Stem Cell Clinic

Takeda Expands Cell Therapy Efforts with New R&D Manufacturing Plant in Boston – BioSpace

By Stem Cell Clinic

Takeda Pharmaceutical opened a new 24,000-square-foot R&D cell therapy manufacturing facility in Boston, Massachusetts. It is at the site of the companys R&D headquarters.

It will provide end-to-end R&D capabilities and advance the companys plans to develop next-generation cell therapies. The initial plan is to focus on oncology then expand into other areas.

We are collaborating with some of the best scientists and innovators around the world establishing a highly differentiated immuno-oncology pipeline leapfrogging into new modalities and mechanisms with curative potential, said Chris Arendt, Head of Takedas Oncology Therapeutic Area.

He went on to say, With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in fiscal year 2021, we are working with urgency and purpose for patients. This new facility helps us rapidly scale our manufacturing capabilities so we can simultaneously advance multiple highly differentiated cell therapy programs.

The facility will manufacture cell therapies all the way up to pivotal Phase IIb trials. Its current Good Manufacturing Practices (cGMP) facility meets all U.S., European Union and Japanese regulatory requirements for cell therapy manufacturing that can be used for Takeda clinical trials globally.

Takeda and MD Anderson are testing a possible best-in-class allogeneic cell therapy, TAK-007, a CD19-targeted CAR-NK cell therapy for off-the shelf use in patients with r/r non-Hodgkins lymphoma and chronic lymphocytic leukemia. It is currently in Phase I/II trials. Two more Phase I trials of the companys cell therapies were recently launched, including 19(T2)28z1xx CAR T-cells (TAK-940), a next-generation CAR-T signaling domain developed with MD Anderson Sloan Kettering Cancer Center for r/r B-cell cancer and a cytokine and chemokine armored CAR-T (TAK-102). TAK-102 was developed with Noile-Immune Biotech to treat GPC3-expressing previously treated tumors.

Late last week, Takeda released data from the Phase III TOURMALINE-MM2 trial of Ninlaro (ixazomib) to lenalidomide and dexamethasone compared to lenalidomide and dexamethasone plus placebo in treating newly diagnosed multiple myeloma patients who were not eligible for autologous stem cell transplant. The trial did not meet statistical significance for the primary endpoint of progression-free survival (PFS).

The addition of Ninlaro resulted in a 13.5 month increase in median PFS, 35.3 months in the Ninlaro arm compared to 21.8 months in the placebo arm, but although there was a numerical improvement, it did not hit the threshold for statistical significance.

There is a specific need in newly diagnosed multiple myeloma, given there are currently no approved all-oral, proteasome inhibitor-based treatment options, said Thierry Facon, Lille University Hospital, principal investigator and lead author of TOURMALINE-MM2.

Facon added, Findings from the TOURMALINE-MM2 trial are important overall for this patient population as well as across multiple subgroups including patients with high-risk cytogenetics. We hope these data will help inform future research and further progress for the multiple myeloma community.

Ninlaro is an oral proteasome inhibitor. It is being evaluated across a broad range of MM treatment settings. It was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for patients with MM who have received at least one previous therapy. It is currently approved in more than 65 countries.

Earlier, Takeda indicated it had entered an agreement to sell some noncore prescription drugs that are sold primarily in Europe and Canada to Germanys Cheplapharm for $562 million. Last month the company sold off a big chunk of its consumer health products to Blackstone Group for $2.3 billion. The company has a goal of divesting $10 billion.

Takedas five key focus areas are gastroenterology, rare diseases, oncology, plasma-derived therapies and neuroscience. It has $59 billion in debt from acquiring Shire and is selling off noncore areas to help pay down that debt.

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Takeda Expands Cell Therapy Efforts with New R&D Manufacturing Plant in Boston - BioSpace

Allow your body to heal on its own with the help of Stemcure Clinic – Lowvelder

By Stem Cell Clinic

Platelet rich plasma treatment (PRP) and stem cell therapy encourage your body to heal on its own, by using its cells to stimulate the healing process.

PRP is a relatively new treatment for muscular-, skeletal-, orthopaedic- and brain-related injuries in South Africa. It uses part of the bodys natural inflammatory process to accelerate and enhance healing. Stemcure Clinic has the only specialists offering this treatment in Mpumalanga.

