Transcript:

Nelson Chao, MD: Thank you for joining us at the Targeted Oncology Virtual Tumor Board, which is focused on practice updates in graft-versus-host disease [GVHD]. In todays presentation, my colleagues and I will review 3 clinical cases. We will discuss approaches to treating patients who are at risk or who develop graft-versus-host disease. We will share our perspectives on key clinical trial data that may impact our decisions. I am Dr Nelson Chao from Duke University [Durham, North Carolina]. Today, I am joined by Dr Corey Cutler from Dana-Farber Cancer Institute [Boston, Massachusetts] and Kerry [King] Minor from Duke University. Thank you for joining us.

I would like to start by giving a brief overview of the process for allogeneic transplant. We need to collect donor cells, which could be related or unrelated. The stem cells can be separated from the blood or given as a whole. There is a conditioning, or treatment of the recipient. Chemotherapy and/or radiation will kill the cancer and weaken the donor immune system. The cells are infused to the patient and then we wait for engraftment. Graft-versus-host disease is a leading cause of non-relapse mortality following allogeneic transplantation. In acute GVHD, the reaction of the donor immune cells against host tissues is the ideology of the disease. Three main tissues are affected: the skin, the liver, the gut. In chronic graft-versus-host disease, the syndrome is quite variable with features resembling autoimmune or other immunologic disorders. In chronic GVHD, you could have a single organ, or it might be widespread and have a significant impact on quality of life. The risk factors for acute and chronic are similar, although the greatest impact of chronic is having acute prior. With standard prophylaxis, 25% to 50% of patients receiving HLA [human leukocyte antigen]-matched transplant will develop acute GVHD. That may require high-dose systemic steroids, and up to 50% of patients will have inadequate response to steroid therapy, which is associated with poor prognosis.

So this is a sort of a classical slide down demonstrating the pathology where in number 1, the recipient, who received the conditioning regimen, ends up with tissue damage. Those tissues release inflammatory cytokines such as IL [interleukin]-1 and IL-6, and then there is damage to the small bowel, usually releasing LPS [lipopolysaccharides]. These go down through different pathways, one goes to host antigen-presenting cells, which will activate the donor cells that release IL-12, IFN [interferon-gamma]-, and IL-2. Both are within the small bowel because of the LPS, as well as the microbiota entry, and release of those pattern associated damage receptors. There is target cell apoptosis of the gut, which then amplifies the response from the cytotoxic lymphocytes and NK [natural killer] cells together with TNF [tumor necrosis factor]- and IL-1. So most commonly the GVHD prophylaxis includes calcineurin inhibitors; methotrexate; MMF [mycophenolate mofetil]; sirolimus [Rapamune]; T-cell antibody; Ex vivo T-cell depletion, such as CD34 selection; posttransplant cyclophosphamide; and then obviously the standard combination of tacrolimus and methotrexate. So Im going to stop here for a second and ask Dr Cutler to give us a sense of where these regimens fall within the Dana-Farber Cancer Institute.

Corey Cutler, MD, MPH, FRCPC: Sure. Thanks for the introduction, Nelson. At our center, the predominant regimen that we use in the mild of greater setting is still the classic combination of tacrolimus and methotrexate. In the reduced intensity setting, we often add in the M200 meter cells. We are using the posttransplant cyclophosphamide regimen whenever we do haploidentical transplants. At the moment, there isnt compelling data that suggests a superior regimen to tackling the methotrexate. So most of us dont use it as a matter of routine outside of either the clinical trials or the haploidentical setting.

Nelson Chao, MD: And Ms. Minor, what do you think are the major toxicities that you see with these standard regimens?

Kerry King Minor, MSN, ANP-BC: Well, we always educate the patients that are going to be receiving the methotrexate about the risk of mucositis. Thats probably 1 of the biggest things that we see in patient education with that prophylaxis agent and tacrolimus. We prepare them and monitor very closely for side effects, such as headaches, effects on their blood pressure, effects on their kidneys and their knees. Thats basically it. With cyclophosphamide, typically patients tolerate that fairly well.

Transcript edited for clarity.

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An Overview on Graft-Versus-Host Disease and Prophylaxis - Targeted Oncology

April 1st, 2022

Company Name: Representative:

HEALIOS K.K.

Hardy TS Kagimoto, Chairman & CEO

(TSE Mothers Code: 4593)

Joint Research with the Division of Regenerative Medicine, the Institute of Medical Science for Developing a Mass Production Method of UDC Liver Buds

HEALIOS K.K. ("Healios") is currently developing a regenerative medicine treatment whereby liver organ buds created from iPS cells are injected into the liver and grown into functioning liver tissue, with the aim of improving or restoring the function of a damaged liver (development code: HLCL041). This treatment could potentially replace the need for an organ transplant for certain patients. Liver buds are created by co-culturing liver progenitor cells, which can differentiate into hepatocytes; MSCs, which have the ability to develop into various types of connective-tissues; and vascular endothelial cells, which form blood vessels. Healios has pursued research and generated data on functional assessments and quality standards for these component cells and the liver buds created from them, and it is also proceeding with the development of mass culturing and manufacturing methods.

In addition, as announced on October 20th, 2020, Healios established Universal Donor Cells ("UDCs")*, which are next-generation iPS cells created with gene-editing technology that have a reduced risk of immune rejection regardless of a patient's HLA type, and its proprietary clinical-grade UDC line. We are currently conducting research both internally and through joint collaborations with several institutions on new treatments for diseases for which there is no existing cure.

As part of these efforts, Healios is pleased to announce that it has entered into a joint research agreement with the Division of Regenerative Medicine (Prof. Hideki Taniguchi) of the Institute of Medical Science at the University of Tokyo, to advance HLCL041 utilizing UDCs. In this joint research, we plan to establish a new method for inducing differentiation of liver buds using UDCs and to develop a highly efficient and scalable cell culturing and mass manufacturing system.

