Cancer

BCG Vaccine Shortage Ends in the United States

Karen McClorey Hackett — Wed, 19 Feb 2025 15:08:09 +0000

Reviewer:

Following years of inadequate supply, a recently approved recombinant Bacillus Calmette-Guérin (rBCG) is now available in the United States to treat non-muscle invasive bladder cancer (NMIBC) patients.

Access to this vaccine may end the multi-year shortage of the TICE® BCG vaccine.

ImmunityBio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has authorized an expanded access program that will bring an alternative source of BCG, a standard-of-care medicine in bladder cancer, to patients in the United States.

As of February 19, 2025, ImmunityBio says shipments of the Serum Institute of India (SII) TUBERVAC-rBCG vaccine will begin immediately in the U.S.

TUBERVAC-rBCG was approved in India in 2023 as a single-dose tuberculosis (TB) prevention vaccine. In European bladder cancer phase 2 clinical trials, the rBCG vaccine has demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG strains and formulations.

"With the increasing threat of supply shortages of essential medicines, the biopharmaceutical industry must innovate and secure new means of ensuring uninterrupted access to vital therapeutics," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, in a press release.

"Our collaboration with the FDA and SII to ensure a reliable supply of this vital drug for bladder cancer patients underscores ImmunityBio's commitment to addressing critical access issues that affect so many patients."

BCG is a benign bacterium that was developed over 100 years ago as a live vaccine against TB. It has been administered to more than 4 billion individuals worldwide. In 2002, Neonatal BCG vaccination was practiced in 157 countries and territories.

SII is the world's largest manufacturer of BCG vaccines, while Merck & Co. is currently the only manufacturer of the U.S. FDA-approved TICE® BCG vaccine.

The WHO's Civil Society Taskforce on TB confirmed that 16 TB vaccines were available globally. Two gene modifications have been implemented in rBCG to improve its immunogenicity and safety compared to earlier strains and formulations of BCG.

ImmunityBio's FDA-approved ANKTIVA® is a cytokine interleukin-15 that plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that kill cancer cells. ANKTIVA's protocol integrates rBCG vaccinations.

Sub Title:

BCG vaccine is FDA approved to bladder cancer and tuberculosis prevention

Reference:

FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address TICE® BCG Shortage

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HPV9 Vaccines Coming to Latin America

Karen McClorey Hackett — Tue, 11 Feb 2025 09:15:41 +0000

Reviewer:

Robert Carlson, MD

Over the past decade, human papillomavirus (HPV) vaccinations have prevented thousands of cervical cancer cases worldwide.

Beginning in July 2025, the enhanced 9-valent HPV vaccine will become more available in the Region of the Americas.

The Pan American Health Organization (PAHO) Revolving Fund announced on February 7, 2025, that the general availability of the 9-valent HPV vaccine will be easier and more affordable for Latin American countries.

This PAHO initiative is expected to help immunization programs access tools to protect their populations against the most prevalent genotypes in cervical cancer and reduce the overall burden of HPV-related diseases. The HPV9 vaccine has five more valencies than its previous version (quadrivalent) against the genotypes.

This is an essential PAHO program since, in 2022, more than 78,000 women were diagnosed with cervical cancer, and about 40,000 died from this preventable disease in the Americas.

Furthermore, mortality rates are three times higher in Latin America and the Caribbean as compared to North America, Canada, and the United States.

In a press release, Santiago Cornejo, Executive Manager of PAHO's Regional Revolving Funds, commented, "By working together, we can make life-saving vaccines more accessible to all and continue the goal of eliminating cervical cancer by 2030."

Currently, the HPV9 vaccine is recommended for the entire population from 9 to 26 years of age, depending on the immunization schedules of each country.

The PAHO Elimination Initiative seeks to end more than 30 diseases by 2030, including cervical cancer, using vaccination as a key tool. The goal is to vaccinate 90% of girls before the age of 15 with at least one dose of the HPV vaccine.

The PAHO Revolving Fund allows countries to combine their purchasing power to negotiate better prices and ensure a permanent and timely supply of their vaccines and other related inputs. This approach reduces costs and simplifies the procurement process for participating countries.

WHO prequalifies all vaccines included in the PAHO Revolving Fund portfolio or a reference authority. It seeks to offer quality, safe health technologies that meet technical criteria.

In the United States, Merck's GARDASIL 9® vaccine is the leading HPV vaccine. In 2025, it is generally available for boys and girls at health clinics and pharmacies.

Sub Title:

HPV9 vaccine is US FDA approved in 2025

References:

Americas will be able to access the HPV9 vaccine from mid-2025 through the PAHO Revolving Fund

Analysis of the situation of cervical cancer in the Region of the Americas

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Global HPV Vaccinations Lead Sales and Decreasing Cervical Cancer Cases

Karen McClorey Hackett — Wed, 05 Feb 2025 19:53:53 +0000

Reviewer:

Robert Carlson, MD

Over the past decades, human papillomavirus (HPV) vaccines have been approved in numerous countries, producing two very positive trends.

