Category Archives: Cell Therapy

Washington [US], June 12 (ANI): A new study has found that a patient can undergo T cell therapy designed to target cancerous tumours, the patients entire immune system must be destroyed with chemotherapy or radiation.

The study was published in the journal Nature.

The toxic side effects are well known, including nausea, extreme fatigue and hair loss. Now a research team, led by UCLAs Anusha Kalbasi, MD, in collaboration with scientists from Stanford and the University of Pennsylvania, has shown that a synthetic IL-9 receptor allows those cancer-fighting T cells to do their work without the need for chemo or radiation. T cells engineered with the synthetic IL-9 receptor, designed in the laboratory of Christopher Garcia, PhD, at Stanford, were potent against tumors in mice.

When T cells are signalling through the synthetic IL-9 receptor, they gain new functions that help them not only outcompete the existing immune system but also kill cancer cells more efficiently, Kalbasi said. I have a patient right now struggling through toxic chemotherapy just to wipe out his existing immune system so T cell therapy can have a fighting chance. But with this technology you might give T cell therapy without having to wipe out the immune system beforehand.

Kalbasi, a researcher at the UCLA Jonsson Comprehensive Cancer Center and an assistant professor of radiation oncology at the David Geffen School of Medicine at UCLA, began the work while under the mentorship of Antoni Ribas, MD, PhD, a senior investigator on the study. The study was also led by Mikko Siurala, PhD, from the laboratory of Carl June, MD, at Penn, and Leon L. Su, PhD, of the Garcia Lab at Stanford.

This finding opens a door for us to be able to give T cells a lot like we give a blood transfusion, Ribas said.

Ribas and Garcia collaborated on a paper published in 2018 that focused on the concept that a synthetic version of interleukin-2 (IL-2), a critical T cell growth cytokine, could be used to stimulate T cells engineered with a matching synthetic receptor for the synthetic IL-2. With this system, T cells can be manipulated even after they have been given to a patient, by treating the patient with the synthetic cytokine (which has no effect on other cells in the body). Intrigued by that work, Kalbasi and colleagues were interested in testing modified versions of the synthetic receptor that transmit other cytokine signals from the common-gamma chain family: IL-4, -7, -9 and -21.

It was clear early on that, among the synthetic common-gamma chain signals, the IL-9 signal was worth investigating, Kalbasi said, adding that, unlike other common-gamma chain cytokines, IL-9 signalling is not typically active in naturally occurring T cells. The synthetic IL-9 signal made T cells take on a unique mix of both stem-cell and killer-like qualities that made them more robust in fighting tumours. In one of our cancer models, we cured over half the mice that were treated with the synthetic IL-9 receptor T cells.

Kalbasi said the therapy proved to be effective in multiple systems. They targeted two types of hard-to-treat cancer models in mice pancreatic cancer and melanoma and used T cells targeted to cancer cells through the natural T cell receptor or a chimeric antigen receptor (CAR).

The therapy also worked whether we gave the cytokine to the whole mouse or directly to the tumour. In all cases, T cells engineered with synthetic IL-9 receptor signalling were superior and helped us cure some tumours in mice when we couldnt do it otherwise. (ANI)

This report is auto-generated from ANI news service. ThePrint holds no responsibility for its content.

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Radiation pre-T cell therapy can alleviate need for chemo, says study - ThePrint

Thirty-nine percent of oncologists working in the community setting refer 2 out of 5 patients to receive chimeric antigen receptor (CAR) T-cell therapy at hospitals, according to data from a surveydisseminated by Cardinal Health Specialty Solutions.1

The research also showed that a decent portion of oncologists (27%), do not refer or administer CAR T-cell therapy at all, and a small proportion, 6%, perform in-office infusions. The survey raises questions about how to improve CAR T-cell availability for patients treated at community clinics. The recommendation born from the survey was to align stakeholders to address the concerns of the oncology population

In an interview with Targeted Oncology, Bruce Feinberg, DO, vice president, chief medical officer Cardinal Health Specialty Solutions, discussed the use of CAR T-cell therapy in the community oncology setting, the challenges oncologist face, and the next wave of innovation to improve CAR T-cell administration for patients.

TARGETED ONCOLOGY: Can you discuss CAR T-cell therapies that are FDA-approved in hematologic malignancies? How have these therapies impacted treatment?

Feinberg: The story of CAR T goes back a little before the drugs were approved. The recognition that our view of cancer in general was thinking of cancer as an invader. The way we thought about bacteria or viruses so that they were the enemy that we are going to then destroy.The recognition that changed all that was rather than thinking about cancer as the external alien enemy, because cancer was created by cells, and they are human cells that are transforming, should we be thinking about how to then look at the problem a little bit differently and see it as a failure of the host, as opposed to the invader.The story really begins as we think about empowering the immune system. The first aspects of that go back to the 1980s with interferons, interleukins, and tumor-infiltrating lymphocytes, and that was the first round.

The second way begins as we started to now think about the mid-2000 teams with the immune checkpoint inhibitors and start to look at manipulating T cells. The T-cell manipulation that begins with CART is not stopping with CAR T. It is going to be developing into bispecific antibodies, and natural killer cells that are then manipulated, so we are going to be seeing a rapid expansion of this host empowerment, how we really trigger the immune system to do its job, and then control this process, which really is a process of self as opposed to the external enemy.

Now that we have CAR T cells, what are the key challenges community oncologists facewith giving this treatment to patients?

The good news regarding these challenges is that we have had these challenges before. I mentioned that we think back in the early first phase of empowering the immune system with treatments like interleukin-2, we have the same kind of problem intensive treatment performed in hospital patients in ICU environments. We have also had that same world-specific to hematologic malignancies when we think about transplant, initially allogeneic transplant and then with autologous transplant, but similarly intensive complex programs, and multi-step approaches to patient care often done in tertiary care academic environments. There has been a background that really helps this field move forward quickly, based on that prior experience.

