who might be at risk of fungal meningitis because they received epidural anesthesia at the clinics of interest in 2023.

Three of these patients (two probable cases and one confirmed case) have died.

Various laboratories have detected fungal signals consistent with the Fusarium solani species complex from the cerebrospinal fluid (CSF) of patients receiving follow-up care in Mexico or the U.S.

In addition, elevated levels of beta-D-glucan, a biomarker of fungal infection, have been detected in the CSF of at least six patients. Efforts by public health officials are ongoing to find and notify additional patients who might be at risk.

Healthcare providers, public health officials, and the public should be aware that all patients, including those without symptoms, who underwent medical or surgical procedures under epidural anesthesia in Matamoros, Mexico, since January 1, 2023, should be evaluated for fungal meningitis as soon as possible.

As of June 2, 2023, the WHO advises against the application of any travel or trade restrictions on Mexico and the U.S. based on the current information available on this event.

Globally, nearly two million new COVID-19 cases and over 12,000 related fatalities were reported in the last 28 days, a decrease of 30% and 39%, respectively, compared to the previous 28 days, reported the World Health Organization (WHO).

As of June 1, 2023, the situation is mixed at the regional level, with increases in reported cases seen in the Western Pacific Region and the African Region and decreases in related fatalities in all six WHO regions.

During this 28-day reporting period, 150 of 243 (62%) countries and territories reported at least one COVID-19 case.

The European Region had the highest proportion of countries reporting data on new hospitalizations (19 countries; 31%).

Globally, XBB.1.5 has been reported from 115 countries since the variant emerged.

The journal PLOS One reported every 75 seconds, a child under five dies of malaria, and children bear the highest burden of malaria in Sub-Saharan Africa (SSA).

On May 31, 2023, the pooled prevalence of malaria among children aged 6–59 months was 27.41% (95% CI: 17.94%-36.88%) in SSA.

Infection rates range from 5.04% in Senegal to 62.57% in Sierra Leone. 

This study revealed that older under-five children living in large families with low incomes in rural areas are most vulnerable to malaria infection. 

To notify international travelers of their potential health risks, the U.S. CDC issued a Level 2 travel advisory focused on malaria outbreaks in Costa Rica. 

While there are malaria vaccines available in June 2023, the deployment has yet to reach critical mass in SSA.

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO™, the company’s bivalent Respiratory Syncytial Virus (RSV) prefusion F (RSVpreF) vaccine.

This FDA approval on May 31, 2023, prevents lower respiratory tract disease caused by RSV in individuals 60 years and older.

On May 3, 2023, the FDA approved the initial RSV vaccine, Arexvy™, which GSK produces.

According to statements, both RSV vaccines could be available for seniors in late 2023.

Other RSV vaccine candidates, including vaccines for pregnant women, are conducting late-stage clinical trials as of June 1, 2023.

The U.S. Centers for Disease Control and Prevention published a report on April 7, 2023, that indicated the 2022–23 RSV season started later than the 2021–22 season but earlier than the prepandemic seasons, suggesting a return toward prepandemic seasonality. 

A study published by the Journal of Infectious Diseases determined that RSV-related fatalities in infants <1 year peaked at one month of age.

Over the 20-year study period, RSV, bronchiolitis, and influenza were listed as the underlying causes of death on 932, 1,046, and 52,293 death certificates, respectively.

Over 95% of these infections in children occur in low- and middle-income countries outside the U.S.