According to Merck's financial results for 2024, its market-leading HPV vaccines, GARDASIL and GARDASIL 9, produced $8.6 billion in sales, with higher demand in most international regions, particularly Japan.

Robert M. Davis, Merck's chairman and chief executive officer, commented in a press release on February 4, 2025, "We're continuing to progress our pipeline, advance key clinical programs, and augment our pipeline through promising business development. Our business remains well-positioned thanks to the dedication of our talented global team, and I am more confident than ever in our long-term growth potential."

While HPV vaccines have proven to reduce several related cancers, the downward trend in cervical cancer may be its most significant achievement.

A recent Medical University of South Carolina Research Letter published by JAMA showed a dramatic decline in cervical cancer rates among young women. The data indicated a 12% per year decline (overall, 65% reduction) in cervical cancer incidence from 2012 to 2019.

These data did not surprise University of Colorado Cancer Center member Jill Alldredge, M.D., assistant professor of gynecologic oncology in the CU School of Medicine.

In a media release on January 17, 2025, Dr. Alldredge stated she agrees with the study's authors that the primary reason for the drop is the broader adoption of the HPV vaccine over the past 20 years.

"This is something we anticipated would happen as HPV vaccination rollout increased nationally," says Alldredge. "It's fantastic to see that that's starting to materialize as planned."

Initially recommended for women between the ages of 9 and 26, HPV vaccinations have expanded, and the vaccine is now targeted at both women/men from ages 9 to 45.

"A lot of people who didn't have access to it as kids can now get it as adults, and it's available to men and women," Alldredge says. "That increasing breadth of accessibility to the vaccine is now resulting in fewer cervical cancers, which was exactly the hope."

However, there are more significant vaccination opportunities in 2025.

The Colorado rural population lags in HPV vaccination rates.

Only 10%–30% of the population completes the entire vaccine cycle, compared to around 60% in the rest of Colorado.

With these clinical results and under-vaccinated populations, we can expect Merck to continue reporting significant HPV vaccine sales.

As of February 2025, HPV vaccines are generally offered at health clinics and pharmacies in the United States.

Sub Title:

HPV vaccination offered at clinics and pharmacies in 2025

References:

Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results

JAMA - Cervical Cancer Mortality Among US Women Younger Than 25 Years, 1992-2021

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by TréVoy Kelly

One-Dose HPV Vaccinations Save More Women from Cervical Cancer

Karen McClorey Hackett — Sun, 17 Nov 2024 18:48:21 +0000

Reviewer:

Robert Carlson, MD

Four years ago to the day, 194 countries resolved to eliminate cervical cancer, with the World Health Organization (WHO) leading a global strategy. Since then, significant progress has been made.

According to the WHO, on November 17, 2024, at least 144 countries had introduced a human papillomavirus (HPV) vaccine, and over 60 countries now include HPV testing in their cervical screening programs, the fourth most common cancer in women.

As world leaders arrive in Brazil for the G20 Summit this weekend, health prevention advocates are joining the WHO to mobilize efforts on a worldwide "Day of Action for Cervical Cancer Elimination."

"I thank all the health workers who are playing a critical role in this global effort," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a media release.

"Only with strong leadership and sustained investment can we achieve our shared goal of equitable access for communities most in need."

In 2022, the WHO aimed to fully vaccinate 90% of women with the HPV vaccine by age 15.

While the 90% vaccination goal has not been achieved, the WHO has led an expansion in access to HPV vaccines and a reduction in the suggested number of doses.

Data released in July 2024 indicates that the one-dose HPV vaccine coverage among young women increased from 20% in 2022 to 27% in 2023.

In 2023, 37 countries were implementing the single-dose schedule.

WHO estimates that the single-dose schedule adoption has resulted in at least 6 million additional young women being reached with HPV vaccines in 2023.

And as of late 2024, 57 countries are implementing the single-dose schedule.

Furthermore, the WHO took action to increase HPV vaccine supply.

WHO announced in October that a fourth WHO-prequalified HPV vaccine product, Cecolin®, has been confirmed for use in a single-dose schedule. This important milestone will contribute to improving the sustainable supply of HPV vaccines—allowing more women to be reached with the vaccines that prevent cervical cancer, says the WHO.

Dr Kate O'Brien, Director of the Department of Immunization, Vaccines and Biologicals at WHO, commented in a previous press release, "Given the continuing supply challenges, this addition of single-dose vaccine product means countries will have greater choice of vaccines to reach more girls."

In the United States, HPV causes about 37,800 cancer cases. In addition to cervical cancer, HPV causes cancers of the vagina, vulva, penis, anus, rectum, and oropharynx.

