Cancer Vaccine Breaking News

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

Nov 22, 2022 • 6:56 am CST
by Niek Verlaan

Northwest Biotherapeutics reported that in its Phase III clinical trial, median survival and the “long tail” of extended survival increased in newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L.

The trial results published by The JAMA Network on November 17, 2022, have met both the primary and the secondary endpoints under the Statistical Analysis Plan for the trial.

The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma and the first time in almost 30 years that a Phase III trial of any treatment has shown such survival extension in recurrent glioblastoma.

Nov 8, 2022 • 2:15 pm CST
by gregory kirk johnson

Immunomic Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced that the U.S. FDA granted Fast Track Designation to the ITI-3000 program for treating patients with Merkel cell carcinoma.

The company is currently enrolling a phase 1 study evaluating ITI-3000, a plasmid DNA vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer typically caused by the Merkel cell polyomavirus.

Dr. William Hearl, Chief Executive Officer of ITI, stated in a press release, "We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer."

"We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next-phase clinical study design while simultaneously continuing dialogue with possible partners."

Nov 8, 2022 • 7:29 am CST

Geneos Therapeutics announced positive safety and efficacy data from the first 24 patients enrolled in GT-30. GT-30 is an ongoing single-arm open-label multi-center Phase 1b/2a study to evaluate safety, immunogenicity, and efficacy of PTCV (GNOS-PV02) administered in combination with plasmid-encoded IL-12 (pIL12) and pembrolizumab in patients with unresectable or metastatic hepatocellular carcinoma (HCC) who progress on, or are intolerant to, first-line tyrosine kinase inhibitors (sorafenib or lenvatinib).

By RECIST1.1 an overall response rate of 29.2 percent in the modified intent-to-treat analysis (mITT) was observed, including complete responses in two patients as well as a third cancer-free patient who achieved secondary resectability and four additional partial responses.

  • To date, no dose-limiting toxicities nor PTCV + pIL12 related serious adverse events (SAEs) or Grade 3 or 4 adverse events (AEs) have been reported. Grade 1 and 2 PTCV + pIL12 related AEs have been transient and mild.
  • By RECIST1.1, disease control rate is 54.2 percent (13/24; mITT) consisting of two complete responses (CR), five partial responses (PR), six stable disease (SD) and 10 progressive disease (PD).
  • A third patient (deemed a radiological PR) is cancer-free after a liver primary lesion and two lung metastases all reduced in size to become fully responsive to surgery and radiation therapy.
  • One patient discontinued treatment due to a non-treatment-related SAE and was deemed unevaluable but included in the mITT analysis.
  • Novel and expanded T cell clones, predominantly CD8+ with activated phenotype, were identified in 100 percent of evaluated patients via pre-/post-vaccination analysis of T cell receptor (TCR) repertoire in peripheral blood and tumor tissue. These clones trafficked to the tumor microenvironment (TME) by week nine, potentially mediating the observed tumor regressions.

“As a physician who has been managing patients with advanced liver cancer for more than two decades, I am thrilled by the response rate and immunologic activity we are seeing with this promising form of therapeutic cancer vaccination,” stated Dr. Gane, professor of medicine at the University of Auckland, New Zealand, hepatologist and deputy director of the New Zealand Liver Unit at Auckland City Hospital, in a press release on November 7, 2022.

“To see three cancer-free patients out of 23 evaluable in second-line advanced HCC, with treatment this well tolerated, tells me that personalized therapeutic cancer vaccination may now, finally, be here to stay."

"If these response rates are maintained as the program advances toward registration, then I see PTCV becoming a core foundation of cancer immunotherapy, not just for HCC, but broadly.”

Nov 7, 2022 • 9:29 am CST
by PD Pics

Apros Therapeutics, Inc. today announced that they would present interim pharmacokinetic and pharmacodynamic Phase 1 clinical data for APR003, a first-in-class orally-administered gastrointestinal (GI)- and liver-targeted TLR7 agonist.

