Cancer Vaccine Breaking News

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

Mar 5, 2021 • 6:40 am CST

On International human papillomavirus (HPV) Awareness Day, Tennessee-based St. Jude Children's Research Hospital announced the HPV Cancer Prevention Program's launch. With an investment of $12 million, St. Jude is launching outreach programs to reduce HPV-related cancer deaths by increasing vaccination rates locally, nationally, and eventually, globally.

Heather Brandt, Ph.D., leads the St. Jude HPV Cancer Prevention Program.

"Since 2006, we have had a safe, effective, and durable vaccine to prevent six types of HPV-related cancers in men and women," Brandt stated in a press release.

"However, rates of this cancer-prevention vaccination remain low, especially in areas of the Southeastern and Mid-Southern United States where HPV-related cancer rates are high. We also know there are vast differences in uptake among some populations, so there is an urgent need to address these inequities."

"Far too few have taken advantage of this cancer prevention tool, and I look forward to joining forces with other partners to improve vaccination rates."

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Mar 4, 2021 • 2:55 pm CST

The National Comprehensive Cancer Network (NCCN) recently released preliminary guidelines for COVID-19 vaccination in patients with cancer.

The new Recommendations of the NCCN COVID-19 Vaccination Advisory Committee state:

  • Patients with cancer should be prioritized for vaccination (CDC priority group 1b/c) and immunized when vaccination is available to them.
  • Immunization is recommended for all patients receiving active therapy, understanding that there are limited safety and efficacy data in these patients.
  • Reasons for delay of vaccines are similar to those that impede delivery to the general public (eg, recent exposure to COVID-19), and there are also cancer-specific factors.
  • Vaccination should be delayed for at least 3 months following hematopoietic cell transplantation or engineered cellular therapy (eg, chimeric antigen receptor [CAR] T cells) to maximize vaccine efficacy.

The NCCN says 'vaccination prioritization is challenging to develop when considering the diverse population of patients with varied comorbidities, demographic and social factors known to increase risk of COVID-19 acquisition, morbidity, and/or mortality. Decisions must be made in accordance with state and local vaccine guidance on allocation.'

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Mar 2, 2021 • 4:04 pm CST

California-based NGM Biopharmaceuticals, Inc. announced it had dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients with metastatic pancreatic cancer.

NGM120 is an antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling.

This placebo-controlled study will evaluate the effect of NGM120 on both cancer and cancer-related cachexia.

Cachexia is the uncontrolled wasting of both skeletal muscle and fat linked to many cancers. It is estimated to affect 60% to 80% of advanced cancer patients and to be responsible for approximately 30% of all cancer deaths. 

This proof-of-concept expansion represents a pre-planned progression of an ongoing Phase 1a/1b dose-finding clinical trial NGM is conducting in patients with select advanced solid tumors and metastatic pancreatic cancer.

“We are pleased to advance NGM120 into a placebo-controlled, Phase 1b expansion in patients with metastatic pancreatic cancer. Patients with this aggressive disease are in particularly dire need of therapeutic solutions to fight their disease and enhance their quality of life,” commented Alex DePaoli, M.D., SVP, Chief Translational Officer at NGM, in a press release.

“Our approach of targeting the GDF15 receptor, GFRAL, gives NGM120 a novel profile in the GDF15 inhibition space and enables us to evaluate NGM120 as a potential treatment for both cancer-related cachexia and underlying cancer.”

NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on a scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases, and oncology. 

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Mar 1, 2021 • 9:34 am CST

France-based Transgene and BioInvent International AB announced that the first patient in a Phase I/IIa clinical trial of the novel dual mechanism-of-action oncolytic Vaccinia virus BT-001 had been enrolled at Institut Bergonié, located in Bordeaux, France.

By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. Also, delivering the anti-CTLA4 antibody directly to the tumor microenvironment aims to induce local Treg depletion and strong therapeutic activity.

Consequently, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA4 antibody will be greatly improved.

Hedi Ben Brahim, Chairman, and CEO of Transgene, stated in a press release, “This first Invir.IO™ based oncolytic virus entering the clinic has been shown to induce long-lasting antitumor immune responses and abscopal effects in several preclinical tumor models; in these experiments, the activity of BT001 was further enhanced through combination with an anti-PD-1 antibody treatment. It has a unique mode of action, and the outstanding results so far indicate it could make a significant difference to cancer patients.”

Transgene (Euronext: TNG) is a publicly-traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.

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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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