Cancer Vaccine Breaking News

Cancer vaccine breaking news brought to you by Vax Before Cancer.

Feb 28, 2021 • 7:55 am CST

A 20-year study by Tata Memorial Hospital(TMC) in Mumbai, India, proved that clinical breast examination is a woman-friendly and cost-effective alternative to mammography to check for breast cancer.

Dr.Rajendra Badwe, Director TMC, a co-author of the study published on February 25, 2021, said in a press release, “If implemented as a breast screening method in India, CBE would save 15,000 deaths from breast cancer each year and 40,000 lives globally in low and middle-income countries (LMICs). All this at a fraction of screening cost, thereby reducing stress on the overburdened healthcare systems.”

The Mumbai study is clearly a stimulus for more research to help mitigate the problems of over-detection and overtreatment. Some studies further indicate that about 15-35% of women are non-compliant to mammography due to certain factors like physical discomfort, fear of the procedure, and delay in receiving results.

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Feb 25, 2021 • 9:11 am CST

California-based AIVITA Biomedical, Inc. recently announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1, in patients with newly diagnosed glioblastoma (GBM). The analysis focused on 57 patients scheduled to receive up to eight doses of AV-GBM-1 over approximately six months.

At the time of the analysis in 2020, surviving patients had completed therapy and had been followed between 7.2 and 24.2 months. The median length of progression-free survival was 10.0 months (95% CI 8.5 to 11.5 months), an improvement of approximately 45% compared to a median of 6.9 months (95% CI 5.8 to 8.2 months) progression-free survival in the landmark study that established the standard of care for patients with newly diagnosed GBM.

This represented a 38% reduction in risk of progression or death at 6.9 months of treatment.

“The improvement in GBM patients who were treated with AV-GBM-1, compared to studies with the standard of care, is a very promising indication that our therapy confers a benefit to patients in need,” commented Robert O. Dillman, M.D., chief medical officer of AIVITA, in a press statement.

AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. 

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Feb 24, 2021 • 11:25 am CST

A new technology, NV-VPAC1™, may help doctors more accurately diagnose childhood cancers, according to Utah-based developer NuView Life Sciences. Today’s diagnostic tools often rely on invasive procedures, like surgical biopsies, or scans that use radiation to pinpoint cancers in children accurately, says the company.

For example, if a child has suspected kidney cancer, doctors would only need a voided urine specimen to test for the presence of and positively identify shed cancer cells.

NV-VPAC1, a peptide analog by pairing a diagnostic imaging positron emitter, uses a shed cell assay that targets the vasoactive intestinal peptide receptor type 1. This analog was originally developed by Drs. Madhukar Thakur and Leonard Gomella at Thomas Jefferson University.

Paul Crowe, CEO of NuView Life Sciences, commented in a press release issued on February 8, 2021, “Many of the current diagnostic tests and treatment options for pediatric cancers are based on information derived from methods used in adult patients and may affect kids negatively."

"When our clinical trials resume [post-COVID-19], we hope to show that our proprietary technology, NV-VPAC1, actually helps make cancer diagnosis easier, detected earlier, and lead to more precise treatments that are individualized for younger patients.”

Founded in 2005, NuView Life Sciences is a clinical-stage oncology company located in Park City, Utah, advancing the way cancer is diagnosed and treated in our modern healthcare system.

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Feb 24, 2021 • 9:34 am CST

Ontario-based Theralase Technologies Inc., a clinical-stage pharmaceutical company focused on the research and development of light-activated Photo Dynamic Compounds and their associated drug formulations used to safely and effectively destroy various cancers, bacteria, and viruses, announced on February 24, 2021, that the University of Wisconsin Health-Madison has received site Institutional Review Board (“IRB”) approval to commence a pivotal Phase II Non-Muscle Invasive Bladder Cancer Clinical Study to enroll and treat patients with Bacillus Calmette Guerin (BCG) - Unresponsive Carcinoma In-Situ or who are intolerant to BCG Therapy.

