Cancer Vaccine Breaking News

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

Jun 29, 2021 • 2:23 pm CDT

A study published by the JAMA Pediatrics on June 28, 2021, suggests that safety concerns or adverse effects as the main reason for refusing HPV vaccination increased over the years.

This finding has several important implications. First, given that concerns about vaccine safety are critical for vaccine confidence, rising safety concerns could negatively affect HPV vaccine uptake at the population level. Considering recent evidence of slowing routine HPV vaccination uptake, addressing safety concerns about vaccines should be of utmost public health importance.

Second, the findings of this study suggest that disinformation campaigns aimed at hampering vaccine trust are thriving. There has been a substantial rise of vaccine misinformation in the US that has culminated in public mistrust of vaccines.

The advent of social media and its exponential growth in popularity has spread misinformation to a wider audience within the general public. In some instances, misinformation has also been supported by influential public and political figures.

While these findings point to a need for widespread dissemination of educational programs within the general population, it is also crucial that public health agencies work with social media companies to develop campaigns to combat misinformation online.

Lastly, physicians have a crucial frontline role to play in addressing vaccine hesitancy during parent-physician encounters.

Despite several strengths of our study, including using a rigorously designed nationally representative sample, our study is not without limitations, including low response rate and potential nonresponse bias. However, statistical adjustments, including standard weighting procedures, have been applied to account for such potential biases.

Jun 29, 2021 • 1:05 pm CDT

InnoCare Pharma announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation (BTD) to its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL).

Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell malignancy and autoimmune diseases.

Dr. Jasmine Cui, the co-founder, chairwoman, and CEO of InnoCare, said in a press release issued on June 28, 2021, “We are very proud that orelabrutinib was granted BTD after obtaining FDA Orphan Drug Designation."

"We will continue to uphold the concept of ‘Science drives innovation for the benefit of patients’ and accelerate clinical trials for multiple indications of orelabrutinib in China and the rest of the world to benefit patients worldwide.”

On December 25, 2020, orelabrutinib was approved by the China National Medical Products Administration in two indications: the treatment of patients with R/R CLL / small lymphocytic lymphoma and the treatment of patients with R/R MCL.

Jun 29, 2021 • 10:07 am CDT

The AC Journals published an Original Article on June 29, 2021, focused on prostate cancer (CaP) treatment. The study authors aimed to assess the role of race-related treatment benefit in access to CaP treatment in a single-payer population.

The study used the Veterans Health Administration (VHA) Corporate Data Warehouse identified 35,427 men to perform a retrospective cohort study of veterans diagnosed with low- or intermediate-risk CaP between 2011 and 2017.

When they controlled for covariates, Black men at a VA facility had 1.05 times the odds of receiving treatment compared to non-Black men, and high-treatment-benefit men had 1.4 times the odds of receiving treatment compared to those in the low-treatment-benefit group.

And the interaction of race and treatment benefit was significant. Black men in the high-treatment-benefit category were less likely to receive treatment than non-Black men in the same treatment category (odds ratio, 0.89; P < .001).

The study author's conclusion was: Although race does appear to influence the receipt of definitive treatment in the VHA, this relationship varies in the context of the patient's treatment benefit, with Black men receiving less definitive treatment in high-benefit situations.

And, the influence of patient race at high treatment benefit levels invites further investigation into the driving forces behind this persistent disparity in this consequential group.

'Prostate cancer is the second most common cancer among men (skin cancer), but it can often be treated successfully. If you have prostate cancer or are close to someone who does, knowing what to expect can help you cope. Here you can find out all about prostate cancer, including risk factors, symptoms, how it is found, and how it is treated,' says Cancer.org.

The U.S. National Cancer Institute estimates that 248,000 men will be diagnosed with prostate cancer in 2021, most in its earliest stages.

Jun 28, 2021 • 2:44 pm CDT

Veru Inc. announced updated clinical results from the ongoing Phase 1b/2 clinical study of sabizabulin (VERU-111), an oral cytoskeleton disruptor being evaluated to treat metastatic castration-resistant prostate cancer in men who progressed on an androgen receptor targeting agent.

