Cancer Vaccine Breaking News

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

Oct 19, 2021 • 7:25 pm CDT

California-based ImmunityBio, Inc. announced that Papillary disease (Cohort B), the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade NMIBC, also met its primary endpoints with disease-free survival of 57% of patients at 12 months.

To date, 73 patients have enrolled in Cohort B with a median follow-up of 17.3 months. 

The Company previously reported that the primary endpoint of Cohort A, patients with CIS disease, has been met with a complete response of 72% (58/81).

Non-muscle invasive bladder cancer (NMIBC) makes up 75%-85% of all bladder cancers in the U.S.

And approximately 90% of NMIBC cases are papillary (stages Ta and T1).

The current standard of care for the high-grade papillary disease is intravesical BCG, with a 40% non-response rate.

The primary endpoint was met with a disease-free rate at 12-months of 57% (95% CI: 43.7%, 68.5%) and at 18-months, 53% (95% CI: 38.8%, 64.6%) by Kaplan-Meier analysis. Durable responses were noted in both cohorts, and the therapy resulted in significant avoidance of cystectomy.

The safety profile of Anktiva (N-803) in Cohort B was consistent with that seen in Cohort A, which was recently presented at the American Urological Association's 2021 Annual meeting, in which 0% SAEs, including 0% immune-related SAEs, were detected.

In addition, 85% of the patients were able to avoid a cystectomy. A full analysis of efficacy and safety data for both Cohorts A (CIS) and B (Papillary) has been submitted to the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO GU) which is taking place in February 2022.

"Intravesical BCG has been the standard of care for more than 30 years for patients with non-invasive papillary tumors, yet, unfortunately, some 40% of them don't respond," said Patrick Soon-Shiong, M.D., Founder, and Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.

"Anktiva has demonstrated strong disease control in CIS, and based on the latest data from our study, it is showing the same effect in papillary tumors."

"This gives us confidence in the potential for all BCG-unresponsive NMIBC patients to benefit from this combination therapeutic."

The U.S. Patent & Trademark Office has recently allowed ImmunityBio's patent application for a method of treating cancer, including non-muscle invasive bladder cancer, using Anktiva (N-803) in combination with Bacillus Calmette-Guerin (BCG). The new patent will extend patent life on the N-803/BCG combination therapy for bladder cancer to at least 2035.

Oct 14, 2021 • 1:27 pm CDT

Oesophageal cancer cases have tripled in under the 50s age group over the past 30 years, a new study presented at UEG Week Virtual 2021 has found. The dramatic increases were seen in patients with oesophageal adenocarcinoma.

The research was published on October 8, 2021, conducted in the Netherlands on almost 60,000 patients, found new cases of oesophageal adenocarcinoma had risen from 0.34 to 0.92 per 100,000 population between 1989 and 2018.

There was an average increase of 1.5% in males and 3% in females.

These experts believe that the rise in cases of oesophageal adenocarcinoma reflects changes in lifestyle-related risk factors for the disease, with increases in unhealthy habits including smoking, poor diet, and reduced physical exercise.

Ali Al-Kaabi, from Radboud University Medical Centre in Nijmegen, Netherlands, and lead author of the study explained, in a press release, "The incidence of oesophageal adenocarcinoma is increasing in young adults. We know the disease is associated with Barrett's Oesophagus, which is a premalignant condition in the lower end of the esophagus."

"Gastro-oesophageal reflux (acid reflux), obesity, and smoking are also important risk factors for oesophageal adenocarcinoma."

"We also know that rates of these risk factors have all increased in young adults over the past thirty years."

Oesophageal cancer is the seventh most common cancer worldwide, and it is a highly fatal disease, accounting for 500,000 deaths each year.

Oesophageal cancer is when abnormal cells in the food pipe (esophagus) grow in an uncontrolled way. The esophagus is also known as the gullet. It is the tube that carries food from your mouth to your stomach. Most people are over the age of 60 when they are diagnosed. 

There are two main subtypes; oesophageal adenocarcinoma (linked to obesity and gastro-oesophageal reflux disease) and oesophageal squamous cell carcinoma (linked to alcohol and tobacco consumption).

Oct 13, 2021 • 3:52 pm CDT

The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test, on October 13, 2021.