The Study evaluates TLD-1433, Theralase’s lead PDC for the primary endpoint of safety and tolerability, a secondary endpoint of pharmacokinetics (movement and exit of a drug within tissue), and an exploratory endpoint of efficacy, primarily at 90 days and secondarily at 180 days post-treatment.

This marks the fifth US clinical site that has successfully obtained site IRB approval through a central IRB. One additional US clinical study site is pending IRB site approval in 1Q2021.

Shawn Shirazi, Ph.D., Chief Executive Officer, Theralase, stated in a press statement, “Each Study II will aid in our objective of enrolling and treating 10 patients in early 2021 to achieve a total of 25 patients for potential Breakthrough Designation Approval and approximately 75 to 100 additional patients in 2021 / 2022.” 

To date, 15 patients have been treated in Study II. 

BCG is used in many countries to prevent childhood tuberculous, meningitis, bladder cancer, and other diseases. The BCG vaccine is not generally recommended for use in the USA because of the low risk of infection with Mycobacterium tuberculosis, says the CDC. BCG should only be considered for very select people who meet specific criteria.

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Feb 23, 2021 • 10:53 am CST

California-based GRAIL, Inc. announced an agreement with Quest Diagnostics (NYSE: DGX) to provide phlebotomy services to support Galleri™, a multi-cancer early detection blood test. 

In studies, the Galleri test has shown the ability to detect multiple cancers through a simple blood draw. Most of these cancers cannot be detected through current screening paradigms.

Galleri is available under investigational use in PATHFINDER, GRAIL’s perspective, an interventional study evaluating the implementation of Galleri in clinical practice. Galleri is also expected to be offered to eligible patients in the United Kingdom.

“Today, the majority of cancers go undetected until too late when outcomes are often deadly, and we believe Galleri could offer a unique and potentially life-saving solution by finding multiple types of cancers earlier,” commented Dr. Joshua Ofman, CMO and head of external affairs at GRAIL. “Our agreement with Quest will help us support convenient access to blood collection for patients and healthcare providers.”  

Quest Diagnostics maintains approximately 2,200 patient service centers and, through its ExamOne business, 5,000 mobile phlebotomists with expertise in at-home visits. Quest’s phlebotomy network will help provide blood specimen collection for Galleri in the USA once the test becomes available this year.

GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. 

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Feb 23, 2021 • 9:05 am CST

Massachusetts-based Elicio Therapeutics announced it had received Investigational New Drug clearance from the U.S. Food and Drug Administration for ELI-002, an Amphiphile (AMP) KRAS therapeutic vaccine containing AMP mKRAS peptides and a proprietary AMP CpG adjuvant.

The company’s novel therapeutic vaccine targets KRAS mutations that drive 99% of all KRAS-driven cancers.

KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, 30% of non-small cell lung, 30% of bile duct, 14% of endometrial, and 14% of ovarian cancers.

“Previous vaccine approaches utilizing synthetic peptides have not effectively targeted the critical immune cells residing in the lymph nodes and have elicited only weak or undetectable immune responses in patients,” said Christopher Haqq, M.D., Ph.D., Elicio’s EVP, Head of Research and Development, and CMO, in a press release issued on February 23, 2021.

“The Amphiphile technology allows us to simultaneously generate immune response to all the mutations commonly present in KRAS driven cancers by targeting antigenic peptides with a powerful adjuvant directly to the lymph nodes, significantly amplifying the resulting immune responses, and producing highly functional mKRAS-specific T cells capable of destroying mKRAS positive cells like tumor cells.”

Phase I/II clinical trials of ELI-002 will enroll patients with mKRAS+ pancreatic ductal adenocarcinoma and other solid tumors.

Elicio Therapeutics is advancing the Amphiphile technology across immunotherapy platforms to defeat cancers and infectious diseases. 

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Feb 22, 2021 • 8:58 pm CST

Oslo-based Ultimovacs ASA announced on February 18, 2021, the first patient's treatment in the Phase I TENDU trial, representing the start of clinical evaluation for the Company's Tetanus-Epitope Targeting (TET)-platform.

