Dec 1, 2020 • 11:09 am CST
Colon Cancer Phase 2 Study Expands Objectives
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.”
Nov 30, 2020 • 5:09 pm CST
First Patient Dosed in Phase 2 Study for Patients with Recurrent Glioblastoma
Istari Oncology, Inc. announced the first patient was dosed in the LUMINOS-101 Phase 2 clinical trial, assessing the safety and efficacy of PVSRIPO in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda®) in patients with recurrent glioblastoma multiforme (rGBM).
PVSRIPO is a novel viral immunotherapy that activates a patient’s innate and adaptive immunity to facilitate a targeted anti-tumor immune response. This study seeks to determine whether PVSRIPO and pembrolizumab will be able to generate an anti-tumor response in patients with rGBM, given their complementary mechanisms of action, says the company.
“Combining PVSRIPO’s ability to generate an antitumor immune response with a checkpoint inhibitor holds the promise of more effective therapy for this devastating disease,” said W. Garrett Nichols, M.D., CMO at Istari Oncology, in a press release. “Achieving rapid disease control is critical in patients with rGBM, one of the most aggressive and treatment-refractory tumors.”
Nov 28, 2020 • 12:13 pm CST
MS Patients Not At Greater Risk For Breast and Colorectal Cancer
A very large study conducted in Canada published by Neurology on November 25, 2020, found the incidence of breast and colorectal cancers was similar between people with and without multiple sclerosis (MS). However, MS patients were found to have an increased incidence of other cancers, such as bladder cancer.
Nov 28, 2020 • 11:20 am CST
mRNA-Based Personalized Cancer Vaccine Candidate Reduced Tumors
Moderna, Inc. shared interim data on November 11, 2020, from the expansion cohort of its ongoing Phase 1 study of the Company’s mRNA personalized cancer vaccine mRNA-4157 in combination with Merck’s Keytruda®, was found well tolerated at all dose levels and produced responses as measured by tumor shrinkage by RECIST 1.1 criteria in HPV(-) HNSCC patients. No responses were observed in the MSS-CRC group of patients.
“We are encouraged by these interim data from our personalized cancer vaccine program, which involves designing and manufacturing a unique vaccine for each patient based on their specific tumor,” said Stephen Hoge, M.D., President of Moderna, in a press release.
Nov 25, 2020 • 4:38 am CST
Prostate Cancer Drug Candidate Granted Fast Track Designation by the U.S. FDA
RhoVac AB announced that the U.S. FDA has granted Fast Track Designation to the company’s drug candidate, RV001, an immuno-oncologic drug that is presented to the immune system as an antigen, stimulating T-cells to identify and destroy cells that carry this protein, i.e. metastatic or metastatic potential cells.
Historically, so-called “cancer vaccines” have shown inadequate efficacy in treating solid tumors, which have various mechanisms for evading and excluding the immune system. However, RV001 is not designed to deal with solid tumors; it targets only metastatic cancer cells and metastases in early formation. This makes a big difference in terms of the ability of the immune system to be effective, says the company.
RhoVac's CEO, Anders Månsson, commented: "... the fact that the FDA has reviewed our data, and found our drug candidate worthy of this level of priority, obviously sends a clear signal of recognition of the drug’s potential to all our would-be partners, which is something of great importance to us.”
Nov 24, 2020 • 5:09 am CST
Bone Targeted Therapy for Cancer Patients to Be Approved
Amgen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved XGEVA (denosumab), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was approved following a 6-month priority review by the FDA but is not indicated for the prevention of SREs in patients with multiple myeloma.
Kevin Sharer, CEO of Amgen stated "A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating. We are pleased to offer this new advance to patients and their healthcare providers."
Nov 23, 2020 • 8:02 pm CST
Breast Cancer Vaccine Candidate Files New Drug Application
Anixa Biosciences, Inc. announced that an Investigational New Drug application for its prophylactic breast cancer vaccine has been filed with the U.S. FDA. The technology takes advantage of self-proteins that have a function at certain times in life, but then become "retired" and disappear from the body.
One such protein, alpha-lactalbumin, is expressed only in the mammary glands during lactation and then disappears once lactation ceases, says the company's press release issued on November 23, 2020.
This vaccine technology was invented by a research team from Cleveland Clinic, led by Dr. Vincent Tuohy, in the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute.
Nov 23, 2020 • 3:20 pm CST
Innovative Prostate Cancer Test Launches in Puerto Rico
miR Scientific, LLC and the Puerto Rico Health Insurance Administration (ASES) announced a cooperation agreement aimed at evaluating the clinical and economic utility of the miR Sentinel™ PCC4 Assay and its potential impact in Puerto Rico.
