On October 18, 2022 Verseon International Corporation, the company leading a technology-driven transformation of the pharmaceutical industry, reported that it has acquired Edammo, Inc (Press release, Verseon, OCT 18, 2022, View Source [SID1234622139]).

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Verseon has spent much of the past two decades pioneering scientific advances in molecular physics, chemistry, biology, and AI to create the world’s most advanced drug-discovery platform. This platform now systematically produces entire families of novel drug candidates that cannot be found by any other current method—candidates whose uniquely desirable therapeutic profiles promise to change the standard of care for every disease they address. The company has officially announced seven programs to date for conditions that include heart disease, diabetes, and cancer.

When developing completely novel drugs, the available dataset is often small and sparse. And big-data dependent AI can’t solve small-data problems easily. Verseon has continued to develop its own specialized AI tools internally to handle these situations.

The company has also kept an eye on external developments and found that Edammo’s Extreme AutoML technology performs particularly well in a variety of life-sciences tasks. Edammo’s novel approach to AI is superior to other current technologies for utilizing small datasets, and has a significantly lower error rate than external industry-benchmarks like Google AutoML.

Announcing the acquisition, Verseon Co-Founder and CEO Adityo Prakash commented, "As we continue to expand Verseon’s capabilities through both in-house development and strategic acquisitions, Edammo’s AI technology will be an excellent addition to our platform."

Edammo’s CEO Ed Ratner added, "We are pleased that Verseon determined our Extreme AutoML will enhance the machine-learning components of Verseon’s platform. While it’s useful in many different settings, applying Edammo’s technology to help develop critical new medicines is a highly rewarding opportunity to improve billions of lives around the world."

On October 18, 2022 Ikena Oncology, a targeted oncology company forging new territory in patient-directed cancer treatment, reported a research & development update on the Company’s lead targeted oncology program in TEAD inhibition (Press release, Ikena Oncology, OCT 18, 2022, View Source,genes%20as%20well%20as%20other [SID1234622136]). Ikena also reported a clinical trial collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for the evaluation of TAGRISSO (osimertinib), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with Ikena’s IK-930 as treatment for patients with EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).

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TEAD consists of a family of transcription factors that is comprised of multiple paralogs, variations of the same gene with slightly different functions. IK-930 is a paralog-selective TEAD inhibitor designed to maximize both efficacy and safety and is currently being studied as a monotherapy in a first-in-human Phase 1 clinical trial in patients with advanced solid tumors (NCT05228015), including NF2-deficient malignant mesothelioma, for which the FDA granted Fast Track designation earlier this year.

"Patients with Hippo-altered cancers are in need of therapies that are effective, safe, and significantly improve their quality of life. IK-930 is specifically designed as a paralog-selective TEAD inhibitor that has the potential to provide patients with a differentiated treatment option," said Mark Manfredi, PhD, Chief Executive Officer of Ikena. "As a first in its class, IK-930’s selectivity profile has potential to distinguish itself not only as a monotherapy, but in combination with other targeted therapies where resistance has emerged. I am thrilled AstraZeneca shares in this vision and that we will be exploring IK-930 in combination with osimertinib."

The ongoing IK-930 clinical trial has planned cohorts exploring combinations with targeted therapies in which treatment-induced activation of the Hippo pathway may drive resistance. The first combination cohort will be evaluating IK-930’s potential to overcome resistance to EGFR inhibitors. In EGFRm NSCLC, only 50% of patients who develop resistance to osimertinib have potentially identifiable and actionable mechanisms with available therapies, leaving 50% without clear treatment options, representing a significant unmet need. Preclinical results demonstrate that IK-930 combined with osimertinib results in increased induction of apoptosis and improved anti-tumor activity in multiple EGFRm tumor models. This benefit is mediated in part by the Hippo pathway’s role in the proliferation of persister cells, a subpopulation of cancer cells that drive EGFR resistance through TEAD-mediated induction of genes involved in cell cycle re-entry, DNA replication and apoptosis avoidance. Under the clinical trial collaboration agreement AstraZeneca will provide Ikena with osimertinib non-exclusively for evaluation in combination with IK-930 in patients with EGFRm resistant NSCLC.

"Expanding the number of patients that could benefit from targeted oncology treatments is an important goal for our team. We believe that targeted oncology has incredible potential as a monotherapy for a portion of patients as well as in combination for patients that experience therapeutic resistance. By understanding the mechanism in which cancers resist therapies, we can create combination regimens that block key compensatory survival pathways," commented Jeffrey Ecsedy, PhD, Chief Development Officer of Ikena. "The Hippo pathway is implicated in therapeutic resistance to multiple therapies, including osimertinib. Working with AstraZeneca will allow us to investigate how IK-930 could benefit patients with EGFR mutated cancers who have had difficulty responding to current treatments alone and demonstrate how combination with IK-930 could potentially enable deeper and prolonged anti-tumor responses."

Ikena Oncology continues to remain focused on developing therapies that target the underlying mechanisms driving cancer survival and growth through an integrated approach leveraging translational science, drug discovery and cancer biology to address unmet patient needs. Further data on the effectiveness and differentiation of IK-930 in multiple animal models both as a monotherapy and in combination with other targeted therapies will be presented at upcoming conferences, and initial clinical data from the first in human Phase 1 study are expected in 2023.