The TET platform allows for the production of multiple therapeutic cancer vaccines that can strengthen and increase T cell responses to cancer cells by targeting antigens that are specific to one type of cancer or common to many tumor types.

By combining cancer antigens and the vaccine adjuvant in the same molecule, this unique platform can generate vaccine candidates with a beneficial safety and administration profile, presenting an opportunity to treat patients at an early stage of their disease.

The TENDU clinical trial, conducted at the Oslo University Hospital, is a first-in-human, dose-escalation study designed to generate initial safety and immune activation data for a prostate cancer-specific therapeutic TET-based vaccine in relapsed prostate cancer patients.

Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs' lead universal cancer vaccine candidate UV1 leverages the high prevalence of the human telomerase to be effective across the dynamic stages of the tumor's growth and its microenvironment. The Company expects to provide the first interim, preliminary safety readout from the trial by the end of 2021.

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Feb 7, 2021 • 1:31 pm CST

The U.S. Food and Drug Administration (FDA) announced on February 5, 2021, the approval of Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after, at least two other types of systemic treatment. Breyanzi is not indicated for treating patients with primary central nervous system lymphoma.

Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL).

“Today’s approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement.

“Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens.”

To further evaluate the long-term safety, the FDA is requiring the manufacturer, Juno Therapeutics Inc., a Bristol-Myers Squibb Company, to conduct a post-marketing observational study involving patients treated with Breyanzi.

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Feb 4, 2021 • 9:55 am CST

Dr. André Ilbawi, from the WHO’s Department of Noncommunicable Diseases, stated in a UN News press release issued on February 2, 2021, 'More than a year since the new coronavirus crisis began, its impact on cancer care has been stark, with 50 percent of governments (having) cancer services partially or completely disrupted because of the COVID-19 pandemic."

Amid uncertainty over which COVID-19 vaccine might be most suitable for cancer patients, given the increased vulnerability of some individuals, Dr. Ilbawi said that data from ongoing clinical vaccine trials had yet to be published.

“In 2020, the number of people diagnosed with cancer globally reached 19.3 million, with the number of people dying increasing to 10 million”, said Dr. Ilbawi. 

According to the WHO, there were 2.3 million new breast cancer cases in 2020, representing almost 12 percent of all cancer cases. It is also the leading cause of cancer death worldwide among women. 

Speaking from Geneva ahead of World Cancer Day, Dr. Ilbawi noted that “for the first time, breast cancer now constitutes the most commonly occurring cancer globally, followed by lung, which has historically been leading cause in most of, of cancer, and third colorectal.” 

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Feb 2, 2021 • 3:29 pm CST

Human papillomavirus (HPV) infections are found in children, but transmission modes and outcomes are incompletely understood, commented researchers in a new study published by the U.S. CDC on January 29, 2021.

These evaluated oral samples from 331 children in Finland who participated in the Finnish Family HPV Study from birth during 9 follow-up visits (mean time 51.9 months). They tested samples for 24 HPV genotypes.

Oral HPV prevalence for children varied from 8.7% (at a 36-month visit) to 22.8% (at birth).

And 18 HPV genotypes were identified. HPV16 was the most prevalent type to persist, followed by HPV18, HPV33, and HPV6.

Persistent, oral, high-risk HPV infection for children was associated with oral HPV carriage of the mother at birth and seroconversion of the mother to high-risk HPV during follow-up (odds ratio 1.60–1.92, 95% CI 1.02–2.74).

In summary, these researchers stated, 'our results indicate that HPV infection can be acquired nonsexually and is already common at an early age. The oral cavity is the common site of the first HPV exposure, and mothers are the most likely source of first HPV infection in her child.'

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Jan 28, 2021 • 5:44 pm CST

During California’s stay-at-home order during the COVID-19 pandemic, cervical cancer screening rates among approximately 1.5 million women in the Kaiser Permanente Southern California (KPSC) network decreased approximately 80% compared with baseline. The decrease was similar across all racial/ethnic groups of KPSC and returned to near normal after reopening, reported the U.S. CDC Morbidity and Mortality Weekly Report issued on January 28, 2021.

