Cancer Vaccine Breaking News

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

Dec 16, 2020 • 5:51 am CST

A team of researchers assessed the trends in the incidence and outcomes of “young-onset” esophageal adenocarcinoma using a population-based database. Published on December 11, 2020, their study found esophageal adenocarcinoma incidence has increased in patients <50 years of age, with an annual percentage change of 2.9%, from 1975 to 2015.

Patients with esophageal adenocarcinoma < 50 years present at more advanced stages with higher esophageal adenocarcinoma–specific mortality than older peer-groups.

These researchers suggest 'current diagnostic and management strategies for young-onset esophageal adenocarcinoma may need to be reevaluated.'

Dec 14, 2020 • 11:40 am CST

AstraZeneca and Daiichi Sankyo's trastuzumab deruxtecan has been recommended for conditional marketing authorization in the European Union as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens.

Trastuzumab deruxtecan is approved under the brand name Enhertu (5.4mg/kg) in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial. In September 2020, Enhertu (6.4mg/kg) was approved in Japan for patients with HER2-positive unresectable advanced or recurrent gastric cancer that progressed after chemotherapy based on the DESTINY-Gastric01 trial.

José Baselga, AstraZeneca's EVP, Oncology R&D, said in a press release issued on December 14, 2020: “The durable responses demonstrated in the DESTINY-Breast01 trial have never been seen before in this patient setting. If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2-positive metastatic breast cancer.”

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, said the company.

Dec 11, 2020 • 10:22 am CST

Innovent Biologics, Inc. announced that the first patient has been successfully enrolled and dosed in the randomized, double-blind, phase 2 multi-center clinical trial (NCT04590599) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT® (sintilimab injection) for the treatment of patients with second-line or above advanced cervical cancer.

 Dr. Hui Zhou, Vice President and Head of Medical Sciences and Oncology Strategy of Innovent, stated: "CTLA-4 is an important immunosuppressive receptor. Currently, only one antibody drug targeting CTLA-4 has been approved and marketed globally, though lots of clinical trials on CTLA-4 targeted drugs have been conducted."

"So far there is no CTLA-4 targeted drug approved in China. With the most advanced progress in clinical development in China, IBI310 in combination with TYVYT® (sintilimab injection) has shown promising preliminary anti-tumor potential value. We will evaluate the efficacy of IBI310 combined with TYVYT® (sintilimab injection) in the phase II trial and we hope to provide more effective treatment to benefit patients and their families.”

Dec 9, 2020 • 12:32 pm CST

INOVIO announced positive Phase 2 efficacy results demonstrating that DNA medicine VGX-3100, the company's lead immunotherapy asset, showed resolution of HPV-16/18-associated precancerous anal lesions in 50% of subjects 6-months following the start of treatment.

Dec 8, 2020 • 4:47 pm CST

Should cancer patients be vaccinated with the experimental COVID-19 vaccines? Kelvin Lee, M.D., Chair of Immunology at Roswell Park and a member of the New York State COVID-19 Clinical Advisory Task Force, answers this and other key questions.

As an example, 'Very little is known right now about the interactions of the vaccine with cancer therapy. Your cancer treatments would probably have a negative effect on the vaccine because the vaccine works with your immune system, and most cancer treatments suppress your immune response. It may be that the vaccine won’t work very well in people who are in active treatment,' posted Dr. Lee on December 7, 2020.

Dec 8, 2020 • 11:40 am CST

Pfizer Inc. announced safety and clinical response results from the ongoing Phase 1 clinical study for PF-06863135, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody. Data from 30 patients with relapsed or refractory multiple myeloma showed manageable safety across all subcutaneous dose levels with no dose-limiting toxicities observed, and 83% of patients achieved a clinical response at the highest dose level.

“Despite treatment advances, multiple myeloma remains incurable and there is a substantial need for breakthroughs for patients,” stated Jeff Settleman, SVP & Chief Scientific Officer, Oncology R&D, Pfizer, in a press release. 

“The very high response rate observed with PF-06863135, coupled with manageable safety and the convenience of subcutaneous administration, underscores the potential impact this medicine may have for people living with this devastating disease. These findings support the continued development of PF-06863135 for people with multiple myeloma, both as monotherapy and in combination with standard or novel therapies.”

Dec 7, 2020 • 11:55 am CST

As a first-of-its-kind technology, NuView Life Sciences announced on November 16, 2020, it combined their proprietary NV-VPAC1 peptide construct with the radionucleotide Copper-64 for diagnostics and Cu for treatment. The company says 'research shows that malignant cells accumulate Cu in much greater quantities compared to normal, healthy cells. As a result, the NV-VPAC1 peptide construct targets cancer cells, binding to specific receptors, called VPAC1 receptors, which are overexpressed on the surface of cancer cells.

“NV-VPAC1 is a unique binary molecular tool, with the ability to diagnose cancer in vivo, to treat primary and metastatic lesions, and to allow one to determine the efficacy of therapeutic interventions,” stated Dr. Mathew Thakur, who invented NV-VPAC1, along with a team of colleagues at Thomas Jefferson University.

