On March 24, 2025 Sermonix Pharmaceuticals, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), and Regor Therapeutics Group, a clinical-stage global biopharmaceutical company, reported a strategic collaboration to optimize Regor’s proprietary, cutting-edge rCARD (Regor Computer Accelerated Rational Discovery) platform for identification of novel targets and therapeutics that fulfill unmet patient clinical needs and preferences in the breast oncology arena (Press release, Sermonix Pharmaceuticals, MAR 24, 2025, View Source [SID1234651378]).

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The partnership will unite the key core competencies of both organizations to leverage expertise from early discovery through preclinical, clinical, and commercial launch, resulting in treatments that deliver on the promise of fulfilling on efficacy but also developing therapies with tolerability and quality of life profiles that are aligned with patient priorities and concerns.

With a Phase 3 asset – oral lasofoxifene – in development for the treatment of ESR1-mutated ER+ HER2- mBC, the Sermonix team has expertise within the clinical drug development and commercialization arena and understands the landscape and value proposition of new treatments, which are requirements for launch success and adoption by both patients and health care providers.

Patient insights and unmet needs within the arena of onco-sexuality and cardio oncology, in addition to patient concerns with respect to bone health, have been increasing in importance and are areas for which Sermonix also has expertise and interest in exploring. These areas are currently gaps within the breast cancer treatment patient arena and hold great concern for patients as breast cancer potentially evolves from a lethal to a chronic disease.

Regor’s leading rCARD platform empowers drug discovery and development from target identification and validation, molecular design and optimization, to translational research and clinical development with unprecedented speed, efficiency, and success rate.

"Regor’s translational to clinical approach – and then confirmation of clinical impact – is one we greatly admire and is producing molecules for development that will be best in class from both an efficacy and tolerability perspective," said Dr. David Portman, Sermonix founder and chief executive officer. "At Sermonix, we believe patients deserve not only highly efficacious treatments, but also ones that are well tolerated and potentially improve quality of life for breast cancer patients. Deep patient insights and the potential to develop targets that can ultimately provide efficacy while addressing areas of key concerns to patients such as vaginal, bone, and cardiovascular health would be fulfilling on the promise of optimized drug development. It is an honor to collaborate with Regor in that shared mission."

Sermonix is currently enrolling its Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-3) study, comparing targeted lasofoxifene in combination with the CDK 4/6 inhibitor abemaciclib versus fulvestrant plus abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

"After engaging in extensive discussions with Sermonix, closely watching its clinical and commercial market development efforts in the breast oncology segment, it is obvious the company shares the vision and dedication of our team at Regor," said Dr. Xiayang Qiu, founder and CEO of Regor. "The Sermonix team demonstrates both expertise and passion, and we are truly excited to embrace that as part of our work in identifying optimal drug candidates that can make a significant impact for patients with metastatic breast cancer."

On March 24, 2025 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported two abstract presentations at the 2025 European Association of Urology congress (EAU) in Madrid, Spain, highlighting the benefits of Blue Light Cystoscopy (BLC), notably its impact on recurrence risk and ability to help urologists make the best bladder cancer management choices for their patients (Press release, PhotoCure, MAR 24, 2025, View Source [SID1234651377]).

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The EAU annual meeting is one of the largest international meetings in the urology calendar, showcasing the latest and most relevant clinical and scientific advancements in this area of patient care. This year’s event was held on March 21-24, 2025, and attracted urologists from all over the world. Photocure participated with its Hexvix product designed for better detection and resection of bladder tumors under the theme that "Seeing is believing". As in the past two years, Photocure will make 2025 EAU bladder cancer session highlights available to healthcare professionals after the event, by means of video interviews with the presenters of these sessions at the Photocure booth B28. This successful initiative is once again supported by two of the leading names in Bladder Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University Paris, France and Prof. P. Gontero, Division of Urology, University of Studies of Torino, Italy.

In addition to this educational activity, the EAU scientific program prominently features Photocure’s Hexvix product and/or the blue light cystoscopy procedure in which it is used. In particular, two notable abstract presentations were:

The impact of PDD on recurrence and progression in BCG-treated NMIBC* patients: a nationwide follow-up study (Abstract session 39: Sunday, March 23rd, 5:15pm CET – NMIBC: Advances in diagnosis and follow-up)

This nationwide cohort study investigates the association of PDD on recurrence and progression risk in BCG-treated NMIBC patients, using Danish registry data from 2009-2022 assessing patients treated with BCG for primary NMIBC.

In the study, 4318 patients from the Danish registry were identified with a first-time NMIBC diagnosis that were treated with BCG. Of the study subjects, 2388 (55%) of patients were diagnosed with the assistance of PDD. Basic demographics, stage and grade was comparable between the two groups. There were no differences in BCG-response across exposure groups. Age adjusted relative risk of recurrence was 0.88 (0.79 – 0.97) and 0.97 (0.89 – 1.05) at 1 and 5 years, respectively for the PDD-group compared to the non PDD-group. Age adjusted relative risk for progression was 0.93 (0.73 – 1.19) and 1.01 (0.84 – 1.21) at 1 and 5 years, respectively for the PDD-group.

