Nuvalent to Present at the 44th Annual J.P. Morgan Healthcare Conference

On December 22, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PT in San Francisco.

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

(Press release, Nuvalent, DEC 22, 2025, View Source [SID1234661596])

Mondego Bio Announces Selection of a PTPN2 Inhibitor Clinical Candidate and Targets First-in-Human Trials in H1 2026

On December 22, 2025 Mondego Bio, a clinical-stage biotechnology company developing next-generation small-molecule immuno-oncology therapies, reported the formal selection of its lead clinical candidate, ZE00-0388, a highly selective inhibitor of PTPN2. Candidate nomination follows completion of an extensive preclinical evaluation package demonstrating a favorable safety and tolerability profile in relevant animal models.

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With this milestone, Mondego Bio is transitioning into clinical-stage operations and plans to initiate a first-in-human (FIH) Phase 1 clinical study in the first half of 2026.

The planned clinical program is designed to characterize initial safety, tolerability, and pharmacokinetics, while enabling exploratory translational assessments in oncology. The Phase 1 study is expected to include a dual-track design, consisting of a healthy volunteer cohort intended to assess safety, tolerability, and pharmacokinetics to inform dose selection and exposure characterization, and oncology patient cohorts designed to explore the safety, tolerability, and pharmacologic profile of ZE00-0388 when administered as monotherapy and in combination with immune checkpoint inhibitors, with evaluation of selected biomarkers in patients with solid tumors.

"The selection of ZE00-0388 marks a pivotal transition for Mondego Bio from discovery into clinical development," said Nikolay Savchuk, PhD, Chief Executive Officer of Mondego Bio. "Our preclinical data support a disciplined and measured entry into the clinic. By selectively targeting PTPN2, we aim to investigate its potential role in modulating immune signaling pathways, including in combination with established immuno-oncology approaches."

ZE00-0388 is an AI-designed, highly selective small-molecule inhibitor of PTPN2 (Protein Tyrosine Phosphatase Non-Receptor Type 2), an intracellular regulator of cytokine and interferon signaling. PTPN2 acts as a negative regulator of the JAK–STAT pathway and has been implicated in mechanisms of immune regulation within the tumor microenvironment. Preclinical studies suggest that modulation of PTPN2 activity may influence interferon signaling and immune cell function, supporting further clinical investigation in oncology settings.

Advancement of ZE00-0388 into clinical development is supported by the Company’s recent Series A financing, led by Biovance Capital, with participation from OrbiMed and Torrey Pines Investment.

(Press release, Mondego Bio, DEC 22, 2025, View Source [SID1234661595])

Flagship Pioneering and Repertoire® Immune Medicines Announce Agreement to Identify T Cell-Targeted Immune Medicines for Prostate Cancer Under Strategic Partnership with Pfizer

On December 22, 2025 Flagship Pioneering, a scientific innovation engine for transformative platforms and products, reported a research program under its strategic collaboration with Pfizer whereby Flagship-founded Repertoire Immune Medicines will identify and optimize TCR bispecifics for metastatic prostate cancer.

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Pioneering Medicines, Flagship’s in house drug discovery and development unit, is responsible for leading the strategic partnership with Pfizer, including driving the exploration process to rapidly surface potential drug development programs built on Flagship’s diverse bioplatforms and modalities. The Repertoire agreement is the eighth program initiated under Flagship’s strategic partnership with Pfizer announced in July 2023.

"Repertoire’s DECODE platform uniquely maps the entire immune synapse, presenting enormous uncharted potential to discover new antigens capable of activating the immune system to fight cancer, and when coupled with Repertoire’s immune medicine engineering technologies and capabilities, places us in a strong position to generate targeted medicines to engage them," said Torben Straight Nissen, Ph.D., Chairman and CEO of Repertoire and Executive Partner at Flagship Pioneering. "Guided by Pfizer’s drug development expertise in oncology, we will apply our platform to uncover new potential T-cell targeted medicines."

As many as one in five men with prostate cancer progress to metastatic disease with many going on to develop resistance to successive lines of therapy. T cell receptor (TCR) bispecifics have emerged as a promising immunotherapy with the potential to overcome several barriers associated with disease progression. The aim of the research program is to identify and develop an early optimized TCR bispecific lead that could provide durable disease control and reduced toxicity.

"This research program with Repertoire demonstrates both the continued momentum in our strategic alliance with Pfizer and the breadth of novel modalities our Flagship companies offer as a supply chain of potential therapeutic innovation," said Paul Biondi, Flagship Pioneering Managing Partner. "We have now collaborated on eight programs across multiple modalities and five therapeutic areas in our shared commitment with Pfizer to co-create a pipeline of novel candidates that have a potential to become differentiated medicines with greater precision, speed, and scale for the patients who need them most."

(Press release, Pfizer, DEC 22, 2025, View Source [SID1234661594])

Ginkgo Bioworks Partners with Carnegie-Mellon University to Develop Innovative New Cancer Screening Approach

On December 22, 2025 Ginkgo Bioworks (NYSE: DNA) reported its partnership with Carnegie-Mellon University (CMU) for an award by the Advanced Research Projects Agency for Health (ARPA-H) for its POSEIDON program (Platform Optimizing SynBio for Early Intervention and Detection in Oncology). With Ginkgo Bioworks serving as the Commercial Partner, the project will also be led by Rebecca Taylor (principal investigator), professor of mechanical engineering at Carnegie Mellon University.

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Combining recent advancements in synthetic biology with cutting-edge detection technology, the team expects to develop both a highly innovative orally administered pill containing specially engineered, tumor-targeting sensors and a user-friendly cancer screening device designed for at-home testing. As part of this team, Ginkgo plans to apply its cell and enzyme engineering expertise to support development of these new diagnostic tools.

Using a combination of synthetic biology and nucleic acid nanotechnology, the pill’s specially engineered, tumor-targeting sensors aim to detect tumor-specific conditions, such as low oxygen, acidity, and lactate—hallmarks of cancer. The sensors will then release reporters to indicate the presence of a tumor and its specific tissue of origin. Synthetic reporters will then be excreted into urine to collect the results.

"Our dual-function approach is designed to provide an unprecedented level of precision, effectively illuminating hidden tumors from within the body, which then signals the presence of disease through a simple urine test," explained Taylor. "This is a scientific leap forward that we believe will profoundly change how we approach early cancer diagnostics."

"We are truly excited to get to support this effort," said Jesse Dill, Government BD Lead at Ginkgo Bioworks. "This type of interdisciplinary teaming, and ambitious vision, are essential for bringing transformative new diagnostics to the market. We hope that patients and doctors will be empowered to make well-informed decisions, to the benefit of all."

In addition to Carnegie Mellon researchers, the multidisciplinary project team includes academic experts from the University of Pittsburgh, the University of Massachusetts Amherst, and KU Leuven, as well as corporate partners at Ginkgo Bioworks, Velentium Medical, Clinical Research Strategies, and Platypus Bio.

(Press release, Ginkgo Bioworks, DEC 22, 2025, View Source [SID1234661593])

Gilead Sciences to Present at Upcoming Investor Conference

On December 22, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conference:

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J.P. Morgan Healthcare Conference on Monday, January 12, 2026 beginning at 11:15 a.m. Pacific Time
The live webcast can be accessed at investors.gilead.com and the replay will be available for at least 30 days following the presentation.

(Press release, Gilead Sciences, DEC 22, 2025, View Source [SID1234661589])