On December 8, 2021 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 detailed, analysis of the integration site of the cytochrome P450 2B1 gene from the augmented HEK293 cell clone that PharmaCyte uses in its CypCap product (Press release, PharmaCyte Biotech, DEC 8, 2021, View Source [SID1234596612]). This assay is one of the assays required by the U.S. Food and Drug Administration (FDA) in order to have the FDA’s clinical hold lifted on PharmaCyte’s Investigational New Drug Application (IND) for the treatment of locally advanced, inoperable pancreatic cancer (LAPC).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are elated to have completed this sequencing assay given its importance to the FDA, and how incredibly difficult it was to arrive at this successful conclusion. We can report that the DNA sequence analysis of the cytochrome P450 2B1 augmented cells is now complete, and it is a great challenge that is now behind us. This kind of analysis is technically demanding, and we spent a great deal of time getting this right. In addition to extending our characterization of the augmented cells, the data also verifies our previous studies on the cells that are the active component of our novel LAPC therapy."

In previous studies, PharmaCyte showed that the cytochrome P450 2B1 gene in the augmented HEK293 cell clone was located on human chromosome 9 and the flanking sequence had already been determined. The FDA requested that the exact sequence of the cytochrome P450 2B1 gene inserted at that location should also be determined. This is technologically challenging because the introduced DNA is large and concatenated, causing the Company to turn to nanopore sequencing technology for this analysis. Nanopore sequencing is a cutting edge, unique and scalable technology that enables direct, real-time analysis of long DNA fragments. The technology was successfully used to determine the sequence of the introduced DNA, and the analysis of the sequence data shows that it is both intact and complete.

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 8, 2021 IsoPlexis (NASDAQ: ISO), the leader in functional single cell proteomics, reported that new data generated on its IsoLight platform will be presented at the 63rd annual American Society of Hematology (ASH) (Free ASH Whitepaper) conference, taking place December 11-13 at the Georgia World Congress Center in Atlanta, Georgia (Press release, IsoPlexis, DEC 8, 2021, View Source [SID1234596629]).

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At ASH (Free ASH Whitepaper), IsoPlexis’ presented data will outline how to leverage unique powerful single-cell subsets of highly functional "superhero" cells, critical to driving longer term response in cell and immune therapies via functional proteins. The presentation will highlight how to fully leverage these superhero cells for optimization of CAR-T manufacturing, as well as clinical combination immunotherapies for hematologic malignancies and functional biomarkers of potency, durability, and survival.

The presentation, titled "Single-Cell Functional Biomarkers of Potency, Durability, and Survival in Cell Therapy Optimization and Combination Immunotherapies for Hematologic Diseases," will be given on Saturday, December 11 from 1:30 p.m. – 1:45 p.m. eastern time. The presentation will be located in Theater 5 of Exhibit Hall – Building B at the Georgia World Congress Center.

Additionally, the following poster presentations from Stanford University, Medical College of Wisconsin, and Atara Biotherapeutics will also highlight novel applications in acute graft-versus-host disease (aGvHD), bispecific CAR-T cells, and off-the-shelf allogenic T-cell therapies, respectively:

P#1684: Combinatorial Cytokine Secretion Signature of Donor-Derived T Cells Infused with the Graft: A New Potential Biomarker of Acute Graft-Versus-Host Disease in Aβt-Cell/CD19 B-Cell Depleted Hematopoietic Stem Cell Transplant Recipients
P#1728: Bispecific LV20.19 CAR T-Cells Expanded in IL-7 and IL-15 Have Greater Polyfunctionality and Polyfunctional Strength Than CAR T-Cells Expanded in IL-2
P#2809: Comprehensive Activation Profiling of the Tabelecleucel Library, and Off-the-Shelf, Allogeneic EBV-Specific T-Cell Therapy

On December 8, 2021 Hoffmann-La Roche reported that invite investors and analysts to participate in our virtual event on Wednesday, 15 December, 2021, highlighting Roche data presented at the virtual American Society of Hematology (ASH) (Free ASH Whitepaper) 63rd Annual Meeting, from 11-14th December (Press release, Hoffmann-La Roche, DEC 8, 2021, View Source [SID1234596593]).

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16:00 – 17:30 CET / 15:00 – 16:30 GMT
10:00 – 11:30 am EST / 7:00 – 8:30 am PST

The webinar will start with a presentation, followed by a Q&A session (live access to the speakers).

