On October 22, 2024 Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, reported that it presented data on its proprietary radiolabelled peptide SS0110 (satoreotide), a first-in-class antagonist of the somatostatin receptor 2 (SSTR2), at this year’s European Association of Nuclear Medicine (EANM) Annual Conference, held in Hamburg, Germany from 19-23 October 2024 (Press release, Ariceum Therapeutics, OCT 22, 2024, View Source [SID1234647300]).

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The Top-Rated Oral Presentation (TROP) entitled ‘225Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225Ac-DOTA-TATE and 161Tb-DOTA-TATE in the treatment of SSTR2-positive tumour xenografts’, details the anti-tumour efficacy of different radiolabelled satoreotide antagonists (225Ac, 161Tb, 177Lu-labelled SSO110) versus respective DOTA-TATE agonists (225Ac- and 161Tb-labelled DOTA-TATE) in mice engrafted with SSTR2 positive xenografts of small cell lung cancer (SCLC) and pancreatic cancer using clinically relevant associated dose ranges.

Results demonstrate that 225Ac-satoreotide shows the strongest anti-tumoural effect in vivo at a low single dose when evaluating satoreotide and DOTA-TATE radiolabelled with different radionuclides. Irrespective of the radionuclides used, satoreotide demonstrated a higher pre-clinical anti-tumour efficacy when compared to DOTA-TATE which was less potent and required increased dose levels. Satoreotide was well tolerated across all dose levels and with all used radionuclides. These comparisons between satoreotide and DOTA-TATE will facilitate and guide further clinical development of satoreotide across multiple indications expressing SSTR2, such as SCLC, pancreatic cancers and Merkel Cell Carcinoma (MCC).

Previous comparisons between satoreotide and DOTA-TATE demonstrated that antagonist, 225Ac-satoreotide, is multiple times more potent than SSTR2 agonist, 225Ac-DOTA-TATE, signifying a durable complete response in standard murine xenograft models of SCLC in animal models, versus tumour growth delay.

Ariceum had previously shown at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting 2024 that 212Pb was not seen to be more potent than Lutetium or Terbium but caused more side effects and hence was not further pursued.

Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "These results provide strong evidence for satoreotide and its potential to clinically outperform SSTR2 targeting agonists, by demonstrating significantly better efficacy in tumour growth control, up to complete tumour eradication depending on isotope used. In addition, when a single dose of 30 kBq 225Ac-satoreotide was administered, we observed high frequency of complete durable responses and 100% survival which strongly supports further clinical development for the treatment of SCLC, MCC and other cancers."

Details of the oral presentation are as follow:

Title: 225Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225Ac-DOTA-TATE and 161Tb-DOTA-TATE in the treatment of SSTR2-positive tumour xenografts

Presenting Author: Prachi Desai, Scientist at Ariceum Therapeutics

Session Number: 1204

Session Title: M2M Track – TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation

Oral Presentation Date & Time: Tuesday 22 October 2024, 09:00 AM – 09:10 AM CEST

Abstract Authors: Prachi Desai, Manuel Sturzbecher-Hoehne, Dennis Mewis, Manfred Ruediger & Anika Jaekel of Ariceum Therapeutics

Session Date & Time: Tuesday 22 October 2024, 08:00 AM – 09:30 AM CEST

Location: Session Hall X1-X4

Abstracts are available in the September edition of Springer’s European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) abstract book here and on the Ariceum website here.

On October 22, 2024 Akiram Therapeutics, a Swedish biotech company specializing in molecular radiation therapy, reported that the Swedish Medical Products Agency has approved the initiation of a Phase 1 clinical trial for its drug candidate 177Lu-AKIR001 (Press release, Akiram Therapeutics, OCT 22, 2024, View Source [SID1234647299]). This marks a key milestone in the company’s development of a pioneering cancer treatment aimed at offering new hope for patients with hard-to-treat tumors.

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Akiram Therapeutics has developed a new type of targeted radioimmunotherapy, 177Lu-AKIR001. The therapy holds the potential to become a first-in-class treatment in multiple cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer. The drug is composed of a target recognition molecule, to which therapeutic radioactivity is coupled for effect on tumor cells.

The academic trial will be led by Karolinska University Hospital, overseeing all clinical aspects including patient recruitment and trial management. The primary goal is to assess the safety and tolerability of 177Lu-AKIR001. Recruitment is expected to begin in the fall of 2024 and will continue for two years. The study is funded by grants from, among others, the Sjöberg Foundation, the Erling Persson Foundation, and the Swedish Cancer Society. Akiram Therapeutics contributes to the study by providing the drug candidate 177Lu-AKIR001.

