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PreciseDxⓇ Presents New Data for PreciseBreastⓇ, an AI Digital Pathology Test to Predict Breast Cancer Recurrence, at the 2025 San Antonio Breast Cancer Symposium

On December 4, 2025 PreciseDx, the leading innovator behind PreciseBreast, a novel AI digital pathology test, reported the upcoming presentation of three abstracts that further validate the test’s ability to assess risk of recurrence in early-stage breast cancer. Ongoing studies aim to demonstrate PreciseBreast’s ability to predict treatment benefit.

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Three abstracts will be presented during the annual San Antonio Breast Cancer Symposium (SABCS) taking place December 9-12, 2025, in San Antonio, TX. These presentations underscore the growing momentum and clinical success of PreciseBreast which utilizes our proprietary AI platform to combine AI-enabled image feature data with key clinical factors to deliver a PreciseBreastⓇ Score that accurately stratifies patients by recurrence risk.

SABCS-accepted abstracts presented by PreciseDx

PS113-13: Clinical validation of an Artificial Intelligence digital pathology-based prognostic test to predict risk of recurrence using biopsy specimens from patients with invasive breast cancer

Author/Presented by: Michael J. Donovan, PhD, MD
Poster Presentation: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM
PS4-12-28: A novel approach for phenotyping triple negative breast cancer using an Artificial Intelligence digital pathology-based prognostic test to assess recurrence risk and response to therapy

Author/Presented by: Nicholas Stanzione MD, David Geffen School of Medicine, UCLA
Poster Presentation: Thursday, December 11, 2025, 5:00 PM – 6:30 PM
SABCS-accepted abstract presented by Lankenau Medical Center/Main Line Health

PS3-06-02: Prospective Evaluation of "PreciseBreast" AI Tool in Early-Stage Invasive Breast Cancer Risk Stratification

Author/Presented by: Lankenau Medical Center, Main Line Health, Talar Telvizian, MD
Poster Presentation: Thursday, December 11, 2025, 12:30 PM – 2:00 PM
"These results build on our prior publications validating PreciseBreast’s clinical and analytical accuracy in early-stage invasive breast cancer by demonstrating the ability to use the patient’s biopsy specimen to risk stratify as well as advancing our understanding of patients with triple negative breast cancer," shared Eric Converse, CEO of PreciseDx. "We’re particularly excited about the independent, real-world experience at Lankenau Medical Center using PreciseBreast in patients with HR+, HER2- early breast cancer and continuing our collaboration with NSABP to further evaluate PreciseBreast’s ability to predict chemotherapy benefit in this population."

(Press release, PreciseDx, DEC 4, 2025, View Source [SID1234661144])

Intensity Therapeutics Announces Two Presentations at the Upcoming 2025 San Antonio Breast Cancer Symposium

On December 4, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, today announces two presentations at the upcoming 2025 San Antonio Breast Cancer Symposium (SABCS), in San Antonio, TX on December 9-12, 2025.

Presentations:

Title:

Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations

Date:

Thursday, December 11, 2025

Time:

5 p.m. – 6:30 p.m. CT

Abstract/Poster:

#801 Poster PS4-10-15

Presenting author:

Lewis Bender, M.S. M.A. M.B.A., Intensity Therapeutics

Title:

Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer: Early observations from INVINCIBLE-4-SAKK 66/22 (NCT06358573), a Phase II Randomized Clinical Trial

Date:

Friday, December 12, 2025

Time:

12 p.m. – 1:30pm CT

Abstract/Poster:

#1589 PS5-01-04

Presenting author:

Andreas Müller, M.D., Swiss Cancer Institute

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

J & D Pharmaceuticals LLC Receives Orphan Drug Designation for Treatment of Hepatocellular Carcinoma (HCC)

On December 4, 2025 J & D Pharmaceuticals LLC reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s investigational therapy for the treatment of Hepatocellular Carcinoma (HCC) a rare and life-threatening disorder that is estimated to occur in approximately 73,000 individuals in the United States in 2025.