But the barriers that we have witnessed are those barriers we have seen before. Having an educated community workforce of healthcare providers who are knowledgeable about these treatments, an academic, tertiary care environment, where they remove all the barriers to those patient referrals, and hopefully patients who understand to some degree that complexity of the program will be willing to undergo consent for those procedures. Each of those barriers exist, but each of those barriers has been seen before, and we can rely on past experiences to help guide us forward.

Cardinal Health conducted a survey around in-office infusion and referrals for CAR T-cell therapy. How did community oncologists respond?

The research has been focused on both understanding physician perceptions. Are these therapies ready for primetime? Do they adopt and support these therapies? If they do support and adopt, what are the barriers to being able to refer patients for these treatments? Then lastly, what are the outcomes of these patients by getting into the chart itself and understanding the outcomes of patients? We have done all that in recent years, and some of that work was just recently presented at iSPOR.

At iSPOR, particularly regarding diffuse large B-cell lymphoma, there were 2 observational research studies that were done. One looked at the feasibility of being able to use that electronic health record in the community oncologist office to be able to understand the full journey of the patient who undergoes CAR T therapy, and can it understandthe scope and quality of the data that is housed within that medical record?

The second aspect of it was understanding. Could you be able to assess outcomes from the data within that medical record? So,2 parallel studies that were done specifically in diffuse large B-cell lymphoma, and also studies that have been done trying to look at new areas like multiple myeloma and understanding what physicians' perceptions about another hematologic malignancyin which there will be CAR T therapy available.

How do you interpret the findings from this survey?

For the community oncologist's electronic health record as a data source for conducting research on patients who are undergoing CAR T and other therapies, what we found is that the data source was rich and robust. For almost every major benchmark, in terms of the patient journey for CAR T,prior therapy, the timing of that prior therapy, the nature of that prior therapy, the referral to the tertiary center for consideration for CAR T, the actual evaluation for CAR T, the pheresis procedure, the site of the lympho-depletion procedure, chemotherapy, the actual administration of CAR T, the subsequent adverse event tracking, and the ER visits and hospitalizations, as well as the return to the community oncology clinic, all of that data was available within the community oncologist health record. That is a treasure trove of data that we can use as we start to expand the CAR T arsenal to understand the patient experience with CAR T in the real-world setting.

As we know, patients and clinical trials are often not representative of what is happening in real-world patients and clinical trials. First, less than 3% of adults with cancer participate in oncologic clinical trials, and those that do are healthier, they are less diverse, they are younger, they often are more health literate, and they have a higher socioeconomic status. That lack of representation becomes a problem that we start to extrapolate to all comers. Understanding what is happening in the real world to these patients is critical, and our data demonstrates that using the community oncologists to abstract the records is giving us that data that is necessary to understand the patient's experience. That is1 key outcome is that in the feasibility study, we saw as a strong positive for a new data source that can evaluate the real-world experience of patients undergoing CAR T-cell therapy.

The second outcome is that based on the feasibility of that data, could we find interesting details and insights about those patients being treated?We saw some interesting patterns of care that seemed to be geographically different. The timing of referrals and the nature of the CAR T-cell treatmentwere different as we looked across the major geographic regions of the country. Trying to understand that is going to be critical as the research continues, so are these trends and patterns related to Centers of Excellence and the KOLs, who often speak from those centers of excellence within a region?

Memorial Sloan Kettering often influences what happens in the Mid Atlantic, MD Anderson influences what happens in the South and the Southwest, and a center like UCLA influenceswhat's happens on the West Coast. As the Centers of Excellence have an influence, are we going to see differences in patterns of care in these different regions? Then, what were the outcome differences between those patterns of care?

Can you provide background on your study of CAR T-cell utilization patterns for relapsed/refractory diffuse large B-cell lymphoma in the US-based community hematologists/oncologists?

It has been almost 7 years since we first started to evaluate and publish on the broader world of empowering the host through immunologic therapies in the treatment of cancer. Our CAR T work now is 5 years, there have been a half dozen publications, similar tothe ones that we are talking about now, over the course of the past 5 years. We are trending that rate of adoption, that perceptions of physicians, the perceived barriers they find, and we are not just doing that assessment of physicians in the community, but we are also gathering experts from the major tertiary care centers to understand what they are perceiving as barriers and a general sense that CAR T therapy currently is under-utilized for those reasons and those barriers. What we find is there are still problems. The patients undergoing CAR T therapy have advanced disease, and are not clinically stable. The current timeline for CAR T, which can take 6 weeks from point of referral to point of CAR T-cell administration, often is problematic because of that patient instability.

Then, there are a host of new therapies which entered the armamentarium of treating physicians, which are making it confusing as to which is the appropriate second-line, third-line treatment. Recent data from ZUMA-7 [NCT03391466]trial has demonstrated that CAR T is a more effective therapythan autologous stem cell transplant as the first salvage treatment. That also adds a dynamic so that when we are doing this research, it can't be viewed as static. We have to be viewing it as a need for recurrent evaluations, as therapy indications change, and as new therapies come alive. Part of the basis for this research is really to be able to constantly trend what's happening in the field of newer therapies and how physicians perceive those new therapies and what are the outcomes of the patients. They're referring for those therapies. That was the focus of the work we've recently have done in diffuse large B-cell lymphoma.

Based on these 2 studies, how do you think the challenges that oncologists are experiencing with CAR T cells are impacting patient care?

I think overall, it is a good story. I think all physicians who treat cancer, particularly patients who have refractory or relapsed disease, for whom cure has been elusive, are looking for new therapeutic options. CAR T came with a tremendous amount of enthusiasm and excitement, but also with some concern about itstoxicity. Now, we are seeing second- and third-generation CAR T therapies, we're seeing expanded indications for earlier line of treatment. I think that excitement continues, and I think reservations are decreasing.