"177Lu-AKIR001 has the potential to transform how we treat hard-to-treat tumors and could represent a major advancement in precision medicine," says Renske Altena, Senior Physician and Primary Investigator in oncology and internal medicine at Karolinska Comprehensive Cancer Center. "By targeting the radiation specifically at the cancer marker CD44v6, we hope to achieve greater precision and higher efficacy than current treatment options, especially for patients whose tumors no longer respond to existing therapies."

Renske Altena adds, "For patients with aggressive and treatment-resistant cancer types, we hope this innovation can bring about a real change in their treatment plans and quality of life. A successful tailored treatment would be a significant step forward in oncology and precision medicine."

"The start of the Phase 1 clinical trial is a significant milestone for Akiram and an important step forward in molecular radiation therapy," says Marika Nestor, CEO and co-founder of Akiram Therapeutics. "We are excited to collaborate with Karolinska University Hospital and are confident in AKIR001’s potential to improve treatment outcomes for patients."

The study is registered on ClinicalTrials.gov: NCT06639191.

About Akiram’s drug candidate
Developed through antibody phage display and affinity maturation targeting the CD44v6 cancer marker, 177Lu-AKIR001 combines the radiation component lutetium-177 with a targeted molecule. Preclinical studies have demonstrated its potential as a promising, first-in-class radiopharmaceutical therapy for cancers with high CD44v6 expression.

On October 22, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, and Orano Med, a clinical-stage radiopharmaceutical company developing targeted alpha therapies with lead-212 (212Pb), reported the oral presentation of the latest preclinical data supporting MP0712 as a Radio-DARPin Therapeutic (RDT) at the European Assocation of Nuclear Medicine (EANM) Congress which runs October 19-23, 2024 in Hamburg, Germany (Press release, Molecular Partners, OCT 22, 2024, View Source [SID1234647292]). MP0712 is a co-developed 212Pb-labeled RDT candidate targeting delta-like ligand 3 (DLL3). Molecular Partners and Orano Med anticipate initiating first-in-human studies, pending regulatory clearance, in 2025. Initial clinical data of MP0712 is also anticipated in 2025.

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"The latest data on MP0712, our DLL3 RDT co-developed with Orano Med, confirms the high tumor uptake in a model with matched target expression level to the human cancer setting, while keeping kidney exposure low. The additional in vivo efficacy and safety data further strengthen the momentum for our planned clinical entry next year, likely constituting the first DLL3-targeting 212Pb agent in development," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Together with our partner Orano Med, we’ve been able to kidney-stealth engineer our DARPins and add tumor uptake by half-life tuning to evolve our Radio-DARPin platform. These learnings are directly being applied to the next candidates in our RDT pipeline."

"We are very pleased with the results of MP0712, to date. The homogeneous distribution observed through alpha camera imaging not only supports our DLL3 program but also highlights the promising potential of the collaboration between Molecular Partners and Orano Med. Their DARPin vectors are particularly well-suited for Targeted Alpha Therapy (TAT) with lead-212. By leveraging the expertise of both teams, we aim to build a robust platform and significantly shorten development timelines," said Julien Torgue, Ph.D., Chief Scientific Officer of Orano Med.

Details of this Top-Rated Oral Presentation (TROP):

Presentation Title: Preclinical assessment of lead-212 (212Pb) Radio-DARPin Therapeutic (RDT) targeting delta-like ligand 3 (DLL3) in small cell lung cancer (SCLC)
Presentation Number: OP-535
Session Title: M2M Track – TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation (session number: 1204)
Session Date, Timing & Location: 22 October 2024; 8:00-9:30 am CEST; Hall X1-X4
The presentation highlights that attractive tumor to kidney (T:K) ratios of >2 can be achieved in biodistribution studies across several models, including in a disseminated tumor model with clinically relevant DLL3 expression levels. This suggests strong uptake by the targeted tissue while minimally impacting healthy tissues. In addition, in vivo data indicated that tumor uptake was specific to DLL3.

Dose-range finding studies in mice confirmed that treatment at a clinically relevant dosage was well tolerated, supporting a favorable safety profile. Finally, MP0712 led to strong and dose-dependent efficacy in mice bearing established tumors with clinically-relevant levels of DLL3 expression and at a clinically-relevant dose, as compared to a positive control of a radiolabelled anti-DLL3 antibody rovalpituzumab (Rova).

DLL3 is a highly relevant target for radiopharmaceutical therapy due to its abundant expression in tumors of patients with small cell lung cancer (present in >85% of tumors) and other aggressive neuroendocrine tumors, while expression in healthy tissues is low. MP0712 has picomolar affinity and high specificity to human DLL3.