HCC is a devastating disorder that has a very poor prognosis. With FDA approved medications the amount of time extended in patient with HCC is only 2.5 months. There is a need for a safer and more effective medication for HCC.

"Receiving Orphan Drug Designation is yet another significant milestone for J & D Pharmaceuticals," said Lenard Lichtenberger, PhD, Chief Scientific Officer. "This designation adds to the two previous orphan drug designations we received and continues to underscore the urgent need for innovative therapies for HCC patients and strengthens our commitment to developing solutions that we expect to transform the lives of those affected by this debilitating condition not just by adding years to their lives but life to those years."

The FDA’s Orphan Drug Designation program provides incentives to encourage the development of treatments for rare diseases, including tax credits for qualified clinical testing, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon regulatory approval.

J & D Pharmaceuticals plans to advance its HCC program into clinical development and will continue working closely with the FDA and the HCC community to accelerate progress toward delivering a novel treatment option to patients in need.

(Press release, J & D Pharmaceuticals, DEC 4, 2025, View Source;d-pharmaceuticals-llc-receives-orphan-drug-designation-for-treatment-of-hepatocellular-carcinoma-hcc-302632020.html [SID1234661142])

Formycon and MS Pharma sign exclusive commercialization partnership for Keytruda® biosimilar candidate FYB206 for the MENA Region

On December 4, 2025 Formycon AG (FSE: FYB, Prime Standard) and MS Pharma reported that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206, Formycon’s biosimilar candidate to the blockbuster drug Keytruda[1] (pembrolizumab), in the Middle East and North Africa ("MENA region"). The agreement includes an option for future technology transfer.

"This licensing deal for the MENA region represents the start of the commercial partnering activities for our Keytruda biosimilar candidate. Further agreements for additional regions and countries shall follow in due time. With MS Pharma, we are leveraging the well-established excellent collaboration that has already been successfully implemented for our biosimilars FYB201, FYB202, and FYB203. MS Pharma is a strong player that can sustainably improve access to this important cancer drug across the MENA region. FYB206 is currently approaching the end of its clinical development phase, and we expect results for the primary endpoint in the first quarter of 2026," said Nicola Mikulcik, CBO of Formycon AG.

"Extending our partnership with Formycon for FYB206 (pembrolizumab), is a strategically important milestone for MS Pharma. This collaboration not only strengthens our position as a leader in biosimilars across the MENA region but also demonstrates our commitment to expanding access to innovative cancer therapies. Leveraging Formycon’s scientific expertise with our established local capabilities and our advanced manufacturing facility in Saudi Arabia, we are well-positioned to deliver high-quality biosimilars that meet the needs of patients and healthcare systems in the MENA region," commented Kalle Känd, CEO of MS Pharma.

Upon signature of the agreement, Formycon will receive an upfront remuneration and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones, Formycon will further receive a significant share of the gross profits generated in the region.

MS Pharma will continue to contribute to greater treatment availability while supporting national strategies focused on localization, resilience, and sustainable access to oncology care. This collaboration reinforces MS Pharma’s role as a long-term partner to governments and healthcare institutions across the region, helping maintain continuity and quality of care for patients.

Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 2024[2], Keytruda is currently one of the world’s best-selling drugs. In the MENA region, estimated sales reached approximately US$ 240 million[3], positioning it as the highest-selling biologic in the region and underscoring the substantial oncology demand and market potential across MENA.

(Press release, Formycon, DEC 4, 2025, View Source [SID1234661141])

iOnctura initiates Phase I/II trial in patients with myelofibrosis ahead of new non-clinical data at ASH

On December 4, 2025 iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, reported it has dosed the first patient in its Phase I/II clinical trial evaluating roginolisib in patients with MF who are no longer responding to JAK inhibition. Further details of the trial will be presented in a poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida on Sunday, December 7 at 6pm EST.

This milestone marks an important step toward addressing the significant unmet medical needs of MF patients who face diminishing therapeutic options, as their disease progresses or becomes resistant to standard-of-care JAK inhibitor treatment.

The Phase I/II trial is part of a comprehensive development program evaluating next-generation PI3Kδ inhibitor roginolisib’s tolerability and anti-tumor response across a number of solid and hematologic malignancies.

