On January 21, 2026 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, ireported both its scientific foundation for its D-Domain platform technology and commercial preparedness for anito-cel for the potential treatment of multiple myeloma with three presentations at the 2026 Tandem Meetings. One presentation reinforces anito-cel’s unique ability to transiently engage BCMA, potentially resulting in tumor cell clearance without prolonged inflammation and providing a mechanistic rationale for the clinically differentiated efficacy and safety profile observed with anito-cel for multiple myeloma. Additionally, two new research studies are being presented, one on health economics and one on treatment sequencing outcomes. The meetings will be held February 4-7, 2026, at the Salt Palace Convention Center in Salt Lake City, Utah. Anito-cel is partnered with Kite, a Gilead Company.

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Tandem Presentation Details
Title and ID: Anito-cel’s D-Domain Binder Has a Fast Off-Rate and Contributes to Its Differentiated Pharmacology Profile in Multiple Myeloma (abstract ID: 28119)
Speaker: Kevin C. Hart, PhD
Session: Engineered Immune Cells (CAR-T, NK, TCR): Basic/Preclinical – Antigen Finding, Safety
Session Date: Thursday, February 5, 2026
Session Time: 6:30 – 8:00 p.m. MT
Location: Hall AB

Title and ID: Impact of Treatment Sequencing with CAR T-cell Therapies and Bispecific Antibodies on Long-Term Survival in 4L+ RRMM in the U.S.: A Simulation Model (abstract ID: 27320)
Speaker: Jodi Lipof, MD
Session: Engineered Immune cells – clinical (toxicity, practice, economics, correlative, autoimmunity, malignant, and non-malignant indications)
Session Date: Thursday, February 5, 2026
Session Time: 6:30 – 8:00 p.m. MT
Location: Hall AB

Title and ID: Visualizing Geographic Variation and Systemic Inequities of Disease Burden and CAR T-cell Therapy Access in Multiple Myeloma in the U.S. (abstract ID: 27927)
Speaker: Brandon Blue, MD
Session: Health Services and Barriers to Access
Session Date: Thursday, February 5, 2026
Session Time: 6:30 – 8:00 p.m. MT
Location: Hall AB

About Multiple Myeloma

Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About Anitocabtagene Autoleucel (anito-cel)

Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

(Press release, Arcellx, JAN 21, 2026, View Source [SID1234662149])

On January 21, 2026 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that the Garvan Institute of Medical Research in Sydney ("Garvan Institute") has been awarded a $3 million grant under the Australian Government’s Medical Research Future Fund ("MRFF") to conduct two multicentre Australian clinical studies in advanced pancreatic cancer, one of which will evaluate Syntara’s investigational anti-fibrotic LOX inhibitor amsulostat (SNT-5505) in combination with standard-of-care chemotherapy.

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Under the collaboration, Syntara will supply the drug in addition to scientific and clinical expertise to support the program. Syntara will not be required to provide cash funding as part of the clinical study.

The inclusion of amsulostat in this MRFF-funded clinical program builds on ground-breaking preclinical research led by the Garvan Institute and published in Nature Cancer (see ASX announcement 29 August 2023). The research demonstrated that targeting tumour fibrosis weakens the dense barrier that surrounds pancreatic tumours, enabling chemotherapy drugs to penetrate more effectively and destroy more cancer cells, as well as reducing cancer cell invasion and metastasis.

Pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer, remains one of the most lethal cancers, with poor long-term survival outcomes. A key driver of treatment resistance is the fibrous "stromal" barrier that forms a fortress around tumours, limiting drug delivery and supporting tumour progression.

Professor Thomas Cox, Laboratory Head at the Garvan Institute and Conjoint Professor at St Vincent’s Clinical School, Faculty of Medicine and Health, UNSW Sydney said: "Pancreatic cancer creates a dense, scar-like barrier that diminishes patient response to therapy. Through our long-standing collaboration with Syntara, we’ve identified a promising strategy to target lysyl oxidases, the key enzymes that build and strengthen this scar tissue. The proposed phase I/II trial with amsulostat in combination with chemotherapy represents a critical step in validating and translating our laboratory findings into new treatment options for patients with advanced pancreatic cancer."

The MRFF-funded studies are expected to commence recruitment in mid-2026, enrolling patients with advanced pancreatic cancer across leading cancer centres in New South Wales, including Westmead Hospital, St Vincent’s Hospital Sydney and Wollongong Hospital. Further details regarding study design, participating sites and timelines will be announced closer to study commencement.

In addition to assessing safety and clinical activity, the studies will incorporate a precision medicine strategy, including deep molecular and genetic profiling of tumour and blood samples collected before and during treatment. This analysis aims to identify biomarkers and patient subgroups most likely to benefit, with the potential to guide more targeted therapy in future clinical development.

The approach of targeting tumour fibrosis may have broader implications for other solid cancers characterised by fibrous barriers that impede treatment delivery, including certain breast, liver and lung cancers and is supported by peerreviewed publications from academic collaborators using amsulostat.

