On February 1, 2023 Celularity Inc. (Nasdaq: CELU) ("Celularity" or the "Company"), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, reported that, in response to its October 2022 Pre-Request for Designation (Pre-RFD) for its investigational Celularity Tendon Wrap (CTW), the U.S. Food and Drug Administration (FDA) has reviewed information provided by the Company and other relevant available information, and agreed with the Company’s recommendation that its investigational CTW product be regulated as a device by the FDA Center for Devices and Radiologic Health (CDRH) (Press release, Celularity, FEB 1, 2023, View Source [SID1234626699]). The FDA feedback is preliminary and non-binding. Celularity intends to submit a 510(k) application for regulatory clearance to CDRH by the end of 2023.

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Celularity’s 510(k) submission to CDRH for CTW is intended to be for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue as a structural barrier for injured tendon tissue, and does depend on chemical action to mediate this effect, to be classified as a surgical mesh.

"We are delighted to receive this feedback from the FDA on preliminary CTW product classification and CDRH jurisdiction," said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. "Our unique business model continues to generate innovative therapeutic products from the biomaterials and stem, progenitor and immune cells derived from the placenta. We have had a history of developing and commercializing products for degenerative diseases and see great potential to use this part of our business as a revenue engine to help support continue research and development as well as enhance the value proposition for our investors. We will work with the FDA to provide the appropriate pre-clinical data to support a 510(k) pre-market notification submission later this year, and expect to launch our product in 2024."

As part of its CTW Pre-RFD submission, Celularity also provided supporting data demonstrating that its proprietary processing steps are designed to remove from CTW all cells, cellular debris, residual nucleic acids, cytokines and chemokines, residual hormones, growth factors and other regulators of wound healing, scarring and fibrosis, and well as anti- and pro- inflammatory factors.

The global tendon repair market was valued at $2.1 billion in 2021 and is expected to exhibit a compound annual growth rate (CAGR) of 7.5 percent through 2030, according to a 2022 report by Grand View Research. In terms of regional breakdown, in 2021 North America accounted for the highest revenue share, $821.1 million or 45.2 percent.

About 510(k) Submission

A 510(k) submission refers to Section 510(k) of the Food, Drug and Cosmetic Act, which requires device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Pre-market Notification, also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

Celularity’s Advanced Biomaterial Products

Celularity markets a suite of commercial placenta-derived biomaterial products. Most recently, the Company announced an exclusive territory agreement with CH Trading Group, an international import, export, and trading company, to distribute Celularity’s branded regenerative biomaterial products — which are Halal-Certified under globally recognized Circle H International Inc. standards — in more than 100 countries.

Celularity’s advanced biomaterial products include:

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 is indicated for use in the United States as a natural scaffold to support the body’s wound healing process.
Biovance 3L and Biovance 3L Ocular, tri-layer human amniotic membrane products focused on the surgical and ocular markets and available in both sheet and disk form.
Interfyl, a human connective tissue matrix derived from the placenta of a healthy, full-term pregnancy. It is indicated for use in the United States to replace or supplement damaged or inadequate integumental tissue resulting from wounds, trauma, or surgery.
CentaFlex, a decellularized human placental matrix derived from the umbilical cord that is indicated for use in the United States as a surgical covering, wrap or barrier to protect and support the repair of damaged tissue.

On February 1, 2023 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, will be reported its results for the fourth quarter 2022 on Thursday 16 February 2023. The briefing will take place at 10:00 am CET at (Press release, BerGenBio, FEB 1, 2023, View Source [SID1234626698]).

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Carnegie AS, Fjordalleen 16, Aker Brygge, 5th Floor, Oslo

where BerGenBio’s senior management team will provide an update on the Company
followed by a Q&A session. To attend in person please register by mail to
[email protected]

The presentation will webcast live and a link will be available at www.bergenbio.com in the Investors/Financial Reports section and a recording will be available shortly after the webcast has finished.

The fourth quarter financial report and presentation will be made available on the Company’s website in the Investors/Financial Reports section from 7:00am CET the same day.

On February 1, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Company will participate in two upcoming investor conferences (Press release, BeiGene, FEB 1, 2023, View Source [SID1234626697]).

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The Guggenheim Oncology Conference 2023 on Wednesday, February 8, 2023 at 9:35 a.m. ET; and
The SVB Securities Global Biopharma Conference on Wednesday, February 15, 2023 at 1:40 p.m. ET.
Live webcasts of these events can be accessed from the investors section of BeiGene’s website at View Source and archived replays will be available for 90 days following the events.

On February 1, 2023 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that the first patient has been dosed in the United States in its Phase 1/2 clinical trial evaluating AU-007 for the treatment of solid tumors (Press release, Aulos Bioscience, FEB 1, 2023, View Source [SID1234626696]). AU-007 is a human monoclonal antibody computationally designed by Biolojic Design to harness the power of interleukin-2 (IL-2) and eradicate solid tumors.

