On December 2, 2020 Bluestar Genomics, an innovative company leading the development of next-generation epigenomic approaches to cancer detection, and University of Chicago reported the publication of a genome-wide 5-hydroxymethylcytosine (5hmC) map across multiple human tissue types (Press release, Bluestar Genomics, DEC 2, 2020, View Source [SID1234572095]). The study, published in the peer-reviewed journal Nature Communications, demonstrated the robust performance of 5hmC as a global biomarker for the detection of multiple serious illnesses, such as cancer and various chronic diseases. Unlike 5mC which is a gene repression mark, 5hmC is a gene activation mark representing one of the most prevalent pathways involved in the regulation of embryogenesis, neurological processes, and carcinogenesis. The new map advances the understanding of diverse biological drivers in various diseases, which is necessary for the development of next-generation diagnostic tests.

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"While previous studies have shown that 5hmC can serve as an excellent biomarker for the diagnosis and prognosis of human diseases including cancer, the lack of a whole-body tissue map limits our global understanding of this mark and its potential tissue specificity," says Dr. Chuan He, Professor of Chemistry at the University of Chicago and the senior author of the study. "Through this collaboration with Bluestar Genomics, the new publication significantly expands our understanding of this global biomarker, delivering what we believe is the broadest reported human tissue map that catalogs 5hmC modifications. The new map confirms 5hmC as a prevalent gene activation mark for both gene bodies and enhancers with superb tissue and cell type specificity, which is key to future early diagnosis of human cancer and monitoring of human chronic diseases."

In this study, the University of Chicago scientists collaborated with Bluestar Genomics to evaluate the performance and reproducibility of 5hmC as a biomarker across 19 tissue types from multiple male and female organs. The published results demonstrate that the 5hmC profiles identified in the new map provide an unprecedented database of potential diagnostic development, specifically in cancer.

Based on a study of 96 samples representing ten major organ systems: nervous, cardiovascular, digestive, reproductive, endocrine, respiratory, urinary, integumentary, skeletal, and lymphatic, the map represents the most comprehensive examination of 5hmC as a biomarker for cancer detection. The data confirms the profiling accuracy (Spearman r = 0.82 compared with gold standard TAB-seq profiles) and reproducibility (Spearman r = 0.974) of the genome-wide 5hmC profiles obtained in various tissues, which underscores its clinical relevance and provides a unique resource to study distributions of 5hmC in the human genome.

Building on Bluestar Genomics’ previously published work, the new publication highlights that 5hmC reveals known biology in human tissues by enabling the measurement of gene transcriptional and gene regulation activity with the same assay. The published map, which characterizes the genomic distributions of 5hmC in 19 human tissues derived from ten organ systems lays the foundation for the future development of diagnostic tests.

"With the ultimate goal of developing a robust cancer screening test, this map brings us a step closer to enhancing our ability to accurately read and interpret cancer signals coming from tumor tissues in cell-free DNA," says Samuel Levy, Ph.D., Chief Executive and Chief Scientific Officer at Bluestar Genomics, co-senior author of the study. "I’m proud that our work will also contribute to the broader scientific community by deepening scientists’ precise understanding of the breadth of biology through the utilization of 5hmC."

On December 2, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that it will be presenting at the Annual LD Micro Main Event to be held virtually from December 14-15, 2020 (Press release, Greenwich LifeSciences, DEC 2, 2020, View Source [SID1234572094]).

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Snehal Patel, CEO of Greenwich LifeSciences, will present and then participate in a live Q&A session by a panel of investors. The presentation will be held at 1:20 pm EST on December 15, 2020, and will highlight the Company’s recently published GP2 data and its plans to commence a Phase III clinical trial. The corporate presentation is currently available on the investor section of the Company’s website at: View Source

About LD Micro

LD Micro is the host of the most influential conferences in the small-cap world. LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into several influential events annually (Invitational, Summit, and Main Event). With the recent SRAX acquisition, LD has access to the largest active base of micro-cap investors in the world at over 2 million and counting. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On December 2, 2020 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported that it will host a webcast on Monday, December 7 at 6:00PM EST to discuss presentations at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held virtually December 5-8, 2020 (Press release, Rocket Pharmaceuticals, DEC 2, 2020, View Source [SID1234572093]). The ASH (Free ASH Whitepaper) presentations will highlight data from the Fanconi Anemia, Leukocyte Adhesion Deficiency-I and the Pyruvate Kinase Deficiency programs.

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Following the discussion, Rocket management and key opinion leaders will be available for a brief Q&A session.

To access the live webcast and presentation, please click here. The webcast replay will be available on the Rocket website following the completion of the call.

Investors may listen to the call by dialing (866) 866-1333 from locations in the United States or +1 (404) 260-1421 from outside the United States. Please refer to conference ID number 50038102.

