On December 5, 2024 Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, reported upcoming scientific presentations, including updates from the company’s Phase 1/2 study of WU-CART-007 (Press release, Wugen, DEC 5, 2024, View Source [SID1234648831]). Researchers will present Phase 1/2 updates and studies for its investigational cell therapies this week at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, Dec. 7-10 in San Diego.

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Results from Phase 1/2 showed continued anti-leukemic activity and clinically manageable safety in adults and adolescents. WU-CART-007 is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy under evaluation for treatment of patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL).

Based on findings to date with WU-CART-007, including this week’s data, Wugen will initiate the first pivotal Phase 2 study for an off-the-shelf CD7-targeted CAR-T cell therapy.

"Maturing evidence, including the Phase 1/2 study being presented, suggest WU-CART-007 has the potential to improve current standard of care for patients with these blood cancers. T-ALL/LBL are malignancies associated with high rates of relapse and mortality in patients, many of whom are young," said Armin Ghobadi, M.D, professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy (CGCI) at the Washington University School of Medicine in St. Louis.

"At this year’s ASH (Free ASH Whitepaper) meeting, we will present clinical data from adult and adolescent patients that support our soon to open pivotal trial for patients with relapsed or refractory T-ALL/LBL," said Wugen Chief Medical Officer, Cherry Thomas, M.D. "We are looking forward to working with experienced investigators to provide meaningful clinical benefit to patients with limited treatment options."

The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will involve two groups: a R/R cohort and subsequently an exploratory minimal residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia.

Wugen Presentations at ASH (Free ASH Whitepaper)

3450 WU-CART-007 (WT-7), an Allogeneic CAR T-Cell Targeting CD7 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL): Phase 2 Results

Presenter: Armin Ghobadi, M.D., Washington University School of Medicine, St. Louis

Presentation type: Poster

Time/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,H
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II

3461 WU-CART-007 (WT-7) Is an Effective Treatment for Adolescent Patients with Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) – Subgroup Analysis of WU-CART-007 1001

Presenter: Shannon L. Maude, M.D., Division of Oncology, Center for Childhood Cancer Research and Cancer Immunotherapy Program, Children’s Hospital of Philadelphia, Philadelphia

Presentation type: Poster

Time/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,H
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II

Wugen researchers will also present the following abstracts for the company’s investigational memory natural killer cell therapy, WU-NK-101:

916 W-NK1 Choreographs Innate and Adaptive Immune Responses to Provide a Robust and Durable Anti-AML Response

Presenter: Tom Leedom, Wugen, Inc., St. Louis

Presentation type: Oral

Time/location: Monday, Dec. 9, 3:30 p.m. PT; Marriott Grand Ballroom 8-9, Marriott Marquis San Diego Marina

Session: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Enhancing NK Cell Therapeutics Hematology Disease Topics & Pathways: Research, Translational Research 2:45-4:15 p.m. PT

4257 WUN101-01: First in Human (FIH) Phase 1 Study of WU-NK-101 (W-NK1) in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

Presenter: Amanda F. Cashen, M.D., Washington University School of Medicine, St. Louis

Presentation type: Poster

Time/location: Monday, Dec. 9, 6:00-8:00 p.m. PT; Halls G, H

Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III

Hematology Disease Topics & Pathways: Research, Clinical trials, Translational Research, Clinical Research

Investigator-initiated research

2066 Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients with CD7+ T-Cell Non-Hodgkin Lymphoma

Presenter: Michael H. Kramer, M.D., Ph.D., Washington University School of Medicine, Saint Louis

Presentation type: Poster

Time/location: Sat., Dec. 7, 5:30-7:30 p.m. PT; Halls G, H

Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I;

About WU-CART-007

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794.

WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.

On December 5, 2024 Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, reported the launch of SHORTEN-ctDNA, a clinical trial at Columbia University (Press release, Foresight Diagnostics, DEC 5, 2024, View Source [SID1234648847]). The study aims to evaluate the ability to utilize Foresight CLARITY MRD detection to enable real-time treatment optimization for patients with diffuse large B-cell lymphoma (DLBCL).

