On October 15, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported US Food and Drug Administration (FDA) clearance and successful technology transfer for its UltraPorator system, an exclusive device and proprietary software solution for the scale-up of rapid and cost-effective manufacturing of UltraCAR-T therapies (Press release, Precigen, OCT 15, 2020, View Source [SID1234568524]). The FDA cleared UltraPorator as a manufacturing device for clinical trials of Precigen’s investigational UltraCAR-T therapies in compliance with current good manufacturing practices (cGMP). In addition, the Precigen team has successfully completed technology transfer of the UltraPorator system for the manufacturing of UltraCAR-T in the ongoing clinical trials for PRGN-3005 in ovarian cancer at the University of Washington/Fred Hutchinson Cancer Research Center and for PRGN-3006 in acute myeloid leukemia (AML) at the Moffitt Cancer Center.

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"UltraPorator is a game-changer for rapid manufacturing of UltraCAR-T therapy for our PRGN-3005 clinical trial," said Mary L. (Nora) Disis, MD, faculty member at the University of Washington and Fred Hutchinson Cancer Research Center and one of the lead investigators for the PRGN-3005 study. "With the tech transfer process complete, we are now ready to use UltraPorator to rapidly deliver personalized UltraCAR-T therapy to patients."

The UltraPorator device is a high-throughput, semi-closed electroporation system for reprograming T-cells using Precigen’s Sleeping Beauty non-viral gene transfer technology. The UltraPorator system includes proprietary hardware and software solutions and potentially represents major advancements over current electroporation devices by significantly reducing the processing time and contamination risk. UltraPorator is intended to be a viable scale-up and commercialization solution for decentralized UltraCAR-T manufacturing. The UltraPorator device was designed to enable rapid manufacturing for a range of gene and cell therapies beyond UltraCAR-T and is available as a stand-alone device for strategic partnerships.

"UltraPorator is poised to transform the manufacturing and accessibility of CAR-T therapies for cancer patients," said Dr. Helen Sabzevari, President and CEO of Precigen. "For patients with cancer, delays associated with current CAR-T treatments can have significant negative impacts on health outcomes and survival. Precigen’s exclusive UltraPorator device improves the scalability of the UltraCAR-T rapid manufacturing process and supports overnight delivery of personalized UltraCAR-T to patients."

The UltraCAR-T platform is differentiated from the current generation of CAR-T therapies that rely on a long and complex manufacturing process that includes the use of viral vectors and several weeks of CAR-T cell expansion in centralized facilities before treatment is administered to patients. UltraCAR-T is comprised of genetically modified autologous T-cells that simultaneously express an antigen-specific CAR, membrane bound IL-15 and a kill switch. The inclusion of the gene encoding membrane bound IL-15 slows the aging of UltraCAR-T cells, which results in superior expansion of cells in vivo, eliminating the need for multiple weeks of expansion in culture. The kill switch, which allows for rapid destruction of UltraCAR-T cells in the event of any significant adverse events, has the potential to improve the safety profile of UltraCAR-T therapies.

Current methods for gene transfer rely on electroporation devices requiring labor intensive and manual handling of samples which may increase contamination risk and require multiple batches and extensive hours to manufacture a single dose. In contrast, UltraPorator is capable of handling the electroporation of billions of T-cells in minutes and further streamlines the UltraCAR-T overnight manufacturing process. "UltraPorator represents a pivotal advance in the field of personalized gene and cell therapy, allowing us to bring the drug manufacturing process as close as possible to patients in a commercially viable and expedient way," Dr. Sabzevari concluded.

On October 15, 2020 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that it will host a conference call and audio webcast on Thursday, October 22, 2020 at 2:30 p.m. CET (8:30 a.m. ET) to discuss its third quarter 2020 financial results and provide a business update (Press release, argenx, OCT 15, 2020, View Source [SID1234568523]).

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A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the call.

On October 15, 2020 Adaptimmune Therapeutics plc ("Adaptimmune") (Nasdaq: ADAP), reported a leader in cell therapy to treat cancer is aware of the early release of the abstract entitled "Initial safety, efficacy, and product attributes from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating an affinity optimized TCR targeting MAGE-A4 and a CD8α co-receptor" by the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") Conference (Press release, Adaptimmune, OCT 15, 2020, View Source [SID1234568522]).

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The full abstract is attached to this release.

The Company will update on the full dose escalation cohort of the SURPASS trial (6 patients in total) at the virtual SITC (Free SITC Whitepaper) conference on November 11, 2020 at 9 AM EST when posters are made available online.

On October 15, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the publication of a manuscript in Blood Advances, a journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, MacroGenics, OCT 15, 2020, View Source [SID1234568521]). This represents the third publication of flotetuzumab data in 2020. Flotetuzumab (also known as MGD006), is an investigational, clinical-stage bispecific DART molecule that recognizes both CD123 on leukemic cells and CD3 on T cells, with the intended result of T-cell-mediated killing of leukemic blasts. This most recent publication reports on the role of flotetuzumab in the immunotherapy of TP53-positive acute myeloid leukemia (AML).

