NUCLIDIUM Announces Issuance of New U.S. Patent Covering its 61Cu-based Radiodiagnostic Program for PSMA-positive Prostate Cancer

On January 26, 2026 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, reported that U.S. Patent No. 12,527,885 has been granted by the United States Patent and Trademark Office (USPTO). This critical achievement strengthens and extends the scope of the intellectual property portfolio for NUCLIDIUM’s NU101 radiotheranostic program. The patent protects the Copper-61 based diagnostic as well as its use in combination with the Copper-67 based therapeutic in a theranostic setting. NUCLIDIUM’s NU101 theranostic program was designed to utilize high-radiopure Copper-61 to diagnose and Copper-67 to treat Prostate-Specific Membrane Antigen (PSMA)-positive tumors, making it a true theranostic by using the same radiometal.

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"This patent grant validates the scientific innovation behind our copper-based radiopharmaceutical platform and strengthens our ability to advance differentiated therapies across our pipeline. Robust intellectual property is critical as we accelerate the clinical development of our best-in-class copper-based radiotheranostic programs and strive to deliver new treatment options for patients with difficult-to-treat cancers, including prostate and metastatic breast cancer," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM.

The issued patent covers the composition of matter and methods of using the radiodiagnostic 61Cu-NU101 in radioimaging, including Positron Emission Tomography (PET) and Single Photon Emission Computed Tomography (SPECT) imaging of PSMA-positive tumors, as well as the subsequent combination with the therapeutic pair 67Cu-NU101. Over 90% of prostate tumors express PSMA[1], rendering this surface-level antigen an attractive target for cancer diagnosis and treatment. NUCLIDIUM’s 61Cu-based NU101 diagnostic component allows for delayed imaging, in which even very small metastases can be detected. Based on these imaging data, the 67Cu-based NU101 therapeutic can enable targeted treatment with a potentially reduced radiation burden for the patient.

The diagnostic component 61Cu-NU101 is currently in clinical evaluation. Data from a Phase 1 trial showed favorable imaging performance for 61Cu-NU101 in PSMA-positive prostate cancer compared with an FDA-approved standard of care diagnostic imaging agent. 61Cu-NU101 visualized additional lesions in 50% of the patients which were not seen with the FDA-approved standard of care agent and demonstrated favorable tumor-to-background ratios. The number of detected lesions on the 61Cu-NU101 PET increased for up to 4 hours after administration, highlighting the diagnostic benefits of 61Cu-NU101’s 3.3-hour half-life and high positron yield. Based on these favorable data, NUCLIDIUM is planning to initiate Phase 2 clinical trials for the NU101 diagnostic and therapeutic pair in 2026.

(Press release, NUCLIDIUM, JAN 26, 2026, https://nuclidium.com/nuclidium-announces-issuance-of-new-u-s-patent-covering-its-61cu-based-radiodiagnostic-program-for-psma-positive-prostate-cancer/ [SID1234662211])

Primmune Therapeutics Announces Additional Close of Series B Financing

On January 26, 2026 Primmune Therapeutics, a biotech company harnessing the power of the innate immune system, reported an additional close of its Series B financing round for a total of $8.6 million with participation from Bioqube Ventures, Oberland Capital and Samsara Biocapital. This close brings the total Series B raise to $23.3 million. These funds will be used to support the further clinical development of PRTX007, a novel orally administered, systemically acting, small molecule toll-like receptor 7 (TLR7) agonist as an immunotherapy for solid tumors.

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With the latest close of the Series B financing, Primmune Therapeutics will initiate Study PRTX007-003, a Phase 2 neoadjuvant efficacy study using PRTX007 in combination with standard-of-care anti-PD-1 therapy in patients with Stage III resectable melanoma.

"This financing enables us to rapidly advance PRTX007 into a clearly defined proof-of-principle study with validated efficacy and safety endpoints, with the goal of establishing PRTX007 as a class-leading immunotherapy option for patients with solid tumors," said Charlie McDermott, Chief Executive Officer and Director of Primmune Therapeutics. The study will be conducted entirely in Australia by Primmune Therapeutics Pty Ltd. in conjunction with Novotech acting as the in country clinical research organization.

About PRTX007
PRTX007 is a novel orally administered, systemically acting, toll-like receptor 7 (TLR7) agonist designed in house at Primmune to functionally tune immune signaling toward an IRF7-driven poly-interferon response and away from the NF-KB-mediated pro-inflammatory cytokine signaling that has limited the utility of systemically acting TLR7, TLR7/8, and TLR8 agonists. PRTX007 has been administered to over 100 healthy human volunteers in two separate phase 1 clinical studies (Study PRTX007-001 and Study PRTX007-002). In these studies, PRTX007 drove the desired systemic IRF7 poly-IFN response without the undesired NF-KB pro-inflammatory response. PRTX007 was generally well-tolerated with no serious adverse events (SAEs).