Jorge Galva, Executive Director of ASES stated: "The breakthrough Sentinel PCC4 Assay is non-invasive and can very accurately detect prostate cancer and as well as classify the risk category of the disease based only on a single urine specimen and without the need for invasive biopsies. This will allow us to manage the disease much better, allocate resources more efficiently, and focus on high-risk patients who are in need of definitive treatment quickly."
Nov 23, 2020 • 10:00 am CST
Can BCG Vaccination Reduce Bladder Cancer Cases?
A study published by The Lancet on November 21, 2020, found 'Patients with high-risk non–muscle-invasive tumors that do not respond to adjuvant therapy with the standard-of-care immunotherapy, Bacille Calmette-Guérin (BCG), constitute a challenging patient population to manage and many alternative therapies are being studied.'
'While intravesical BCG vaccination has remained the mainstay of therapy for intermediate and high-risk non–muscle-invasive bladder cancer, the therapeutic options for the muscle-invasive and advanced disease has expanded to include immunotherapy with checkpoint inhibition, targeted therapies, and antibody-drug conjugates,' concluded these cancer researchers.
Nov 22, 2020 • 3:46 am CST
Assay Detects Circulating Tumor Cells
Biocept, Inc. announced the results of a study analyzing cerebrospinal fluid (CSF) samples in patients with primary lung or breast cancer with either brain or leptomeningeal disease.
The findings indicate that Target Selector™ CSF assays are a viable and sensitive platform for circulating tumor cell (CTC) detection and molecular analysis compared to the current standard of care, CSF cytology, which is typically used to establish or confirm leptomeningeal disease when imaging findings are suspicious or equivocal.
CSF cytology has limited sensitivity and provides no additional information needed for target therapy choice.
Nov 22, 2020 • 3:00 am CST
Lymphoma Treatment Granted FDA Priority Review
ADC Therapeutics SA announced that the U.S. FDA has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status. The FDA has set a Prescription Drug User Fee Act target date of May 21, 2021.
Lonca, the Company’s lead product candidate, has been evaluated in a pivotal Phase 2 clinical trial for the treatment of relapsed or refractory DLBCL that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint.
Nov 21, 2020 • 9:58 am CST
Glioblastoma Combo Therapy Demonstrates Immunogenicity and Tolerability
INOVIO announced that data from the company's novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo® (cemiplimab) in the treatment of newly diagnosed glioblastoma (GBM).
The study demonstrated that INO-5401 + INO-9012 with Libtayo, radiation, and temozolomide are tolerable, immunogenic, and may improve median survival for patients with newly diagnosed GBM.
Survival data at 18 months showed that 70% (14/20) of MGMT promoter methylated GBM patients were alive, and 50% (16/32) of MGMT promoter unmethylated patients, which are the more difficult to treat group, were alive after 18 months. And the median overall survival in the unmethylated GBM patients was 17.9 months, which compares favorably to historical controls; Median OS for methylated patients has not yet been reached and the study is ongoing.
Dr. David Reardon, Clinical Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and coordinating principal investigator of GBM-001, commented on November 20, 2020: "This is a landmark combination trial in which a novel DNA vaccine is combined with a checkpoint inhibitor and radiation and chemotherapy. We look forward to continuing to review these data, with an eye towards those patients who are most likely to benefit from this innovative approach and to see whether, over time, there is an extension of survival in these very hard-to-treat patients. Coupling immune response with the clinical outcome may prove insightful."
Nov 20, 2020 • 12:58 pm CST
Glioblastoma Study Shows Improved Progression Free Survival
AIVITA Biomedical, Inc. announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1, in patients with newly diagnosed glioblastoma (GBM).
AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor-initiating cells. The treatment is administered in a series of subcutaneous injections. The treatment is uniquely pan-antigenic, targeting multiple antigens from autologous tumor-initiating cells that are responsible for the rapid growth of the disease.
“The improvement in glioblastoma patients who were treated with AV-GBM-1, compared to studies with the standard of care, is a very promising indication that our therapy confers a benefit to patients in need,” said Robert O. Dillman, M.D., chief medical officer of AIVITA, in a press release issued on November 17, 2020.
Nov 20, 2020 • 6:42 am CST
Precision Medicine Empowers Genomically Driven Clinical Decisions
Despite advances in the screening and treatment of prostate cancer, later stage therapies remain limited, and the treatment-resistant setting represents a serious unmet medical need, said researchers in a review published by Nature on November 17, 2020.
