BeiGene to Present at the Morgan Stanley 17th Annual Global Healthcare Conference

On September 3, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that the company will present at the Morgan Stanley 17th Annual Global Healthcare Conference in New York, NY (Press release, BeiGene, SEP 3, 2019, View Source [SID1234539213]). The presentation is scheduled for 1:30 p.m. EDT on Tuesday, September 10, 2019.

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source An archived replay will be available for 90 days following the event.

Fate Therapeutics Announces FDA Clearance of IND Application for FT596 Off-the-Shelf, iPSC-derived CAR NK Cell Cancer Immunotherapy

On September 3, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT596, the Company’s first off-the-shelf chimeric antigen receptor (CAR) natural killer (NK) cell cancer immunotherapy which targets multiple tumor-associated antigens (Press release, Fate Therapeutics, SEP 3, 2019, View Source [SID1234539212]). FT596 is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional modalities designed to optimize anti-tumor activity: a proprietary CAR targeting B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor; and an interleukin-15 receptor fusion (IL-15RF). The Company plans to initiate clinical investigation of FT596 as a monotherapy and in combination with CD20-directed monoclonal antibodies for the treatment of B-cell lymphoma and chronic lymphocytic leukemia.

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"FT596 is a ground-breaking product candidate with the potential to supplant current-generation patient-specific and allogeneic CAR19 T-cell immunotherapies, which recognize only one antigen and fail to address the significant risk of relapse due to antigen escape," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Our robust clinical development strategy for FT596 is designed to target multiple tumor-associated antigens for the treatment of B-cell lymphomas and leukemias. We believe the product candidate’s engineered functionality, coupled with its ability to be cost-effectively administered on-demand in multiple treatment cycles, will deliver a deeper and more durable response to patients compared to single-antigen targeted CAR19 T cells."

While CAR19 T-cell therapies have demonstrated profound initial responses, not all patients respond to therapy and, even for those who initially respond, durability of response remains a significant limitation. Downregulation of target antigen CD19 from the tumor cell surface has been clinically demonstrated to be an important mechanism of resistance.

FT596, which is the first cellular immunotherapy engineered with three active anti-tumor components cleared for clinical investigation by the FDA, is uniquely designed to overcome CD19 antigen escape. In addition to a proprietary CAR targeting CD19, FT596 expresses a novel hnCD16 Fc receptor that has been modified to augment antibody-dependent cellular cytotoxicity, enabling coincident targeting of CD19 and additional antigens such as CD20. FT596 also expresses IL-15RF, a potent cytokine complex that promotes survival, proliferation and trans-activation of NK cells and CD8 T cells without the need for systemic cytokine support. Together, these features of FT596 are intended to maximize potency and minimize toxicity in treated patients.

FT596 is the third off-the-shelf, iPSC-derived NK cell product candidate from the Company’s proprietary iPSC product platform cleared for clinical investigation by the FDA in less than one year. The Company is conducting first-in-human clinical trials of FT516, an off-the-shelf NK cell cancer immunotherapy engineered to express hnCD16, for the treatment of acute myeloid leukemia and B-cell lymphoma, and FT500, an off-the-shelf NK cell cancer immunotherapy, for the treatment of advanced solid tumors.

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, which contains a NKG2D transmembrane domain, a 2B4 co-stimulatory domain and a CD3-zeta signaling domain, that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor that has been modified to augment antibody-dependent cellular cytotoxicity by preventing CD16 down-regulation and enhancing CD16 binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that promotes enhanced NK cell activity. In preclinical studies of FT596, the Company has demonstrated that the concurrent activation of the CAR and hnCD16 targeting modalities, in combination with IL-15RF signaling, convey synergistic anti-tumor activity. Increased degranulation and cytokine release were observed upon concurrent receptor activation in lymphoma cancer cells as compared to activation of each receptor alone, indicating that dual-antigen engagement may elicit a deeper and more durable response. Additionally, in a mixed cellular composition cytotoxicity assay comprised of CD19+ and CD19- tumor cells, FT596 combined with rituximab effectively eliminated the heterogeneous population of tumor cells, a result that was not observed with single-antigen targeted CAR19 T cells.