HPV vaccinations are recommended for two and three doses and are available at health clinics and pharmacies.

Sub Title:

37 countries offer one dose HPV vaccines for young women

References:

2020 - Global strategy to accelerate the elimination of cervical cancer

WHO and partners rally cervical cancer elimination efforts

WHO adds an HPV vaccine for single-dose use

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by Keith Johnston

Reduce Cervical Cancer in the Americas with One HPV Dose

Karen McClorey Hackett — Mon, 30 Sep 2024 18:21:18 +0000

Reviewer:

Robert Carlson, MD

A recent report on cervical cancer in the region of the Americas published by the Pan American Health Organization (PAHO) urges countries to implement innovations in cervical cancer prevention, testing, and treatment to achieve the elimination goals by 2030.

The Latin America and the Caribbean region accounts for 80% of all cases in the Americas and 84% of deaths, making it the region with the second-highest rates of cervical cancer cases and deaths in the world, after Africa.

The primary cause of cervical cancer is persistent infection with high-risk types of human papillomaviruses (HPV), which can be prevented through vaccination.

According to the new PAHO report, while 32 of 35 countries of the Americas have introduced the HPV vaccine into their national immunization schedules, coverage varies widely from less than 10% to over 80%.

To tackle this variance, PAHO recommends implementing strategies to increase coverage, such as switching to a one-dose schedule.

“While increasing HPV vaccination coverage is key to eliminating cervical cancer, countries of the Americas must also urgently step up efforts to shift from conventional PAP to HPV testing and improve cancer treatment,” stated Dr. Anselm Hennis, Director of Noncommunicable Diseases and Mental Health at PAHO, in WHO press release on September 26, 2024.

As of September 2024, 21 of 35 countries are implementing communications campaigns to raise awareness around the HPV vaccine. Countries should also strengthen vaccine delivery strategies, ensure outreach efforts for those in hard-to-reach areas, and work alongside ministries of education to encourage school vaccination with at least one dose of HPV vaccine by age 15.

In 2020, member states of the World Health Organization (WHO) adopted the Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem.

The WHO strategy outlines three objectives for 2030: 90% HPV vaccination coverage in girls by the age of 15, 70% screening coverage of women with high-performance tests by the ages of 35 and 45 years, and 90% treatment of precancerous lesions and management of invasive cancer cases (known as the 90-70-90 targets).

As of September 2024, six licensed HPV vaccines protect males and females against cancers caused by HPV. These bivalent, quadrivalent, and nonavalent HPV vaccines are available in 140 countries.

In the United States, the CDC updated HPV vaccination schedules in 2024.

Sub Title:

HPV vaccinations offered at pharmacies and clinics in 2024

Reference:

PAHO - HPV vaccinations - Sept 2024

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Northern Texas Leads Lower HPV Vaccination Rate

Karen McClorey Hackett — Mon, 09 Sep 2024 21:44:24 +0000

Reviewer:

Robert Carlson, MD

Since human papillomavirus (HPV) vaccines were first recommended in the United States in 2006, uptake rates increased for most of the years.

Recent data indicates that HPV vaccination rates have recently stalled around 62%, with some states reporting variable rates segmented by urban and rural counties.

According to an Original Investigation published by the JAMA Network Open, northern Texas's counties and health service regions (HSR) have a higher incidence of HPV-related cancers and lower HPV vaccination rates than elsewhere in the state.

'Some counties and HSRs in west, east, and south Texas are doing well in vaccination coverage, whereas others are lagging,' stated these researchers.

Published on September 5, 2024, this study found that across 254 counties and 8 HSRs in Texas, HPV vaccination series initiation rates, up-to-date status, and the incidence of HPV-related cancer varied widely.

According to the National Immunization Survey-Teen in 2022, the estimated HPV vaccination coverage among teenagers aged 13 to 17 years in Texas is 58.5%, which ranks Texas 48th in the U.S.

These researchers reported that the mean 2021 to 2022 county-level HPV vaccination series initiation estimates ranged from 6.3% to 69.1% for females and 7.0% to 77.6% for male children and teenagers aged 9 to 17.

Up-to-date estimates of Texas county-level vaccination were generally lower than initiation estimates, ranging from 1.6% to 30.4% for females and 2.1% to 34.8% for male children and teenagers.

This data confirms previous studies' findings that Texas has one of the lowest HPV vaccination rates in the U.S. Other states with lower overall vaccination rates include Mississippi, Alaska, Kentucky, and Oklahoma.

In most cases, HPV goes away on its own and does not cause any health problems, says the Texas Department of State Health Services. But when HPV does not go away, it can lead to serious health problems, including cancer.

With the Vaccines for Children (VFC) program, the cost of HPV vaccinations should not be a concern in Texas or any state. The HPV vaccine is available to all uninsured or underinsured males and females between the ages of 9 and 18 through the Texas VFC program.

