Instil Bio Receives Orphan Drug Designation for ITIL-168 in Melanoma

On April 27, 2021 Instil Bio, Inc. ("Instil") (Nasdaq: TIL) reported that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV with its ITIL-168 TIL therapy (Press release, Instil Bio, APR 27, 2021, View Source [SID1234583993]).

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"The Orphan Drug Designation incentivizes biotech companies to develop new therapies that are important for patients. We are pleased to advance development of ITIL-168 for the treatment of melanoma stages IIB to IV with this designation," said Bronson Crouch, Chief Executive Officer of Instil.
Orphan Drug Designation confers potential benefits to sponsors, including tax credits for qualified clinical testing, waiver of BLA user fees, and eligibility of market exclusivity for 7 years upon marketing approval.

About ITIL-168

ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. ITIL-168 is manufactured with Instil’s proprietary, optimized, and scalable manufacturing process, which has been designed to capture and preserve the maximum diversity of each patient’s TILs; the manufacturing process also offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. Instil plans to investigate ITIL-168 in a global phase 2 trial in advanced melanoma in 2021 and additional solid tumor indications in Phase 1 clinical trials beginning in 2022.

Novartis First Quarter 2021

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Poseida Therapeutics to Present at American Society of Gene and Cell Therapy 2021 Annual Meeting

On April 27, 2021 Poseida Therapeutics, Inc. (NASDAQ: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported three data presentations to be delivered at the upcoming American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting, being held virtually May 11-14, 2021 (Press release, Poseida Therapeutics, APR 27, 2021, View Source [SID1234578669]).

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Poseida will present the following research at the 2021 ASGCT (Free ASGCT Whitepaper) Annual Meeting:

Oral Presentation
Title: Preclinical Evaluation of Combined Adeno-Associated Virus and Nanoparticle Delivery of piggyBac Transposon System for Durable Transgene Expression in the Growing Neonatal Murine Liver
Session Date/Time: Tuesday, May 11, 2021, 5:45pm – 6:00pm ET
Abstract Number: 30

Poster Presentations
Title: P-BCMA-ALLO1 — A Fully Allogeneic Stem Cell Memory T Cell (TSCM) CAR-T Therapy Targeting BCMA for the Treatment of Multiple Myeloma Shows Potent Anti-Tumor Activity
Session Date/Time: Tuesday, May 11, 2021, 8:00am – 10:00am ET
Abstract Number: 789

Title: Anti-c-kit CAR-T Cells Afford Effective Eradication of Human AML and Normal Hematopoietic Cells in a Preclinical Model of Safer Non-Genotoxic Stem Cell Transplant Conditioning
Session Date/Time: Tuesday, May 11, 2021, 8:00am – 10:00am ET
Abstract Number: 715

Sangamo Therapeutics Announces First Quarter 2021 Conference Call and Webcast

On April 27, 2021 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the Company has scheduled the release of its first quarter 2021 financial results after the market closes on Tuesday, May 4, 2021 (Press release, Sangamo Therapeutics, APR 27, 2021, View Source [SID1234578666]). The press release will be followed by a conference call at 5:00 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide business updates.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5714729. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5714729.

Calliditas Therapeutics’ 2020 Annual Report Published

On April 27, 2021 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) reported that the Annual Report for 2020 now is available at the company’s website: www.calliditas.com (Press release, Calliditas Therapeutics, APR 27, 2021, View Source [SID1234578599]).

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This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 14:30 CET on April 27, 2021.