I think communication between tertiary care centers and community oncologists is improving, and we're getting closer to that point where patients will not have to leave home and leave their communities for this treatment, but we are not there yet.We are still testing and trying to understand what it will take for community physicians to participate in this aspect of care. I think that is going to be the next wave of innovation, and it will be operational innovation, rather than just drug development innovation, on how we can get these therapies to be done closer to the time of need.

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Understanding CAR T-Cell Therapy Utilization Patterns in the Community Oncology Setting - Targeted Oncology

ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc., (ITI), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein) -mediated nucleic acid-based immunotherapy today announced the appointment of Brian Stamper to Vice President, Cell Therapy Operations. Brian joins the company with over 20 years of experience in cell therapy operations, pharmaceutical manufacturing, and process engineering.

Prior to joining ITI, Mr. Stamper held director roles in manufacturing at Kite Pharma, a global biopharmaceutical company whose focus is cell therapy to treat and cure cancer. Prior to that, Mr. Stamper held positions of increasing responsibility in various operational areas at Lonza Pharmaceuticals and Biotechnology, AstraZeneca Biologics and Eli Lilly & Company.

We are delighted to welcome Brian to the Immunomic team, said William Hearl, Ph.D., Immunomic Therapeutics Chief Executive Officer. Brians specific and deep knowledge of cell therapy manufacturing and operations will be invaluable as we prepare for phase 3 testing of ITI-1000, our lead dendritic cell therapy for the treatment of glioblastoma multiforme (GBM).

Mr. Stamper holds a Master of Biotechnology Enterprise and Entrepreneurship Degree (MBEE) from Johns Hopkins University, a Master of Science Degree in Biologics Engineering from Purdue University, and a Bachelor of Science Degree in Biochemistry from Indiana University.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the bodys natural biochemistry to develop vaccines that generate broad immune responses. UNITE has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The Company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease, and allergy. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit http://www.immunomix.com.

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Immunomic Therapeutics Appoints Vice President, Cell Therapy - Business Wire

ABSTRACTS 7518, 7509, 8009

Promising clinical results with cellular therapies for patients with blood cancers highlight advances being presented by researchers from The University of Texas MD Anderson Cancer Center at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

These findings include long-term outcomes of patients receiving an infusion of brexucabtagene autoleucel (KTE-X19) for mantle cell lymphoma, efficacy of gamma delta CAR T therapy for aggressive B-cell lymphoma and responses of umbilical cord blood-derived expanded natural killer cells when given together with combination therapy before stem cell transplant.

CAR T cell therapy shows durable responses after three years for patients with mantle cell lymphoma (Abstract 7518)Three-year follow-up data from the Phase II ZUMA-2 trial showed a long-term survival benefit and low disease relapse potential with one infusion of the anti-CD19 chimeric antigen receptor (CAR) T cell therapy brexucabtagene autoleucel (KTE-X19) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). Principal investigator Michael Wang, M.D., professor of Lymphoma and Myeloma, presented results from the trial, and study results were published in the Journal of Clinical Oncology.

The updated results include all 68 patients treated with KTE-X19 on the trial with an additional two years of follow-up. After 35.6 months median follow-up, the overall response rate was 91%, with a 68% complete response rate. The median duration of response was 28.2 months, with 25 of 68 treated patients still in ongoing response at data cutoff.

This represents the longest follow-up of CAR T cell therapy in patients with mantle cell lymphoma to date, Wang said. It is encouraging to see this therapy induced durable long-term responses and a low relapse rate for these patients.

All patients had R/R disease after receiving up to five therapies, and all had received previous Brutons tyrosine kinase (BTK) inhibitor therapy. BTK inhibitors have greatly improved outcomes in R/R MCL, yet patients who have subsequent disease progression are likely to have poor outcomes, with median overall survival of just six to 10 months. Few patients in this category qualify to proceed to an allogeneic stem cell transplant.

Response and survival benefits were positive regardless of the prior BTK inhibitor type. Ongoing effectiveness trended lower in patients with prior acalabrutinib exposure. More investigation is needed to determine the mechanism behind these differences. The findings support future study of CD19-directed CAR T cell therapy in patients with high-risk MCL in earlier treatment lines.

The researchers also evaluated minimal residual disease (MRD) as an exploratory endpoint using next-generation sequencing on 29 patients. Of those, 24 were MRD-negative at one month, and 15 of 19 with available data were MRD-negative at six months. Circulating tumor DNA analysis of MRD at three and six months was predictive of disease relapse.

The treatment was well tolerated, as reported in previous studies with this therapy. Only 3% of treatment-emergent adverse events (AE) of interest occurred since the primary report. The most frequent Grade 3 AE was neutropenia.

The study was funded by Kite Pharma, a Gilead Company. Wang has received research support and has served on the advisory board and as a consultant for Kite Pharma. A complete list of collaborating authors can be found within the abstract here.

Allogeneic gamma delta CAR T cell therapy displayed encouraging efficacy in B-cell lymphoma (Abstract 7509)In the Phase 1 GLEAN trial of ADI-001, an anti-CD20 CAR-engineered allogeneic gamma delta T cell product, the treatment was well tolerated and showed continued efficacy in patients with R/R aggressive B-cell lymphoma. Results from the ongoing trial were presented by Sattva Neelapu, M.D., professor ofLymphoma and Myeloma.

The first-in-human trial enrolled ten patients and eight were evaluable and monitored for at least 28 days. The median age was 62 years and patients received a median of 4 prior therapies. At Day 28, the overall response rate (ORR) and complete response (CR) rate based upon PET/CT was 75%. The ORR and CR rate was 80% at dose levels two and three combined. The ORR and CR rate in CAR-T relapsed patients was 100%.