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It has previously been shown1 that an inflammatory (IFN-γ-related) gene expression signature in patients with AML correlated with a lack of response to induction chemotherapy. The same gene signature was shown to be associated with an increased probability of this subset of patients to respond to flotetuzumab. As further described in the article titled "TP53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in AML," AML with TP53 abnormalities was also associated with immune infiltration in the tumor microenvironment (TME); moreover, patients with TP53 abnormalities derived benefit from flotetuzumab immunotherapy.

"Previous translational studies demonstrated that patients who failed to respond to induction therapy (primary induction failure, or PIF, AML) or those who relapsed within six months of achieving an initial remission (early relapsed, or ER, AML) had an immune-infiltrated TME that not only associated with resistance to standard-of-care chemotherapy regimens, but also with response to flotetuzumab," said Sergio Rutella, M.D., Ph.D., FRCPath, John van Geest Cancer Research Centre, College of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom. "Included in this PIF/ER AML population are patients harboring TP53 abnormalities, a particularly difficult to treat subset of AML associated with poor prognosis. Interestingly, these patients who responded poorly when treated with standard-of-care chemotherapy regimens appeared to benefit from flotetuzumab therapy."

"The results published today in Blood Advances, combined with data from previous articles published in Blood and Science Translational Medicine, further support our decision to conduct a pivotal study of flotetuzumab in AML patients who have previously experienced either a primary induction failure or an early relapse when treated with standard-of-care chemotherapy regimens. These individuals represent approximately 40-50% of all AML patients," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Our single arm clinical trial is ongoing as an expansion of the Phase 1/2 study, for which we plan to enroll up to 200 patients. We plan to present interim results at a medical conference later this year."

1 "Flotetuzumab as Salvage Immunotherapy for Refractory Acute Myeloid Leukemia," Blood, 2020; and "Immune Landscapes Predict Chemotherapy Resistance and Immunotherapy Response in Acute Myeloid Leukemia," Science Translational Medicine, 2020.

About Acute Myeloid Leukemia

AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure, or PIF) or experience disease recurrence after a short remission duration (<6 months; early relapsed, or ER). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations. The discovery by the Rutella lab of an immunological gene signature in the AML tumor microenvironment forms the basis for a potential predictive biomarker for further clinical validation.

About Flotetuzumab

Flotetuzumab (also known as MGD006) is a clinical-stage bispecific, investigational DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. Data from the Phase 1/2 clinical study of flotetuzumab in patients with primary induction failure / early relapse (PIF/ER) AML were presented in December 2019 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956; to be updated). The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML. (Press release, MacroGenics, OCT 15, 2020, View Source [SID1234568521])

On October 15, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that biomarkers associated with clinical response in patients with r/r DLBCL treated with DPX-Survivac combination therapy will be presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting (Press release, IMV, OCT 15, 2020, View Source [SID1234568520]).

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Poster Title:

Baseline PD-L1 expression and tumor immune infiltration is associated with clinical response in patients with r/r DLBCL treated with DPX-Survivac, low-dose cyclophosphamide and pembrolizumab

Poster Presentation Details:

Presenter: Neil Berinstein, MD, FRCPC, ABIM
Hematologist at the Sunnybrook Health Science Centre, Toronto.
Abstract Number: 356

Important dates:

November 9 – 8.00am EST: Full abstract will be released on the SITC (Free SITC Whitepaper) meeting platform,

November 11 – 9.00am EST: Poster will be posted on Company’s website and poster presentation will be available on the SITC (Free SITC Whitepaper) conference platform,

November 12 – 8.00am EST: Company will discuss data during a live webcast,

November 12 from 4.50-5.20pm EST and November 14 from 1.00-1.30pm EST, a Q&A session will be held on the SITC (Free SITC Whitepaper) meeting platform.

The final poster presentation will include additional data collected between the abstract submission on April 1, 2020 and the presentation itself. The poster will be available under the Scientific Publications & Posters section on IMV’s website on the day of presentation.

Webcast registration will be available under "Events, Webcasts and Presentations" in the Investors section of IMV’s website. The video recording will be available for replay shortly thereafter.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that generates targeted and sustained immune response in vivo. Treatments with DPX-Survivac have demonstrated the potential for sustained and targeted cancer cell killing capabilities with limited adverse events.

DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

DPX-Survivac is currently being evaluated in three Phase 2 studies: advanced ovarian cancer, relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and a basket trial of five solid tumors. All of which are expected to report topline results in 2020.

About the SPiReL Study

"SPiReL" is a Phase 2 non-randomized, open label, efficacy and safety study of a novel immunotherapy combination with DPX-Survivac and pembrolizumab. Intermittent low dose cyclophosphamide is given as an immune-modulator. Subjects with r/r incurable DLBCL and survivin expression are eligible for participation. The primary outcome is to document the objective response rate using modified Cheson criteria to the combination treatment. Secondary outcomes include the documentation of: changes in tumor volume, toxicity profile, duration of response (Cheson criteria).