On January 12, 2026 Curasight A/S ("Curasight" or "the Company" – TICKER: CURAS), a clinical-stage radiopharmaceutical company developing first-in-class drug candidate uTREAT targeting uPAR (urokinase-type plasminogen activator receptor), the functional driver of invasion, angiogenesis, and metastasis across most solid tumors, reported encouraging preliminary data from the first patient dosed in ongoing Phase 1 clinical trial in patients with high-grade gliomas.

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Position emission tomography (PET)-images from the first treated patient showed clear and sustained uptake of uTREAT in the tumor, confirming that the drug successfully targets cancer tissue. The signal remained visible for at least 24 hours, indicating prolonged tumor binding and supporting the potential for effective radiation delivery to the tumor. The patient’s PET signal persisted until the last PET scan (24 hours), demonstrating that uTREAT has protracted binding kinetics, translating to a maximized tumor absorbed dose.

These early results provide support for Curasight’s uPAR-targeted approach in radiopharmaceuticals and the potential of uTREAT as a novel therapy for patients with high-grade gliomas and other uPAR expressing aggressive solid tumors (>85% of solid tumors).

The preliminary dosimetry readout of uTREAT was in line with expectations and supports to continue with additional GBM patients. Currently more patients are enrolled, and top-line data is expected in Q2 2026.

"This first-patient data represents an important early milestone for Curasight and uTREAT," says Ulrich Krasilnikoff, CEO of Curasight. "The clear tumor uptake and high retention observed in aggressive glioblastoma provide early clinical validation of our uPAR-targeted radiopharmaceutical approach. The results further support the potential of uTREAT as a next generation radiopharmaceutical targeting uPAR for multiple solid aggressive tumors using one drug and one target. It further supports our theranostic uPAR platform designed to provide highly specific and personalized treatment for certain types of cancer".

About the uTREAT Phase 1 trial in glioblastoma

The phase 1 clinical trial is designed to evaluate the dosimetry and safety of Curasight’s drug candidate uTREAT as a first-in-class uPAR targeted radiopharmaceutical therapy in patients with newly diagnosed, verified or suspected glioblastoma (GBM). Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders.

About the uPAR theranostic platform

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE (highly precise PET imaging diagnostic) and uTREAT (highly precise radiopharmaceutical therapy) both targeting uPAR (urokinase-type plasminogen activator receptor) with the same uPAR binding peptide AE105. Together, they form an integrated approach to next generation radiopharmaceuticals in aggressive solid tumors. uTRACE is fully developed, GMP manufactured and validated in 9 clinical trials (450 patients). uTRACE is partnered with Curium Inc. in the field of diagnostics for prostate cancer.

About high grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors, and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approx. 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50 % of the patients die within 14 months and after five years from diagnosis only 5 % are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.

(Press release, Curasight, JAN 12, 2026, View Source [SID1234661991])

On January 12, 2026 Kainova Therapeutics ("Kainova" or "the Company"), a catalyst for breakthrough treatments for patients in immuno-oncology and inflammation, reported a transformative rebrand. The new name and brand reflect the Company’s clinical momentum, global focus, and readiness for the next chapter of strategic growth, anchored by a mature pipeline of G Protein-Coupled Receptor (GPCR)-modulating therapies.

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The name "Kainova" combines "Kairos," the opportune or decisive moment, and "Nova," symbolizing innovation and renewal. It embodies the Company’s transformation and ambition, reflecting its drive to innovate, determination to deliver, and commitment to therapies that truly transform lives. Built on a strong scientific foundation, a proprietary discovery platform, an integrated development approach, and experienced leadership, the new brand underscores Kainova’s commitment to clinical excellence, value creation, and lasting impact.

"The rebrand is not a break from our scientific or strategic roots", said Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics. "It is the clearer expression of who we are today and the impact we strive to deliver for patients. It highlights a continuation between our past successes and the growth path we envision for the future. Above all, Kainova Therapeutics embodies our belief that better is always possible."

Leveraging decades of scientific and medical expertise and a proven track record of collaborations with pharma, Kainova is advancing innovative, clinically differentiated therapies designed to unlock the untapped potential of GPCRs.

Kainova employs a fully integrated, forward-thinking approach to GPCR drug discovery and smart development, moving programs efficiently from concept to clinic and strengthening its position as a leader in the field. The Company’s leading programs include DT-7012, a Treg-depleting anti-CCR8 antibody with competitive properties in Phase I/II trials for solid tumors, DT-9046, a first-in-modality, pre-IND biased PAR2 antagonist in inflammation, and DT-9081, a Phase II-ready EP4 receptor antagonist for solid tumors.