The U.S. CDC recently wrote, 'Healthcare providers should make strong recommendations for all routine vaccines and verify that adolescents, particularly those eligible for the VFC program, are up to date with all recommended vaccines.'

In Texas, HPV vaccines are offered at health clinics and pharmacies.

Sub Title:

Texas ranks 48th in HPV vaccinations

References:

Human Papillomavirus Vaccination and Human Papillomavirus–Related Cancer Rates

US CDC HPV vaccinations 2022

National Immunization Survey-Teen, United States, 2023

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US CDC HPV vaccination trends 2024

Innovative Cancer Treatment Through Targeted Bacterial Vaccines

Donald Hackett — Sun, 01 Sep 2024 19:36:00 +0000

Reviewer:

Robert Carlson, MD

Bacterial vaccines offer a promising solution by targeting specific pathogens without harming the broader microbiome. However, researchers wrote on August 30, 2024, that developing effective bacterial vaccines is challenging due to the weak immunogenicity of major bacterial antigens.

This emerging antibacterial nanovaccine delivers enhanced chemotherapy by selectively eliminating tumor-colonizing bacteria.

In Science Bulletin, Volume 69, Issue 16, these researchers commented that although adjuvants can enhance the humoral response, effective vaccines require robust activation of the antigen-specific cellular response to eliminate intracellular pathogens.

Hence, there is a strong desire for an antibacterial vaccine capable of eliciting robust immune responses to eradicate F. nucleatum while selectively preserving other microbiota.

To address these challenges, a research team led by Professor Qian Chen from Soochow University (Institute of Functional Nano & Soft Materials, FUNSOM) proposed a novel bacterial vaccine (LipoFM-CPG) by inserting cholesterol-modified agonist CpG into F.nucleatum derived membranes.

Compared with traditional emulsions with inactivated bacteria and Alum adjuvant, LipoFM-CPG co-delivers antigens and adjuvants, significantly enhancing dendritic cell maturation and antigen presentation.

This stimulation leads to robust antibacterial cellular and humoral immune responses.

The nanovaccine has demonstrated the ability to selectively and efficiently eradicate F. nucleatum, enhancing chemotherapy efficacy and reducing cancer metastasis in F. nucleatum-infected CRC.

Notably, compared to systemic or oral antibiotics, the nanovaccine has a negligible impact on the intratumoral and gut microbiota.

This nanovaccine, with a simple manufacturing process, strong immunogenicity, and desired biocompatibility, should be a promising technology for selectively eliminating intratumoral bacteria and improving the therapeutic effect in bacteria-infected cancer.

Overall, this work represents the rational application of bacterial nanovaccine and provides a blueprint for future development in enhancing the antitumor effect against bacterial-infected cancer.

The study's authors declare that they have no conflict of interest. The National Research Programs of China partially supported this article.

Sub Title:

Novel bacterial nanovaccine LipoFM-CPG inserts cholesterol-modified agonist CpG into F.nucleatum derived membranes.

Reference:

An emerging antibacterial nanovaccine for enhanced chemotherapy by selectively eliminating tumor-colonizing bacteria

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Science China Press 2024

HPV Cancer Vaccinations Stall for Second Year

Karen McClorey Hackett — Fri, 23 Aug 2024 20:49:31 +0000

Reviewer:

Robert Carlson, MD

New data published by the U.S. Centers for Disease Control and Prevention (CDC) indicates that Human papillomavirus (HPV) vaccination coverage among adolescents in the United States did not increase.

Published in the Morbidity and Mortality Weekly Report (73(33);715–721) on August 22, 2024, the CDC's National Center for Immunization and Respiratory Diseases data shows that HPV vaccinations decreased slightly last year, reaching 61.4% in 2023, lower than the 62.6% reported in 2022.

This is concerning because HPV vaccines are a crucial public health tool in preventing most cervical cancers in women.

Worldwide, cervical cancer is the fourth most common cancer among women.

HPV vaccination has been reported to prevent about 92% of HPV-attributable cancers.

Contrary to this CDC-reported trend, Merck announced in late July 2024 that its HPV vaccine products experienced sales increases.

Merck confirmed a 4% growth in the market-leading GARDSAIL / GARDASIL 9 HPV vaccines primarily due to higher sales in the U.S.

As of August 23, 2024, HPV vaccines remain available for eligible people at most clinics and pharmacies in the U.S.

Furthermore, the CDC's Vaccines for Children program provides recommended vaccines at no cost to eligible children and adolescents. Overall, vaccination coverage among VFC-eligible adolescents remained stable last year.

Sub Title:

Vaccination can prevent HPV cancers

References:

Human Papillomavirus Vaccination Coverage Among Adolescent Girls Aged 13–17 Years

National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2023

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US CDC HPV vaccination trends August 2024

More Bladder Cancer Patients Can Access Innovative Therapy

Donald Hackett — Mon, 12 Aug 2024 20:07:13 +0000

Reviewer:

Robert Carlson, MD

While the 100-year-old BCG vaccine has been used to treat certain bladder cancer pages for years, many patients were seeking a more efficient therapy.

