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 Defence Therapeutics Inc., ("Defence" or the "Company"), a publicly traded biotechnology company, reported an evolution of its corporate positioning to reflect its focus as a precision intracellular drug-delivery company advancing its proprietary Accum platform through both internal development programs and strategic partnerships. Designed to unlock the full potential of complex cancer biologics, Accum enhances intracellular delivery to increase therapeutic potency while reducing toxicity.

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At the center of this strategy is Accum, Defence Therapeutics’ proprietary precision drug-delivery platform designed to solve one of oncology’s most persistent challenges: effective intracellular delivery. By enhancing cellular uptake and payload release, Accum increases therapeutic potency at lower doses, with the potential to reduce toxicity and improve patient access to advanced cancer treatments.

Defence is prioritizing this platform and partnering model through a dual strategy that combines internal R&D programs with strategic partnerships across the biotech and pharmaceutical ecosystem. This approach enables the enhancement of both existing and next-generation assets, including antibody-drug conjugates (ADCs), radiopharmaceuticals, and other complex biologics, transforming therapies traditionally used in later lines into safer, more effective first-line treatment options.

"Our focus is clear: solve drug delivery at the cellular level so cancer therapies, whether developed by Defence or by our partners, can reach their full potential," said Sébastien Plouffe, CEO of Defence Therapeutics. "Accum is designed to create optimal value for partners while ultimately delivering better outcomes for patients."

With this refined positioning, Defence Therapeutics reinforces its commitment to precision oncology, collaboration, and translating cutting-edge science into life-changing treatments, with a business model designed to generate scalable value for partners and long-term value for shareholders.

(Press release, Defence Therapeutics, JAN 21, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-sharpens-strategic-focus-on-precision-drug-delivery-to-unlock-the-full-potential-of-cancer-biologics [SID1234662128])

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 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 14,351 million in 2025. Net trade sales were USD 8,266 million in the U.S. and USD 6,085 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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(Press release, Genmab, JAN 21, 2026, View Source [SID1234662129])

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])