Disease classification based on genomic sequencing is a promising approach for identifying patients whose tumors exhibit actionable targets and for making more informed treatment decisions. These researchers discuss how precision oncology can be accelerated to inform broader genomically driven clinical decisions for advanced prostate cancer patients, to inform drug development, and, ultimately, to contribute to new treatment paradigms.
A similar study previously stated 'Tissue-based molecular biomarkers may improve risk stratification when added to standard clinical parameters, but the Expert Panel endorses their use only in situations in which the assay results, when considered as a whole with routine clinical factors, are likely to affect a clinical decision.'
Nov 20, 2020 • 6:32 am CST
BRCA1 and BRCA2 Mutations Differentially Affect Response to Checkpoint Blockade Immunotherapy
New findings reveal the divergent effects of BRCA1 and BRCA2 deficiency on Immune checkpoint blockade (ICB) treatment outcomes and have important implications for elucidating the genetic and microenvironmental determinants of response to immunotherapy.
This report published by Nature on November 17, 2020, found differential effects of mutations in the homologous recombination genes BRCA1 and BRCA2 on response to ICB in mouse and human tumors, and further show that truncating mutations in BRCA2 are associated with a superior response, when compared to those in BRCA1.
Nov 17, 2020 • 3:19 pm CST
Personalized Cancer Vaccine Clinical Study Expands in Arizona
A clinical trial at the University of Arizona (UA) Health Sciences designed to study the safety and effectiveness of a personalized cancer vaccine in combination with the immunotherapy drug Pembrolizumab announced on November 16, 2020, it will expand its cohort after promising preliminary data were presented at the annual meeting of the Society for the Immunotherapy of Cancer.
The preliminary response rate of 50% is notable when compared to patients in clinical trials that receive Pembrolizumab immunotherapy alone without the personalized cancer vaccine. In those studies, the reported response rate is approximately 15%, said this UA press statement.
Nov 17, 2020 • 6:31 am CST
Utah is the Best, While Kentucky Ranks Last for Lung Cancer
While lung cancer disease remains the leading cause of cancer deaths among both women and men in the USA, over the past 5-years, the survival rate has increased from 13% to about 22%, reports the American Lung Association.
The “State of Lung Cancer” report published on November 17, 2020, provides a state-specific understanding of the burden of lung cancer and opportunities to address this deadly disease. The report finds that Utah has the nation’s best lung cancer rate, while Kentucky has the worst at almost 2.5 times the incidence rate of Utah.
However, over the last 5-years, the rate of new lung cancer cases decreased by 9% nationally.
Nov 17, 2020 • 1:33 am CST
Increasing HPV Vaccinations Is Cost-Effective
A study published by The NEJM found (3) interventions for increasing quadrivalent human papillomavirus (HPV) vaccination are cost-effective at common thresholds compared with the status quo. HPV vaccination interventions are a high-value use of state funding and could prevent from 3,000 to 14,000 incident HPV cancers over the next 50 years, stated these researchers.
Nov 11, 2020 • 9:51 am CST
Potential for Immunotherapies Based on Dendritic Cells Identified
The introduction of dendritic cell vaccine immunotherapy into cancer therapeutics has caused several scientific and medical hurdles to overcome as opportunities linked for many cancer patients.
Researchers from the University of Texas in Houston published a study in April 2020, which indicates an in vitro-generated CD103+ cDC1 vaccine elicits systemic and long-lasting tumor-specific T cell-mediated cytotoxicity, which restrains primary and metastatic tumor growth. The CD103+ cDC1 vaccine was found superior to MoDCs and enhanced response to immune checkpoint blockade.
These results suggest the potential for new immunotherapies based on the use of cDC1s alone or in combination with checkpoint blockade.
Nov 9, 2020 • 4:01 pm CST
Prostate Cancer Therapeutic Restarts Phase 1 Study
California based Poseida Therapeutics, Inc., announced the U.S. FDA lifted a clinical hold on November 2, 2020, of the Company's Phase 1 study of P-PSMA-101 in metastatic castration-resistant prostate cancer (mCRPC) and plans to resume the trial immediately. The Phase 1 trial of P-PSMA-101 was initiated in May 2020.
P-PSMA-101 is an autologous CAR-T therapeutic candidate in metastatic castration-resistant prostate cancer (mCRPC). It is designed to target prostate-specific membrane antigen, which is expressed on mCRPC cells. It was developed using Poseida's proprietary piggyBac DNA Modification System, which produces product candidates with a high percentage of stem cell memory T cells.