Molecular Partners is developing its RDT platform for targeted delivery of radioactive payloads to solid tumors. Due to their small size, high specificity and affinity, DARPins are well-suited as potential vectors for efficient delivery of therapeutic radionuclides. DARPins are also readily designed as multispecifics, making bi-specific (or larger) candidates a promising area of growth for Molecular Partner’s RDT portfolio as additional targeting may help address target heterogeneity in many tumors. The portfolio includes programs being developed in-house as well as via collaborations with Orano Med and Novartis.

The presentation given today will be made available on Molecular Partner’s website in the Scientific Documents section.

On October 21, 2024 Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage gene editing company, and Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio, reported that they have entered into a collaboration and nonexclusive license agreement to combine Editas Medicine’s CRISPR Cas12a genome editing systems with Genevant’s proprietary LNP technology in the development of in vivo gene editing medicines directed to two undisclosed targets in Editas’ upregulation strategy (Press release, Genevant Sciences, OCT 21, 2024, https://www.genevant.com/editas-medicine-and-genevant-sciences-to-collaborate-to-develop-novel-mrna-lnp-gene-editing-therapeutics/ [SID1234649375]).

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"Editas has made significant strides to achieve our vision of becoming a leader in in vivo programmable gene editing medicine, and we are making strong progress towards the clinic as we develop our pipeline of futuremedicines," said Linda C. Burkly, Ph.D., Chief Scientific Officer, Editas Medicine. "As we investigated the delivery landscape to identify systems for our in vivo upregulation strategy that would best complement our gene editing technology, we quickly identified Genevant, an established leader in the LNP space, and we are delighted to launch this collaboration."

"We are thrilled to be working with Editas, a gene editing pioneer, to develop potentially transformative gene editing treatments," said James Heyes, Chief Scientific Officer of Genevant Sciences. "LNPs have emerged as a preferred approach for delivering gene editing constructs, and we are excited by the promise of combining our industry-leading LNP technology with Editas’s innovation in this burgeoning field."

Under the terms of the agreement, Genevant has granted to Editas a nonexclusive worldwide license under certain Genevant LNP technology to exploit mRNA-CRISPR Cas12a-LNP products directed to two undisclosed targets for specified fields. Genevant is eligible to receive up to $238 million in upfront and contingent milestone payments, as well as tiered royalties on future product sales.

On October 21, 2024 Thermo Fisher Scientific, the world leader in serving science, reported to have received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO (vorasidenib) tablets (Press release, Thermo Fisher Scientific, OCT 21, 2024, View Source [SID1234647296]). VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection. As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options.

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Gliomas are the most common malignant primary brain tumor in adults, representing approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation and testing for these mutations is essential for accurate treatment decisions. Further, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend IDH mutation testing in all patients with a glioma, noting its impact on diagnosis and prognosis of gliomas. IDH mutation status has been a key factor in the NCCN treatment guidelines for years. With the FDA approval of VORANIGO, determining the IDH mutation status of patients with glioma will be even more critical.

"VORANIGO is the first and only targeted therapy for patients living with grade 2 IDH mutant glioma, a relentless and incurable type of brain cancer that hasn’t seen treatment advances in nearly 25 years," said David K. Lee, CEO of Servier Pharmaceuticals. "As more targeted therapies become available to patients, identifying key driver mutations is essential to help the right patients find the right treatment, at the right time."

In addition to the approval for IDH-mutant diffuse glioma, the Oncomine Dx Target Test, has also previously received approvals for indications in non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC). As a distributable companion diagnostic, the test simultaneously delivers biomarker results for multiple targeted therapies from one sample, helping quickly match patients with the right targeted therapies.

"As the healthcare system works to realize the impact of precision medicine, patients must have access to the proper testing that helps unlock targeted treatment options based on their unique genomic profiles. This access is the driving motivation behind the extensive work we do with pharma partners to help connect the right patients to new therapies as soon as they are approved," said Kathy Davy, president, clinical next-generation sequencing at Thermo Fisher Scientific. "The work we do every day reflects our Mission, and combining our CDx technology with Servier’s breakthrough therapy will help dramatically impact care for patients with aggressive brain tumors."

Today’s approval expands clinical indications for the Oncomine Dx Target Test, which is currently approved and reimbursed by government and commercial insurers in 19 countries, including the U.S., Japan, South Korea and countries across Europe and the Middle East, covering more than 550 million lives globally.

Following this approval, the two organizations will continue to collaborate on an additional companion diagnostics with the Ion Torrent Oncomine Dx Express Test.* Available on the Ion Torrent Genexus Dx System*, the Oncomine Dx Express Test can return results in as little as a single day, dramatically accelerating the pace with which patients can be matched with optimal treatments based on their genomic results.

*The Oncomine Dx Express Test and the Genexus Dx System are currently available only in countries that accept the CE mark.