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

On January 22, 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 both batches of the company’s manufactured clinical trial product have undergone and passed all 10 of the necessary "release tests" required by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 22, 2020, View Source [SID1234553417]).

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PharmaCyte’s partner, Austrianova Singapore (Austrianova), is now completing and signing the paperwork to issue PharmaCyte a Certificate of Analysis for each batch of the company’s clinical trial product. Austrianova will also be turning over all of the completed batch records to PharmaCyte for both production runs that tested the company’s clinical trial product for the "functionality" of the encapsulated cells and the "safety" of the clinical trial product. These tests will provide essential data for PharmaCyte to complete its Investigational New Drug application (IND) to the FDA to request approval for our planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "After completing the production of our clinical trial product, it is extremely good news to learn that our capsules and the live cells inside are functioning and safe to put inside patients in our upcoming planned clinical trial in locally advanced, inoperable pancreatic cancer. There were 20 tests in total over both batches, and our clinical trial product passed all of them. This proves that our years of hard work and working through each challenging hurdle was well worth it. We now eagerly await the two Certificates of Analysis and the records from both batches from Austrianova so that we can begin to compile and enter that data into our IND application."

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