On February 27, 2026 Bayer reported results from the ongoing global Phase I first-in-human, dose-escalation PAnTHa study (NCT06217822) evaluating the safety, tolerability and preliminary efficacy of 225Ac-PSMA-Trillium (BAY 3563254), a next-generation targeted alpha therapy (TAT) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). The dose for expansion was successfully identified, with ≥80% of patients achieving a PSA50 response at the expansion dose.

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New data were presented during the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place in San Francisco, CA, United States, from February 26-28, 2026. These clinical data represent the first disclosure for 225Ac-PSMA-Trillium and were selected as part of the rapid oral session focused on advanced prostate cancer research. They support advancing 225Ac-PSMA-Trillium to the next phase of clinical development. TAT is a strategic pillar of precision oncology at Bayer, with the potential to accelerate novel treatment options for patients with mCRPC.

"We are excited to see the results from the Phase I PAnTHa study demonstrating the potential of our next-generation targeted alpha therapy to provide new treatment options for patients with advanced metastatic castration-resistant prostate cancer (mCRPC), a type of cancer with limited treatment options and poor prognosis," said Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. "The development of 225Ac-PSMA-Trillium confirms our ongoing focus on prostate cancer treatment and continued drive to develop precise and personalized healthcare solutions."

"Despite progress, patients with metastatic castration-resistant prostate cancer continue to face high mortality, highlighting the urgent need for new precision therapies," said Fred Saad, MD, FRCS, Professor and Chairman of Surgery at the University of Montreal and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), Canada. "The promising data support the further investigation of this molecule to provide a potentially meaningful clinical benefit for patients with mCRPC."

225Ac-PSMA-Trillium (BAY 3563254) is a next-generation investigational TAT labeled with actinium-225 and comprising a novel PSMA (prostate-specific membrane antigen)-targeting small molecule with a customized albumin-binding moiety. The compound is designed specifically to increase uptake within the tumor, with the goal to provide a differentiated safety and efficacy profile.

Prostate cancer is the second most commonly diagnosed cancer in men with less than three years median survival among metastatic patients, who have developed castration-resistance. There is an increasing unmet need to improve the outcomes of men with mCRPC.6

About the PAnTHa study (NCT06217822)
PSMA-targeted Actinium-225-Trillium FiH study in Advanced mCRPC (PAnTHa), is a Phase I, open-label, first-in-human, multicenter study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of 225Ac-PSMA-Trillium (BAY 3563254) in participants with advanced metastatic castration resistant prostate cancer (mCRPC) that have at least 1 PSMA-positive lesion on PSMA-PET. In the trial, patients received 225Ac-PSMA-Trillium intravenously every 6 weeks for up to 4 doses. At data cut-off, 50 patients were enrolled across four dose levels in the escalation cohort and 80% completed all four cycles of 225Ac-PSMA-Trillium (range: 75 to 150 kBq/kg; 12-13 patients/cohort).

Detailed Results from PAnTHa
To date, 225Ac-PSMA-Trillium has had no dose-limiting toxicities (DLTs) or treatment-related deaths. Most common treatment-emergent adverse events (TEAEs) were dry mouth, fatigue and nausea. Overall, 38% of patients had Gr ≥3 TEAEs, most commonly lymphopenia, 16% of patients had serious TEAEs and 4% of patients discontinued treatment due to TEAEs. The overall response rate per PCWG3 criteria across all doses in patients with measurable disease at baseline (n=24) was 46%, with disease control rate of 83%. Respective PSA50 and PSA90 response rates were 58% and 36% overall, and 83% and 58% at the Recommended Dose for Expansion (RDE). This was further supported by the decline in circulating tumor DNA (ctDNA) fraction at the RDE. Further, PSA50 responses were observed across all baseline mean Standardized Uptake Value (SUVmean) groups.

About 225Ac-PSMA-Trillium (BAY 3563254)
225Ac-PSMA-Trillium (BAY 3563254) is a next-generation TAT that comprises a highly specific PSMA-targeting motif, an albumin-binding domain to optimize tumor uptake and retention, and a MacropaTM chelator complexed with the alpha-emitter actinium-225. The distinctive structural components are designed to provide a differentiated safety and efficacy profile. Both in vitro and in vivo characterization of 225Ac-PSMA-Trillium demonstrates high tumor uptake and retention. Potent antitumor efficacy has been observed in several preclinical models of prostate cancer. PSMA-Trillium resulted from the acquisition of PSMA Therapeutics and Noria Therapeutics in 2021 and are now under clinical investigation.

About Targeted Alpha Therapy
Targeted alpha therapy (TAT) is an emerging class of radionuclide therapy that can be used against a variety of tumors. It delivers alpha particle radiation directly to the tumor inside the body, either via its bone-seeking property (radium-223) or by combining alpha radionuclides, such as actinium-225, with specific targeting moieties.