Sabizabulin, an oral, first-in-class alpha and beta-tubulin inhibitor/cytoskeleton disruptor small molecule for the treatment of metastatic castration-resistant and androgen receptor targeting agent resistant prostate cancer.

“The data from our Phase 1b/2 trial show that oral, daily sabizabulin is well tolerated and based upon its efficacy has the potential to fill the largest and growing unmet clinical need in men who have metastatic castration-resistant prostate cancer and who have developed progression of prostate cancer while being treated with an androgen receptor targeting agent, but before using IV chemotherapy,” said Dr. Mitchell S. Steiner, Chairman, President, and CEO of Veru Inc, in a press statement.

“We are excited to be initiating the Phase 3 VERACITY trial in this patient population.”

Dr. Robert H. Getzenberg, Veru, EVP for Medical Affairs, will lead a poster presentation at the European Association of Urology 36th Annual Congress being held virtually on July 11, 2021.

Miami-based Veru Inc. is an oncology biopharmaceutical company focusing on developing novel medicines for the management of prostate cancer and breast cancer.

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Jun 27, 2021 • 3:19 pm CDT

The European Medicines Agency (EMA) announced on June 25, 2021; it had recommended granting a conditional marketing authorization in the European Union for Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment.

Despite the development and approval of a range of new medicines for the treatment of multiple myeloma over the past few years, there are limited therapeutic options for patients who have already received three major classes of drugs (immunomodulatory agents, proteasome inhibitors, and monoclonal antibodies) and no longer respond to these medicines.

Therefore, new medicines are needed for patients whose disease returns after treatment.

Abecma is a genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy and the first cell-based gene therapy to treat adult patients with multiple myeloma. Each dose of Abecma is created by collecting a patient’s own T-cells (i.e., white blood cells that help the body fight infections) and genetically modifying them to include a new gene that helps the body target and kill the body myeloma cells. These modified immune cells are then infused back into the patient’s blood.

Multiple myeloma is a rare cancer of a type of white blood cell called plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system. Plasma cells make the antibodies that enable the body to recognize and attack germs such as viruses or bacteria. In multiple myeloma, the proliferation of plasma cells is out of control, resulting in abnormal, immature plasma cells multiplying and filling up the bone marrow. When plasma cells become cancerous, they no longer protect the body from infections and produce abnormal proteins that can cause problems affecting the kidneys, bones, or blood.

The U.S. Food and Drug Administration approved Abecma on March 27, 2021.

Jun 25, 2021 • 8:57 am CDT

Miami-based Veru Inc. announced that it had enrolled the first patient in its Phase 3 VERACITY clinical trial of sabizabulin, an oral, first-in-class, new chemical entity, androgen receptor transport disruptor, for metastatic castration and androgen receptor targeting agent resistant prostate cancer.

The Phase 3 VERACITY clinical trial is an open-label, randomized, multicenter registration study to evaluate the efficacy and safety of sabizabulin 32mg oral daily dosing versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naïve men with metastatic castration-resistant prostate cancer who have progressed on at least one androgen receptor targeting agent.

The primary endpoint is median radiographic progression-free survival, and key secondary endpoints are overall response rate, duration of objective response, overall survival, time to chemotherapy, and pain progression. The study is expected to enroll 245 patients and will be conducted in over 45 clinical sites across the USA.

Veru Inc. is an oncology biopharmaceutical company focusing on developing novel medicines for the management of prostate cancer and breast cancer.

Jun 18, 2021 • 9:41 am CDT

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on June 1, 2021, that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma.

This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen and CD3 receptors, follows a PRIME designation from the European Medicines Agency received earlier in 2021.

Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients.

“We are pleased to have received Breakthrough Therapy and PRIME Designations for our novel bispecific antibody, teclistamab,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC, in a press statement.

The U.S. FDA grants BTD to expedite the development and regulatory review of an investigational medicine intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Jun 10, 2021 • 9:15 pm CDT

California-based AIVITA Biomedical Inc. announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1. The analysis focused on the 57 Phase 2 patients who received eight doses of AV-GBM-1 over approximately six months.