The clinic has been operating in White River for a number of years after Dr Hein van Wyks stem cell research yielded some interesting insight. He found that on their own, stem cells dont work as well as they should when used in treatments, as they are unable to grow when toxins are present.

The perfect environment is one where there is no inflammation and no toxins. So he took a new approach to this treatment by combining a specific type of detox (which focuses on cleansing the cells) with PRP therapy.

Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells, he said.

This combination proved to be the key to stem cells working optimally, as it drastically improved their survival rate. They hold a great deal of potential and with the current research, we are learning more about the capabilities of these unique cells, he continued.

Stem cell therapy is a non-invasive procedure, which means there is no surgery involved and there will be very little to no pain. The treatment at Stemcure Clinic consists of using stem cells from your own body. They have the ability to become whatever cells your body needs, which is what makes them so unique.

What is cellular therapy? Cellular therapy involves cellular material (living cells) being injected into the patient and is used to successfully treat a variety of conditions, while it is also used for cosmetic procedures. The clinic offers stem cell therapy to treat patients. Using those harvested from their own bodies, they help patients to regenerate cells quicker, in order to heal faster. What is a stem cell and why should you consider stem cell treatment? A stem cell is an undifferentiated cell which has the ability to become just about any kind your body needs. Our bodies are reservoirs of stem cells! Effective, safe and non-invasive are just a few of the words used to describe the treatment. Many patients have recovered from ailments and injuries faster when having stem cell therapy. What is PRP treatment?

PRP, or platelet rich plasma treatment is the ideal option for various kinds of pain. It involves using your own blood plasma to give your natural inflammatory system regenerative process a kick-start! This is relatively painless, non-invasive procedure.

Today, Hein and his son, Louis, who followed his fathers footsteps into the medical profession, treat patients from all over the country while also providing their expert services to people from Namibia, China and Malawi. You can look and feel great. This is just one of the things we tell our patients. At Stemcure Clinic, you will be in the most caring of hands.

We are a team that is exceptionally passionate about everything we do, and we are even more passionate about the health of our patients. Our practice has been helping people from all walks of life to improve their health, to treat chronic pain and to boost their bodys natural rejuvenation processes using safe, non-invasive medical procedures. And we can assist you too.

Vein Solutions is a centre of excellence in the comprehensive evaluation and treatment of vein disorders. Dr Gideon van Wyk has a profound understanding of the relationship between veins and the bodys overall circulation.

He utilises his unique knowledge, perspective, and experience of more than 16 years, to provide the best overall medical treatment for his patients. Vein Solutions features minimally invasive treatments that provide immediate and long-term results. Gideon is a member of the American College of Phlebology, which is the leading resource for vein-care physicians, health professionals and patients.

To determine if a venous problem exists, a comprehensive evaluation is performed through an in-depth medical history and a physical examination by an experienced specialist surgeon. In addition, an extensive ultrasound study is performed by a registered sonographer to help determine the diagnosis. At Vein Solutions, the physician and patient mutually discuss the findings to determine the best treatment plan for the problem.

According to Gideon, they are experienced in all vein treatment modalities and are able to recommend the best for the individual. These procedures are performed daily, in a patient-friendly environment and usually in less than an hour.

Almost all procedures are done under local anaesthesia, thereby reducing risk and increasing convenience. Most patients resume normal activities within 24 hours and return to work in days instead of weeks.

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Allow your body to heal on its own with the help of Stemcure Clinic - Lowvelder

Proteins Role in Hair Cell Development Is Identified – Technology Networks

By Stell Cell Research

Credit: Mark Paton on Unsplash.

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Researchers at the University of Maryland School of Medicine (UMSOM) have conducted a study that has determined the role that a critical protein plays in the development of hair cells. These hair cells are vital for hearing. Some of these cells amplify sounds that come into the ear, and others transform sound waves into electrical signals that travel to the brain.

Ronna Hertzano, MD, PhD, Associate Professor in the Department of Otorhinolaryngology Head and Neck Surgery at UMSOM andMaggie Matern, PhD, a postdoctoral fellow at Stanford University, demonstrated that the protein, called GFI1, may be critical for determining whether an embryonic hair cell matures into a functional adult hair cell or becomes a different cell that functions more like a nerve cell or neuron.

The study was published in the journalDevelopment, and was conducted by physician-scientists and researchers at theUMSOM Department of Otorhinolaryngology Head and Neck Surgeryand theUMSOM Institute for Genome Sciences (IGS), in collaboration with researchers at the Sackler School of Medicine at Tel Aviv University in Israel.

Hearing relies on the proper functioning of specialized cells within the inner ear called hair cells. When the hair cells do not develop properly or are damaged by environmental stresses like loud noise, it results in a loss of hearing function.

In the United States, the prevalence of hearing loss doubles with every 10-year increase in age, affecting about half of all adults in their 70s and about 80 percent of those who are over age 85. Researchers have been focusing on describing the developmental steps that lead to a functional hair cell, in order to potentially generate new hair cells when old ones are damaged.

To conduct her latest study, Dr. Hertzano and her team utilized cutting-edge methods to study gene expression in the hair cells of genetically modified newborn mice that did not produce GFI1. They demonstrated that, in the absence of this vital protein, embryonic hair cells failed to progress in their development to become fully functional adult cells. In fact, the genes expressed by these cells indicated that they were likely to develop into neuron-like cells.

Our findings explain why GFI1 is critical to enable embryonic cells to progress into functioning adult hair cells, said Dr. Hertzano. These data also explain the importance of GFI1 in experimental protocols to regenerate hair cells from stem cells. These regenerative methods have the potential of being used for patients who have experienced hearing loss due to age or environmental factors like exposure to loud noise.

Dr. Hertzano first became interested in GFI1 while completing her M.D., Ph.D. at Tel Aviv University. As part of her dissertation, she discovered that the hearing loss resulting from mutations in another protein called POU4F3 appeared to largely result from a loss of GFI1 in the hair cells. Since then, she has been conducting studies to discover the role of GFI1 and other proteins in hearing. Other research groups in the field are now testing these proteins to determine whether they can be used as a cocktail to regenerate lost hair cells and restore hearing.

Hearing research has been going through a Renaissance period, not only from advances in genomics and methodology, but also thanks to its uniquely collaborative nature among researchers, said Dr. Herzano.

The new study was funded by the National Institute on Deafness and Other Communication Disorders (NIDCD) which is part of the National Institutes of Health (NIH). It was also funded by the Binational Scientific Foundation (BSF).

This is an exciting new finding that underscores the importance of basic research to lay the foundation for future clinical innovations, saidE. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "Identifying the complex pathways that lead to normal hearing could prove to be the key for reversing hearing loss in millions of Americans."

Reference: Matern MS, Milon B, Lipford EL, et al. GFI1 functions to repress neuronal gene expression in the developing inner ear hair cells. Development. 2020;147(17):dev186015. doi:10.1242/dev.186015.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Proteins Role in Hair Cell Development Is Identified - Technology Networks

GlycoT Therapeutics Grants Sublicense of Glycoengineering Technology to Daiichi Sankyo – PRNewswire

By Stell Cell Research

BALTIMORE, Sept. 14, 2020 /PRNewswire/ --GlycoT Therapeutics LLC,aUM Ventures start-upcompany based on intellectual property (IP) developed at the University of Maryland, Baltimore (UMB) and University of Maryland, College Park (UMCP),has executed a sublicense agreement for its glycoengineering technology with Daiichi Sankyo Company, Limited (Daiichi Sankyo; http://www.daiichisankyo.com).The agreement grants Daiichi Sankyo worldwide and non-exclusive rights to IP that GlycoT currently licenses from UMB and UMCP, and includes an undisclosed upfront payment, annual fees, and adequate royalties of sales to GlycoT.

GlycoT's enzymatic glycoengineering technology provides a platform to precisely change and modify the sugars on antibodies. Daiichi Sankyoplans to use this cutting-edge technology to prepare new drug candidates.

"We are very excited to see the growing potential for GlycoT's glycoengineering technology," said Phil Robilotto, DO, MBA, associate vice president of UMB's Office of Technology Transfer and director of UM Ventures, which is UMB and UMCP's joint technology transfer initiative. "This is a great example of how university innovators continue to fuel therapeutic development across the globe."

Lai-Xi Wang, PhD, Founder and President of GlycoT Therapeutics and UMCP Professor in the Department of Chemistry and Biochemistry, developed the technologies that are the basis for the GlycoT/Daiichi Sankyo license agreement in his lab, first at UMB and later at UMCP.

"We are pleased to provide the opportunity for Daiichi Sankyo to use this technology,"said Dr. Wang. "We believe our technology has the potential to open new avenues for developing novel therapeutics for the treatment of human diseases."

About GlycoT Therapeutics LLCGlycoT Therapeutics aims to apply its innovative and proprietary chemoenzymatic glycosylation technology for glycoengineering of therapeutic proteins such as monoclonal antibodies to improve their therapeutic efficacy. For more information, visit http://www.glycot.com.

About UM VenturesUM Ventures, the joint technology transfer initiative of University of Maryland, Baltimore (UMB) and University of Maryland, College Park (UMCP), commercializes University of Maryland's breakthrough discoveries, fueling the creation of innovative start-up companies and attracting industry leaders and entrepreneurs to the universities. Researchers at UMB and UMCP have created hundreds of life science innovations that are available for licensing. Our Discovery Portfolio offers a mix of cutting-edge technologies, including vaccines, therapeutics, diagnostics, devices, and software that promise to make a quantifiable impact on human health and the environment. The internationally-recognized genomics, cancer, vaccine, stem cell, pharmaceutical and bioengineering research underway at the University of Maryland provides a robust pipeline of more than 250 new innovations each year. Visit our portfolio at umventures.org.

SOURCE University of Maryland Ventures

http://www.umventures.org

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GlycoT Therapeutics Grants Sublicense of Glycoengineering Technology to Daiichi Sankyo - PRNewswire

Global Regenerative Medicine Market Analysis & Forecast to 2025 – ResearchAndMarkets.com – Business Wire

By Stem Cell Treatment

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Market Analysis & Forecast to 2025; Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries" report has been added to ResearchAndMarkets.com's offering.

This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials. The analysis indicates that the global regenerative medicine market was worth $35 billion in 2019 and will grow to over $124 billion by 2025, with a CAGR of 23.3% between this time frame. This report describes the evolution of such a huge market in 15 chapters supported by over 350 tables and figures in 700 pages.

Key Questions Answered

Key Topics Covered:

1.0 Report Synopsis

2.0 Introduction

3.0 Stem Cells and Clinical Trials

4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing

5.0 Stem Cell Biomarkers

6.0 Manufacturing Stem Cell Products

7.0 Investment & Funding

8.0 Regenerative Medicine Market Analysis & Forecast to 2025

9.0 Stem Cell Market Analysis & Forecast to 2025

10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2025

11.0 Biobanking Market Analysis

12.0 Global Access & Challenges of the Regenerative Medicine Market

13.0 Cell and CAR T Therapy

14.0 Company Profiles

15.0 SWOT Industry Analysis

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/dfpyeg

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Global Regenerative Medicine Market Analysis & Forecast to 2025 - ResearchAndMarkets.com - Business Wire

Cell Culture Market: Chemically Defined Mediums Adaptation to Boost Market Growth – BioSpace

By Stem Cell Treatment

In a recent report by Transparency Market Research, thecell culturemarketis rapidly being adopted in the field of pharmaceuticals. Companies managing the global cell culture market are more focused on increasing strategic collaborations and expanding product development worldwide. Furthermore, they are aiming at expanding their footprints in emerging markets such as Latin America and Asia Pacific. An example of such collaboration would be the announcement of collaboration of Valneva SE and GE Healthcare in Nov, 2016 which optimized virus productivity in Valnevas EB66 cell line. Furthermore, the inauguration of EX-CELL Advanced HD perfusion mediums, is expected to help strengthen the streamline and production of regulatory compliances.

Read Report Overview - https://www.transparencymarketresearch.com/cell-culture-market.html

According to TMR, Thermo Fisher Scientific Inc., Dickinson and Company, GE Healthcare, Sartorius AG, and Lonza are some of the leading companies operating in the market. The position in the market is established by leading players and they are enjoying brand loyalty among customers. These manufacturers have extensive distribution network across the world and offer a wide variety of product range. On the back of these factors, they enjoy a stronghold in the global cell culturemarket.

According to TMR report, the global cell culture market is expected to register a 9.5% CAGR during the forecast period of 2017 to 2025. The valuation of 2016 was around US$13.00 bn and is anticipated to remain stable by the end of the forecast period. Owing to increased focus on Research and Development activities, and the development of healthcare sector and high unmet clinical needs in the region, the cell culture market is expanding with 10.0% CAGR in Asia Pacific.

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Increase Use of Stem-Cell Structure to Boost Market

Stem cell culture aids in the stabilization of manufacturing of drugs and allows to produce a wide variety of cell lines and its related products. There is a high potential for growth of the cell culture market with applications likestem cellresearch in the years to come. Stem cell therapies serve to treat the cause of the disease whereas the old time pharmaceutical therapeutics could only aid in treating the symptoms of the disease. Thus, there is high prospect for the global cell culture market in the field of stem cell culture for developing drugs.

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Cell structure is considered one of the most important steps in biosimilar production for antibodies. Cell structure reduces manufacturing cost and also increases the productivity and efficiency of biosimilar antibodies.

A majority of manufacturers are persistently trying to expand their product portfolio by launching new and advanced system for large-scale production. This involves both low risk of contamination and is cost-effective providing a win-win situation for the manufacturers.

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Strict Regulatory Framework and High Quality Standards Restricting Growth

The imposition of solid regulatory framework and high quality standards set by market leaders may limit the speed of market perforation by newcomers. Furthermore, ethical issues corresponding to the use of high cost of infrastructure, stringent regulations, and fetal bovine serum required for cell culture are expected to hinder the market during the forecast period.

However, there is increase in scope for the use of cell culture in biologics as the research and development in biopharmaceuticals field concentrates on the discovery of new therapeutics for new mechanisms of drug action and rare diseases. Owing to the treatment of chronic diseases in both developing as well as developed countries, there is an increase in demand for cost-effective and efficient products. With this, the demand for approval of biosimilar products have also raised. Due to the rise in demand, the global cell culture market is anticipated to provide lucrative opportunities in the course of the forecast period.

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This review is based on the findings of a TMR report titled, Cell Culture Market (Product - Instruments (Cell Culture Vessels (Bioreactors), Carbon Dioxide Incubators, Biosafety Cabinets, Cryogenic Tanks), Mediums (Chemically Defined Mediums, Classical Mediums, Lysogeny Broths, Serum-free Mediums, Protein-free Mediums, Specialty Mediums), Sera, Reagents (Growth Factors & Cytokines, Albumin, Protease Inhibitors, Thrombin, Attachment Factors, Amino Acids); End use - Biotechnology Companies, Pharmaceutical Companies, Academic Institutes, and Research Institutes) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2017 - 2025.

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Cell Culture Market: Chemically Defined Mediums Adaptation to Boost Market Growth - BioSpace

Additional Analytical Results of the US-Based Phase 2b Clinical Trial of Regenerative Cell Medicine SB623 for the Treatment of Chronic Motor Deficit…

By Stem Cell Treatment

TOKYO--(BUSINESS WIRE)--SanBio Co., Ltd. (headquarters: Chuo-ku, Tokyo, Representative Director and President: Keita Mori, hereafter SanBio) hereby announces that it has obtained new analytical results from the Phase 2b clinical trial (the trial) of SB623 for the treatment of chronic motor deficit resulting from ischemic stroke the SanBio Group (SanBio Co., Ltd. and its subsidiary SanBio, Inc.) conducted in the US. It also announces that based on the newly obtained results, it has updated its development plans, including in regard to late-stage clinical trials for the ischemic stroke and hemorrhagic stroke programs of SB623 in Japan.

The trial evaluated efficacy and safety of SB623 in 163 patients suffering from chronic motor dysfunction from ischemic stroke. On January 29, 2019, SanBio announced that the trial did not meet its primary endpoint, as it failed to demonstrate statistical significance in the difference in the proportion of patients whose Fugl-Meyer Motor Scale (FMMS) score improved by 10 or more points from the baseline (primary endpoint) between the treatment group that received SB623 and the control group. Since then, the SanBio Group had continued to work on additional analysis of the trial data, and results of the additional analysis are as follows.

In conducting the additional analysis, from the perspective of minimal clinically important difference (MCID, or the minimal change in scores or other metrics that could be interpreted to mean the change in a patient is clinically meaningful) and based on the results of the Phase 2 clinical trial of SB623 for the treatment of chronic motor deficit from traumatic brain injury (TBI; STEMTRA trial), the company reevaluated trial data using composite FMMS. Of the total 163 patients enrolled in the trial, the company specifically looked at 77 patients who had infarct areas smaller than a certain size (47% of all patients enrolled in this trial). The SanBio Group evaluated the proportion of patients that met one or more of the following FMMS score improvement criteria 24 weeks after treatment: 6-point improvement on FMMS score for upper extremity, 4-point improvement on FMMS score for lower extremity, and 9-point improvement on FMMS total score (all from the baseline). Of the 51 patients in the treatment group that received SB623, improvement was seen in 49%, versus in 19% of 26 patients in the control group that received sham surgery, the difference between the two groups being statistically significant (p-value of 0.02). SanBio Group thinks that even compared to the primary endpointthe proportion of patients whose FMMS score improved by 10 or more points over the baseline six months after treatmentthe endpoint using composite FMMS can adequately explain clinical significance of the treatment efficacy. Details of the additional analysis results will be announced at the financial results briefing for institutional investors and the media held on September 15, 2020. The briefing video will be made available to the public on our website on the 16th of September or thereafter.

Based on the above results, the SanBio Group has begun preparations for the next late-stage clinical trials in the ischemic stroke and hemorrhagic stroke programs of SB623. 2021. Specific designs of the clinical trials and the contents of development for those two programs will be announced promptly upon being finalized. To maximize the value of SB623 at an early stage by selecting areas to focus the Groups management resources on, the SanBio Group plans to prioritize the development of the ischemic stroke and hemorrhagic stroke programs in Japan at the same time as it prepares to file for approval of SB623 for the treatment of chronic motor deficit resulting from TBI in Japan by the end of the current fiscal year (ending January 2021). The Group, however, postponed the global Phase 3 clinical trial for the TBI program of SB623 it had planned to commence this fiscal year to the next or subsequent fiscal years.

Many patients suffering from the chronic effects of ischemic stroke are said to be regularly taking drugs to prevent recurrence. However, because there is no drug that can fundamentally cure motor dysfunction, there is high unmet need for therapeutic drugs to restore motor functions for patients in the chronic phase of stroke. The SanBio Group aims to contribute to improving the lives of these patients, as well as of their family members, suffering from motor impairment and difficulties it causes in carrying out their daily lives through SB623.

About SB623

SB623 is an allogeneic mesenchymal stem cell produced by modifying and culturing bone marrow derived from healthy donors. Implantation of SB623 cells into nerve tissues is expected to promote regeneration of damaged nerve cells. Because SB623 is made from allogeneic cells, large-scale production is possible and there is no need for complex cell processing required for treatments using autologous cells, e.g., cell preparation for each patient at medical institutions. Hence, pharmaceutical products made from allogeneic cells, such as SB623, can be provided to many patients in uniform quality.

About SanBio Co., Ltd. and SanBio, Inc.

SanBio Group is engaged in the regenerative cell medicine business, spanning research, development, manufacture, and sales of regenerative cell medicines. The Companys propriety regenerative cell medicine product, SB623, is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and ischemic stroke. The Company is headquartered in Tokyo, Japan and Mountain View, California, and additional information about SanBio Group is available at https://sanbio.com.

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Additional Analytical Results of the US-Based Phase 2b Clinical Trial of Regenerative Cell Medicine SB623 for the Treatment of Chronic Motor Deficit...

Outcomes After Daratumumab Addition to Induction Therapy in Newly Diagnosed Multiple Myeloma – Hematology Advisor

By Stem Cell Treatment

The addition of daratumumab (D) to standard frontline lenalidomide, bortezomib, and dexamethasone (RVd) induction therapy prior to autologous stem cell transplantation (ASCT) yielded higher rates of stringent complete response (sCR) and minimal residual disease (MRD) negativity compared with RVd in patients with newly diagnosed multiple myeloma (MM), according to results from the phase 2 GRIFFIN trial (ClinicalTrials.gov Identifier, NCT02874742), which was published in Blood.

Eligible patients with newly diagnosed MM (207 patients) were randomly assigned (1:1) to receive 4 cycles of D-RVd or RVd induction, 2 cycles of ASCT, D-RVd or RVd consolidation, and 26 cycles of lenalidomide plus D or lenalidomide maintenance. The primary endpoint was sCR rate by the end of post-ASCT consolidation.