With operations in North America, France, and Australia, and a growing clinical pipeline, Kainova is entering its next chapter, shaping the future of GPCR-modulating therapies, transforming lives, and expanding its global reach.

The Kainova leadership will be in San Francisco during the J.P. Morgan Healthcare Conference, January 12–15, 2026, and welcomes the opportunity to share how the Company is advancing its clinical pipeline of GPCR-modulating therapies to create a meaningful impact for patients.

(Press release, Domain Therapeutics, JAN 12, 2026, View Source [SID1234661989])

On January 12, 2026 AbbVie (NYSE: ABBV) and RemeGen reported an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 (PD-1)/Vascular Endothelial Growth Factor (VEGF)-targeted bispecific antibody. RC148 is currently being developed by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumors.

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PD-1/VEGF-targeted bispecific antibodies represent a new class of cancer therapies that aim to help the immune system fight tumors more effectively and potentially overcome tumor resistance mechanisms by blocking both PD-1 and VEGF simultaneously. Additionally, given their potential to modulate both immune suppression and foster a favorable tumor microenvironment for antibody-drug conjugate (ADC) activity, PD-1/VEGF bispecific antibodies are also being explored in combination with ADCs. In early clinical studies, RC148 has shown initial favorable antitumor activity in combination with an ADC.

RC148 further strengthens AbbVie’s diverse oncology portfolio. In particular, it may offer new opportunities to explore combination regimens with AbbVie’s ADCs such as investigational telisotuzumab adizutecan (Temab-A), across multiple solid tumors with high unmet need including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

"Our partnership with RemeGen reflects AbbVie’s commitment to not only advance novel oncology treatments, but also to build strong collaborations with biopharmaceutical innovators globally as an increasingly important source of scientific and clinical progress," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology at AbbVie. "By combining the immune checkpoint inhibition and anti-angiogenic activity of RC148 together with the targeted cytotoxic activity of ADCs, we have the potential to identify meaningful options for patients across a range of solid tumors."

"This collaboration is a significant milestone for RemeGen, highlighting the innovative potential of RC148 in addressing critical unmet medical needs in cancer treatment," said Dr. Jianmin Fang, chief executive officer of RemeGen. "The deal further underscores RemeGen’s commitment to bringing cutting-edge therapies to patients worldwide. Working with AbbVie, we look forward to maximizing RC148’s clinical and commercial potential in China and globally."

Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize RC148 outside of the Greater China territory. RemeGen will receive an upfront payment of USD $650 million and is eligible to receive up to USD $4.95 billion in aggregate development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales outside the Greater China territory.

(Press release, AbbVie, JAN 12, 2026, View Source [SID1234661988])

On January 12, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported an update on the rapid commercialization momentum and growing market adoption of PAPZIMEOSTM (zopapogene imadenovec-drba), the first-and-only US Food and Drug Administration (FDA)-approved therapy for recurrent respiratory papillomatosis (RRP). Precigen’s company presentation at the 44th Annual J.P. Morgan Healthcare Conference will be on January 15, 2026 at 7:30 AM PT.

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"Commercialization of PAPZIMEOS is proceeding as planned following FDA approval, with rapid and broad adoption supported by compelling safety, efficacy, and long-term durability data, expanding payer access, and strong engagement across major medical centers and community practices nationwide," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are seeing tremendous enthusiasm from physicians across the country who are eager to bring this therapy to their patients. Importantly, we are moving rapidly to make PAPZIMEOS available globally, highlighted by the European Medicines Agency validation of the Marketing Authorization Application. As the first-and-only FDA-approved therapy for adults with RRP, PAPZIMEOS is redefining the treatment paradigm, and the momentum we are seeing underscores its impact and value as we advance toward anticipated cash-flow break-even and global expansion."

"Our commercial launch continues to build strong momentum, with patient hub enrollment doubling since November, expanding commercial health plan coverage alongside Medicare and Medicaid, and near-complete field engagement across target centers," said Phil Tennant, Chief Commercial Officer of Precigen. "Manufacturing and supply chain capabilities are fully in place to meet current demand and anticipated growth, and patients are now receiving PAPZIMEOS nationwide. Importantly, PAPZIMEOS remains the only FDA-approved therapy for adults with RRP, providing an exclusive window to execute our commercial strategy. Based on these dynamics, we expect adoption to continue accelerating as PAPZIMEOS becomes established as the preferred first-line treatment and new standard of care."