At the time of the analysis, surviving patients had completed therapy and followed between 10.1 and 27.6 months from enrollment. The median length of PFS was 10.4 months (95% confidence interval; 8.6 to 11.7 months), an improvement of approximately 50% compared to a median PFS of 6.9 months (95% confidence interval; 5.8 to 8.2 months) in the landmark STUPP study that established the standard of care for patients with newly diagnosed glioblastoma (GBM).

This represents a 42% reduction in the risk of progression or death at 6.9 months.

Median survival has not been reached and will be assessed after the final patient has a minimum follow-up of 15 months. Overall, the treatment was well tolerated. There were 54 serious adverse events among 28 of 57 patients, but none were attributed to the vaccine.

“The potential for AV-GBM-1 to significantly improve Progression Free Survival (PFS) in newly diagnosed GBM patients over and above the current standard of care is very encouraging,” commented Robert O. Dillman, M.D., chief medical officer of AIVITA, in a press release. 

“We look forward to confirming this benefit in a randomized Phase 3 multi-center trial.”

AIVITA is currently conducting clinical studies in the United States investigating its platform immunotherapy in patients with GBM.

Glioblastoma, also referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. It invades the nearby brain tissue but generally does not spread to distant organs.

AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor neoantigens derived from self-renewing tumor-initiating cells isolated from tumors after routine surgical debulking. The treatment is administered to patients via subcutaneous injection. The treatment is uniquely pan-antigenic, targeting multiple antigens, including all neoantigens, from autologous tumor-initiating cells responsible for the tumor growth.

“This milestone is an encouraging first step in the fight against GBM, a disease that has a devastating impact on patients and their families,” said study principal investigator Daniela Bota, M.D., Ph.D., Director, University of California, Irvine (UCI) Alpha Stem Cell Clinical and medical director, UCI Health Comprehensive Brain Tumor Program.

AIVITA Biomedical was founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical, Inc. utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient, and economical manufacturing systems which support its therapeutic pipeline. 

Jun 9, 2021 • 5:34 pm CDT

In a cohort study published by JAMA Oncology on June 4, 2021, of 1,891 Black breast cancer survivors, higher waist-to-hip ratio and body adiposity at approximately 10 months after diagnosis were associated with significantly worse overall and breast cancer cancer-specific survival.

The New Jersey State Cancer Registry was used to identify women living in 10 counties in New Jersey recruited from March 2006 to February 29, 2020, and followed up until September 2, 2020.

This study’s findings suggest 'although measurements using dual-energy x-ray absorptiometry or computed tomography may be ideal when evaluating the association of body composition with breast cancer prognosis, the findings of the present study suggest that simple measures of central obesity (waist circumference and WHR) and body composition (percent body fat and FMI using a portable bioelectrical impedance analysis scale) are clinically useful tools for identifying Black breast cancer survivors at higher risk of death.'

These findings may be particularly relevant for primary care physicians, who are typically responsible for the long-term care of breast cancer survivors and clinical settings with limited resources.

Jun 9, 2021 • 12:44 pm CDT

Idaho-based Therapeutic Solutions International, Inc. reported potent synergy between its tumor blood vessel targeting StemVacs-V iPSC immunotherapy and several classical tumor-specific therapeutic vaccines. 

In a series of experiments, tumor growth administration of dead tumor cells together with StemVacs-V resulted in potent immunological memory to the tumor cells, which could be transferred to immunologically naïve mice. 

Additionally, the experiments demonstrated killing tumor cells using conventional approaches such as chemotherapy, when performed together with StemVacs-V iPSC, led to the development of immunological memory towards specific cancer.

"By targeting the blood vessels that feed the cancer, StemVacs-V iPSC causes enhanced necrotic cell death, which stimulates systemic immunity against cancer throughout the whole body," said Dr. James Veltmeyer, Chief Medical Officer of the Company, in a press release issued on June 7, 2021.

