RegulationOrphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Regenerative Medicine Advanced Therapy (United States), Conditional marketing approval (European Union), Conditional marketing approval (United Kingdom)

Structure/Sequence

Sequence Code 1277314386

Source: *****

Clinical Trials associated with Obecabatagene autoleucel

NCT07400029

/ RecruitingPhase 2IIT

A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease

The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).

Start Date03 Feb 2026

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT07053800

/ RecruitingPhase 2

A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis

This trial aims to find out if obe-cel gets rid of harmful B cells that contribute to systemic lupus erythematosus (SLE)/lupus nephritis (LN) when available treatments have not worked (refractory). The trial includes only 1 group of patients (single arm), including adolescent and adult patients aged 12 to 65 years. The objective is to look for benefits of obe-cel in making signs of LN completely disappear (remission) at 6 months after obe-cel treatment in patients with severe, active LN. The trial will also look for other benefits of obe-cel for up to 24 months after treatment, including the percentage of patients who respond to obe-cel treatment, SLE/LN activity, time to and length of remission, and quality of life. The trial will also assess how long obe-cel stays in the body and the safety of obe-cel.

Start Date16 Jan 2026

Sponsor / Collaborator

Autolus Ltd.

[+1]

NCT07053059

/ RecruitingPhase 2IIT

Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)

The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy. Consolidation therapy is given after the first phase of treatment.

Start Date26 Aug 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Obecabatagene autoleucel

100 Translational Medicine associated with Obecabatagene autoleucel

100 Patents (Medical) associated with Obecabatagene autoleucel

Literatures (Medical) associated with Obecabatagene autoleucel

01 Dec 2025·Current Hematologic Malignancy Reports

Transforming the Treatment of Acute Lymphoblastic Leukemia: the Role of Bispecific Antibodies, Antibody-Drug Conjugates, and CAR T-cell Therapy

Review

Author: Chalhoub, Joe ; Haddad, Fadi G ; Khanfour, Sarah ; Sakkal, Shereen ; Najdi, Tala ; Kourie, Hampig Raphael

PURPOSE OF REVIEW:

B-cell acute lymphoblastic leukemia (B-ALL) is a highly aggressive hematologic malignancy, with particularly poor outcomes in relapsed or refractory cases. Relapses remain a major challenge, often resulting in short remission durations and limited survival. This review summarizes emerging therapeutic strategies for B-ALL, focusing on novel immunotherapies and targeted approaches beyond the relapsed/refractory setting.

RECENT FINDINGS:

Transformative therapies such as chimeric antigen receptor (CAR) T-cell therapy, antibody-drug conjugates (ADCs), and bispecific antibodies have shown promising efficacy. Beyond the R/R setting, both blinatumomab and inotuzumab ozogamicin demonstrated high rates of eradication of measurable residual disease (MRD) up to 97% and 80%, respectively. Furthermore, the addition of blinatumomab following chemotherapy in the frontline setting in patients with patients with Philadelphia chromosome (Ph)-negative B-ALL who achieved negative MRD was showing to improve outcomes with a 3-year overall survival rate of 85% compared to 68% with chemotherapy alone. Tisagenlecleucel, brexucabtagene autoleucel, and obecabtagene autoleucel, are chimeric antigen receptor (CAR) T-cell therapies that improved survival compared to chemotherapy alone in patients with relapsed/refractory ALL. In newly diagnosed Ph-positive ALL, chemotherapy-free regimens combining blinatumomab with TKIs resulted in high rates of MRD negativity and improved survival. The combination of blinatumomab and ponatinib led to a 98% MRD negativity rates by next-generation sequencing and a 3-year overall survival of 91% without reliance on allogeneic stem cell transplantation. Novel immunotherapies and targeted agents offer new avenues to improve outcomes in B-ALL. Expanding the use of blinatumomab, inotuzumab ozogamicin, and CAR T-cell therapy across treatment phases, together with strategic sequencing, may help overcome relapsed/refractory disease. These approaches provide renewed hope for achieving durable remissions and extending survival in patients with B-ALL.