Ki-67 is a marker of cellular proliferation. And Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.   

"Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options," said Jacob Van Naarden, SVP, CEO of Loxo Oncology at Lilly and president, Lilly Oncology, in a press release.

"We are pleased with this initial approval in the adjuvant setting, and as these data continue to mature, we look forward to furthering opportunities to work with health authorities to expand the use of Verzenio in this setting."

This approval is based on efficacy results from an analysis of this subgroup with additional follow-up conducted post-hoc. In this analysis, Verzenio given in combination with ET continued to demonstrate a clinically meaningful benefit, with a 37 percent decrease in the risk of breast cancer recurrence or death compared to standard adjuvant ET alone for patients with high risk clinical and pathological features and a Ki-67 score ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), and an absolute benefit in IDFS event rate of 7.1 percent at three years.

The number of IDFS events at this analysis was 104 with Verzenio plus ET compared to 158 with ET alone. Overall survival data were not mature, and additional follow-up is ongoing.

Adverse reactions from monarchE were consistent with the known safety profile for Verzenio.2 Safety and tolerability were evaluated in 5,591 patients. 

For more than 50 years, Indiana-based Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world.

To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.

Sep 29, 2021 • 1:13 pm CDT

New York-based Regeneron Pharmaceuticals, Inc. announced on September 28, 2021, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.

The target action date for the FDA decision is January 30, 2022.

The sBLA is also being reviewed under the FDA's Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada, and Switzerland. Additional global regulatory submissions are planned, including in the European Union, by the end of 2021.

The use of Libtayo in advanced cervical cancer is investigational, and its safety and efficacy have not been thoroughly evaluated by any regulatory authority.

Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology. Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Regeneron and Sanofi jointly develop it under a global collaboration agreement.

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Sep 28, 2021 • 4:28 pm CDT

California-based Nonagen Bioscience Corp today announced Oncuria™, their non-invasive bladder cancer test capable of predicting response to therapy, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation.

This FDA designation is granted to technologies that have the potential to provide more effective treatment, diagnosis, or prognosis of life-threatening diseases, such as cancer.

The designation enables close collaboration with an expedited review by the FDA and formally acknowledges Oncuria's utility and potential clinical benefit.

"Oncuria is designed to provide a prediction of response to therapy, allowing for timely interventions that could result in more favorable outcomes for our patients," stated Charles J. Rosser, CEO of Nonagen, in a related press statement.

"We are proud that the FDA has decided to grant Breakthrough Device Designation to our lead diagnostic, Oncuria™, acknowledging growing recognition of the benefit our test can offer to clinicians and patients."

Oncuria is reported more sensitive for bladder cancer detection than urine cytology for both disease stage and by grade, says the Company.

Using a well-established Luminex Corporation platform, we are close to adding a robust diagnostic test in our fight against bladder cancer. Please take a look at our white paper to understand our journey and see how we stack up to competitors, says the Company's website.

Sep 27, 2021 • 2:27 pm CDT

New Jersey-based Bristol Myers Squibb announced on September 20, 2021, that Opdivo®(nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

The FDA approval is based on the Phase 3 CheckMate -274 trial, which compared Opdivo 240 mg (n=353) to placebo (n=356).

"This approval is a major milestone for patients who have undergone major surgery to remove the bladder or parts of the urinary tract and require additional treatment approaches that can help reduce the risk of their UC returning," commented Matthew D. Galsky, M.D., a CheckMate -274 primary investigator and Professor of Medicine, Director of Genitourinary Medical Oncology, Co-Director of the Center of Excellence for Bladder Cancer, and Associate Director for Translational Research at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai.

"Nivolumabprovides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate -274, and has the potential to become a new standard of care option in this setting," added Dr. Galsky in a related press release.

This application was approved under the FDA's Real-Time Oncology Review pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.

Urothelial carcinoma most frequently begins in the cells that line the inside of the bladder, which is the most common type of bladder cancer in adults in the United States. Each year, 81,000 new cases of bladder cancer are diagnosed, and a majority of those cases are UC. In addition to the bladder, UC can occur in other parts of the urinary tract, including the ureter and renal pelvis.

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea, and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea, and Taiwan.

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.