"We are extremely enthusiastic by the current data showing that our blood vessel targeting approach can be used to synergize with both cancer immunotherapies and non-immune therapies of cancer such as chemotherapy and radiation therapy."

The company stated It is believed that by starving the cancer of its blood supply, StemVacs-V iPSC may convert cold tumors to immunotherapy sensitive "hot tumors."

"This new finding is extremely exciting because it opens the door to synergies with other immunotherapies such as CAR-T therapies, which although successful in liquid tumors, to date have not yielded promising results in solid and/or cold tumors," commented Timothy Dixon, President, and CEO of the Company. 

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases.

Jun 1, 2021 • 7:26 pm CDT

New Jersey-based Janssen Pharmaceutical Companies announced today that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation (BTD) for teclistamab to treat relapsed or refractory multiple myeloma.

This distinction for teclistamab, an off-the-shelf, T-cell redirecting, a bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME designation from the European Medicines Agency received earlier in 2021.

“We are pleased to have received Breakthrough Therapy and PRIME Designations for our novel bispecific antibody, teclistamab,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC., in a press release.

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, says Cancer.net. When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2021, it is estimated that nearly 35,000 people will be diagnosed, and more than 12,000 will die from the disease in the USA.

The FDA grants BTD to expedite the development and regulatory review of an investigational medicine intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

The Breakthrough and PRIME designations are supported by data from the Phase 1 MajesTEC-1 study, an open-label, multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with measurable multiple myeloma that is relapsed or refractory to established therapies or be intolerant of those established multiple myeloma therapies.

Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Learn more at www.janssen.com.

Jun 1, 2021 • 1:17 pm CDT

Norway-based Ultimovacs ASA announced that a peer-reviewed article on the ongoing NIPU Phase II trial of the Company’s universal cancer vaccine, UV1, in malignant pleural mesothelioma (MPM) was published. Journal of Translational Medicine.

This article outlines the mechanistic rationale for using the combination of UV1 with two checkpoint inhibitors, ipilimumab and nivolumab.

The dual-use of ipilimumab and nivolumab was recently approved as first-line therapy in MPM, where few therapeutic options are currently available.

However, as Haakensen et al. explains in the article, observed response rates with checkpoint inhibitors have been moderate in MPM compared to documented performance for the combination of checkpoint inhibitors in other cancers, suggesting that checkpoint inhibitors alone may be insufficient to trigger an immune response.

Earlier phase I/II studies have shown that UV1 is safe on its own and when used in combination with checkpoint inhibitors and that it induces vaccine-specific immune response associated with survival.

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as an “off-the-shelf” therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy, which requires an ongoing T cell response for their mode of action.

To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

“The NIPU trial is important in understanding the potentially synergistic activities of checkpoint inhibitors and our universal cancer vaccine, UV1,” stated Jens Bjørheim, Chief Medical Officer at Ultimovacs, in a press release. 

“Malignant pleural mesothelioma is a challenging disease to treat even with checkpoint inhibitors that have been effective in other types of cancer. The article published today explains how we think UV1 may help in meeting that challenge.”

NIPU is a randomized, multi-center, open-label, proof of concept study comparing the efficacy and safety of nivolumab and ipilimumab with or without UV1 in patients with inoperable malignant pleural mesothelioma after first-line platinum-based chemotherapy.

Article details:  Haakensen, V.D., Nowak, A.K., Ellingsen, E.B. et al. NIPU: a randomized, open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1 vaccination as second-line treatment in patients with malignant mesothelioma. J Transl Med 19, 232 (2021).

About Ultimovacs: Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to treat a broad range of cancers. For further information, please see www.ultimovacs.com.

May 27, 2021 • 5:17 pm CDT

Sweden-based BioInvent International AB and Transgene announced that their Investigational New Drug application for BT-001 had been granted by the U.S. Food and Drug Administration. BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene.

This news enables patients in the USA to enroll in the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001.

The ongoing Phase 1/2a study is a multicenter, open-label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). The Phase 1 part of the trial has already been initiated in Europe, where it is enrolling patients in several countries.

