Cancer Vaccine Breaking News

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

Jan 19, 2022 • 9:11 am CST

The JAMA Network published an Orginal Investigation on January 18, 2022 that found that U.S. Preventive Services Task Force guideline-concordant cervical cancer screening rates decreased between 2005 and 2019, before the COVID-19 pandemic.

The most common reason for not receiving cervical cancer screening was 'not knowing cancer screening was needed.'

Among women in the older age cohort, those responding they 'did not' receive screening was because they did not have a recommendation from healthcare practitioners more than doubled in 2019, from 5.5% to 12%.

In this cross-sectional study of 20,557 women eligible for cervical cancer screening in the U.S., the proportion of women without up-to-date screening significantly increased from 14.4% in 2005 to 23.0% in 2019 among all sociodemographic groups.

The study's findings also revealed that barriers to screening significantly varied by sociodemographic factors, suggesting cultural adaptation of interventions will be an essential factor in the success of efforts to increase cervical cancer screening uptake.

Along with increasing HPV vaccine coverage, improving cervical cancer screening rates represents an essential strategy for national campaigns to eliminate cervical cancer as a public health concern.

Campaigns addressing patient knowledge and practitioner communication may help to improve cervical cancer screening rates, and cultural adaptation of interventions is needed to reduce existing disparities.

Corresponding Author: Ryan Suk, Ph.D., MS, Department of Management, Policy, and Community Health, University of Texas Health Science Center at Houston School of Public Health ([email protected]). No industry conflicts of interest were disclosed. 

Jan 19, 2022 • 8:12 am CST

California-based ImmunityBio, Inc. announced interim results in its metastatic pancreatic cancer trial (QUILT 88), showing that the overall survival rate for patients doubled compared to the historical survival rate of three months after two prior lines of therapy.

The data of the Phase 2 trial studying combination immunotherapy (Nant Cancer Vaccine) also show treatment-related serious adverse events were uncommon (8%), and no treatment-related deaths were reported.

Based on these findings, ImmunityBio plans to meet with the U.S. FDA in 2022 to discuss the path for the Approval of combination therapies for pancreatic cancer.

"There are thousands of patients in advanced stages of this disease, and there are few, if any, treatment options for them," commented Patrick Soon-Shiong, M.D., Founder, and Global Chief Scientific and Medical Officer of ImmunityBio, Inc, in a press statement issued on January 18, 2022.

"Based on this encouraging data from our QUILT 88 trial, we are hopeful that our Nant Cancer Vaccine can potentially address this unmet need."

"What's more, we designed this therapeutic candidate to be administered in an outpatient setting, making it more accessible to future patients than traditional immune checkpoint inhibitors."

The results were presented today at the American Society of Clinical Oncology Gastrointestinal conference being held virtually.

To date, 27% of third-line or greater patients (17/63) remain on study. The median overall survival in this highly advanced group of patients, who failed two to six prior lines of treatment, is 5.8 months (95% CI: 3.9, 6.9 months), exceeding the approximately three-month historical median overall survival.

Of the 63 patients, 30 (48%) had progressed after two prior lines of therapy.

The median overall survival in this group was 6.3 months (95% CI: 5.0, 9.8 months), more than doubling the overall historical survival.

The company has expanded enrollment in the third-line or greater cohort on the strength of this early data and significant unmet medical need.

Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. every year.

Located in Culver City, CA, ImmunityBio's clinical pipeline consists of 21 clinical trials—13 of which are in Phase II or III development—across 12 indications in solid and liquid cancers and infectious diseases.

Jan 18, 2022 • 4:02 pm CST

The Harvard Business Review (HBR) published an article on January 17, 2022, that while the rate of new cancer cases is similar for white and Black patients, the death rate for Black cancer patients continues to be slightly higher than for white individuals.

While the gap has narrowed over the past two decades, disparities exist for several types of cancer, including prostate, colorectal, breast cancer, and multiple myeloma.

'The same urgency and cooperation triggered by the racial disparities in the Covid-19 death rate and the enrollment of people of color in Covid-19 vaccination trials are needed to reduce disparities in cancer deaths,' wrote the HBR's Kathy Giusti and Richard G. Hamermesh.