The responses to ADI-001 in this population of heavily pre-treated and refractory lymphoma patients, including in those with prior CD19 CAR T cell therapy, is very promising, Neelapu said. These results suggest the potential for off-the-shelf gamma delta CAR T cell therapy to be an effective treatment possibility for patients with B-cell lymphoma.

While autologous CD19-targeted CAR T cell therapy has been effective in R/R large B-cell lymphoma, there remains a need for alternative cell-based therapies. This study uses a subset of T cells, known as gamma delta 1 T cells, isolated from the peripheral blood of donors as the basis for CAR T cell therapy.

Gamma delta 1 T cells are desirable because they are able to combine both innate and adaptive mechanisms to recognize and kill malignant cells, and high levels of these cells in hematologic and solid tumors are associated with improved clinical outcomes. ADI-001 expresses major histocompatibility complex (MHC)-independent gamma delta T cell receptors, therefore lowering the risk of graft versus host disease (GvHD) without the need for gene editing.

The median age on the study was 62 years, and patients had received a median of 4 prior therapies. The treatment was well tolerated with most related events being grade 1 or 2. There were two cases of cytokine release syndrome and one case of immune effector cell-associated neurotoxicity syndrome. There were no reported cases of GvHD or dose-limiting toxicity.

Enrollment in the trial is ongoing and a potentially pivotal program is planned.

The study was funded by Adicet Bio, Inc. Neelapu has received research support and has served on the advisory board and as a consultant for Adicet Bio and has intellectual property related to cell therapy. A complete list of collaborating authors can be found within the abstract here.

Expanded NK cells combined with chemoimmunotherapy achieved durable responses in multiple myeloma (Abstract 8009)Results from the expansion phase of a Phase II clinical trial demonstrated that umbilical cord blood-derived expanded natural killer (NK) cells combined with chemotherapy and immunotherapies achieved durable responses in patients with multiple myeloma. Results from the completed clinical trial were presented by Samer Srour M.D., assistant professor of Stem Cell Transplantation & Cellular Therapy.

Thirty patients on the trial received NK cells plus elotuzumab (an immunotherapy monoclonal antibody), lenalidomide (an immunomodulatory drug) and high-dose melphalan chemotherapy before autologous stem cell transplant (ASCT).

At three months post-transplant, 97% of patients achieved at least a very good partial response (VGPR), including 76% with a complete response or stringent complete response, while 75% were minimal residual disease (MRD)-negative. At a median follow-up of 26 months, only four patients had progressed. At two years, the progression-free survival rate was 83% and the overall survival rate was 97%.

Patients with high-risk multiple myeloma have more options to treat their disease than previous years, but they continue to have poor outcomes, Srour said. These results indicate excellent hematologic and minimal residual disease responses and improved survival for these patients, suggesting this approach could provide an additional treatment opportunity.

NK cells are white blood cells that monitor the body for virus-infected and cancerous cells. MD Anderson researchers pioneered the approach to isolate and expand NK cells from umbilical cord blood to be used as cellular therapies. Lenalidomide enhances NK cell function and antibody-mediated cell toxicity against tumor targets. Preclinical data showed that lab-expanded NK cells demonstrated higher elotuzumab-mediated cytotoxicity against myeloma targets than non-expanded cells, and that the addition of elotuzumab to lenalidomide amplified the cord blood-NK cell antibody-dependent cellular cytotoxicity against a commonly used cell line to evaluate novel therapies for multiple myeloma (MM1.S) targets.

The study enrolled 30 patients with high-risk multiple myeloma, with a median age of 63. Twenty-nine patients (97%) had Revised Multiple Myeloma International Staging System (R-ISS) stages 2/3, 40% had 2 high-risk genetic abnormalities, and 23% had deletions or mutations of TP53. The primary endpoints were best response rate (VGPR) and MRD three months after ASCT.

Before the ASCT, stem cells are taken from the patient and stored. After treatment with the immunotherapy and chemotherapy drugs, stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

The treatment was well tolerated, with no unexpected serious adverse effects attributable to NK cells noted. The investigators plan to launch a randomized clinical trial to further explore this treatment combination for patients with high-risk multiple myeloma.

This study was supported with funding from the High-Risk Multiple Myeloma Moon Shot, part of MD Andersons Moon Shots Program, a collaborative effort to accelerate the development of scientific discoveries into clinical advances that save patients lives. The research also was supported by Celgene, a Bristol Myers Squibb company.

Srour has no conflicts of interest. A complete list of collaborating authors can be found within the abstract here.

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MD Anderson researchers present cellular therapy advances at the 2022 ASCO Annual Meeting - EurekAlert

Basel, June 12, 2022 Novartis today announced long-term results from the ELIANA pivotal clinical trial of Kymriah (tisagenlecleucel), the first-ever approved CAR-T cell therapy, in children and young adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL), with a maximum survival follow-up of 5.9 years. For the 79 patients treated with Kymriah in this study, the five-year overall survival (OS) rate was 55% (95% CI, 43-66), while the median event-free survival (EFS) for patients in remission within three months of infusion (n=65) was 43.8 months. These findings demonstrate the curative potential of Kymriah, the only CAR-T cell therapy available for these patients who previously had limited treatment options. These data were presented as an oral presentation during the 2022 European Hematology Association (EHA) Hybrid Congress (Abstract #S112)1.

These data mark a moment of profound hope for children, young adults and their families with relapsed or refractory B-cell ALL, as relapse after five years is rare, said Stephan Grupp, MD, PhD, Section Chief of the Cellular Therapy and Transplant Section, and Inaugural Director of the Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy at Children's Hospital of Philadelphia (CHOP). Since the approval of Kymriah nearly five years ago, we have been able to offer a truly game-changing option to patients who previously faced a five-year survival rate of less than 10 percent.