05 Oct 2025·CHINESE MEDICAL JOURNAL

Novel CD19 Fast-CAR-T cells vs. CD19 conventional CAR-T cells for the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia

Article

Author: Wang, Lu ; Liu, Li ; Wang, Sanbin ; Liu, Ligen ; Zhang, Cheng ; Zhou, Jian ; Wang, Xiaoqi ; Wang, Jishi ; Ge, Jian ; Tu, Sanfang ; Tan, Xu ; Chen, Shangjun ; Yao, Han ; Li, Yuhua ; Zhang, Xi ; Yi, Hai ; Hu, Yongxian ; Chen, Guo

Abstract:

Background::

Treatment with chimeric antigen receptor-T (CAR-T) cells has shown promising effectiveness in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), although the process of preparing for this therapy usually takes a long time. We have recently created CD19 Fast-CAR-T (F-CAR-T) cells, which can be produced within a single day. The objective of this study was to evaluate and contrast the effectiveness and safety of CD19 F-CAR-T cells with those of CD19 conventional CAR-T cells in the management of R/R B-ALL.

Methods::

A multicenter, retrospective analysis of the clinical data of 44 patients with R/R B-ALL was conducted. Overall, 23 patients were administered with innovative CD19 F-CAR-T cells (F-CAR-T group), whereas 21 patients were given CD19 conventional CAR-T cells (C-CAR-T group). We compared the rates of complete remission (CR), minimal residual disease (MRD)-negative CR, leukemia-free survival (LFS), overall survival (OS), and the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups.

Results::

Compared with the C-CAR-T group, the F-CAR-T group had significantly higher CR and MRD-negative rates (95.7% and 91.3%, respectively; 71.4% and 66.7%, respectively; P = 0.036 and P = 0.044). No significant differences were observed in the 1-year or 2-year LFS or OS rates between the two groups: the 1-year and 2-year LFS for the F-CAR-T group vs. C-CAR-T group were 47.8% and 43.5% vs . 38.1% and 23.8% ( P = 0.384 and P = 0.216), while the 1-year and 2-year OS rates were 65.2% and 56.5% vs . 52.4% and 47.6% ( P = 0.395 and P = 0.540). Additionally, among CR patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) following CAR-T-cell therapy, there were no significant differences in the 1-year or 2-year LFS or OS rates: 57.1% and 50.0% vs . 47.8% and 34.8% ( P = 0.506 and P = 0.356), 64.3% and 57.1% vs . 65.2% and 56.5% ( P = 0.985 and P = 0.883), respectively. The incidence of CRS was greater in the F-CAR-T group (91.3%) than in the C-CAR-T group (66.7%) ( P = 0.044). The incidence of ICANS was also greater in the F-CAR-T group (30.4%) than in the C-CAR-T group (9.5%) ( P = 0.085), but no treatment-related deaths occurred in the two groups.

Conclusion::

Compared with C-CAR-T-cell therapy, F-CAR-T-cell therapy has a superior remission rate but also leads to a tolerably increased incidence of CRS/ICANS. Further research is needed to explore the function of allo-HSCT as an intermediary therapy after CAR-T-cell therapy.

01 Oct 2025·ZEITSCHRIFT FUR RHEUMATOLOGIE

Article

Author: Wirsching, Andreas ; Grieshaber-Bouyer, Ricardo ; Hagen, Melanie ; Mackensen, Andreas ; Müller, Fabian ; Böltz, Sebastian ; Schett, Georg ; Kharboutli, Soraya ; Taubmann, Jule ; Garantziotis, Panagiotis ; Völkl, Simon ; Aigner, Michael ; Spörl, Silvia

News (Medical) associated with Obecabatagene autoleucel

22 Apr 2026

·www.globenewswire.com

Advancing Drug Pipelines Drive Biotech Valuations as Scientific Progress Gains Financial Recognition