'We offer a three-part strategy for enrolling more patients in cancer research that can be implemented immediately.'

'After applying this approach to reduce the disparity in the mortality rate for Black vs. white cancer patients, it can be used to address other populations and diseases.'

To read the full HBR article, visit this weblink.

Jan 18, 2022 • 5:31 am CST

Cancer Research UK, Vaccitech plc, and the Ludwig Institute for Cancer Research today announced the first patient dosed in the MAGE clinical trial, which is testing a novel immunotherapeutic, VTP-600, in patients with the most common type of lung cancer.

Unlike preventative vaccines, such as the influenza vaccine, which is given to healthy people to protect them against future disease, VTP-600 is immunotherapy given to people who already have lung cancer.

The phase I/IIa trial is expected to enroll approximately 86 people over 2-3 years who have been newly diagnosed with non-small cell lung cancer (NSCLC) and will be testing the safety and initial efficacy of VTP-600 in these patients.

VTP-600 will be given in combination with the current first-line treatment for NSCLC. Depending on its effectiveness in NSCLC, VTP-600 could be evaluated in other types of cancer in the future, including breast, bowel, bladder, and melanoma.

VTP-600 is a 'prime-boost' immunotherapy, meaning an initial 'prime' dose is administered, and then a second 'booster' dose is given 21 days later. This 'prime-boost' approach is expected to improve the size and length of the anti-cancer immune response.

Even though two doses are administered, the immunotherapy comprises three parts. ChAdOx1-MAGE-A3-NY-ESO-1 is the prime immunotherapy administered to all patients, MVA MAGE-A3 with or without MVA NY-ESO-1 is given as the second booster immunotherapy, depending on the type of antigens expressed on the patient's tumor.

Chief investigator for the MAGE clinical trial, Professor Fiona Blackhall, who is consultant medical oncologist and director of research and innovation at The Christie NHS Foundation Trust, stated in a press release issued on January 18, 2022, "There is an urgent need to find better treatments for patients with NSCLC."

"The VTP-600 immunotherapeutic vaccine is a cutting-edge technology to target a patient's immune system to tackle the cancer cells."

The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. 

Jan 17, 2022 • 11:08 am CST

California-based Allogene Therapeutics, Inc. announced on January 10, 2022, that the U.S. Food and Drug Administration (FDA) had removed the clinical hold on the Company's five AlloCAR T clinical trials.

Allogene will be working with clinical trial investigators to resume study activities across AlloCAR T development programs as quickly as possible. Pending final discussions with the FDA, the Company also plans to initiate its pivotal Phase 2 trial of ALLO-501A in relapsed/refractory Large B Cell Lymphoma (LBCL) mid-year 2022.

On October 7, 2021, a report of a chromosomal abnormality was detected post-AlloCAR T administration in a single patient treated with ALLO-501A in the ALPHA2 study.

Since then, investigations concluded that the chromosomal abnormality was unrelated to TALEN® gene editing or Allogene's manufacturing process and had no clinical significance.

Rafael Amado, M.D., EVP of Research and Development and Chief Medical Officer, stated in a press release, "Allogeneic CAR T therapy is a rapidly developing field that continues to evolve both in scope and impact, and the findings from our investigation will help advance innovation in the fields of gene editing and cell and gene therapy."

"As the leading developer of allogeneic cell products, we look forward to resuming our clinical trials as we work to fulfill our commitment to bring patients the first allogeneic CAR T product."

Allogene Therapeutics is headquartered in South San Francisco, pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. 

Jan 17, 2022 • 10:04 am CST

California-based ImmunityBio, Inc. announced on December 20, 2021, the Company has held discussions with the U.S. FDA to file a biologics license application for Anktiva™ (VesAnktiva) for intravesical administration plus BCG for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (CIS).

By January 2022, the median follow-up of patients with high-risk CIS BCG responsive disease will exceed 24 months.

“We are advancing our clinical development at an increasing rate with the goal of positioning ourselves to apply for regulatory approval in 2022,” said Richard Adcock, President, and CEO of ImmunityBio, in a press release.

