On February 22, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the results of an additional, more finely detailed, analysis of the integration site of the cytochrome P450 2B1 gene from the augmented HEK293 cell clone that is used in PharmaCyte’s pancreatic cancer product candidate known as CypCaps (Press release, PharmaCyte Biotech, FEB 22, 2022, View Source [SID1234608833]).

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Previous studies that PharmaCyte conducted showed that the cytochrome P450 2B1 gene in the augmented HEK293 cell clone was located on human chromosome 9. As PharmaCyte announced on December 8, 2021, the flanking sequence around the site of integration was sequenced in its entirety. In this new study, PharmaCyte has been able to confirm the previously elucidated structure of the integrated transgene sequence using more data points.

These studies also set the stage for a next step analysis to determine the genetic stability of the cytochrome P450 2B1 gene at the DNA level after multiple rounds of cell growth. This new study was completed by comparing the original Research Cell Bank cells with cells from the Master Cell Bank, and the analysis confirmed that the cytochrome P450 2B1 and the surrounding sequence has remained stable with no changes detected at the DNA level.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch PharmaCyte’s documentary video complete with medical animations at: View Source

On February 22, 2022 City of Hope, one of the largest cancer research and treatment organizations in the United States and a leading research center for diabetes and other life-threatening illnesses, reported that its Department of Stem Cell Biology and Regenerative Medicine received a $4.9 million grant to train the next generation of scientific leaders in basic stem cell research and its translation into novel, lifesaving treatments (Press release, City of Hope, FEB 22, 2022, View Source [SID1234608832]).

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The award from the California Institute for Regenerative Medicine (CIRM) contributes to the more than $121 million in grants that Beckman Research Institute of City of Hope has received from CIRM to date, indicating the state-funded agency’s confidence in City of Hope’s long-standing leadership in stem cell-related therapies. As a biomedical institution, City of Hope has deep expertise in developmental and stem cell biology, resulting in strong clinical programs in bone marrow transplantation, cancer immunotherapy, gene therapy to correct genetic defects, and cell replacement and tissue regeneration strategies to treat diabetes.

"Our mission is to train predoctoral and postdoctoral CIRM scholars in basic stem cell and developmental biology, and the translation of this foundational knowledge into novel and effective therapies for patients with cancers, degenerative diseases, genetically caused conditions and other maladies," said Michael Barish, Ph.D., professor in the Department of Stem Cell Biology and Regenerative Medicine and program director of the CIRM-funded educational project.

The five-year grant will be used to mentor junior scientists with the help of City of Hope’s Irell & Manella Graduate School of Biological Sciences at Beckman Research Institute. The program will leverage City of Hope’s position as one of the few cancer centers in the United States with on-campus good manufacturing practice facilities capable of creating clinical-grade biologics and small molecules. Lastly, students will benefit from the fact that their classrooms and laboratories are within walking distance from where patients receive compassionate patient care.

City of Hope has an integrated, multidisciplinary approach to translating fundamental research findings into clinical practice for patients’ benefit. In addition to laboratory research, the CIRM scholars will learn how to implement cell-based therapies, engineer and manufacture cells, obtain regulatory approval and commercialize biomedical products. Instruction will come from scientific and clinical faculty, research nurses and experts in the ethics of stem cell research and its application to medicine.

Due to the program’s proximity to patient care areas, students will also have the unique opportunity to receive mentorship from both City of Hope’s Department of Supportive Care Medicine and Division of Health Equities, where they will be exposed to experts in patient engagement and community outreach programs.

"This program originates from City of Hope’s longstanding expertise in conducting clinical trials and applying fundamental stem cell biology and gene therapy to the treatment of diseases. The program reflects City of Hope’s commitment to ensuring that future scientific leaders understand the varied needs of diverse patient populations, and the inequities that presently affect both biomedical research and the development of and access to innovative therapies," said Nadia Carlesso, M.D., Ph.D., professor and chair of the Department of Stem Cell Biology and Regenerative Medicine and co-investigator of the CIRM project.

Other leaders in this CIRM-funded stem cell and regenerative medicine training program include City of Hope’s Yanhong Shi, Ph.D., Herbert Horvitz Professor in Neuroscience, Rick Kittles, Ph.D., M.S., professor and director of the Division of Health Equities, and Keely Walker, Ph.D., director of the Office of Faculty and Institutional Support.

The new program is one element of City of Hope’s broad commitment to education, including the Irell & Manella Graduate School of Biological Sciences at Beckman Research Institute, which offers doctoral programs in biological sciences and translational medicine, as well as master’s programs in regulatory affairs and translational medicine. City of Hope also supports a portfolio of National Cancer Institute-supported training programs in cancer metabolism, DNA damage and pathways to cancer, as well as training programs for students from traditionally underrepresented backgrounds (supported by the National Institute of Diabetes and Digestive and Kidney Diseases).

On February 22, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported the ability of its CNSide cerebrospinal fluid (CSF) assay to aid in therapeutic research programs for metastatic brain cancer in a presentation at the Molecular & Precision Med Tri-Con meeting (Press release, Biocept, FEB 22, 2022, View Source [SID1234608831]). The company is also exhibiting (booth #508) at the conference, which is the leading international meeting for the precision medicine community, Feb. 21-23, 2022, in San Diego.

