RCS - Hemogenyx Pharma Plc - HEMO-CAR-T Analytical Release Tests Completed

Hemogenyx PharmaceuticalsAnnouncement

23/03/2023 13:45

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230323:nRSW0547Ua&default-theme=true

RNS Number : 0547U  Hemogenyx Pharmaceuticals PLC  23 March 2023

23 March 2023

 

RNS Reach - Non-Regulatory

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

HEMO-CAR-T Analytical Release Tests Completed

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group
developing new therapies and treatments for deadly blood diseases, is pleased
to announce the successful completion of a full set of analytical tests
required to verify the quality of the cells manufactured during three Process
Qualification ("PQ") runs of the end-to-end process for HEMO-CAR-T production.
Each PQ run is an end-to-end process of the manufacture of HEMO-CAR-T cells.
The PQ runs were carried out in the Company's current Good Manufacturing
Practice ("cGMP") compliant clean rooms. They were followed by analytical
release tests that were conducted both by the Company and a third party to
ensure that manufactured HEMO-CAR-T cells comply with a set of required
quality attributes. Among these attributes are viability, potency and
sterility of the manufactured HEMO-CAR-T cells.

 

The completion of the full set of analytical tests of all PQ runs is the last
manufacturing requirement that is necessary for the submission of an
Investigational New Drug ("IND") application to the US Food and Drug
Administration ("FDA"), which is now in the course of preparation. The IND is
needed to obtain authorization from the FDA to commence Phase I clinical
trials of HEMO-CAR-T. All PQ runs as well as analytical tests data will be
compiled for inclusion in the IND submission pack.

 

 

Enquiries:

 

 Hemogenyx Pharmaceuticals plc                                   https://hemogenyx.com (https://hemogenyx.com/)
 Dr Vladislav Sandler, Chief Executive Officer & Co-Founder      headquarters@hemogenyx.com (mailto:headquarters@hemogenyx.com)
 Peter Redmond, Director                                         peter.redmond@hemogenyx.com (mailto:peter.redmond@hemogenyx.com)

 SP Angel Corporate Finance LLP                                  Tel: +44 (0)20 3470 0470
 Matthew Johnson, Vadim Alexandre, Adam Cowl

 Peterhouse Capital Limited                                      Tel: +44 (0)20 7469 0930
 Lucy Williams, Duncan Vasey, Charles Goodfellow

 

 

About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO)
headquartered in London, with its US operating subsidiaries, Hemogenyx
Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its
state-of-the-art research facility.

 

The Company is a pre-clinical stage biopharmaceutical group developing new
medicines and treatments to treat blood and autoimmune disease and to bring
the curative power of bone marrow transplantation to a greater number of
patients suffering from otherwise incurable life-threatening diseases.
Hemogenyx Pharmaceuticals is developing several distinct and complementary
product candidates, as well as platform technologies that it uses as engines
for novel product development.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAXXLFLXXLXBBB