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Category Archives: Stem Cell Therapy

Nektar and Collaborators Present Preclinical Data on NKTR-255, a Novel IL-15 Receptor Agonist, in combination with CAR Cell Therapies at the 2022…

SAN FRANCISCO, April 23, 2022 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) announced that collaborators from the Cairo Laboratory at New York Medical College today presented data from several preclinical studies demonstrating the potential of NKTR-255 to enhance the anti-tumor activities of different CAR-T therapies in a variety of cancer preclinical models. Presentations include an oral presentation by Wen Luo, Ph.D., assistant professor of pediatrics at NYMC, on in vivo and in vitro efficacy of NKTR-255 combined with anti-MCAMa CARb modified Natural Killer (NK) cells in several tumor models, and a poster presentation by Yaya Chu, Ph.D., assistant professor of pediatrics at NYMC, presenting studies of NKTR-255 in combination with ex vivo expanded anti-CD19 CAR NK cells and anti-CD20 or anti-CD79 antibodies in models of Burkitt Lymphoma (BL).

"Our research builds on the body of knowledge for the role of an agent which activates the full IL-15 biology pathway in the field of cell therapy," said Mitchell S. Cairo, M.D., director of the Cairo Laboratory, chief of pediatric hematology, oncology and stem cell transplantation, director of the Children and Adolescent Cancer and Blood Diseases Center, associate chairman of the Department of Pediatrics and professor of pediatrics, medicine, pathology, microbiology and immunology and cell biology and anatomy at NYMC. "My lab's findings show that NKTR-255's ability to expand and proliferate NK cells resulted in the enhancement of the efficacy of two different CAR therapies in our preclinical models."

The oral presentation will be virtually live streamed on Saturday April 23rd, 2022 at 3:00 PM MT and is accessible through the meeting organizer's website at https://www.astct.org/attend/tandem-meetings. These presentations are available for download at http://www.nektar.com/science/scientific-posters.

Key details and takeaways from the two collaborator presentations include:

Abstract 27:"Targeting Ewing sarcoma, Osteosarcoma and Neuroblastoma with Anti-MCAM Chimeric Antigen Receptor Modified Natural Killer Cells" Luo, W., et al.Presentation Type:Oral PresentationPresenting Author:Wen Luo, Ph.D.Session:Oral Abstract - Session C - Immune and Gene TherapyVirtual Live Stream of the presentation will begin at 3:00 PM MT on Saturday April 23rd, 2022

Abstract 201:"Optimizing Chimeric Antigen Receptor (CAR) Engineered NK Cell- Mediated Cytotoxicity Combined with anti-CD20 or anti-CD79 Therapeutic Antibodies and NKTR-255 in Burkitt Lymphoma (BL)" Chu, Y., et al.Presentation Type: Poster

Posters will be on displaySunday, April 24, 2022 from 11:00 am to 7:15 pm; Monday, April 25, 2022 from 7:00 am to 7:00 pm; Tuesday, April 26, 2022 from 7:00 am to 12:00pm (all times MDT)

Poster Receptionsare on Sunday, April 24, 2022 from 6:30 pm to 7:15 pm MDT

About NYMCFounded in 1860, New York Medical College is one of the oldest and largest health sciences colleges in the country with nearly 1,500 students and 330 residents and clinical fellows, more than 2,600 faculty members and 23,200 living alumni. The College, which joined Touro University in 2011, is located in Westchester County, New York, and offers degrees from the School of Medicine, the Graduate School of Basic Medical Sciences, the School of Health Sciences and Practice, the Touro College of Dental Medicine at NYMC, and the Touro College School of Health Sciences' nursing program at NYMC. NYMC provides a wide variety of clinical training opportunities for students, residents, and practitioners. For more information, visit http://www.nymc.edu.