On December 2, 2020 PharmaCyte Biotech, Inc. (OTCQB: 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 that it has successfully completed the nine-months product stability testing that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps final product, which will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (Press release, PharmaCyte Biotech, DEC 2, 2020, View Source [SID1234572092]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed nine-month stability study, "The product stability studies of our CypCaps product initiated prior to submitting our Investigational New Drug application (IND) to the FDA are still proceeding smoothly while we are answering the questions raised by the FDA following our IND submission. We are also starting additional studies designed to provide information that the FDA has requested, which are mainly focused on the handling of the CypCaps product in the clinic, and on additional animal data to add to the data that we have already supplied in our IND package.

"The ongoing stability study is designed to determine the shelf life of the Cell-in-a-Box encapsulated cell product, CypCaps, frozen at -80°C, and I am pleased to report that the nine-month time point was recently reached and that CypCaps passed all of the necessary tests, including cell viability, enzyme activity and cell potency, pH, label check, capsule appearance and integrity. This nine-month data, as well as all future longer-term time points of the shelf life analyses, such as the next milestone, the 12-month time point, will be reported to the FDA as an update to our submitted IND."

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 the company’s documentary video complete with medical animations at: View Source

On December 2, 2020 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR platform, reported that it has expanded its ADAPTIR bispecific platform technology to include a new multi-specific platform technology, ADAPTIR-FLEX (Press release, Aptevo Therapeutics, DEC 2, 2020, View Source [SID1234572091]). Aptevo also announced that it has developed a new bispecific candidate, APVO442, that uses ADAPTIR-FLEX platform technology. APVO442 is a unique T-cell engager designed to target PSMA (prostate specific membrane antigen) and CD3 with low affinity for the treatment of prostate cancer. Prostate cancer is one of the most common forms of cancer in men.

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ADAPTIR-FLEX expands Aptevo’s ability to create novel therapeutic multi-specific candidates with the potential of exhibiting a wide variety of mechanisms of action. The new ADAPTR-FLEX platform technology enables the design of candidates that have modified affinity and valency to a target, which has the potential to improve specificity, tumor targeting, and therapeutic benefit with application to multiple hematologic and solid tumors. ADAPTIR-FLEX utilizes the same IgG-backbone and linkers found in ADAPTIR, but in a heterodimeric format, while retaining good manufacturability attributes and extended half-life that may enable improved dosing regimens in clinical development.

Aptevo also announced that it has developed a new bispecific candidate, APVO442, that utilizes ADAPTIR-FLEX platform technology targeting PSMA and CD3 for the treatment of prostate cancer. There has been early clinical validation of the combination of PSMA x CD3 as a bispecific in clinical development. Aptevo designed the new bispecific candidate APVO442 to have two binding domains targeting PSMA, to potentially increase avidity (strength) of binding to the tumor antigen PSMA, with one binding domain to CD3 with reduced binding affinity to T cells demonstrated in vitro.

"We are very excited about the launch of our second platform technology, ADAPTIR-FLEX, which expands our capability to design candidates with multiple new mechanisms of action, with potential best-in-class attributes," said Mr. Marvin White, President and CEO of Aptevo. "Recently, we had two patients in cohort 6 of our phase 1 APVO436 clinical trial achieve complete remission, which strengthened our resolve around the capabilities of our ADAPTIR platform technology. Our new bispecific candidate APVO442, built on ADAPTIR-FLEX, is a unique T-cell engager targeting PSMA and CD3 for the treatment of prostate cancer, and we are optimistic about the potential outcomes for patients impacted by these tumors," concluded Mr. White.

"The low affinity to CD3 and increased binding strength to PSMA are designed to potentially achieve better biodistribution to PSMA-positive tumors. Reducing the affinity to CD3 may have improved therapeutic benefit for treatment of prostate cancer compared to other CD3-based bispecifics targeting PSMA. In addition, this approach, using ADAPTIR-FLEX, can be applied to additional solid tumor types," said Jane Gross Ph.D., Chief Scientific Officer of Aptevo.

Aptevo believes that ADAPTIR-FLEX CD3-based candidates have the potential to demonstrate reduced production of cytokines consistent with other ADAPTIR-based T-cell engagers like observations made for APVO436 in preclinical studies. The reduced cytokine profile has been demonstrated for APVO442 in both in vitro and in vivo preclinical studies when T cells are challenged in the presence of drug and antigen-expressing tumors. This may reduce toxicities compared to those observed by other CD3-based T cell engagers with potential to achieve better efficacy and an increased therapeutic index in clinical development.

The therapeutic candidates APVO436, ALG.APV-527 and APVO603 based on the bivalent, bispecific ADAPTIR platform technology are advancing in clinical and preclinical development, respectively. Both the ADAPTIR platform technology and the ADAPTIR-FLEX platform technology will be used to develop therapeutic candidates based on desired mechanisms of action, to populate our portfolio with new bispecific and multi-specific protein therapeutics to potentially address unmet medical needs.