It is currently being evaluated in an ongoing Phase 1 dose-escalation clinical trial in relapsed/refractory colorectal cancer (CRC) patients with hepatic metastasis.

Pharmacodynamic analysis revealed that upon weekly dosing, APR003 elicited robust Interferon-alpha, Interferon-gamma inducible protein 10 (IP-10), and Interferon Stimulated Gene 15 (ISG15) responses, suggesting strong immune priming.

In addition, APR003 achieved a similar or greater IP-10 response compared to other (non-targeted) agents of the same class, indicating that the tissue-targeted approach may have an increased safety window.

These data support further clinical investigation of APR003 in other GI and Liver malignancies and metastatic disease as a single agent and in combination with checkpoint inhibitors or complementary therapies.

Nov 3, 2022 • 5:53 am CDT
from Pixabay

Transgene announced that following an interim analysis of its randomized controlled Phase II clinical study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV16- positive anogenital tumors, the Independent Data Monitoring Committee (IDMC) has recommended the study continue.

Transgene anticipates the last patient to be randomized in the trial in H1 2024.

TG4001 is designed to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens found in HPV16-related tumors and to induce a specific cellular immune response against these cancer cells.

"We are very pleased with the outcome of this interim analysis," said Hedi Ben Brahim, CEO of Transgene, in a press release on November 2, 2022.

"The IDMC's recommendation to continue the study reinforces our confidence in TG4001, which follows promising data from our earlier Phase Ib/II trial."

To date, the treatment has been well tolerated. Adverse events are consistent with previous observations made in the Phase Ib/II trial.

TG4001 is based on an MVA vector engineered to express HPV16 antigens (E6 & E7) and interleukin 2 (IL-2).

Nov 2, 2022 • 9:16 am CDT
by Bok Skapet

Sonnet BioTherapeutics Holdings, Inc. announced today that the safety of SON-1010 dosing in several study cohorts had been formally reviewed in both Phase 1 clinical trials and that dose escalation is continuing as early data becomes available.

"We have now dosed 12 cancer patients at increasing drug levels in the SB101 study and 24 healthy volunteers in SB102," said Richard Kenney, M.D., Sonnet's Chief Medical Officer, in a press release on November 2, 2022.

SON-1010 is a proprietary version of human interleukin-12 (IL-12), configured using Sonnet's Fully Human Albumin Binding (FHAB®) platform.

SB101 is a multiple-dose trial for adult patients with advanced solid tumors (NCT05352750) that commenced in April 2022 and has now started treating the fourth dose cohort.

SB102 is a single-ascending dose trial in healthy volunteers (NCT05408572) that started in July and is dosing the third cohort.

Safety Review Committees found no safety concerns and approved advancing to the next higher dose levels for both studies.

"No dose-limiting toxicities have occurred to date using this novel approach to enhance the safety of cytokine-based immunotherapy, and we are starting to get encouraging data back on the pharmacokinetic and pharmacodynamic  responses."

"By linking the IL-12 cytokine to an albumin-binding domain that can target tumor tissue and extend the cytokine half-life in the body, we believe our proprietary FHAB technology will allow us to use higher doses of cytokines without triggering unacceptable toxicity."

"This could be the key to inducing a successful local immune response to Il-12 in the tumor microenvironment."

The data will be presented at a webinar at 8:30 am ET today.

Oct 31, 2022 • 9:37 am CDT
by Gerd Altmann

Defence Therapeutics Inc. announced today it is initiating a new research and development program designed to exploit the Accum technology in engineering messenger RNA (mRNA) vaccines targeting cancer.

Accum is designed for intracellular accumulation with the capability to deliver an increased drug delivery to the targeted cells.