About NKTR-255NKTR-255 is an investigational IL15 receptor agonist designed to boost the immune system's natural ability to fight cancer. NKTR-255 increases the proliferation and survival of cancer-killing natural killer (NK) cells and memory CD8+ T cells. NKTR-255 engages the entire IL-15 receptor complex (IL15R/IL15R) to enhance the formation of long-term immunological memory, which may lead to sustained antitumor immune response.

NKTR-255 is specifically engineered using Nektar's expertise in polymer chemistry to mimic the natural biological activity of the body's own IL-15, resulting in optimal activation of the IL-15 pathway. NKTR-255 is uniquely designed to overcome the challenges of recombinant IL-15, which has to be given in high doses due to rapid clearance from the body, limiting its utility due to toxicity and lack of convenience and use.

About NektarNektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and inflammatory diseases as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements which can be identified by words such as: "will," "may," "design," "potential," "initiate," "plan," "advance" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the future development plans and the timing of data readouts for bempegaldesleukin. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of bempegaldesleukin are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) bempegaldesleukin is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) bempegaldesleukin remains in clinical development and the risk of clinical failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the end of clinical trials and the availability of clinical data may be delayed or unsuccessful due; (v) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2022. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:

For Investors:Vivian Wu of Nektar Therapeutics628-895-0661

For Media:Dan Budwick of 1AB973-271-6085[emailprotected]

a) MCAM: Melanoma Cell Adhesion Moleculeb) CAR: Chimeric Antigen Receptor

SOURCE Nektar Therapeutics

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Nektar and Collaborators Present Preclinical Data on NKTR-255, a Novel IL-15 Receptor Agonist, in combination with CAR Cell Therapies at the 2022...

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Stem Cell Therapy Market: North America Leads the Market Owing to Rising Awareness among People – BioSpace

Albany NY, United States: Stem cells are found in all human beings, from the initial stages of human growth to the end of life. All stem cells are beneficial for medical research; however, each of the different kinds of stem cells has both limitations and promise. Embryonic stem cells that can be obtained from a very initial stage in human development have the prospect to develop all of the cell types in the human body. Adult stem cells are found in definite tissues in fully developed humans.

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Stem cells are basic cells of all multicellular animals having the ability to differentiate into a wide range of adult cells. Totipotency and self-renewal are characteristics of stem cells. However, totipotency is seen in very early embryonic stem cells. The adult stem cells owes multipotency and difference flexibility which can be exploited for next generation therapeutic options. Recently, scientists have also recognized stem cells in the placenta and umbilical cord blood that can give rise to several types of blood cells.

Research for stem cells is being undertaken with the expectation of achieving major medical inventions. Scientists are attempting to develop therapies that replace or rebuild spoiled cells with the tissues generated from stem cells and offer hope to people suffering from diabetes, cancer, spinal-cord injuries, cardiovascular disease, and many other disorders.

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The stem cell therapy market is segmented on the basis of type, therapeutic applications, cell source, and geography. On the basis of type, the stem cell therapy market is categorized into allogeneic stem cell therapy and autologous stem cell therapy. Allogeneic stem cell therapy includes transferring the stem cells from a healthy person (the donor) to the patients body through high-intensity radiation or chemotherapy.

Allogeneic stem cell therapy is used to treat patients who do not respond fully to treatment, who have high risk of relapse, and relapse after prior successful treatment. Autologous stem cell therapy is a type of therapy that uses the person's own stem cells. These type of cells are collected earlier and returned in future.

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The use of stem cells is done to replace damaged cells by high doses of chemotherapy, and to treat the person's underlying disease. On the basis of therapeutic applications, the stem cell therapy market is segmented into cardiovascular diseases, wounds and injuries, musculoskeletal disorders, gastrointestinal diseases, surgeries, neurodegenerative disorders, and others. On the basis of cell source, stem cells therapy is segmented into bone marrow-derived mesenchyme stem cells, adipose tissue-derived mesenchyme stem cells, and cord blood or embryonic stem cells.

By geography, the market for stem cell therapy is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America leads the stem cell therapy market owing to rising awareness among people, early treatment adoption, and new product innovations. Europe is the second leading market for stem cell therapy due to development and expansion of more efficient and advanced technologies.

