Cell therapies involve the transfer of live cells into a patient to help treat, prevent or potentially cure diseases. One category of cell therapy focuses specifically on the use of stem cells, or cells within the body that have the potential to replace those that are lost through injury or disease. Their versatility and ability to transform allow them to replace problematic or deactivated cells with new, healthy ones is giving patients around the world a second chance at life.Stem cells are found all throughout the human bodyincluding the skin, muscle tissue and even deep inside bone marrow.

Bone marrow, the spongy substance that fills the inner cavities of our bones, is a rich source ofhematopoietic stem cells. These cells are particularly valuable for their ability to develop into all types of blood cells, including white blood cells, red blood cells and platelets. Due to their unique ability,hematopoietic cells can be used to treat certain types of cancer, such as leukemia and lymphomaand have become a staple in the field of regenerative medicine.

Bone marrow aspirate concentrate(BMAC) is a procedure that collects bone marrow from a patient's body and then concentrates it to create the optimal level of stem cells and other crucial growth factors, which can offer a variety of health benefits that traditional surgical methods simply can't offer. Stem cells and their descendants, known as progenitor cells, combined with other bone marrow cells and platelets, have the potential to restore function when injected directly into the patient's damaged tissue. The BMAC procedure is popularly used by physicians who practice orthopedic surgery, pain management and sports medicine. It has been shown torepair tissue damage, preserving function and strengthand in some cases has even beenused as an alternative for more intensive procedures such as joint and hip replacements.

Bone Marrow Aspirate Concentrate is currently being used to:

While there are many bone marrow concentrate technologies currently out on the market, there are none quite like theThermoGenesis PXPSystem. The PXPSystem is an automated, closed system designed for sterile bone marrow separation and concentration. The automated system utilizes highly sensitive sensors to reduce the amount of red blood cells (RBCs) from the initial bone marrow aspirate, providing physicians with a high-quality final product.Red blood cell contaminationis, by far, the biggest issue physicians encounter when using open, non-automated bone marrow processing systems. When high RBC contamination occurs in the bone marrow concentrate, it can impair cell function and diminish the overall effectiveness of the cell treatments. The PXPSystem is specifically designed to eliminate RBCs contamination head-on, boasting aRBC reduction of over 99 percent.

[Link]

The PXPSystem obtains bone marrow concentrates easily, consistently, and reliably, setting itself apart from any other competitors on the market today. The automated nature of the system eliminates factors created by human error and allows for increased precision and control. It gives its user the ability to harvest a precise volume of cell concentrate from the bone marrow aspirate, while producing consistently high mononuclear cells (MNCs) and CD34+ progenitor cell recoveries.

[Link][Link]

Bone marrow aspirate is collected from the patient through a minimally invasive procedure, usually done under local or general anesthesia. After extraction, the aspirate is transferred into the PXP System and processed in a centrifuge to compartmentalize the aspirate into three separate chambers within the Disposable Cartridge - the central processing chamber, the red blood cell depletion chamber and the harvest chamber. The plasma, nucleated cells and RBCs are all sorted by density to create maximum separation of components. The RBCs are then removed and transferred to the depletion chamber, leaving users with a 6 ml harvest of enriched bone marrow concentrate (containing stem cells, platelets, growth factors) ready to be reintroduced into the patient.

The entire process only takes about twenty minutes from the moment the bone marrow aspirate is placed in the system to the point where it can be reinjected. For added convenience, the automated control module provides users with accurate data tracking and serves as a record for the entire process.

The PXPSystem is a tool for physicians looking for a quick, easy and efficient system for processing bone marrow. It is one of the most innovative systems available on the market and our mission is to make it even better. We are currently working with our partners in the field and evolving our products based on their feedback. Based on their response, we've begun designing a stripped-down version of the PXPSystem that requires less accessories and generates a smaller footprint, while still delivering a high-quality final product. Our applications are being developed with the needs of laboratories and physicians in mind, giving them the resources, they need to better serve their patients.

