On June 10, 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 will be presenting a poster demonstrating the efficacy of its somatostatin receptor 2 (SST2) antagonist, SS0110 (satoreotide), relative to SST2-targeting agonists, at this year’s Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held 8-11 June 2024 in Toronto, Canada (Press release, Ariceum Therapeutics, JUN 10, 2024, View Source [SID1234644218]).

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The poster presentation entitled ‘[225Ac]Ac-SSO110 and [177Lu]Lu-SSO110 demonstrate significantly better efficacy than [225Ac]Ac-DOTA-TATE in the treatment of SST2-positive tumor xenografts’ compares satoreotide with the SST2 agonist, 225Ac-DOTATATE, and reveals that single doses of 20 MBq 177Lu-satoreotide or 30 kBq 225Ac-satoreotide induce significantly better efficacy than a single dose of 30 kBq 225Ac-DOTATATE. Most remarkably, 30 kBq 225Ac-satoreotide induced complete tumor regression in the NCI-H69 model, something not observed with the same or higher doses of 225Ac-DOTATATE.

These data highlight the significantly higher tumor uptake and longer tumor retention leading to a higher tumor to background and tumor to kidney ratios of satoreotide which translates into higher pre-clinical efficacy than SST2-targeting agonists when labelled with isotopes, 225Ac-satoreotide and 177Lu-satoreotide. This demonstrates the potential for satoreotide to clinically outperform SST2-targeting agonists and strongly supports its further clinical development for the treatment of SST2 positive tumors such as Small Cell Lung Cancer (SCLC) and Merkel Cell Carcinoma (MCC).

Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "With this significant data we demonstrate that satoreotide has the potential to be a game changer for the treatment of SCLC and MCC. Satoreotide is multiple times more potent than DOTATATE, irrespective of the isotope, and this confirms the superiority of SST2 antagonist over agonist. We look forward to presenting our findings at this year’s SNMMI meeting."

Details of the poster presentation are as follow:

Title: [225Ac]Ac-SSO110 and [177Lu]Lu-SSO110 demonstrate significantly better efficacy than [225Ac]Ac-DOTA-TATE in the treatment of SST2-positive tumor xenografts

Authors: Anika Jaekel, Prachi Desai, Germo Gericke, Manuel Sturzbecher-Hoehne, Dennis Mewis & Manfred Rüdiger

Presenter: Anika Jaekel, Senior Director, Head of Translational Biology and Non-Clinical Pharmacology at Ariceum Therapeutics

Session: MTA07 POPs/Meet the Author: Oncology, Basic & Translational 2
Session Date and Time: Monday, June 10, 2024, 10:00 – 11:15 DST
Abstract ID: 242038

On June 10, 2024 J INTS BIO reported an update of its ongoing Phase 1 clinical study of JIN-A02, a 4th generation EGFR-TKI for NSCLC treatment, during the 3rd of June poster session of the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held at McCormick Place in Chicago, USA, from May 31 to June 4 (Press release, J INTS BIO, JUN 10, 2024, View Source;jin-a02-showed-tumor-reductions-including-brain-metastasis-in-the-ongoing-first-in-human-dose-finding-phase-1-clinical-study-302168022.html [SID1234644234]).

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This latest study update of JIN-A02 reported another tumor Partial Response (PR) in a patient in Cohort 4 (100mg daily). The first tumor Partial Response (PR) recorded in this study, was a patient in the earlier Cohort at a lower dose of 50mg daily. In addition, the first instance of brain tumor activity was recorded in Cohort 4, with a 28.6% reduction of the brain metastasis.

To-date, Partial Response (PR) has been confirmed in two patients and Stable Diseases in three other, including the patient with reduction of brain metastasis in Cohort 4 and two patients from the lower Cohorts at a lower dose.

The final patient in Cohort 4 (100mg) is expected to complete the dose-limiting toxicity (DLT) assessment period soon and thus far, no DLT has been detected. In addition, no rash, diarrhea, or cardiac toxicity (side effects commonly associated with EGFR TKIs use), has been reported in this study despite the positive efficacy signals and clinical benefits already observed. The next Cohort at 150mg daily will begin end of June.