The COVID-19 pandemic has highlighted a critical need for effective cancer screening methods for patients who cannot or prefer not to have in-person appointments.

For colorectal cancer screening, KPSC has been using self-sampling fecal immunochemical test (FIT) kits available by mail or pharmacy and has continued mailing these to patients’ homes during the pandemic without interruptions. This FIT approach might serve as a future cervical cancer screening model through self-collected samples for HPV testing.

The US Food and Drug Administration has not yet approved self-sampling for HPV tests, but the evidence base for self-sampling demonstrates good accuracy and high acceptability among women. The adoption of self-sampling for HPV testing might help maximize patient safety and overcome the barrier of fear of SARS-CoV-2 infection from clinic visits.

However, for women who have abnormal screening results, follow-up care at a clinic could remain a challenge, says the CDC.

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Jan 28, 2021 • 12:40 pm CST

OncoSec Medical Incorporated announced on January 27, 2021, that it has dosed several subjects in its Phase 1 clinical trial of CORVax12, the only vaccine candidate to include an immunostimulatory cytokine to address COVID-19.

This clinical trial, entitled, CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19, will address safety and anti-viral immunological responses with the combination of a DNA-encodable stabilized SARS-CoV-2 spike glycoprotein and OnocSec's cancer immunotherapy candidate, TAVO™ (tavokinogene telseplasmid), a potent and well-characterized plasmid-based IL-12 cytokine.

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Jan 27, 2021 • 7:10 pm CST

AstraZeneca and Daiichi Sankyo Company, Limited’s Enhertu (trastuzumab deruxtecan) announced the conditional approval in the European Union (EU) on January 20, 2021, as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

The European Commission's approval was based on positive results from the single-arm DESTINY-Breast01 Phase II trial. Enhertu showed clinically meaningful and durable antitumor activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based regimens. 

The approval follows the December 2020 recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency, which reviewed the application under its accelerated assessment procedure.

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Jan 27, 2021 • 11:43 am CST

A new report regarding cancer deaths attributable to cigarette smoking in 152 U.S. metropolitan or micropolitan statistical areas, 2013–2017 was published on January 26, 2021.

There are limited data on the burden of cancer attributable to cigarette smoking by metropolitan areas to inform local tobacco control policies in the USA. These researchers estimated the proportion of cancer deaths attributable to cigarette smoking (or population attributable fraction [PAF]) in 152 U.S. metropolitan or micropolitan statistical areas (MMSAs).

The proportion of cancer deaths attributable to cigarette smoking is considerable in each MMSA, with as many as 4 in 10 cancer deaths attributable to smoking in the South region and Appalachia. Broad and equitable implementation and enforcement of proven tobacco control interventions at all government levels could avert many cancer deaths across the USA.

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Jan 26, 2021 • 7:05 pm CST

Social media has a history of being a popular place for health discussions, and the HPV vaccine is one of the most discussed vaccines on the internet. Monique Luisi, an assistant professor in the University of Missouri School of Journalism, has studied more than 6,500 public HPV vaccine-related posts on Facebook from 2006 to 2016.

Luisi suggests this negative trend on Facebook may also cause people to develop a false perception of the health risk of HPV vaccines.

After looking at the percentage of posts that made the vaccine seem more dangerous, less dangerous, or neither, Luisi found nearly 40% of Facebook posts about the HPV vaccine amplified a perceived risk, and the study data suggests these posts had momentum over time.

"We should not assume that only the disease is perceived as a risk, but when research supports it, that medical treatments and interventions might unfortunately also be perceived as risks," she said. "It's more likely that people are going to see things on social media, particularly on Facebook, that are not only negative about the HPV vaccine but will also suggest the HPV vaccine could be harmful. It amplifies the fear that people may have about the vaccine, and we see that posts that amplify fear are more likely to trend than those that don't."