ThermoGenesis Holdings, Inc. (formerly Cesca Therapeutics Inc.), is a pioneer and market leader in the development and commercialization of automated cell processing technologies for the cell and gene therapy fields. We market a full suite of solutions for automated clinical biobanking, COVID-19 testing, point-of-care applications and large-scale cell processing and manufacturing with a special emphasis on the emerging CAR-T immunotherapy market. We are committed to making the world a healthier place by creating innovative solutions for those in need.

To see our full suiteof automated solutions,please visit the shop portion of our website today.

Disclaimer

Thermogenesis Holdings Inc. published this content on 08 December 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 December 2020 18:24:01 UTC

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The Technology Behind Bone Marrow Cellular Processing: The PXP System - marketscreener.com

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Dec. 8, 2020 16:00 UTC

DUARTE, Calif.--(BUSINESS WIRE)-- City of Hope doctors participated in research presented at the American Society of Hematology (ASH) virtual meeting, Dec. 5 to 8, that are helping advance the treatment of blood cancers, including one study which demonstrated allogeneic stem cell transplants do have a survival benefit for older adults with myelodysplastic syndromes (MDS) compared with current standard of care.

The study is the largest and most definitive trial to demonstrate the benefits of an allogeneic stem cell transplantation for older adults with MDS, and is just one of numerous studies that City of Hope doctors help lead with the aim of finding more effective treatments of various blood cancers.

This years ASH conference truly showcases City of Hopes leadership in finding more effective treatments for blood cancers, said Stephen J. Forman, M.D., director of City of Hopes Hematologic Malignancies Research Institute. Whether its finding innovative treatments to make it possible for more older adults with cancer to receive stem cell transplants, or pursuing therapies that are more effective with fewer side effects, City of Hope doctors continue to lead innovative research in blood cancers and other hematological malignancies.

City of Hope doctors are leading novel clinical trials for patients with leukemia, lymphoma and other blood cancers.

Multicenter clinical trial led by City of Hope makes stem cell transplant possible for older adults with myelodysplastic syndromes

Allogeneic hematopoietic cell transplantation, or stem cell/bone marrow transplants, for blood cancers that have recurred or are difficult to treat can put the disease into long-term remission and provide a potential cure. The therapy establishes a new, disease-free blood and immune system by transplanting healthy blood stem cells from a donor into a cancer patient after destroying the patients unhealthy bone marrow.

City of Hope and other institutions started this therapy in 1976, primarily for younger patients with blood cancers. The therapy involves using high-dose chemotherapy and/or radiotherapy to make room for a person to receive new stem cells; serious side effects can also occur after transplant. Because of these and other considerations, for many years, older adults with blood cancers have not been considered for transplants.

City of Hope has been leading the way to make transplants possible for more older adults with various cancers.

A new study presented at ASH demonstrates transplants are now a possibility and beneficial for patients with myelodysplastic syndromes (MDS). Approximately 13,000 people in the United States each year are diagnosed with MDS, an umbrella term describing several blood disorders that begin in the bone marrow.

Co-led by City of Hopes Ryotaro Nakamura, M.D., director of City of Hopes Center for Stem Cell Transplantation, the study is the largest and first trial to demonstrate the benefits of an allogeneic stem cell transplantation for older adults with MDS as opposed to the standard of care currently provided to these patients. The multicenter trial for patients aged 50 to 75 with serious MDS compared how long transplant patients survived with those who didnt receive a transplant, as well as disease progression and quality of life. The transplant therapy used reduced-intensity conditioning, which delivers less chemotherapy and radiation before transplant and relies more on the anti-tumor effects of the therapy.

Between 2014 and 2018, the study enrolled 384 participants at 34 cancer centers nationwide. It included 260 patients who were able to find a donor for a transplant, as well as 124 patients who did not find a donor for a transplant.

After three years, nearly 48% of MDS patients who found a donor for transplant had survived compared with about 27% of those patients who didnt have a donor for transplant and received current hypomethylating therapy, a type of chemotherapy that is current standard of care for MDS. Leukemia-free survival which is relevant because myelodysplastic syndrome can develop into leukemia was also greater in transplant recipients after three years nearly 36% compared with about 21% for those who did not have a transplant.

