On November 18, 2021 Immunomic Therapeutics, Inc. (‘ITI’), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that Kristen Batich, MD, Ph.D. and a team from Duke University School of Medicine will present clinical data at the 2021 Society for Neurology (SNO) Annual Meeting being held in Boston, MA, November 18-21st, 2021 (Press release, Immunomic Therapeutics, NOV 18, 2021, View Source [SID1234595813]).

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The data to be presented at the SNO meeting are from three sequential clinical trials utilizing Cytomegalovirus (CMV)–specific dendritic cell vaccines that encode the chimeric CMV protein LAMP-pp65 in patients with primary Glioblastoma. The patients were given serial vaccination through adjuvant temozolomide cycles. The Phase II ATTAC study (NCT00639639) led to an expanded cohort trial (ATTAC-GM: NCT00693639) resulting in positive immunologic and clinical response. The larger confirmatory trial, ELEVATE (NCT02366728), revealed significantly longer overall survival (OS) in patients randomized to LAMP pp65 RNA loaded DC vaccines combined with tetanus-diphtheria booster. The results demonstrate that a CMV pp65-LAMP RNA-pulsed dendritic cell vaccination was associated with positive immunologic and clinical response in patients with glioblastoma (GBM).

"The clinical data to be presented demonstrates the potential impact of our UNITE technology platform, powered by LAMP, and will help validate our therapeutic approach utilizing vaccines to treat difficult cancers like glioblastoma," said Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics, Inc. "We are encouraged by the immunological response shown with this patient group and we look forward to Dr. Batich’s presentation of these positive findings at the SNO meeting."

Abstract Session: Clinical Trials I

Title: Reproducibility of clinical trials using CMV-targeted dendritic cell vaccines in patients with glioblastoma
Category: CTIM-10
Date and Time: Friday, November 19, 2021 4:45 PM – 4:50 PM EST
Location: Ballroom C, Hynes Convention Center, Boston, MA

Presenter:

Kristen A. Batich, MD, PhD
Duke University Medical Center
Durham, United States

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improve survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP-1), an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On November 18, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported the presentation of a multi-institutional case series showing that its CNSide cerebrospinal fluid assay helps physicians monitor treatment response and detects actionable mutations in patients with metastatic breast cancer and leptomeningeal disease (LMD) (Press release, Biocept, NOV 18, 2021, View Source [SID1234595812]). The poster will be presented virtually at the Society for Neuro-Oncology Annual Meeting in Boston, Nov. 19, 2021, from 7:30-9:30 p.m. ET, and Biocept will be exhibiting at booth #303.

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Breast cancer is one of the most common cancers associated with LMD, a devastating complication in which cancer spreads to the membrane surrounding the brain and spinal cord. The current standard of care for diagnosing LMD is through clinical evaluation, imaging and cytology, which have limited sensitivity. Median survival after a diagnosis of LMD is just two to three months.

The case series included four breast cancer patients, ages 32 to 57, with suspected LMD who were treated at four different institutions. CNSide and cytology were used in parallel to detect tumor cells in the cerebrospinal fluid at diagnosis and throughout treatment. CNSide was also used to determine tumor cell counts and the presence of HER2 amplification to help guide therapy. At diagnosis, CNSide detected cancer cells in three of three patients, compared with two of three patients for cytology. (The fourth patient was diagnosed before CNSide was available.) CNSide detected CSF tumor cells in all eleven measurements taken, compared to six of eleven using cytology. Throughout treatment, CNSide showed a decrease in CSF tumor cells in all four patients, ranging from 99.7% to 100%, corresponding with an improved clinical response.

"Having a quantitative assay that provides tumor cell counts, rather than just a positive or negative result, is a major advance in the management of patients with leptomeningeal disease," said Priya Kumthekar, M.D., Neuro-Oncologist and Associate Professor of Neurology at Northwestern Medicine’s Feinberg School of Medicine, who will present the case series poster. "A positive cytology result may suggest that the patient is not responding to treatment, which could lead to therapy being stopped or changed. As this case series shows, CNSide’s quantitative results may show that, in fact, the tumor cell count has dropped dramatically, indicating that the patient is responding, and therapy should be continued."

