On April 17, 2019 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported several presentations at the upcoming 2019 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting that will be held from April 29 to May 2, 2019 in Washington, DC (Press release, Cellectis, APR 17, 2019, View Source [SID1234535172]). Details on date and times of presentations can be found below.

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An oral presentation will demonstrate the potential of UCARTCS1A as a treatment approach for patients with Multiple Myeloma. This presentation follows the recent clearance of the UCARTCS1A IND by the FDA, IRB approvals as well as clinical batch release.

A poster presentation will showcase Cellectis’ allogeneic CAR T-cell manufacturing expertise, focusing on a novel, straightforward and efficient strategy to generate Universal CAR T-Cells. This exemplifies how Cellectis’ cutting-edge gene editing and cell engineering capabilities can be leveraged to improve key features of our product candidates.

Furthermore, Julianne Smith, Ph.D., Vice President of Translational Sciences, will be participating in a corporate review session at the Gene Editing Workshop on Sunday, April 28, 2019 from 5:00 PM to 6:00 PM EDT. Julianne will also be giving a presentation entitled "Allogeneic Gene-Edited CAR T-Cells: From Preclinical to Clinical Proof of Concept" on Tuesday, April 30 from 8:00 AM to 8:30 AM EDT during the Scientific Symposium "Towards the Holy Grail of Cancer Gene Therapies: Universal Cells, Targeted Vectors and Solid Tumor CART Efficacy".

Finally, Philippe Duchateau, Ph.D., Chief Scientific Officer of Cellectis, will be participating in the Scientific Symposium "Innovation in First Time in Human Study Clinical Studies" held on Monday, April 29 with a presentation titled "Universal Gene-Edited CAR T-Cell Immunotherapy" from 9:30 AM to 10:00 AM EDT.

Oral presentation details:

UCARTCS1A: Allogeneic CAR T-Cells Targeting CS1 as Treatment for Multiple Myeloma
Roman Galetto1, Rohit Mathur2, Mathilde Dusseaux1, Isabelle Chion-Sotinel1, Jing Yang2, Diane Le Clerre1, Stephanie Filipe1, Sattva Neelapu2, Julianne Smith3, Agnès Gouble1

1Cellectis SA, Paris, France
2MD Anderson Cancer Center, Houston, TX, USA
3Cellectis Inc, New York, NY, USA

Monday, April 29 – 3 :45 PM – 4 :00 PM EDT
CAR-T Cell Therapies for Cancer Session
Room: International Ballroom West
Abstract Number: 139

Poster presentation details:

A Straightforward and Efficient Strategy to Generate Universal CAR T-Cells
Alexandre Juillerat1, Ming Yang1, Diane Tkach1, Mohit Sachdeva1, Alex Boyne1, Julien Valton1, Laurent Poirot2, Philippe Duchateau2

1Cellectis, Inc., 430E, 29th street, New York, NY 10016, USA
2Cellectis, 8 rue de la croix Jarry, 75013 Paris, France

Wednesday, May 1 – 5 :00 PM – 6 :00 PM EDT
Cell Therapies III Session
Room: Columbia Hall
Abstract Number: 874

Abstracts are available on the ASGCT (Free ASGCT Whitepaper) website. The two abstract presentations (oral and poster) to be presented at the 2019 ASGCT (Free ASGCT Whitepaper) Annual Meeting will be available on the Cellectis website after May 1, 2019.

On April 17, 2019 Exelixis, Inc. (NASDAQ: EXEL) reported that its first quarter 2019 financial results will be released on Wednesday, May 1, 2019 after the markets close (Press release, Exelixis, APR 17, 2019, View Source [SID1234535171]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 4774486 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on May 3, 2019. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 4774486. A webcast replay will also be archived on www.exelixis.com for one year.

On April 17, 2019 ArQule, Inc. (Nasdaq: ARQL) reported it will report financial results for the first quarter of 2019 before the market opens on Wednesday, May 1, 2019 (Press release, ArQule, APR 17, 2019, View Source [SID1234535170]). The Company will hold a conference call and webcast on the same day at 9:00 a.m. ET to discuss these results and provide a general business update.

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The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

On April 17, 2019 AngioDynamics, Inc. (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that the Company received central Institutional Review Board (IRB) approval to conduct its NanoKnife Irreversible Electroporation "Direct IRE Cancer Treatment" clinical study (DIRECT). The IRB approval closely follows the United States Food and Drug Administration’s (FDA) approval of AngioDynamics’ investigational device exemption (IDE) application announced on April 1 (Press release, AngioDynamics, APR 17, 2019, View Source [SID1234535169]).

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Today’s approval enables AngioDynamics to accelerate its engagement with local IRBs and marks a significant milestone in the process of making Irreversible Electroporation (IRE) available to patients through the DIRECT clinical study. The Western IRB (WIRB) will serve as AngioDynamics’ IRB of record for the DIRECT clinical study.