There was a large and significant improvement in survival for patients who had a transplant, Nakamura said. The benefit margin in overall survival was over 20% (21.3%) for patients who had a transplant.

In addition, quality of life was the same for both transplant and nontransplant patients. There were no clinically significant differences when taking such measurements as physical and mental competency scores.

This is an extremely exciting study because it provides evidence that stem cell transplant is highly beneficial for older patients with serious MDS and will likely be practice-changing for this group, Nakamura said. Before, many doctors wouldnt even consider a transplant for this group of patients, but our study demonstrates that these patients should be evaluated for a transplant, which could potentially provide a cure for their disease.

The trial is part of Blood and Marrow Transplant Clinical Trials Network, which was established with support from the National Heart, Lung, and Blood Institute and National Cancer Institute, because of a critical need for multi-institutional clinical trials focused directly on improving survival for patients undergoing hematopoietic cell transplantation.

Updated results from a study of a potential new CAR T cell therapy, liso-cel, for relapsed/refractory chronic lymphocytic leukemia

Patients with relapsed or difficult-to-treat chronic lymphocytic leukemia/small lymphocytic leukemia continue to do well 24 months after receiving lisocabtagene maraleucel (liso-cel) chimeric antigen receptor (CAR) T cells, according to Tanya Siddiqi, M.D., director of City of Hopes Chronic Lymphocytic Leukemia (CLL) Program, which is part of the Toni Stephenson Lymphoma Center. She presented these findings during the 2020 ASH annual meeting virtual conference.

Overall, 23 and 22 patients were evaluated for safety and efficacy in this phase 1 trial, respectively. Their median age was 66 and they had received a median of four prior therapies; all patients had received prior ibrutinib, which is one of the standard of care drugs for CLL.

The overall response rate, or patients whose CLL diminished after liso-cel CAR T cell therapy, was 82%, and 45% of patients also had complete responses, or remissions.

After 15 months of treatment, 53% of patients maintained their responses to the therapy, and six patients continued to be in remission. After 18 months, 50% of patients maintained their response, and there were five remissions. All seven patients who completed the 24-month study maintained their response. Median progression-free survival, or the amount of time the cancer did not worsen during and after treatment, was 18 months.

As early as 30 days after receiving liso-cel, about 75% of 20 patients evaluated for the therapys efficacy had undetectable minimal residual disease (MRD, or no detectable traces of cancer) in the blood and 65% had undetectable MRD in the marrow.

These are remarkable results for a group of patients that prior to this CAR T treatment had no good treatment options if they had already progressed on novel targeted therapies like ibrutinib and venetoclax, Siddiqi said. Liso-cel is providing new hope for CLL patients, and the remissions are also long lasting with few serious side effects.

Because of its safety and effectiveness in clinical trials, liso-cel, which targets the CD19 protein on cancer cells, may soon receive approval from the Food and Drug Administration as a commercial therapy for relapsed or refractory B cell lymphoma. City of Hope is also taking part in the phase 2 trial of liso-cel in CLL patients.

Consolidation treatment with brentuximab vedotin/nivolumab after auto stem cell transplant for relapsed/refractory Hodgkin lymphoma patients leads to 18-month progression free-survival

Patients who have Hodgkin lymphoma that has not been cured by initial treatment will usually receive more chemotherapy and an autologous hematopoietic cell transplant. But even after a stem cell transplant, recurrence of the lymphoma is possible.

This multicenter phase 2 clinical trial, led by City of Hope, examined whether treating patients with brentuximab vedotin (BV), an antibody-based treatment that targets delivery of chemotherapy only to Hodgkin lymphoma cells, and nivolumab, which works by blocking the PD-1 immune checkpoint pathway that Hodgkin lymphoma hijacks to evade the immune system, was safe and effective as consolidation to prevent disease recurrence after transplant in patients with high-risk Hodgkin lymphoma.