On September 13, 2021, principal investigator Dr. Karim Chamie at UCLA reported positive results in 58 of the 81 patients (72%) in one cohort to treatment with a combination of intravesical BCG plus N-803 (Anktiva). 

Non-muscle invasive bladder cancer (NMIBC) is the most common form of bladder cancer. It accounts for between 75%-85% of all diagnoses. The standard treatment for NMIBC for three decades has been Bacillus Calmette–Guérin (BCG)

However, while the BCG vaccine is an effective treatment for many patients, it doesn’t work for an estimated 40% of NMIBC cases.

ImmunityBio and its scientists published over twenty scientific papers on its immunotherapy portfolio in 2021, and the Company has over 750 granted patents for its immunotherapy technologies, including the Nant Cancer Vaccine.

Jan 16, 2022 • 9:34 am CST

Massachusetts-based Pieris Pharmaceuticals, Inc. announced on January 14, 2022, that the first patient had been dosed in the phase 2 study of cinrebafusp alfa (PRS-343), a 4-1BB/HER2 Anticalin-based bispecific for the treatment of HER2-expressing gastric cancer.

The two-arm, multicenter, open-label phase 2 study evaluates the efficacy, safety, and tolerability of cinrebafusp alfa combined with ramucirumab and paclitaxel in patients with HER2-high gastric cancer and combination with tucatinib in patients with HER2-low gastric cancer.

Patients in the phase 2 study will receive a loading dose of 18 mg/kg in weeks one and three, followed by maintenance doses of 8 mg/kg for both arms in the study.

In phase 1 studies, cinrebafusp alfa has shown an acceptable safety profile at all doses tested with no dose-limiting toxicities.

The bispecific also showed a dose-response and a 4-1BB-driven mechanism based on clinical benefit and pharmacodynamic correlations.

"The dosing of the first patient in this next phase of development of cinrebafusp alfa marks an important milestone for patients who have gastric cancer without adequate treatment options, and we look forward to further evaluating the potential of this drug," said Tim Demuth, M.D., Ph.D., Chief Medical Officer of Pieris, in a press statement.

"We believe cinrebafusp alfa can provide differentiated treatment options for patients with gastric cancer via 4-1BB-mediated T-cell engagement, both in terms of efficacy and safety."

Pieris is a clinical-stage biotechnology company located in Boston, MA, combining leading protein engineering capabilities and deep understanding into molecular drivers of disease to develop medicines that drive local biology to produce superior clinical outcomes for patients. 

Jan 15, 2022 • 5:38 pm CST

The National Comprehensive Cancer Network® (NCCN) published significant updates on January 4, 2022, to the recommendations on vaccination and pre-exposure prophylaxis of COVID-19 in people with cancer.

The updated guidance — available at — includes information on the preventive use of human monoclonal antibodies in addition to the following principles:

  • Patients with cancer should get fully immunized, including third doses and/or any approved boosters;
  • There is a strong preference for mRNA vaccines;
  • To maximize vaccine efficacy, vaccination should be delayed for at least three months following hematopoietic cell transplantation or engineered cellular therapy (e.g., chimeric antigen receptor [CAR] T-cells). Vaccine delays in patients with cancer should also include those recommended for the general public (e.g., recent exposure to COVID-19, recent monoclonal Ab therapy);
  • Full vaccination is also recommended for caregivers, household/close contacts, and the general public;
  • The committee strongly supports full vaccination mandates for healthcare workers.

"All of us are called to do everything we can to save as many lives as possible during the ongoing pandemic," said Robert W. Carlson, MD, Chief Executive Officer, NCCN, in a press statement.

"Vaccination is our most effective approach for avoiding serious COVID-19 complications, including hospitalization and death."

"However, research shows many immunocompromised people develop inadequate immune responses from vaccines."

"Thankfully, we now have additional tools to help people in active treatment for cancer, solid organ transplant recipients, engineered cellular therapy (e.g., CAR T-cell) or stem cell transplant recipients (a.k.a. hematopoietic stem cells), and those with other immunodeficiency-causing conditions (such as HIV, DiGeorge syndrome, or Wiskott-Aldrich syndrome)."