Nov 5, 2020 • 5:11 am CST
SNAP Cancer Vaccine Candidate Administered IV Generates Improved Efficacy
Maryland based Avidea Technologies, Inc. announced on November 2, 2020, the publication of preclinical studies in Nature Immunology showing that SNAP Cancer Vaccine (SNAP CV) induced a higher proportion of stem-like (TCF1+) tumor antigen-specific CD8+ T cell responses associated with improved tumor clearance when administered intravenously (IV) as compared with more conventional routes of vaccination. Ahmed and colleagues reported SNAP CV delivered IV provides a means of generating a key CD8 T cell population that works synergistically with CPIs.
Phase 1 clinical trials of SNAP CV are planned for 2021, says the company.
"By design, SNAP CV can be administered by any route, including IV, which provides maximal flexibility to control the differentiation of anti-tumor T cells as we pursue SNAP CV monotherapy and combination immunotherapies to combat cancer," said Dr. Geoffrey Lynn, Avidea's CEO, in a press statement.
Nov 4, 2020 • 8:31 am CST
Prostate Cancer Mortality Rate Found Similarities
'There is concern that African American men with low-risk prostate cancer may harbor more aggressive disease than non-Hispanic White men, said researchers in a new study published by the JAMA on November 3, 2020.
In this retrospective cohort study of men with low-risk prostate cancer followed up for a median of 7.6 years, African American men, compared with non-Hispanic White men, had a statistically similar (0.1%) metastasis or prostate cancer-specific mortality rate.
Nov 3, 2020 • 7:56 am CST
Universal Cancer Vaccine Presents Positive Phase 1 Results
Norway based Ultimovacs ASA announced on November 2, 2020, the acceptance of publication in Frontiers in Immunology, outlining the positive long-term follow-up data from the company's Phase I trial evaluating its proprietary universal cancer vaccine, UV1, in non-small cell lung cancer.
In the study, a total of 18 non-small cell lung cancer patients whose disease had not progressed after receiving at least 2nd line treatment with chemotherapy were enrolled to receive UV1 monotherapy as a maintenance treatment. Patients were assigned to three different dose-groups, of 100, 300, and 700 µg, with each cohort enrolling 6 patients. Data in the publication with a cut-off date of March 2020, demonstrated that administration of UV1 resulted in specific T-cell responses in the majority of the patients.
The highest dose of 700 µg, resulted in the highest proportion of immune responses. In addition, immune responses in the high-dose cohort were stronger, occurred at an earlier timeframe, and were associated with long survival. The 4-year overall survival for the patients in the highest cohort was 83%, as compared to 39% for the total patient group.
Nov 2, 2020 • 9:35 am CST
Phase 2 Glioblastoma Immunotherapy Study Reports Positive Results
California-based AIVITA Biomedical, Inc. announced that treatment has been completed for all 57 patients in a Phase 2 clinical trial of AV-GBM-1 in patients with glioblastoma. The company was able to manufacture the final product at a notable 94% success rate, showing strong commercial and clinical viability.
Out of the 57 patients who participated in the study, the average number of doses injected was 6.9 out of a possible 8.
AIVITA achieved a 97% success rate in both growing tumor-initiating cells from each patient and in collecting sufficient monocytes from the peripheral blood from which to derive dendritic cells, resulting in a 94% overall success rate for manufacturing a final treatment given to patients.
“This milestone brings us closer to having a better understanding of the potential for AV-GBM-1 to effectively treat patients with glioblastoma,” said Bob Dillman, M.D., chief medical officer of AIVITA, in a press release issued on November 2, 2020. “With such a high manufacturing success rate and no significant side effects, we are hoping this technology will chart a new path forward in immunotherapy.”
Nov 2, 2020 • 9:26 am CST
mCRPC Therapeutic Candidate To Resume Phase 1 Study
California based Poseida Therapeutics, Inc. announced the U.S. FDA has lifted a clinical hold on the Company's Phase 1 study of P-PSMA-101 in metastatic castration-resistant prostate cancer (mCRPC) and plans to resume the trial immediately.
The Company stated on November 2, 2020, it has agreed to implement protocol amendments intended to increase patient compliance and safety that include modified inclusion and exclusion criteria and frequency of monitoring and laboratory testing.