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 can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of 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 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 capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 250 issued patents and 150 pending patent applications.

TRACON Pharmaceuticals To Present At The Rodman & Renshaw 21st Annual Global Investment Conference Sponsored By H.C. Wainwright

On September 3, 2019 TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and CEO, will present at the Rodman & Renshaw 21st Annual Global Investment Conference sponsored by H.C. Wainwright in New York on Monday, September 9th, at 3:50pm EDT (Press release, Tracon Pharmaceuticals, SEP 3, 2019, View Source [SID1234539211]).

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To access a live webcast of the presentation, please visit the "Events and Presentations" page within the "Investors" section of the TRACON Pharmaceuticals website at www.traconpharma.com. A replay of the webcast will be available on the website for 60 days following the event.

Selecta Biosciences to Present at the Janney Healthcare Conference

On September 3, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will present at the Janney Healthcare Conference in New York on Monday, September 9 at 9:55 a.m. Eastern Time (Press release, Selecta Biosciences, SEP 3, 2019, View Source [SID1234539210]). A live webcast of the presentation will be available on the Investors & Media section of the Selecta website at www.selectabio.com.

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Data from Incyte’s Oncology Portfolio to be Featured at the 2019 ESMO Congress

On September 3, 2019 Incyte (Nasdaq:INCY) reported that abstracts highlighting data from its oncology portfolio will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress taking place in Barcelona, Spain from September 27-October 1, 2019 (Press release, Incyte, SEP 3, 2019, View Source [SID1234539209]).

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Results from FIGHT-202, a Phase 2 study of pemigatinib as a second-line treatment for patients with advanced/metastatic or surgically unresectable cholangiocarcinoma, including updated safety and efficacy data in patients with FGFR2 fusions or rearrangements, as well as genomic profiling and correlations with clinical outcomes will be presented. Results from the Phase 1 study of INCB001158, an arginase inhibitor being developed with Calithera Biosciences, alone and in combination with pembrolizumab as a treatment for advanced or metastatic solid tumors, will also be presented.

"Incyte is committed to advancing treatments that have the potential to address areas of high unmet need and we look forward to sharing data on our investigational therapies with the oncology community at ESMO (Free ESMO Whitepaper) 2019," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Data from the Phase 2 FIGHT-202 study assessing pemigatinib as a potential treatment for cholangiocarcinoma are encouraging and may represent an important step forward for patients in urgent need of effective treatment options."

Abstracts will be available on the ESMO (Free ESMO Whitepaper) Congress website at View Source

Oral Presentations:

FIGHT-202: a Phase 2 study of pemigatinib in patients (pts) with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) (Abstract #2550, proffered paper session)

Friday, September 27, 2019 from 3:00 p.m. CEST to 3:15 p.m. CEST (9 a.m. ET to 9:15 a.m. ET) in Madrid Auditorium (Hall 2)
Phase 1 study of the arginase inhibitor INCB001158 (1158) alone and in combination with pembrolizumab (PEM) in patients (Pts) with advanced/metastatic (Adv/Met) solid tumors (Abstract #1621, oral abstract session)

Sunday, September 29, 2019 from 4:54 p.m. CEST to 5:06 p.m. CEST (10:54 a.m. ET to 11:06 a.m. ET) in Malaga Auditorium (Hall 5)
Poster Details:

Comprehensive genomic profiling and clinical outcomes in patients (pts) with fibroblast growth factor receptor rearrangement-positive (FGFR2+) cholangiocarcinoma (CCA) treated with pemigatinib in the FIGHT-202 trial (Abstract #2078, poster session)

Sunday, September 29, 2019 from 12:00 p.m. CEST to 1:00 p.m. CEST (6:00 a.m. ET to 7:00 a.m. ET) in Poster Area (Hall 4)
Full session details and data presentation listings for ESMO (Free ESMO Whitepaper) 2019 can be found at: View Source