On January 12, 2026 Infinitusbio.AI, a U.S.-based Pharmatech company and creator of the proprietary Simulative AI Digital Cell Clone platform, and Oncovita, a Paris-based biotechnology company spun out of the Institut Pasteur and specialized in in situ cancer immuno-oncolytic virotherapy, announce a strategic partnership aimed at accelerating the development of next-generation cancer immunotherapies while creating long-term value for both companies. The partnership follows infinitusbio.AI’s successful Digital Cell Clone simulations using Oncovita’s vaccine candidates, which confirmed the wet‑lab results generated by Oncovita.

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On the J.P. Morgan Healthcare Conference, held in San Francisco from January 12 to 15, Stéphane Altaba, CEO, and Patrick Spies, CFO of Oncovita, will present the company and this new partnership with infinitusbio.AI during a SimulativeBio session hosted at PricewaterhouseCoopers LLP on Wednesday, January 14, from 3:30 p.m. to 7:00 p.m. (PST). The session will explore the theme: "Cells, Machines, and the Future of Pharma: The case for simulative AI as the viable approach to modeling complex biological systems at scale."

In addition, Oncovita will present its strategy and latest developments at the RESI Conference on Tuesday, January 13 at 4:00 p.m. (PST) at the Marriott Marquis Hotel, San Francisco.

A strategic partnership to optimize the development of new therapeutics candidates from its Measovir platform.
This collaboration combines infinitusbio.AI’s unique Simulative AI Digital Cell Clone platform with Oncovita’s deep expertise in developing new cancer treatments based on genetically modified Measles vaccine virus, creating a powerful engine for faster, more cost‑efficient advancement of new oncology therapies.
The partnership will leverage infinitusbio.AI’s Digital Cell Clone platform, which can directly incorporate real‑world patient data to strengthen the IND‑enabling process by integrating it with animal testing results.
Oncovita’s Measovir proprietary platform enables the creation of customized therapeutic candidates based on the safe and lifelong protective measle vaccine to target solid tumor cancers. infinitusbio.AI will support Oncovita in selecting additional cancer indications for its current candidate MVdeltaC and suitable payloads for its future candidates, enabling efficient expansion of Oncovita’s drug pipeline and enhancing the company’s overall value.

« We’re delighted to enter this collaboration and advance our next generation immunotherapy programs with the support of infinitusbio.AI’s Digital Cell Clone platform. The partnership follows infinitusbio.AI’s successful Digital Cell Clone simulations using Oncovita’s vaccine candidates, which confirmed the wet‑lab results generated by Oncovita. Integrating infinitusbio.AI’s unique capabilities into our research aligns perfectly with our commitment to adopting smarter, more efficient R&D practices. This partnership will help us broaden the applicability of our Measovir platform to address additional cancer types, design new payloaded-engineered candidates and significantly shorten the time needed to deliver new therapies to patients.", said Stephane Altaba, CEO of Oncovita.

"We are very pleased to begin this strategic partnership with Oncovita, an exceptionally innovative French biotech company. We believe the combination of infinitusbio.AI’s Digital Cell Clones Lab platform and Oncovita’s deep expertise in immune-onco virotherapy will clearly demonstrate the transformative power of Simulative AI—from accelerating disease‑target discovery to optimizing clinical trial design. As we look ahead to an exciting 2026, we are confident this collaboration will drive meaningful progress in Oncovita’s next generation immunotherapy treatment development for the benefit of patients," explains Khai Pham, Founder & CEO of infinitusbio.AI.

Oncovita’s development strategy includes combination‑therapy to enhance efficacy in specific clinical settings. infinitusbio.AI’s platform can accelerate this exploration without requiring a dedicated training dataset, using its Human Cell Intelligent Model that can auto‑differentiate into any digital cell clone within minutes to infer potential outcomes.
infinitusbio.AI’s mechanistic digital cell clones will play a key role in validating the mechanism of action of Oncovita’s next generation immunotherapy, providing deeper insights into its biological efficacy. infinitusbio.AI’s digital cell clones will enable comparative analyses, helping Oncovita evaluate its cancer immunotherapy against existing cancer therapies.
The collaboration will also support Oncovita in identifying predictive biomarkers that can guide patient selection and improve clinical success.

(Press release, Oncovita, JAN 12, 2026, View Source [SID1234662042])

On January 12, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported its recent pipeline progress and strategic priorities for 2026.

