BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

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.

Ariceum Therapeutics to Present Outstanding New Preclinical Data at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting 2024

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

Theralase® Successfully Destroys Lung Cancer

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]).

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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.

MAIA Biotechnology’s Telomere Targeting Functionality is Shown Viable by FDA’s Approval of a Telomerase Inhibitor Agent Therapy

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]).

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"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.

Calyx / Invicro Forges a Strategic Collaboration with BAMF Health to Accelerate Clinical Translation of Radioligand Therapies and Immuno-Oncology Agents

On June 7, 2024 Calyx / Invicro, a global leader in providing medical imaging solutions and development services to the clinical research community, reported a strategic partnership with BAMF Health, a world leader in molecular imaging and theranostics (Press release, Invicro, JUN 7, 2024, View Source;invicro-forges-a-strategic-collaboration-with-bamf-health-to-accelerate-clinical-translation-of-radioligand-therapies-and-immuno-oncology-agents-302167367.html [SID1234644201]). The partnership aims to accelerate the clinical translation of radioligand therapies (RLT) and immuno-oncology (IO) agents.

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This collaboration addresses challenges caused by fragmented service ecosystems, which have led to duplicative efforts, slow knowledge transfer, and prolonged development timelines. By combining Calyx / Invicro’s radiochemistry and imaging biomarker solutions with BAMF Health’s advanced radiopharmacy facility—which supports a range of alpha, beta, and gamma agents, and molecular imaging and therapy clinics—biotech and pharmaceutical companies now have an end-to-end resource for translating these advanced programs into clinical trials.

A catalyzing project for this partnership is an actinium-225 initiative, for which TerraPower is supplying actinium-225, and BAMF is leveraging its GE HealthCare StarGuide SPECT/CT and dosimetry expertise to enhance the study and application of actinium-225 in RLT.

This association represents a key moment in our industry, as contract research organizations, contract manufacturing organizations, and imaging clinics must collaborate more than ever to support these complicated and technically demanding RLT and IO programs. This collaboration and working relationship streamlines operations with easier contracting and communication, brings together knowledge across scientific, regulatory, and operational areas, and provides access to the latest technologies from early preclinical research to patient imaging.

"The success of Calyx / Invicro’s translational model in the CNS field, demonstrated at our London and New Haven clinics, shows the effectiveness of an integrated service approach. We believe our partnership with BAMF Health will bring the same level of innovation and acceleration to oncology," said Edward Hogan, COO of Calyx / Invicro.

BAMF Health’s Director of Clinical Trials, Dan Rogers, added, "Combining our strengths with Calyx / Invicro allows us to tackle the unique challenges of developing radioligand and immuno-oncology therapies. This collaboration is set to enhance and speed up the development process, towards our mission of making precision medicine available and affordable to everyone."

Through this partnership, Calyx / Invicro and BAMF Health aim to tackle key hurdles in the clinical translation of radioligand and immuno-oncology treatments. Their combined efforts highlight a commitment to advancing these therapies, redefining oncology care standards, and ensuring faster access to promising treatments for patients.