The median patient age was 59 years (range, 29-70 years) in the D-RVd arm and 61 years (range, 40-70 years) in the RVd arm. Other patient and disease characteristics were also well balanced among the arms.

The sCR rate by the end of post-ASCT consolidation was higher in the D-RVd arm compared with the RVd arm (42.4% vs 32.0%; odds ratio, 1.57; 95% CI, 0.87-2.82; 1-sided P =.068; meeting the prespecified 1-sided a of 0.10). The rate of MRD negativity (10-5 threshold) was also higher in the D-RVd arm compared with the RVd arm (21.2% vs 5.8%; P =.0019) in the intent-to-treat population.

At a median follow up of 22.1 months, the responses deepened in both arms. The sCR rates improved to 62.6% for D-RVd and 45.4% for RVd (P =.0177); the MRD negativity rates also improved (51.0% vs 20.4%, respectively; P <.0001).

Neither median progression-free survival (PFS) nor overall survival were reached in either arm. The Kaplan-Meier estimate of the 24-month PFS rates were 95.8% and 89.8% in the D-RVd and RVd arms, respectively. Disease progression occurred in 3.8% and 6.8% of patients in the D-RVd (4 patients) and RVd arm (7 patients), respectively.

No new safety concerns were reported. Grade 3/4 hematologic adverse events were more common with D-RVd compared with RVd (neutropenia, 41.4% vs 21.6%; lymphopenia, 23.2% vs 21.6%; thrombocytopenia, 16.2% vs 8.8%; leukopenia, 16.2% vs 6.9%; anemia, 9.1% vs 5.9%). Infections were more common with D-RVd compared with RVd (90.9% vs 61.8%); however, grade 3/4 infection rates were similar between the arms (23.2% vs 21.6%).

Study results from GRIFFIN are promising and practice informing; this randomized phase 2 study was designed to expediently provide efficacy and safety information on a new regimen of great interest to myeloma clinicians, wrote the authors.

These results provide a support for the ongoing phase 3 PERSEUS registration study (ClinicalTrials.gov Identifier: NCT03710603), which is assessing PFS in transplant-eligible patients with newly diagnosed MM receiving D-RVd or RVd.

Disclosures: Some authors have declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.

Voorhees PM, Kaufman JL, Laubach JP, et al. Daratumumab, Lenalidomide, Bortezomib, & Dexamethasone for Transplant-eligible Newly Diagnosed Multiple Myeloma: GRIFFIN. Blood. 2020;136(8):936-945. doi:10.1182/blood.2020005288

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Outcomes After Daratumumab Addition to Induction Therapy in Newly Diagnosed Multiple Myeloma - Hematology Advisor

What Certain Patients with DLBCL Need To Know About Monjuvi-Revlimid – Curetoday.com

By Stem Cell Treatment

The combination of Monjuvi (tafasitamab-cxix) and Revlimid (lenalidomide) is a recently approved treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are unable to undergo autologous stem cell transplant, and while there are still questions to be answered about its sequencing, it may work best just after stopping a previous therapy, according to the lead researcher of the study that led to its approval.

In an interview with CURE, Dr. Gilles Salles, head of the hematology department of the Centre Hospitalier Lyon-Sud in France, discusses the key factors patients should know about the treatment and what physicians should discuss with them before they start taking the combination.

Transcription:

They should probably know that the sooner this form of therapy is installed, the better the result. That is classical in cancer, but when you are at the first failure of your previous line, it works a little bit better than when you use it later.

What they should know is that other agents have been approved, essentially in the third-line setting, and we have been talking about CAR-T cells. And CAR-T cells are genetically engineered immune cells, T cells that fight the disease. This is a great tool for patients. We don't know exactly at this time how we should optimally sequence, if needed, the combination of tafasitamab/lenalidomide and CAR-T cell, whether it's better to use one before, like tafasitamab, or whether it may or not diminish the potential efficacy of CAR-T cell in the future.

So, it's the ideas and research here, so we need to discuss that with patients. Other than that, what they should know is that, at the present time for patients that have got benefit of (therapy for) this disease, there is a continuous treatment. Tafasitamab is delivered as an IV infusion every two weeks, so they have to continue to come to the hospital every two weeks to receive an infusion.

