On January 13, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, reported the execution of a supply agreement for non-carrier-added (n.c.a.) Actinium-225 (Ac-225) to support the development of Ariceum’s novel targeted radiopharmaceutical therapies (RPT) pipeline, including its lead radiopharmaceutical drug, satoreotide for the treatment of aggressive, hard-to-treat cancers.

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Under the terms of the agreement, ITM will supply the therapeutic medical radioisotope, Ac-225, produced by Actineer Inc, ITM’s joint venture company with Canadian Nuclear Laboratories, for use in Ariceum’s Actinium-based pipeline candidates. Actineer is advancing cutting-edge technologies to secure and expand its supply chain and produce industrial-scale quantities of Ac-225 at rapid speed by irradiating Radium-226 (Ra-226) in cyclotrons to meet the growing demand for this promising medical radioisotope on a global scale. Additional details of the supply agreement have not been disclosed.

"We value our partnership with Ariceum which marks a significant step forward in advancing our mission to provide this critical medical radioisotope to the radiopharmaceutical industry," said Dr. Andrew Cavey, Chief Executive Officer at ITM. "With our extensive experience in the production and supply of Lutetium-177, we are well-equipped to apply that expertise to Actinium-225 via our joint venture, Actineer. Our agreement with Ariceum strengthens our commitment to advancing innovative solutions for cancer treatment and to meeting the needs of our partners and people living with cancer worldwide."

Ac-225 is a rare medical radioisotope used in RPTs for the treatment of various cancer indications. It emits high-energy alpha particles with a short penetration range in tissue, enabling precise targeting of tumor cells. This unique quality has made Ac-225 an increasingly sought-after resource in the field, with growing demand. Its natural scarcity and manufacturing complexities have contributed to critical shortages that have threatened the development of novel radiopharmaceuticals that have the potential to treat challenging cancer indications.

"Securing a reliable and plentiful supply of n.c.a. Ac-225 is critical to our efforts in developing innovative cancer treatments with our pipeline of novel targeted radiopharmaceuticals," commented Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics. "Our agreement with ITM and its joint venture company Actineer supports our access to valuable resources needed to explore the full potential of Ac-225 in unlocking and advancing new Targeted Alpha Therapy approaches for patients living with difficult-to-treat cancers."

(Press release, ITM Isotopen Technologien Munchen, JAN 13, 2025, View Source [SID1234661159])

On January 13, 2025 Aprea therapeutics presented its corporate presentation (Presentation, Aprea, JAN 13, 2025, View Source [SID1234649634]).

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On January 13, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported program updates and upcoming milestones (Press release, Elevation Oncology, JAN 13, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-provides-updates-on-differentiated-adc-programs-and-upcoming-milestones [SID1234649651]).

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"We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "As we enter 2025, we are honing our focus, leveraging the competitive anti-tumor activity and differentiated safety profile of EO-3021 to explore combination approaches in the first- and second-line settings. With our Phase 1 clinical trial ongoing and now enrolling both monotherapy and combination cohorts, we are in a leading position to explore the compelling potential of EO-3021, our differentiated Claudin 18.2 ADC, to improve outcomes for people living with advanced gastric/GEJ cancer."

Mr. Ferra continued, "We look forward to sharing additional data from our Phase 1 dose escalation and expansion study of EO-3021 in the first half of 2025. With this readout, we aim to build on the promising initial data reported in August 2024, reinforcing EO-3021’s robust anti-tumor activity and potential better combinability, while garnering additional insights to inform our go-forward clinical development efforts. We are enthusiastic about the potential of EO-3021 in addressing meaningful market opportunities and look forward to a transformative 2025."

Program Updates and Upcoming Milestones

EO-3021: Elevation Oncology is developing EO-3021, a differentiated, potentially best-in-class antibody drug conjugate (ADC) for the treatment of patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric/GEJ cancer.

In August 2024, Elevation Oncology reported promising initial monotherapy data from the dose escalation portion of its ongoing Phase 1 clinical trial of EO-3021, demonstrating competitive efficacy, with a 42.8% confirmed overall response rate (ORR) in a biomarker-enriched population, and a differentiated safety profile, including minimal hematological toxicity and hepatotoxicity, and no peripheral neuropathy/hypoesthesia.

Based on these data, Elevation Oncology is focusing the clinical development of EO-3021 on the first- and second-line treatment of advanced gastric/GEJ cancer, where EO-3021’s key attributes can potentially provide differentiated benefits and address unmet needs in both patient outcomes and safety.

Monotherapy:

The dose expansion portion of Elevation Oncology’s Phase 1 clinical trial of monotherapy EO-3021 is ongoing. As of January 2025, Elevation Oncology has implemented prospective Claudin 18.2 expression testing as part of the patient screening process, focusing enrollment on patients with ≥25% of tumor cells at IHC 1+/2+/3+. Elevation Oncology expects to report additional safety and efficacy data from the dose escalation and expansion portions of the study in the first half of 2025.