J INTS BIO said, "It is very meaningful to be able to share key clinical results in large-scale global conferences attended by global anticancer experts and research and development officials." and "JIN-A02 is expected to be a game changer to improve the life of patients with EGFR C797S positive NSCLC, for which there is currently no approved treatment," they added. According to the company, JIN-A02 is scheduled to enter phase 2 clinical trial by the end of this year.

On June 10, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on June 6, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 18 new employees in restricted stock units for an aggregate of 90,591 shares of the Company’s common stock (Press release, BridgeBio, JUN 10, 2024, View Source [SID1234644219]). One-fourth of the shares underlying each employee’s restricted stock units will vest on May 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019, and amended and restated on February 10, 2023 and on December 13, 2023.

On June 10, 2024 Hudson Therapeutics reported that Shaperon (KOSDAQ 378800, CEO Seung-Yong Seong), an innovative biopharmaceutical company specializing in immune therapeutics, has signed a Memorandum of Understanding (MOU) with Dong-A ST (KOSPI 170900, CEO Min-Young Kim) for the development of nanobody-based new drugs (Press release, Shaperon, JUN 10, 2024, View Source [SID1234644235]).

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A representative from Shaperon stated, "This MOU aims to leverage Shaperon’s nanobody development platform technology and Dong-A ST’s expertise in antibody commercialization to increase development speed and commercialization potential." Additionally, they stated, "We plan to select the most effective nanobodies in mouse models with human tumor transplants by the end of this year."

Since 2021, the two companies have collaborated on developing triple nanobody antibodies for cancer treatment. This involves using nanobodies to bring killer T cells and cancer cells into proximity by binding to targets on both cell types. Shaperon will advance nanobody development using its full-cycle platform, while Dong-A ST will leverage its antibody commercialization expertise for global biopharmaceutical development.

Nanobodies, about one-tenth the size of conventional antibodies, are gaining attention for next-generation immune checkpoint inhibitors due to their high stability, solubility, and production yield. Shaperon, the only domestic company with a full-cycle platform for nanobody production, development, and analysis from alpaca immunization, is developing a diverse pipeline targeting inflammation and cancer, including immune checkpoint dual antibodies and nanobody-based therapeutics.

Shaperon, the only domestic company with a full-cycle platform for nanobody production, development, and analysis from alpaca immunization, is developing a diverse pipeline targeting inflammation and cancer. This includes immune checkpoint dual antibodies and nanobodies for infectious diseases. Shaperon is also exploring nanobody-based protein therapeutics, such as antibody-drug conjugates (ADCs) and radiopharmaceutical therapies. Recently, they published preclinical results on influenza-targeting nanobodies and presented anti-cancer PDL1-CD47 dual nanobodies at the AACR (Free AACR Whitepaper), gaining recognition for their technological capabilities.

Janice Marie McCourt of Hudson Therapeutics in the US stated, "We have numerous global biotech companies that we met at BIO, Bio Europe, Bio Asia and the Pharm Summit conferences who are signing confidentiality agreements to license the current preclinical immune-oncology bispecific lead program, along with collaborating on Shaperon’s nanobody development platform to create bispecific and trispecific nanobody antibodies in orphan indications, immunology, inflammation, oncology and infectious disease targets that are first-in-class or best-in-class assets with significant commercial potential. We are so excited that the global R&D scientists and clinicians are excited to collaborate with us and create an impact focused on patients with significant unmet needs."

On June 10, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported that it received an approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel where the study will be conducted (Press release, Can-Fite BioPharma, JUN 10, 2024, View Source [SID1234644220]). The approved protocol has been submitted now to the Ministry of Health (MOH).

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"This Phase IIa study is designed as an open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment. Our positive Namodenoson data in pancreatic carcinoma experimental models together with the positive data in the Phase II advanced liver cancer study, with a patient showing overall survival of >7 years, encouraged us to initiate the current Phase IIa study," stated Can-Fite’s Medical Director Dr. Michael Silverman.

The protocol of the clinical study is CF102-222PC entitled: "A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma," ClinicalTrials.gov Identifier: NCT06387342.

The study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

The study will be conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel.

Namodenoson recently received peer-reviewed recognition for its efficacy findings in pancreatic cancer including from the American Association of Cancer Research (AACR) (Free AACR Whitepaper) which accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway" for a poster presentation at the AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer, and from Biomolecules, a scientific journal focused on the function and mechanism of bioactive molecules, which published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling Pathways".

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.