Launched in May 2020, P-PSMA-101 is an autologous CAR-T therapeutic candidate in metastatic castration-resistant prostate cancer (mCRPC). It is designed to target prostate-specific membrane antigen (PSMA), which is expressed on mCRPC cells. It was developed using Poseida's proprietary piggyBac DNA Modification System, which produces product candidates with a high percentage of stem cell memory T (TSCM) cells.
Nov 1, 2020 • 6:08 am CST
Cancer Genomic Research Depends on Innovative Technologies
Cancer genomics research depends on infrastructure and analysis tools that collect, process, analyze, and annotate vast quantities of valuable sequencing data, states a recent article published by the Ontario Institute for Cancer Research (OICR) on October 15, 2020.
In a Q&A session with Morgan Taschuk, OICR’s new Director of Genome Sequence Informatics, she reflects on her new role and her outlook on the next few years.
Oct 30, 2020 • 6:23 pm CDT
'Re-Teach Immune Systems that Cancer Cells Don't Belong There'
'A big difference between the lung cancer vaccines being developed and a common existing vaccine, the flu shot, is timing,' wrote Juhi Kunde, MA, LUNGevity Science Writer, on October 27, 2020.
Flu shots are preventive: they are given to people before they are sick to train the immune system on what to look for, so the immune system can quickly attack the virus if it appears in the body.
And the lung cancer vaccines being developed are therapeutic: they are intended to treat lung cancer after the immune system has already allowed the tumor to stay and grow in the body.
“This creates a unique type of challenge that researchers have been grappling with,” explains Edward Garon, M.D., professor of Medicine at the Jonsson Comprehensive Cancer Center at UCLA and a member of LUNGevity’s Scientific Advisory Board. “We have to find ways to “re-teach” the immune system that the cancer cells shouldn’t be there.”
Oct 29, 2020 • 11:38 am CDT
Alternating Vector Therapy to Treat HPV16+ Cancers Launches Phase 1 Study
HOOKIPA Pharma Inc., based in Austria, announced a replicating arenavirus therapy based on the Pichinde Virus (PICV) has dosed the first patient dosed with HB-202, which is part of a sequential alternating regimen of HB-202/HB-201 for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers.
HB-202 and HB-201 are engineered using HOOKIPA’s replicating arenaviral vector platform. They are designed to use different arenavirus backbones (PICV for HB-202 and LCMV for HB- 201) while expressing the same antigen, an E7/E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-202 and HB-201 resulted in a 10-fold increase in immune response and better disease control than either compound alone.
“We are excited to expand our ongoing Phase 1/2 trial in HPV to explore the potential of combining HB-202 and HB-201 as an alternating 2-vector therapy to enhance and focus the immune response against HPV16+ cancers,” said Joern Aldag, CEO of HOOKIPA, in a press release issued on October 29, 2020.
Oct 29, 2020 • 8:02 am CDT
Do Lipid‐Lowering Medications Improve Cancer Patient's Survival?
An increasing number of preclinical and epidemiological studies are claiming lipid‐lowering medications primarily statins have anti-cancer properties to inhibit proliferation, activate apoptosis, and reduce metastasis.
In this context, a new study from Australia published on October 20, 2020, found adherence to lipid‐lowering medication is inversely associated with a decline in cancer‐specific mortality in breast and colorectal cancer and melanoma, Lipophilic statins show greater reductions in cancer‐specific mortality, and the inverse association is not altered by receiving endocrine therapy in breast cancer.
Oct 29, 2020 • 6:33 am CDT
Metastatic Breast Cancer Study Competes Patient Recruitment
Switzerland based Polyphor AG announced that it has completed recruitment in its FORTRESS Phase III study of balixafortide in metastatic breast cancer. The FORTRESS study (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial that investigates the efficacy, safety, and tolerability of intravenous balixafortide given with eribulin, versus eribulin alone, in the treatment of HER2 negative, locally recurrent, or metastatic breast cancer.
As previously communicated by Polyphor, data on the key primary endpoint of FORTRESS, progression-free survival in the overall population, is planned for Q4 2021. An analysis of the objective response rate in eligible patients in third and later lines of chemotherapy is planned for Q2 2021.
Oct 28, 2020 • 6:42 am CDT
Gastric Cancer Treatment Granted Priority Review
Delaware based AstraZeneca announced Daiichi Sankyo Company’s ENHERTU has received acceptance for its supplemental Biologics License Application and has also been granted Priority Review in the USA for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
There are more than 27,000 new cases of gastric cancer each year, of which approximately 20% are HER2 positive.