AUSTIN, Texas, April 22, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: The biotechnology industry is experiencing a subtle yet meaningful transformation that is redefining how value is interpreted within a sector long associated with extended development cycles and inherent uncertainty. As therapeutic candidates advance toward commercialization, scientific achievement is no longer viewed purely as an expense tied to research and development but rather as something that can be quantified as a financial asset. This transition is supported by fair-value accounting principles under U.S. GAAP, which enable life sciences companies to incorporate clinical progress, probability of success and expected commercialization timelines into measurable balance sheet value. Companies at the forefront of this shift, including Oncotelic Therapeutics Inc. (OTCQB: OTLC) (profile), are actively leveraging this evolving framework. Operating at the intersection of oncology therapeutics and AI-driven drug development, Oncotelic demonstrates how scientific advancement can influence financial positioning. Through a diversified pipeline and strategic holdings, including a 45% interest in GMP Bio, which was recently assessed at more than $1 billion in enterprise value, the company illustrates how innovation can be reflected in tangible economic terms. As the industry increasingly aligns valuation with development progress rather than current revenue, Oncotelic represents a compelling example of science emerging as a recognized asset class. The company is part of a broader group of organizations developing advanced therapies at the genetic and molecular level, including Autolus Therapeutics plc (NASDAQ: AUTL), Wave Life Sciences Ltd. (NASDAQ: WVE), IO Biotech Inc. (OTC: IOBTQ) and Roche Holding AG (OTC: RHHBY). The biotech sector is transitioning away from a framework dominated by long-term research spending toward one in which scientific progress can be directly reflected in financial valuation.As drug candidates progress through the stages of clinical development, their value tends to rise substantially due to increasing probabilities of success and closer proximity to commercialization.Oncotelic Therapeutics provides a clear example of the growing adoption of fair-value accounting through the remeasurement of its stake in GMP Bio.Based on this evolving investment landscape, Oncotelic Therapeutics is situated to benefit from increasing institutional interest in pipeline-driven valuation.The company operates within this key convergence by combining oncology-focused development with AI-enabled platforms and exposure to manufacturing capabilities. Click here to view the custom infographic of the Oncotelic Therapeutics editorial. Scientific Advancement Emerging as Measurable Value The biotech sector is transitioning away from a framework dominated by long-term research spending toward one in which scientific progress can be directly reflected in financial valuation. Traditionally, investors relied heavily on discounted cash-flow models tied to eventual commercialization outcomes, which often created a disconnect between innovation and perceived value. With the growing adoption of fair-value accounting methodologies under U.S. GAAP, that gap is beginning to close as companies gain the ability to adjust asset valuations in response to clinical and regulatory progress. Under guidance from the Financial Accounting Standards Board, particularly ASC 820, companies can determine the fair value of assets, including early-stage or illiquid investments, using a combination of observable and unobservable inputs. This includes Level 3 classifications, which are frequently applied in biotechnology to assess the value of pipeline programs and strategic holdings. These valuation approaches allow organizations to incorporate factors such as clinical advancement, regulatory status and probability of success into financial reporting. Leading advisory firms have emphasized that valuation in the life sciences sector increasingly depends on forward-looking inputs, including development progress and anticipated commercialization potential. Because fair-value accounting requires assets to be measured from the perspective of market participants, these frameworks inherently incorporate expectations about future economic benefit. As a result, financial reporting becomes more closely aligned with the operational realities of drug development, where revenue generation often lags innovation. This evolving approach is particularly relevant for Oncotelic Therapeutics, whose value is closely tied to the advancement of its therapeutic pipeline. By aligning financial reporting with clinical and strategic milestones, the company reflects a broader industry shift toward recognizing scientific progress as a core driver of enterprise value. Advancing Pipelines and Valuation Acceleration As drug candidates progress through