"The use of mRNA vaccines .... has definitely sparked a major line of interest in the use of this technology for other diseases such as cancer. The success of these mRNA anti-cancer vaccines relies primarily on their ability to escape endosomes to reach the cytoplasm of the cell where the final protein product is generated," says Mr. Plouffe, the CEO of Defence Therapeutics, in a press release on October 31, 2022.

Defence and its scientific team see that the application of Accum makes perfect sense as this platform is specially designed to overcome one "global and limiting step" for any molecular biopharmaceutical: endosomal escape.

Oct 28, 2022 • 9:03 am CDT
from Pixabay

Vaccitech plc announced yesterday the publication of research in preclinical animal models demonstrating the potential of SNAPvax for use in a novel paradigm for cancer treatment referred to as "VAX-INNATE."

The results show that intravenous administration of SNAPvax not only primes and expands tumor-specific cytotoxic T cells that mediate tumor killing but also reverses suppression in the tumor microenvironment associated with significantly improved tumor regression.

The research evaluated SNAPvax co-delivering tumor antigens and a powerful Toll-like receptor (TLR)-7/8 adjuvant by two different routes (IV or subcutaneous) in tumor-bearing mice.

While SNAPvax primed and expanded a high magnitude of antigen-specific T cells by both routes of administration, SNAPvax administered by the IV route induced systemic Type I interferon that markedly reduced the number of immunosuppressive monocytes and macrophages in the TME leading to improved T cell-mediated tumor regression.

"The research by Baharom and the Seder Lab at NIH offers new insights as to how cancer vaccines can be best leveraged to maximize therapeutic effect," said Andrew Ishizuka, M.D., Ph.D., SVP at Vaccitech, in a press release on October 27, 2022.

"It is broadly recognized that T cells and checkpoint inhibitors that unleash their potential are essential, but this study highlights the critical importance of engaging the innate immune system to reverse suppressor populations in the TME that can otherwise inhibit T cells."

"SNAPvax and our viral platforms, ChAdOx and MVA, are ideal for providing these essential ingredients."

"We look forward to validating SNAPvax's potential alone and combined with ChAdOx in upcoming clinical studies."

Oct 27, 2022 • 1:01 pm CDT
by Fernando Zhiminaicela

NovAccess Global Inc. recently announced the approval of its application with the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma and other high-grade gliomas.

Glioblastoma is a form of aggressive brain cancer that annually impacts approximately 250,000 people globally.

TLR-AD1 is designed to activate anti-tumor immune responses against these brain tumors using immune-activating dendritic cells combined with the patient’s tumor proteins.

The resulting dendritic cell vaccines are matured with a proprietary combination of Toll-like receptor (TLR) adjuvants to boost their immune-activating potency beyond current vaccine preparations.

“Orphan Drug Designation is yet another timely milestone achieved by NovAccess Global as we prepare an Investigative New Drug (IND) application for FDA approval to start human clinical trials. We expect to submit the IND in the first half of 2023,” said the Company’s CEO, Dr. Dwain K. Irvin, in a press release on October 26, 2022.

“The designation represents a critical step forward as we address an important and unmet healthcare challenge in treating brain cancers.”

NovAccess Global expects to submit an IND application to the FDA for TLR-AD1 in the first half of 2023.

In advance of the IND filing, the Company expects to announce a partnership with a clinical manufacturing organization for vaccine testing and production readiness for phase I-II clinical trials of TLR-AD1.

Oct 27, 2022 • 5:12 am CDT
by B Anathe

Anixa Biosciences, Inc. announced yesterday the initiation of a Phase 1b trial for its preventative breast cancer vaccine at the Cleveland Clinic. 

This novel study, funded by a grant from the U.S. Department of Defense, has begun recruitment of healthy, cancer-free participants at high risk for developing breast cancer who have decided to undergo a voluntary bilateral mastectomy to lower their risk. 

The new study is estimated to be completed by the end of 2023.

Typically, those women carry mutations in the BRCA1 or related genes and are at risk of developing triple-negative breast cancer or have a high familial risk for any form of breast cancer.