But this infusion is given, it's usually much better tolerated when we go further down the road. We actually stop lenalidomide, the second drug, after one year and we use tafasitamab alone; that has much less side effect and the infusion lasts 90 minutes. And we do hope that continuing this treatment will prevent any recurrence of the disease.

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What Certain Patients with DLBCL Need To Know About Monjuvi-Revlimid - Curetoday.com

LAVA Therapeutics, Amsterdam UMC and Monash University Announce Publication of a Novel Cancer Immunotherapy Approach in Nature Cancer – Business Wire

By Stem Cell Treatment

UTRECHT, The Netherlands & PHILADELPHIA--(BUSINESS WIRE)--LAVA Therapeutics B.V., a biotech company pioneering bispecific gamma-delta T cell engagers for cancer, Amsterdam UMC and the Monash Biomedicine Discovery Institute in Australia, today announced that Nature Cancer has published their co-authored paper titled, A single domain bispecific antibody targeting CD1d and the NKT T cell receptor induces a potent antitumor response, detailing a novel immune-oncology approach for the potential treatment of cancer.

Findings in the paper highlight the potential for a LAVA-derived antibody fragment, known as a single domain antibody, that acts as a bridge to link together two key immune cell receptors the CD1d receptor and the T cell receptor of natural killer T (NKT) cells in order to enhance the bodys immune response to cancer. The CD1d receptor is frequently expressed by tumor cells and NKT cells are positioned at the interface between the innate and adaptive immune system and play an important role in the host-rejection of both tumors and virally infected cells. Preclinical research through the companies collaboration demonstrates that a CD1d-NKT cell targeting antibody resulted in significant activation of NKT cells and the subsequent killing of CD1d-expressing tumor cells in multiple tumor samples, including multiple myeloma and acute myeloid leukemia.

These data underscore the potential of LAVAs bispecific antibody approach to target and activate NKT cells for the treatment of cancer, said Hans van der Vliet, professor in medical oncology at Amsterdam UMC and chief scientific officer of LAVA Therapeutics. By targeting and boosting natural immune cells that are inherent in all humans, such as NKT and gamma-delta T cells, for an enhanced therapeutic effect, our approach could translate into a broadly applicable immunotherapeutic strategy for treating a range of cancer indications.

Using the Australian Synchrotron, the team at Monash University provided detailed atomic insight into how the single domain antibodies exerted their effect on immune cells in a cancer model. Through this, we were able to precisely visualize how the single domain antibody simultaneously recognized CD1d and the NKT T cell receptor, thereby providing a molecular basis for their anti-tumor properties, professor Jamie Rossjohn, Australian Research Council Laureate Fellow at Monash University stated. The collaboration with LAVA Therapeutics on this ground-breaking approach was very effective.

Instrumental to the study were joint first authors Dr. Roeland Lameris from Amsterdam UMC and Dr. Adam Shahine from Monash University.

About LAVA Therapeutics

LAVA Therapeutics, B.V., is developing a proprietary bispecific antibody platform that engages gamma-delta T cells for the treatment of hematological and solid cancers. The companys first-in-class immuno-oncology approach activates V9V2 T cells upon binding to membrane-expressed tumor targets. LAVA was founded in 2016 based on intellectual property originating from Hans van der Vliet`s group at the Amsterdam UMC, and is backed by Lupus Ventures, Biox Biosciences, Versant Ventures, Gilde Healthcare and MRL Ventures Fund. The company has established a highly experienced antibody research and development team located in Utrecht, the Netherlands (headquarters) and Philadelphia. For more information, please visit http://www.lavatherapeutics.com.

About the Monash Biomedicine Discovery Institute at Monash University

Committed to making the discoveries that will relieve the future burden of disease, the newly established Monash Biomedicine Discovery Institute at Monash University brings together more than 120 internationally-renowned research teams. Spanning six discovery programs across Cancer, Cardiovascular Disease, Development and Stem Cells, Infection and Immunity, Metabolic Disease and Obesity, and Neuroscience, Monash BDI is one of the largest biomedical research institutes in Australia. Our researchers are supported by world-class technology and infrastructure, and partner with industry, clinicians and researchers internationally to enhance lives through discovery.

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LAVA Therapeutics, Amsterdam UMC and Monash University Announce Publication of a Novel Cancer Immunotherapy Approach in Nature Cancer - Business Wire

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