the stages of clinical development, their value tends to rise substantially due to increasing probabilities of success and closer proximity to commercialization. This progression, often described as a valuation inflection point, is widely observed across the biotechnology landscape. Assets in late-stage development, particularly those nearing regulatory approval, frequently represent a disproportionate share of overall company value. Research from McKinsey & Company indicates that value creation within biopharma is heavily concentrated in later-stage programs, where reduced uncertainty and clearer pathways to market translate into stronger expected returns. Additional industry analysis supports the view that assets approaching commercialization often drive significant increases in valuation due to improved probability-adjusted outcomes and anticipated market entry. This trend underscores a broader shift in how investors evaluate biotechnology companies. Rather than concentrating primarily on existing revenue or earnings, attention is increasingly directed toward the maturity and forward trajectory of pipeline assets. Consequently, companies with advanced-stage programs may experience meaningful increases in valuation even prior to generating commercial revenue. For Oncotelic Therapeutics, this dynamic is applicable given its focus on oncology therapies and its positioning within high-value development pathways. As the company’s pipeline advances toward later stages, its valuation profile aligns with the broader industry movement toward pipeline-driven value recognition. Fair-Value Frameworks Gain Momentum in Biotech The growing adoption of fair-value accounting within biotechnology is supporting more accurate and timely representation of asset value. Under GAAP, Level 3 valuation methodologies are applied to assets without observable market prices, using models that rely on forward-looking assumptions such as expected cash flows and probability-weighted scenarios. The ASC 820 framework describes fair value as the price that would be received in an orderly transaction between market participants at the measurement date. It establishes an organized hierarchy for valuing complex or illiquid assets using the best available information and market-based assumptions. This approach ensures that financial reporting reflects a current and economically relevant view of asset value. Oncotelic Therapeutics provides a clear example of this methodology through the remeasurement of its stake in GMP Bio, which reflects an enterprise valuation exceeding $1 billion. This shows how clinical advancement and strategic positioning can translate into measurable balance sheet strength, reinforcing the concept that scientific progress carries financial significance. Institutional Investors Embrace Prerevenue Opportunities Institutional investors are acknowledging the value of clinical-stage biotechnology assets, even in the absence of current revenue. This swing indicates increasing confidence in structured valuation approaches that encompass scientific progress instead of only on traditional financial metrics. In many cases, biotech companies are assessed based mostly on the strength of their development pipelines rather than current income streams. Given the extended timelines required to bring therapies to market, valuation is often driven by factors such as clinical stage, probability of success and regulatory milestones. This framework highlights that value creation in the sector frequently occurs well before commercialization, as investors rely on milestone-based and probability-adjusted methodologies to assess future potential. Based on this evolving investment landscape, Oncotelic Therapeutics is situated to benefit from increasing institutional interest in pipeline-driven valuation. The companys varied assets and strategic investments align with the kinds of opportunities that are attracting capital across the biotechnology sector. Integration of AI, Manufacturing and Market Readiness Technological advancements in artificial intelligence and GMP-compliant manufacturing are fast-tracking development timelines while enhancing scalability throughout the biotechnology sector. These innovations support increasingly efficient clinical workflows, improved data analysis and streamlined production procedures, ultimately decreasing development time and cost. Artificial intelligence is playing a greater role in identifying therapeutic targets, optimizing clinical trial design and analyzing complex datasets. These capabilities improve the likelihood of success in drug-development programs. In addition, advancements in GMP-compliant manufacturing are supporting more consistent and scalable production, which becomes critical as therapies move closer to commercialization. Industry research suggests that data-driven methods are becoming central to value creation in biopharma, with AI and advanced