BT-001 is expected to elicit a strong and effective antitumoral response by selectively targeting and modulating the tumor microenvironment. In addition, delivering the anti-CTLA4 antibody directly to the tumor aims to induce local Treg depletion and strong therapeutic activity.

“We are pleased to receive IND approval for this Phase 1/2a clinical trial of BT-001, which is BioInvent’s fourth clinical program. This unique oncolytic virus has very exciting potential as it combines multiple mechanisms of action and anti-cancer properties, and we are looking forward to developing it further with our partners at Transgene,” said Martin Welschof, CEO of BioInvent, in a press release.

BT-001 is a novel oncolytic virus developed with Transgene’s Invir.IO™ platform. Invir.IO™’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR-. This optimization enhances the safety profile of the virus.

BT-001 is engineered to encode both a highly differentiated Treg depleting anti-CTLA4 antibody and the human GM-CSF cytokine.

The recombinant antibody recognizing human CTLA4 was generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms. The use of an oncolytic virus to deliver the anti-CTLA4 locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both transgenes, eliciting a stronger and more effective antitumor response by reducing systemic exposure to a very low level.

BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. 

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May 27, 2021 • 9:07 am CDT

Prostate-specific antigen (PSA) screening was associated with better oncologic outcomes in African American patients with prostate cancer, according to data presented by Edmund M. Qiao, BS, of the University of California San Diego, reported Audrey Sternberg with The Cancer Network on May 20, 2021.

An increase in the frequency of PSA screening was linked to a nearly 25% reduction in prostate cancer-specific mortality and an approximately 40% lower risk of having the metastatic disease at the time of a prostate cancer diagnosis.

The “high PSA screening” group had received an average of 3 prior screening tests, and the “low PSA screening” group had received an average of 0.5 prior screening tests.

Overall, the study included 4,726 African American men diagnosed with prostate cancer. The mean patient age was 51.8 years. The mean number of previous PSA screening tests was 1.9.

The US Preventive Services Task Force PSA screening policy is a grade C recommendation for men aged 55 to 69 years, meaning in this population, an individual decision on screening should be made based on a physician-clinician discussion of the potential benefits and risks.

May 25, 2021 • 7:19 am CDT

Zydus Cadila announced on May 24, 2021, it launched Trastuzumab Emtansine, the first Antibody Drug Conjugate (ADC) biosimilar and a highly effective drug for treating both Early and Advanced HER2 positive Breast Cancer, under the brand name ‘Ujvira’.

HER2-positive Breast Cancer is considered an aggressive form and constitutes 20 to 25% of all breast cancer cases.

In a step that can significantly reduce treatment cost by almost 80%, the drug is being offered at Rs. 32495 for a 100 mg vial. The current MRP of the existing Trastuzumab Emtansine drug is Rs. 1,59,225 for a 100 mg vial.

Ujvira will be available in two strengths, 100 mg, and 160 mg.

Speaking on this milestone, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited stated in a press release, “The launch of Ujvira reinforces the innovation capabilities that India has to be able to create complex therapies like ADCs and Zydus' ongoing commitment to offer breakthroughs backed by science and innovation."

"This research breakthrough enables access to a critical drug for patients who are undergoing therapy for breast cancer. We hope that with this innovation, patients will be able to adhere to the treatment and stand to benefit from the advanced technology without worrying about the cost of the treatment.”

Trastuzumab Emtansine ADC biosimilar is a developmental breakthrough due to its complexity in manufacturing and similarity assays. This drug is made by combining Trastuzumab and the cytotoxic compound Emtansine with the help of a stable linker by a process called Antibody Drug Conjugation.

Due to this technology, the targeted delivery of the cytotoxic agent is enabled and the other toxicities on the body are reduced.

Patients already treated with Trastuzumab may still have the disease and would require this therapy as the next step. The high cost of therapy is a barrier to availing this therapy and Ujvira bridges this need, said the company.

Based in India, Zydus Cadila is an innovation-driven, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics, and vaccines. The company employs nearly 25,000 people worldwide, including 1,400 scientists engaged in R & D.