This long-term follow up of ELIANA demonstrated the potential for Kymriah to transform cancer treatment in pediatric and young adult patients with r/r B-cell ALL, significantly improving outcomes with durable responses and a consistent safety profile in this patient population1:

At Novartis, we strive for cures. With nearly six-year follow-up data in these pediatric and young adults treated for B-cell ALL, we have our strongest evidence yet that one-time treatment with Kymriah has curative potential, said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. These results strengthen our confidence in CAR-T cell therapies as a truly transformative and paradigm-shifting advance in cancer care, as well as our commitment to continue developing this technology with next-generation platforms.

Additional updates on the Novartis CAR-T program presented at the 2022 EHA Congress include new data from more patients and longer follow-up from the first-in-human dose-escalation trials with YTB323 in adults with r/r diffuse large B-cell lymphoma and PHE885 in adults with r/r multiple myeloma, the first Novartis CAR-T cell therapies developed using the Novartis T-Charge platform2,3,4. Visit https://www.hcp.novartis.com/virtual-congress/eha-2022/ to learn more about these data and our ongoing commitment to reimagining cancer care with CAR-T cell therapies.

About KymriahKymriah is the first-ever FDA-approved CAR-T cell therapy. It is a one-time treatment designed to empower patients immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia (ALL), r/r adult diffuse large B-cell lymphoma (DLBCL) and r/r adult follicular lymphoma1.

About the ELIANA TrialELIANA was the first pediatric global CAR-T cell therapy registration trial, examining patients in 25 centers in 11 countries across the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy, Norway and Spain. The trial was an open-label, multicenter, single-arm, global Phase II trial investigating the efficacy and safety of Kymriah in pediatric and young adult patients in r/r B-cell ALL who were primary refractory, chemorefractory, relapsed after, or were not eligible for allogeneic stem cell transplantation (SCT). The primary endpoint was overall remission rate (ORR), defined as best overall response of CR or CR with incomplete blood count recovery (CRi) within 3 months and maintained for 28 day. The secondary endpoints include CR/CRi with undetectable minimal residual disease (MRD), duration of remission, event-free survival, overall survival, cellular kinetics and safety5.

About T-ChargeT-Charge is a next-generation CAR-T platform, innovated at the Novartis Institutes for BioMedical Research (NIBR), that will serve as the foundation for various new investigational CAR-T cell therapies in the Novartis pipeline. By implementing the T-Charge platform, we aim to revolutionize CAR-T cell therapy with new products that have the potential to offer patients a higher likelihood of better and more durable responses, improved long-term outcomes and a reduced risk of severe adverse events. The T-Charge platform preserves T cell stemness (T cell ability to self-renew and mature), an important T cell characteristic closely tied to its therapeutic potential, which results in a product containing greater proliferative potential and fewer exhausted T cells. With T-Charge, CAR-T cell expansion occurs primarily within the patients body (in-vivo), eliminating the need for an extended culture time outside of the body (ex-vivo). The T-Charge platform, which implements important process efficiencies, will be rapid, compared with traditional CAR-T, and reliable, through simplified processes and streamlined quality control. Multiple CAR-T therapies, including YTB323 and PHE885, are being developed using the Novartis T-Charge platform.

About Novartis commitment to Oncology Cell TherapyAs part of the unique Novartis strategy to pursue four cancer treatment platforms radioligand therapy, targeted therapy, immunotherapy and cell and gene therapy we strive for cures through cell therapies in order to enable more patients to live cancer-free. We will continue to pioneer the science and invest in our manufacturing and supply chain process to further advance transformative innovation.

Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of the Novartis commitment to CAR-T cell therapy.

We have made strong progress in broadening our delivery of Kymriah, which is currently available for use in at least one indication in 30 countries and at more than 370 certified treatment centers, with clinical and real-world experience from administration to more than6,900 patients. We continue to pioneer in cell therapy, leveraging our vast experience to develop next-generation CAR-T cell therapies. These therapies will utilize our new T-Charge platform being evaluated to expand across hematological malignancies and bring hope for a cure to patients with other cancer types.

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more athttps://www.novartis.com.

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Novartis five-year Kymriah data show durable remission and long-term survival maintained in children and young adults with advanced B-cell ALL -...

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Arcellx (NASDAQ:ACLX) is a clinical-stage biotech whose stated goal is to develop potentially "safer, more effective, and more broadly accessible" CAR-T cell therapies for cancers and incurable diseases.

For anyone who is unfamiliar with CAR-T cell therapy, the following is an easy-to-understand explanation from National Cancer Institute.

cancer.gov

Simply put, CAR T-cell therapy is using & equipping patients' own T-cells to recognize, tag, and destroy cancer cells.

Currently, there are six CAR-T cell therapies approved by the FDA to treat five types of refractory* or relapsed* blood cancers (see below), including relapsed or refractory multiple myeloma (r/r MM).

*Note: Refractory means a cancer has stopped responding to treatments; Relapsed means a cancer has come back.

cancer.gov

Before I dive into ACLX's data in r/r MM, I would like to cover briefly what the company says about its underlying technology, which ACLX believes has the potential to produce "Best-in-Class" CAR-T cell therapies.

In order for a CAR-T cell therapy to work, the engineered T-cells, capable of expressing cancer-specific CAR (Chimeric Antigen Receptor), need to accomplish two very important tasks:

1. to recognize and tag the cancer cells by binding to the target antigen, e.g. CD19, BCMA, that is highly expressed on the surface of cancer cells;

2. once that part is done, the engineered T-cells then are activated (or signaled) to kill the tagged cancer cells.

According to the National Institute of Cancer, much innovation has taken place on the signaling part (that's inside the T-cells), see below.

cancer.gov

According to ACLX, their innovation is on the Antigen-binding domain (on the outside of T-cells, called D-Domain, which is smaller and more stable than the binding domains of other CAR-T therapies (below, slide 6).

ACLX thinks that these differences in the binding domain can potentially lead to improvements in safety, efficacy, and availability of their ddCAR T-cell therapy which they called ARC- (Antigen Receptor Complex) T cells.