Earlier in 2024, Anktiva® (nogapendekin alfa) became a U.S. FDA-approved first-in-class interleukin-15 agonist IgG1 fusion complex consisting of an IL-15 mutant fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells.

As of August 12, 2024, progress has been made in expanding market access of ANKTIVA to patients through both commercial and government insurance programs in the United States.

ImmunityBio, Inc. anticipates achieving agreements to extend the lives covered in the coming months. It is currently working with the top insurance plans and academic institutions in the U.S. to increase ANKTIVA accessibility.

Additionally, ImmunityBio announced plans to expand its bladder cancer program globally, notably in the European Union, India, and the United Kingdom.

New regulatory filings include 30 countries, 27 in the EU and three in the European Economic Area. The company anticipates completing the submission of the initial EMA filing in Q4 2024.

“The approval of ANKTIVA with a first-in-class mechanism of action of activating natural killer cells, CD8 killer T cells, and memory T cells, marks the beginning of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release.

“The quest of developing a cancer vaccine by orchestrating the innate and adaptive immune system has begun, and we look forward to developing ANKTIVA as the foundation across multiple tumor types and even in subjects without cancer but at high risk, such as in Lynch syndrome.”

Recently, ImmunityBio’s commercial team executed key market access initiatives, which have resulted in more than 100 million medical lives being covered by medical reimbursement policies that include eligibility for ANKTIVA reimbursement since the therapeutic became available and was added to the National Comprehensive Cancer Network guidelines in May 2024.

“We are encouraged by the keen interest that physicians are showing in ANKTIVA as a treatment option for their patients with non-muscle invasive bladder cancer with carcinoma in situ, as well as by our conversations with payers as we see them adding our approved product into their policies,” commented Richard Adcock, President and CEO of ImmunityBio.

“Our team continues to focus on streamlining the processes for bringing this specialty medication to more qualified patients. We are acutely aware that with cancer, every day matters.”

From a clinical perspective, ImmunityBio continues to add U.S. sites to the BCG naïve trial (QUILT-2.005) and enroll patients in the study.

Further, the company has received regulatory approval to begin patient enrollment in QUILT-2.005 in India, and the necessary medicines have been successfully imported into the country for use in the trial. Additionally, the company plans to submit an application to the South African regulatory authorities in Q3 2024 to initiate the QUILT-2.005 trial in that country.

Moreover, on April 25, 2024, the company announced positive overall survival results of ANKTIVA combined with checkpoint inhibitors in NSCLC from the completed QUILT 3.055 trial. In that trial, the median overall survival was almost double that of standard-of-care chemotherapy in second and third-line NSCLC patients whose cancer did not respond to checkpoint inhibitors, with or without chemotherapy.

After meeting with the FDA in June 2024 to discuss a path to a registration filing for ANKTIVA plus checkpoint inhibitors for this indication, the company is preparing additional study information responsive to the Agency’s input on an NSCLC pivotal trial.

ImmunityBio plans a subsequent meeting with the FDA to discuss the study endpoints for potential approval on various timelines.

Sub Title:

Access to ANKTIVA increases through commercial and government insurance programs

Reference:

ImmunityBio’s ANKTIVA® Now Covered By More Than a Dozen Insurance Plans

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Plain Language Review Explains Innovative Bladder Cancer Therapy

Donald Hackett — Thu, 18 Jul 2024 23:06:11 +0000

Reviewer:

Robert Carlson, MD

A recent Plain Language Summary of Publication stated ImmunityBio Inc.'s newly approved Anktiva® (N-803) plus Bacillus Calmette-Guérin (BCG) vaccine combination therapy produced positive results for certain bladder cancer patients.

The review of two company-sponsored clinical trials concluded that the addition of the IL-15 superagonist N-803 to BCG therapy produces a high rate of success in eliminating non-muscle invasive bladder cancer in both BCG-naive and BCG-unresponsive patients, with long-lasting effects that allow patients to avoid surgical removal of the bladder.

This clinical information is vital since bladder cancer treatment costs about $2 billion annually.

One small study was a Phase 1b study that tested increasing doses of N-803 in combination with the same dose of BCG in people with NMIBC who had never received BCG previously (BCG-naive).

The other study is a Phase 2/3 study of N-803 and BCG in people with NMIBC whose cancer wasn't eliminated by BCG alone (BCG unresponsive).

Treatments were delivered directly into the bladder once a week for six consecutive weeks.

In the Phase 1b study, the nine participants were split into three groups of 3 who received 100, 200, or 400 μg N-803 doses along with a standard 50 mg dose of BCG. In the Phase 2/3 study, one group (cohort A) of participants with carcinoma in situ disease and another group (cohort B) with papillary disease were treated with 400 μg N-803 plus 50 mg BCG. There was also a cohort C that received only 400 μg N-803.