Agenda:

Welcome
Karl Mahler, Head of Investor Relations

Hematology franchise overview
Peter Ahnesorg, Franchise Head Hematology

Review of key clinical data presented at ASH (Free ASH Whitepaper): Hemlibra, mosun, glofit, cevostamab
Charles Fuchs, Senior Vice President – Global Head Of Oncology And Hematology Product Development

Presentation of POLARIX data
Franck Morschhauser, MD, PhD, Professor of Hematology, University of Lille; President of LYSA, LYSARC

Q&A

The slides will be available for download at 15:00 CET on the day of the event. > click here

Should you be unable to register for the webinar due to your company IT policy, please send an email to [email protected].

On December 8, 2021 SynDevRx, Inc., a clinical-stage biotechnology company leading the development in treatments for cancers sensitive to dysregulated metabolic hormones, reported they will be presenting pre-clinical mechanistic/molecular data with evexomostat (SDX-7320) using the Her2+ xenograft model (BT474) in combination with capivasertib/AZD-5363 during the 2021 San Antonio Breast Cancer Symposium (Press release, SynDevRx, DEC 8, 2021, View Source [SID1234596613]).

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Akt inhibitors frequently cause severe elevations in blood glucose. Hyperglycemia is a highly problematic, on-target toxicity associated with Akt inhibition that can lead to treatment resistance (which is likely mediated via subsequent hyperinsulinemia) or dose reductions. Furthermore, this on-target effect can require intense medical support, often from outside endocrinologists. Balancing capivasertib-induced hyperglycemia via dose titration while also titrating anti-diabetic medications to remediate the high blood sugar can be challenging and may lead to sub-optimal cancer treatment.

SynDevRx will be presenting data based on a series of experiments that investigated the impact of evexomostat (SDX-732) on Akt treatment-induced hyperglycemia, as well as the anti-tumor effects of evexomostat when combined with capivasertib. Mechanistically, data showing changes in the expression of a number of key hypoxia and innate immune system gene sets will be presented.

The poster, P5-05-04 "Inhibition of HER2+ tumor growth with SDX-7320, a novel MetAP2 inhibitor, alone and in combination with capivasertib/AZD-5363: Reduced expression of hypoxia-inducible genes" is being presented on Friday, December 10 from 7:00-8:30 AM.

About SDX-7320

SynDevRx believes that evexomostat (SDX-7320) is the first drug being developed specifically for cancer patients with metabolic complications, such as obesity, diabetes, high blood glucose or high HbA1c, pre-diabetes or insulin/leptin resistance. For certain tumor types, metabolic hormones stimulate oncogenic pathways, making the cancer more aggressive and deadlier. Evexomostat acts by binding irreversibly to its target enzyme MetAP2, triggering downstream improvements in the metabolic hormones insulin, leptin and adiponectin, improvements in key lipids, and inhibition of the important angiogenic proteins bFGF and VEGF-C, as was demonstrated in a Phase 1 clinical study in late-stage cancer patients. In preclinical studies using models of breast cancer, evexomostat (in combination with a CDK4/6 inhibitor) decreased levels of multiple cell cycle proteins in ER+ tumors, provided synergistic anti-tumor effects in combination with a PI3K inhibitor, reduced angiogenesis, controlled aberrant metabolic hormone signaling, and reversed obesity-induced immune suppression within the tumor micro-environment of tumor-bearing obese mice. Evexomostat (SDX-7320) is being developed for use in combination with standard-of-care cancer therapies for breast and prostate cancers.

On December 8, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that management will host a virtual event entitled "B -cell Lymphoma Franchise Update" on Tuesday, December 14, 2021 at 8:00 AM ET (Press release, Fate Therapeutics, DEC 8, 2021, View Source [SID1234596594]).

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The event will highlight interim Phase 1 clinical data from the Company’s FT516 and FT596 programs for the treatment of relapsed / refractory B-cell lymphomas.

The live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

The event is not an official program of the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in a multi-dose Phase 1 clinical trial as a monotherapy for the treatment of relapsed / refractory acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of relapsed / refractory B-cell lymphoma (NCT04023071).

About FT596
FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors enhances cytotoxic activity, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma as a monotherapy and in combination with rituximab, and for the treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) as a monotherapy and in combination with obinutuzumab (NCT04245722).