ACLX June 2022 presentation

Furthermore, ACLX believes their ARC-T cell therapy can work with their second proprietary platform, called ARC-SparX platform.

SparX [proteins] stands for soluble protein antigen-receptor X-linker.

ACLX believes that this platform can develop novel CAR-T cell therapies that, unlike the current ones, are "dosable, controllable, and adoptable" T-cell therapies.

For anyone interested, there is a ~2min video on the company website explaining how ARC-SparX is supposed to work.

ACLX website

The cell (in light blue) with light blue tags on the outside represents the ARC-T cells.

The upside-down Y shape thing represent SparX proteins which have two ends, i.e. the Universal-tag end (a white-ish tag) that binds to ARC-T cells, and antigen-receptor end (in purple) that binds to the antigens (in pinkish color) on cancer cells.

So patients are dosed with SparX proteins that are designed to recognize and bind to antigen on cancer cells on the one end and bind to ARC-T cells on the other hand, which would activate the ARC-T cells to kill the tagged cancer cells.

In theory, SparX will recognize and bind to antigens that are specific to each cancer, and ARC-T cells are only activated when bound to SparX which are already bound to cancer cells.

Therefore by controlling SparX proteins, e.g. dose or antigen-receptor design, ACLX believes that such ARC-SparX T-cell therapy can potentially be " dosable, controllable, and adoptable", i.e. one-time infusion of ARC-T cells, but different doses or antigens of SparX proteins, if necessary.

I find this rationale very interesting and I can see it being very impactful & beneficial as a cancer treatment if successfully developed.

Let us now turn to the results presented at the 2022 ASCO meeting that seems to have impressed the market.

ACLX announced the presentations at ASCO on Friday, June 3, which must have impressed the market, as on Monday, June 6, the stock of ACLX rose 20%, i.e. from $13.09 to $15.79, see below.

ACLX 5-day chart ending on June 7, 2022 (Seeking Alpha)

The table below lists the headlines from ACLX's r/r MM p1 trial:

(Source: Emphasis by author)

To put these data in context, ACLX presents a table comparing their results with other approved MM treatments (see below):

ACLX presentation

As can be seen above, relative to other approved treatments for MM, ACLX's lead candidate CART-ddBCMA showed very promising efficacy and safety data so far, i.e. best ORR (100%), best safety (0% in Grade3/4 CRS [Cytokine release syndrome]).

Perhaps the strong efficacy and safety r/r MM p1 data so far explains the enthusiastic price action by the market.

More on this next.

According to ACLX, MM is the third most common blood cancer, affection 100,000 patients per year, and total addressable market by T-cell therapy is around $10B, see below.

ACLX ASCO 2022 presetation

It is important to remember ACLX's r/r MM data, though very promising, are early data, which means that one cannot assume too much.

In the same PR, the company mentioned that a pivotal p2 trial is on track to start by YE 2022, and if the pivotal trial is successful, the company anticipates BLA (Biologic License Application) filing to take place in 1H 2025 (slide 10).

As discussed in these market reports (here, here), CART-ddBCMA's early data seem to be "in-line" with the current CAR-T therapy leader, Carvykti, from Johnson & Johnson (JNJ) and Legend Biotech (LEGN).

A bullish outlook will be that CART-ddBCMA, continues to report positive data both in p1 & pivotal p2 trial, and ultimately be approved & commercialized.

As seen above, CART-ddBCMA has the potential to be safer and more effective than the currently available MM treatments, CAR-T or other therapies.

If so, then CART-ddBCMA will no doubt be very competitive in this space, translating in a significant potential upside.

For example, LEGN's lead CAR-T cell therapy, Carvykti, was approved in March 2022, and LEGN is currently valued at $7.09B (on June 7), 15 times ACLX's $467M market cap.

Or even if it's only comparable, as availability of CAR-T therapies is a rate-limiting step (more demand than the supply), a newly approved CAR-T should still be making very meaningful contribution to MM patients.

Significant risks to the investment thesis include but are not limited to: disappointing p1 & p2 data or trial failures, delays or difficulties in manufacturing, CMC (chemistry, Manufacturing, Control) data, delays or failures in regulatory process, dilution risks, etc.

According to the latest 10Q (page 18), as of March 31, 2022, ACLX had cash and cash equivalents and marketable securities of $210.9 million and a net loss of $32.4M in Q1, 2022.

The company believes the cash position is "adequate to fund operations into the second half of 2023".

This article on ACLX marks a personal-first for me: it's my first SA article covering a cancer drug. In the past, I have largely stayed away from the oncology space, due to very high failure rate of cancer trials.

Hopefully, this marks the beginning of something good.

As I have expressed many times in my past bullish articles, small clinical-stage biotech stocks are highly speculative and price action volatile. While good news does not always send the stock upwards, bad news will certainly send it down.

In the recent days, the short-term price action of the whole biotech sector is even more volatile and seemingly driven by anything but company-specific material news, as seen in ACLX's 1 year chart.

ACLX 1-year chart ending on June 7, 2022 (Seeking Alpha)

While it is very encouraging to see a clearly positive move to ACLX's r/r MM data, there is no guarantee that this stock, has turned to a sustainable up-trend.

With this in mind, please invest prudently with only money you are prepared to lose, if after doing your own due diligence, you find the upside potential suits your risk tolerance and investment time frame.

Thanks for reading and wishing you all the best!

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Arcellx: Speculative Buy For Their CAR-T Cell Therapy (NASDAQ:ACLX) - Seeking Alpha

Objective: to clinically validate efficacy of a new form of immunotherapy utilizing CAR-T cells to target multiple difficult-to-treat tumors

PARIS, June 13, 2022 /PRNewswire/ -- Mnemo Therapeutics, a biotechnology company developing transformational immunotherapies, today announced the kick-off of their participation in the prestigious Hospital-University Research in Health (RHU) program. Designed by France's National Research Agency, the RHU funding supports cutting-edge research and cross-institutional collaborations, bringing together academia, businesses, and hospitals to push the boundaries of what is possible in healthcare.

