Avacta and Daewoong Pharmaceutical expand partnership to include COVID-19 neutralising Affimer therapy – Business Wire

CAMBRIDGE & WETHERBY, England--(BUSINESS WIRE)--Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is pleased to announce an expansion of its collaboration and license agreement with Daewoong Pharmaceutical Co. Ltd. (KSX: 069620) and AffyXell Therapeutics, the joint venture established in South Korea by the two companies, to develop stem cell treatments incorporating Avactas neutralising Affimer therapy for the treatment of seriously ill patients with COVID-19 and to also prepare to rapidly develop similar therapies for future global pandemics.

Respiratory diseases such as COVID-19 can cause serious damage to the lungs as a consequence of over-activation of the patient's immune system, resulting in cytokine release syndrome that can potentially lead to multiple organ failure and death. Stem cell therapies offer a very promising approach to repair the damage to lung tissues in these pulmonary diseases by controlling the immune balance.

AffyXell Therapeutics, the next-generation cell and gene therapy joint venture between Avacta and Daewoong Pharmaceutical, is developing a novel class of mesenchymal stem cell (MSC) treatments that are engineered to also produce Affimer therapies in the patient at the site of action.

The expansion of the agreement between Avacta, Daewoong Pharmaceutical and AffyXell announced today extends the scope of the partnership to include Affimer molecules that target viruses, such as coronaviruses, in order to develop therapies that repair the lung damage caused by COVID-19 whilst also producing neutralising Affimer molecules to prevent the progression of the disease.

AffyXell will engineer mesenchymal stem cells to express SARS-COV-2 neutralising Affimer molecules in order to develop treatments for seriously ill COVID-19 patients, and will also prepare for rapid development of next-generation stem cell therapies for future infectious respiratory disease outbreaks.

Dr. Alastair Smith, Chief Executive of Avacta Group commented: I am very pleased to have extended our collaboration and license agreement with Daewoong Pharmaceutical to include the SARS-COV-2 neutralising Affimer molecules for the treatment of COVID-19 and to create the potential to respond very rapidly in future to global virus threats.

AffyXell will address the need over the coming years for advanced stem cell therapies to treat lung damage caused by cytokine release syndrome suffered by COVID-19 patients and, at the same time, help prevent disease progression in these patients through the action of a neutralising Affimer therapy.

More broadly, one of the key areas of unmet clinical need that AffyXell can address with its next-generation mesenchymal stem cell therapies is acute pulmonary diseases such as COPD and acute respiratory distress syndrome. We, and our partners in South Korea, are very excited by the potential to develop life improving treatments for patients with these serious respiratory diseases as well as COVID-19.

I look forward to further updating the market on progress in our ground-breaking programmes with AffyXell in due course, and on progress with our COVID-19 diagnostics programmes shortly.

Seng-ho Jeon, CEO of Daewoong Pharmaceutical and AffyXell Therapeutics, commented:

It is very encouraging that AffyXell now has the opportunity to expand the application of its next-generation stem cell platform technology to target viruses. The SARS-COV-2 neutralising Affimer to be developed in combination with AffyXells cell and gene technology is expected to be an innovative solution for COVID-19 patients suffering cytokine release syndrome.

Daewoong has been also conducting several research programs and clinical trial for COVID-19. As the COVID-19 crisis has caused great difficulties worldwide, we will continue to focus our efforts to develop a novel therapeutic agent for COVID-19.

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

See the original post:
Avacta and Daewoong Pharmaceutical expand partnership to include COVID-19 neutralising Affimer therapy - Business Wire

FDA Approves New CAR-T Therapy for Mantle Cell Lymphoma – Cancer Health Treatment News

On July 24, the Food and Drug Administration (FDA) granted accelerated approval of a new CAR-T therapy, Tecartus (brexucabtagene autoleucel), for adults with mantle cell lymphoma who have not responded to or who have relapsed after other kinds of treatment.

Tecartus (formerly known as KTE-X19), manufactured by Kite, a Gilead Company, is a living drug that reprograms a patients own T cells to fight cancer. About two thirds of participants treated in the ZUMA-2 study experienced complete remission, which in a majority of cases lasted at least a year.

"This approval is yet another example of customized treatments that use a patients own immune system to help fight cancer, Peter Marks, MD, PhD, director of the FDAs Center for Biologics Evaluation and Research, said in a press release. Were seeing continued advances in the field of gene therapy and remain committed to supporting innovation in this promising new area of medicine.