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The Asia Pacific stem cell therapy market is also anticipated to grow at an increasing rate owing to increasing healthcare spending, adoption of western lifestyles, and growth in research and development. Asia Pacific is the fastest growing region for stem cell therapy as several players have invested in the development of new stem cell technologies. These factors are expected to drive the growth of the stem cell therapy market globally during the forecast period.

The major player in the stem cell therapy market are Regenexx, Takara Bio Company, Genea Biocells, PromoCell GmbH, CellGenix GmbH, Cellular Engineering Technologies, BIOTIME, INC., Astellas Pharma US, Inc., AlloSource, RTI Surgical, Inc., NuVasive, Inc., JCR Pharmaceuticals Co., Ltd., Holostem Terapie Avanzate S.r.l., PHARMICELL Co., Ltd, ANTEROGEN.CO., LTD., The Future of Biotechnology, and Osiris Therapeutics, Inc. Rising demand for advanced stem cell therapies will increase the competition between players in the stem cell therapy market.

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Continuous Glucose Monitoring Market: Increase in incidence and prevalence rate of diabetes type 1 and type 2 across the globe is anticipated to boost the growth of the global market during the forecast period. Continuous glucose monitoring systems are real-time glucose sensing and monitoring devices that measure and display glucose levels of a patient at regular intervals.

Diabetes Management Market: The biggest driving factor for the market growth is the growing prevalence of both Type I as well as Type II diabetes. This condition coupled with considerable rise in the obese population across the globe is also helping the global diabetes management market to develop.

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Stem Cell Therapy Market: North America Leads the Market Owing to Rising Awareness among People - BioSpace

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UCI Health awarded FACT accreditation for bone marrow transplantation and CAR-T cell therapy – UCI Health

Orange Countys only adult hematopoietic stem cell transplantation and cellular therapy program provides life-saving treatment for blood-based cancers

April 08, 2022

UCI Chao Family Comprehensive Cancer Center and UCI Healths adult hematopoietic stem cell transplantation program has received accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT), the national standard for excellence in cellular therapy programs.

Hematopoietic stem cell and bone marrow transplantation is an advanced procedure that can prolong the survival of and cure many patients with high-risk blood cancers including leukemia, lymphoma and myeloma. Until recently, Orange County residents had to travel far from home to receive this therapy. Launched in 2020, the UCI Health Hematopoietic Stem Cell Transplantation and Cellular Therapy Programallows local residents to receive this treatment close to home, and also serves patients from across Southern California. In addition, the program offers cutting-edge cellular immunotherapy options and access to novel clinical trials.

FACT accreditation is the standard for excellence in stem cell transplantation and cellular therapy. FACT-accredited organizations voluntarily seek and maintain accreditation of their program through a rigorous process, demonstrating their belief that adhering to the highest standards in patient care are paramount.

FACT accreditation is extremely important for any transplant program, both to ensure quality of care and to meet requirements of third party payers, said Dr. Stefan Ciurea, UCI Health hematologist and director of the Hematopoietic Stem Cell Transplantation and Cellular Therapy Program. We started this program less than two years ago and our team has worked extremely hard to obtain full accreditation of all components of an established program, including autologous and allogeneic transplantation, as well as CAR T cell therapy.

FACT accreditation is based upon compliance with the most comprehensive standards in the field, verified by rigorous peer-reviewed inspections, qualified by training and experience to perform cellular therapy in their daily practice. FACT-accredited organizations meet the follow standards:

Having our transplant and cell therapy program join the prestigious community of FACT-accredited programs demonstrates to our patients, referring physicians, and third-party payers our commitment to highest quality patient care and UCI Healths commitment to the highest standards in cellular therapy services, said Dr. Richard Van Etten, UCI Health hematologist and director of the Chao Family Comprehensive Cancer Center.

