Instituto de Biologia Molecular e Celular

Celularity Announces Commercial Biomaterial Products Receive Saudi Food and Drug Authority (SFDA) Product Classification

Retrieved on: 
Wednesday, October 18, 2023
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FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia. The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:

Key Points: 
  • FLORHAM PARK, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies and advanced biomaterial products, today announced that its Halal Certified biomaterial products have been classified by the Saudi Food and Drug Authority (SFDA) as “Minimally Manipulated Biological Products” for importation license purposes in the Kingdom of Saudi Arabia.
  • The SFDA independently reviewed and issued classifications for each of the following Celularity Halal Certified biomaterial products:
    Biovance®, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy.
  • Biovance® is an intact, extracellular matrix structure that provides a natural scaffold to support the body’s wound-healing process.
  • “The SFDA’s Minimally Manipulated Biological Product classification establishes a clear regulatory pathway for the importation of our Halal Certified biomaterial products into Saudi Arabia,” said Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and Founder of Celularity.

Celularity Announces Multi-Year Research Collaboration Services Agreement With Regeneron

Retrieved on: 
Tuesday, August 29, 2023
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Celularity to provide research support for Regeneron's targeted, allogeneic, chimeric antigen receptor (CAR) T-cell therapy

Key Points: 
  • Celularity to provide research support for Regeneron's targeted, allogeneic, chimeric antigen receptor (CAR) T-cell therapy
    FLORHAM PARK, N.J., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing allogeneic cell therapies and biomaterial products, announced today a multi-year Research Collaboration Services Agreement with Regeneron Pharmaceuticals, Inc. (Regeneron) to support the research of Regeneron’s allogeneic cell therapy candidates.
  • The agreement’s initial focus is the research on a targeted allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy owned by Regeneron designed to enhance proliferation and potency against solid tumors.
  • The research will take place at Celularity’s state-of-the-art facility located in Florham Park, N.J. Financial terms were not disclosed.
  • “The agreement with Regeneron announced today is an important milestone for Celularity that recognizes our expertise in the research of cellular therapies, including the engineering of CAR-T cells.

Global Allogeneic Cell Therapy Market Trends and Forecasts, 2023-2035, Featuring 378 Companies and Unveiling Key Regional Opportunities - ResearchAndMarkets.com

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Friday, August 4, 2023
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The "Global Allogeneic Cell Therapy Market Trends and Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Allogeneic Cell Therapy Market Trends and Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering.
  • Allogeneic vs. Autologous Cell Therapy: Allogeneic cell therapy differs from autologous cell therapy, which uses a patient's own cells.
  • Geographical Market Share: North America is anticipated to capture over 60% of the global allogeneic cell therapy market share by 2035.
  • Key Companies: Key players in the allogeneic cell therapy market include Artiva Biotherapeutics, Allogene Therapeutics, Atara Biotherapeutics, Celularity, CRISPR Therapeutics, Fate Therapeutics, Mesoblast, Poseida Therapeutics, and more.

Molecular Templates Announces Executive Leadership Changes

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Wednesday, August 2, 2023
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AUSTIN, Texas, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology with potent differentiated mechanisms of action, today announced executive management changes to implement its next phase of development.

Key Points: 
  • AUSTIN, Texas, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology with potent differentiated mechanisms of action, today announced executive management changes to implement its next phase of development.
  • These appointments were made to better enable Molecular Templates to execute on its clinical and corporate objectives.
  • Dr. Grace Kim joined Molecular Templates in 2022 with 20 years of experience driving investor strategy, corporate strategy, and business development.
  • These management changes will help enable us to execute efficiently in the clinic and in our corporate goals,” said Eric Poma, PhD., Chief Executive and Chief Scientific Officer of Molecular Templates.

Celularity Inc. Announces $3 Million Registered Direct Offering

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Thursday, July 27, 2023
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The closing of the offering and sale of the Securities is expected to occur on or about July 31, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the offering and sale of the Securities is expected to occur on or about July 31, 2023, subject to the satisfaction of customary closing conditions.
  • A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.
  • This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No 333-266786) previously filed with the U.S. Securities and Exchange Commission (the "SEC").
  • A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov.

Celularity and Verséa Ophthalmics Announce Exclusive U.S. Commercialization Agreement to Distribute Biovance® and Biovance® 3l Ocular For Ophthalmic Applications

Retrieved on: 
Thursday, July 27, 2023
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BIOVANCE® and BIOVANCE® 3L Ocular, which are single-layer and three-layer (3L) allografts, respectively, are intended for use as a biological membrane covering that provides an extracellular matrix.