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Currently the standard treatment for newly diagnosed DLBCL requires six cycles of combination rituximab and chemotherapy regardless of individual patient response. This one-size-fits-all approach leaves little room for personalization, potentially exposing patients to unnecessary treatment. The SHORTEN-ctDNA trial will investigate whether patients who achieve early clearance of circulating tumor DNA (ctDNA) can safely receive fewer cycles of chemotherapy while maintaining long-term survival outcomes.

"Although PET scans remain our standard tool for monitoring lymphoma treatment, their inconsistent results in identifying active disease limit our ability to make real-time treatment decisions," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "Foresight CLARITY’s detection of residual disease could be the game-changer we need, potentially allowing us to confidently adjust therapy based on each patient’s actual response to treatment with a more dynamic and sensitive tool than imaging."

The study will enroll approximately 32 newly diagnosed DLBCL patients. After three cycles of R-CHOP or pola-R-CHP therapy, participants will undergo ctDNA testing. Those with detectable disease (MRD-positive) will continue with rituximab plus chemotherapy for their remaining cycles, while patients who achieve undetectable ctDNA levels (MRD-negative) will de-escalate to rituximab alone for their final two cycles.

"Recent evidence suggests many patients achieve very deep remissions earlier in their R-chemo treatment than previously thought," said Hua-Jay Cherng, MD, assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and Principal Investigator of the study. "By using next-generation, ultra-sensitive ctDNA technology, SHORTEN-ctDNA aims to identify these early responders and personalize their treatment strategy, potentially reducing treatment duration and associated toxicity and hopefully getting patients back to their normal lives sooner."

On December 5, 2024 Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, and Eckert & Ziegler, one of the world’s largest providers of isotopes for medical, scientific and industrial use, reported the signing of a global supply agreement for the medical radionuclides Actinium-225 (Ac-225) and Lutetium-177 (Lu-177) (Press release, Ariceum Therapeutics, DEC 5, 2024, View Source [SID1234648823]).

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Following limited global availability, alongside increasing demand for Ac-225, which comes with intricate manufacturing complexities, this collaboration is a significant step forward in accelerating Ariceum’s novel targeted radiopharmaceutical pipeline programs.

Under the terms of the agreement, Eckert & Ziegler will supply Ariceum with the required quantities of non-carrier-added (n.c.a.) Ac-225 and Lu-177. Both radionuclides will be used to radiolabel Ariceum’s proprietary lead radiopharmaceutical drug (SS0110) satoreotide targeting hard-to-treat cancers in clinical studies and subsequent commercial phases. The agreement also includes options for expansion to other drugs as well as the use of additional radionuclides in preparation for future commercialisation activities.

Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, said: "This important global supply agreement with Eckert & Ziegler for n.c.a. Ac-225 and Lu-177 will ensure an adequate supply of radionuclide isotopes to conduct our clinical trials. We are looking forward to working with the Eckert & Ziegler team to build a robust supply chain and to reliably deliver targeted theranostic treatments for patients with hard-to-treat cancers. Our lead radiopharmaceutical drug, satoreotide is a first-in-class, antagonist of the somatostatin receptor 2 (SSTR2) labelled with Ac-225 to enter clinical development in small cell lung cancer and in Merkel Cell Carcinoma very soon."

Dr. Harald Hasselmann, Chief Executive Officer of Eckert & Ziegler, commented: "In collaborating with Ariceum, we support their mission to develop innovative radiopharmaceuticals for the benefit of patients. Both the production start for Ac-225, announced earlier this week, and the successful European approval of Theralugand, show that our goal is to sustainably reduce the shortage of high-quality radioisotopes. We aim to foster the progress of novel treatments in clinical trials and beyond, and thus contribute to saving lives."

On December 5, 2024 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to treat cancers, reported it has entered into a Clinical Trial Services Agreement (the "Agreement") with the Israel-based biotechnology company PeriNess Ltd. ("PeriNess") to advance the Company’s development program for its systemic DNase I candidate in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors toward exploratory clinical studies (Press release, Xenetic Biosciences, DEC 5, 2024, View Source [SID1234648832]).

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"We are pleased to be working with PeriNess, and to have the opportunity to leverage their experience for the development of Xenetic’s intravenous DNase I candidate through preclinical and early-stage clinical programs. We are excited to take this step forward on the path to the clinic and look forward to investigating our systemic DNase I candidate, XBIO-015, as an adjunctive treatment," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.