Learn more

About FACT

Founded in 1996, FACT establishes standards for high quality patient care and laboratory practice in cellular therapies and regenerative medicine. FACT is a non-profit corporation co-founded by the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT) for the voluntary inspection and accreditation in the field of cellular therapy. FACT promotes improvement and progress by establishing minimum standards, providing education, and inspecting and accrediting programs worldwide. For more information, visit http://www.factwebsite.org.

UCI Healthis the clinical enterprise of the University of California, Irvine, and the only academic health system in Orange County. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus,UCI Medical Center in Orange, Calif. The 459-bed acute care hospital, listed among Americas Best Hospitals byU.S. News & World Reportfor 21consecutive years, provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation services. UCI Medical Center is home to Orange Countys onlyNational Cancer Institute-designated comprehensive cancer center,high-risk perinatal/neonatal programand American College of Surgeons-verified Level I adult and Level II pediatric trauma center and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us onFacebook, Instagram, LinkedIn andTwitter.

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UCI Health awarded FACT accreditation for bone marrow transplantation and CAR-T cell therapy - UCI Health

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First ever cellular Therapy Training Centre set up in City – The News International

LAHORE:The International Society for Stem Cell Applications (ISSCA) and Global Stem Cells Group (GSCG) announced a new partnership with a local hospital to develop autologous bone marrow stem cell and exosome-based cell therapies and advance new therapeutic options for patients in the region and in this regard, the first-ever two-day physician workshop and training course was held in the City.

Benito Novas, CEO of the Global Stem Cells Group and Managing Director of ISSCA USA said, We look forward to strengthening our relationship with the country and offering more support within the region.

Regenerative medicine is a fast-paced field that is growing exponentially every year as more research is being conducted and products are being used in clinics and doctors offices worldwide, said Benito Novas Managing Director of the ISSCA on Tuesday.

This is the first time the ISSCA and Ramzan Ali Syed Hospital join forces for a stem cell certification course in the country. This collaboration was born out of a desire to bring new technologies and cutting-edge treatment to patients throughout the country, said Prof Dr Mehmood Shaukat, Head of Ramzan Ali Syed Stem Cell Centre.

The International Society for Stem Cell Application (ISSCA) is a multidisciplinary community of scientists and physicians, all of whom aspire to treat diseases and lessen human suffering through advances in science, technology, and the practice of regenerative medicine.

Ramzan Ali Stem Cell Centre is an all-inclusive healthcare facility in regenerative medicine located in the premises of Ramzan Ali Syed Hospital at Temple Road. It is a pioneering institution with a passion for the safety of all its patients.

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First ever cellular Therapy Training Centre set up in City - The News International

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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress…

SUNNYVALE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for BCDA-04, a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive (NK1R+). This allows BioCardia to initiate its First-in-Human Phase I/II trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, with trial initiation expected in the third quarter of 2022.

The first part of the clinical trial will evaluate increasing doses of the NK1R+ MSCs and the optimal dose will be taken to Phase II in a randomized study in adult patients recovering from ARDS due to COVID-19. "This investigational cell therapy is administered intravenously (IV) and follows a significant body of compelling clinical results by NIH investigators and peer companies," said Ian McNiece, Ph.D., BioCardias Chief Scientific Officer. "After IV delivery, the cells migrate to the lungs for local therapeutic benefit. We expect the anti-inflammatory nature of these mesenchymal stem cells to have a positive impact in ARDS because of the interaction of the Neurokinin-1 receptors with Substance P, a neuropeptide that has long been known to be a primary mediator of inflammation in the lungs. Our goal is to help recovering patients with ARDS due to COVID-19 recover faster and more fully, while avoiding longer term respiratory issues."

"In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA's acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and validation for its potential to provide therapeutic benefit beyond the cardiovascular system," said Peter Altman, Ph.D., Chief Executive Officer. "Our off the shelf MSC platform may have significant advantages over others in clinical development for multiple indications because the MSCs express the biologically important NK1 receptor which binds Substance P. Our in-house clinical cell manufacturing is also expected to be an important strategic asset that enables rapid and cost-effective development."