Combination:

Patient dosing is ongoing in the combination portion of Elevation Oncology’s Phase 1 clinical trial of EO-3021. The combination cohorts are evaluating EO-3021 in combination with dostarlimab, a PD-1 inhibitor, in the first line setting and with ramucirumab, a VEGFR2 inhibitor, in the second line setting.

By combining EO-3021 and dostarlimab, an immune checkpoint inhibitor, Elevation Oncology aims to deliver synergistic benefit, potentially offering patients improved outcomes beyond those seen with the existing combination of immunotherapy and chemotherapy. The combination of an immunotherapy and chemotherapy agent is the standard of care for the treatment of gastric/GEJ cancer in the front-line setting.

With the EO-3021 and ramucirumab combination, Elevation Oncology aims to deliver improved tolerability and synergistic anti-tumor activity compared to the approved combination of ramucirumab and paclitaxel. The combination of ramucirumab and paclitaxel is the standard of care for the treatment of second-line gastric/GEJ cancer.

Elevation Oncology expects to report initial data from the combination cohorts in the fourth quarter of 2025 or the first quarter of 2026.

EO-1022: Elevation Oncology is developing EO-1022, a differentiated HER3 ADC for the treatment of patients with HER3-expressing solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer, and pancreatic cancer. EO-1022 combines seribantumab, a fully human anti-HER3 monoclonal antibody, and a monomethyl auristatin E (MMAE) payload with site-specific conjugation to glycan. It is designed to leverage seribantumab’s desirable internalization capability and the latest site-specific ADC technology to deliver a safe, effective option for patients living with solid tumors that express HER3.

Elevation Oncology expects to present preclinical data for EO-1022 in the first half of 2025 and to file an IND application in 2026.

Financial Guidance

Elevation Oncology expects that its cash, cash equivalents and marketable securities as of September 30, 2024, will be sufficient to fund its current operations into 2026.

On January 13, 2025 Olema oncology presented its corporate presentation (Presentation, Olema Oncology, JAN 13, 2025, View Source [SID1234649667]).

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On January 13, 2025 Rappta Therapeutics ("Rappta"), focused on developing first-in-class anti-cancer drugs activating protein phosphatase 2A (PP2A), reported an exclusive global license agreement with SpringWorks Therapeutics ("SpringWorks") for RPT04402, a first-in-class molecular glue of specific Protein Phosphatase 2A (PP2A) complexes (Press release, Rappta Therapeutics, JAN 13, 2025, View Source [SID1234649683]).

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Rappta’s PP2A-reactivating technologies developed using its proprietary high resolution structural data have the potential to create a new class of anti-cancer drugs for treating a broad range of human cancers. PP2A is a critical enzyme in regulating protein de-phosphorylation and its reactivation is fundamental for tumor suppression, but it has been historically hard to target.

PP2A mutations are oncogenic drivers in molecularly defined subsets of uterine cancer and represent a targetable subset of patients with a high unmet clinical need. In pre-clinical models of PP2A mutant uterine cancer, RPT0402 achieved rapid, deep and durable tumor regressions at as monotherapy.

Under the exclusive license agreement, SpringWorks Therapeutics will be responsible for global development and commercialization of RPT04402. SpringWorks has paid Rappta $13 million upfront, and Rappta is also eligible to receive further clinical, regulatory and commercial milestone payments, and tiered single-digit royalties on net sales. SpringWorks expects to file an Investigational New Drug (IND) application for RPT04402 by the end of 2025.

Sunjeet Sawhney, Chief Executive Officer of Rappta Therapeutics, commented: "Rappta is the only company to have successfully targeted PP2A, a notoriously difficult and undruggable target. Data we generated demonstrated the potential of RPT04402 for treating large, underserved patient populations. SpringWorks, a leader in the targeted oncology space, has the expertise and knowledge to accelerate the further development of our first in class asset. I would like to thank our team and investors who have supported our journey and we look forward to following the progress made in this area"

Goutham Narla, Chief Scientific Officer of Rappta Therapeutics and Professor of Internal Medicine and Human Genetics at the University of Michigan, said: "Our team at Rappta Therapeutics has been able to leverage our proprietary structural data to develop a first-in-class series of molecular glues to the previously undruggable tumor suppressor PP2A. We are excited to be able to work with SpringWorks to potentially translate this approach to the clinic with the hope that this approach will have broad applications for the treatment of human cancers."

Rappta was founded by Goutham Narla & Mikko Mannerkoski, back in 2019 with funding from Novartis Venture Fund ("NVF"), Novo Holdings, Advent Life Sciences and a family office in Series A financing alongside other non-dilutive funding from Business Finland.