analytics contributing to faster development timelines and improved execution. The intersection of technology, manufacturing and clinical development is redefining how value is generated and assessed within the sector. Companies capable of integrating these capabilities are better positioned to advance therapies efficiently while maintaining regulatory compliance. Oncotelic Therapeutics operates within this convergence by combining oncology-focused development with AI-enabled platforms and exposure to manufacturing capabilities. This cohesive strategy encourages both innovation and financial valuation, placing the company in a key biotech growth trend. The biotechnology industry is seeing a new chapter in which scientific advancement is increasingly recognized as a measurable financial asset rather than mainly a cost center. As fair-value accounting, pipeline maturity and AI-fueled development continue to redefine the sector, the conventional divide between innovation and valuation is decreasing. Savvy companies such as Oncotelic Therapeutics demonstrate how this change is taking place in practice, showing that clinical progress can strengthen financial positioning even prior to revenue generation. As investor focus continues to shift toward pipeline-driven value, the ability to convert scientific progress into measurable economic impact is becoming a defining feature of modern biotechnology. Biotech Advances Drive Valuation Momentum Biotechnology advancements remain central to how companies are valued, as clinical progress, regulatory milestones and platform innovations often serve as key inflection points for both therapeutic development and investor perception. As drug candidates move through trials and toward commercialization, each update can reshape expectations around risk, scalability and long-term revenue potential, reinforcing the close link between scientific progress and market valuation. Autolus Therapeutics plc (NASDAQ: AUTL) is reporting continued progress across its platform, noting that it is developing, manufacturing and delivering next-generation programmed T cell therapies. In its Q4 and FY2025 update, the company noted a strong first year of launch of AUCATZYL in the U.S., building a market-leading position in adult patients with relapsed or refractory B-ALL and demonstrating strong commercial execution, including reliable, high-quality product delivery with consistent turn-around time. Wave Life Sciences Ltd. (NASDAQ: WVE) noted new 2026 developments centered on its RNA-based therapeutics pipeline, including progress in obesity and genetic disease programs. In its latest update, the company emphasized that it is focused on unlocking the broad potential of RNA medicines to transform human health. The announcement underscored advancing clinical trials and expanding applications of RNA editing and RNA interference technologies, reinforcing the growing role of precision genetic medicine in addressing both rare and common diseases. IO Biotech Inc. (OTC: IOBTQ) announced a strategic shift in 2026 as it evaluates future pathways to maximize value. The company is developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines. IO Biotech has a T-win platform based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. Roche Holding AG (OTC: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Gazyva(R)/Gazyvaro(R) (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). The acceptance is based on positive results from the phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint of SLE Responder Index 4 (SRI-4) at 52 weeks, a measure that assesses changes in disease severity, symptoms and physical condition. These updates reflect a biotechnology sector defined by rapid scientific innovation, platform diversification and increasingly complex development pathways. From cell therapies and RNA-based medicines to immuno-oncology and neurodegenerative research, progress across multiple fronts continues to shape both therapeutic potential and market expectations. As companies advance through clinical milestones and refine their strategic direction, the interplay between innovation and valuation remains a defining feature of the biotech landscape. For more information, visit Oncotelic Therapeutics Inc. About BioMedWire BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.The Article and content related to the profiled company represent the personal and subjective views of the Author and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, BMW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. 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The forward-looking statements in this release are made as of the date hereof and BMW undertakes no obligation to update such statements.Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/DisclaimerBioMedWireAustin, Texaswww.BioMedWire.com512.354.7000 OfficeEditor@BioMedWire.comBioMedWire is powered by IBN

