Gamida Cell Announces Agreement with Editas Medicine to Evaluate Use of CRISPR Genome Editing Technology in NAM-NK Cells

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.

Apexigen to present at upcoming Investor Conferences

On February 19, 2019 Apexigen, Inc., a clinical-stage biopharmaceutical company, reported that Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer, will present at the following upcoming investor conferences (Press release, Apexigen, FEB 19, 2019, View Source [SID1234590998]):

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Citi’s 7th Annual Immuno-oncology Leadership Summit
New York, NY
Tuesday, February 19, 2019 at 3:30 pm ET

SVB Leerink’s 8th Annual Global Healthcare Conference
New York, NY
Wednesday, February 27, 2019 at 2:10 pm ET

Cowen’s 39th Annual Healthcare Conference
Boston, MA
Tuesday, March 12, 2019 at 4:00 pm ET

William Blair’s IO Conference
New York, NY
Thursday, March 21, 2019 at 2:05 pm ET

CASI PHARMACEUTICALS ANNOUNCES CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) APPROVAL OF CTA TO CONDUCT CONFIRMATORY CLINICAL TRIAL FOR ZEVALIN®

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."

Incyte to Present at Upcoming Investor Conferences

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.

Corcept Therapeutics To Announce Audited Financial Results, Provide Corporate Update And Host Conference Call

On February 19, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report its audited 2018 fourth quarter and full-year financial results and provide a corporate update on February 25, 2019 (Press release, Corcept Therapeutics, FEB 19, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-audited-financial-results-provide [SID1234533488]). The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information

To participate, dial 1-888-220-8451 from the United States or 1-323-794-2588 internationally approximately ten minutes before the start of the call. The passcode will be 6598298.

A replay will be available through March 11, 2019 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 6598298.