José Baselga, Executive Vice President, stated on October 28, 2020: “Once patients with HER2-positive metastatic gastric cancer progress following initial treatment with an anti-HER2 regimen, there are no approved HER2-directed medicines. The prognosis for these patients is poor, as available treatment options offer only limited clinical benefit. This milestone brings us one step closer to delivering a potentially practice-changing medicine to patients with gastric cancer in the USA.”
Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, added: “The results of the DESTINY-Gastric01 trial are unprecedented as they represent the first time a HER2-directed medicine has demonstrated an improvement in survival following chemotherapy and HER2 treatment in the metastatic setting."
Oct 28, 2020 • 5:19 am CDT
HPV-16 Therapeutic Vaccine Candidate Announced Positive Study Results
France-based Transgene announced the detailed results from the Phase 1b/2 trial combining TG4001, an HPV16-targeted therapeutic vaccine, with avelumab (BAVENCIO®), a human anti-PD-L1 antibody, in HPV16-positive recurrent and/or metastatic malignancies.
The purpose of this exploratory Phase 1b/2 trial announced on October 27, 2020, was to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor in a heterogeneous group of patients with aggressive, recurrent, and/or metastatic HPV16-positive cancers.
The key findings of the trial were: The combination of TG4001 and avelumab demonstrates anti-tumor activity (23.5% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers; the presence of liver metastases has a profound impact on outcome in terms of ORR and PFS. In patients without liver metastases, an ORR of 34.8% and a median PFS of 5.6 months were achieved.
Commenting on this novel immunotherapy regimen, Prof. Christophe Le Tourneau, M.D., Principal Investigator of the trial, commented: “We have seen very encouraging efficacy results in this hard-to-treat patient population, as well as a satisfying safety profile. I believe this combination regimen has the opportunity to provide real hope for patients with HPV-16 related cancers.”
Oct 27, 2020 • 3:27 pm CDT
Colorectal Cancer Screening Should Start at Age 45
The U.S. Preventive Services Task Force issued new draft recommendations on October 27, 2020, that most Americans should start being screened for colorectal cancer at age 45. instead of 50, to reduce the increasing rates of cancer in middle-aged people.
“New science about colorectal cancer in younger people has enabled us to expand our recommendation to screen all adults starting at age 45, especially Black adults who are more likely to die from this disease,” says Task Force member Michael Barry, M.D. “Screening earlier will help prevent more people from dying from colorectal cancer.”
Oct 27, 2020 • 2:37 pm CDT
Real-World Evidence Shows Prostate Cancer Treatment Regimen Prolonged Median Survival by 14.5 Months
Dendreon Pharmaceuticals announced the publication of an analysis examining real-world survival outcomes in men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with PROVENGE® (sipuleucel-T) and commonly prescribed oral treatments.
The analysis of Medicare claims data from more than 6,000 fee-for-service beneficiaries published on October 7, 2020, showed that the addition of PROVENGE to either abiraterone acetate (Zytiga®) or enzalutamide (Xtandi®), at any point in a patient’s mCRPC treatment regimen, reduced the risk of death by 41% and prolonged median overall survival by 14.5 months.
Oct 26, 2020 • 4:02 pm CDT
Therapy Combination with Advanced Cervical Cancer Chemoradiotherapy Launches Phase 2 Studies
New Jersey-based PDS Biotechnology Corporation announced that the Phase 2 clinical trial of PDS0101 in combination with standard of care chemoradiotherapy (CRT) for the treatment of locally advanced cervical cancer.
PDS0101 targets cancers associated with the human papillomavirus (HPV) and combines the utility of the Versamune® platform with targeted antigens against HPV-expressing cancers.
In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer.
And in partnership with the National Cancer Institute, PDS Biotech is has initiated a phase 2 study studying a combination of PDS0101 and two clinical-stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers.
Oct 25, 2020 • 10:44 am CDT
Positive Pancreatic Cancer Treatment Study Results Announced
Pennsylvania based Galera Therapeutics, Inc. announced the release of the abstract containing interim data from the first 19 patients in its pilot Phase 1/2 clinical trial designed to evaluate the safety and efficacy of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT), compared with SBRT and placebo, in patients with locally advanced pancreatic cancer (LAPC).
In the initial analysis of the intent-to-treat cohort which comprises all patients followed for over 1-year, median overall survival (OS) had not yet been reached in the GC4419 arm, compared to 40.4 weeks (HR=0.3; 95% CI 0.09-1.05; p=0.046) in the placebo arm.