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"We’re pleased that our team has satisfied the FDA’s inquiries, enabling us to enroll and dose patients in the United States in our Phase 1/2 trial of AU-007," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "As the first computationally designed monoclonal antibody to enter a human clinical trial, AU-007 holds promise to become a potential new therapy for patients with advanced or metastatic solid tumor cancers. Based on early clinical data and strong preclinical data, it appears that AU-007 is safe and well tolerated to date. We thank the patients and clinical trial investigators who have chosen to participate in our study. We look forward to significantly expanding the number of trial sites in both the U.S. and Australia as well as presenting updated clinical data by year-end."

The Phase 1/2 clinical trial of AU-007 is a single, global protocol currently enrolling patients at four site locations in Australia and one site in Huntersville, North Carolina. The open label, first-in-human study is evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Phase 1 consists of three dose escalation arms evaluating AU-007 either as a monotherapy, in combination with a single loading dose of recombinant human IL-2 (aldesleukin), or with both AU-007 and aldesleukin administered once every two weeks. The aldesleukin will be administered subcutaneously, at much lower doses and much less frequently than the approved regimen of intravenously administered aldesleukin. The Phase 2 portion of the trial will evaluate a dosing regimen selected from dose escalation for expansion in specified tumor types to further define the safety and initial efficacy of AU-007.

"In low doses, IL-2 is an immune suppressant and at high levels, it is toxic. With AU-007, we are seeking to overcome these challenges through precision routing of IL-2 while producing an anti-cancer effect," said Jim Vasselli, M.D., Aulos Bioscience’s chief medical officer. "The unique profile we’ve seen so far with AU-007 gives it an advantage over all other IL-2 therapies currently in development. Through artificial intelligence, AU-007 has been designed to redirect IL-2 away from immunosuppressive Tregs and the vasculature and toward T effector and NK cells. By binding to IL-2 and not the IL-2 receptor, AU-007 has shown promising preclinical and initial clinical evidence that it can break the negative feedback loop to Tregs."

Early clinical data from the Phase 1/2 study were presented at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November. The data showed an overall trend toward decreasing Tregs, which is consistent with data findings in preclinical studies – and completely unlike data reported from other IL-2 therapeutics, which demonstrate substantial increases in T regulatory cells (Tregs) due to the negative feedback loop induced by IL-2 produced endogenously by activated T cells. Additionally, initial pharmacokinetic data from the first three patients administered AU-007 as a monotherapy demonstrate characteristics similar to other IgG1 therapeutic human monoclonal antibodies.

To learn more about the clinical trial program, including study locations in the U.S. and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626).

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On February 1, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported preclinical data highlighting the Company’s next generation DaggerTM platform technology at the Emerging Cellular Therapies at the Forefront of Cancer Immunotherapy Keystone Symposia in Banff, Alberta, Canada (Press release, Allogene, FEB 1, 2023, View Source [SID1234626695]).

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The Dagger technology, first unveiled at the Company’s R&D Showcase in November 2022, is designed to resist rejection of AlloCAR T cells by the host immune cells, enabling a prolonged window of persistence during which AlloCAR T cells can expand and actively target and destroy cancer cells. Dagger is a component of Allogene’s anti-CD70 product candidate ALLO-316, which is being evaluated in TRAVERSE, a Phase 1 study of patients with relapsed/refractory renal cell carcinoma (RCC).

"We are excited by the potential of this proprietary technology to enhance AlloCAR T cell function by preventing premature rejection of the cells while potentially reducing dependence on other lymphodepletion strategies," said Barbra Sasu, Ph.D., Chief Scientific Officer at Allogene. "The early clinical experience with ALLO-316 in advanced renal cell carcinoma suggests Dagger can meaningfully enhance AlloCAR T cell expansion and persistence. We are keen to apply this technology to other product candidates targeting both hematologic and solid tumors."

The Dagger platform arms AlloCAR T cells with a CD70-targeting receptor designed to recognize and deplete CD70 positive host cells while also masking the CD70 molecule expressed on the AlloCAR T cells themselves, preventing fratricide. CD70 is expressed on activated T cells and NK cells, and by selectively depleting alloreactive host cells, Dagger can potentially prevent the immune rejection of AlloCAR T cells. The results from these pre-clinical studies show that:

A CD70 Dagger construct was optimized to selectively eliminate alloreactive T cells, enabling enhanced AlloCAR T cell survival in several in vitro models of rejection
Allogeneic CAR T cells expressing dual CD19 CAR and CD70 Dagger receptors demonstrated the ability to simultaneously kill CD19-positive tumor cells and resist rejection and fratricide
CD19 AlloCAR T cells armed with a CD70 Dagger were endowed with dual specificity and prevented CD19 antigen loss dependent escape by tumor cells in vitro and in vivo
The Company has pursued an integrated strategy within Research and Development aimed at matching technology with insights obtained from the clinic to improve patient outcomes. In addition to ALLO-316, the Company plans to deploy Dagger technology to enhance the persistence and activity of next generation AlloCAR T products.

About ALLO-316
ALLO-316, an AlloCAR T investigational product targets CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In March 2022, The U.S. Food and Drug Administration granted Fast Track Designation (FTD) based on the potential of ALLO-316 to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies.