On June 14, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase biology platform, reported that new findings from its platform will be presented in a poster today at the Keystone Symposia Tissue Fibrosis and Repair: Mechanisms, Human Disease and Therapeutics in Keystone, CO (Press release, aTyr Pharma, JUN 14, 2022, View Source [SID1234615971]).

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The poster presents findings from aTyr’s innovative tRNA synthetase platform, whereby selected fragments of Alanyl-tRNA Synthetase (AARS) and Aspartyl-tRNA Synthetase (DARS) were found to bind to the surface of specific human cell types via novel binding partners. Additionally, the target receptor of the fragment AARS-1 was identified as fibroblast growth factor receptor 4 (FGFR4), indicating that AARS-1 may have therapeutic potential in fibrosis, inflammation and cancer. Moreover, the methods utilized in the study can be further employed to identify and validate new molecular targets from aTyr’s tRNA synthetase platform.

Details of the poster presentation appear below. The poster will be available on the aTyr website once presented.

Title: Identification of key extracellular binding proteins implicate role in inflammation and fibrosis for alanyl- and aspartyl-tRNA synthetases
Authors: Ryan A. Adams, Tarsis F. Brust, Yeeting E. Chong, Ann L. Menefee, Andrew Imfeld, Michaela Ferrer, Zachary Fogassy, Alison G. Barber, Suzanne Paz, Leslie A. Nangle. aTyr Pharma, San Diego.
Poster Number: 2022
Poster Session: Poster Session 2
Date: Tuesday, June 14, 2022

"We are very pleased that our novel approach to drug discovery has yielded the identification of a receptor target for yet another tRNA synthetase from our platform," said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. "The target receptor identified for the fragment AARS-1, FGFR4, is involved in many cellular processes including cell proliferation, differentiation and tissue repair. FGFR4 is known to play a role in diseases related to inflammation and fibrosis, including conditions where unchecked fibrosis can precede the development of certain cancers. We look forward to further interrogating the interaction between AARS-1 and FGFR4 and the implications for disease in order to explore this synthetase fragment as a potential pipeline candidate.

On June 14, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the management team will participate in and attend one-on-one meetings at three investor conferences in June 2022 as follows (Press release, Gracell Biotechnologies, JUN 14, 2022, View Source [SID1234615987]):

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Goldman Sachs Virtual Healthcare Corporate Day

One-on-one meetings: June 20 – 24

Truist Securities Cell Therapy Symposium – symposia-cel (in person)

One-on-one meetings: June 28
Location: New York, NY

Stifel 2022 Virtual Cell Therapy Summit

Panel: June 30 at 11:30 am ET
Corporate Panel: Allogeneic CAR-T – What Have We Learned, and Where are We Going

On June 14, 2022 Patrys reported the publication of new data from a series of studies by our collaborators Dr James Hansen, of Yale School of Medicine and Dr Kim O’Sullivan, of Monash University, showing that PAT‑DX1 suppresses the formation of neutrophil extracellular traps (NETs), which may reduce metastasis in some cancers (Press release, Patrys, JUN 14, 2022, View Source [SID1234615955]).

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The paper, which is published in the peer-reviewed journal ImmunoHorizons, is the first study showing that PAT-DX1 may be used to regulate the formation of NETs, which are believed to contribute to immunity, inflammation and the pathophysiology of various inflammatory diseases and some cancers.

Patrys CEO and MD, Dr. James Campbell said:

"This is an unexpected and important discovery for Patrys, offering mechanistic rationale to the previously-described ability of PAT-DX1 to reduce cancer spread by metastasis, and opening the door to broader uses of deoxymabs in non-cancer indications, particularly chronic inflammatory conditions that are driven by NET formation."

On June 14, 2022 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Dr. Reddy’s Sorafenib Tablets, USP, 200 mg, a therapeutic generic equivalent of Nexavar (sorafenib) Tablets in the U.S. market following the approval by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, JUN 14, 2022, View Source [SID1234615972]).

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"We are pleased to launch this important generic product, illustrating our continued commitment to bring affordable generic medicines to market for patients," says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories Inc.

Dr. Reddy’s Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.

Please click here: View Source to see the full prescribing information.

Nexavar is a trademark of Bayer HealthCare Pharmaceuticals Inc.

RDY-0522-415

On June 14, 2022 Cellenkos, Inc., a privately held, clinical stage biotech company that focuses on developing transformative T regulatory cell therapies for rare inflammatory diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1b, open-label study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib (Press release, Cellenkos, JUN 14, 2022, View Source [SID1234615988]).

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CK0804 is a novel allogeneic, CXCR4 enriched, T regulatory cell therapy product that utilizes Cellenkos’ proprietary CRANE technology to generate disease specific products. This Phase 1b clinical trial is being launched in partnership with Incyte as part of their LIMBER initiative (Leading in MPNs Beyond Ruxolitinib). The study (LIMBER-TREG108) will examine the safety of monthly doses of CK0804 as add on therapy in myelofibrosis patients who will continue treatment with ruxolitinib.

"We are thrilled to have received IND clearance for our CK0804 program in myelofibrosis, marking our fourth IND Clearance as a company and our second hematological malignancy program to reach clinical development," said Tara Sadeghi, Chief Operating Officer of Cellenkos Inc. "Clearance of this IND is a testament to the quality preclinical data supporting CK0804 through our internal R&D and our ongoing partnership with the University of Texas at MD Anderson Cancer Center as well as the strong chemistry, manufacturing, and control (CMC) and cGMP manufacturing capabilities we have developed internally. Our clinical development plans across multiple disease processes utilizes our proprietary CRANE technology that allows for us to create disease specific T regulatory cell therapeutics supporting our rich pipeline. We are excited by the promise of CK0804 to offer a potentially transformative treatment for myelofibrosis patients."

"We are pleased to be partnering with Cellenkos to initiate this new LIMBER study evaluating CK0804 and ruxolitinib as we continue to explore new treatment options for patients with myelofibrosis," said Ekaterine Asatiani, M.D., Division Vice President and Head of Early Development at Incyte.

About Myelofibrosis
Myelofibrosis is a rare, chronic and progressive blood cancer that is part of a group of diseases known as myeloproliferative neoplasms. In myelofibrosis, scar tissue forms in the bone marrow and impairs its ability to produce normal blood cells. This can result in an enlarged spleen, as well as symptoms such as fatigue, itching and night sweats, which can severely impact a patient’s quality of life. About 16,000 to 18,500 people in the U.S. are living with myelofibrosis. Patients who have had a suboptimal response to the standard of care treatment using ruxolitinib have limited options and a poor prognosis.

About CK0804
CK0804 is a novel allogenic cell therapy product consisting of T-regulatory cells that exploit the CXCR4/CXCL12 axis and are derived from clinical-grade umbilical cord blood units and manufactured using Cellenkos’ proprietary CRANE process. Multiple doses of CK0804 can be manufactured from a single umbilical cord blood unit, where the final cryopreserved product is readily available for use. No requirement for HLA matching to the patients makes CK0804 an ideal therapy that can be infused intravenously, in the outpatient setting.

About Ruxolitinib (Jakafi)
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.