Mantle cell lymphoma (MCL) is an uncommon form of non-Hodgkinlymphoma that involves overgrowth of abnormal B cells in lymph nodes. By the time it is diagnosed, MCL has often spread to the bone marrow and other organs, and it is frequently refractory (nonresponsive) to existing treatments or relapses following a period of remission.

Chimeric antigen receptor T-cell therapybetter known as CAR-Tinvolves removing a sample of a patients white blood cells, genetically reprogramming the T cells to recognize and attack their cancer, manufacturing a large number of the modified cells in a laboratory and infusing them back into the body. Like Kites previously approved CAR-T Yescarta (axicabtagene ciloleucel), Tecartus targets the CD19 protein on B cells, but the manufacturing process includes greater T-cell selection and lymphocyte enrichment.

The Phase II ZUMA-2 trial enrolled 74 adults with relapsed or refractory MCL in the United States and Europe who had previously tried up to five prior therapies. Six people ended up not receiving Tecartus because of manufacturing failures or death due to disease progression.

The primary analysis included 60 treated participants. Most were men, and the median age was 65. Most had Stage IV metastatic cancer, more than 80% had tried three or more prior treatments and 43% had received a bone marrow stem cell transplant.

A sample of the patients T cells were collected and modified, and they received strong conditioning chemotherapy to kill off some of their existing immune cells to make room for the new ones. They then received a single infusion of the genetically engineered cells.

As described at last years American Society of Hematology Annual Meeting and in The New England Journal of Medicine, the overall response rate, meaning complete or partial remission, was 93%, including 67% with complete responses. After a year of follow-up, 57% were still in remission, as were 43% of those followed for two years. The estimated one-year progression-free survival rate was 61%, and the estimated overall survival rate was 83%.

In a press release announcing the approval, Gilead/Kite gave an updated overall response rate of 87% and a complete response rate of 62%.

Therapies that receive FDA accelerated approval based on overall response rates are expected to undergo further testing in larger trials to confirm clinical benefits, and the agencycan rescind approval if they do not measure up. Tecartus is also currently in Phase I/II trials for acute lymphoblastic leukemia and chronic lymphocytic leukemia.

Treatment with Tecartus was generally safe. The most common severe adverse events were low blood cell counts due to the conditioning chemotherapy and infections. Introducing engineered T cells can trigger a strong immune reaction known as cytokine release syndrome (CRS), which can lead to falling blood pressure and organ failure. As previously reported, 15% of study participants experienced Grade 3 or higher CRS, and 31% developed severe neurological side effects. Based on a larger group of patients, Gilead/Kite updated these figures to 18% and 37%, respectively. These side effects were managed with corticosteroids or Actemra (tocilizumab), and none were fatal.

A risk evaluation and mitigation strategy (REMS) for Tecartus has been approved by the FDA and combined with the YescartaREMS (www.YescartaTecartusREMS.com). This program informs health care professionals about the risks associated with CAR-T therapy and how to manage it.

Tecartus will be produced at Kites commercial manufacturing facility in El Segundo, California. The median turnaround time from T-cell collection to administration of the modified cells is around 15 days, according to the press release. The Kite Konnectprogram offers financial and logistical support for eligible patients receiving Tecartus or Yescarta.

Despite promising advances, there are still major gaps in treatment for patients with MCL who progress following initial therapy, ZUMA-2 lead investigator Michael Wang, MD, of University of Texas MD Anderson Cancer Center, said in the press release. Many patients have high-risk disease and are more likely to keep progressing, even after subsequent treatments. The availability of Tecartus as the first-ever cell therapy for patients with relapsed/refractory MCL provides an important option with a response rate of nearly 90% and early clinical evidence suggesting durable remissions in later lines of therapy.

Click here to learn more about lymphoma.

Original post:
FDA Approves New CAR-T Therapy for Mantle Cell Lymphoma - Cancer Health Treatment News

R3 Stem Cell International Now Offering Four Joint Injections for Only $3950 in Mexico – Benzinga

SCOTTSDALE, Ariz., July 29, 2020 /PRNewswire-PRWeb/ -- R3 Stem Cell International is now offering patients the opportunity to receive four stem cell joint injections for only $3950. With 50 million stem cells total, patients may choose which extremities they would like treated.

Several studies have shown just how well stem cell therapy works for arthritic joints (BMC Musculoskelet Disord. 2016). At R3 International, umbilical cord tissue is obtained from a lab with a long history of accreditation and pristine safety record. The lab abides by quality assurance standards that exceed those of the FDA.

Stem cell treatment for knees in Mexico at R3 works amazingly well. Patient satisfaction surveys at the center reveal that nine out of ten patients say they would have the procedure again and recommend it to friends and family.

