Research is ongoing in Japan and overseas with the aim of realizing cell transplantation therapy using iPS cells. One safety issue of concern is the risk of tumor formation. CiRA in particular has focused its resources on this issue.

Broadly speaking, there are two main theories as to the mechanism whereby iPS cells may form tumors. One theory is that iPS cells form tumors in response either to reactivation of the reprogramming factors inserted into the cell or through damage caused to the original cell genome through the artificial insertion of the reprogramming factors. In response, a search was launched for optimal reprogramming factors which do not cause reactivation, and a method of generating iPS cells was developed in which reprogramming factors are not incorporated into the cell chromosomes and damage to the host genome is therefore avoided.

The other theory is that residues of undifferentiated cells - cells which have not successfully completed differentiation to the target cell type - or other factors lead to the formation of teratomas, a kind of benign tumor. This theory requires research on iPS cell proliferation and differentiation.

1. Search for optimal reprogramming factorsWhen Professor Shinya Yamanaka and his research team announced the successful generation of mouse iPS cells, one of the reprogramming factors they used was c-Myc, which is known to be an oncogene, that is a cancer-causing gene. There have been suggestions that this gene may be activated within the cell and cause a tumor to form. However, in 2010, CiRA Lecturer Masato Nakagawa and his team reported that L-Myc was a promising replacement factor for c-Myc. iPS cells created using L-Myc not only display almost no tumor formation, they also have a high rate of successful generation and a high degree of pluripotency.

2. Search for optimal vectorsWhen the reprogramming factors required to generate iPS cells were inserted into the cells of the skin or other body tissues, early methods employed a retrovirus or lentivirus as a "vector," or carrier. In these methods, the target genes are inserted into the viruses with the which the cells were then infected in order to deliver the target genes. When a retrovirus or lentivirus is used as a vector, however, the viruses are incorporated into the cells genomic DNA in a random fashion. This may cause some of the cells original genes to be lost, or in other cases activated, resulting in a risk of cancerous changes.

In 2008, to remedy this risk, CiRA Lecturer Keisuke Okita and his team explored the use of a circular DNA fragment known as a plasmid, which is not incorporated into the cell chromosome, as a substitute to the retrovirus or lentivirus methods. In this way, they developed a method of generating iPS cells in which the reprogramming factors are not incorporated into the cell chromosome. In 2011, Okita and his team further improved the efficiency generation by introducing into a self-replicating episomal plasmid six factors - OCT3/4, SOX2, KLF4, LIN28, L-MYC, and p53shRNA.

3. Establishing a method for generating and screening safe cellsOnce iPS cells have been induced to differentiate into the target somatic cells using the appropriate genes and gene insertion methods as explained above, the differentiated cells can be relied upon not to revert to the undifferentiated state. However, there may sometimes be a residue of undifferentiated cells which have not completed the process of differentiation into the target cells, and it is possible that these cells, however few, may form a tumor. Scientists had already established that different iPS cell lines, even if generated from the same individual using the same method, might nevertheless display differences in proliferation and differentiation potentials. This meant that, if iPS cells with low differentiation potential were used, there was a risk that a residue of cells in the cell group might fail to fully differentiate and result in the formation of a teratoma. In 2013, a team led by CiRA Lecturer Kazutoshi Takahashi and Dr. Michiyo Aoi, now an assistant professor at Kobe University, developed a simple method to screen for iPS cell lines that have high potential to differentiate into nerve cells. There is also a risk of tumorigenesis from genomic or other damage arising at the iPS cell generation stage or at the subsequent culture stage. CiRA Assistant Professor Akira Watanabe and his team have developed a sensitive method to detect genomic and other damage in iPS cells using the latest equipment.

4. Developing a reliable method of differentiation into the target cell typeIn cell transplantation therapy, iPS cells are not transplanted directly into the human body. Instead, cells are transplanted after first being differentiated into the target cell type. It is therefore important to develop a reliable method of inducing iPS cells to differentiate into the target cell type. CiRA is currently working to develop technology for differentiation into a range of different cell types from iPS cells. CiRA Professor Jun Takahashi and his team have developed a highly efficient method of inducing iPS cells to differentiate into dopamine-producing nerve cells. In 2014, CiRA Professor Koji Eto and his team reported a method of producing platelets from iPS cells that is both reliable and can yield high volumes. These findings represent a major step toward iPS cell-based regenerative medicine for nerve diseases such as Parkinsons disease and blood diseases such as aplastic anemia.

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What are iPS cells? | For the Public | CiRA | Center for iPS Cell ...

ViaNautis Bio appoints Dr Adi Hoess as Chief Executive Officer

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ViaNautis Bio appoints Dr Adi Hoess as Chief Executive Officer

Phase III trial results of novel triple combination pill for hypertension published in The Lancet

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Phase III trial results of novel triple combination pill for hypertension published in The Lancet

Combined company will emerge as a leading global health and wellness company by providing better products and solutions for pets, people, and families

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UPDATE -- Better Choice Company Chairman Issues Letter to Shareholders as Company Continues to Make Progress Towards the Closing of its SRx Health...

CONSHOHOCKEN, Pa., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) announced today that it will release its third-quarter 2024 financial results on Thursday, Oct. 31, 2024, prior to the open of the U.S. financial markets.