The U.S. FDA has issued an emergency use authorization for the monoclonal antibody (mAbs) combination of tixagevimab plus cilgavimab (Evusheld) for pre-exposure protection from COVID-19 in adults and certain children starting at age 12 who have moderate to severe immune compromise and may not be responsive to vaccination.

Patients with blood cancers (including those receiving stem cell transplantation or engineered cellular therapy) are more likely to have inadequate responses to COVID-19 vaccination and are at the highest risk of major COVID-19 complications.

The NCCN committee states that it is reasonable to prioritize these patients for tixagevimab plus cilgavimab before patients with solid tumor cancers in the event of limited supply.

"We have new agents to prevent and treat COVID-19 that will benefit patients with cancer," said Brahm Segal, MD, Roswell Park Comprehensive Cancer Center, Co-Leader of the NCCN Advisory Committee on COVID-19 Vaccination and Pre-exposure Prophylaxis. 

"An important challenge on a national level is to ensure drug availability to patients with cancer and others at high risk for COVID-19. The revised recommendations from the NCCN Advisory Committee on COVID-19 Vaccination and Pre-exposure Prophylaxis will guide the use of these agents for patients with cancer, including prioritization when supplies are limited."

An updated listing of authorized and experimental mAbs is published on this Precision Vaccinations webpage.

Jan 14, 2022 • 3:02 pm CST

A study published in the journal Blood on January 6, 2022, aimed to assess which factors contributed to the impaired antibody response after COVID-19 vaccination. Patients with hematological neoplasms, including lymphoma patients, have a high risk for severe COVID-19 disease.

The interval between the last anti-CD20 treatment and dosing of the COVID-19 vaccine was positively associated with increasing seroconversion rates.

Patients with their last anti-CD20 treatment at least 12 months before their first vaccination benefitted most with an overall response (OR) rate of 68%.

In contrast, response rates in patients who had received their last anti-CD20 treatment within 3 months to 12 months or <3 months were decreased with 22% (>12 vs 3 months to 12 months; P = .001) and 16% (>12 months vs <3 months; P < .001), respectively.

We further investigated if antibody response rates differed between patients who received anti-CD20 monotherapy or combination treatment with chemotherapy.

 No statistically significant difference was found between these subgroups (anti-CD20 monotherapy 36%, anti-CD20/chemotherapy 56%, P = .2).

And cancer patients who received anti-CD20 treatment and novel agents or novel agents after the failure of anti-CD20 containing treatments had very low seroconversion rates (17% and 0%, respectively).

The seroconversion rate after homologous mRNA-based vaccination was 41%, 0% after non-mRNA-based vaccination, and 71% after heterologous vaccination.

'Of note, even if infections cannot be prevented, it is still possible that T-cell responses are sufficient to ensure a mild course of COVID-19 disease. Taken together, COVID-19 vaccinations might be beneficial for anti-CD20-treated patients due to T-cell immunity,' concluded this letter.

Correspondence: Sascha Dietrich, Department of Hematology, University Hospital of Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany; e-mail: [email protected].

Jan 13, 2022 • 8:25 am CST

California-based Gritstone bio, Inc. announced that the first patient had been enrolled in the Phase 2/3 GRANITE-CRC-1L trial.

This clinical trial evaluates the individualized neoantigen vaccine GRANITE combined with immune checkpoint blockade for the first line (1L) maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC).

GRANITE is an individualized neoantigen-based immunotherapy and uses a priming adenoviral vector (GRT-C901) and self-amplifying mRNA (samRNA) vector (GRT-R902) to deliver individualized immunotherapy containing the relevant neoantigens. GRANITE was granted Fast Track designation by the U.S. FDA for treating MSS-CRC.

Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens identified by the company using its proprietary Gritstone EDGE™ artificial intelligence platform.

“Building on the success of our GRANITE program, which continues to demonstrate extended survival in multiple end-stage colorectal cancer patients, we are excited to launch this randomized, open-label Phase 2/3 trial to evaluate earlier use of GRANITE as a maintenance treatment in newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer,” said Andrew Allen, M.D., Ph.D., Co-founder, President and CEO of Gritstone, in a press release issued on January 13, 2022.

