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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On March 24, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the third quarter ended December 31, 2024, and provided a business update (Press release, Bolt Biotherapeutics, MAR 24, 2025, View Source [SID1234651370]).

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"2024 was a transformational year for Bolt as we focused the company on efficient development of the programs that could be most impactful for patients," said Willie Quinn, Chief Executive Officer. "BDC-4182, our next-generation ISAC, is poised to enter the clinic in the second quarter. As the only ISAC targeting the validated tumor target claudin 18.2, we believe that BDC-4182 has the potential to offer a better option for patients with stomach and other claudin 18.2-expressing cancers. We are particularly excited about BDC-4182 as validation for our Boltbody ISAC approach. We’ve also completed enrollment and have cleared the DLT window for the highest dose level in the BDC-3042 Phase 1 dose escalation trial and will provide a data update next quarter at a medical meeting. BDC-3042 is our first-in-class dectin-2 agonist, and has potential across a broad range of solid tumors with high unmet medical need."

Recent Highlights and Anticipated Milestones

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Completed enrollment of the Phase 1 study of BDC-3042 in patients with advanced cancers. BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable solid tumors including non-small cell lung cancer (NSCLC). BDC-3042 has been well tolerated with no dose-limiting toxicities (DLTs) and evidence of biological activity. Results from the trial will be presented at an upcoming medical meeting in the second quarter of 2025.
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Finalizing preparations for first-in-human trial of BDC-4182 in patients with gastric cancer. BDC-4182 is a next-generation BoltbodyTM ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models. BDC-4182 was tolerated in non-human primates at the highest dose tested (12mg/kg) with an acceptable safety profile. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs, using MMAE or TOPO1, in syngeneic models. Key learnings were presented at SITC (Free SITC Whitepaper) 2024 and the dose escalation trial is planned to start in Australia in the second quarter of 2025.
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Collaborations with Genmab and Toray continue to progress. The Company continues to work with Genmab to discover and develop next-generation ISACs for the treatment of cancer. Genmab and the Company are working together to advance the collaboration’s first development candidate, and the collaboration also continues research and development on additional programs. The Toray collaboration combines the Company’s immunostimulatory linker-payloads with Toray antibodies targeting Caprin-1, a tumor-specific antigen that is strongly expressed on the cell membrane in multiple solid tumor types.
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Cash, cash equivalents, and marketable securities were $70.2 million as of December 31, 2024. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

Fourth Quarter and Full Year 2024 Financial Results

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Collaboration Revenue – The Company recently reassessed its expected future performance obligations under the Genmab Agreement, and as a result reported no collaboration revenue for the quarter. Total collaboration revenue was $7.7 million for the fourth and full year ended December 31, 2024, respectively, compared to $2.1 million and $7.9 million for the same quarter and year in 2023,, respectively. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.

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Research and Development (R&D) Expenses – R&D expenses were $11.7 million for the quarter and $57.5 million for the full year ended December 31, 2024, respectively, compared to $16.3 million and $61.5 million for the same quarter and year in 2023, respectively. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring partially offset by an increase in contract manufacturing expenses.

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General and Administrative (G&A) Expenses – G&A expenses were $3.9 million for the quarter and $18.5 million for the full year ended December 31, 2024, respectively, compared to $5.5 million and $22.5 million for the same quarter and year in 2023, respectively. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.

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Loss from Operations – Loss from operations was $16.9 million for the quarter and $73.0 million for the full year ended December 31, 2024, respectively, compared to $19.8 million and $76.2 million for the same quarter and year in 2023, respectively.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

On March 24, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported its Vice President of Business Development, Mathew Lazarus, will be presenting at the 2025 Cancer Advocacy Group of Louisiana ("CAGLA") NeauxCancer Conference taking place on March 27-29, 2025 at the The Roosevelt Hotel in New Orleans (Press release, Pasithea Therapeutics, MAR 24, 2025, View Source [SID1234651369]).

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Mr. Lazarus’s presentation will provide an overview of Pasithea’s next generation macrocyclic MEK inihibitor, PAS-004, including interim safety, tolerability and pharmacokinetic (PK) data from the Company’s ongoing open-label dose escalation Phase 1 study in advanced cancer patients with MAPK pathway-driven advanced tumors. He will discuss the Company’s latest progress in clinical development and how Pasithea is advancing its next-generation molecule to transform cancer and NF1 treatment.

Details of the presentation are as follows:

Event: 2025 CAGLA NeauxCancer Conference
Date: March 28, 2025
Time: 11:00 AM CDT
Location: The Roosevelt New Orleans
Webcast: CAGLA 2025 Livestreams

The CAGLA NeauxCancer Conference is a premier gathering of leading oncology researchers, industry executives, and medical professionals focused on groundbreaking developments in cancer treatment and care.

For more information about the conference, visit View Source