The authors conclude that, since the BCG-response across exposures were equal, the reduced risk of recurrence at 1 year was likely due to the detection effect of PDD: "The present study did not support the hypothesis of PDD modulating the BCG-response in NMIBC patients, suggesting a different mechanism for the impact of PDD on recurrence and progression in BCG-treated NMIBC patients."

Read the abstract: View Source

Trans Urethral Laser Ablation of bladder tumors under local anesthesia: A prospective study of pain and recurrences
(Abstract session 50: Monday, March 24th, 12:30pm CET – NMIBC: Innovations and outcomes 2)

This study investigated the short- and long-term oncology safety regarding recurrence and progression as well as perioperative pain after office-based Transurethral Laser Ablation (TULA) or fulguration by PDD-assisted flexible cystoscopy.

This prospective observational study enrolled eligible patients from August 2017 to June 2022 at Oslo University Hospital. 329 patients were enrolled, with a median age of 74 years. The median NRS (numeric rating scale) for perioperative pain was 4 (IQR: 3-5) for both the laser and fulguration group. The 12-month relapse-free survival (RFS) was 91% overall, 93% for fulguration, and 89% for laser ablation. The 12-month PFS was 94% for the laser group and 97% for the fulguration group.

The authors conclude that office-based TULA under local anesthesia using PDD-assisted flexible cystoscopy is associated with low perioperative pain and does not compromise short- or long-term RFS or PFS. Therefore, it is a feasible option regarding perioperative pain and oncological safety.

Read the abstract: View Source

"These new study data presented at EAU continue to emphasize the importance of using Blue Light Cystoscopy in the diagnostic pathway for bladder cancer. Minimally invasive procedures are on the rise and these abstracts also address data gaps in the long-term use of BLC in high-risk patients, where accurate staging determines all further treatment decisions", said Anders Neijber, Chief Medical Officer of Photocure. "BLC has been shown to clinically increase TURBT quality, more accurately stage disease, and enable better recurrence monitoring to help improve the lives of patients with bladder cancer."

During the EAU Congress, on March 21, Photocure, in collaboration with Olympus, also hosted a well-attended scientific event on ‘Precision Imaging in Bladder Cancer: Focus on Blue Light Cystoscopy’. The event, chaired by Ms. Bernadett Szabados (UCLH, London, UK) and Professor Christian Beisland (Haukeland University Hospital, Bergen, Norway), brought together leading experts who exchanged insights on the importance of advanced imaging technologies in urology. This collaboration between Photocure and Olympus underscores a shared commitment to innovation in cancer imaging and improving patient outcomes.

On March 24, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported it has entered into an agreement for the supply of Actinium-225 (Ac-225) with Eckert & Ziegler (Press release, Actinium Pharmaceuticals, MAR 24, 2025, View Source [SID1234651376]). Under this agreement, Actinium Pharmaceuticals will have access to Eckert & Ziegler’s high-quality Actinium-225 to further develop its lead product Actimab-A as well as additional early and late-stage development candidates for both U.S. and international clinical trials.

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Targeted radiotherapies using Ac-225 have shown great promise in the treatment of cancer. The radioisotope releases powerful alpha particles with high energy and low penetration depth, enabling precise targeting of tumor cells, including hard-to-reach micrometastases, while minimizing effects on surrounding healthy tissue. Actimab-A is an Ac-225 based radiotherapy agent, directed against CD33, a receptor overexpressed in patients with acute myeloid leukemia (AML) and other myeloid indications.

Sandesh Seth, Chairman and CEO at Actium Pharmaceuticals, Inc. commented: "We believe that targeted radiation therapy with Actinium-225 is one of the most promising approaches for treating patients with myeloid malignancies and solid tumors. As we have highlighted recently, we are advancing our lead targeted radiotherapy Actimab-A into a pivotal Phase 2/3 trial for patients with relapsed or refractory acute myeloid leukemia and in the frontline setting in a Phase 1 trial under our CRADA with the NCI. Additionally, we have launched our Actimab-A solid tumor program to combine with PD-1 checkpoint inhibitors KEYTRUDA and OPDIVO for patients with head and neck squamous carcinoma and non-small cell lung cancer in multiple trials. As a pioneer in the development of target radiotherapies, we have aggressive plans to expand our clinical pipeline to address indications with high unmet needs. With this supply agreement with Eckert & Ziegler, we will have access to reliable and constant supply of Ac-225 to advance our product development both in the U.S. as well as internationally."

"We are happy to contribute to the continuous expansion of indications for Actinium-225, which is significantly being advanced by Actinium Pharmaceuticals," explained Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. "The progress we have made in our Ac-225 project over the past year marks only the start of our program to address the global shortage of this vital radionuclide."

Eckert & Ziegler reliably supplies high-quality Gallium-68, Lutetium-177, Yttrium-90, and Actinium-225 to leading pharmaceutical companies, and research institutions worldwide. With expertise in radioisotope production and global logistics, the company is committed to continuously support the development and delivery of innovative radiopharmaceuticals.

On March 24, 2025 Pyxis Oncology presented its corporate presenteation (Presentation, Pyxis Oncology, MAR 24, 2025, View Source [SID1234651372]).

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On March 24, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that management will participate in the CG Horizons in Oncology Virtual Conference on April 7, 2025 at 10:00 a.m. ET (Press release, Delcath Systems, MAR 24, 2025, View Source [SID1234651371]). Investors interested in participating should contact their Canaccord representative.

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