Alex Herrera, M.D., assistant professor in City of Hope's Department of Hematology & Hematopoietic Cell Transplantation, discussed 19-month progression-free survival for trial participants, as well as overall survival, safety and response rates during ASH.

Fifty-nine patients were enrolled in the trial. Patients received the consolidation treatment starting a median of 54 days after transplant, and received a median of eight cycles of the therapy. The 19-month progression-free survival in patients was 92%, and overall survival in patients was 98%. Only three patients relapsed after receiving BV and nivolumab consolidation after transplant, and one patient passed away due to PCP pneumonia unrelated to the study treatment.

The most common sides effects related to the treatment were peripheral neuropathy (51%), neutropenia (42%), fatigue (37%) and diarrhea (29%).

Using brentuximab vedotin and nivolumab after transplant is a promising approach for preventing relapse of Hodgkin lymphoma after transplant that merits further study, Herrera said.

City of Hope doctors published research on innovative approaches against graft-versus-host-disease

Historically, a bone marrow/stem cell transplant is more likely to be effective if patients have a donor who is a 100% match, or as close to that as possible. Finding that perfect match is more difficult for African Americans, Latinos, Asian Americans and other ethnic groups as bone marrow donor registries are still trying to increase the number of non-white donors.

Transplant doctors are also looking for ways to make the transplant more effective if a perfect match cant be found; donors who are not a 100% or close match are referred to as mismatched unrelated. One major barrier to these transplants being effective is a condition known as graft-versus-host-disease (GVHD). The condition, which is more common in transplants involving mismatched donors, is caused by donated cells that recognize the recipient's cells as foreign and attack them, damaging the skin, eyes, lungs, liver and digestive tract.

In order to help prevent GVHD, therapies can be given to patients after transplant. A prospective clinical trial at City of Hope examined whether using cyclophosphamide after an infusion of stem cells could prevent GVHD.

Thirty-eight patients were enrolled in the trial, which is the first to examine the use of cyclophosphamide in transplants with a mismatched unrelated donor.

With a median follow-up period of 18 months, 87% of patients had survived, and the majority did not relapse or develop severe GVHD.

During the first 100 days post-transplant, acute GVHD incidence was around 50%; most cases were mild to moderate while severe GVHD was only 15%. A year after transplant, 52% of patients had some form of chronic GVHD, but only 3% had moderate or severe chronic GVHD.

The trial also examined toxicities, infections and immune system recovery after the transplant.

Our study showed that patients who received a transplant from a mismatched unrelated donor using post-transplant cyclophosphamide had a comparable outcome to what we see in matched donor transplants with few cases of serious GVHD cases, said Monzr Al Malki, M.D., associate clinical professor of City of Hopes Department of Hematology & Hematopoietic Cell Transplantation and director of unrelated donor BMT and haploidentical transplant programs. Our data support further development of this therapy in transplant patients who would otherwise have no suitable donors and limited treatment options.

City of Hopes Anthony Stein, M.D., also led a pilot trial that examined whether a new treatment approach may reduce the rate of GVHD in patients with acute myelogenous leukemia (AML) who have received an allogeneic hematopoietic cell transplant. Although a transplant can put AML into remission, GVHD remains the main serious complication after transplant, impacting a patients quality of life and increasing health care costs.

Eighteen patients between the ages of 18 and 60 enrolled in the trial. Each patient received a novel conditioning regimen of total marrow and lymphoid irradiation, which targets a patients marrow and lymph nodes while reducing radiation to other parts of the body, and cyclophosphamide, a therapy that suppresses the immune system. Tacrolimus was also provided to patients.

Radiation was delivered twice daily on the fourth day before transplant and on the day of transplant without chemotherapy. Cyclophosphamide was given to patients on the third and fourth day after transplant.

There were mild to moderate toxicities. Acute GVHD developed in two patients and only one patient developed the most serious GVHD. Five patients developed mild chronic GVHD. Nearly 60% of patients had not developed GVHD or the condition had not worsened after a year.

After a year, all patients had survived, and 83% had not relapsed. After two years, nearly 86% of patients had survived, and the relapse number remained the same.

