On March 25, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that new nonclinical data for taletrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 25–30, 2025 in Chicago, Illinois (Press release, Nuvation Bio, MAR 25, 2025, View Source [SID1234651437]).

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Presentation Overview:

Title: Taletrectinib, a next generation selective ROS1 inhibitor, inhibits growth of ROS1 wild-type and ROS1-G2032R xenografts
Presenter: Hitisha Patel, Ph.D., Director of Research, Nuvation Bio
Session Category: Experimental and Molecular Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 3
Date: Tuesday, April 29, 2025
Session Time and Location: 2:00 – 5:00 p.m. CT / 3:00 – 6:00 p.m. ET; Poster Section 20
Poster Board Number: 22
Abstract Number: 5612

The materials will be made available in the Publications section of Nuvation Bio’s website after the presentation.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China’s NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

On March 25, 2025 Eli Lilly and Company (NYSE: LLY) reported that preclinical data for agents targeting SMARCA2 (BRM) and multiple KRAS mutations will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25 – 30 in Chicago (Press release, Eli Lilly, MAR 25, 2025, View Source [SID1234651407]).

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In an oral presentation, Lilly, in collaboration with Foghorn Therapeutics, will present new preclinical data for LY4050784, a selective inhibitor of SMARCA2, in combination with chemotherapy, pembrolizumab, and KRAS inhibitors in preclinical models of SMARCA4 mutant cancers. Preclinical data for LY4066434, a pan-KRAS inhibitor that is highly selective over HRAS and NRAS, will also be presented. Both programs are currently enrolling Phase 1 studies.

Details on presentations are below:

Presentation Title: LY4050784, a selective inhibitor of SMARCA2, demonstrates synergistic activity in combinations with pembrolizumab or KRAS inhibitors
Abstract Number: 3779
Session Date & Time: Monday, April 28, 2:30-4:30 p.m. CST
Session Title: Continuum of Innovation: Biological Therapeutic Agents
Presenter: Nathan Brooks

Presentation Title: LY4066434, an oral small molecule pan-KRAS inhibitor, demonstrates robust anti-tumor activity in KRAS-mutant models, including in the CNS
Abstract Number: 4375
Session Date & Time: Tuesday, April 29, 9 a.m.-12 p.m. CST
Session Title: RAS Inhibitors
Presenter: Hong Gao

On March 25, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported it will host an investor call at 8:00 am ET that will feature KOL Dr. Ehab Atallah, Professor of Medicine at the Medical College of Wisconsin and principal investigator of the Actimab-A + CLAG-M combination trial in patients with relapsed/refractory acute myeloid leukemia (r/r AML) (Press release, Actinium Pharmaceuticals, MAR 25, 2025, View Source [SID1234651422]). Dr. Atallah will discuss Actimab-A clinical results to date including recently published long-term survival outcomes and the planned pivotal Phase 2/3 clinical trial in r/r AML and trials to be conducted under Actinium’s cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). In addition, Actinium’s management will detail its recently announced Actimab-A solid tumor program, which is comprised of several controlled, head-to-head clinical trials that will evaluate the combination of Actimab-A with KEYTRUDA versus KEYTRUDA alone, and Actimab-A with OPDIVO versus OPDIVO alone initially in patients with head and neck squamous cell carcinoma and non-small cell lung cancer with a separate trial for each indication.

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Actinium’s company update will highlight the 3 separate potential multi-billion-dollar blockbuster market opportunities being pursued with its targeted radiotherapies including the following:

– Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including AML and myelodysplastic syndromes (MDS) across multiple treatment settings

– Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs)

– Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes

To register for the KOL Call & Company Update please use the following link:

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On March 25, 2025 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, reported the presentation of new data from the Phase 2 portion of its Phase 1/2 clinical trial of AU-007 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Aulos Bioscience, MAR 25, 2025, View Source [SID1234651438]). The presentation will focus on promising results for AU-007 in second-line treatment of melanoma.