For many diseases where the only effective treatment is an organ transplant, Healios believes that organ buds created from iPSCs, which have the potential to restore organ function, hold significant promise as an alternative to organ transplants and as a means to address the perennial shortage of organ donors.

This agreement does not have a material impact on our consolidated financial results for the current fiscal year. We will promptly make an announcement on any matter that requires disclosure in the future.

Outline of the Collaboration Partner

Name of the Collaborator: Division of Regenerative Medicine, The Institute of Medical Science Adress:4-6-1 Shirokanedai Minato-ku, Tokyo, 108-8639, Japan

Representative: Professor Taniguchi Hideki

* UDCs

UDCs are iPS cells created using gene-editing technology that allows them to avoid and / or reduce the body's immune rejection response. The production of Healios' UDCs involve the removal of certain HLA genes that elicit a rejection response, the introduction of an immunosuppression gene to improve immune evasion, and the addition of a suicide gene serving as a safety mechanism, each in an allogeneic iPS cell. This next-generation technology platform allows for the creation of regenerative medicine products with enhanced safety and a lower risk of immune rejection, while preserving the inherent ability of iPS cells to replicate themselves continuously and their pluripotency in differentiating into various other kinds of cells.

About the Division of Regenerative Medicine, The Institute of Medical Science:

Regenerative medicine is a challenging scientific field that is going to convert the pioneering knowledge of developmental biology and stem cell biology to clinical application. For patients with end-stage organ failure, organ transplantation is the only effective treatment; however, the paucity of transplantable organs hinders the application of this treatment for most patients. Recently, regenerative medicine with transplantable organs has attracted attention. Our laboratory is developing a novel therapeutic strategy to substitute organ transplantation. We have established novel organoid culture technologies to reconstruct human organs from stem cells, including human induced pluripotent stem cells (iPSCs), and we are going to realize transplantation of human liver primordia (liver buds [LBs]) generated from iPSCs for the treatment of liver diseases. https://stemcell-imsut.org/laboratory/?id=en#labo1

About Healios:

Healios is Japan's leading clinical stage biotechnology company harnessing the potential of stem cells for regenerative medicine. It aims to offer new therapies for patients suffering from diseases without effective treatment options. Healios is a pioneer in the development of regenerative medicines in Japan, where it has established a proprietary, gene-edited "universal donor" induced pluripotent stem cell (iPSC) line to develop next generation regenerative treatments in immuno-oncology, ophthalmology, liver diseases, and other areas of severe unmet medical need. Healios' lead iPSC-derived cell therapy candidate, HLCN061, is a next generation NK cell treatment for solid tumors that has been functionally enhanced through gene-editing. Its near-term pipeline includes the somatic stem cell product HLCM051, which is currently being evaluated in Japan in Phase 2/3 and Phase 2 trials in ischemic stroke and acute respiratory distress syndrome (ARDS), respectively. Healios was established in 2011 and has been listed on the Tokyo Stock Exchange since 2015 (TSE Mothers: 4593). https://www.healios.co.jp/en .

Contact:

Department of Corporate Communications, HEALIOS K.K.

E-mail:ir@healios.jp

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Healios K K : Joint Research with the Division of Regenerative Medicine, the Institute of Medical Science for Developing a Mass Production Method of...

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Four-way distribution partnership provides quality, consistent rasH2 supply to India and China, better serving global customers Four-way distribution partnership provides quality, consistent rasH2 supply to India and China, better serving global customers

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atai Life Sciences to Participate in Upcoming March Investor Conferences

Announces decision to discontinue development of ORIC-101

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ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Operational Update

Philip Perera, M.D., to retire while continuing to participate as an advisor to Longboard Philip Perera, M.D., to retire while continuing to participate as an advisor to Longboard

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TELA Bio Reports Fourth Quarter and Full Year 2021 Financial Results

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Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (epinephrine) Injection for Potential Manufacturing Defect

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DICE Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Highlights

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Terns Reports Top-line Results from Phase 1 AVIATION Trial of VAP-1 Inhibitor TERN-201

- VRDN-002 incorporates clinically validated half-life extension technology to support development as a low volume subcutaneous injection that could broaden settings of care -

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AnaptysBio Appoints Daniel Faga As Interim Chief Executive Officer

BILLERICA, Mass., March 21, 2022 (GLOBE NEWSWIRE) -- SeqLL Inc. (“SeqLL” or the “Company”) (NASDAQ: SQL; SQLLW), a technology company providing life sciences instrumentation and research services for collaborative partnerships, today announced the formation of a Scientific Advisory Board (“SAB”) comprised of distinguished and world-renowned leaders of the scientific community. The SAB will discuss with management potential new development opportunities that leverage the Company’s unique True Single Molecule Sequencing (tSMS®) technology across the “omics” fields, as well as advise management with their existing collaborative, scientific, & development partnerships. Each leader has previously utilized the tSMS platform and will leverage their expertise to provide valuable insight to our company.

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SeqLL Announces Formation of Scientific Advisory Board

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Statera Biopharma Announces Proposed Underwritten Public Offering

Orphazyme A/SCompany announcementNo. 12/2022www.orphazyme.comCompany Registration No. 32266355

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Orphazyme A/S has filed for voluntary delisting of ADSs

MALVERN, Pa., March 21, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced the appointment of Jessica Crespo, CPA, as Chief Accounting Officer and Senior Vice President, Finance. She assumed the role effective March 18, 2022.

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Ocugen, Inc. Appoints Jessica Crespo, CPA, to Chief Accounting Officer and Senior Vice President, Finance

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Telix Radiopharmaceutical Production Facility Buildout Commences