Syntara Chief Executive Officer Gary Phillips said: "Whilst our focus remains on the treatment of haematological malignancies like MF and MDS, the pre-clinical work conducted by Professor Cox and others regarding chemotherapy resistant tumours is compelling. We are delighted that the MRFF have seen the value of translating this work into the clinic and look forward to supporting the Garvan and the clinical trial team to deliver results for pancreatic cancer patients

This MRFF supported pancreatic cancer study is now one of four Syntara clinical studies funded with non-dilutive capital, totalling more than $10m. This level of success in competitive grant processes is a very positive reflection on the quality of the pre-clinical science undertaken by Syntara and its research collaborators worldwide over a sustained period of time."

The initiation of the pancreatic cancer study later this year adds to an already rich clinical development program in 2026, which will see the SNT-4728 study in iRBD deliver top line results in Q2 2026, followed by two amsulostat studies in MDS and two skin scarring studies all due to report data later this year.

(Press release, Syntara, JAN 21, 2026, View Source [SID1234662104])

On January 21, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that new clinical data will be presented in two oral and seven poster sessions at the 2026 Tandem Meetings of ASTCT and CIBMTR from February 4-7 in Salt Lake City, UT.

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The presentations will include data on the company’s pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematological malignancies, including Orca-T, Orca-Q and the Orca-T and allogeneic CAR-T combination therapy, OrCAR-T.

"Our presentations at this year’s Tandem Meetings reflect the growing body of evidence supporting the use of Orca-T as a precision-engineered cellular immunotherapy administered through an allogeneic stem cell transplant," said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. "From new data in myelodysplastic syndromes, to evaluations in reduced intensity conditioning, and a report on our ability to reliably distribute our products to patients nationwide, these findings represent our ongoing efforts to improve outcomes for the transplant community. We look forward to engaging with our peers and partners to discuss how these advancements can help redefine the treatment landscape for patients with blood cancer."

The Tandem abstracts are now available at www.tandemmeetings.com. Details of the Orca Bio presentations follow:

Oral Session: Session A – Clinical Progress in GVHD Prevention, Risk Stratification, and Treatment

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients

Presentation ID: 7

Date and Time: Wednesday, February 4, 3:15 PM – 3:30 PM MST

Location: Ballroom AB

Oral Session: Session E – Acute Lymphoid Leukemias: Advances in CAR T and Transplant Approaches

Title: Mature Outcomes from the Phase I Trial of Orca-T and Allogeneic CD19/CD22 CAR-T cells for Adults with High-Risk B-ALL

Presentation ID: 31

Date and Time: Thursday, February 5, 3:15 PM – 3:30 PM MST

Location: Ballroom AB

Poster Session: Myeloid Neoplasms Including Relapse – Clinical

Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison

Presentation ID: 534

Date and Time: Thursday, February 5, 6:30 PM – 8:00 PM MST

Location: Poster Hall AB

Poster Session: Cell and Gene Therapy – Clinical

Title: Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy

Presentation ID: 161

Date and Time: Thursday, February 5, 6:30 PM – 8:00 PM MST

Location: Poster Hall AB

Poster Session: GVHD Clinical – Prevention and Treatment

Title: Clinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison

Presentation ID: 366

Date and Time: Thursday, February 5, 6:30 PM – 8:00 PM MST

Location: Poster Hall AB

Poster Session: GVHD Clinical – Prevention and Treatment

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors

Presentation ID: 345

Date and Time: Thursday, February 5, 6:30 PM – 8:00 PM MST

Location: Poster Hall AB

Poster Session: Conditioning Regimens

Title: Single Center Phase 1b Study of Orca-T Following Escalated Doses of Total Marrow and Lymphoid Irradiation (TMLI) in Patients with Acute Leukemia or MDS

Presentation ID: 172

Date and Time: Thursday, February 5, 6:30 PM – 8:00 PM MST

Location: Poster Hall AB

Poster Session: Health Services and Barriers to Access

Title: Orca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT Plus Tac/MTX for GVHD Prevention in a Randomized phase 3 Clinical Trial (Precision-T)

Presentation ID: 402

Date and Time: Thursday, February 5, 6:30 PM – 8:00 PM MST

Location: Poster Hall AB

Poster Session: Health Services and Barriers to Access

Title: Cost-Effectiveness of Orca-T Vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States

Presentation ID: 401

Date and Time: Thursday, February 5, 6:30 PM – 8:00 PM MST

Location: Poster Hall AB

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

(Press release, Orca Bio, JAN 21, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-new-clinical-data-on-its-high-precision-cell-therapies-at-the-2026-tandem-meetings-of-astct-and-cibmtr [SID1234662134])

On January 21, 2026 Soley Therapeutics reported the publication of a peer-reviewed study in Scientific Reports describing a new approach to understanding how living cells react to drug molecules, inverting traditional target-based drug discovery methods. The study shows that dynamic live-cell stress responses to drugs over time encode mechanistic information about a cell’s trajectory to survive, adapt, or die – information that is largely missed by traditional snapshot-based assays. This work establishes the scientific foundation for Soley’s platform, which enables a novel, proprietary live-cell approach to drug discovery based on how cells sense and respond to stress.