“We expect to report initial Phase 2 data from the GRANITE-CRC-1L trial in mid-2023.”

Gritstone bio, Inc. is a clinical-stage biotechnology company located in Emeryville, CA, developing the next generation of immunotherapies against multiple cancer types and infectious diseases. 

Jan 12, 2022 • 5:14 pm CST

Three studies presented during the 63rd American Society of Hematology Annual Meeting and Exposition on January 11, 2022, spotlights novel approaches to screening for and treating blood diseases.

As well as an unexpected potential association between a blood abnormality and Alzheimer's disease.

The first study demonstrates how the use of high-sensitivity screening techniques for the early detection of blood abnormalities may identify people at high risk for multiple myeloma earlier – especially Black patients and those with a first-degree relative with the disease – giving them more timely access to treatment.

The second reveals a surprising possible association between a fairly common blood abnormality in older adults and a reduced risk for Alzheimer's disease, the most common cause of dementia.

And in the third ­– the most extensive study to date of gene therapy for a blood disorder – investigators report on a novel treatment strategy with the potential to dramatically improve the quality and quantity of life for patients with a severe form of an inherited blood disease.

"Each of these studies is compelling in its own way," said press briefing moderator Joseph Mikhael, M.D., of the Translational Genomics Research Institute.

"The first presents a strong case for screening people at high risk for multiple myeloma."

"This could have important health equity implications because multiple myeloma is twice as common among African Americans as in the general population."

To ensure adequate representation of people of African descent in the study population, Dr. Ghobrial and colleagues also identified and screened Black people who had contributed blood samples to a sizeable biological specimen repository, the Mass General Brigham Biobank in Boston.

The investigators report interim screening findings for 7,622 participants in the current study, including 2,439 Black people.

"Ours is the largest cohort of Black people to be recruited for a myeloma screening study and the first prospective study to actively recruit people at high risk for multiple myeloma, follow them over time to estimate the prevalence of MGUS accurately, and explore outcomes for patients with this precursor condition," said Dr. Ghobrial.

Jan 11, 2022 • 2:50 pm CST

California-based Polynoma LLC today announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on a pivotal Phase 3 clinical study of seviprotimut-L, Polynoma's melanoma cancer vaccine.

This SPA is for the adjuvant treatment of patients 60 years and younger with Stage IIB or IIC melanoma following definitive surgical resection to improve recurrence-free survival.

Seviprotimut-L previously received Fast Track designation from the U.S. FDA.

The final analysis of Part B1 data from the Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was recently published in the Journal for ImmunoTherapy of Cancer.

A subgroup analysis of patients receiving seviprotimut-L with AJCC Stage IIB/IIC melanoma, under age 60 with a median follow-up time of 45.8 months (3.8 years), showed clinically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 68% (HR=0.32; 95% CI, 0.121, 0.864) compared to patients receiving placebo.

Additionally, RFS was more favorable in patients under age 60 with ulcerated melanomas (HR 0.21; 95% CI: 0.065-0.702), and there was a trend toward improved overall survival (HR 0.34; 95% CI: 0.117, 0.975) for patients that received seviprotimut-L compared to those receiving placebo.

There were no immune-mediated AEs, or other treatment-related serious AEs observed.

"Vaccination with seviprotimut- L has an advantage of having very low toxicity, without significant immune-related adverse events and no significant increase in toxicity over placebo," said Craig L. Slingluff, Jr., M.D., Professor of Surgery and Director of the Human Immune Therapy Center and lead author of the JITC research paper on MAVIS, in a press statement issued on January 11, 2022. 

"If the definitive evaluation of this vaccine therapy confirms clinical benefit in patients with Stage IIB/IIC melanoma, particularly those aged 60 and younger, the low toxicity of this approach will be a valuable option for these patients."

Seviprotimut-L is an allogeneic, polyvalent, partially purified shed melanoma antigen vaccine derived from three proprietary human melanoma cell lines. Seviprotimut-L stimulates humoral and cellular immune responses. 

Melanoma-associated antigens (MAAs) found in seviprotimut-L are taken up by antigen-presenting cells (dendritic cells), which then activate the production of antigen-specific cytotoxic T-lymphocytes (CTLs) as well as develop antibody responses against MAAs. 