"Based on non-clinical data being presented at ASH (Free ASH Whitepaper), we anticipate that targeting both the PI3Kδ and JAK pathways could have a synergistic effect in MF — an approach that has previously eluded older generation PI3Kδ inhibitors because of their unfavorable tolerability profiles." said Dr Michael Lahn, Chief Medical Officer of iOnctura.

Overactivation of the PI3K-Akt signaling pathway contributes to the occurrence and progression of cancer[1]. In MF, pathway activation is a well described mechanism of resistance in response to JAK inhibition[2]. Inhibition of this pathway using roginolisib may overcome the lack of response and lead to a beneficial therapeutic effect. Non-clinical evidence in support of this mechanism is being presented at ASH (Free ASH Whitepaper) on Monday, December 8, 2025 at 6pm EST.

These data demonstrate monotherapy activity of roginolisib against MF cell lines and in vitro models of primary MF cells. Further, roginolisib and JAK inhibition (ruxolitinib or momelotinib) exerts a synergistic anti-cancer effect. These data support the rationale behind the ongoing HEMA-MED clinical trial.

Professor Alessandro Vannucchi, Professor of Hematology and Department Head of the Center for Research and Innovation in Myeloproliferative Neoplasms (CRIMM) at the University of Florence, Florence, Italy and Principal Investigator of the HEMA-MED study said: "Myelofibrosis patients often have suboptimal responses to ruxolitinib and/or acquire resistance over time. Roginolisib’s intriguing mechanism of action and favorable toxicity profile position it as a compelling partner for ruxolitinib. By combining these agents, we could unlock more durable responses and redefine therapeutic expectations for this challenging rare disease."

In addition to the two posters related to MF, trials in progress posters for the ongoing investigations of roginolisib in peripheral T-cell lymphoma and chronic lymphocytic leukemia (CLL) will also be presented at ASH (Free ASH Whitepaper).

iOnctura poster presentations at the 67th ASH (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, USA:

1. A Vannucchi et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-4153: A study of roginolisib in combination with ruxolitinib in patients with myelofibrosis who are unresponsive to JAK inhibitors (HEMA-MED)

2. M Balliu et al.: Monday, December 8, 06:00 PM – 08:00 PM EST

Abstract 25-7102: The selective PI3Kd inhibitor roginolisib synergizes with ruxolitinib against progenitor cells from naïve and JAK-inhibitor-refractory/resistant patients with myelofibrosis

3. D Sibon et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-11050: PlatΤform: A multicenter, multi-arm, academic platform trial evaluating novel agents and combinations in relapsed or refractory peripheral T-cell lymphomas

4. J Brown et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-7765: Roginolisib (IOA-244), an orally bioavailable, selective PI3Kδ inhibitor, in combination with venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL)

About myelofibrosis (MF)

MF is a rare myeloproliferative neoplasm marked by activation and growth of mutated cells in the bone marrow, with approximately 0.5 cases per 100,000 individuals diagnosed globally a year[3].

JAK inhibitors are a key treatment option for MF patients and improve symptoms and quality of life, but approximately half of patients discontinue therapy within three years[4]. Reasons for discontinuation include disease progression, tolerability and adverse events and death resulting from resistance to the JAK therapy[5],[6].

About the HEMA-MED clinical trial

The HEMA-MED trial (NCT06887803) is a prospective, multi-center, open-label Phase I/II single arm trial consisting of two parts. Part 1 (Phase 1) will enroll 13 patients to assess the safety of the combination of the PI3Kδ inhibitor roginolisib in combination with the JAK inhibitor ruxolitinib, and Part 2 (Phase 2) will expand to enroll 13 additional patients to further allow the assessment of benefit/risk for all 26 patients. In addition to safety, the secondary endpoints of the HEMA-MED trial include blood biomarker and spleen reduction responses, and improvements of MF related symptoms. Exploratory measures will assess endpoints associated with the mechanism of action (MOA) of roginolisib.

(Press release, iOnctura, DEC 4, 2025, View Source [SID1234661140])