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During the presentation, Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director, discussed the growing interest in improving the diagnosis and treatment of leptomeningeal disease (LMD), a devastating complication in which metastatic cancer spreads to the membrane surrounding the brain and spinal cord. Newer targeted therapies can often reduce or resolve debilitating symptoms of LMD and extend life expectancy. However, the current standards of care, CSF cytology and radiological imaging, have limited sensitivity for detecting central nervous system metastasis, and do not identify molecular treatment targets or quantify tumor cell counts.

"A key to precision medicine is identifying molecular targets for therapy," Dr. Dugan said. "Relying on the primary tumor is not sufficient because biomarker status often differs between the primary and metastatic tumors. With CNSide, we have the first commercially available method to measure biomarker status in real-time during therapy and quantify changes in tumor cell counts to really understand how patients are responding to therapy—as opposed to waiting months for radiologic changes or another surgical biopsy."

"Companies developing novel therapies for metastatic brain cancers face significant challenges in determining treatment response with traditional methods," said Samuel D. Riccitelli, Biocept’s Chairman, and Interim President and CEO. "We believe that serial quantitative monitoring with our CNSide assay can have a tremendous impact on the success of many therapeutic clinical trials, and we are pleased to support these important research efforts aimed at providing new treatments for patients with limited time and options."

CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. The assay answers three key questions that may help inform treatment decisions: Is there tumor? Is there a target for treatment? Is there a trend to treatment response? Because genetic changes can occur as metastatic cancer spreads to the central nervous system, the evaluation of cerebrospinal fluid provides a unique opportunity to identify biomarkers such as HER2 and EGFR in patients with metastatic breast, lung, and other cancers, to help guide therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to more effectively monitor the response to therapy than other current methods.

A recording of the presentation, titled "A Novel CSF Assay to Help Diagnose, Manage, and Follow Response to Therapy in Patients with Leptomeningeal Metastasis," will be available on the Biocept website after the conference concludes.

On February 22, 2022 BostonGene reported its publication, "Conserved pan-cancer microenvironment subtypes predict response to immunotherapy," has been selected by Cancer Cell as one of ten research articles that represent cutting-edge areas of cancer research and oncology in 2021 (Press release, BostonGene, FEB 22, 2022, View Source [SID1234608830]).

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The manuscript describes a transcriptomic-based tumor classification platform that identified four unique tumor microenvironment subtypes across 20 different cancers, predicting prognosis and response to immune checkpoint blockade. BostonGene also created a personalized tumor map to visually depict the key molecular and immune characteristics of each tumor. The microenvironment classification platform and tumor map provide a clinically useful and robust methodology for response prediction and incorporate precision medicine strategies across varied cancer types.

"We are thrilled to be recognized by Cancer Cell for our innovative multi-platform analytics combined with cutting-edge software to improve patient outcomes," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our findings underscore the power of integrated analysis to uncover unique and clinically applicable characteristics of the tumor microenvironment, and we are committed to enabling doctors to personalize therapy for cancer patients."

The research results provided the foundation to launch BostonGene Tumor PortraitTM Tests, which are designed to reveal key drivers of each tumor, including immune microenvironment properties, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies.

On February 22, 2022 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that Dr. Klaus Wagner has been appointed as Chief Medical Officer (Press release, Boundless Bio, FEB 22, 2022, View Source [SID1234608829]).

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"We are excited to have Klaus join at this pivotal time as we advance the first ecDNA therapeutics towards the clinic," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "Klaus brings extensive experience in oncology drug development from both industry and clinical research settings. Over the course of his career, he has developed a deep understanding of how cancer targeted therapies and immunotherapies perform in the clinic. His leadership over Boundless Bio’s clinical development will bring significant value to our ecDNA-directed therapeutic (ecDTx) programs and importantly, help us bring new treatment options to patients with oncogene amplified cancer."

Dr. Wagner comes to Boundless Bio previously serving as Executive Vice President and Chief Medical Officer at Inhibrx, Inc. At Inhibrx, Dr. Wagner built and led an integrated clinical development organization responsible for advancing four therapeutic candidates, including three oncology programs, from pre-IND into the clinic. Dr. Wagner previously served as Medical Oncologist at Banner MD Anderson Cancer Center and as Adjunct Assistant Professor in the Department of Thoracic, Head & Neck Medical Oncology at MD Anderson Cancer Center, where he led molecularly targeted therapy and cancer immunotherapy trials in non-small cell lung cancer as a local principal investigator. Before that, Dr. Wagner trained at MD Anderson Cancer Center as a fellow in Medical Oncology. Prior to that Dr. Wagner’s scientific work at Genentech, Inc. and the Genomics Institute of the Novartis Research Foundation focused on cancer drug discovery and predictive biomarker development. Dr. Wagner was a scholar of the German National Academic Scholarship Foundation. Dr. Wagner received his M.D. and Ph.D. from the Friedrich-Alexander University of Erlangen in Germany.

"It is a privilege to join Boundless Bio, a company founded on interrogating a fundamental and important area of cancer biology, ecDNA that appears to play a significant role in the poor prognosis and treatment challenges associated with oncogene amplified cancers," said Dr. Wagner. "In my career as a scientist and clinician, I have always been excited to bring innovative treatments to patients with high unmet needs cancer. There are very few therapies that effectively address oncogene amplification. Boundless Bio’s pipeline is uniquely tailored to develop treatments for these patients."