22 Apr 2026

·www.uclb.com

UCL Advanced Therapies Symposium 2026: an ecosystem turning science into patient impact

As over 250 experts attend the UCL Advanced Therapies Symposium 2026 today, we examine how more than scientific excellence alone is needed for UCL to change lives. CAR T-cell and gene therapies have revolutionised how we help patients with many hard-to-treat conditions. UCL Advanced Therapies Symposium 2026 examines the university’s wide-reaching role, as well as how UCL researchers are generating discoveries with real‑world impact. A new report from the UCL Translational Research Office (TRO) and UCLB, Success: From Lab to Market 2026, highlights just how far that ecosystem has come, and why UCL is one of the world’s leading universities discovering, developing and delivering advanced therapies. UCLB’s role in this structure is critical. Working alongside UCL clinicians, researchers and the TRO, it helps shape early‑stage discovery into investable, deliverable opportunities, guiding innovations from lab to market with clarity, rigour and purpose. This important contribution has helped UCL achieve one of the largest advanced therapy medicinal products (ATMP) development pipelines globally, spanning early discovery through to getting therapies available on the NHS. Professor Geraint Rees, UCL Vice-Provost for Research, Innovation and Global Engagement, added: “UCL’s ATMP pipeline is one expression of a broader strategic ambition to ensure that UCL’s research translates swiftly from lab to market, delivering innovations that benefit citizens in the UK and worldwide. The scale of this pipeline, combined with deep partnerships across London’s life sciences ecosystem, demonstrates UCL’s role in anchoring the UK’s innovation landscape.” UCL partner hospitals (Barts Health NHS Trust; Great Ormond Street Hospital for Children NHS Trust; Moorfields Eye Hospital NHS Foundation Trust; Royal Free London NHS Foundation Trust; University College London Hospitals NHS Foundation Trust) are critical to the UK’s advanced therapies success story. Around 44% of the UK’s academically sponsored ATMP clinical trials, and over 50% of commercially sponsored ATMP trials, are delivered through UCL partner hospitals. This concentration reflects an environment designed to support complex therapies through development, regulation and adoption. Within this landscape, UCLB works closely with the TRO, Therapeutic Innovation Networks (TINs) and specialist manufacturing and clinical partners. Together, they support researchers to address the questions that determine whether an advanced therapy can succeed beyond the lab. IP, risk reduction, and what evidence regulators and partners will need are crucial challenges when deciding which route to market is most appropriate. The impact of this joined‑up approach can be seen in UCL’s growing portfolio of advanced therapy spinout ventures. Autolus’ CAR T-cell immunotherapy (AUCATZYL (obe-cel)) for acute lymphoblastic leukaemia recently received regulatory approval and is now available to NHS patients. Beginning its journey with Proof of Concept funding, UCLB’s support included facilitating the spinout process, managing intellectual property, and fostering partnerships. The company has raised over $1.1bn of investment capital since incorporation. The foundational research underpinning obe-cel was conducted at UCL and led by Dr. Martin Pule, and his collaborators at the UCL Cancer Institute and Great Ormond Street Institute of Child Health. Another UCL biotech spinout, EpilepsyGTx is focusing on gene therapies for focal refractory epilepsy (FRE), a condition where seizures originate from a specific brain region and do not respond to at least two standard anti-seizure medications. EpilepsyGTx is developing EPY201, a gene therapy aimed at stopping seizures in patients with focal refractory epilepsy through a single, targeted treatment. UCLB supported Epilepsy GTx’s formation, intellectual property protection, and helped secure £10m seed funding in 2024 for preclinical studies and Phase 1/2a trials. Dr. Anne Lane, CEO, of UCLB, said: “2025 was truly a turning point in our work to bring cell and gene therapies from the lab to the clinic and the success stories we have seen this year show the effectiveness of the close collaboration between UCL Business, the Translational Research Office, UCL researchers, partner hospitals and funding and investment partners.” Read more about UCLB’s advanced therapies, including Autolus and EpilepsyGtx, in this year’s Impact Report. Such successes are underpinned by sustained investment across the pipeline. UCL’s active ATMP portfolio includes more than £70m invested in preclinical and Phase I/II projects, alongside targeted funding for over 50 discovery‑stage programmes. UCLB helps academics navigate this landscape, aligning funding, partnerships and commercial strategy to build momentum without compromising scientific integrity. This model, built on partnership, patience and purpose, continues to shape the future of medicine. Read Success: From Lab to Market 2026.

Clinical StudyImmunotherapyGene Therapy

14 Apr 2026

·www.biospace.com

Asgard Therapeutics appoints Professor Dr Wolfram Brugger as Chief Medical Officer as it advances transformative ‘personalized off-the-shelf’ immunotherapy toward clinical development

Medical oncologist (ex AstraZeneca, MorphoSys, Autolus Therapeutics) joins to advance Asgard’s lead asset AT-108 into Phase 1 clinical development AT-108 is a transformative immunotherapy that triggers a personalized immune response against a patient’s tumors, despite being an off-the-shelf drug Asgard is currently progressing IND-enabling studies of this first-in-class therapy, which reprograms cancer cells in vivo, forcing them to present their antigens to the immune system LUND, Sweden, April 14, 2026 (GLOBE NEWSWIRE) -- Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, today announces the appointment of Prof Dr Wolfram Brugger as Chief Medical Officer. Prof Dr Brugger, who has been involved in more than 130 Phase I-III clinical oncology trials with numerous modalities across a wide variety of cancer types, including solid tumors, will strengthen Asgard’s leadership as it prepares to transition to a clinical-stage biotech. Cristiana Pires, Co-founder and Chief Executive Officer of Asgard Therapeutics, said : “Strengthening our leadership team with Wolfram, who is such a highly experienced clinical trials expert and practicing medical oncologist, is a privilege and we are excited to welcome him on board. Wolfram’s proven capabilities and track record will ensure that Asgard is perfectly positioned as we advance AT-108 towards the clinic." Prof Dr Wolfram Brugger, incoming Chief Medical Officer of Asgard Therapeutics, said: “I’ve always been driven by bringing new modalities to patients, and I am excited to be developing a ‘personalized off-the-shelf’ immunotherapy which has great potential to help patients with a wide variety of cancers. Asgard’s in vivo cell reprogramming technology has transformative potential, and the pre-clinical proof-of-concept data, both published and upcoming data to be presented at key scientific conferences, is highly convincing. Having treated hundreds of cancer patients in clinical trials throughout my career, I look forward to utilizing my experience to shape Asgard’s clinical strategy, driving AT-108 through clinical development.” Wolfram joins Asgard from NASDAQ-listed Autolus Therapeutics where he led the global clinical development program of AUTO1 (AUCATZYL® / obe-cel), an autologous CD19 CAR T therapy, in hematological and autoimmune indications. AUTO1 received FDA approval in 2024 for relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL) and conditional approval was granted by the EMA and MHRA in 2025. Prior to this he was at MorphoSys where he headed the global clinical development program for the monoclonal antibody tafasitamab across various blood cancer indications. Tafasitamab (in combination with lenalidomide) was granted accelerated approval by the FDA in relapsed/refractory DLBCL in 2020 and conditional approval by the EMA in the same indication in 2021. At AstraZeneca, he was global medical lead for Phase I / early Phase II trials for several oncology assets in numerous cancer types, including testing them in combination with checkpoint inhibitors. Prior to moving into drug development, he was Chief & Medical Director in the Department of Hematology, Oncology, Immunology & Infectious Diseases at a Teaching Hospital of Freiburg University in Germany. He holds an MD and PhD from Albert-Ludwigs University Freiburg and Eberhard-Karls University Tübingen, Germany, with a specialist registration in Internal Medicine, Medical Oncology and Hematology. Asgard is currently focused on advancing IND-enabling studies and CMC activities to support clinical development of AT-108. Key proof-of-concept data on AT-108 were published in 2024 in the high-impact, peer-reviewed journal Science 1 . For further information, please contact: Asgard Therapeutics Cristiana Pires, Co-founder and CEO    Email: cristiana.pires@asgardthx.com Optimum Strategic Communications Mary Clark, Stephen Adams, Elena Bates Tel: +44 (0) 20 8142 3740 Email: asgard@optimumcomms.com Notes to Editors About Asgard Therapeutics Asgard Therapeutics is a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy. The company builds on ground-breaking and proprietary reprogramming technologies to develop gene therapy products designed to set in motion efficient and personalized immune responses. Asgard Therapeutics aims to establish a pipeline of off-the shelf cancer immunotherapies that trigger personalized anti-cancer immune responses for the benefit of cancer patients in need. Asgard is backed by Novo Holdings, Boehringer Ingelheim Venture Fund, Industrifonden, RV Invest and Johnson & Johnson Innovation – JJDC, Inc. For more information, please visit: About AT-108 AT-108 is a first-in-class, off-the-shelf gene therapy that directly reprograms tumor cells into a rare subset of dendritic cells critical for mounting efficient cytotoxic T cell responses, cDC1 cells (conventional dendritic cells type 1). Reprogramming forces the tumor cells to present their tumor antigens, ultimately leading to a personalized anti-tumor immune response. It is based on a replication-deficient adenoviral vector that delivers three proprietary reprogramming factors into tumor cells, rewiring their gene expression signatures and thus “programming” them to become antigen-presenting cDC1-like cells. _______________________ 1