The therapeutic approach did not interfere with the transplant process as all patients engrafted, or the donors cells started to produce bone marrow and immune cells.

This is welcome news for AML patients who receive an allogeneic transplant and are concerned about developing GVHD, said Stein, associate director of City of Hope's Gehr Family Center for Leukemia Research. Our study demonstrated that using this new combination of therapies is safe and feasible and does not interfere with the engraftment process.

In addition, after a year, patients in this trial were no longer taking immunosuppressive therapy and had an improved quality of life, Stein said. He added that because many of the patients didnt have GVHD, health care costs after a year were also lower than if patients required treatment for the condition.

City of Hope now plans to start a larger phase 2 trial using this treatment approach.

Bispecific antibodies continue to show promise against blood cancers

Mosunetuzumab is a promising new immunotherapy for the treatment of relapsed/refractory non-Hodgkin lymphoma (NHL) that recently received breakthrough therapy designation from the Food and Drug Administration. The designation is intended to expedite the development and review of drugs for serious or life-threatening diseases.

Elizabeth Budde, M.D., Ph.D., assistant professor in City of Hope's Department of Hematology & Hematopoietic Cell Transplantation, is leading clinical trials that are showing how well mosunetuzumab works against NHL. At this years ASH, one trial discussed is how the therapy is working for patients with follicular lymphoma.

Mosunetuzumab is a bispecific antibody targeting both CD3 (a protein found on the surface on T cells) and CD20 on the surface of B cells. The therapy redirects T cells to engage and eliminate malignant B cells.

Sixty-two patients, ranging in age from 27 to 85 years old, were enrolled in the trial for follicular lymphoma. They received intravenous doses of mosunetuzumab.

Sixty-eight percent of the patients responded to the therapy, and 50% had a complete response, or went into remission. Consistent complete response rates occurred even in patients with double refractory disease and patients who received prior CAR T cell therapy. Median duration of response was approximately 20 months, and media progression free survival was nearly one year.

Side effects were reported in 60 patients with serious adverse effects in 22 patients. The most frequently reported serious side effects were hypophosphatemia, an electrolyte disorder, and neutropenia, a condition caused by low numbers of white blood cells. Fourteen patients experienced cytokine release syndrome, but none required extensive treatment for it.

Neurological side effects included headache, insomnia and dizziness.

Patients in this trial had high response rates and their disease remained in control for a year, Budde said. This is remarkable because many patients were no longer responding to other therapies.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope has been ranked among the nations Best Hospitals in cancer by U.S. News & World Report for 14 consecutive years. Its main campus is located near Los Angeles, with additional locations throughout Southern California. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

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City of Hope Doctors Present Innovative Therapies to Better Treat Blood Cancers at American Society of Hematology Virtual Conference - BioSpace

Skin Stem Cells Comments Off on City of Hope Doctors Present Innovative Therapies to Better Treat Blood Cancers at American Society of Hematology Virtual Conference – BioSpace | December 9th, 2020

HAMBURG, GERMANY / ACCESSWIRE / December 9, 2020 / Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the life science company Sartorius announced today that they have entered into a partnership with the recently established Curexsys GmbH, a Goettingen, Germany-based technology leader specialising in the emerging field of therapeutic exosomes.

Curexsys delivers a proprietary isolation technology for exosomes based on a traceless immune-affinity process. This process is different from commonly used antibody-based processes and enables the company to overcome a key hurdle in exosome preparation, i.e. remaining antibodies in the final preparation. Curexsys is founded by Herbert Stadler, a serial biotech entrepreneur, and Jens Gruber, a former group leader of Medical RNA Biology who is going to lead Curexsys as Chief Scientific Officer.

Under the terms of the agreement, Evotec and Curexsys will collaborate with the production of Human Mesenchymal Stem Cells ("MSCs"), which serve as a source for exosomes. These are small vesicles that are naturally released from a cell. They contain proteins, nucleic acids and metabolites, which carry information from secreting to receiving cells. Exosomes have immunomodulatory and anti-inflammatory effects, which makes them a promising novel approach for innovative regenerative therapies, as therapeutics in age-related conditions, but also for diagnostic purposes. Curexsys aims to develop targeted approaches for a variety of diseases, initially focusing on Sicca Syndrome, commonly known as "dry eye", an inflammatory condition affecting 14% to 17% of the adult population for whom there is currently no effective treatment available.

