On March 11, 2025 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, reported that it has scheduled a Scientific Advice Meeting (SAM) in the third quarter of 2025 to discuss the Innovative Licensing and Access Pathway (ILAP) with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for OST-HER2, its immunotherapy candidate for the prevention of recurrence of metastases in osteosarcoma (Press release, OS Therapies, MAR 11, 2025, View Source [SID1234651086]). The Company released positive Phase 2b data in January 2025 that demonstrates statistically significant results in the primary endpoint of the study, 12-month event free survival (EFS). The meeting with MHRA has been scheduled to position the Company to bring OST-HER2 to market in the UK in 2025.

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"Today’s announcement marks the beginning of the regulatory process required to bring our OST-HER2 immunotherapy to market globally," stated OS Therapies’ CEO Paul Romness. "As we prepare for regulatory interactions in the UK, US, Europe and other regulatory bodies worldwide, we are now focused on aligning our regulatory strategy to getting our product to patients as quickly as possible."

The UK is a reference country for multiple national drug approval agencies worldwide, meaning that if the Company receives approval in the UK then it becomes eligible to receive approval in other certain countries including Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Spain, and Sweden. OST-HER2 has received Fast Track and Orphan Drug designations from the European Medicines Agency.

On March 11, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported the first patient enrollment in PROSTATE-IQ, a Phase 3 clinical trial in men with prostate cancer recurrence after prostatectomy (Press release, Artera, MAR 11, 2025, View Source [SID1234651085]). The trial utilizes the ArteraAI Prostate Test to enable treatment personalization by determining cancer metastasis risk and identifying whether patients may be able to reduce or avoid hormone therapy.

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The trial is being led by Karen Elizabeth Hoffman, M.D., Professor of Radiation Oncology, and Mays Radiation Oncology Center Medical Director at The University of Texas MD Anderson Cancer Center.

"We are excited to partner with some of the world’s leading institutions on this transformational clinical trial, one that can radically improve not only patient outcomes but the quality of life for men with prostate cancer," said Tim Showalter, M.D., Chief Medical Officer of Artera. "There has been tremendous eagerness from the medical community to start adopting risk stratification tools in this fashion with this patient population – those with biochemical recurrence after prostatectomy. We’re excited to see our test being used to help determine the optimal treatment therapy, reduce unnecessary side effects, and increase confidence in treatment planning."

The current standard of care for these patients is radiation, oftentimes combined with a hormone therapy called androgen deprivation therapy (ADT). ADT is often successful in improving outcomes, but it also causes many difficult side effects including fatigue, sexual dysfunction, hot flashes, cognitive changes, metabolic dysregulation, and weight gain, negatively impacting men’s quality of life.

Using the ArteraAI Prostate Test on post-prostatectomy surgical specimens, patients in the trial will be risk-stratified into two groups: 1) low-risk patients who will be randomized to either 6 months of ADT or apalutamide monotherapy, which avoids the difficult side effects of testosterone suppression, thereby preserving their quality of life, and 2) high-risk patients who will be randomized to either 24 months of ADT or 6 months of ADT with apalutamide.

The trial’s primary endpoint will assess the patients’ general quality of life, using questionnaires and wearable devices. Secondary endpoints will include physician-reported toxicity, patient-reported activity, sleep, cognitive function, mental health, body composition changes, and cancer control metrics.

The primary site for the trial is MD Anderson Cancer Center, with up to 10 additional sites including Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, and OhioHealth. The trial is actively enrolling patients across sites.

To learn more or to enroll in the trial, visit: View Source

On March 11, 2025 Luminary Therapeutics reported that it has been awarded up to $5.8 million in funding from the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services, to develop a mesothelin chimeric antigen receptor T cells ("CAR T") targeting non-small cell lung cancer and colorectal cancer (Press release, Luminary Therapeutics, MAR 11, 2025, View Source [SID1234651084]).

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"While CAR T therapies have been effective for blood cancers, solid tumors like lung and colorectal cancers have proven to be resistant to current CAR T therapies", said Jeff Liter, CEO and President of Luminary Therapeutics. "This project combines an allogeneic CAR T for direct killing of tumor cells with the ability to utilize the patient’s immune system to target tumor cells by also leveraging the gamma delta cell’s ability to work as professional antigen-presenting cells (APCs) and presenting tumor-specific neo antigens. Combining neo antigen-presenting functions with CAR directed killing in a single cellular chassis will increase the effectiveness of cellular therapies by recruiting a patient’s immune system to increase the response and durability of tumor clearance."

Since its founding in 2019, Luminary Therapeutics has developed a proprietary gamma delta expansion platform that is unique in the industry and allows Luminary to manufacture cell therapies with a significantly lower cost and reduced time to clinic. Leveraging this platform, the Company has developed two groundbreaking therapeutic programs designed to overcome current challenges of CAR T therapies for solid tumors and autoimmune disorders. The award from ARPA-H represents not only a significant step forward in scaling Luminary’s therapeutic pipeline, while expanding the capabilities of its gamma delta expansion platform, but also aligns with ARPA-H’s mission to improve health outcomes for everyone.

On March 11, 2025 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators within the Caris Precision Oncology Alliance (Caris POA) will collectively present five studies across multiple gynecological tumor types at the Society of Gynecologic Oncology’s (SGO) Annual Meeting on Women’s Cancer, March 14-17, 2025, in Seattle, Washington (Press release, Caris Life Sciences, MAR 11, 2025, View Source [SID1234651083]). The findings demonstrate the power of Caris’ comprehensive clinico-genomic database to enable novel insights into cancer that could have profound effects on a patient’s diagnosis, prognosis, care plan and response to treatment.