“By combining our investigational dismutase mimetics with SBRT, we believe we have an opportunity to improve tumor response and survival outcomes. This is the first clinical data assessing the anti-cancer activity of one of our dismutase mimetics, and we are encouraged by this analysis of the initial cohort which suggests a meaningful survival benefit in pancreatic cancer,” said Mel Sorensen, M.D., President and CEO of Galera, in a press release published on October 23, 2020.
Oct 25, 2020 • 9:41 am CDT
Chemotherapy-Induced Peripheral Neuropathy Phase 2 Study Initiated
California based MediciNova, Inc. announced its plans to initiate a Phase 2b trial to evaluate MN-166 (ibudilast) in chemotherapy-induced peripheral neuropathy (CIPN). Peripheral neuropathy is a set of symptoms caused by damage to the nerves that are outside of the brain and spinal cord.
The company stated on October 22, 2020, the proposed clinical trial will evaluate MN-166 (ibudilast) as a potential treatment to reduce acute neurotoxicity severity and CIPN in patients with metastatic colorectal cancer.
MN-166 is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor inhibitor and phosphodiesterase -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors.
Dr. Janette Vardy, the Principal Investigator for this study, commented, “The findings from our initial study were encouraging, and we plan to explore further the potential clinical utility of ibudilast in a larger sample of patients who experience oxaliplatin-induced acute neurotoxicity and chronic CIPN.”
Oct 24, 2020 • 10:39 am CDT
'Mr.Bojangles' Writer Dies From Throat Cancer
American country music singer and songwriter Jerry Jeff Walker (Ronald Clyde Crosby) passed away on October 23, 2020, after a 3-year battle with throat cancer. Austin, Texas-based Walker is often remembered for writing the 1968 song "Mr. Bojangles".
Oct 23, 2020 • 12:01 pm CDT
Non-Invasive Blood-based Test Helps Diagnosis of Gastric Cancer
After 8-years of research, product development, and clinical validation by The National University Health System involving over 5,000 subjects from Singapore and South Korea, a team of clinicians and scientists from Singapore has developed a non-invasive blood-based, a cost-effective diagnostic test for gastric cancer (stomach cancer).
The test is able to detect 87% of all gastric cancers, including 87.5% of patients with stage I cancers.
"This non-invasive blood test is a breakthrough in gastric cancer diagnosis and it may potentially be used as an effective screening test for the early diagnosis of gastric cancer," explained Professor So in a press statement issued on October 23, 2020, who is the Head and Senior Consultant with the Division of Surgical Oncology, National University Cancer Institute, Singapore.
Endoscopy is currently the standard diagnostic test for gastric cancer in Singapore. However, it is perceived as invasive and expensive, hence many patients are reluctant to undergo endoscopy even if they have gastric symptoms.
Oct 23, 2020 • 9:10 am CDT
Cancer Care Costs Exceeds $183 Billion
The Washington, D.C. based American Cancer Society Cancer Action Network (ACS CAN) released a report detailing the costs of treating cancer, specifically out-of-pocket costs typical cancer patients face. The report found U.S. cancer patients in 2018 spent $5.6 billion in out-of-pocket costs for cancer treatment.
Overall, the disease cost the country $183 billion in direct cancer-related healthcare spending in 2015, an amount that is projected to increase to $246 billion by 2030.
Lisa Lacasse, president of ACS CAN stated in a press release issued on October 22, 2020: “Research shows that paying five or ten thousand dollars out of pocket – often within a span of only 1-3 months – is extremely challenging even under the best-case scenario."
Oct 21, 2020 • 4:24 pm CDT
Therapeutic Cancer Vaccine Posts Positive Phase I Results
Norway-based Ultimovacs ASA announced 5-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in patients with non-small cell lung cancer. The results confirmed on October 19, 2020, the achievement of the primary endpoints of safety and tolerability and indicate encouraging initial signals of long-term survival benefit.
The company says UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action.'
To date, UV1 has been tested in (4) phase I clinical trials in a total of 82 patients, says the company.
Oct 21, 2020 • 12:58 pm CDT
Orphan Drug Designation Granted for Treating Three Cancers
California based Apexigen, Inc. announced on October 15, 2020, that the U.S. Food and Drug Administration (FDA) granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer.
APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response, and targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems.
“We are evaluating APX005M in a broad clinical program that includes more than 10 clinical trials in various indications and therapeutic combinations,” said Xiaodong Yang, M.D., Ph.D., Chief Executive Officer of Apexigen.
Oct 21, 2020 • 11:38 am CDT
Lung Cancer Treatment Reduced Disease Recurrence by 80%
UK based AstraZeneca announced Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) epidermal growth factor receptor-mutated non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.