Dec 7, 2020 • 11:30 am CST

Atara Biotherapeutics, Inc. and Bayer announced an exclusive worldwide license agreement and research, development, and manufacturing collaboration for mesothelin-directed CAR T-cell therapies for the treatment of solid tumors. The agreement includes the development candidate ATA3271, an armored allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer.

“This collaboration will accelerate the development of mesothelin-targeted CAR T-cell therapies for multiple solid tumors and helps us advance the power of our allogeneic cell therapy platform to patients as quickly as possible,” said Pascal Touchon, CEO of Atara, in a press statement.

Dec 7, 2020 • 9:46 am CST

Odonate Therapeutics, Inc. announced the initiation of Cohort 3 of CONTESSA TRIO, which will evaluate tesetaxel monotherapy in approximately 60 non-elderly patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC).

This new study will expand on results from TOB203, a Phase 2 study that evaluated tesetaxel monotherapy in 38 patients with hormone receptor-positive, HER2-negative MBC, which confirmed a response rate of 45%.

Lee Schwartzberg, M.D., FACP, Chief Medical Director, West Cancer Center & Research Institute added in a press statement: “The promising clinical results to date, combined with tesetaxel’s unique, once-every-three-weeks oral dosing regimen, make this investigational agent an exciting potential new treatment option for patients.”

Dec 7, 2020 • 7:07 am CST

Kite announced results from the interim analysis of ZUMA-12, a multicenter, open-label, single-arm Phase 2 study evaluating Yescarta® (axicabtagene ciloleucel) as first-line therapy in patients with high-risk large B-cell lymphoma.

After a single infusion of Yescarta, 85% of patients achieved a response, including 74% of patients with a complete response.

Sattva S. Neelapu, M.D., Professor, Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, stated in a press release: “Only half of these patients achieve long-term remission with standard first-line therapy, so there is a major need for therapies with potential to improve outcomes for more patients. These early results from the ZUMA-12 trial are highly encouraging for the potential of CAR T in this earlier setting in patients with high risk.”

Dec 4, 2020 • 9:52 am CST

On November 25, 2020, the U.S. FDA granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy.

“We believe that DANYELZA in combination with GM-CSF is a much-needed treatment for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have historically not had approved treatments available. This approval of Y-mAbs’ first BLA represents a key step in working towards our mission of becoming a world leader in developing better and safer antibody-based oncology products addressing unmet pediatric and adult medical needs,” said Claus Moller, CEO, in a related press release.

Dec 3, 2020 • 4:48 pm CST

enGene Inc. announced today that the U.S. FDA has granted Fast Track Designation to enGene for EG-70, the company's lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin (BCG) -unresponsive non-muscle invasive bladder cancer.

Jason Hanson, Chief Executive Officer at enGene, stated in a press release: "We are pleased with the FDA's recognition of our EG-70 program with this designation and we look forward to working closely with the FDA throughout the clinical development process to bring this innovative treatment to patients as quickly as possible."

Dec 3, 2020 • 3:44 pm CST

In a serial cross-sectional, US population-based study using cancer registry data from 497,452 adolescents and young adults (AYA), the rate of cancer increased by 29.6% from 1973 to 2015, with kidney carcinoma increasing at the greatest rate, reported the JAMA on December 1, 2020.

Breast carcinoma and testicular cancer were the most common cancer diagnoses for female and male AYAs, respectively.

Dec 3, 2020 • 8:35 am CST

Sumitomo Dainippon Pharma Oncology, Inc. announced the first patient has been dosed in the Phase 2 expansion portion of the study, last updated on November 2, 2020, evaluating DSP-7888, an investigational immunotherapeutic cancer vaccine that targets Wilms Tumor 1, in combination with checkpoint inhibitor pembrolizumab, in patients with platinum-resistant ovarian cancer.

DSP-7888 is an investigational immunotherapeutic cancer vaccine containing two peptides that induce WT1-specific cytotoxic T lymphocytes (WT1-CTL) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that by adding helper T cell inducing peptides, improved outcomes may be achieved compared to a killer peptide treatment regimen alone.

"Patients with platinum-resistant ovarian cancer have a high unmet need with limited treatment options; therefore, we are excited to advance the study of DSP-7888 plus pembrolizumab and evaluate its role and potential benefits," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology, in a press statement.

Dec 1, 2020 • 11:09 am CST

Agenus Inc. announced the expansion of a Phase 2 trial into colon cancer based on a new objective clinical response in a colorectal cancer patient in addition to a significant tumor reduction of 27% and biomarker reduction observed in a patient with MSS colon cancer.

With this recent response in colon cancer, AGEN1181 +/- balstilimab (anti-PD-1) has reported 4 clinical responses, plus a significant tumor reduction of more than 27% in a fifth patient. In addition, 19 patients have achieved disease stabilization out of 41 patients treated in what was designed as a dose-escalation study, stated the company's December 1, 2020, press release.

Dr. Joseph Grossman, Head of Exploratory Medicine at Agenus, added: “AGEN1181 has potential to not only broaden the population of responders to CPIs, but also to reach tumors traditionally considered “cold” or unresponsive to immune therapies. I am excited to see the potential broadened benefit of our next-generation anti-CTLA-4’s design, particularly its Fc-enhancement, and the validation of Agenus’ incredible R&D capabilities.”