Published by the journal Taylor and Francis Online on July 2, 2024, N-803 plus BCG eliminated NMIBC in all nine BCG-naive participants, and the effects were long-lasting, with participants remaining NMIBC-free for a range of 8.3 to 9.2 years.

In April 2024, ImmunityBio announced that the U.S. Food and Drug Administration had approved ANKTIVA plus BCG. On June 20, 2024, ImmunityBio announced the initial treatments in the U.S. had begun.

The 100-year-old BCG vaccine has been a well-established immunotherapy for NMIBC since the 1970s.

The authors of this review are affiliated with ImmunityBio, Inc., the manufacturer of N-803 and sponsor of the studies.

Sub Title:

Adding IL-15 superagonist N-803 to BCG therapy reduces non-muscle invasive bladder cancer

Reference:

A Plain Language Review

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Friday, July 19, 2024 - 06:15

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ImmunityBio website July 2024

Some Seniors Get HPV Too

Karen McClorey Hackett — Wed, 10 Jul 2024 13:48:04 +0000

Reviewer:

Robert Carlson, MD

According to a new study from FAIR Health, those aged 65 and older were the group with the most significant increase (23.8%) in sexually transmitted disease (STD) diagnoses from 2020-2023.

Among the other FAIR Health findings, people 65 and older had the most significant increase (32.2%) in human papillomavirus (HPV) diagnoses.

Furthermore, 21.9% of HPV cases occurred among patients aged 55 to 64.

However, Fair Health's data did not disclose if these HPV cases were in adults who had been vaccinated, when they were vaccinated, or were unvaccinated.

Based on data analysis from FAIR Health’s repository of over 47 billion commercial healthcare claim records, the study results were announced on July 8, 2024.

In a press release, FAIR Health President Robin Gelburd stated, “It is central to FAIR Health’s mission to use our vast repository of claims data to provide data on public health concerns and support research by others."

"We hope this information brings greater clarity to the incidence of STDs.”

The FAIR Health findings are consistent with data recently released by the U.S. Centers for Disease Control and Prevention (CDC), showing rising rates of STDs among people aged 55 and older from 2012 to 2022.

The CDC's HPV vaccination schedule for 2024 includes a three-dose HPV series (0, 1-2, 6 months) for persons who initiate vaccination at ages 15 through 45 years and for immunocompromised persons.

The 9-valent HPV vaccine has been U.S. FDA approved for years and protects against HPV types 16 and 18, which cause about 66% of cervical cancers and most other HPV-attributable cancers in the U.S., and five additional cancer-causing types, which account for about 15% of cervical cancers. It also protects against HPV 6 and 11, which cause most anogenital warts. says the CDC.

FAIR Health is a national, independent nonprofit organization.

Sub Title:

HPV diagnoses increase in those over 65 years of age

References:

Fair Health study - July 8, 2024

CDC HPV vaccination schedule 2024

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Age Groups:

Seniors

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Fair Health - percentage of patients with STD diagnoses from 2020 to 2023

Bladder Cancer Immunotherapy First Commercial Doses Administered

Karen McClorey Hackett — Mon, 24 Jun 2024 19:18:58 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Over the past two months, people confronting a specific type of bladder cancer have received some optimistic news.

Multiple cancer patients have been treated with ANKTIVA® less than eight weeks after the U.S. FDA approved ImmunityBio Inc.’s approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.

On June 20, 2024, ImmunityBio confirmed the initial treatments with ANKTIVA in multiple patients in the United States. The company previously announced that ANKTIVA Drug Substance was released with two-year storage stability data sufficient for 170,000 doses.

And urologists treating eligible bladder cancer patients in the U.S. can now access the ImmunityBio CARE™ support program, which supports healthcare professionals and patients through comprehensive resources, from benefits investigation to billing assistance.

“We are pleased to see interest in our bladder cancer therapeutic among healthcare providers and are encouraged by the number of health plans covering this first-in-class therapy. These updates underscore the importance of a new treatment option for this difficult-to-treat cancer, and we’re actively working to increase access to this treatment for as many patients as we can," wrote Richard Adcock, President & CEO of ImmunityBio, in a message to Precision Vaccinations.

ImmunityBio's Cancer Moonshot program (QUILT clinical trials) launched in January 2016.

ANKTIVA's commercial launch in 2024 initiates the next era of immunotherapy beyond checkpoint inhibitors based on cytokines and natural killer (NK) cells.

The company says the drug’s novel mechanism of action activates the body’s immune system of NK and killer T cells to attack BCG-resistant tumor cells and induce memory T cells, resulting in a long duration of complete response exceeding 47 months.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells.

