On February 19, 2019 Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported that management will host a conference call in conjunction with the announcement of its fourth quarter and full-year 2018 financial results and present at the 8th Annual Leerink Partners Health Care Conference (Press release, Epizyme, FEB 19, 2019, View Source [SID1234533504]). Details of both events are as follows:

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Fourth Quarter and Full-Year 2018 Financial Results: Management will host a conference call and webcast to discuss its fourth quarter and full year 2018 financial results and other business highlights at 8:30 a.m. ET on Tuesday, February 26, 2019. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 1088195.
8th Annual SVB Leerink Global Health Care Conference Presentation: Management will present a company overview at the 8th Annual SVB Leerink Global Health Care Conference on Thursday, February 28, 2019 at 2:30 p.m. ET in New York City.
Live webcasts will be available in the investor section of the company’s website at www.epizyme.com. The webcasts also will be archived for 60 days following the call and presentation.

On February 19, 2019 Fusion Pharmaceuticals, a biopharmaceutical company focused on radiotherapeutics (specifically, targeted alpha therapeutics), reported that the first patient was dosed in a Phase 1, first-in-human clinical trial of lead product candidate [225Ac]-FPI-1434 in patients with advanced solid tumors (Press release, Fusion Pharmaceuticals, FEB 19, 2019, View Source [SID1234533468]).

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"The entire Fusion team takes tremendous pride in having developed a new targeted alpha therapeutic and in moving it from the discovery phase to a clinical trial," said John Valliant, Ph.D., Founder and Chief Executive Officer of Fusion Pharmaceuticals. "We are excited to start clinical development of a new generation of radiopharmaceuticals utilizing our Fast-ClearTM Linker to address the need for better cancer treatments."

The Phase 1 clinical study (FPX-01-01) is a dose-escalation study that will characterize the safety and tolerability of a single dose [225Ac]-FPI-1434 Injection in patients with advanced solid tumors. [225Ac]-FPI-1434 is a targeted alpha radioimmunoconjugate that consists of a humanized monoclonal antibody targeting the insulin-like growth factor-1 receptor 1 (IGF-1R), Fusion’s Fast-ClearTM Linker, a bifunctional chelate, and actinium-225. Patients will be screened for target expression with the imaging agent [111In]-FPI-1547. [111In]-FPI-1547 contains the same targeting antibody, Linker, and bifunctional chelate as the [225Ac]-FPI-1434 therapeutic form, however it will contain indium-111 in place of actinium-225. Only those patients who have IGF-1R expression will be receiving the [225Ac]-FPI-1434 therapeutic radioimmunoconjugate. Investigators will evaluate the safety and tolerability of a targeted alpha-emitting radiotherapeutic. Up to 30 patients will be treated and followed for safety and for signs of efficacy. For more information about this study, visit: View Source

About Fusion’s Fast-Clear Technology Platform and FPI-1434

Fusion uses its proprietary Fast-Clear Technology Platform to convert molecules into radiopharmaceuticals. Fast-ClearTM linkers promote increased clearance of radoisotopes – the linkers are engineered to improve the safety of radiopharmaceuticals without impacting efficacy. The predecessor [225Ac]-FPI-1434 antibody (AVE1642) is a humanized antibody against IGF-1R (insulin-like growth factor receptor) that had previously been in Phase I and II clinical trials. Fusion has an exclusive license to AVE1642 from ImmunoGen, Inc. Fusion applied its Fast-Clear linker to convert AVE1642 into a potent radiopharmaceutical, [225Ac]-FPI-1434.

On February 19, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported an agreement with Editas Medicine, Inc., a leading genome editing company, to evaluate the potential use of Editas Medicine’s CRISPR technology to edit NAM-NK cells, which are natural killer cells that have been expanded using Gamida Cell’s proprietary nicotinamide-based, or NAM, technology (Press release, Gamida Cell, FEB 19, 2019, View Source [SID1234533505]). Through this agreement, the companies aim to discover optimized NAM-NK cells that could be used to improve the treatment of hematologic malignancies (blood cancers) and solid tumors.

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"We are encouraged by the early data generated in the Phase 1 study of NAM-NK as an investigational therapy for patients with non-Hodgkin lymphoma and multiple myeloma, and we are pleased to have the opportunity to accelerate and broaden our NAM-NK research efforts through this agreement," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "By leveraging the collective expertise of the Gamida Cell and Editas Medicine teams, we hope to enhance the efficacy of NAM-NK cells through CRISPR editing and potentially bring life-changing immunotherapy treatments to patients."

"Natural killer cells are increasingly recognized as a potential breakthrough approach to treating various cancers. This agreement with Gamida Cell enables us to combine our industry-leading genome editing platform with Gamida Cell’s proprietary NAM-NK cells in an effort to develop best-in-class cellular medicines," said Charles Albright, Ph.D., chief scientific officer of Editas Medicine.

Under the terms of the agreement, Gamida Cell and Editas Medicine will engage in joint research to evaluate unnamed targets by combining Gamida Cell’s proprietary NAM-based cell expansion technology with Editas Medicine’s CRISPR technology. The research initiative is focused on exploring the potential to edit NAM-NK cells to further optimize their tumor-killing properties, and compare the function of the edited and unedited cells in inducing NK cell tumor clearance.

About NAM-NK
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with standard-of-care antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1

NAM-NK is an investigational therapy, and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On February 19, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. based pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world, reported that the National Medical Products Administration (NMPA) has approved the Company’s Clinical Trial Application (CTA) to allow for a confirmatory clinical trial to evaluate the efficacy and safety of ibritumomab tiuxetan injection (ZEVALIN) (Press release, CASI Pharmaceuticals, FEB 19, 2019, View Source [SID1234533487]). Ibritumomab tiuxetan (ZEVALIN) is a U.S. Food and Drug Administration (FDA)-approved product indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL) and is currently marketed in the U.S. by Spectrum Pharmaceuticals, Inc. (Spectrum). The Company previously acquired greater China rights to ZEVALIN from Spectrum and intends to launch ZEVALIN in China as soon as the confirmatory trial is completed and marketing approval is received from the NMPA.

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The Company currently is addressing certain requirements provided by the Center for Drug Evaluation (CDE), a part of the NMPA; upon satisfying those requirements, the Company will start the ZEVALIN clinical development program in China.

Ibritumomab tiuxetan (ZEVALIN) is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma who achieve a partial or complete response to first-line chemotherapy. Ibritumomab tiuxetan (ZEVALIN) builds on the combined therapeutic effects of a monoclonal antibody directed against the CD20 antigen, augmented with a beta-emitting radioisotope. Rituximab and rituximab biosimilars target the same CD20 antigen.

Wei-Wu He, Ph.D., the Company’s Executive Chairman commented, "We are extremely pleased with NMPA’s approval to start the confirmatory clinical trial for ZEVALIN in China. This is another important milestone for CASI as the approval further demonstrates our team’s regulatory strength in working with the NMPA and the effective cross-border operations of our teams in the U.S. and China."

On February 19, 2019 Incyte Corporation (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of March (Press release, Incyte, FEB 19, 2019, View Source [SID1234533470]):

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Cowen and Company 39th Annual Health Care Conference onMonday, March 11, 2019 at 12:00 pm (EDT) in Boston; and
Barclays Global Healthcare Conference on Wednesday, March 13, 2019 at 9:00 am (EDT) in Miami
The presentations will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcast should log on before the start time in order to download any software required.