"These cases illustrate the value of CNSide in treatment response monitoring and identification of targets for therapy that can produce a sustained response in leptomeningeal disease," said Michael Dugan, M.D., Chief Medical Officer and Medical Director of Biocept. "CNSide has the potential to allow clinicians to have more confidence in their treatment decisions, improving the clinical management of leptomeningeal disease in a way that may help patients see improvement in symptoms and live significantly longer lives."

The case series was completed by neuro-oncologists from Smilow Cancer Hospital at Yale New Haven Health, Lou and Jean Malnati Brain Tumor Institute at Northwestern Medicine, UT Southwestern Medical Center and Barrow Neurological Institute. The abstract (#BIOM-05), titled "Case Series of Multi-Institutional Utility of CNSide to Manage Leptomeningeal Disease in Patients with Metastatic Breast Cancer," can be accessed here.

On November 18, 2021 Onco360, the nation’s leading independent Specialty Pharmacy, reported that has been selected by PharmaEssentia to be a specialty pharmacy partner for BESREMi (ropeginterferon alfa-2b-njft) which is now approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with polycythemia vera (Press release, Onco360, NOV 18, 2021, View Source [SID1234595811]).

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"Onco360 is honored to become a specialty pharmacy provider for BESREMi patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are committed to supporting the highly specialized needs of polycythemia vera patients and their physicians across the United States."

According to the National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of Myeloproliferative Neoplasms, polycythemia vera is one of several disorders of the hematopoietic system under a broader classification known as Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs). The prevalence of polycythemia in the United States is approximately 148,000 cases.1 Polycythemia vera results from abnormal red blood cell proliferation due to genetic mutations involving the Janus Kinase 2 (JAK2) gene. Due to over-production of red blood cells, patients with polycythemia vera have blood which is thicker than normal, potentially resulting in increased risks for thrombosis and reduction in blood flow.2 The average age at initial polycythemia vera diagnosis is 60-65 years old. The median overall survival for patients diagnosed with polycythemia vera is approximately 20 years.3

BESREMi is manufactured by PharmaEssentia, a growing biopharmaceutical innovator based in Taiwan. The FDA’s approval of BESREMi is based upon the results of the PEGINVERA study, a prospective, multicenter, single-arm trial of 7.5 years duration. This study demonstrated that BESREMi administration resulted in 61% of patients achieving a complete hematological response (CHR) during the treatment period defined as hematocrit <45% and no phlebotomy in the preceding 2 months, platelets < 400 x 109/L and leukocytes < 10 x 109/L, normal spleen size assessed by ultrasound and absence of thromboembolic events.4

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see accompanying full Prescribing Information, including Boxed Warning. For more information, visit www.BESREMi.com.

On November 18, 2021 City of Hope, a world-renowned research and treatment organization for cancer, diabetes and other life-threatening diseases, reported the opening of a first-in-human clinical trial evaluating the use of a cancer-killing oncolytic virus to treat patients with metastatic triple-negative breast cancer (Press release, City of Hope, NOV 18, 2021, View Source [SID1234595810]).

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The City of Hope-developed therapy, CF33-hNIS-antiPDL1, is genetically engineered from a naturally occurring virus (chimeric oncolytic orthopoxvirus). The patents covering CF33-hNIS-antiPDL1 have been licensed to Imugene Limited (ASX:IMU), a company developing immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. CF33-hNIS-antiPDL1 is designed to infect, replicate in and kill cancer cells while sparing healthy cells.

"The study is designed to determine the safety and optimal biological dose that may induce an immune response in triple-negative breast cancer tumors," said Yuan Yuan, M.D., Ph.D., associate professor in City of Hope’s Department of Medical Oncology & Therapeutics Research and principal investigator of the Phase 1 clinical trial. "Current approved therapies do not offer a cure for this aggressive type of breast cancer, which often becomes resistant to chemotherapy. Clinical trials like this one seek durable responses and better quality of life for patients."