During the course of the study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.

Anixa's breast cancer vaccine, currently in Phase 1 trials, takes advantage of endogenously produced proteins that function at certain times in life but then become "retired" and disappear from the body.

The Phase 1a study includes patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are tumor-free but at high risk for recurrence.

One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues but is present in most triple-negative breast cancers. 

Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. 

The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing.

"We are excited to commence the second stage of the Phase 1 trials for our breast cancer vaccine," stated Dr. Amit Kumar, Chairman, and CEO of Anixa, in a press release on October 26, 2022.

"While the Phase 1a trial is ongoing, the results have given us the confidence to move into this next study earlier than planned."  Dr. Kumar added,

"This vaccine has the potential to prevent the development of triple-negative breast cancer, the most lethal form of breast cancer, and we look forward to advancing this promising technology through further clinical development."

This vaccine technology was invented by Dr. Vincent Tuohy, which Cleveland Clinic exclusively licensed to Anixa Biosciences.

Jun 23, 2022 • 1:13 pm CDT
U.S. FDA

Massachusetts-based VBI Vaccines Inc. announced yesterday that the U.S. FDA granted Orphan Drug Designation for VBI-1901, a bivalent vaccine candidate for the treatment of glioblastoma (GBM).

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens gB and pp65. 

“This orphan drug designation is another significant milestone for our VBI-1901 program, and it underscores the urgency of our effort to develop meaningful new treatment options for patients with this devastating cancer,” said Jeff Baxter, President, and CEO of VBI, in a press release issued on June 22, 2022.

“With this orphan drug status, we look forward to working closely with the FDA and clinical investigators to build on that data, advancing the potential of this program to be a valuable part of the fight against GBM.”

GBM is among the most common and aggressive malignant primary brain tumors in humans.

In the U.S. alone, 14,000 new cases are diagnosed each year.

The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy.

Unfortunately, even with aggressive treatment, GBM progresses rapidly and has a high mortality.

In June 2021, the FDA also granted Fast Track Designation for VBI-1901 to treat recurrent GBM in patients with first tumor recurrence.

Note: This press release was manually curated for mobile readers.

May 17, 2022 • 9:17 am CDT
CDC

The U.S. CDC recently published updated COVID-19 testing suggestions when traveling and confirmed an at-home test solution available for free. As of May 16, 2022, the CDC's website encourages anyone planning to travel to get tested for the SARS-CoV-2 coronavirus within three days of departure.

And to get tested after travel if your trip involved visiting situations with an increased risk of virus exposure, such as a crowded, indoor place.

Furthermore, suppose you are returning to the U.S. from overseas.

In that case, air passengers (2+ yrs.) must show a negative test result taken no more than one day before departure or Documentation of Recovery from COVID-19 in the past 90 days.

To help travelers access these tests, the CDC confirmed every home in the U.S. is now eligible to order the 3rd round of free at-home tests.

These self-tests are rapid antigen at-home tests, not PCR, can be taken anywhere, and most importantly, deliver results within 30 minutes (no lab drop-off required).

Each order now includes eight rapid antigen COVID-19 tests, which arrive in separate packages (4 tests in each box), and are shipped for free!

Fill in this form with your contact and shipping information, or call 1-800-232-0233 to order your tests.

At-home tests are also available for sale. Check with local pharmacies to see where they are available.

Whether you test positive or negative for COVID-19, you should take preventive measures to protect yourself, and others, says the CDC.

As of May 13, 2022, the CDC has confirmed over 847 million COVID-19 test results.

Note: The CDC information was manually curated for mobile readership.

Mar 8, 2022 • 7:15 am CST
Image by Claudio Scott

The Annals of Internal Medicine published Original Research on March 1, 2022, 'Estimation of Breast Cancer Overdiagnosis in a U.S. Breast Screening Cohort,' funded by the National Cancer Institute.