In December of 2021, 17 proposals were selected for the RHU funding. Among them, receiving close to 10 million euros, is the EpCART project. Under the leadership of Sebastian Amigorena, Ph.D., one of Mnemo's scientific co-founders and head of the Immune Responses and Cancer Team at Institut Curie, the EpCART project aims to clinically validate a novel approach to CAR-T immunotherapy.

"We are honored to be named a laureate for this prestigious initiative and work alongside our long-standing partners at Institut Curie, as well as the MEARY Cell and Gene Therapy Center at Saint-Louis Hospital, AP-HP," said Mnemo CEO, Robert LaCaze.

The EpCART project focuses on epigenetic reprogramming of CAR-T cells. Through the inactivation of SUV39H1, a key enzyme in the differentiation pathway of T cells, the memory phenotype of these cells can be greatly increased. This works to achieve long-lasting tumor control, addressing patient relapse.

"Current immuno-oncology therapies often suffer from immune-cell memory loss, causing therapies to become less active and persistent in their ability to attack cancer cells over time," said Dr. Amigorena. "The EpCART project mines insights into the memory of the immune system to overcome this challenge and produce a new class of CAR-T therapies with enhanced memory and persistence. We believe this will drive more durable responses for cancer patients."

Over the next five years, the EpCART project will seek to clinically validate this technology as an autologous therapy. Mnemo will work in collaboration with the other EpCART partners to conduct a Phase I-II clinical trial, investigating the activity of these innovative CAR-T therapies in a cohort of 35 patients with difficult-to-treat solid tumors.

The EpCART project will accelerate research on Mnemo's EnfiniT Discovery Engine, an integrated drug discovery tool combining key technologies to create lasting immune memory, identify novel cancer-specific targets, and more.

"Today is an exciting step in our journey to develop transformational immunotherapies with the aim of improving the body's ability to detect, fight, and overcome cancer," said Mnemo Co-Founder and Chief Operating Officer, Alain Maiore. "We are truly honored to collaborate with such esteemed partners and look forward to the fruits of this initiative."

About Mnemo Therapeutics

Mnemo is developing transformational immunotherapies to improve the body's ability to fight and overcome cancer. Integral to Mnemo's approach is the EnfiniT Discovery Engine, composed of key technologies that work to identify novel cancer-specific antigens and enhance immune cells' memory and persistence. Mnemo will harness these technologies with multiple modalities across a range of oncology indications, engineering the future of immunotherapies to transform the lives of people with cancer. Mnemo is headquartered in Paris with an office in New York City, and it maintains state of the art laboratories in Paris, New York, and Princeton, New Jersey. The company leverages an international talent pool and global resources in its quest to create immunological cures.

SOURCE Mnemo Therapeutics

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Mnemo Therapeutics Launches RHU Project in Collaboration with Leading European Research Partners, Institut Curie and MEARY Cell and Gene Therapy...

The first CAR-T cell therapy, a type of gene therapy, to treat cancers of blood and lymphatic system is likely to be available in India from 2023, offering hope to patients who cant afford to travel abroad for the expensive treatment.

On June 11, ImmunoACT, an Indian Institute of Technology, Bombay spin-off company, launched its facility to start production on a large scale. As of now, CAR-T cell therapy is not available in India, Patients have to travel to countries like the US and it costs nearly Rs 3-4 crore.

The indigenously developed CAR-T cell therapy was the result of intense research over the last eight years and had now been patented,Rahul Purwar, a senior IIT-Bombay faculty who is also the founder and CEO of ImmunoACT, said.

Incubated at the Society of Innovation and Entrepreneurship at IIT-B, ImmunoACT now has Hyderabad-based pharmaceutical major Laurus Labs as a partner and is looking to make the treatment available at Rs 20-30 lakh a patient in India, the company said.

The facility has the capacity to treat nearly 1,200 patients a year.

As part of the therapys Phase-1 clinical trial at Tata Memorial Hospitals Advanced Centre for Treatment, Research and Education in Cancer in Mumbai, 10 lymphoma patients have been treated with no relapse so far.

The company is now looking to seek regulatory approvals from the Central Drugs Standard Control Organisation for Phase 2 trials with about 40 patients.

In its initial trials, the project received support from the Centres department of biotechnology and Biotechnology Industry Research Assistance Council.

What is CAR-T Cell therapy?

Chimeric Antigen Receptor (CAR)- T cells are a patients own immune cells, which are engineered in the laboratory to fight cancer.

It is mostly effective in blood cancer and lymphoma (cancer beginning in the cells of the lymph system), though studies are on to assess its role in solid tumours and auto-immune diseases as well.

Also read:Explainer | Dostarlimab for cancer cure: Hope or hype?

As of now, the therapy is usually offered as second-line treatment for late-stage leukemia and lymphoma patients who are either not responding to conventional treatments like chemotherapy and bone-marrow transplant or have a case of relapsed cancer.

Research from abroad has shown that the therapy can be effective in 40-50 percent of the patients, with slightly better results in pediatric populations.

Estimates suggest that about 40,000-50,000 new leukemia and lymphoma patients are diagnosed in India every year.

Ray of hope for cancer patients in India

According to Puwar, ImmunoACT's patented CAR-T cell platform provides a unique design algorithm to develop novel CAR-T cells and its first product, HCAR19, showed favourable balance of efficacy and toxicity.

It can be offered to patients with CD19 marker in B cells (the protein that is used to diagnose cancers that arise from B type of cellwhite blood cells that produce antibodies such as B cell lymphomas, acute lymphoblastic leukemia, and chronic lymphocytic leukemia), said Purwar.

He said that the majority of B cell malignancies have normal to high levels of CD19.

