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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

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").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF) a clinical stage pharmaceutical company that is dedicated to the research and development of light and/or radiation activated small molecules for the safe and effective destruction of various cancers, bacteria and viruses, reported that it’s lead compound, RuvidarTM, combined with transferrin to form the compound Rutherrin, has been proven effective preclinically in the destruction of Non-Small Cell Lung Cancer ("NSCLC") (Press release, Theralase, JUN 10, 2024, View Source [SID1234644217]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Theralase recently completed experiments in NSCLC, using a Lewis Lung Cancer ("LLC1") orthotopic model. In this model, mouse lungs are subjected to lung cancer cells, which induces these mice to develop very aggressive, fast growing and metastatic lung tumours.

As shown in Figure 1, lung tumours retained Rutherrin longer than normal lung tissues (p> 0.01), leading to a substantially improved selectivity of Rutherrin to target lung cancer.

On June 7, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage company developing telomere-targeting immunotherapies for cancer, reported the validation of clinical and regulatory pathways for viable therapies leveraging the cell’s telomeric functions as evidenced by the U.S. Food and Drug Administration (FDA) approval of imetelstat, a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation (Press release, MAIA Biotechnology, JUN 7, 2024, View Source [SID1234644202]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"MAIA is one of the earliest pioneers of telomere targeting as a therapeutic strategy, and we share in the enthusiasm for the FDA approval of imetelstat for rare blood cancers originating in bone marrow. We have found that telomere targeting as a mechanism of action plays a key role in treating certain cancers, and we are studying this science in our Phase 2 trial of THIO in high-risk non-small cell lung cancer (NSCLC)," said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. "Our most recent clinical data shows THIO’s exceptional efficacy in checkpoint inhibitor and chemo-resistant patients in NSCLC. We salute Geron for validating the pathway," concluded Dr. Vitoc.

Telomerase is present in over 85% of human cancers and contributes significantly to the proliferation and reproductive immortality of cancer cells. MAIA’s lead candidate is THIO, a telomere targeting agent in clinical development (Phase 2 THIO-101) to evaluate its activity in NSCLC. THIO is recognized by telomerase and incorporated into telomeres in cancer cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends and thus resulting in rapid tumor cell death.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.