On May 5, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported that it will share preclinical data at the International Society for Cell & Gene Therapy (ISCT) 2022, being held in San Francisco, CA, May 4-7, 2022 on GDA-301 and GDA-601, two product candidates in the Company’s NAM-enabled genetically modified natural killer (NK) pipeline (Press release, Gamida Cell, MAY 5, 2022, View Source [SID1234613700]).

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"The preclinical data generated from our expanding pipeline of NAM-enabled cell therapies is already showing signs of meaningful potential as a future approach to fighting cancer," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "With evidence of enhanced cytotoxicity demonstrated across hematologic cancers and solid tumors with these diverse, genetically modified NK cell immunotherapy programs, we look forward to continuing our progress toward opening new frontiers in cancer immunotherapy."

GDA-301 is an investigational genetically modified NAM-NK cell therapy candidate aimed at targeting hematologic malignancies and solid tumors. The poster (#501), titled "GDA-301: Engineered NAM-NK Cells via CISH Knockout and Membrane-Bound IL-15 Expression Increases Cytotoxicity Against Malignancies," demonstrated that after six hours of co-culture with a chronic myelogenous leukemia (K562) or multiple myeloma (RPMI) cell line, GDA-301, a combined genetic manipulation of CISH gene editing and the engineered expression of mb IL-15, showed increased cytotoxicity compared with control NAM-NK cells. Additional in vitro assays showed elevation of degranulation marker CD107a, and intracellular proinflammatory cytokines interferon-γ and tumor necrosis factor-α, suggesting increased potency of GDA-301 compared with control. The potency and cytotoxicity data suggest that GDA-301 represents a novel potential immunotherapeutic targeting hematologic malignancies as well as solid tumors.

The poster on GDA-301 was selected for presentation at the conference’s Elevator Pitch Session 2 on Thursday, May 5, 2022 at 6:00 p.m. EST/3:00 p.m. PST – 7:00 p.m. EST/4:00 p.m. PST.

GDA-301 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

GDA-601 is an investigational genetically engineered NAM-NK cell therapy candidate designed to target multiple myeloma (MM) cells. The poster (#517), titled "GDA-601: NAM-NK Cells With CD38 Knockout Expresses Enhanced CD38 Chimeric Antigen Receptor and Targets Multiple Myeloma Cells With Increased Cytotoxicity," showed that in vitro killing assays performed six hours after co-culture of GDA-601 with a MM (RPMI) cell line showed increased cytotoxicity compared with control NAM-NK cells. Fratricide attributable to CD38 antigen was effectively eliminated with GDA-601. There was a significant enhancement of potency against CD38-positive MM cells demonstrated by elevation of the degranulation marker CD107a and intracellular proinflammatory cytokines interferon-γ and tumor necrosis factor-α in vitro. These results suggest that GDA-601 displays superior antitumoral responses against MM cells and represent a promising adoptive cell therapeutic strategy against MM.

Both posters will be presented on Thursday, May 5, 2022 at Poster Session 2, at 5:45 p.m. EST/2:45 p.m. PST – 7:15 p.m. EST/4:15 p.m. PST.

GDA-601 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

For more information, please visit isctglobal.org.

About NAM Technology

Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

On May 5, 2022 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, reported that it has entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of registered securities of the Company in a registered direct offering for gross proceeds to Aeglea of approximately $45 million, prior to deducting placement agent fees and estimated offering expenses (Press release, Aeglea BioTherapeutics, MAY 5, 2022, View Source [SID1234613699]). The financing includes participation from Bain Capital Life Sciences, LP, Great Point Partners, LLC, clients of Nantahala Capital Management, Sio Capital Management, LLC and other institutional investors.

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The financing includes 10,752,688 shares of the Company’s common stock at a price of $1.60 per share and pre-funded warrants to purchase 17,372,397 shares of common stock, at a price of $1.5999 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 exercise price for each pre-funded warrant. The offering is expected to close on or about May 9, 2022, subject to customary closing conditions.

JonesTrading Institutional Services LLC is acting as placement agent for the registered direct offering.

The shares of common stock and pre-funded warrants were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-239706), which was declared effective by the United States Securities and Exchange Commission ("SEC") on July 14, 2020. The Company intends to use the proceeds from the offering, together with its existing cash resources, to fund the Company’s activities related to our ongoing Biologics License Application submission for pegzilarginase and its potential commercialization in the United States for patients with Arginase 1 Deficiency, advance the clinical development of AGLE-177 through its Phase 1/2 clinical trial and prepare for a potential Phase 3 trial for the treatment of patients with Homocystinuria, and to advance AGLE-325 for Cystinuria through IND-enabling activities, and the remainder to fund continued research and development, manufacturing, working capital and general corporate purposes. The Company expects the net proceeds from this offering, together with its existing cash, cash equivalents, and marketable securities, to fund operations through the second quarter of 2023.

A prospectus supplement relating to the shares of common stock will be filed by the Company with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from JonesTrading Institutional Services LLC at [email protected].

On May 5, 2022 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the company will be showcasing and exhibiting its Focal One Robotic High Intensity Focused Ultrasound (HIFU) platform at the upcoming Annual Meeting of the American Urological Association (AUA), the largest gathering of urologists worldwide, which will be held May 13th through 15th in New Orleans (Press release, EDAP TMS, MAY 5, 2022, View Source [SID1234613698]).

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Focal One will be a featured topic at AUA, during both plenary presentations and instructional courses. Several notable presentations will be given by leading academic centers describing the growing clinical acceptance of the role of focal therapy in the management of prostate cancer. An AUA hands-on skills training will be teaching urologists how to implement focal treatments in their practice and will allow them to utilize Focal One under the guidance of expert faculty.

Ryan Rhodes, CEO of EDAP U.S., said, "We are very pleased to have such a notable presence at AUA, the most high-profile urology meeting of the year. Focal therapy is quickly becoming a necessary prostate cancer treatment option, and we are pleased that many highly regarded healthcare institutions will be on hand to describe their experience to date. We believe Focal One is the most advanced focal therapy platform available today, and we look forward to demonstrating this cutting-edge technology to the many urology thought leaders who will be in attendance."

Ongoing Focal One and ExactVu Micro-Ultrasound hands-on simulations will be provided to urologists at the EDAP Focal One booth (#117) throughout the meeting. ExactVu will be featured in two skill-enhancement workshops about the scientific evidence of microultrasound and the flexibility for transperineal or transrectal approaches.

On May 5, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, May 12, 2022 to provide a corporate update and discuss the Company’s financial results for the first quarter ended March 31, 2022 (Press release, Scynexis, MAY 5, 2022, View Source [SID1234613697]).

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A live audio webcast can be accessed by visiting the Investor Relations section of the Company’s website, www.scynexis.com. A replay of the webcast will be archived on the SCYNEXIS website for 90 days following the event.

On May 5, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported that Jonathan Drachman, M.D., Chief Executive Officer, will participate in two upcoming investor conferences (Press release, Neoleukin Therapeutics, MAY 5, 2022, View Source [SID1234613696]). Presentation details are as follows:

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BofA Securities 2022 Healthcare Conference – Las Vegas, NV

Fireside chat
Wednesday May 11, 2022, at 1:20 p.m. Pacific
H.C. Wainwright Global Investment Conference – Miami, FL

Company presentation
Wednesday, May 25, 2022, at 12:30 p.m. Eastern
The webcast presentations can be accessed from the investors section of the Neoleukin website at View Source Archived replays will also be available on the company website for at least 30 days following the event.