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"2025 was a transformative year for Disc, marked by strong execution across our portfolio and meaningful progress toward becoming a fully integrated clinical and commercial organization," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. "Most notably, bitopertin received CNPV designation and we submitted our NDA under the accelerated approval pathway, positioning the NDA for rapid review by the FDA. We also reported positive initial Phase 2 data from the RALLY-MF study of DISC-0974 in anemia of myelofibrosis, demonstrating robust and broad hematologic activity, and advanced our third program DISC-3405 into proof-of-concept studies for polycythemia vera and sickle cell disease."

"As we look ahead to 2026, we are entering an exciting and pivotal period for Disc," continued Dr. Quisel. "We are preparing to execute a successful US launch of bitopertin for EPP while continuing enrollment in the global APOLLO confirmatory study. Across our pipeline, we expect multiple Phase 2 updates for DISC-0974 and DISC-3405, including important regulatory interactions and expansion into new indications. Together, we believe these milestones position Disc for sustained growth as we work to deliver meaningful new therapies to patients with serious hematologic diseases."

Summary of Key Achievements During 2025

Bitopertin NDA submitted and accepted under the accelerated approval pathway with priority review
Bitopertin awarded the Commissioner’s National Priority Voucher (CNPV), a pilot program designed to accelerate the NDA review period to 1-2 months
Transition to commercial-ready organization through build out of marketing, market access, medical science liaison, and sales teams and related infrastructure
Presentation of positive initial data from the Phase 2 RALLY-MF study of DISC-0974 for anemia of MF, demonstrating robust and broad hematologic efficacy across patient segments
Issuance of a Composition of Matter patent for DISC-0974, providing patent exclusivity until 2041, not including potential extensions
Initiated Phase 2 study of DISC-3405 in PV and Phase 1b study of DISC-3405 in SCD
Strengthened balance sheet through two equity offerings, bringing unaudited cash, cash equivalents, and marketable securities to $791 million as of December 31, 2025, which provides runway into 2029

Key Business Objectives and Milestones for 2026
Bitopertin: GlyT1 Inhibitor (Heme Synthesis)

Anticipate FDA approval decision regarding NDA for bitopertin for the treatment of EPP under the CNPV program
Successful launch and initial commercialization of bitopertin in the US, if approved
Continue enrollment of the global, confirmatory APOLLO study with topline data expected by early 2027

DISC-0974: Anti-hemojuvelin Antibody (Hepcidin Suppression)

Progress ongoing Phase 2 MF anemia trial with updated data expected H2 2026
Conduct End of Phase 2 meeting with the FDA about DISC-0974 in MF anemia in H2 2026
Initiate a Phase 2 study of DISC-0974 in patients with anemia and inflammatory bowel disease (IBD)

DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Progress ongoing Phase 2 PV trial with updated data expected H2 2026
Progress ongoing Phase 1b SCD trial with updated data expected H2 2026

Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide.

(Press release, Disc Medicine, JAN 12, 2026, View Source [SID1234661946])

On January 12, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported operational highlights for 2025 and anticipated upcoming milestones.

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"2025 was a transformative and highly productive year for ORIC, marked by meaningful progress across our pipeline, including data that further strengthened our conviction in the potential best-in-class profiles of rinzimetostat in prostate cancer and enozertinib in lung cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "We also bolstered our leadership team and substantially extended our cash runway into 2H 2028 in anticipation of these programs advancing towards registrational studies and, ultimately, commercialization."

2025 Key Accomplishments

Rinzimetostat: a potent and selective allosteric inhibitor of PRC2

Completed Phase 1b dose exploration in prostate cancer and selected provisional recommended Phase 2 doses (RP2Ds) of rinzimetostat to be tested in combination with the approved doses of darolutamide and apalutamide in dose optimization.
Reported potential best-in-class efficacy and safety dose exploration data in combination with darolutamide and apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Data demonstrated:
PSA responses and ctDNA reductions across all rinzimetostat dose levels and at comparable rates in combination with apalutamide or with darolutamide.
Broad and deep PSA responses that compare favorably to competitor PRC2 inhibitors, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed).
Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.
Both combination regimens demonstrated a clearly differentiated safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition.
Presented preclinical data at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics demonstrating potential utility of rinzimetostat combined with AR inhibition in castration-sensitive prostate cancer and combined with KRAS inhibition in KRAS G12C-mutant NSCLC and colorectal cancer models.

