Uncategorized – Page 1131 – 1stOncology™: Cancer Intelligence Service

Tubulis Unveils Alco5 Conjugation Platform’s Ability to Expand ADC Payload Scope in Nature Communications

On January 21, 2026 Tubulis reported the publication of preclinical proof-of-concept data for its novel Alco5 conjugation platform in Nature Communications. The paper describes the company’s novel antibody-drug conjugate (ADC) technology and highlights its ability to link antibodies with an expanded set of previously inaccessible hydroxy-containing payloads. This new chemical concept has the potential to open new therapeutic avenues in cancer treatment and counteract resistance by expanding ADC’s payload spectrum with novel modes of action (MOAs) including protein degradation while preserving favorable ADC properties.

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The full publication titled "Expanding the payload scope in antibody-drug conjugates by delivery of hydroxy-containing drugs through self-immolative phosphoramidates" is available here.

"Our Alco5 linker platform represents a key step forward in unlocking the full potential of ADCs to drive meaningful patient benefit in oncology," commented Dr. Jonas Helma-Smets, Chief Scientific Officer and Co-Founder of Tubulis. "The broad applicability and excellent safety and efficacy profile will enable us to explore novel antibody-drug combinations, further solidifying Tubulis’ position at the forefront of scientific ADC breakthroughs."

Tubulis designed the Alco5 linker system to expand the payload spectrum beyond the three MOAs currently used in approved ADCs, specifically tubulin-inhibition, topoisomerase-I-inhibition and DNA damage-induction. The phosphoramidate-based Alco5 system enables safe and stable linkage to a broad range of structurally diverse alcohols that can be tracelessly released within the cytosol of target cancer cells. The resulting ADCs have a high and homogenous drug-to-antibody ratio (DAR) and demonstrated superior serum stability, in vivo efficacy and antibody-like pharmacokinetic profiles compared to approved topoisomerase-I-inhibitor-based ADCs.

Key data from the publication:

The Alco5 linker system was successfully applied to a wide range of ten hydroxy-containing antiproliferative agents, including the creation of ADCs carrying nucleoside analogues, or elongation factor-inhibitors for which this is the first time an in vitro potency was described.
All payloads with activity below 1 nM in the unconjugated state also showed activity when delivered by an ADC, clearly demonstrating the broad applicability of the described linker system to efficiently deliver payloads with chemically diverse hydroxyl groups.
Alco5-conjugated payloads demonstrated strong and selective anti-tumor effect in vitro and in vivo showcasing the potential to widen the therapeutic window of hydroxy-containing drugs by stably and durably delivering them to the tumor over a long period of time after a single administration.
"Publishing our findings in such a highly regarded journal underlines the potential of our novel linker technology to expand the horizons of ADC design," said Dr. Marc-André Kasper, Vice President Chemistry and Early Development at Tubulis. "We are highly encouraged by these results and look forward to investigating novel candidates based on the Alco5 technology to provide novel solutions for patients while addressing the growing resistance development to current ADCs."

(Press release, Tubulis, JAN 21, 2026, View Source [SID1234662148])

Neurocrine Biosciences Announces Conference Call and Webcast of Fourth Quarter and Year-End 2025 Financial Results

On January 21, 2026 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it has scheduled its fourth quarter and year-end 2025 financial results conference call and webcast for 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on February 11, 2026.

The schedule for the press release and conference call / webcast is as follows:

Q4 and Year-End 2025 Press Release: February 11, 2026 at 1:00 p.m. PT / 4:00 p.m. ET

Q4 and Year-End 2025 Conference Call: February 11, 2026 at 1:30 p.m. PT / 4:30 p.m. ET

Domestic Dial-In Number: 800-579-2543

International Dial-In Number: 785-424-1789

Conference ID: NBIX
The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

(Press release, Neurocrine Biosciences, JAN 21, 2026, View Source [SID1234662133])

Arcellx to Advance the Conversation on Its Platform and the Importance of Early CAR T Access for Patients with Multiple Myeloma During the 2026 Tandem Meetings

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.

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])

Amsulostat in pancreatic cancer Phase 1/2 clinical trial in collaboration with the Garvan, funded by MRFF

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.

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])

Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 2026 Tandem Meetings of ASTCT® and CIBMTR®

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.

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