Also read:Current surge in Covid-19 cases not start of fourth wave, say authorities

The majority of the commercially available CAR-T cell therapies are also associated with severe toxicity, Purwar said, adding the therapy developed in India was far better on that count.

He also said that the therapy was likely to be available at cancer hospitals after the Phase 2 trial of the research projects, while the late-stage trial would continue concurrently.

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Ray of hope for blood cancer, lymphoma patients as CAR-T cell therapy to be available in India - Moneycontrol

SEATTLE and PESSAC, France, June 10, 2022 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells to treat patients with solid and hematologic malignancies, and TreeFrog Therapeutics, a biotechnology company aimed at making safer, more efficient and more affordable cell therapies based on induced pluripotent stem cells (iPSCs), announced today that they have entered into a collaboration to evaluate Umojas iPSC platform within TreeFrogs C-Stem technology for scalable expansion and immune cell differentiation in bioreactors.

Together, the successful pairing of Umojas RACR engineered iPS cells and TreeFrogs C-Stem technology could overcome several challenges facing ex vivo allogeneic therapies, said Ryan Larson, Ph.D., Vice President and Head of Translational Science at Umoja. Two major industry-wide challenges include the ability to scale iPSC-based culture while maintaining cell health, quality, and efficient immune cell differentiation. TreeFrogs biomimetic C-Stem technology is the perfect complementary development platform for our RACR technology, a pairing which could result in controlled, efficient iPSC expansion and differentiation into immune cells, with improved yields and quality. In addition to enhancing the differentiation and yield of immune cells within the manufacturing process, our RACR system should bring therapeutic benefit to patients, allowing for safe in vivo engraftment and persistence of tumor-killing cells without requirements for toxic lymphodepleting chemotherapy.

Umoja is developing an engineered iPSC platform that addressesmany challenges associated with ex vivo cell therapy manufacturing, including limited scalability and manufacturing complexity.Umojas iPSCs are engineered with a synthetic rapamycin-activated cytokine receptor (RACR) to drive differentiation to, and expansion of innate cytotoxic lymphoid cells, including but not limited to natural killer (NK) cells in the absence of exogenous cytokines and feeder cells. TreeFrogs proprietary C-Stem technology relies on the high-throughput encapsulation (>1,000 capsules/second) of hiPSCs within biomimetic alginate shells, which promote in vivo-like exponential growth and protect cells from external stress. In 2021, C-Stem was demonstrated to allow for unprecedented iPSC expansion in 10L bioreactors, while preserving stem cell quality. Also enabling direct in-capsule iPSC differentiation, C-Stem constitutes a scalable, end-to-end, and GMP-compatible manufacturing platform for iPSC-derived cell therapies.

Frdric Desdouits, Ph.D., Chief Executive Officer at TreeFrog added, Our primary goal is to bring the benefits of the C-Stem technology to patients as fast as possible, either through in-house programs or strategic alliances with cell therapy leaders. Partnering with Umoja is an important step forward in immuno-oncology. Besides scale-up and cell quality, the in vivo persistence of allogeneic therapies remains a critical challenge in the industry. We believe Umojas platform will allow for safer and more efficient allogeneic cell therapies in immuno-oncology. We look forward to rapidly advancing this joint approach to clinic and contributing to the future of off-the-shelf cancer treatments.

About Umoja BiopharmaUmoja Biopharma, Inc. is an early clinical-stage company advancing an entirely new approach to immunotherapy. Umoja Biopharma, Inc. is a transformative multi-platform immuno-oncology company founded with the goal of creating curative treatments for solid and hematological malignancies by reprogramming immune cells in vivo to target and fight cancer. Founded based on pioneering work performed at Seattle Childrens Research Institute and Purdue University, Umojas novel approach is powered by integrated cellular immunotherapy technologies including the VivoVec in vivo delivery platform, the RACR/CAR in vivo cell expansion/control platform, and the TumorTag targeting platform. Designed from the ground up to work together, these platforms are being developed to create and harness a powerful immune response in the body to directly, safely, and controllably attack cancer. Umoja believes that its approach can provide broader access to the most advanced immunotherapies and enable more patients to live better, fuller lives. To learn more, visithttp://umoja-biopharma.com/.

About TreeFrog TherapeuticsTreeFrog Therapeutics is a French-based biotech company aiming to unlock access to cell therapies for millions of patients. TreeFrog Therapeutics is developing a pipeline of therapeutic candidates using proprietary C-Stem technology, allowing for the mass production of induced pluripotent stem cells and their differentiation into ready-to-transplant microtissues with unprecedented scalability and cell quality. Bringing together over 80 biophysicists, cell biologists and bioproduction engineers, TreeFrog Therapeutics raised $82M over the past 3 years to advance its pipeline in regenerative medicine and immuno-oncology. The company is currently opening technological hubs in Boston, USA, and Kobe, Japan, to drive the adoption of C-Stem and build strategic alliances with leading academic, biotech and industry players in the field of cell therapy.

Umoja Biopharma Media Contact:Darren Opland, Ph.D.LifeSci Communicationsdarren@lifescicomms.com

TreeFrog Therapeutics Media Contact:Pierre-Emmanuel GaultierTreeFrog Therapeuticspierre@treefrog.fr

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/012ae87d-b7c6-4fa2-81dc-c769877b182c

Link:
Umoja Biopharma and TreeFrog Therapeutics Announce Collaboration to Address Current Challenges Facing Ex Vivo Allogeneic Therapies in Immuno-Oncology...

This report studies the Dendritic Cell Therapy Market with many aspects of the industry like the market size, market status, market trends and forecast, the report also provides brief information of the competitors and the specific growth opportunities with key market drivers. Find the complete Dendritic Cell Therapy Market analysis segmented by companies, region, type and applications in the report.

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What are the Dendritic Cell Therapy Market Strategies? - Digital Journal