On January 22, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will participate in the Precision Medicine World Conference (PMWC) 2020 in Santa Clara, CA January 22-24 (Press release, Personalis, JAN 22, 2020, View Source [SID1234553421]).

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The presentation titled "Enabling Advanced Composite Biomarkers for Precision Oncology and Cancer Diagnostics," will describe the Personalis universal cancer immunogenomics platform, ImmunoID NeXT. Richard Chen, MS, MD, Chief Scientific Officer, will present for Personalis. Dr. Chen will provide an overview of how the platform can be used to explore critical immunotherapy-related resistance mechanisms and novel composite biomarkers of response utilizing analytics, including human leukocyte antigen (HLA) typing and HLA loss of heterozygosity (LOH), neoantigen prediction and load, immune repertoire characterization, oncoviral detection, as well as the evaluation of tumor mutational burden (TMB) and microsatellite instability (MSI) status.

ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a single tumor specimen.

Personalis will also be exhibiting during the conference (Exhibit #D2820). Representatives will be available to answer questions about the company’s cancer immunogenomics capabilities.

On January 22, 2020 Celularity, Inc. ("Celularity" or the "Company"), a clinical-stage company developing allogeneic cellular therapies from human placentas, reported the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application for CYNK-001 in patients with glioblastoma multiforme (GBM) (Press release, Celularity, JAN 22, 2020, View Source [SID1234553420]).

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The clinical investigation of CYNK-001 in patients with GBM is expected to be the first clinical trial in the U.S. to investigate intratumoral administration of an allogeneic NK cell therapy. The Company plans to initiate first-in-human clinical testing of CYNK-001 administered either intravenously or intratumorally. This study is expected to evaluate the safety, feasibility, and tolerability of multiple doses of CYNK-001 in subjects with relapsed GBM.

"The FDA clearance of our IND validates the versatility of our allogeneic, off-the-shelf, placental-derived NK cell therapy platform to generate novel clinical candidates against a broad range of devastating cancers. This IND represents a significant step toward a potential immunotherapy option that is more accessible and tolerable to patients with glioblastoma multiforme," said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. "We will continue to work diligently to advance our investigational and development programs, and to deliver the next-generation of scalable, high quality immunologic approaches for the treatment of devastating cancers."

Nonclinical safety and efficacy data presented at the 2019 Society for Neuro-Oncology (SNO) Annual Meeting, demonstrated that a single administration of CYNK-001 was well-tolerated and showed enhanced in vivo anti-tumor activity against glioblastoma multiforme (GBM). CYNK-001 is currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and as a potential treatment option for various solid tumors.

About CYNK-001
CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. NK cells derived from the placenta are intrinsically safe and versatile, allowing potential uses across a range of organs and tissues.

On January 22, 2020 Phesi, a data-driven provider of premier integrated clinical development analytics products and services, reported that OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS) has purchased a multi-year ClinSite license to enable more accurate and precise planning for Phase 2 and 3 clinical trials of anticancer immunotherapies developed with OncoSec’s plasmid DNA delivery platform (Press release, OncoSec Medical, JAN 22, 2020, View Source [SID1234553419]). ClinSite is a self-service, artificial intelligence (AI)-powered tool that allows biopharmaceutical companies to search for and select top-performing investigator sites for clinical trials in all therapeutic areas.

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"As a ClinSite licencee, OncoSec can utilize this novel tool to select the right investigator sites for their immune-oncology clinical trials across a range of tumor types," said Gen Li, PhD, MBA, Phesi founder and president. "Many drug studies fail or are unnecessarily prolonged due to the lack of timely and precise data to inform trial protocols and investigator site selection. With our AI-driven predictive analytics and insights, Phesi’s tools generate accurate, real-time data, allowing companies such as OncoSec to accelerate their trial timelines and enhance their efficiency."

"Access to Phesi’s innovative technology will be a boon to OncoSec’s clinical development programs, particularly our later-stage trials in advanced melanoma, head and neck cancer, and triple-negative breast cancer," noted Kellie Malloy Foerter, chief clinical development officer at OncoSec. "Despite the relatively small patient populations affected by these malignancies, the array of unmet medical needs, combined with the sheer number of ongoing and planned clinical trials in these indications, presents a complex landscape for patients, investigators, and trial sponsors to negotiate. We are therefore excited to deploy ClinSite to optimize our clinical development planning processes, and are eager to see the results as Phesi’s ClinSite reporting capabilities evolve."

On January 22, 2020 Genialis, a leader in applied data science for the development of precision medicines, reported a collaborative partnership with Oncologie, an international, clinical-stage biopharma developing next-generation immunotherapies for cancer (Press release, Oncologie, JAN 22, 2020, View Source [SID1234553407]). Initial activities will focus on the use of Genialis’ Expressions software platform and analytics IP with Oncologie’s clinical and translational expertise to refine patient stratification methodologies.

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"We are incredibly excited to work with Genialis on this cutting-edge, precision medicine project. To be able to better understand the patient’s tumor microenvironment phenotype and how it is related to patient benefit represents a key objective for the future success of our company," says Oncologie CEO Laura Benjamin.

Early work between the two companies has thus far focused on modeling gene expression signatures predictive of treatment for gastric cancer. The patent-pending enhanced methodology will further Oncologie’s clinical development plans to expand beyond gastric cancer to other tumor microenvironment phenotypes.

"One of the most encouraging trends in drug development is innovation around integrating and interrogating diverse datasets. Data from historical literature, public population studies, first in human trials, et cetera, can be leveraged to answer significant questions on how to make safe and effective treatments more readily available to patients fighting debilitating and deadly diseases," says Genialis CEO Rafael Rosengarten. "Our work in data science requires a great deal of artistry in addition to technology. And benefits from hand-in-hand collaboration with biology domain experts, which makes this opportunity with Oncologie so special. Right from the start, we knew we shared a vision and a commitment to the process."

This week Genialis will present its work on predictive models for patient stratification at the Precision Medicine World Conference in Santa Clara, CA on January 22.

On January 22, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Knut Niss, Ph.D., Chief Technology Officer, will deliver a presentation titled "Non-viral vector platform: an update and review" at the Phacilitate Leaders World & World Stem Cell Summit 2020, at 2:35 PM EST today (Press release, Mustang Bio, JAN 22, 2020, View Source [SID1234553418]). The conference is being held January 21 – 24, 2020, at the Hyatt Regency Hotel in Miami, Florida.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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For additional information on the meeting, please visit: View Source