Cancer Vaccine Breaking News

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

Jul 13, 2021 • 10:29 am CDT

Obese men with a form of advanced prostate cancer survive longer than overweight and normal-weight patients, new research has found. Although obesity is usually associated with an increased risk of death from many cancers and some other chronic diseases, there is some evidence in a few cancers of a survival advantage for patients with a high body mass index.

This phenomenon is known as the ‘obesity paradox.'

The study, presented today at the European Association of Urology Congress on July 8, 2021, followed more than 1,500 patients over three years. Patients classed as obese – with a BMI over 30 – had a 10% higher survival rate than thinner men.

At San Raffaele University in Italy and Mount Sinai Hospital in New York, NY, Alberto Martini and colleagues wanted to test whether the ‘obesity paradox’ held for patients with metastatic castration-resistant prostate cancer – an advanced form of the disease that no longer responds to testosterone lowering treatments.

”Nevertheless, we would not recommend weight gain to anyone with this or another disease. Obesity is a risk factor for many cancers and other diseases, and patients should always aim for a healthy BMI of 18 to 24.”

Professor Peter Albers, from Düsseldorf University, who chairs the EAU Scientific Congress Office, said: “There are many possible explanations for the association of body weight with a positive outcome in metastatic cancers. For example, it might be that patients with higher BMI can tolerate the toxicity of the treatments and their side effects better; in prostate cancer, it might be due to the protective impact of hormones found in tissue fat; and it is known that healthy men with slightly higher BMI have a higher overall life expectancy compared to very slim ones.

“However, at the moment, these are just hypotheses. Further research is needed to identify the biological mechanism behind these different outcomes. Until that mechanism is proven, we can’t recommend any change to treatment for patients with advanced prostate cancer.”

Jul 9, 2021 • 9:16 am CDT

Shanghai-based I-Mab announced today the signing of two new collaborations with emerging biotech companies in China to strengthen its next-generation innovation pipeline. The collaborations with Immorna, an mRNA biotech company, and neoX Biotech, an AI-enabled R&D biotech company, allow I-Mab access to transformative technologies in its quest to discover and develop novel oncology therapeutics.

I-Mab will be developing novel anti-cancer antibody therapeutics through Immorna's pioneering self-replicating mRNA platform.

Moreover, I-Mab will work with neoX Biotech for up to 10 novel biologics programs using neoX's proprietary artificial intelligence algorithm through a strategic collaboration agreement.

Today's announcement is the new addition to the existing collaboration agreements with Complix for cell-penetrating antibody platform and Affinity for masking antibody platform in March 2021, positioning the Company to continually expand its globally competitive pipeline of next-generation antibody assets enabled by transformative technologies.

"Since the launch of our discovery initiative earlier this year, we have identified transformative technologies that can enable us to rapidly expand the emerging portfolio of next-generation novel antibody assets to sustain our innovative immuno-oncology pipeline," said Dr. Taylor Guo, Chief Scientific Officer of I-Mab, in a press statement.

"The immense success of COVID-19 mRNA vaccines exemplifies that mRNA-based drugs have finally established themselves as transformative medicines. And channeling the power of AI into drug discovery holds great promise from unlocking novel targets and modalities to accelerating all aspects of R&D. By embracing these technologies, we have again demonstrated our commitment in executing against our long-term innovation strategy."

I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development, and soon commercialization of novel and highly differentiated biologics in the immuno-oncology therapeutic area.

Jul 8, 2021 • 3:36 pm CDT

Australia-based Imugene Limited announced on July 2, 2021, the City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles, has received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to initiate a Phase I clinical trial of its oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1).

The clinical trial is titled “A Phase I Study of Intratumoral Administration of CF33-hNIS-antiPDL1 in Patients with Advanced or Metastatic Triple-Negative Breast Cancer”.

The FDA approval of the IND enables Imugene and the City of Hope to start patient recruitment and dosing in Phase 1 clinical trial for triple-negative breast cancer patients.

The purpose of the study is to evaluate the safety and initial evidence of the efficacy of intra-tumoral administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The trial will involve a dose escalation, followed by an expansion to 12 patients at the final dose, the recommended phase 2 dose.

CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus.

The Principal Investigator leading the trial is Dr. Yuan Yuan MD, Ph.D. Principal Investigator said in a related press statement, “Our team is excited to be part of this important study and the search for effective new treatments for triple-negative breast cancer as there are limited options for patients.”

Jul 8, 2021 • 6:52 am CDT

Copenhagen-based Evaxion Biotech A/S announced today results from its Phase 1/2a trial of cancer immunotherapy EVX-01 in metastatic melanoma and interim Phase 1/2a trial of cancer immunotherapy EVX-02 adjuvant melanoma.

Data from the trial of EVX-01, a novel patient-specific cancer neoepitope immunotherapy based on Evaxion’s PIONEER AI technology combined with a PD-1 checkpoint inhibitor, showed a safety profile with only Grade 1 and 2 adverse events observed.

Combined therapy with EVX-01 demonstrated an objective response rate of 67% across all nine patients compared with historical data of 40% with anti-PD1 treatment alone.

The study also demonstrated a complete response rate of 22%, compared with a historical 7% with anti-PD1 treatment alone, and a partial response rate of 44%, versus 33% compared with anti-PD1 treatment alone.

Among the four patients on the highest two doses, there was an objective response rate of 75%In addition, three patients with Stable Disease for 10, 8, and 9 months on anti-PD1 treatment alone achieved CR, CR, and PR respectively following EVX-01 administration and subsequent activation of a neoepitope-specific de novo T-cell response.

Evaxion Biotech A/S is a clinical-stage AI-immunology platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer and vaccines against bacterial diseases and viral infections. 

Jul 1, 2021 • 9:27 am CDT

The COVID-19 pandemic might have exacerbated disparities as supply and demand for cancer screening services were reduced, according to research published in advance of October 2021 by Science Direct.

These researchers examined COVID-19's impact on National Breast and Cervical Cancer Early Detection Program  (NBCCEDP) screening services during January-June 2020. They found the total number of NBCCEDP-funded breast and cervical cancer screening tests declined by 87% and 84%, respectively, during April 2020 compared with the previous 5-year averages for that month.

Furthermore, the extent of screening declines varied by geography.

In April 2020, screening test volume declined most severely in Health and Human Services Region 2 - New York (96% for breast, 95% for cervical cancer screening) than the previous 5-year averages. 

By June 2020, NBCCEDP breast and cervical cancer screening test volume was only 39% and 40% below the 5-year average for that month, respectively. However, breast cancer screening remained over 50% below the 5-year average among women in rural areas. 

Jun 30, 2021 • 10:09 am CDT

Immunicum AB announced on June 28, 2021, that it had received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency (EMA) for the Company’s lead cancer relapse vaccine candidate, DCP-001.

The EMA and the Committee for Advanced Therapies have concluded that DCP-001 meets the ATMP classification criteria and classifies it as a somatic cell therapy medicinal product. The ATMP classification provides further guidance regarding the regulatory path forward for DCP-001.

DCP-001 is derived from Immunicum’s proprietary human DCOne cell line. It is currently being evaluated as a cancer relapse vaccine to prevent tumor recurrence in two ongoing clinical studies addressing acute myeloid leukemia and ovarian cancer.

DCP-001 is administered as an intradermal vaccine and has been shown to trigger systemic immune responses against different tumor-associated antigens, potentially contributing to the immune system’s control over the residual disease.

DCP-001 has been developed using Immunicum’s expertise in allogeneic dendritic cell biology, resulting in a highly immunogenic vaccine carrying multiple endogenous tumor-associated antigens, which have the potential to boost the immune system to control residual disease and prevent or reduce tumor recurrence. It has demonstrated an excellent safety profile in clinical studies. It is currently evaluated in an ongoing international Phase II clinical trial in acute myeloid leukemia patients and a Phase I clinical trial in patients with High-Grade Serous Ovarian Cancer.

Based in Sweden and the Netherlands, Immunicum is publicly traded on the Nasdaq Stockholm.

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.