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"Caris and our POA collaborators are proud to present five studies at this year’s SGO Annual Meeting highlighting the critical role of molecular profiling and biomarkers in personalizing treatment for gynecological cancers," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "By utilizing our comprehensive clinico-genomic database, we have improved the understanding of tumor biology and shown how specific molecular characteristics affect prognosis and treatment efficacy. This work exemplifies our dedication to advancing precision medicine and optimizing oncology treatment strategies."

Oral Presentations

Improved Real World Outcomes in Patients with Low-Grade Serous Ovarian Carcinoma and MAPK Pathway Mutations Treated with Trametinib
Focused Forum IV Finding IMPACT: The Needle in the Haystack
March 15: 4:52-4:58 PM PST

Impact of CCNE1 Amplification on Molecular Signatures and Patient Outcomes in High Grade Serous Ovarian and Endometrial Cancer
Focused Forum X Future IMPACT
March 16: 3:32-3:40 PM PST
Oral Featured Poster

Genomic and Immunohistochemical Characterization of NSMP Endometrial Cancer: A Novel Approach to Estrogen Receptor Positivity
Oral Featured Poster Session II: Multiple Ways to Make an IMPACT
March 15: 4:23-4:26 PM PST
Posters

GPR171, a Prognostic Marker of Improved Survival in Cervix Cancer – A Deep South Consortium in Oncology (DSCO) Project
Poster Session | March 16, 2:00 – 3:30 PM PST

Comparison of Breast and Gastric HER2 Immunohistochemistry (IHC) Scoring Criteria in the Assessment of Endometrial Carcinoma
Poster Session | March 16, 2:00 – 3:30 PM PST
Poster and abstract summaries highlighting this research will be available onsite at Caris’ booth #416. The full abstracts will be available on the Caris website following the presentation.

The Caris POA includes 96 cancer centers, academic institutions, research consortia and healthcare systems, including 47 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research to improve clinical outcomes for cancer patients.

On March 11, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported that the first clinical trial under its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Actimab-A has been initiated (Press release, Actinium Pharmaceuticals, MAR 11, 2025, View Source [SID1234651081]). The trial (NCT06802523) will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Venetoclax in combination with HMAs (Ven-HMA) is approved for patients with newly diagnosed AML. Actimab-A, a humanized anti-CD33 antibody conjugated to Actinium-225 (Ac-225) targets CD33, a marker expressed ubiquitously on myeloid blasts in patients with AML and other hematologic malignancies. The potent alpha-particle payload Ac-225 causes lethal double strand DNA breaks for which there are no known resistance or repair mechanisms. This study will evaluate the rate and duration of Complete Remission (CR), as well as safety, including the optimal dose of Actimab-A in combination with Venetoclax and ASTX-727 for potential future studies.

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Dr. Avinash Desai, Actinium’s Chief Medical Officer, commented, "We are incredibly excited that the first Actimab-A trial initiated under our CRADA with the NCI is this triplet combination with Venetoclax and Taiho’s ASTX-727. While Ven-HMA has positively impacted outcomes in AML, a significant number of patients have poor responses or relapse quickly resulting in dismal outcomes. We believe Actimab-A’s potentially synergistic, and mutation agnostic mechanism of action can improve clinical outcomes for these patients by producing deeper remissions, including measurable residual disease negativity, that are more durable. Due to its mutation agnostic mechanism, Actimab-A can overcome high-risk features, such as TP53 mutations, and has demonstrated the ability to improve outcomes in these patients where Ven-HMA has had limited success. This triplet regimen can be conveniently administered in the outpatient setting as Venetoclax and ASTX-727 are both oral agents and Actimab-A does not require isolation given that it is an alpha-particle emitter. We are eager to collaborate with NCI on this important study to evaluate earlier intervention with a CD33 targeted radiotherapy in patients with AML."

Actimab-A in combination with Venetoclax was previously studied in a multi-center Phase 1 trial. The combination was shown to be well tolerated with manageable adverse events. Preclinical studies showed that Actimab-A can synergize with Venetoclax by depleting MCL-1, which mediates Venetoclax resistance.

Sandesh Seth, Actinium’s Chairman & CEO, said, "We believe 2025 will be a transformational year for Actimab-A and that the initiation of this triplet trial is a significant catalyst. It is our objective to establish Actimab-A as a backbone therapy across the treatment continuum of AML and other myeloid malignancies leveraging the broad expression of CD33 and the mutation agnostic Ac-225 payload. Driven by the compelling clinical results in over 150 patients in multiple treatment settings and the high visibility of our NCI CRADA, we are seeing strong enthusiasm from investigators for Actimab-A. As the only CD33 targeted radiotherapy in development for myeloid malignancies, we are focused on capitalizing on the tremendous opportunity to improve outcomes for a significant patient population that continues to have high unmet medical needs that are not addressed by current therapies. Over the course of 2025, we expect to generate preclinical data and initiate additional clinical trials that will further differentiate Actimab-A and demonstrate material progress in establishing Actimab-A as a first-in-class backbone radiotherapy for the over 100,000 patients with AML and other myeloid malignancies in the U.S. and other major international markets."