Tagrisso is approved for both the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the USA, Japan, China, the EU, and many other countries around the world.
Oct 20, 2020 • 4:42 pm CDT
AI Algorithm Found Successful in Diagnosing Prostate Cancer
A recent study published by The Lancet reports the successful development, external clinical validation, and deployment in clinical practice of an AI-based algorithm to accurately detect, grade, and evaluate clinically relevant findings in digitized slides of prostate core needle biopsies.
Adenocarcinoma of the prostate is the second most common cancer diagnosed in men, with more than 1 million newly diagnosed cases of prostate cancer annually.
Oct 20, 2020 • 4:21 pm CDT
Japan Launches Pancreatic Cancer Therapy Launches Phase 1 Study
New Jersey based Rafael Pharmaceuticals, Inc. announced its partner Ono Pharmaceutical Co., Ltd. has begun a Phase 1 study in Japan for patients with pancreatic cancer. The multicenter, open-label study is evaluating the efficacy and safety of Rafael’s lead compound, CPI-613 (devimistat), labeled as ONO-7912 in Japan, in combination with modified FOLFIRINOX (mFFX) in patients with pancreatic cancer refractory or intolerance to chemotherapy, including gemcitabine.
Oct 17, 2020 • 2:07 pm CDT
Ontario Students Encouraged to Get Their HPV Vaccination
An Ontario Medical Association (OMA) podcast published on October 15, 2020, is emphasizing the importance of Ontario adolescents getting the human papillomavirus (HPV) vaccine either through their schools or public health units, reported Len Gillis, local journalism initiative reporter.
The OMA podcast featured a conversation with Dr. Amanda Selk, an OB/GYN who practices at Women’s College Hospital, Mount Sinai Hospital, and the Toronto General Hospital, in Canada.
Oct 16, 2020 • 7:59 am CDT
Personalized Cancer Vaccine Plus Medication Combo Found Effective
The study results from a Phase Ib clinical trial published in the journal Cell on October 15, 2020, indicate the safety and preliminary efficacy of combined treatment with the personalized, neoantigen-based vaccine NEO-PV-01, and the anti-PD-1 checkpoint inhibitor nivolumab (Opdivo), for patients with advanced melanoma, non-small cell lung cancer, or bladder cancer.
These data support the safety and immunogenicity of this regimen in patients with advanced solid tumors.
Neoantigens arise from mutations in cancer cells and are important targets of T cell-mediated anti-tumor immunity.
Oct 15, 2020 • 10:42 am CDT
U.S. FDA Approves Refractory Classical Hodgkin Lymphoma Therapy
New Jersey-based Merck announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
The approval is based on results from the Phase 3 KEYNOTE-204 trial in which KEYTRUDA significantly reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88; p<0.0027]) compared to brentuximab vedotin (BV).
Additionally, median progression-free survival (PFS) was 13.2 months (95% CI, 10.9-19.4) for patients treated with KEYTRUDA and 8.3 months (95% CI, 5.7-8.8) for patients treated with BV.
The FDA also approved an updated pediatric indication for KEYTRUDA for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy.
Oct 14, 2020 • 8:31 pm CDT
Statins Decrease Cancer Risk Separately From Cholesterol
A new study published by eLife on October 13, 2020, found cholesterol-lowering drugs called statins may reduce cancer risk in humans through a pathway unrelated to cholesterol. These results predict that statins reduce cancer risk but other lipid-lowering treatments do not.
'Our work highlights that the effectiveness of statins must be urgently evaluated by large clinical trials for potential use in cancer prevention,' stated senior author Stephen Burgess, Group Leader at the Medical Research Council Biostatistics Unit, part of the University of Cambridge.
Oct 14, 2020 • 6:13 pm CDT
Early-Stage Vaccine Candidate Shows Positive Action in Lung Cancer Study
California based Lineage Cell Therapeutics, Inc. and Cancer Research UK announced on October 13, 2020, encouraging preliminary results from an ongoing Phase 1 clinical study of VAC2 in non-small cell lung cancer (NSCLC).
VAC2 demonstrated remarkably potent induction of immune responses in all patients dosed to date, with high levels of peripheral antigen-specific immunogenicity observed at multiple time points and confirmed by multimer staining.
On the basis of these findings, and following completion of the ongoing VAC2 clinical study in NSCLC, Lineage will seek to evaluate VAC2 in combination with therapies considered biologically complementary to VAC2, such as chemotherapy and the immune cell protectant properties offered by anti-PD1 immunotherapy.