Cancer Vaccine Breaking News

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

Jan 19, 2023 • 10:57 am CST
ImmunityBio, Inc. 2023

ImmunityBio, Inc. today announced positive results in its fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88), showing that the overall survival (OS) rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy.

The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS.

In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS.

The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml.

In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).

"We are encouraged by the positive results in these patients with 3rd, 4th, 5th, and even 7th line advanced pancreatic cancer and the considered and helpful feedback from the FDA," said Patrick Soon-Shiong, M.D., Executive Chairman, and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on January 19, 2023.

"Treatments for pancreatic cancer in the advanced setting remain an unmet need."

"We are committed to confirming our hypothesis that orchestrating the innate and adaptive immune system will advance the care of these patients."

This therapy is essential since pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. annually.

The QUILT 88 study results were presented at the American Society of Clinical Oncology Gastrointestinal conference on January 19-21, 2023.

ImmunityBio also announced that it held two productive Type B meetings with the U.S. FDA in December 2022. 

Jan 18, 2023 • 4:16 pm CST
from Pixabay

Evaxion Biotech A/S recently announced that the U.S. Food and Drug Administration (FDA) determined that the Company may proceed with its Phase 2b clinical trial of EVX-01 targeting malignant melanoma.

The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia and in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®. 

The trial was first initiated in Australia with the enrollment of the first patient in September 2022.

In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation application to the FDA for a Phase 2b clinical trial.

The Company anticipates a response from the FDA to the Fast Track designation submission in the first quarter of 2023.

“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma. Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,” says Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2023.

Jan 12, 2023 • 2:16 pm CST
by Wolfgang Eckert

The American Cancer Society (ACS) today released Cancer Statistics, 2023, the organization's annual report on cancer facts and trends.

According to the new ACS report, overall cancer mortality has dropped 33% since 1991, averting an estimated 3.8 million cancer deaths.

Based on ACS data, in 2023, there are projected to be 1,958,310 new cancer cases and 609,820 cancer deaths in the U.S.

Prostate cancer, which is the second leading cause of cancer death for men in the U.S., increased by 3% per year from 2014 through 2019 after two decades of decline.

Most concerning is that the diagnosis of advanced disease drove this increase.

Since 2011, the diagnosis of advanced-stage (regional- or distant-stage) prostate cancer has increased by 4% to 5% annually, and the proportion of men diagnosed with the distant-stage disease has doubled.

These findings underscore the importance of understanding and reducing this trend.

"The increasing percentage of men presenting with advanced prostate cancer, which is much more difficult to treat and often incurable, is highly discouraging," said Dr. Karen E. Knudsen, chief executive officer at the ACS, in a press release on January 12, 2023.

"In order to end cancer as we know it, for everyone, it is imperative for us to focus on cancers where trends for incidence and mortality are going in the wrong direction." 

These major findings were published today in CA: A Cancer Journal for Clinicians, alongside its consumer-friendly companion, Cancer Facts & Figures 2023, available at https://www.cancer.org/research/cancer-facts-statistics.html.

Jan 12, 2023 • 8:50 am CST
by Manuel Alvarez

Health Canada recently approved Enhertu™ for treating adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Patients with hormone receptor-positive (HR+) breast cancer should have received at least one and be no longer considered eligible for endocrine therapy.1 

Enhertu (trastuzumab deruxtecan) is a specifically engineered HER2-directed antibody-drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The approval by Health Canada on January 6, 2023, was based on the DESTINY-Breast04 Phase III trial results.

"Since the approval of HER2-targeted therapies in breast cancer more than twenty years ago, only patients with HER2-positive disease have been eligible for these therapies – leaving those with tumors with lower levels of HER2 expression with limited effective treatment options," said Dr. Jan-Willem Henning, Medical Oncologist, Tom Baker Cancer Centre, and Clinical Associate Professor, Cumming School of Medicine, University of Calgary, in a press release on January 12, 2023.

"The recent Health Canada approval of Enhertu in the HER2-low patient population is a significant milestone in the treatment of metastatic breast cancer and is the first anti-HER2 molecule to demonstrate efficacy outside of traditional HER2-positive breast cancer.

"Based on the promising data from the DESTINY-Breast04 trial, we're now able to differentiate levels of HER2 expression to redefine how we classify and treat metastatic breast cancer, providing additional patients with the opportunity to benefit from HER2-directed therapy."

In Canada, 10% of newly diagnosed breast cancers are metastatic; for those initially diagnosed with early-stage breast cancer, approximately 30% will progress to metastatic disease.

HER2 expression is currently defined as either positive or negative and is determined by an IHC test which estimates the amount of HER2 protein on a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells.

However, approximately half of all breast cancers are HER2-low, and previously these patients had limited effective treatment options following progression on endocrine (hormone) therapy.

Health Canada reviewed and approved Enhertu for this indication under the Priority Review and Project Orbis FDA collaboration pathways seven months from filing, enabling the timely availability to bring this new treatment option to HER2-low breast cancer patients as quickly as possible.

Note: ENHERTU is U.S. FDA-approved for treating several types of 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.