About ARDS

Acute respiratory distress syndrome (ARDS) occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. The fluid keeps the lungs from filling with enough air, which means less oxygen reaches the bloodstream. This deprives organs of the oxygen they need to function. ARDS typically occurs in people who are already critically ill or who have significant injuries. Severe shortness of breath the main symptom of ARDS usually develops within a few hours to a few days after the precipitating injury or infection. Many people who develop ARDS don't survive. The risk of death increases with age and severity of illness. Of the people who do survive ARDS, some recover completely while others experience lasting damage to their lungs1. Based on preliminary clinical reports on COVID-19, respiratory failure complicated by ARDs is the leading cause of death for COVID-19 patients.2 Despite multiple clinical studies, no pharmacological treatments have proven effective for ARDS.3, 4

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Companys biotherapeutic platforms that enable four product candidates in clinical development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS reimbursement. For more information visit:www.BioCardia.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, initiation of our BCDA-04 clinical trial, and the mechanism of action and ease of administration of our NK1R+ MSC therapy.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on March 29, 2022, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

_________________________________________________________________________________________________________

Media Contact:Anne Laluc, MarketingEmail:alaluc@BioCardia.comPhone: 650-226-0120

Investor Contact:David McClung, Chief Financial OfficerEmail:dmcclung@BioCardia.comPhone: 650-226-0120

(1)MayoClinic.Org

(2)Rajagopal K, Keller SP, Akkanti B, et al. Advanced pulmonary and cardiac support of COVID-19 patients, emerging recommendations from ASAIOa living working document. Circ Heart Fail. 2020 May;13(5).

(3)Thompson BT, Chambers RC, Liu KD (2017) Acute respiratory distress syndrome. N Engl J Med 377(19):19041905.

(4)3. Group RC, Horby P, Lim WS et al (2020) Dexamethasone in hospitalized patients with Covid-19preliminary report. N Engl J Med.

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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress...

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‘Truly Impressive’ Responses in Lymphoma With Novel Cell Therapy – Medscape

Cancer researchers confessed to being "favorably surprised" by the quality of tumor responses among patients with relapsed or refractory CD30-positive lymphomas who were treated with a novel cellular therapy consisting of natural killer (NK) cells complexed with a bispecific antibody.

The first-in-class therapy is composed of NK cells derived from cord blood that are "preactivated"with cytokines and expanded in the laboratory, and are combined with a novel CD30/CD16A bispecific antibody construct labeled Innate Cell Engager (ICE) AFM13 (developed by Affimed). The antibody binds to CD30 on lymphoma cells and 16A on NK cells.

The responses were seen in a Phase 2/3 study in patients with lymphoma that had relapsed after many different treatments, and some patients were in a very poor condition at enrolment, the researchers said.

"We were surprised at the beginning; we saw very good responses from the get-go, even at the first dose level, and we were very definitely surprised,"said principal investigator Yago L. Nieto, MD, PhD, from the Department of Stem Cell Transplantation and Cellular Therapy at the University of Texas MD Anderson Cancer Center (MDACC) in Houston.

"We're not surprised anymore," he added. "We treat patients now and expect them to respond."

"Among the first few patients that we treated, some were very debilitated and they tolerated this treatment extremely well," Nieto said in an interview with Medscape Medical News.

He presented clinical results of the new product here at the American Association for Cancer Research (AACR) 2022 annual meeting.

"This is truly a first-in-human approach, and never before in mankind have we seen this approach really leading to very staggering results," said Timothy A. Yap, MBBS, PhD, who is also at MDACC but was not involved in the study. He moderated a conference media briefing during which the new results were highlighted.

Yap said that anyone looking at the study's waterfall plot of tumor responses "can see for themselves how impressive these results are, and in addition to that, the tolerability profile is truly excellent, with no instances of the cytokine release syndrome, no neurotoxicity, and no [graft-vs-host disease]. Truly, truly impressive."