The collaboration combines Evotec's industry-leading induced Pluripotent Stem Cell ("iPSC") platform with Curexsys' proprietary technology to selectively isolate exosomes. Sartorius will support Curexsys to set up a GMP-compliant and scalable manufacturing platform.

Furthermore, Evotec and Sartorius have formed a consortium to jointly invest in Curexsys' 8.2 m seed financing round with Evotec acquiring an equity stake of approx. 37% in Curexsys and Sartorius of approx. 21%.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Therapeutic exosomes hold significant promise for regenerative medicine and beyond. Steadily increasing evidence suggests that exosomes derived from stem cells can aid tissue repair and engineering vesicles could carry drugs to diseased tissues. These efforts have been held back by a dearth of standardised methods to isolate and study vesicles. Combining Evotec's industrial-grade iPSC and PanOmics platforms with Curexsys' proprietary exosome isolation technology and Sartorius' ability to translate these into a fully GMP-compliant process is a unique opportunity to build the leading exosome company in the industry."

Dr Ren Faber, Head of Sartorius' Bioprocess Solutions Division, said: "With our integrated portfolio of manufacturing solutions Sartorius is the 'go-to' partner for developers of such new modalities when it comes to implementing GMP-compliant, flexible production processes. We are very much looking forward to contributing our proven and scalable technology platform to Curexsys process and help them achieve their next milestones faster."

Dr Jens Gruber, Chief Scientific Officer of Curexsys, added: "We are very happy that we were able to form such a consortium with industry leaders in their field. This unique constellation gives Curexsys an optimal starting position to advance our technologies for highly specific isolation of exosomes and to rapidly approach therapeutic applications."

About Exosomes and CurexsysExosomes are extracellular, nanoscale vesicles that are actively secreted from cells to transfer information to neighbouring cells and distant tissues. Exosomes carry information of secreting to receiving cells utilising proteins, nucleic acids and metabolites. MSC-derived exosomes function as paracrine mediators that limit inflammation, reprogram immune cells, and activate endogenous repair pathways, recapitulating to a large extent the therapeutic effects of parental MSCs. Exosomes hold potential as diagnostics, as therapeutics and cosmeceuticals. More than 100 clinical trials involving exosomes are currently ongoing, demonstrating their broad therapeutic potential.

Curexsys is a Goettingen, Germany-based start-up company founded by molecular biologist Dr Jens Gruber and the biochemist and serial entrepreneur Dr Herbert Stadler. With a scalable and semi-automated proprietary system for traceless immune-affinity cell sorting, Curexsys aims to become the leading supplier for clinical grade exosomes in regenerative medicine and anti-aging therapies.

About Evotec and iPSCInduced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec's iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company's proprietary EVOcells platform.

ABOUT SARTORIUSThe Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. With innovative laboratory instruments and consumables, the Group's Lab Products & Services Division concentrates on serving the needs of laboratories performing research and quality control at pharma and biopharma companies and those of academic research institutes. The Bioprocess Solutions Division with its broad product portfolio focusing on single-use solutions helps customers to manufacture biotech medications and vaccines safely and efficiently. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In fiscal 2019, the company earned sales revenue of some 1.83 billion euros. At the end of 2019, more than 9,000 people were employed at the Group's approximately 60 manufacturing and sales sites, serving customers around the globe.