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Madrigal Pharmaceuticals to Release Third-Quarter 2024 Financial Results and Host Webcast on October 31, 2024

WESTLAKE VILLAGE, Calif., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that its wholly-owned subsidiary Arcutis Canada, Inc. has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older. The full Canadian product monograph for ZORYVE is available here.

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Arcutis Announces Health Canada Approval of ZORYVE® (Roflumilast) Foam 0.3% to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older

SARASOTA, Fla., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Oragenics Inc. (NYSE American: OGEN), a company focused on developing new treatments for brain-related health conditions, announced it will be presenting at the Centurion One Capital 2nd Annual Bahamas Summit to be held at the Rosewood Baha Mar Hotel on October 22-23, 2024, in Nassau, Bahamas. Michael Redmond, President of Oragenics, will participate in a corporate presentation and Q&A session on October 22, 2024 at 1:20 pm ET.

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Oragenics, Inc. to Present at The Centurion One Capital 2nd Annual Bahamas Summit

Data Reported by Can-Fite Veterinary Partner Vetbiolix who already exercised its option for a full license deal worth $325M

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Significant Positive Results from Osteoarthritis Clinical Study in Dogs Treated with Piclidenoson

Webinar to be held on Tuesday, October 22, at 8:00 a.m. ET Webinar to be held on Tuesday, October 22, at 8:00 a.m. ET

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Editas Medicine to Host Strategic Update Webinar to Detail Progress Towards 2024 Goals, Including Achievement of Establishing In Vivo Preclinical...

Châtillon, France, October 18, 2024

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DBV Technologies to Participate in Upcoming ACAAI 2024 Congress

Basel, 18 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo® (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.4

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Roche’s Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study

88% of EYLEA HD patients had a last assigned dosing interval of ?12 weeks at week 156, while sustaining visual and anatomic improvements achieved in the first 96 weeks, in this extension study of the Phase 3 PHOTON trial presented at AAO

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Three-year Results for EYLEA HD® (aflibercept) Injection 8 mg Demonstrate Continued Durable Vision Gains and Anatomic Improvements with Extended...

FLORHAM PARK, N.J., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (the “Company”), a regenerative medicine company developing and commercializing placental-derived technologies, today announced that it has received a formal notice from the Listing Qualifications department of the Nasdaq Stock Market LLC (“Nasdaq”) on October 16, 2024, indicating that the Company is subject to delisting due to its inability to timely file its Forms 10-Q for the the periods ended March 31, 2024, and June 30, 2024 (the “Forms 10-Q”) within the prescribed 180-day compliance period. Nasdaq’s notice has no immediate effect on the listing of the Company’s common stock and warrants, which continue to trade on the Nasdaq Capital Market under the symbols “CELU” and “CELUW”, respectively.

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Celularity Inc. Receives Notice from Nasdaq; Confirms Intention to File an Appeal

WARREN, N.J., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen” or “Tevogen Bio Holdings Inc.”) (Nasdaq: TVGN) is a clinical-stage specialty immunotherapy biotech developing off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers.

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Tevogen CEO Expresses Gratitude for Unprecedented Public Support of Company’s Business Model of Commercial Success Through Patient Accessibility and...

SAN DIEGO, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that the staff of NYSE Regulation has determined to commence proceedings to delist the warrants — ticker symbol CLDI WS — of Calidi Biotherapeutics, Inc. (the “Company”), each whole warrant exercisable for 1/10th of a share of common stock at an exercise price of $115.00 per whole share of common stock, from the NYSE American. Trading in the Company’s warrants will be suspended immediately. Trading in the Company’s common stock — ticker symbol CLDI — will continue on the NYSE American.

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NYSE American to Commence Delisting Proceedings with Respect to the Warrants of Calidi Biotherapeutics, Inc. (CLDI WS)

NX-5948 demonstrated robust clinical activity with objective responses observed in 7 of 9 (77.8%) evaluable Waldenstrom’s patients in the ongoing Phase 1a/1b clinical trial

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Nurix Therapeutics Presents Positive Results from the Ongoing Clinical Trial of Its BTK Degrader NX-5948 in Patients with Relapsed/Refractory...

ROME, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Angelini Pharma, part of the privately owned Angelini Industries, and Cureverse Inc., an early-stage research and development company, announced today that they entered into an exclusive global option agreement for the development and commercialization of Cureverse’s innovative brain health asset CV-01.

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Angelini Pharma Enters Into An Exclusive Option Agreement With Cureverse to License Global Development and Commercialization Rights For A Novel and...

Sanofi and CD&R partner to fuel Opella’s ambitions in consumer healthcare

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Press Release: Sanofi and CD&R partner to fuel Opella’s ambitions in consumer healthcare

ViaNautis Appoints Ray Jupp as Chief Scientific Officer

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ViaNautis Appoints Ray Jupp as Chief Scientific Officer

MILAN, Oct. 21, 2024 (GLOBE NEWSWIRE) -- AAVantgarde Bio (AAVantgarde), a clinical-stage, Italian-based international biotechnology company with two proprietary Adeno-Associated Viral (AAV) vector platforms for large gene delivery, today announced the appointment of Lauren Kaskiel, MBA, as their Chief Business Officer. Ms. Kaskiel brings more than 20 years of experience in the biotech and pharmaceutical industry and has joined the Company’s leadership team, reporting to Dr. Natalia Misciattelli, Chief Executive Officer.

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AAVantgarde appoints Ms. Lauren Kaskiel as Chief Business Officer