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AU-007 is a human IgG1 monoclonal antibody designed with the assistance of artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors in patients with unresectable locally advanced or metastatic cancers. The AACR (Free AACR Whitepaper) Annual Meeting is being held April 25-30, 2025, in Chicago, Illinois.

Details of the poster presentation are as follows:

Poster Title: AU-007, a human monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, plus low-dose aldesleukin, in advanced solid tumors: Phase 2 update
Abstract: CT178
Session Title: Phase II Clinical Trials 1
Date and Time: Tuesday, April 29, 2025, 9:00 a.m.-12:00 p.m. CDT

The poster will be presented in Poster Section 49 at McCormick Place. An electronic version will also be available on the AACR (Free AACR Whitepaper) 2025 virtual meeting platform.

About AU-007
AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

On March 25, 2025 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company, reported that the ARTISTRY-7 phase 3 trial of nemvaleukin alfa in combination with Merck’s (known as MSD outside the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus investigator’s choice chemotherapy in patients with platinum-resistant ovarian cancer (PROC) will not continue to final analysis and the company will cease development of nemvaleukin for PROC (Press release, Mural Oncology, MAR 25, 2025, View Source [SID1234651408]). In the pre-specified interim analysis conducted by the independent data monitoring committee, nemvaleukin in combination with pembrolizumab did not achieve a statistically significant improvement in overall survival versus investigator’s choice chemotherapy alone and the company believes the study is highly unlikely to achieve success at the final analysis. Median overall survival was 10.1 months for patients treated with nemvaleukin in combination with pembrolizumab and 9.8 months for patients treated with investigator’s choice chemotherapy (hazard ratio: 0.98).

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"We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to report topline data from our potentially registrational trial in mucosal melanoma later next quarter and will assess all available data to inform our next steps," said Caroline Loew, Ph.D., CEO of Mural Oncology.

Nemvaleukin has a well characterized and favorable safety profile, both as a monotherapy and in combination with pembrolizumab, with over 800 patients treated across the broader clinical program. In the interim analysis of ARTISTRY-7, the safety profile was generally consistent with previously reported data.

Nemvaleukin is currently being evaluated in a potentially registrational, phase 2 trial, ARTISTRY-6, cohort 2 in mucosal melanoma, with a topline data readout expected in Q2 2025. Preliminary data readouts for less-frequent intravenous dosing of nemvaleukin in patients with cutaneous melanoma are expected in the second quarter of 2025 for cohort 3 of ARTISTRY-6 (monotherapy) and the second half of 2025 for cohort 4 of ARTISTRY-6 (combination therapy), subject to patient enrollment.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About the ARTISTRY-7 Trial

ARTISTRY-7 is a phase 3 trial comparing nemvaleukin in combination with pembrolizumab vs. investigator choice single agent chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, with a primary endpoint of overall survival. This four-arm trial also contains two smaller single agent arms, a pembrolizumab and a nemvaleukin arm, to assess contribution of components. A total of 456 patients were enrolled over the four arms of the trial in an approximate 3:1:1:3 randomization. Only arms 1 (nemvaleukin in combination with pembrolizumab) and 4 (investigator’s choice chemotherapy) were designed to be assessed for statistical comparisons. The pre-specified interim analysis was conducted at 77% events (219 events) needed for the final analysis.

About Nemvaleukin

Nemvaleukin alfa (nemvaleukin) is an engineered fusion protein designed to leverage IL-2’s antitumor effects while mitigating the hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in a potentially registrational trial, ARTISTRY-6, cohort 2 in mucosal melanoma, with a topline readout expected in Q2 2025. Preliminary data readouts for less-frequent intravenous dosing of nemvaleukin in patients with cutaneous melanoma are expected in the second quarter of 2025 for cohort 3 of ARTISTRY-6 (monotherapy) and the second half of 2025 for cohort 4 of ARTISTRY-6 (combination therapy), subject to patient enrollment.