The researchers seek to determine the appropriate dose of CF33-hNIS-antiPDL1 and ascertain if it is a safe and potentially effective treatment for patients with triple-negative breast cancer that is advanced or has spread to other places in the body. It will be tested in patients whose cancer has progressed through standard-of-care chemotherapy.

Triple-negative breast cancer affects about 15-20% of all breast cancer patients. It is a challenging disease to treat — most Food and Drug Administration-approved therapies prolong survival for a median of two years, Yuan said. Despite the recent FDA approval of targeted therapy for BRCA gene mutation (that is, immune checkpoint inhibitor pembrolizumab and Trop-2 antibody drug conjugate), the majority of patients continue to progress after the first two lines of therapy. There is an unmet need for patients whose triple-negative breast cancer has progressed despite previous treatment regimens.

The cancer killing effects of CF33 have been observed for the following cancer cell types in the preclinical setting: pancreatic, stomach, lung, ovarian and colon. Published preclinical data show that the CF33 oncolytic virus can increase the presence of immune checkpoint inhibitors, which can help enhance the immune system’s ability to do its job.

"It is an exciting time in immuno-oncology. Preclinical research has shown that this oncolytic virus can direct the killing of cancers and stimulate the immune system to enable further killing of cancers," said Yuman Fong, M.D., the Sangiacomo Family Chair in Surgical Oncology at City of Hope who developed CF33. "This trial is an important step forward."

The three-year trial seeks to enroll patients who have been diagnosed with recurrent metastatic triple-negative breast cancer who experienced disease progression after standard-of-care therapies. Study participants may receive a total of three cycles of six doses of the treatment through direct injection into the tumor.

Scientists will be able to say that the oncolytic virus activated the immune system against breast cancer if they note increased expression of checkpoint targets PD-1, PD-L1 or CTLA-4 and increased CD8+ immune cells. When there are more of these checkpoint targets, current approved and experimental therapies are better able to grab onto and unlock cancer cells to destroy them from the inside.

More information about the clinical trial can be found at CityofHope.org/research/find-a-clinical-trial or clinicaltrials.gov.

On November 18, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported that it is working with Epic to offer providers in-workflow integrations at scale (Press release, Tempus, NOV 18, 2021, View Source [SID1234595809]). Since its founding, Tempus has strived to provide physicians seamless access to next-generation sequencing and the accompanying data to support them in providing personalized patient care.

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Through Epic’s Genomics module, Tempus has been paving the way with live EHR integrations that embed test ordering and discrete genomic data delivery into the existing clinical workflow, with 8 institutions already live and a number underway. Tempus’ initial work with Epic made it the first somatic sequencing lab in the country creating these types of integrations.

"Tempus understands our need for efficient, streamlined ordering and reliable discrete results all in one place so that we can promptly implement the actionable results for our patients," said Karen Huelsman, MS, LGC, Precision Oncology Lead at TriHealth Precision Oncology. "More than that, Tempus continually works with our precision oncology team to optimize the integration and apply Epic’s Genomics module components to fit our specific, changing needs."

Tempus is building on that existing work to accelerate and scale this endeavor. In 2022, Epic and Tempus expect to support large-panel genomic sequencing testing across the Epic network. This new capability is designed to reduce integration timelines from months to weeks and make it significantly easier for health systems to enable Tempus testing options within their Epic EHR.

"We realized that we could significantly reduce the amount of time physicians spend ordering Tempus’ smart diagnostics and viewing results at the point of care, ultimately freeing up more time for them to spend with their patients," said Terron Bruner, Chief Commercial Officer of Tempus. "Epic introduced the technology we needed to make these kinds of integrations not only possible, but also seamless for providers, like TriHealth, seeking these solutions."

"Our work with Tempus presents a tremendous opportunity to advance precision medicine by empowering providers and patients with insights from integrated genomic data," said Alan Hutchison, Vice President of Population Health at Epic. "Together we can deliver on the promise of precision medicine and positively impact early detection, treatment, and survival."