"We are thrilled to enter this strategic Clinical Trial Services Agreement with Xenetic and further advance the development of their systemic DNase I platform. We believe this collaboration is a great example of where we can put substantial synergies from our projects toward accelerating the clinical development of a highly promising DNase I program for patients in need of new therapies," commented Michal Ben Attar, Chief Executive Officer of PeriNess.

A large body of published preclinical data highlights the pivotal role of Neutrophil Extracellular Traps (NETs) in modulating cancer chemotherapy and immunotherapy efficacy and provides a strong rationale for incorporating DNase I as an adjunctive treatment to improve therapeutic responses in patients with pancreatic and colorectal cancers receiving chemotherapy and immunotherapy.

Under the terms of the Agreement, PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.

On December 5, 2024 Mission Bio, a leader in single-cell multiomics solutions for precision medicine, reported the full list of presentations by leading researchers and clinicians spanning multiple indications of blood cancer, leveraging the Tapestri Platform to advance therapeutic research and development at the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Mission Bio, DEC 5, 2024, View Source [SID1234648848]). More than 20 presentations at the event, which takes place Dec. 7-10 in San Diego, will shine a spotlight on how Mission Bio’s customers are using Tapestri and associated products to gain a broader and deeper understanding of Multiple Myeloma, AML, Lymphoma, and CAR-T therapy development.

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Among these presentations, Mission Bio will showcase new datasets for the first time, demonstrating how the Tapestri Single-cell Multiple Myeloma Multiomics Solution, which became commercially available this year, can be used to integrate genomic, immunophenotypic, and clonotypic assessment to pinpoint disease-driving clones in Multiple Myeloma (MM). The team behind the data was led by Mission Bio CTO and co-founder Adam Sciambi.

"Our ongoing mission is to provide scientists with the means to understand hard-to-treat diseases like MM in ways that will lead to new, more effective treatments," Sciambi said. "We’re looking forward to sharing our findings on the role of rare clones in the progression from precursor conditions like monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) to full-blown MM, as well as the comprehensive clonal architecture underlying relapse and treatment resistance. We’re equally excited to see what our customers are doing to advance research into other forms of cancer."

A new study from Heidelberg University Hospital will showcase the value of single-cell DNA+protein multiomics sequencing to refine minimal residual disease (MRD) assessment in acute myeloid leukemia (AML). Presented under the title "Clonal Dynamics of Leukemic and Clonal Hematopoiesis Mutations Predict Relapse in Single Cell MRD Analysis of AML in First Complete Remission," the research uses patient samples to demonstrate how this approach offers greater precision than current techniques, potentially establishing a way to redefine AML MRD.

Researchers from the University of Cincinnati will also introduce the first-ever data demonstrating the feasibility of integrating DNA and fusion profiling at the single-cell level as a multiomic approach. The presentation, titled "Single-Cell Multi-Omic Analysis of KMT2A-Rearranged Pediatric Acute Leukemia Clonal Evolution," is the first of its kind to utilize the combination of simultaneous molecular profiling and fusion identification at the single-cell level for pediatric leukemia.

Following a recent publication in the New England Journal of Medicine, new findings from Stanford University highlight the power of single-cell DNA sequencing to uncover critical genomic insights in chimeric antigen receptor (CAR) T-cell therapy, revealing myeloid predominance for TP53 clonal hematopoiesis in post-CAR therapy myeloid neoplasms (tMN) among non-Hodgkin lymphoma patients. These findings, presented under the title "Single Institution Analysis of Lymphoma Treatment Related Post-CAR Myeloid Neoplasms," underscore the potential of single-cell DNA sequencing to inform CAR T therapy development, enabling safer treatments by addressing risks tied to therapy-induced molecular changes.

Additional institutions included among the presentations at ASH (Free ASH Whitepaper) include the National Institutes of Health, Weill Cornell Medical College, University of Pennsylvania, Berlin Institute of Health, Oxford University Hospitals, University of Miami Miller School of Medicine, and University of Toronto. For the full list of poster and oral presentations, or to schedule a one-on-one meeting with the Mission Bio team at the 2024 ASH (Free ASH Whitepaper) Annual Meeting, please visit View Source Attendees can also learn more about the Tapestri Platform and all of Mission Bio’s multiomics solutions by visiting booth #2112.