PAPZIMEOS: Establishing a New Standard of Care for the Treatment of Adults with RRP

PAPZIMEOS full approval with broad label: In August 2025, the FDA granted full approval of PAPZIMEOS with a broad label and no requirement for a confirmatory trial for the treatment of adults with RRP.
PAPZIMEOS prescribing, treatment, and distribution: PAPZIMEOS is being prescribed nationwide, with patients actively receiving treatment. PAPZIMEOS is currently shipping to prescribers across the US, supported by established cold-chain logistics and coordinated solutions to address site-level needs.
Rapid commercialization: Rapid commercial launch execution is underway with over 96% of target centers engaged since full deployment of the sales team in September. To date, more than 200 patients have been registered in the PAPZIMEOS patient hub, doubling since November. In addition to these registered patients, a significant number of patients have been identified outside of the PAPZIMEOS hub through the Company’s field engagement efforts.
Positive payer coverage: Private health plan coverage is progressing rapidly with approximately 170 million lives covered to date, including the majority of leading insurers. PAPZIMEOS is also covered under Medicare and Medicaid.
Compelling long-term clinical and real-world evidence published: At AAO-HNSF 2025 and SITC (Free SITC Whitepaper) 2025, the Company reported long-term durable complete responses with PAPZIMEOS, and at ISPOR Europe 2025, the Company published data demonstrating the substantial healthcare resource utilization and patient-reported quality-of-life burden of RRP, underscoring the disease’s significant clinical, economic, and human impact.
EMA validation complete: Following a submission in November 2025, the European Medicines Agency has validated the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP.
About RRP
RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. Management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. As the number of lifetime surgeries increases, the risk for irreversible iatrogenic laryngeal injury increases with each surgery, and patients may undergo hundreds of these surgeries over their lifetimes. RRP can impact patients’ work and social lives, financial stability, and mental health. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US.

About PAPZIMEOS (zopapogene imadenovec-drba), for subcutaneous injection only
PAPZIMEOS is the first-and-only FDA-approved therapy for the treatment of adults with RRP and the first-and-only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen’s labs using Precigen’s proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP. Full prescribing information can be found at www.precigen.com/papzimeos-prescribing-information.pdf.

(Press release, Precigen, JAN 12, 2026, View Source [SID1234661987])

On January 12, 2026 Novita Pharmaceuticals, Inc. ("Novita"), a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational small-molecule fascin inhibitor, NP-G2-044, for the treatment of pancreatic cancer. Pancreatic cancer is among the deadliest malignancies, with a five-year survival rate of approximately 12% and limited effective treatment options, particularly in advanced disease.

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"FDA Orphan Drug Designation for our fascin inhibitor represents an important regulatory milestone for Novita and validates the Company’s scientific and clinical approach in the fight against pancreatic cancer, as it remains one of the most lethal solid tumors with limited therapeutic progress over decades," said Stewart Campbell, Chief Executive Officer of Novita Pharmaceuticals. "Fascin inhibition offers a novel approach with the potential to enhance anti-tumor immune activity and improve outcomes for patients with this devastating disease, and we look forward to continuing advancement of NP-G2-044 to address the high unmet need."

Orphan Drug Designation is granted to investigational therapies intended to treat rare diseases affecting fewer than 200,000 patients in the United States. The designation provides development incentives, including eligibility for tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon regulatory approval.

The FDA’s Orphan Drug Designation was granted by the FDA’s Office of Orphan Products Development (OOPD) and includes treatment of pancreatic cancer in the setting of immune checkpoint inhibitor (ICI) therapy, which falls within the scope of the approved orphan indication. As noted by the FDA, orphan designation applies to the active moiety of the drug rather than a specific formulation, and eligibility for orphan drug exclusivity will ultimately depend on the approved indication and demonstration of clinical benefit relative to any approved therapies in the same indication.

About Novita’s Pioneering Research in Fascin Inhibition
Cancer metastasis is the primary cause of over 90% of cancer-related deaths, yet there is currently no drug on the market specifically targeting metastasis. Furthermore, while Immuno-Oncology (IO) therapies, particularly immune checkpoint inhibitors, have made significant strides in cancer treatment, a large proportion of patients do not respond to existing IO treatments. Novita aims to address both of these critical medical needs by developing fascin inhibitors, which target a key protein involved in tumor cell motility and highly expressed in tumor cells and antigen-presenting cells within tumor tissues. The Company’s lead asset, NP-G2-044, is a small-molecule fascin inhibitor that has demonstrated the ability to block metastasis in both preclinical and clinical studies. Additionally, when combined with immune checkpoint inhibitors, NP-G2-044 has shown potential to reinvigorate anti-tumor immune responses. Novita’s multicenter Phase 2 clinical trial, titled "NP-G2-044 as Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies," is currently ongoing.

(Press release, Novita Pharmaceuticals, JAN 12, 2026, View Source [SID1234661986])