SARTORIUS CONTACTPetra KirchhoffHead of Corporate Communications and Investor Relations+49 (0)551.308.3684 petra.kirchhoff@sartorius.comwww.sartorius.com

ABOUT EVOTEC SEEvotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,400 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health. On this basis, Evotec has built a broad and deep pipeline of more than 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to http://www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTSInformation set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

SOURCE: Evotec AG via EQS Newswire

View source version on accesswire.com:https://www.accesswire.com/620112/Evotec-and-Sartorius-Partner-with-Start-Up-Curexsys-on-IPSC-Based-Therapeutic-Exosome-Approach

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Evotec and Sartorius Partner with Start-Up Curexsys on IPSC-Based Therapeutic Exosome Approach - BioSpace

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NEW YORK, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the launch of Galactosemia Together, the first and only industry-led Galactosemia awareness and education campaign. Developed in partnership with the Galactosemia community, this initiative aims to address gaps in education by providing updated, reliable and credible resources to help connect, educate and support those families impacted by this disease.

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Applied Therapeutics Announces Launch of Galactosemia Awareness and Education Initiative

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IRVINE, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced it is nearing completion of patient enrollment in the endpoint clinical trial for its InFoods® Irritable Bowel Syndrome (“IBS”) diagnostic-guided therapy (“DGT”). This double-blinded, randomized, controlled clinical trial is validating the Biomerica InFoods® IBS test to manage the debilitating pain and suffering of patients diagnosed with IBS. Utilizing an antibody guided blood test, the InFoods® IBS product identifies patient-specific foods that may alleviate IBS symptoms when eliminated from the diet.

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Biomerica's InFoods® Irritable Bowel Syndrome Diagnostic-Guided Therapy Clinical Trial Nears Completion of Enrollment

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FLORHAM PARK, N.J., Dec. 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced the appointment of Seth Van Voorhees, Ph.D. as its new Chief Financial Officer effective January 1, 2021.

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Expanding the patent estate for the lead clinical program to treat cancer anorexia Expanding the patent estate for the lead clinical program to treat cancer anorexia

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Artelo Biosciences Files Patent Application for New Formulation of ART27.13

Global News Feed Comments Off on Artelo Biosciences Files Patent Application for New Formulation of ART27.13 | December 9th, 2020

ILUVIEN has been launched for both Diabetic Macular Edema and Non-Infectious Posterior Uveitis Indications ILUVIEN has been launched for both Diabetic Macular Edema and Non-Infectious Posterior Uveitis Indications

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Alimera Sciences Announces Launch of ILUVIEN® in the Netherlands

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BUFFALO, N.Y., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, announced today the presentation of updated Phase 3 PFS and OS data demonstrating clinical benefits in efficacy and tolerability of oral paclitaxel versus IVP in patients with metastatic breast cancer (MBC). The findings further support the superiority of increased ORR observed with oral paclitaxel. These data were presented today during a spotlight poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABCS).

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Athenex Presents Updated Phase 3 Data on Survival and Tolerability Associated with Oral Paclitaxel and Encequidar in Patients with Metastatic Breast...

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SAN DIEGO, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today FDA acceptance of its Investigational New Drug (IND) application for its Phase 1 clinical trials for intravenous (IV) STI-2020 (COVI-AMG). The trials will evaluate the safety, pharmacokinetics and efficacy of a single injection of STI-2020 in healthy volunteers and outpatient COVID-19 patients with mild symptoms.

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Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trials for STI-2020 (COVI-AMG) in Healthy Volunteers and in Newly Diagnosed...

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– Data demonstrate potential of Amunix’s XPAT (XTENylated Protease-Activated T cell engager) platform to mitigate on-target, off-tumor toxicity that has hindered success of T cell engagers in treating solid tumors –

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Amunix Presents Preclinical Data on AMX-818, a Protease-Activated HER2-Targeted T Cell Engager Prodrug, at SABCS 2020

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Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer

Global News Feed Comments Off on Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer | December 9th, 2020

NEW YORK, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that a clinical update on DANYELZA® (naxitamab-gqgk) for the treatment of Refractory/Relapsed High-Risk Neuroblastoma was given at the ESMO Immuno-Oncology Virtual Congress 2020, which is being held December 9 through December 12, 2020. The DANYELZA data was presented by Dr. Jaume Mora from SJD Barcelona Children's Hospital, Spain and Dr. Daniel A. Morgenstern from The Hospital for Sick Children, Toronto, Canada.

