REG - Hemogenyx Pharma Plc - Ultrafast CAR-T Manufacturing

Hemogenyx PharmaceuticalsAnnouncement

19/12/2024 07:00

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RNS Number : 6677Q  Hemogenyx Pharmaceuticals PLC  19 December 2024

19 December 2024

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

 

Ultrafast CAR-T Manufacturing

 

Collaboration with Kure.ai to develop ultrafast CAR-T manufacturing process
for Hemogenyx Pharmaceuticals' AML Treatment

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical company
developing innovative therapies for blood malignancies, and Kure.ai ("Kure"),
a leader in ultrafast CAR-T manufacturing technology, are pleased to announce
a strategic collaboration to advance the production of CAR-T cell therapies
for acute myeloid leukemia (AML) and a subset of acute lymphoblastic leukemia
(ALL).

This partnership aims to integrate Kure's ultrafast manufacturing (UM)
technology with Hemogenyx Pharmaceuticals's proprietary CAR-T therapy, HG-CT-1
(formerly known as HEMO-CAR-T) to enable faster, more efficient production of
CAR-T cells, significantly reducing manufacturing timelines while maintaining
therapeutic potency.

Key Highlights of the Collaboration

1.   Clinical Study:
Hemogenyx Pharmaceuticals will initiate a clinical study to evaluate its CAR-T
therapy for AML and KMT2A-rearranged ALL, utilizing Kure's UM process.

2.   Process Development:
Both parties will collaborate on developing a customized UM process for
Hemogenyx Pharmaceutical's CAR-T therapy, optimizing its application in AML
treatment.

3.   Material and Expertise Sharing:

Hemogenyx Pharmaceuticals will provide critical materials, including
lentiviral vectors, and necessary technical know-how to facilitate process
development.

4.   In Vitro Testing:

Hemogenyx Pharmaceuticals will conduct in vitro testing to assess the potency
and vector copy number (VCN) of CAR-T cells manufactured using Kure's
ultrafast platform.

5.   Adaptation of Manufacturing Technology:

Kure will adapt and refine its ultrafast CAR-T manufacturing process
specifically to the Company's CAR-T therapy requirements.

6.   Licensing Option:
Upon successful completion of process development, Hemogenyx Pharmaceuticals
will have the option to license Kure's UM technology for clinical trial
production, with licensing terms to be negotiated.

 

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:
"One of the most significant challenges in CAR-T therapy is the time and cost
associated with manufacturing. Our partnership with Kure.ai allows us to
explore and integrate a cutting-edge ultrafast manufacturing process that has
the potential to revolutionize CAR-T production. This collaboration is an
important step toward accelerating patient access to life-saving therapies."

 

Dr. David Wald, Founder of Kure.ai and Professor at Case Western Reserve
University, added:

"We are excited to partner with Hemogenyx Pharmaceuticals to adapt our
ultrafast manufacturing platform to their innovative CAR-T therapy. This
collaboration not only advances next-generation CAR-T solutions but also
demonstrates the real-world clinical utility of our technology in addressing
urgent unmet medical needs."

 

About AML and CAR-T Therapy

AML, the most common type of acute leukemia in adults, has poor survival rates
(a five-year survival rate of less than 30% in adults) and is currently
treated using chemotherapy, rather than the potentially more benign and
effective forms of therapy being developed by Hemogenyx Pharmaceuticals. The
successful development of a new therapy for AML would have a major impact on
treatment and survival rates for the disease.

CAR-T therapy is a treatment in which a patient's own T-cells, a type of
immune cell, are modified to recognize and kill the patient's cancer cells.
The procedure involves: isolating T-cells from the patient; modifying the
isolated T-cells in a laboratory using a CAR gene construct (which allows the
cells to recognize the patient's cancer); amplifying (growing to large
numbers) the newly modified cells; and re-introducing the cells back into the
patient.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been inside
information for the purposes of Article 7 of Regulation No 596/2014 (as it
forms part of UK domestic law by virtue of the European Union (Withdrawal) Act
2018) until the release of this announcement. The person responsible for
arranging for the release of this announcement on behalf of Hemogenyx
Pharmaceuticals plc is Dr Vladislav Sandler, Chief Executive Officer &
Co-Founder.

 

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 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 a platform technology that it uses as an engine
for novel product development.

About Kure.ai

Kure.ai is a clinical stage privately owned biotechnology company specializing
in ultrafast CAR-T manufacturing technology. Founded by Dr. David Wald, a
professor at Case Western Reserve University, Kure focuses on optimizing CAR-T
production timelines while maintaining therapeutic quality and efficacy.

 

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