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"This work reflects more than a decade of foundational research into how cells sense and respond to drugs and other external signals," said Yerem Yeghiazarians, M.D., Co-founder and CEO of Soley Therapeutics. "By focusing on the dynamic flow of information inside the cell, rather than static endpoints, we can delineate biology that conventional discovery methods often miss. Live Cell Dynamics is one piece of a much larger platform that Soley has created to translate whole-cell behavior into medicines. Our growing pipeline demonstrates the real-world impact of this pathbreaking science in moving drug hits to clinical candidates faster and at lower cost than traditional approaches."

Using live, label-free cell imaging, which follows living cells over time without dyes or reporter tags, the study establishes a novel approach to extract information that describes cellular stress responses by using proprietary self-supervised machine learning methods. The authors show that subtle information extracted from cells indicates dynamic responses to a drug, providing insight into a drug’s real mechanism across multiple dimensions, including toxicity and selectivity, even when compounds have similar targets and/or produce similar outcomes such as cell death. Incorporating temporal and dose-dependent information improves detection of a drug’s biological activity and mechanism-of-action, highlighting the limitations of binary readouts and morphology-only profiling approaches, particularly in complex cellular disease states.

"Through this research, our goal was to extract dynamic information from live cells for drug discovery and development purposes," said Kurosh Ameri, Ph.D., Co-founder and Chief Scientific Officer of Soley Therapeutics. "We have now shown that live cells sense drugs dynamically and convey different mechanistic information, which is dose- and time-dependent. Our proprietary machine learning methods can extract information about drugs directly from live, unstained images. This ability to measure and interpret detailed information directly from live cells in a scalable and reproducible way demonstrates a significant advance in drug discovery. This comprehensive approach provides a more accurate understanding of complex cellular responses and a drug’s true mechanism-of-action, moving beyond single endpoint and time point assays."

These experimental principles form the scientific underpinnings of Soley’s proprietary platform, which scales this biology-first approach using automation and AI to drive drug discovery across oncology and other complex diseases. The publication adds to Soley’s growing body of peer-reviewed research supporting its differentiated approach as the company advances multiple internally discovered programs toward the clinic.

(Press release, Soley Therapeutics, JAN 21, 2026, View Source [SID1234662135])

On January 21, 2026 Researchers at FIU reported a personalized approach to cancer treatment that is showing increasingly promising results for patients with hard-to-treat disease, supported by new philanthropic investment that is helping expand the science behind the work.

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A recent gift from the Tyler Trent Foundation is accelerating research led by Diana Azzam, whose lab is pioneering functional precision medicine — an emerging strategy that identifies the most effective therapies by testing large libraries of drugs directly on living tumor cells from individual patients.

The support comes as preliminary findings from the next phase of Azzam’s clinical research indicate even stronger responses than those observed in her original study, reinforcing the potential of drug sensitivity testing to guide treatment decisions when standard approaches fail.

"Cancer remains one of the leading causes of death, and many patients eventually run out of effective treatment options," Azzam said. "What we’re seeing in our latest work suggests that functional testing can reveal opportunities that traditional methods may miss."

Beyond genetics alone

Unlike conventional precision oncology, which relies primarily on genetic mutations to guide care, functional precision medicine evaluates how a patient’s cancer actually responds to hundreds of existing drugs. Tumor cells grown from patient samples are exposed to a wide range of compounds, allowing researchers to observe real-time drug sensitivity and resistance.

In earlier clinical research, this approach generated treatment recommendations for all participants, with many patients experiencing improved outcomes. Early data from the newest clinical phase suggest that expanding the range of drugs tested may further enhance both the effectiveness and speed of identifying viable therapies.

The method has drawn particular interest for patients with recurrent or treatment-resistant cancers, including cases where genomic testing reveals few actionable mutations.

"Our goal is to find the right drug for the right person at the right time," Azzam said. "Functional testing gives us another powerful tool to do that."

Expanding the search for effective treatments

The Tyler Trent Foundation’s gift will allow Azzam’s lab to expand its library of FDA-approved generic medications and natural compounds — a carefully curated collection of safe, widely available molecules. Many of these compounds, originally developed as antibiotics, antifungals or antiparasitic, have shown unexpected promise in cancer research and may be repurposed for oncological use.

By focusing on medications with established safety profiles, results from this study are expected to support their earlier introduction in treatment, particularly when they demonstrate synergistic effects with standard therapies. This approach could allow lower doses of conventional chemotherapy to be used, helping reduce toxicity while maintaining or enhancing treatment effectiveness and accelerating the translation from laboratory discovery to patient care.

"When we identify a drug that works, it’s often something physicians already know how to prescribe," Azzam said. "That significantly increases the potential for rapid clinical impact."

A legacy driving discovery

The Tyler Trent Foundation was established in memory of Tyler Trent, who died from osteosarcoma, a rare bone cancer. During his illness, Tyler became known nationally for his optimism and advocacy, using his platform to encourage support for cancer research. His legacy has helped raise millions of dollars to advance cancer science and patient care.

(Press release, Florida International University, JAN 21, 2026, View Source [SID1234662151])