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])

On January 21, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the publication in npj Precision Oncology of the validation study for its Latitude tissue-free molecular residual disease assay (tfMRD) in colorectal cancer (CRC). The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI).

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The study analyzed 1,230 timepoints from 195 CRC patients who participated in the GALAXY clinical trial, one of the largest and most comprehensive tfMRD studies in resectable CRC. The scale and rigor of this dataset, combined with excellent clinical performance, provides support for submission to the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX). Key findings from the publication include:

High sensitivity: longitudinal sensitivity of 84.4%, with median lead time of 4.6 months ahead of radiographic recurrence.
High specificity: 97.2% sample-level specificity and 92.1% patient-level specificity, providing strong actionability when an MRD-positive is observed.
Robust prognostic value: MRD-positivity was associated with worse outcomes in both the MRD (HR: 10, p<0.001) and surveillance settings (HR: 31.9, p<0.001).
Clear predictive value for adjuvant chemotherapy (ACT) benefit: In high-risk stage II and stage III patients, those who were MRD-positive following surgery experienced a significant benefit from ACT (adj.HR=0.014, P<0.0001), compared to MRD-negative patients, who observed no meaningful treatment benefit.
Latitude is a methylation-based test that detects circulating tumor DNA (ctDNA) without the need for tumor tissue. The assay complements Natera’s tumor-informed and personalized Signatera test, providing physicians and patients with a highly-sensitive testing option when tissue is unavailable. Natera is currently developing and validating Latitude for several additional cancer indications, expected to launch in 2026.

"The data from our latest publication underscores Natera’s commitment to providing solutions for patients diagnosed with colorectal cancer," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "Latitude delivers high-performance MRD detection for clinical situations where tumor-informed testing with Signatera is not possible or practical. Since launching in 2025, Latitude has experienced strong interest among clinicians, and we look forward to offering the test in additional histologies."

(Press release, Natera, JAN 21, 2026, View Source [SID1234662147])

On January 21, 2026 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported that OPN-2853, a bromodomain and extra-terminal motif (BET) small molecule inhibitor, has been granted Orphan Drug Designation (ODD) for the treatment of myelofibrosis (MF) by the U.S. Food and Drug Administration (FDA). Additionally, the generic name of zavabresib for OPN-2853 has been approved by the International Nonproprietary Names (INN) for Pharmaceutical Substances.

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Myelofibrosis is a rare and serious type of blood cancer characterized by bone marrow scarring, which leads to ineffective blood cell production and symptoms such as severe fatigue, enlarged spleen, and anemia. Myelofibrosis affects approximately 25,000 people in the U.S.

"Receiving Orphan Drug Designation for zavabresib in myelofibrosis is a significant regulatory milestone for Opna Bio and highlights the urgent need for new and effective treatment options for patients with this disease," said Reinaldo Diaz, chief executive officer of Opna Bio. "Our investigator-sponsored clinical trial with zavabresib and ruxolitinib has shown impressive results to date, including durable spleen reduction in patients with advanced myelofibrosis. We believe that selective BET inhibition alongside JAK inhibition offers a promising new therapeutic approach for patients with myelofibrosis. We are further encouraged by recent positive meetings with the FDA to continue to test zavabresib in additional clinical studies."

The FDA grants Orphan Drug Designation to investigational therapies intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. The designation provides several benefits, including tax credits for clinical trial costs, a waiver of certain FDA fees, and eligibility for seven years of market exclusivity upon approval.

In the ongoing Phase 1 PROMise study led by Professor Adam Mead at the University of Oxford through a collaboration with Cancer Research UK (CRUK), zavabresib is being evaluated as an add-on to ruxolitinib in patients with myelofibrosis who are no longer responding to ruxolitinib alone. Data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) conference in December 2025 showed a 50% or greater reduction of spleen length in 16 of 26 evaluable patients on the combination treatment when compared to baseline.

(Press release, Opna Bio, JAN 21, 2026, View Source [SID1234662146])

On January 21, 2026 NEOK Bio, Inc., an oncology therapeutics company focused on the development of novel antibody drug conjugates (ADCs) for improving outcomes for cancer patients, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for NEOK001, enabling initiation of a Phase 1 clinical trial.

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NEOK001 is a bispecific ADC designed to target B7-H3 and ROR1, two surface proteins highly expressed in cancer cells. The therapy is conjugated with a topoisomerase I inhibitor payload via a linker. Preclinical NEOK001 studies have shown superior in vivo efficacy in solid tumors compared to traditional monovalent ADCs.

"We are thrilled to receive IND clearance for NEOK001, a milestone that allows NEOK Bio to advance this first-in-class bispecific ADC into clinical development. We look forward to studying its potential to address significant unmet needs for patients with cancers that co-express these targets," said Mayank Gandhi, CEO of NEOK Bio. "We anticipate dosing the first patient in the coming months and expect to share initial clinical data in 2027."

Backed by ABL Bio, a global leader in antibody engineering, NEOK Bio was launched last year to advance a pipeline of differentiated bispecific ADCs. NEOK001 is the first program to enter clinical development, representing the company’s commitment to advancing next-generation ADCs and positioning NEOK Bio as an emerging leader in ADC innovation in the U.S.

(Press release, Neok Bio, JAN 21, 2026, View Source [SID1234662145])

On January 21, 2026 Infinitopes, a clinical-stage cancer vaccine biotechnology company, reported the successful completion of the second close of its seed financing round, securing an additional $15.4 million and bringing the total raised to $35.1 million. This latest investment was co-led by Octopus Ventures and new investor Amplify Bio, with further participation from new investor Macmillan Cancer Support alongside existing investors Cancer Research Horizons and Manta Ray Ventures.

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This funding comes as the company launches its first-in-human, double-blind, randomised, placebo-controlled clinical trial of ITOP1, its leading precision therapeutic vaccine aimed at preventing recurrence in oesophageal cancer, an area where clinical need remains largely unmet. The Phase I/IIa VISTA trial is to be conducted across multiple UK NHS university cancer centres and firmly positions Infinitopes at the cutting edge of the sector.

Jonathan Kwok, Chief Executive Officer of Infinitopes, said: "I’m honoured to welcome leading US West Coast biofund Amplify Bio and ecosystem champions for better patient care, Macmillan, onto our cap table. This new funding unlocks our potentially groundbreaking Phase I/IIa trial, enabling proof-of-concept evaluation of Infinitopes’ AI/ML-precision targeted, off-the-shelf vaccine platform to prevent recurrence after surgical resection. We aim to lead the development of innovative medicines that bring hope to patients suffering from cancers with unmet medical needs. We anticipate sharing our early findings at major conferences later this year."

Elliot Hershberg, Partner at Amplify Bio, remarked: "Recent clinical evidence has made it abundantly clear that the time for cancer vaccines is now. After years of searching, Infinitopes has clearly distinguished itself as the company positioned to drive this progress forward. The combination of rigorous AI-powered immunomics profiling, a highly scalable off-the-shelf vector, and a defined clinical strategy is exactly what this field needs. Infinitopes has the potential to redefine immunotherapy and precision oncology in the years to come."

(Press release, Infinitopes, JAN 21, 2026, View Source [SID1234662143])