This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

The proliferation of the trifecta of these immune-killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable, complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

In the U.S., the American Cancer Society (ACS) estimates there will be 83,190 new bladder cancer cases in 2024. The annual projected cost of treatment is over $2 billion. And the average treatment cost per patient ranges from $19,521 to $169,533 (metastatic disease).

In 2024, Anktiva is priced at $35,800 per dose, separate from the cost of Merck TICE® BCG vaccines.

Furthermore, the ACS projects over 16,000 deaths from bladder cancer this year.

More information for patients and healthcare professionals is available on Anktiva.com.

Sub Title:

ImmunityBio ANKTIVA initiates the new era of immunotherapy beyond checkpoint inhibitors

References:

ImmunityBio Announces Insurance Coverage of ANKTIVA®

ACS - Treating Bladder Cancer

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NCI - Bladder cancer 2024

100 Year Old Vaccine Protects People From Infectious Diseases

Donald Hackett — Fri, 14 Jun 2024 02:26:31 +0000

Reviewer:

Robert Carlson, MD

New research published by investigators at Massachusetts General Hospital (MGH) shows that the 100-year-old Bacillus Calmette-Guérin (BCG) vaccine, originally developed to prevent tuberculosis, protects individuals with type 1 diabetes from infectious diseases.

Two back-to-back randomized double-blinded placebo-controlled trials found that the BCG vaccine provided continuous protection for nearly the entire pandemic in the U.S., regardless of the SARS-CoV-2 variant.

The MGH Phase II and Phase III clinical trials testing BCG differed from other BCG trials in important ways.

Instead of receiving one dose of BCG, participants received five or six doses of a particularly potent strain of BCG vaccine.

“Individuals with type 1 diabetes are highly susceptible to infectious diseases and had worse outcomes when they were infected with the SARS-CoV-2 virus,” said senior author Denise Faustman, MD, PhD, director of the Immunobiology Laboratory at MGH and an Associate Professor of Medicine at Harvard Medical School, in a press release.

“....we’ve shown that BCG can protect type 1 diabetics from COVID-19 and other infectious diseases.”

The 18-month Phase III trial, published in iScience, was conducted when the highly transmissible Omicron variant was circulating.

A 15-month Phase II trial was conducted early in the pandemic; the results of that trial were published in Cell Reports Medicine.

During the COVID-19 pandemic, several international trials tested whether BCG, given as a single shot or booster to previously BCG-vaccinated adults, protected them from infection and COVID-19.

However, results from these COVID-19 booster trials were mixed in people previously vaccinated with BCG. Five randomized trials showed efficacy, and seven trials showed no benefit.

“Our study showed that the BCG vaccine neither increased the efficacy of the COVID-19 vaccine nor was it harmful to those who received the COVID-19 vaccine,” said Faustman.

The U.S. participants were followed for 36 months instead of weeks or months.

“We know that in people who are naïve to BCG vaccine, the off-target effects can take at least two years to achieve full protection,” said Faustman. “Giving multiple doses of the vaccine may speed up that process.”

The MGH trials enrolled 141 participants with type 1 diabetes; 93 people in the treatment group received five or six doses of BCG vaccine, and the 48 individuals in the placebo group received sham vaccine and were followed for 36 months to capture diverse COVID-19 genetic variants and many infectious disease exposures.

During the earlier Phase II trial (January 2020 to April 2021), when the virus was more lethal but less transmissible, the BCG vaccine’s efficacy was 92%, comparable to the efficacy of COVID-19 vaccines in healthy adults.

Over 34 months of the pandemic, the BCG vaccine had a significant efficacy of 54.3%.

The investigators also found that the BCG-treated participants had lower viral, bacterial, and fungal infection rates.

This research expanded the extensive global clinical trial database, showing that BCG administered to newborns works as a platform for all infectious diseases, maybe for decades.

In the U.S., BCG vaccinations have been an effective treatment for bladder cancer for several years.

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. This research was supported by The Iacocca Foundation, Boston, MASS. No conflicts of interest were disclosed.

Sub Title:

Multi-dose BCG vaccine protects against tuberculosis, infectious diseases and bladder cancer

Reference:

BCG vaccines protect against COVID-19 and infectious diseases

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iScience May 2024

Should Schools Offer HPV Vaccinations

Karen McClorey Hackett — Fri, 24 May 2024 16:48:24 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

A recent study suggests that providing vaccinations at school can effectively reduce preventable cancers. School-based vaccination programs have successfully demonstrated value in reducing influenza and meningitis.

In a cluster randomized PrevHPV clinical trial involving 91 municipalities, it was found that offering free human papillomavirus (HPV) vaccinations to students on school premises consistently and significantly increased vaccination coverage.

Published by the JAMA Open Network on May 23, 2024, this Original Investigation did not find a significant increase in HPV vaccination rates after training general practitioners or educating and motivating adolescents and their parents.