Abstract discussant Jeffrey S. Miller, MD, an NK cell therapy researcher at the University of Minnesota in Minneapolis, said the study provides proof-of-concept that making memory-like NK cell infusions antigen-specific with a combination engager can lead to excellent short-term responses.

He emphasized that longer follow-up is needed, however, because five of the patients with complete responses relapsedwithin 1 year of follow-up.

Also, he noted that the therapeutic package included multiple active components, including preactivated and expanded cord blood NK cells precomplexed with AMF13, lymphodepleting chemotherapy, and additional AMF13 infusions, so it will be necessary to tease out which specific components contributed to the anti-tumor response.

The study was designed to address the needs of patients with disease progression following treatment with the current standard of care for CD30-positive advanced lymphomas, the antibody-drug conjugate brentuximab vedotin (Adcetris, Seagen).

In previous studies, monotherapy with the AFM13 antibody construct had shown activity against Hodgkin lymphoma, T-cell lymphoma, and peripheral T-cell lymphoma.

But as study coauthor Katy Rezvani, MD, PhD, also from MDACC, showed in animal models, complexing AFM13 with cord blood-derived NK cells prior to infusion was more effective than either AFM13 or unlinked NK cells alone.

To see whether the complex was safe and had synergistic efficacy in humans, investigators enrolled 15 men and seven women who were a median age of 40 years. All patients had CD30-positive lymphomas that had relapsed despite treatment with brentuximab vedotin. All but one patient had previously received immunotherapy with a programmed cell death protein 1 (PD-1) inhibitor, 14 (of the 22) had undergone autologous or allogeneic stem cell transplant, and two had previously received chimeric antigen receptor (CAR) T-cell therapy.

Patients had received a median of six prior therapies for relapsed or progressive disease, but some had received up to 14 prior therapies.

In this trial, patients underwent immune cell conditioning with fludarabine and cyclophosphamide, followed by two cycles of the novel AFM13/NK cell complex, and then additional infusions of AFM13 alone at 7, 14, and 21 days after the second infusion of the complexed cells.

The novel cell-antibody complex was administered at doses of 1 million, 10 million, or 100 million cells/kg; the highest dose was chosen as the recommended phase 2 dose. In all, 53% of patients had a complete response, 37% had a partial response, and 11% had disease progression. The overall response rate was 100% for the 13 patients who received the higher dose (100 million cells/kg), with eight complete and five partial responses.

At a median follow-up of 9 months, the rate of progression-free survival was 52%, and the rate of overall survival was 81%. The respective rates among patients who received the recommended phase 2 dose were 67% and 93%.

Hematologic toxicities were primarily related to pre-infusion conditioning and included neutropenia in 63% of patients and thrombocytopenia in five patients. There were no cases of neutropenic fever or bleeding.

As noted by Yap, there were no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-vs-host disease. In addition, the were no immune-related reactions of any grade among 40 infusions of the AFM13-NK complex, and among 108 infusions of AFM13 alone, there were only five infusion-related reactions, including one of grade 3 and four of grade 2 severity.

Nieto told Medscape Medical News that the study protocol is being amended to allow up to four cycles of the novel complex.

In addition, investigators plan to shorten the interval between cycles and investigate combining the therapy with targeted agents known to enhance NK cell function.

The study was funded by Affimed Therapeutics. Nieto has reported being on the advisory board for Affimed and receiving research funding from the company, as well as from AstraZeneca, Secura Bio, and Novartis. Yap has reported receiving consulting fees from multiple companies. Miller has reported relationships with Fate Therapeutics, GT Biopharma, Sanofi, and ONK Therapeutics.

AACR 2022 Annual Meeting. Abstract CT003. Presented April 10, 2022.

Neil Osterweil, an award-winning medical journalist, is a long-standing and frequent contributor to Medscape.

Follow Medscape on Facebook, Twitter, Instagram, and YouTube.

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'Truly Impressive' Responses in Lymphoma With Novel Cell Therapy - Medscape

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