Key Points: 
  • BIOVANCE® and BIOVANCE® 3L Ocular, which are single-layer and three-layer (3L) allografts, respectively, are intended for use as a biological membrane covering that provides an extracellular matrix.
  • BIOVANCE® 3L Ocular is acellular and consists of three layers of an amniotic membrane that supports treatment of advanced ocular surface disease.
  • As a barrier membrane, BIOVANCE® 3L Ocular is intended to protect the underlying tissue and preserve tissue plane boundaries.
  • “We are excited to partner with Verséa Ophthalmics to distribute our BIOVANCE® and BIOVANCE® 3L Ocular products in the U.S.,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder.

Celularity Human Placental-Derived Advanced Biomaterials Demonstrate Superior Biocompatibility and Better Support Differentiated Cell Functions in Studies

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Tuesday, July 18, 2023
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Benchtop data to be presented demonstrate that:

Key Points: 
  • Benchtop data to be presented demonstrate that:
    DDHAM modulates macrophage behavior, promoting polarization into M2 phenotype, and serves as a scaffold for endogenous cell attachment and proliferation in wound healing.
  • DDHAM-3L supports human corneal epithelial cell activity and attenuates an inflammatory response over time.
  • We believe our unique proprietary process provides superior biocompatibility, and better supports differentiated cell functions, as compared with other human placental-derived biomaterials which may contain cellular residuals,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder.
  • We leverage a diversified portfolio of therapeutic technologies all derived from a single source material — the post-partum placenta.

Celularity Announces Presentation at Upcoming 7th International Conference on Orthopedics

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Thursday, June 29, 2023
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FLORHAM PARK, N.J., June 29, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today that the Company will present data from a new product technology in development for orthopedic applications at the upcoming 7th International Conference on Orthopedics, July 19th – 20th in Rome.

Key Points: 
  • FLORHAM PARK, N.J., June 29, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today that the Company will present data from a new product technology in development for orthopedic applications at the upcoming 7th International Conference on Orthopedics, July 19th – 20th in Rome.
  • As a result, the healed tendon often is mechanically incompetent and prone to degeneration and rupture.
  • “Celularity leverages a diversified portfolio of therapeutic technologies all derived from a single source material — the post-partum placenta.
  • These early tenocyte data are an important demonstration of our ongoing commitment and focus on innovation leveraging the placental platform we have pioneered.”

Celularity Tissue Factor Gene Knockout of Allogeneic Stromal Cells Significantly Lowers Thrombotic Effects; Study Highlights Critical Importance of Gene Editing Capability

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Thursday, June 1, 2023
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FLORHAM PARK, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today the online publication of preclinical data in Cytotherapy, the official journal of the International Society of Cell and Gene Therapy (ISCT).

Key Points: 
  • The paper, “Characterization of CRISPR/Cas9-edited human placental allogenic stromal cells with low tissue factor expression and reduced thrombotic effects,” (Huang, et al.
  • )1 examined methods to reduce the tissue factor expressed by allogeneic stromal cells (ASCs), which has been regarded as a safety concern in clinical applications as it may trigger thrombosis when ASCs are administered intravenously.
  • Thrombogenic risk has been identified in association with intravenous administration of mesenchymal stem cells (MSCs), both allogeneic and autologous.
  • These cells express procoagulant activity linked to the expression of tissue factor that, when in contact with blood, initiates coagulation.

Celularity Announces $45 Million Purchase Order, First Middle East Private Label Agreement For Celularity’s Halal-Certified Biomaterial Products

Retrieved on: 
Tuesday, May 23, 2023
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Celularity biomaterial products are manufactured in its state-of-the-art cGMP/cGTP compliant facility located in Florham Park, New Jersey

Key Points: 
  • Celularity biomaterial products are manufactured in its state-of-the-art cGMP/cGTP compliant facility located in Florham Park, New Jersey
    FLORHAM PARK, N.J., May 23, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, today announced that it has received a $45 million purchase order for Celularity private label Halal-Certified biomaterial products from Jamjoom Medical Store (Jamjoom).
  • This marks the first purchase order received by Celularity under its recently announced expansion into the Middle East market, as part of Celularity’s global market strategy.
  • “We are delighted today to announce receipt of a $45 million purchase order for private label Celularity Halal-Certified biomaterial products from Jamjoom.
  • “We are excited to partner with Jamjoom as the first private label distributor of these products in the Kingdom.”