Furthermore, at-school vaccination was shown to have a similar magnitude of effectiveness among both sexes.

While most media attention has been focused on reducing cervical cancer in women, vaccinating men has been shown to reduce other cancers. This study found HPV-related cancers occurred in unvaccinated men (57 vs 26), which translated into a 54% risk reduction.

According to Nancy Lapid, reporting for Reuters on May 23, 2024, vaccinated males had lower rates of any HPV-related cancer and of head and neck cancers (3.4 and 2.8 cases, respectively, per 100,000 vaccinated patients, compared with 7.5 and 6.3, respectively, per 100,000 unvaccinated patients).

This new study is scheduled for presentation at the upcoming American Society of Clinical Oncology meeting on May 31, 2024.

A recent example is Rio Grande City Consolidated Independent School District in Texas, where a school-based vaccination program dramatically improved HPV vaccination rates. Initiation rates increased to 65.5%–69%, and completion rates increased to 41.5%–43.1% in 2019.

Previously, Dr. Katharine Price, a medical oncologist with the Mayo Clinic Comprehensive Cancer Center, commented in March 2024 that while HPV-related throat cancer is often curable, prevention is best.

Throat cancer is the most common HPV-associated cancer in men, and the rate of infection continues to increase.

"It's much better to get a vaccine that's safe, that has no long-term side effects or complications than to go through surgery, radiation, chemotherapy," says Dr. Price.

As of late May 2024, HPV vaccines are generally available at most clinics and pharmacies in the U.S.

Sub Title:

HPV vaccination reduces throat cancer rates in men

References:

Effectiveness of a School- and Primary Care–Based HPV Vaccination Intervention

American Society of Clinical Oncology meeting

UTMB School-Based HPV Vaccination Program

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by Elena We

Enhanced Recombinant BCG Vaccine Awaits FDA Approval

Donald Hackett — Sat, 04 May 2024 14:57:43 +0000

Reviewer:

Robert Carlson, MD

While the standard Bacillus Calmette-Guerin (sBCG) vaccine has been in use for about 100 years and administered over 4 billion times, its clinical efficacy is debatable.

On May 2, 2024, the Serum Institute of India (SII) confirmed that it is developing a new recombinant BCG vaccine (iBCG) to enhance efficacy and address the current supply shortages.

Founded in 1966, SII, the world's largest vaccine producer, has implemented two gene modifications to improve sBCG's immunogenicity and safety, creating iBCG.

The next-generation recombinant iBCG has completed Phase1/2 human clinical studies in Europe.

According to SII's press release, iBCG has demonstrated potent immunogenicity with CD8+ and CD4+ stimulation and improved safety compared to standard BCG in European clinical trials.

Furthermore, this iBCG vaccine should provide a long-term solution for the recently approved bladder cancer vaccine.

And iBCG is intended for use with ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept-pmln) for currently approved non-muscle invasive bladder cancer (NMIBC) and potential future indications.

"The collaboration between SII and Immunity Bio will undoubtedly transform how we approach cancer treatment. It will improve global access to BCG, and at the same time, this unique therapy is the key to achieving a complete solution for bladder cancer. We are truly excited to witness the incredible impact this collaboration will have on improving patient outcomes and saving countless lives," said Mr. Adar C. Poonawalla, CEO of SII, in a press release.

Originally used as a tuberculosis vaccine, BCG administered via intravesical instillation (delivery to the bladder via a catheter) has been the standard of care for patients with NMIBCr since 1977. BCG is a benign bacterium that induces an immune response in the bladder near the cancer cells, leading to cancer clearance in many patients.

"The scale and quality of vaccines that the Serum Institute manufacturers are unparalleled, and we are honored to partner with Dr. Poonawalla and his leadership team on this important initiative," added Richard Adcock, President and CEO of ImmunityBio.

"By providing another option for BCG, we believe more NMIBC patients will benefit from this proven treatment as both a monotherapy and a combination therapy with ANTKIVA."

ImmunityBio plans to conduct clinical trials to study iBCG and sBCG manufactured by SII in combination with ANKTIVA to treat different types of bladder and other cancers.

The supply of BCG is expected to be available once the protocol for the trial has been authorized by the U.S. FDA. ImmunityBio plans to submit the protocol to the FDA and global regulatory bodies in the next 30 days.

Merck & Co. is currently the only manufacturer of the BCG TICE® vaccine approved for use in the U.S. to prevent tuberculosis and treat certain bladder cancer patients. BCG is limitedly available in the U.S.

Globally, about 16 versions of BCG are in use to prevent tuberculosis in 2024.

Sub Title:

Serum Institute of India produces recombinant BCG vaccine

References:

ImmunityBio, Serum Institute of India Agree on an Exclusive Arrangement for Global Supply of Bacillus Calmette-Guerin

Global Supply of Bacillus Calmette-Guerin (BCG) Across All Cancer Types

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