(Press release, Primmune Therapeutics, JAN 26, 2026, View Source [SID1234662212])

Phio Pharmaceuticals Announces Participation in Third Annual DealFlow Discovery Conference

On January 26, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that it will participate in the DealFlow Discovery Conference, taking place January 28-29, 2026 at the Borgata Hotel in Atlantic City, NJ.

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Robert Bitterman, CEO and Chairman of the Board of Phio Pharmaceuticals will deliver a company presentation on January 28th at 9 AM in Borgata Hotel Room #1 and the management team will be available for one-on-one investor meetings throughout the event.

"All investors are invited to join this event to learn more about Phio Pharmaceuticals and our continuing pursuit towards a cancer free future using our INTASYL technology," stated Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals. "Completion of treatment in the Phase 1b trial for PH-762 marks a significant step forward in advancing a promising treatment option for skin cancer."

Event Details are as follows:

3rd Annual DealFlow Discovery Conference

The Borgata Hotel, Casino & Spa

Atlantic City, NJ

January 28-29, 2026

Investors interested in scheduling a meeting with Phio Pharmaceuticals management team can register (Investors – DealFlow Discovery Conference) to attend the conference at no cost.

(Press release, Phio Pharmaceuticals, JAN 26, 2026, View Source [SID1234662214])

Innovent Announces IBI3003 (GPRC5D/BCMA/CD3 Trispecific Antibody) Receives Fast Track Designation from the U.S. FDA for Relapsed or Refractory Multiple Myeloma

On January 26, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, reported that its anti-GPRC5D/BCMA/CD3 tri-specific antibody IBI3003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). This designation applies to the treatment of relapsed or refractory multiple myeloma, (R/R MM) in patients who have received four or more lines of previous anti-myeloma therapies, that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.

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IBI3003 was discovered and developed using Innovent’s proprietary Sanbody platform and its development is being advanced globally. IBI3003 is currently undergoing a Phase 1/2 clinical trial in patients with relapsed or refractory multiple myeloma in China and Australia, and there are plans to initiate a Phase 1/2 clinical trial in the United States imminently.

Clinical data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 7, 2025[Link], demonstrated a tolerable safety profile and promising efficacy signals for IBI3003 in patients who had failed ≥2 prior lines of myeloma therapy:

Thirty-nine patients with R/R MM who had previously received at least a PI, an IMiD, and an anti-CD38 monoclonal antibody were treated with IBI3003 at dose levels ranging from 0.1 μg/kg to 800 μg/kg and underwent at least one tumor assessment after baseline. As of the data cutoff date of November 7, 2025, the median follow-up duration was 3.25 months (range: 0.4–7.4), and the median treatment duration was 12.14 weeks (range: 1.0–33.0).
Among patients treated at doses ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 stringent complete responses (sCR), 7 very good partial responses (VGPR), and 9 partial responses (PR). In this cohort, the ORR was 80% among 10 patients with extramedullary disease (EMD) and 77.8% among 9 patients previously treated with BCMA- and/or GPRC5D-directed therapies. Among patients who achieved complete response or better, the minimal residual disease (MRD) negativity rate was 100% (n=4), as assessed by validated next generation sequencing, with a threshold of 10-5, performed at a central laboratory.
All cases of cytokine release syndrome (CRS) were Grade 1-2, with only 2 cases of Grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS) reported. Most treatment-emergent adverse events (TEAEs) related to GPRC5D targeting, including those affecting the oral cavity, skin, and nails, were Grade 1–2, with two patients experiencing Grade 3 rash.
Dr. Hui Zhou, Chief R&D Officer of Oncology in Innovent, stated, "IBI3003 monotherapy has demonstrated encouraging efficacy and a favorable safety profile in R/R MM patients who had received three or more prior lines of therapy. Notably, meaningful clinical activity was observed even in high-risk patients with EMD or those previously treated with anti-BCMA and/or GPRC5D-targeted therapies, highlighting IBI3003’s potential to address key unmet needs. Its overall manageable safety profile further supports continued investigation and the potential for durable survival benefit. The Fast Track Designation granted by the U.S. FDA represents an important milestone in the global development of IBI3003, and we look forward to further evaluating its potential to benefit patients worldwide."

Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Programs granted FTD benefit from more frequent interactions with the FDA, which may accelerate clinical development and regulatory review.

