Full Press Release Details
Enters Strategic Collaboration Agreement with Clinical Stage Cell Therapy Company
Celularity World-class Manufacturing Capabilities
PARK, N.J., February 24, 2025 (GLOBE NEWSWIRE) - Celularity Inc. (Nasdaq: CELU) ("Celularity" or the "Company"),
a cellular and regenerative medicine company, today announced that it has entered into a Master Services Collaboration Agreement with
BlueSphere Bio, Inc. (BSB) covering manufacturing activities for certain BSB cell therapy products. This collaboration is the
second of its kind for Celularity and demonstrates the Company's ability to leverage its world class cGMP manufacturing infrastructure
and deep expertise to attract clients like BSB, who are seeking differentiated alternatives to manufacture their therapeutic products
in an ever-changing landscape. This collaboration further evidences the revenue generating potential of Celularity's assets.
The Collaboration Agreement will initially focus
on the production of BSB's novel T cell receptor (TCR) T cell therapies using the technical and manufacturing capabilities at Celularity's
Florham Park, NJ, cGMP-ready facility. This collaboration will extend to all aspects of cell therapy manufacturing including Chemistry,
Manufacturing and Controls (CMC), Quality Assurance and Quality Control. As part of this Collaboration, Celularity will dedicate staff
and a small portion of its 37,000 square foot commercial manufacturing footprint. In coordination with Celularity
management, BSB and its team will have oversight over production of its second cell therapy product for the treatment
of Acute Myelogenous Leukemia (AML) both in the U.S. and abroad.
J. Hariri, M.D., Ph.D., Celularity CEO and Chair, said, "We are delighted to announce this important collaboration, which will
bring together our core strengths in cell manufacturing, process development and BSB's development of novel cell therapies to treat
high risk leukemias. Celularity has invested significant capital in its manufacturing and development infrastructure, with a vision to
not only support its own programs, but to create a collaborative business model for companies like BSB, to leverage Celularity's technical
capabilities. This new relationship with BSB further realizes that objective and helps set the stage for future clients seeking transformative
alternatives for any GMP manufacturing needs."
Keir Loiacono, CEO of BlueSphere noted, "Reliable
and flexible manufacturing are critical to a successful cell therapy program. The quality of Celularity's business model and
facility will provide BlueSphere with the necessary tools to advance our assets to the clinic in an affordable fashion, without relinquishing
control over our processes. The team at Celularity has been welcoming and open to addressing all our needs, and we look forward to
Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and
allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing
the placenta's unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global
needs for effective, accessible, and affordable therapies. For more information, visit www.celularity.com.
BlueSphere Bio is a drug development company with
two near-term clinical assets in AML. BSB-1001 is a TCR T cell therapy targeting the minor histocompatibility antigen-1 (HA-1) and is
the first clinical candidate in the TCX-101 clinical program. Under the TCX-101 clinical program, BSB-1001 will be dosed simultaneously
with allogeneic hematopoietic stem cell transplant in patients with high-risk AML. BlueSphere anticipates dosing its first patient
in the TCX-101 program in 1H2025. BSB has also discovered and nominated three additional miHA targeting TCRs for clinical development,
all for use in the same clinical setting as BSB-1001.
In addition to TCX-101, BSB has further
broadened its AML therapy pipeline to address an additional subset of patients by discovering and nominating a lead TCR reactive against
mutant NPM-1 for the TCX-102 program. The TCX-102 program will be autologous and not given in combination with stem cell transplant.
An IND is expected in the second quarter of 2025.
press release includes "forward-looking statements" (as defined under Federal securities laws). All statements other than
statements of historical facts are "forward-looking statements," including those relating to future events. In some cases,
you can identify forward-looking statements by terminology such as "anticipate," "believe," "can,"
"could," "expect," "forecast," "may," "plan," "project," "should,"
"will," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances).
Forward-looking statements are based on Celularity's current expectations and assumptions. Because forward-looking statements relate
to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated
by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance.
Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those
risk factors set forth under the caption "Risk Factors" in Celularity's annual report on Form 10-K filed with the Securities
and Exchange Commission (SEC) on July 30, 2024, and other filings with the SEC. If any of these risks materialize or underlying assumptions
prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional
risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results
to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity's
current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments
could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity's
views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether
because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Vice President, Celularity Inc.