According to R3 CEO David Greene, MD, MBA, "The biologics don't need preservative and viability exceeds 95%. The pureness and potency truly makes the difference in outcomes. Four joints for under $4000? What we put together for patients is incredible!"

The treatment process begins with a free phone consultation with one of R3's licensed, experienced stem cell doctors. Because the treatment includes 50 million stem cells, four joints may be included. The dedicated patient concierge representative assists with travel logistics. Travel from San Diego is included to the clinic, which is only 20 minutes from the San Diego airport.

Image guidance is used at the Center to ensure injection accuracy. In addition to arthritis treatment, R3 International offers stem cell treatment for autism, Lyme, COPD, kidney failure, neuropathy, diabetes, MS, ALS, stroke and much more.

Call (888) 988-0515 to learn more about therapies offered, and visit https://stemcelltreatmentclinic.com to read about the process.

SOURCE R3 Stem Cell International

See the rest here:
R3 Stem Cell International Now Offering Four Joint Injections for Only $3950 in Mexico - Benzinga

Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 – Bulletin Line

Global Stem Cell Therapy market report presents an overview of the market on the basis of key parameters such as market size, revenue, sales analysis and key drivers. The market size of global Stem Cell Therapy market is anticipated to grow at large scale over the forecast period (2020-2025). The main purpose of the study report is to give users an extensive viewpoint of the market. So that users can apply strategic processes to benchmark themselves against rest of the world. Key drivers as well as challenges of the market are discussed in the report. Also reports provides an in depth analysis of the Stem Cell Therapy market with current and future trends.

Get Sample Copy of this Report:https://www.adroitmarketresearch.com/contacts/request-sample/691

In addition, study report offers an array of opportunities for the players participating in the industry. This ultimately leads into the growth of the global Stem Cell Therapy market. Furthermore, report offers a comprehensive study on market size, revenue, sales, growth factors and risks involved in the growth of the market during the forecast period. The factors which are influencing the growth the market are mentioned in the report as well as the challenges which can hamper the growth of the market over the forecast period.

The main objective of this research report is to present the comprehensive analysis about the factors which are responsible for the growth of the global Stem Cell Therapy market. The study report covers all the recent developments and innovations in the market for a Stem Cell Therapy. The global keyword market is likely to provide insights for the major strategies which is also estimated to have an impact on the overall growth of the market. Several strategies such as the PESTEL analysis and SWOT analysis is also being covered for the global market. These strategies have an impact on the overall market.

Browse the complete report @https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market

Global Stem Cell Therapy market is segmented based by type, application and region.

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCs Bone Marrow-Derived Mesenchymal SCs Embryonic SCs Other Sources

Based on therapeutic application, the market has been segmented into,

Musculoskeletal Disorders Wounds & Injuries Cardiovascular Diseases Gastrointestinal Diseases Immune System Diseases Other Applications

The research report on global Stem Cell Therapy market ensures users to remain competitive in the market. Also report helps to identify the new innovations and developments by existing key players to increase the growth of the global Stem Cell Therapy market. Study report covers all the geographical regions where competitive landscape exists by the players such as North America, Europe, Latin America, Asia-Pacific and Middle East Africa. Thus report helps to identify the key growth countries and regions.

In addition, report presents quantitative as well as qualitative narration of global Stem Cell Therapy market. The research report is beneficial for educators, researchers, strategy managers, academic institutions and analysts. Thus report helps all types of users to identify the strategic initiatives so that they can understand how to expand the global Stem Cell Therapy market business across the globe for the product development. Moreover, research report provides in depth analysis of all the segments which can impact on the market growth.

For Any Query on the Stem Cell Therapy Market:https://www.adroitmarketresearch.com/contacts/enquiry-before-buying/691

About Us :

Adroit Market Research is an India-based business analytics and consulting company. Our target audience is a wide range of corporations, manufacturing companies, product/technology development institutions and industry associations that require understanding of a markets size, key trends, participants and future outlook of an industry. We intend to become our clients knowledge partner and provide them with valuable market insights to help create opportunities that increase their revenues. We follow a code Explore, Learn and Transform. At our core, we are curious people who love to identify and understand industry patterns, create an insightful study around our findings and churn out money-making roadmaps.

Contact Us :

Ryan Johnson Account Manager Global 3131 McKinney Ave Ste 600, Dallas, TX 75204, U.S.A Phone No.: USA: +1 972-362 -8199 / +91 9665341414

Continue reading here:
Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 - Bulletin Line