Actinium-225 is an alpha particle–emitting radionuclide with a 9.9-day half-life. Alpha particles deposit highly ionizing radiation over a short range. This localized delivery of the radioactive payload induces irreparable DNA double-strand breaks, often resulting in cell death.

About prostate cancer
Prostate cancer is the second most commonly diagnosed cancer in men. Despite significant advances in the last decade, the prognosis for men with mCRPC remains poor with a median survival of about 31 months.2 With increasing incidence, more than 300 thousand prostate cancer cases were reported in the US in 2025; 5-year relative survival with distant disease is only 34%.3 Advances in imaging technologies (i.e. PSMA-PET) and their utilization across all stages of prostate cancer will likely result in an increased number of patients diagnosed with metastatic disease earlier. Consequently, more men will be diagnosed with de novo PSMA-positive metastatic disease.

(Press release, Bayer, FEB 27, 2026, View Source [SID1234663138])

On February 27, 2026 Novocure (NASDAQ: NVCR) reported that management will participate in the Leerink Global Healthcare Conference on Tuesday, March 10, 2026. Frank Leonard, Chief Executive Officer, and Christoph Brackmann, Chief Financial Officer, will take part in a fireside chat at 11:20 a.m. EST, as well as one-on-one meetings with investors throughout the event.

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A live audio webcast of this presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

(Press release, NovoCure, FEB 27, 2026, View Source [SID1234663137])

On February 27, 2026 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, reported that its partner IDEAYA Biosciences, Inc. ("IDEAYA"; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investiagational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million milestone payment to Biocytogen.

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According to IDEAYA, the Phase 1 study is designed to characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and IDEAYA also intends to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances.

IDE034 is a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. IDEAYA has stated that IDE034 is designed to preferentially internalize in tumor cells co-expressing B7H3 and PTK7, supporting selectivity and tolerability, and estimates 30–40% co-expression across several major solid tumors with limited dual expression in normal tissues.

"Reaching first dosing in the IDE034 Phase 1 trial marks an important step in translating this bispecific TOP1 ADC concept into clinical evaluation," said Dr. Yuelei Shen, President and CEO of Biocytogen. "We appreciate IDEAYA’s strong execution in advancing IDE034 into the clinic and look forward to the readout of initial safety and PK data from the ongoing Phase 1 study."

(Press release, Biocytogen, FEB 27, 2026, View Source [SID1234663136])

On February 27, 2026 WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global CRDMO (Contract Research, Development, and Manufacturing Organization) specializing in antibody-drug conjugates (ADCs) and other bioconjugates, reported a strategic collaboration with Earendil Labs on WuXi XDC’s proprietary WuXiTecan-2 payload-linker technology platform. Earendil Labs is an AI-powered biotech company focused on researching and developing next-generation innovative biologics for the treatment of autoimmune diseases, cancer, and other conditions with unmet medical needs. This collaboration marks the establishment of a robust strategic partnership aimed at accelerating the development of next-generation ADCs by synergistically combining WuXi XDC’s globally leading ADC technology platform with Earendil Labs’ cutting-edge AI-driven antibody discovery and development capabilities to address significant unmet medical needs.

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Under the agreement, WuXi XDC will grant Earendil Labs an exclusive global license to its proprietary WuXiTecan-2 payload-linker technology for use against multiple specific targets. Earendil Labs will utilize this technology to conjugate antibodies and bispecific antibodies discovered through its AI platform and to advance the development of the ADC candidates against these specific targets. The total potential deal value could reach up to approximately $885 million, comprising an upfront payment, and certain development, regulatory, and sales milestone payments. Additionally, WuXi XDC will be eligible to receive tiered royalties on net sales upon commercialization of any resulting ADC products.

Leveraging its world-leading integrated CRDMO platform, WuXi XDC will also fully support the Chemical, Manufacturing, and Controls (CMC) development and manufacturing of the ADC components within the collaboration. Earendil Labs will focus on subsequent product development, global regulatory submissions, and commercialization. This complementary partnership ensures maximized resource utilization and efficient project progression.

Jimmy Li, PhD, CEO of WuXi XDC, stated, "We are very pleased to establish this strategic partnership with Earendil Labs. This collaboration not only fully demonstrates the value of our WuXiTecan-2 payload-linker technology platform but also marks another significant milestone for WuXi XDC in empowering cutting-edge innovation alongside our partners. Earendil Labs has generated bispecific antibodies with differentiated advantages using its unique AI platform. Combining these with our WuXiTecan-2 technology helps develop more effective and safer next-generation ADCs. We look forward to supporting Earendil Labs in accelerating the R&D and commercialization of their ADCs through our integrated, end-to-end CRDMO service platform, ultimately benefiting patients worldwide."