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Y-mAbs Announces Update on DANYELZA® (naxitamab-gqgk) at ESMO

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SEATTLE, Dec. 09, 2020 (GLOBE NEWSWIRE) -- SEngine Precision Medicine, a precision oncology company revolutionizing cancer therapies by pre-testing drugs on patient-derived tumor organoids, today presented data from a study summarizing the predictive value of the PARIS® Test in breast cancer tumors as a poster session (PS04/01) at the 2020 San Antonio Breast Cancer Symposium, taking place virtually from December 8-11, 2020.

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SEngine Precision Medicine Presents Data Summarizing Predictive Value of PARIS® Test in Breast Cancer Patients at 2020 San Antonio Breast Cancer...

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–EDP1908 announced as clinical candidate in oncology after showing superior preclinical activity over EDP1503––Interim clinical data for EDP1503 suggest potential of orally delivered SINTAX™ product candidates to activate systemic immunity–

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Evelo Biosciences Announces New Clinical Candidate in Oncology and Presents Additional Interim Data from Phase 1/2 Clinical Trial of EDP1503 in...

Global News Feed Comments Off on Evelo Biosciences Announces New Clinical Candidate in Oncology and Presents Additional Interim Data from Phase 1/2 Clinical Trial of EDP1503 in… | December 9th, 2020

TORONTO, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Telo Genomics Corp. (TSX-V: TELO) (the “Company” or “TELO”) is pleased to announce that the Company has presented the results of its Hodgkin’s lymphoma (HL) clinical study at ASH 2020.

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Telo Genomics Presents at ASH 2020 The Results of Hodgkin’s Lymphoma Clinical Study

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WESTLAKE VILLAGE, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced continued progress and future growth drivers related to its immuno-dermatology platform and pipeline, which will be highlighted during today’s Virtual Investor Day at 11:00 am ET.

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Arcutis Highlights Advanced Pipeline & Unique Immuno-Dermatology Drug Development Capabilities at Virtual Investor Day on December 9, 2020

Global News Feed Comments Off on Arcutis Highlights Advanced Pipeline & Unique Immuno-Dermatology Drug Development Capabilities at Virtual Investor Day on December 9, 2020 | December 9th, 2020

MENLO PARK, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, today announced new preclinical data confirming the efficacy of its apelin agonist peptides in a preclinical model of acute respiratory distress syndrome (ARDS). The company expects the apelin agonists to have potential to treat COVID-19 associated ARDS as well as ARDS patients in general, of which there are approximately three million globally.

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CohBar Confirms Efficacy of Novel Apelin Agonists in Acute Respiratory Distress Syndrome (ARDS) Model

Global News Feed Comments Off on CohBar Confirms Efficacy of Novel Apelin Agonists in Acute Respiratory Distress Syndrome (ARDS) Model | December 9th, 2020

Company announcement – No. 58 / 2020

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Transactions in Zealand Pharma shares and/or related securities by persons discharging managerial responsibilities and/or their closely associated...

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Nicosia, Cyprus, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Rafarma Pharmaceuticals, Inc. OTC:(RAFA) is pleased to announce that one of the acquisition companies of the previously-announced Biocogency merger, Bebig LLC (http://en.bebig.ru), received an updated Russian registration certificate for the production and sale of nanostructured microspheres based on yttrium-90, used in the treatment of both primary and metastatic liver lesions. This will start industrial production and sale of ready-made batches of microspheres to medical institutions for use in radiotherapy of primary and metastatic liver tumors. This technology is recognized as the most effective for treating inoperable patients with liver cancer. In total, three companies in the world own this microsphere production technology: MDS Nordion (Canada), Sirtex (Australia), and now Bebig LLC (Russia).

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Rafarma Merger Company Bebig Approved For Production And Sale Of Yttrium-90 For Treatment Of Inoperable Liver Cancer

Global News Feed Comments Off on Rafarma Merger Company Bebig Approved For Production And Sale Of Yttrium-90 For Treatment Of Inoperable Liver Cancer | December 9th, 2020