Enozertinib: a brain-penetrant inhibitor that selectively targets EGFR exon 20 and EGFR PACC mutations

Reported potential best-in-class efficacy and safety data from a Phase 1b trial of enozertinib at the ESMO (Free ESMO Whitepaper) Asia Congress 2025 in NSCLC patients with EGFR exon 20 and EGFR PACC mutations. Data demonstrated:
Systemic activity in 2L EGFR exon 20 and pretreated EGFR PACC exceeding competitor benchmarks.
Highly competitive preliminary 1L systemic activity, with 67% ORR in EGFR exon 20 and 80% ORR in EGFR PACC.
Convincing 1L CNS activity, with 100% intracranial ORR in EGFR exon 20 and 100% intracranial ORR in EGFR PACC in patients with measurable CNS disease, including in patients with active brain metastases.
Competitive safety profile, with no significant off-target toxicity, resulting in low rate of treatment discontinuations.
Announced a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate enozertinib in combination with amivantamab and hyaluronidase-lpuj subcutaneous injection (SC amivantamab) for the 1L treatment of NSCLC patients with EGFR exon 20 mutations.
Announced publication in Cancer Research of preclinical data demonstrating enozertinib’s exquisite selectivity, strong potency, brain-penetrance, and anti-tumor activity across a broad range of EGFR atypical mutant models, including intracranial lung cancer xenografts.

Corporate Highlights:

Announced the appointment of Kevin Brodbeck, PhD, to the newly established role of Chief Technical Officer (CTO).
Strengthened cash position and extended runway with $244 million in gross proceeds raised from new and existing top-tier healthcare specialist funds via private placement in May 2025 and under the ATM (at-the-market) program throughout 2025.

Anticipated Program Milestones:

ORIC anticipates the following upcoming milestones:

Rinzimetostat in mCRPC:
1Q 2026: Combination dose optimization data with AR inhibitor
1H 2026: Initiate first global Phase 3 registrational trial in mCRPC
2H 2026: Program update
Enozertinib in NSCLC:
2H 2026: 1L EGFR exon 20 monotherapy data and combination data with SC amivantamab
2H 2026: 1L EGFR PACC monotherapy data

Financial Guidance
As of September 30, 2025, cash, cash equivalents and investments totaled $413.0 million, which the company expects will be sufficient to fund its operating plan into 2H 2028, beyond several potential value inflection points, including anticipated primary endpoint readout from first Phase 3 trial of rinzimetostat.

Presentation and Webcast
Jacob M. Chacko, M.D., president and chief executive officer, will present a company overview at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2025, at 9:45 a.m. PT. A live webcast will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

(Press release, ORIC Pharmaceuticals, JAN 12, 2026, View Source [SID1234661964])

On January 12, 2026 Merck, a leading science and technology company, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor (TGCT). The application is based on the primary results and longer-term follow-up of the global Phase 3 MANEUVER study, which demonstrated deep and durable tumor responses and meaningful improvements in clinical outcomes with pimicotinib.

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"With pimicotinib, we have an opportunity to significantly advance care for people living with TGCT, a painful and debilitating disease that has few effective and well-tolerated treatment options beyond surgery," said David Weinreich, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. "Based on clinical trial results showing not only a reduction in tumor burden, but also the ability to help alleviate symptoms like pain and stiffness in the global Phase 3 MANEUVER study, we are confident in the important role pimicotinib can play for TGCT patients in the U.S. and worldwide."

The application is based on primary and longer-term results from the global Phase 3 MANEUVER study. In this trial, once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) by RECIST v1.1 compared with placebo at week 25. The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain. These findings were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. Longer-term results with median follow-up of 14.3 months presented at ESMO (Free ESMO Whitepaper) Congress 2025 showed ORR continued to increase over time among patients treated with pimicotinib from the beginning of the study.

TGCT is a rare, locally aggressive tumor occurring in or around the joint leading to progressive swelling, stiffness and reduced mobility of the affected joint, significantly impacting daily activities and quality of life in what is typically an otherwise healthy population. If left untreated or in recurrent cases, TGCT may result in irreversible damage to the bone, joint and surrounding tissues. A significant need remains for highly effective and well-tolerated treatments beyond surgery that can not only shrink tumors but also alleviate pain and restore function.

In December 2025, pimicotinib was approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with symptomatic TGCT for which surgical resection will potentially cause functional limitation or relatively severe morbidity. Additional applications are under review by regulatory bodies in other markets.

(Press release, Merck KGaA, JAN 12, 2026, View Source [SID1234661980])

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])