These CTLs and antibodies then recognize and act on tumor cells expressing the MAAs on their surfaces, causing cell death.

Seviprotimut-L is currently developing for the adjuvant treatment of patients with Stages IIB and IIC melanoma following definitive resection.

Polynoma LLC is a U.S. immuno-oncology focused biopharmaceutical company headquartered in San Diego, CA, and is a wholly-owned subsidiary of CK Life Sciences Int'l., Inc.

Jan 10, 2022 • 10:13 am CST

Florida-based Veru Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Phase 3 registration program for the investigation of enobosarm, a selective androgen receptor targeting agonist, for the treatment of androgen receptor-positive, estrogen receptor-positive, human epidermal growth factor receptor 2 negative (AR+ER+HER2-) metastatic breast cancer patients who have shown previous disease progression on a nonsteroidal AI, fulvestrant, and CDK 4/6 inhibitor therapy, and who have AR% nuclei staining ≥40% in breast cancer tissue (third-line metastatic setting).

“We are very pleased that enobosarm has received Fast Track designation from the FDA, a distinction that underscores the urgent need for new, novel, targeted therapies for this important patient population suffering from this aggressive disease,” commented Mitchell Steiner, M.D., Chairman, President and Chief EEO of Veru Inc., in a press release.

“We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation.”

Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets the androgen receptor in AR+ ER+ HER2- metastatic breast cancer without unwanted masculinizing side effects.

Dec 16, 2021 • 5:59 pm CST

Use of genomic profiling supported by validated criteria can help improve metastatic breast cancer patient outcomes, wrote Mike Bassett with MedPage Today on December 7, 2021.

Fabrice André, M.D., Ph.D., of Gustave Roussy Cancer Campus in Villejuif, France, presented significant findings during a virtual press briefing at the San Antonio Breast Cancer Symposium.

"I cannot overstate how important this clinical trial is," said discussant Virginia Kaklamani, M.D., of UT Health San Antonio in Texas.

"This is the first trial that we have where we used genomic alterations to actively change a patient's treatment plan, and we have found an improvement in the patient's outcomes," she continued.

"What we are trying to do, and which Dr. André showed so eloquently, is that by finding changes in the tumor unique to that patient, and by having targeted therapies available for that change, we're able to treat that patient with that specific targeted therapy, instead of standard of care, which would have been chemotherapy, and improve the patient's outcome."

To read the full article, please visit this webpage.

Dec 15, 2021 • 7:08 am CST

Norway-based Ultimovacs ASA announced today that the first patient had been enrolled in the DOVACC (Durvalumab Olaparib VACCine) study, a randomized Phase II clinical trial assessing the impact of the telomerase vaccine, UV1, on the standard of maintenance care in ovarian cancer.

DOVACC will assess whether UV1 enhances progression-free survival in BRCA-negative (BRCA wild type) advanced ovarian cancer combined with two AstraZeneca drugs, durvalumab and olaparib.

The primary outcome measure for DOVACC is progression-free survival for the UV1-durvalumab-olaparib triple combination versus olaparib alone. The topline DOVACC study data is expected in 2023.

DOVACC will recruit 184 patients across Europe from a network of more than 40 hospitals.

DOVACC is one of five randomized Phase II clinical trials of Ultimovacs' UV1 combined with other immunotherapies.

In 2021, the U.S. FDA granted Fast Track designation to UV1 as an add-on therapy to ipilimumab or pembrolizumab for the treatment of unresectable or metastatic melanoma, as well as Orphan Drug designation to UV1 for the treatment of stage IIB – IV melanoma.

Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of ENGOT, commented in a press release, "The DOVACC study does exactly that by bringing together clinical and commercial organizations in pursuit of a shared goal, in this case extending the effectiveness of maintenance care for ovarian cancer."

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. It is being developed as an "off-the-shelf" therapeutic cancer vaccine for use in combination with other immunotherapies that require an ongoing T cell response for their mode of action.

Innovation Norway granted Ultimovacs NOK 10 million ($1.2 million) to support the Phase II DOVACC study execution.