About IBI3003 (Anti-GPRC5D/BCMA/CD3 Trispecific Antibody)

IBI3003 is a tri-specific TCE developed using Innovent’s proprietary Sanbody platform to target both GPRC5D and BCMA. The molecule is designed to mitigate tumor escape associated with single-antigen targeting. In preclinical studies, IBI3003 demonstrated superior in vitro and in vivo antitumor activity compared with marketed benchmark T-cell engagers, including in cell lines and xenograft models with low BCMA and GPRC5D expression. A Phase 1/2 clinical trial (NCT06083207) is ongoing in China and Australia. In December 2025, IBI3003 received IND approval from the U.S. FDA, enabling initiation of a Phase 1/2 clinical trial in the United States.

About Multiple Myeloma

Multiple myeloma (MM) is a malignant hematologic disease characterized by the clonal proliferation of plasma cells and is the second most common hematologic malignancy [1]. MM remains incurable, and factors such as inadequate depth of response, extramedullary involvement, and short remission duration are associated with poor prognoses [2]. For patients with R/R MM who have received four or more prior lines of therapy, including exposure to PIs, IMiDs, and anti-CD38 antibodies, treatment options include, but are not limited to, BCMA-targeted CAR-T therapies and bispecific antibodies targeting CD3×BCMA or CD3×GPRC5D. However, the benefits of these approaches may be limited by antigen loss and treatment resistance.

(Press release, Innovent Biologics, JAN 26, 2026, View Source [SID1234662218])

HanchorBio and WuXi Biologics Enter Strategic Partnership to Advance Next-Generation Bi-and Multi-Functional Fusion Protein Pipeline

On January 26, 2026 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, and WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), reported the signing of a strategic collaboration agreement to support the development and manufacturing of multiple next-generation bi- and multi-functional fusion programs from HanchorBio’s pipeline.

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Under the agreement, WuXi Biologics will provide integrated, end-to-end biologics development and manufacturing services, including cell line development, process and bioassay development, drug product formulation development, and GMP manufacturing. The collaboration is designed to accelerate clinical translation, enhance CMC execution efficiency, and support scalable global development and manufacturing of HanchorBio’s innovative fusion protein portfolio derived from its Fc-Based Designer Biologics (FBDB) platform.

This partnership reflects HanchorBio’s strategy to advance its platform-derived, multi-asset pipelines with development speed, manufacturing robustness, and capital efficiency from early clinical stages through commercialization. By leveraging WuXi Biologics’ proven capabilities in complex biologics and its global quality systems, HanchorBio aims to shorten development timelines and maintain flexibility across multiple clinical programs.

WuXi Biologics brings extensive experience in complex modalities, including bispecific and multi-specific antibodies, antibody-drug conjugates (ADCs), and fusion proteins. As of 2025, WuXi Biologics’ integrated platform supports 945 projects, approximately 60% of which involve bi- and multi-specific antibodies, ADCs, and fusion proteins, underscoring its strong track record in accelerating the development and manufacturing of advanced therapeutic modalities. Its proprietary technology platforms, such as WuXia TrueSite targeted integration (TI)-based CHO cell line platform and WuXiHighTM high-throughput formulation development platform, are designed to enhance speed, quality, and scalability.

For HanchorBio, the collaboration supports continued expansion of its proprietary FBDB technology platform, which enables the rational design of multi-functional fusion proteins intended to modulate both innate and adaptive immunity. The partnership represents a significant step in aligning discovery innovation with industrial-scale and globally compliant execution as HanchorBio advances its oncology and autoimmune pipelines toward global clinical development.

Scott Liu, Founder, Chairman, and Chief Executive Officer of HanchorBio, commented: "This partnership with WuXi Biologics strengthens our ability to translate platform-driven innovation into high-quality clinical and commercial assets. As we advance multiple next-generation fusion protein programs, execution speed, manufacturing reliability, and scalability are critical. WuXi Biologics’ proven expertise in complex biologics and global development makes them a strong strategic partner as we build a differentiated, multi-asset immunotherapy pipeline."

Dr. Chris Chen, Chief Executive Officer of WuXi Biologics, said: " We are excited to embark on this collaboration with HanchorBio, which underscores the strong trust they placed in WuXi Biologics’ comprehensive, end-to-end capabilities for developing next-generation biologics, especially complex molecules. By leveraging our industry-leading technology platforms, proven expertise, and unwavering commitment to quality, we strive to accelerate the development of HanchorBio’s innovative bi-/multi fusion proteins and help bring transformative therapies to patients worldwide.

(Press release, Hanchor Bio, JAN 26, 2026, View Source [SID1234662219])