Jian Peng, PhD, CEO of Earendil Labs, said, "Partnering with WuXi XDC represents a critical step in our mission to transform biopharmaceutical R&D through AI. WuXi XDC possesses a globally recognized and validated ADC technology platform and end-to-end manufacturing capabilities. This collaboration is a powerful alliance between frontier AI exploration and WuXi XDC’s integrated CRDMO services. We eagerly anticipate working closely with WuXi XDC to drive innovative breakthroughs through technological integration, empowering high-quality development in the global biopharma industry and contributing to the health of patients globally."

Zhenping Zhu, MD, PhD, President & co-CEO of Earendil Labs, added, "ADCs are emerging as a promising class of therapeutics in the treatment of cancer and many other human diseases. At Earendil Labs, we are developing a rich pipeline of bispecific / multi-specific ADCs utilizing our cutting-edge AI and high-throughput biology plaforms. We believe WuXiTecan-2 payload-linker technology will significantly enhance the success rate and speed of our novel ADC development, ultimately bringing these potentially life-transforming treatments to patients worldwide as soon as possible."

(Press release, Earendil Labs, FEB 27, 2026, View Source [SID1234663135])

On February 27, 2026 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, reported results from the first head-to-head study comparing urinary bladder radioactivity between two prostate-specific membrane antigen (PSMA)-targeted PET radiopharmaceuticals. This prospective, multicenter, intra-patient comparison evaluated urinary radioactivity and lesion detection rates of POSLUMA (flotufolastat F 18) and piflufolastat F 18 in men with low prostate-specific antigen (PSA) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy.

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The study met its primary endpoint, demonstrating statistically significant lower urinary bladder radioactivity with POSLUMA compared with piflufolastat F 18, as measured by mean standardized uptake value (SUVmean). Across 55 evaluable patients, median bladder SUVmean was 10.9 for POSLUMA and 29.0 for piflufolastat F 18, with a median difference of 15.1 (interquartile range, 8.5–27.0; p<0.001). Lower urinary radioactivity may help optimize image assessment in regions close to the bladder and ureters, where small recurrent prostate cancer lesions can be challenging to distinguish from urinary activity.

Secondary analyses showed higher patient-level and region-level detection rates with POSLUMA compared with piflufolastat F 18, including among patients with very low PSA levels (≤0.2 ng/mL). In this subgroup, majority-read patient-level detection rates were 52.4% with POSLUMA and 38.1% with piflufolastat F 18. Detection rates were also higher with POSLUMA in the prostate bed and extra-pelvic regions.

No significant safety concerns were observed for either radiopharmaceutical.

Biochemical recurrence refers to a rising PSA level after surgery in a patient who previously had undetectable PSA and can be an early sign that prostate cancer has returned, even before it is visible on conventional imaging. PET tracers that can help clearly show small areas of recurrent disease at very low PSA levels may support earlier and more informed clinical care decisions1.

"For men who have already undergone surgery for prostate cancer, a rising PSA can be deeply concerning, especially when conventional imaging cannot clearly show whether or where the disease has returned," said Dr. Eugene Teoh, Chief Medical Officer of Blue Earth Diagnostics. "This head-to-head study provides important clinical evidence from a rigorous intra-patient comparison, demonstrating that POSLUMA exhibits significantly lower urinary radioactivity while maintaining meaningful detection capability in men with early biochemical recurrence. Urinary activity can impact image interpretation, which is of particular consideration at very low PSA levels, where precise localization is critical. These results reinforce the role of POSLUMA as a PSMA-PET imaging agent intelligently designed to support confident image assessment in anatomically challenging regions and reflect our continued commitment to advancing molecular imaging through high-quality clinical evidence."

"This rigorous head-to-head study provides high quality evidence that POSLUMA has significantly lower urinary bladder radioactivity compared to piflufolastat F 18, confirming prior studies," said Phillip Kuo, Kuo Radiology LLC. "POSLUMA also exhibited higher detection rates for recurrence compared to piflufolastat F 18, which highlights its potential to improve patient management."

Results from Blue Earth Diagnostics’ head-to-head study have been published in the European Journal of Nuclear Medicine and Molecular Imaging and were just presented at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), on February 26, 2026, in San Francisco, California.

About the Head-to-Head Comparator Study
A prospective, multicenter, intra-patient head-to-head comparator study evaluating the urinary bladder radioactivity and lesion detection rates of POSLUMA (flotufolastat F 18) and piflufolastat F 18 in men with low prostate-specific antigen (PSA) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy. A total of 55 patients were evaluated with BCR and PSA levels ≤0.5 ng/mL. The study’s primary endpoint was a calculated difference in bladder SUVmean as determined by quantification software. Secondary endpoints were detection rate analyses including patient level and subgroups, PSA level, prostate bed and related subregions, and pelvic lymph nodes.

(Press release, Blue Earth Diagnostics, FEB 27, 2026, View Source [SID1234663134])