"AngioDynamics is committed to providing physicians and patients with additional options for the treatment of Stage III pancreatic cancer. The DIRECT IRB approval demonstrates our commitment to initiating this next-generation clinical study as quickly as possible to advance our pursuit of innovative, lifesaving treatments," said Brent Boucher, AngioDynamics Senior Vice President and General Manager of Oncology.

AngioDynamics’ DIRECT clinical study features a comprehensive data collection strategy that will provide meaningful clinical information to healthcare professionals, support a regulatory indication for the treatment of Stage III pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians. The next-generation study is classified as a Category B IDE by the FDA, allowing participating sites to obtain coverage for procedures performed as well as related routine costs.

The DIRECT clinical study comprises a Randomized Controlled Trial (RCT) at up to 15 sites, as well as a Real-World Evidence (RWE), next-generation registry at up to 30 sites, each with a NanoKnife System treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival.

As part of the DIRECT clinical study, AngioDynamics launched AngioDIRECT.com to facilitate the enrollment of participants. The online platform provides patients and their families with information about pancreatic cancer and details about the study. It also features a physician locator to help prospective participants and referring healthcare professionals identify clinical study locations.

The DIRECT clinical study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer.

On April 17, 2019 Cell Medica, a leader in next-generation cellular immunotherapies for the treatment of cancer, reported that its collaborators from Baylor College of Medicine and Texas Children’s Hospital will be presenting the latest progress related to its innovative CAR therapy utilizing natural killer T cells (CAR-NKT) at the upcoming 22nd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) April 29 – May 2 in Washington, D.C (Press release, Cell Medica, APR 17, 2019, View Source [SID1234535168]).

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Chris Nowers, Cell Medica’s CEO, said: "Our next-generation CAR-NKT platform combines the unique natural antitumor properties of NKT cells with innovative CAR constructs, enabling the possibility of producing multiple highly tumor-specific therapeutic products. We believe this approach could open up the broad potential of NKT cells to serve as a basis for off-the-shelf cell therapies targeting both solid and hematological tumors. We look forward to the important new updates that our collaborators at Baylor and Texas Children’s Hospital will be sharing at ASGCT (Free ASGCT Whitepaper)."

Details of the three oral presentations:

Harnessing Natural and Engineered Properties of iNKT Cells for Adoptive Cancer Immunotherapy
Presenter: Dr. Leonid Metelitsa, Professor of Pediatrics, Hematology-Oncology, Baylor College of Medicine
Session Title: NK cells Versus iNKT cells (Education Session)
Session Date/Time: Monday Apr 29, 2019 1:30 PM – 3:00 PM
Presentation Time: 1:30 PM – 2:00 PM
Room: Georgetown

NKT Cells Co-expressing a GD2-specific Chimeric Antigen Receptor and IL-15 Show Enhanced In Vivo Persistence and Antitumor Activity Against Neuroblastoma
Presenter: Dr. Andras Heczey, Assistant Professor of Pediatrics, Hematology-Oncology, Baylor College of Medicine
Session Title: Oral Abstract Session V
Session Date/Time: Tuesday Apr 30, 2019 8:00 AM – 10:00 AM
Presentation Time: 8:15 AM – 8:30 AM
Final abstract number: 367
Room: Heights Courtyard 3

Development of an Allogeneic Universally Tolerated NKT Cell Platform for Off-the-Shelf Cancer Immunotherapy
Presenter: Dr. Leonid Metelitsa, Professor of Pediatrics, Hematology-Oncology, Baylor College of Medicine
Session title: Cancer Gene Therapy
Session Date/Time: Wednesday May 1, 2019 3:45 PM – 5:30 PM
Presentation Time: 5:00 PM – 5:15 PM
Final abstract number: 682
Room: Monroe

The full abstracts can be accessed at: View Source

– ENDS –

Notes to Editors

About ASGCT (Free ASGCT Whitepaper)

The American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting provides an international forum where the latest gene and cell therapy developments are presented and critically discussed. As the leading American conference focusing solely on gene and cell therapy, ASGCT (Free ASGCT Whitepaper)’s annual meeting brings together more than 3,400 professionals including scientists, physicians, and patient advocates.

Find out more at: View Source

Media registration is open at: View Source

About GINAKIT2

GINAKIT2 is a first-in-human, dose escalation evaluation of CMD-501 in children with relapsed or refractory (R/R) high risk neuroblastoma (NCT03294954). Neuroblastomas occur primarily in children and account for 7-10 percent of all pediatric cancers. Ninety percent of patients are younger than 5 years at diagnosis. R/R high risk neuroblastoma is one of the deadliest types of childhood cancer and the current median survival is around 1-3 years. Almost all neuroblastomas express GD2, which is targeted by CMD-501. This study is supported by a grant from Alex’s Lemonade Stand Foundation (ALSF), awarded to Baylor College of Medicine investigators, Drs. Heczey and Metelitsa.