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])

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])

On January 26, 2026 EORTC reported the activation of the first site for the VIGOR study (EORTC-2427-BTG), a pivotal Phase III trial evaluating vorasidenib as maintenance treatment following completion of first-line chemoradiotherapy in patients with IDH-mutant glioma WHO CNS Grade 2 or 3 astrocytoma, worked in collaboration with Servier Affaires Médicales (NCT06809322).

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In addition to the first site being activated, the study has already successfully randomised its first patient, marking a strong start to recruitment.

About the VIGOR Study
The VIGOR trial aims to determine whether vorasidenib, an oral brain-penetrant inhibitor of mutant IDH1/2 enzymes, can improve progression-free survival (PFS) compared to placebo, in patients who have completed standard chemoradiotherapy. This approach builds on promising results from the INDIGO trial, which demonstrated significant benefits in delaying disease progression in IDH-mutant gliomas. VIGOR adopts a rigorous design to validate these findings in a broader setting.

It is a Phase III study that is randomised, placebo-controlled, and triple-blind, intending to involve around 470 patients across multiple international sites. The primary endpoint focuses on progression-free survival (PFS) assessed using the RANO 2.0 criteria, while secondary endpoints include overall survival (OS), time to next intervention, safety and adverse events, and health-related quality of life measures, ensuring a comprehensive evaluation of the treatment’s impact.

The VIGOR trial is coordinated by Dr. Matthias Preusser (Medical University of Vienna, Austria) and co-coordinated by Dr. Marjolein Geurts (Erasmus MC Cancer Institute, Rotterdam, The Netherlands).

Dr. Preusser says:

"The VIGOR trial has the potential to define a new standard of care for patients with IDH-mutant gliomas and will provide valuable new insights and opportunities for further research to improve the diagnostic and therapeutic possibilities for this disease".

Dr. Geurts:

"The randomization of the first patient in the VIGOR study is an exciting and important milestone for patients with IDH-mutant astrocytoma. It reflects the strong collaboration and shared commitment to improving outcomes and expanding treatment options early in the disease course. We are very much looking forward to the next milestones as we work together to make a real difference for patients and their families"

Why this study matters
Patients with IDH-mutant astrocytoma typically experience long survival but face inevitable recurrence. VIGOR seeks to establish whether maintenance therapy can extend the time before progression and reduce the need for subsequent interventions, improving long-term outcomes and quality of life.

The activation of the first site, and the successful randomisation of the first patient, represent early and encouraging milestones in this international effort. Recruitment will expand across more than 50 leading cancer centres in Europe and beyond, with EORTC coordinating the study, in collaboration with the Canadian Cancer Trials Group (CCTG) and the Cooperative Trials Group for Neuro-Oncology (COGNO).

(Press release, EORTC, JAN 26, 2026, View Source [SID1234662210])

On January 26, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib.

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"We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "We look forward to the continued collaboration with the FDA as we work to bring the first new treatment option in over twenty years to this patient population."

This Breakthrough Therapy Designation is based on results from the PEAK trial which demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. The combination was well tolerated, and no new safety risks were observed when compared to the known safety profile of sunitinib. Breakthrough Therapy Designation is intended to expedite the review of medicines that treat a serious or life-threatening condition and have shown clinical evidence indicating the potential for substantial improvement over available therapies.

Earlier this month, the FDA agreed to accept Cogent’s NDA under the FDA’s Real-Time Oncology Review (RTOR) program which allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

Cogent plans to present full results from the PEAK trial at a major medical meeting during the first half of 2026. Additionally, in mid-2026 Cogent expects to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.

(Press release, Cogent Biosciences, JAN 26, 2026, View Source [SID1234662208])

On January 26, 2026 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) ("BioMarin") reported that it intends to offer, subject to market and other conditions, $850 million of senior unsecured notes due 2034 (the "Notes").

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BioMarin also announced that, in connection with the pending acquisition (the "Acquisition") of Amicus Therapeutics, Inc. ("Amicus"), it launched the syndication of a new $2 billion senior secured term loan "B" facility (the "Term Loan B Facility"), which Term Loan B Facility is in addition to a $800 million senior secured term loan "A" facility (the "Term Loan A Facility" and, together with the Term Loan B Facility, the "Term Facilities"), and a $600 million senior secured revolving credit facility into which BioMarin expects to enter in connection with the Acquisition (the "New Revolving Facility" and, together with the Term Facilities, the "New Senior Secured Credit Facilities").

BioMarin intends to use the net proceeds from the offering of the Notes, together with borrowings under the Term Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition and related fees and expenses in connection with the Acquisition, the borrowings under the New Senior Secured Credit Facilities, and the issuance of the Notes. The company may also borrow up to $150 million under the New Revolving Facility to pay such fees and expenses.

Gross proceeds from the issuance of the Notes will be deposited into an escrow account at the closing of the Offering, pending consummation of the Acquisition. In the event that the Acquisition is not completed on or prior to December 19, 2026, or upon the occurrence of certain other events, BioMarin will be required to redeem all of the Notes at a redemption price equal to 100% of the initial issue price of the Notes plus accrued and unpaid interest from the date of issuance, or the most recent date to which interest has been paid or provided for, to but excluding the special mandatory redemption date.

The Notes will be jointly and severally guaranteed by certain of BioMarin’s subsidiaries that will guarantee the obligations under the New Senior Secured Credit Facilities, including, after the closing of the Acquisition, Amicus and certain of its subsidiaries that will guarantee the obligations under the New Senior Secured Credit Facilities.

The indenture governing the Notes is expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of BioMarin and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to a limited number of persons who are either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This press release is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. This press release contains information about the pending offering of the Notes, and there can be no assurance that

(Press release, BioMarin, JAN 26, 2026, View Source [SID1234662204]) the offering will be completed. The offering of the Notes may be made only by means of an offering memorandum.