Cancer Vaccine Breaking News

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

Sep 26, 2021 • 9:48 am CDT

Dr. Patrick Soon-Shiong and NantAfrica, a division of NantWorks, announced on September 24, 2021, the official launch of an ambitious initiative to build capacity for advanced cancer and COVID-19 health care in Africa.
 
This initiative will partner with the Council for Scientific and Industrial Research (CSIR) and the South African Medical Research Council (SAMRC).
 
NantWorks LLC has signed a collaboration agreement with the CSIR and the SAMRC to initiate the transfer of biologic manufacturing technology for COVID-19 and cancer vaccines and next-generation cell-based immunotherapies.

This collaboration will enable the rapid clinical development of next-generation vaccines for infectious diseases and cancer at centers of excellence across the country.
 
"It has been a dream of mine, since I left the country as a young physician, to bring state-of-the-art, 21st-century medical care to South Africa and to enable the country to serve as a scientific hub for the continent," said Dr. Patrick Soon-Shiong, founder and CEO of NantWorks.
 
"We are privileged to have the opportunity to bring 30 years of clinical, scientific, and advanced biological know-how to the country and establish much-needed capacity and self-sufficiency."
 
The partnership between NantWorks, the CSIR, and the SAMRC will expedite and expand the manufacturing of biologics, immunotherapeutic, and vaccines in South Africa through technology transfer and state-of-the-art advanced manufacturing facilities.

The CSIR, an entity of the Ministry of Higher Education, Science and Innovation, is one of Africa's leading scientific and technology research, development, and implementation organizations. Constituted by an Act of Parliament in 1945 as a science council, the CSIR undertakes directed and multidisciplinary research and technological innovation, and industrial and scientific development to improve the quality of life of all South Africans. For more information, visit www.csir.co.za .

NantWorks is a multinational, California-based conglomerate that is leading the digital revolution in healthcare, technology, and media by harnessing science, digital infrastructure, supercomputing, and communication.

Sep 21, 2021 • 3:26 pm CDT

Florida-based Veru Inc. announced on September 20, 2021, that updated clinical data from the positive Phase 1b/2 study of sabizabulin (VERU-111) in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel androgen receptor targeting agent were presented at the European Society for Medical Oncology Congress 2021.

Sabizabulin is a new oral chemical entity representing a novel class of agents that target unique binding sites on microtubules to disrupt the cytoskeleton and androgen receptor transport.

As for efficacy, combining patients in Phase 1b/2 study who received 63 mg sabizabulin daily with measurable metastatic disease at baseline (PCWG3 criteria), the median rPFS is estimated to be approximately 7.4 months (3.2 – 30.0+ months) as five patients remain on the study of which two of which have been on sabizabulin without tumor progression for more than two years.

In the Phase 1b/2 population with measurable disease at baseline per RECIST 1.1, the Overall Response Rate (ORR) was 21%.

“These updated findings from our clinical study of sabizabulin continue to support the potential role of sabizabulin in filling a growing unmet medical need in the treatment of men with metastatic prostate cancer that have tumor progression with androgen deprivation and novel androgen receptor targeting agent therapy, but before IV chemotherapy," said Dr. Mitchell S. Steiner, Chairman, President, and CEO of Veru Inc., in a press release.

"Based on this Phase 1b/2 study, sabizabulin has a safety profile similar to what has been reported in the literature for novel androgen receptor targeting agents and with promising efficacy."

"We are greatly anticipating the results of our ongoing Phase 3 VERACITY study, which is enrolling in 45 clinical centers in the United States.”

Veru Inc. (NASDAQ: VERU) is an oncology biopharmaceutical company focusing on developing novel medicines to manage prostate cancer and breast cancer.

Sep 20, 2021 • 3:39 pm CDT

The results of a phase 3 clinical study were presented today in a Presidential Symposium at the European Society for Medical Oncology Congress 2021.

Detailed positive results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) HER2-directed antibody-drug conjugate (ADC), demonstrated superior progression-free survival (PFS) versus trastuzumab emtansine (T-DM1), a HER2-directed ADC currently approved to treat patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

At a prespecified interim analysis of DESTINY-Breast03, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 (hazard ratio [HR] 0.28; 95% confidence interval [CI] 0.22-0.37; p=7.8x10-22).

After 15.5 and 13.9 months of follow-up in the Enhertu and T-DM1 arms, respectively, the median PFS for patients treated with Enhertu was not reached (95% CI 18.5-NE) compared to 6.8 months for T-DM1 (95% CI 5.6-8.2) as assessed by blinded independent central review (BICR).

In the key secondary endpoint of PFS assessed by investigators, patients treated with Enhertu experienced a three-fold improvement in PFS of 25.1 months versus 7.2 months for T-DM1 (HR 0.26; 95% CI 0.20-0.35; p=6.5x10-24).

A consistent PFS benefit was observed in key subgroups of patients treated with Enhertu, including those with a history of stable brain metastases.

There was a strong trend towards improved overall survival (OS) with Enhertu (HR 0.56; 95% CI 0.36-0.86; nominal p=0.007172).

However, this analysis is not yet mature and is not statistically significant.

Nearly all patients treated with Enhertu were alive at one year (94.1%) compared to 85.9% of patients treated with T-DM1.

The confirmed objective response rate (ORR) doubled in the Enhertu arm versus the T-DM1 arm (79.7% vs. 34.2%). Forty-two (16.1%) complete responses (CR) and 166 (63.6%) partial responses (PR) were observed in patients treated with Enhertu compared to 23 (8.7%) CRs and 67 (25.5%) PRs in patients treated with T-DM1.

Javier Cortés, M.D., Ph.D., Head, International Breast Cancer Center, Barcelona, stated in a press release, “Patients with previously treated HER2-positive metastatic breast cancer will typically experience disease progression in less than a year with available HER2-directed treatments."

"The high and consistent benefit was seen across efficacy endpoints, and key subgroups of patients receiving Enhertu in DESTINY-Breast03 is remarkable and supports the potential of Enhertu to become the new standard of care for those who have previously been treated for HER2-positive metastatic breast cancer.”

Breast cancer remains the most common cancer and is one of the leading causes of cancer-related deaths in women worldwide.1 More than two million patients with breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.

Approximately one in five cases of breast cancer are considered HER2-positive.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast, gastric, lung, and colorectal cancers.3 HER2 protein overexpression may occur due to HER2 gene amplification and is often associated with aggressive disease and a poor prognosis in breast cancer.

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu (a HER2-directed ADC) in March 2019 and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

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.