PR99761

Albumedix and Heartseed announce Recombumin(R) as a critical excipient in the manufacture of Heartseed's HS-001 investigational cell therapy as its first in-human trial commences

NOTTINGHAM, England, March 14, 2023 /PRNewswire=KYODO JBN/--

Albumedix Ltd ('Albumedix'), Nottingham, United Kingdom, now part of the global

life science group Sartorius, and Heartseed Inc ('Heartseed'), Tokyo, Japan,

Tuesday 14th March 2023, announce that Recombumin(R) is a critical component of

Heartseed's HS-001, an investigational cardiac remuscularization cell therapy

which has commenced first in human dosing.

- Recombumin, an animal and human origin free recombinant albumin, is an

excipient in the final formulation of Heartseed's HS-001 treatment.

- In February 2023, Heartseed announced successful dosing of HS-001 in their

phase I/II LAPiS trial.

- HS-001 is an innovative cardiac remuscularization cell therapy currently

under development, intended to treat patients suffering with advanced heart

failure.

Albumedix is a recognized global leader in the supply and development of

high-quality recombinant human albumin solutions, specialising in the

enablement of advanced therapies and next-generation biopharmaceuticals.

Collaboration between Albumedix and Heartseed supported the strategic

deployment of Recombumin as an integral excipient in the HS-001 therapy.

Recombumin's functional benefits are also leveraged to support the formation of

cardiomyocyte spheres and to offer enhanced cell viability during

transportation and distribution, which ultimately will support implementation

of the treatment in the clinic.

Albumedix and Heartseed's partnership on this project manifests Albumedix'

commitment to better health through its enablement of advanced therapies. The

high potential of Heartseed's novel HS-001 cell therapy has been recognised

through several awards that Heartseed have received in recognition of their

innovation.

Albumedix' Chief Executive Officer, Mr Jonas Skjodt Moller, reflecting on the

announcement said: "evolution is a hallmark of the advanced therapy space,

however, Heartseed's HS-001 therapy could mark a potential point of revolution.

We are exceptionally excited to see the successful outcome of our close

collaboration, which sees Recombumin used as a safe, consistent, and vital

component of HS-001's development. We are keen to empower excellence in the

creation of truly transformative biopharmaceuticals through our recombinant

human albumin products, and this milestone showcases the power of our

solutions, and our customers' trust in Albumedix".

Heartseed's CMO, Dr Takehiko Kaneko, added: "Heartseed is exceptionally proud

of the milestone that the commencement of our in-human trial marks for HS-001.

Building on the work of our founder and CEO, Dr Keiichi Fukuda, if successful,

our novel cardiac remuscularization therapy stands to revolutionize cardiac

medicine. Albumedix' near four decades of experience with recombinant albumin,

and their Recombumin portfolio, played an important role in supporting the

formulation and manufacture of this novel therapy. Our partnership with

Albumedix helps us towards our goal of advancing standards of care for patients

with heart failure."

Based in Nottingham, United Kingdom, Albumedix' partnership with Heartseed

spotlights the global scale of Albumedix' operations and underlines the

importance of international scientific collaboration in pursuit of better

health.

About Recombumin(R)

The Recombumin(R) product portfolio consists of commercially available,

high-quality, animal and human-origin-free recombinant human albumins.

Recombumin is a multi-functional excipient, ancillary and raw material, and its

stabilizing properties have been validated through long-established use in

multiple marketed life science products. Albumedix' highly pure, safe, and

consistent recombinant albumins support advanced therapies at every stage of

their journey from research and development to in-human application.

About Albumedix

Albumedix, now part of the life sciences group Sartorius, is an

innovation-focused biotechnology company, well recognized as a leader in

albumin-enabled solutions. With its mission dedicated to better health, over

its near four decades of commitment, Albumedix has supported its partners to

deliver safe doses globally, in both clinical development phase and marketed

therapeutics, to millions of patients. Albumedix' portfolio of solutions

includes the world's only USP-NF-compliant recombinant human albumin

(Recombumin(R)); client-centric services, and proprietary drug-enhancing

technology (Veltis(R)).

About Heartseed

Established in 2015, Heartseed has committed its knowledge and resources to

realising a regenerative therapy capable of supporting patients suffering from

heart failure. Heartseed's HS-001 therapy sees cardiomyocytes derived from

allogeneic iPS cells directly transplanted into cardiac tissue. Dr Keiichi

Fukuda MD PhD FACC first reported on generating cardiomyocytes from iPS cells

in 1999; the progression of Heartseed's treatment HS-001 to a human trial marks

a new phase in Heartseed's journey and brings the organization closer to

changing the world with regenerative medicines.

Logo - https://mma.prnewswire.com/media/2030583/Albumedix_Logo.jpg

SOURCE: Albumedix