100 Deals associated with Obecabatagene autoleucel

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	United States	Autolus Ltd.	08 Nov 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent B Acute Lymphoblastic Leukemia	NDA/BLA	United States	Autolus Therapeutics Plc	29 Nov 2023
Refractory B Acute Lymphoblastic Leukemia	NDA/BLA	United States	Autolus Therapeutics Plc	29 Nov 2023
CD19-positive B-cell acute lymphoblastic leukemia	Phase 2	United States	Autolus Ltd.	03 Feb 2026
Lupus Nephritis	Phase 2	United States	Autolus Ltd.	16 Jan 2026
Lupus Nephritis	Phase 2	Brazil	Autolus Ltd.	16 Jan 2026
Lupus Nephritis	Phase 2	United Kingdom	Autolus Ltd.	16 Jan 2026
Acute Lymphoblastic Leukemia	Phase 2	United States	Autolus Ltd.	03 Jun 2020
Acute Lymphoblastic Leukemia	Phase 2	Spain	Autolus Ltd.	03 Jun 2020
Acute Lymphoblastic Leukemia	Phase 2	United Kingdom	Autolus Ltd.	03 Jun 2020
Philadelphia positive acute lymphocytic leukaemia	Phase 2	United States	Autolus Ltd.	03 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07139743 (BOBCAT, ACTRIMS2026)	Phase 1	Multiple Sclerosis, Chronic Progressive	18	Obecabtagene autoleucel (Progressive Multiple Sclerosis or RRMS with PIRA)	zkzphqlvew(ncfsazxevw) = The primary endpoint of adverse events (AEs) will be collected and monitored. Adverse event-related serious events (AESI) will be closely monitored. kpdclwksaq (mgdeikwfms )	Positive	05 Feb 2026
NCT06173518 (CATULUS, Tandem Meetings ASTCT and CIBMTR2026)	Phase 1/2	Recurrent Childhood Acute Lymphoblastic Leukemia CD19	20	Obecabtagene autoleucel	mksjxufsdi(rqmutaezgf) = llacxpjotx lqvgedgqnc (tjwyaulpda, 75.1 - 99.9) View more	Positive	04 Feb 2026
NCT06333483 (CARLYSLE, ASH2025)	Phase 1	Systemic Lupus Erythematosus	10	Obecabtagene autoleucel (obe-cel)	qhjzbtstwl(cwzpyadjtd) = a clinically meaningful reduction (to ≤1) bycbbxlrph (yblaurblob ) View more	Positive	06 Dec 2025
NCT06173518 (CATULUS, ASH2025)	Phase 1/2	Refractory B Acute Lymphoblastic Leukemia	20	obecabtagene autoleucel (obe-cel)	jgfwcqrhvk(kfwicpdllf) = vkxxytexuq dmuzwtfxvg (amssnubzrs, 75.1 - 99.9) View more	Positive	06 Dec 2025
NCT06333483 (CARLYSLE, ACR2025)	Phase 1	Systemic Lupus Erythematosus	7	Obecabtagene autoleucel (obe-cel)	urhpnhqeva(cmzahjlham) = No Gr ≥2 CRS; Transient hypertension was observed in five pts; All pts had Gr ≥3 neutropenia; Infections were transient and manageable; no life-threatening infections were observed. mbneylclke (nkvalshflm ) View more	Positive	24 Oct 2025
NCT04404660 (FELIX, ASCO2025)	Phase 1/2	Recurrent B Acute Lymphoblastic Leukemia CD19	127	Obe-cel	wsxfhzfwas(gmwnowseta) = nywdcbpgfs wewykngaab (ywfuxoufap, 60.9 - 81.7)	Positive	30 May 2025
NCT04404660 (FELIX, ASCO2025)	Phase 1/2	Recurrent B Acute Lymphoblastic Leukemia CD19	127	obecabtagene autoleucel (obe-cel) (Age <55 years)	uwytyxjapj(rmhnuxrvmo) = jgyxzcxkwj emewqnxzfb (hggpjtryqy ) View more	Positive	30 May 2025
NCT04404660 (FELIX, EHA2025)	Phase 1/2	Refractory B Acute Lymphoblastic Leukemia CD19	127	Obe-cel <55 years	kkmiubcknx(mzmeaowbur) = wutnuqoqxx jyeknqfilp (mfhthvuepf ) View more	Positive	14 May 2025
NCT04404660 (FELIX, EHA2025)	Phase 1/2	Refractory B Acute Lymphoblastic Leukemia CD19	127	Obe-cel ≥55 years	kkmiubcknx(mzmeaowbur) = kkzsdmetqf jyeknqfilp (mfhthvuepf ) View more	Positive	14 May 2025
NCT04404660 (FELIX, Pubmed \| N Engl J Med) Manual	Phase 1/2	Recurrent B Acute Lymphoblastic Leukemia \| Refractory B Acute Lymphoblastic Leukemia	127	Obecabtagene autoleucel	ubdsmkglbu(gsnwttaijt) = uscnfkoraj dxqdyjcstb (uwntcnawml, 67 - 85) View more	Positive	12 Dec 2024
NCT04404660 (FELIX, ASH2024)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia ClonoSEQ®next-generation sequencing (NGS) assay	127	Obe-cel	lwebgmqqfr(pcqgxmiwkj) = vdpzggyxhc rqcnyptcqh (bhvfzkbxgh ) View more	Positive	09 Dec 2024
NCT04404660 (FELIX, ASH2024)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia CD19	127	Obecabtagene autoleucel (obe-cel)	bsxefvpyzk(wissplrzpf) = 72 (70.6%) were CRS only hesfrplfvz (tzvtmmywvq ) View more	Positive	09 Dec 2024

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