Mammography screening can lead to overdiagnosis—that is, screen-detected breast cancer that would not have caused symptoms or signs in the remaining lifetime. 

Based on an authoritative U.S. population data set, the analysis projected that among biennially screened women aged 50 to 74 years, about 1 in 7 (14%) cases of screen-detected cancer is overdiagnosed.

The study cohort included 35,986 women, 82,677 mammograms, and 718 breast cancer diagnoses. 

'This information clarifies the risk for breast cancer overdiagnosis in contemporary screening practice and should facilitate shared and informed decision making about mammography screening,' concluded these researchers.

Feb 21, 2022 • 4:33 pm CST

Positive topline results from the pivotal DESTINY-Breast04 phase 3 clinical trial announced today showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2 low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician's choice of chemotherapy, which is the current standard of care.

ENHERTU is a HER2-directed antibody-drug conjugate (ADC) jointly developed by Daiichi Sankyo and New Jersey-based AstraZeneca.

All patients in the trial received a HER2 test, and the results were centrally confirmed.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors and is one of many biomarkers expressed in breast cancer tumors.

HER2 low status was defined as an immunohistochemistry (IHC) score of 1+ or IHC2+ with a negative in-situ hybridization (ISH) score.

HER2 expression is currently defined as either positive or negative.1 HER2 positive cancers are defined as IHC 3+ or IHC 2+/ISH+, and HER2 negative cancers are defined as IHC 0, IHC 1+, or IHC 2+/ISH-. 

Up to 55% of all patients with breast cancer have tumors with a HER2 IHC score of 1+ or a HER2 IHC score of 2+ in combination with a negative ISH test, an expression level not currently eligible for HER2 targeted therapy. 

Low HER2 expression occurs in both hormone receptor (HR) positive and HR negative disease.

HER2 testing is well-established to determine an appropriate treatment strategy in metastatic breast cancer.

Targeting the lower range of HER2 expression may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer. 

Currently, chemotherapy remains the only treatment option for patients with HR-positive tumors following progression on endocrine (hormone) therapy and for those who are HR negative.

"Today's historic news from DESTINY-Breast04 could reshape how breast cancer is classified and treated," said Susan Galbraith, MBBChir, Ph.D., Executive Vice President, Oncology R&D, AstraZeneca, in a press release issued on February 21, 2022.

"A HER2 directed therapy has never before shown a benefit in patients with HER2 low metastatic breast cancer."

"These results for ENHERTU are a huge step forward and could potentially expand our ability to target the full spectrum of HER2 expression, validating the need to change the way we categorize and treat breast cancer."

The companies stated the data will be presented at an upcoming medical meeting and shared with global health authorities.

Daiichi Sankyo is responsible for the manufacturing and supplying ENHERTU and datopotamab deruxtecan.

Feb 18, 2022 • 1:47 pm CST

Cambridge-based Moderna, Inc. today announced that it is expanding its mRNA vaccine pipeline. One of the new vaccines is a checkpoint cancer vaccine candidate, mRNA-4359.

Moderna's mRNA-4359 expresses Indoleamine 2,3-dioxygenase and programmed death-ligand 1 antigens.

Moderna designed mRNA-4359 to stimulate effector T-cells that target and kill suppressive immune and tumor cells that express target antigens. Moderna plans to explore initial indications for advanced or metastatic cutaneous melanoma and non-small cell lung carcinoma (NSCLC).

NSCLC frequently goes undetected, remaining asymptomatic until it has progressed to later stages.

Approximately 115,000 people are diagnosed with metastatic NSCLC or progress to the metastatic disease annually, according to the U.S. CDC.

"We are pleased to announce these new development programs, which reflect the continued productivity of our platform and the potential of our mRNA technology to impact the lives of hundreds of millions of people," said Stéphane Bancel, Chief Executive Officer of Moderna, in a media statement issued on Feb. 18, 2022.

In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA) to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production.