About IK-930
IK-930 is an oral, paralog-selective TEAD inhibitor targeting the Hippo signaling pathway. IK-930 binds to TEAD transcription factors and prevents transcription of multiple genes that drive cancer progression. By targeting the Hippo pathway, a key driver of cancer pathogenesis that is genetically altered in approximately 10% of all cancer types, IK-930 could have a differentiating impact across many cancers with high unmet need. Ikena is advancing IK-930 both as a monotherapy in patients with Hippo pathway mutated cancers and in combination with other approved targeted therapies to combat therapeutic resistance. IK-930 is currently being studied in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors with or without gene alterations in the Hippo pathway, including NF2-deficient malignant mesothelioma, Epithelioid Hemangioendothelioma (EHE) with documented TAZ/CAMTA1 fusion genes as well as other solid tumors with either NF2 deficiency or with YAP/TAZ genetic fusions (NCT05228015).

On October 18, 2022 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported execution of a final agreement with the European Investment Bank ("EIB") to re-align approximately €30.7 million in outstanding debt obligations with the Company’s expected development and commercialization timelines (Press release, Nanobiotix, OCT 18, 2022, View Source [SID1234622135]). Nanobiotix previously announced agreement-in-principle with EIB for this restructuring on September 12th, 2022.

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The original finance contract and royalty agreement established between Nanobiotix and EIB in July 2018 included an initial tranche of €16.0 million drawn in October 2018 and repayable in a single installment at maturity in 2023; and a second tranche of €14.0 million granted in March 2019 and repayable in semi-annual installments of principal and interest after a two-year grace period. The agreement also included a commitment to an annual royalty payment in the low single-digits over a six-year period beginning January 2021.

Terms and Conditions of the Restructuring Agreement

The newly executed restructuring agreement enables Nanobiotix to defer repayment of the remaining €25.3 million in principal for both tranches up to June 2029.

Under the terms of the agreement, €5.4 million in interest accrued on the first tranche since 2018 will be restructured as payment-in-kind ("PIK") and will be deferred up to October 2024. Going forward, principal from the first tranche will accrue interest at the rate of 6% annually, with such interest being capitalized and due as PIK interest at maturity. Interest on the remaining €9.3 million in principal from the second tranche will continue to accrue at a 5% fixed rate paid in semi-annual installments through June 2029.

The annual royalty payment remains in the low single-digits and continues to cover a six-year period but has been re-aligned to begin as of the first year of NBTXR3 commercialization.

The restructuring agreement also includes a new milestone payment of €20 million due in June 2029.

While the restructuring of the finance and royalty agreement is intended to align debt obligations with the Company’s anticipated commercial timelines, the agreement contains provisions that would accelerate the maturity and repayment schedule, should Nanobiotix generate commercial revenue prior to June 2029. Specifically, principal and interest accrued on the first tranche following the amendment would be due in a single installment at the earlier of four years after commercialization or June 2029. Semi-annual principal repayments for the second tranche would resume with a maturity date at the earlier of three years following commercialization or June 2029. Finally, an accelerated redemption schedule for the new €20 million milestone payment would be triggered calling for the repayment in two equal installments due one year and two years after commercialization, respectively.

Further, should the company secure non-dilutive capital through the execution of any business development deal, the €5.4 million PIK interest payment associated with the first tranche would be due by October 2023 and an accelerated redemption schedule for the new €20 million milestone payment would be triggered. The accelerated redemption schedule would reflect a prorated payment amount not exceeding 10% of any upfront or milestone payment received by Nanobiotix with any remaining balance of the €20 million milestone payment due at maturity.

As part of the restructuring, Nanobiotix has agreed to maintain a minimum cash balance equal to the outstanding principal owed to EIB. All other covenants included in the 2018 finance contract remain unchanged.

On October 18, 2022 Myovant Sciences (NYSE: MYOV), a biopharmaceutical company that aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy, reported that it approved equity awards for 10 new employees with a grant date of October 17, 2022 pursuant to Myovant’s 2020 Inducement Plan (Press release, Myovant Sciences, OCT 18, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-new-employment-inducement-grants-7 [SID1234622134]). The equity awards were granted to the employees joining Myovant in accordance with NYSE’s Listed Company Manual Rule 303A.08.

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The new employees received, in the aggregate, restricted stock units (RSUs) to purchase 96,500 common shares of Myovant. One-fourth of the shares underlying each employee’s RSU will vest on the one-year anniversary of the grant date, with the balance of the common shares vesting in twelve equal quarterly installments thereafter, in each case, subject to each such employee’s continued employment with Myovant on such vesting dates. The RSUs are subject to the terms and conditions of the 2020 Inducement Plan and the applicable RSU agreements.

On October 13, 2022 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), ("LIXTE" or the "Company"), a clinical-stage pharmaceutical company focused on developing and commercializing cancer therapies, reported that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) has authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead clinical compound, plus doxorubicin versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS) (Press release, Lixte Biotechnology, OCT 18, 2022, sec.gov/Archives/edgar/data/1335105/000149315222028641/ex99-1.htm [SID1234622133]).

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Dr. John Kovach, the founder and CEO of LIXTE, said, "The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined with doxorubicin in soft tissue sarcomas. Doxorubicin alone has been the cornerstone of first line treatment of ASTS for over 40 years, with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 has consistently enhanced the anti-tumor activity of doxorubicin without apparent increases in toxicity. The interim analysis of this clinical trial will be done before full accrual is completed to determine whether the study has the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit of doxorubicin alone."

Dr. Kovach continued, "This study was designed and will be carried out by the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, or GEIS). GEIS was formed in 1994 by oncologists from four hospitals and has grown to include members from more than 60 medical centers across Spain. For relatively uncommon but life-threatening diseases like ASTS, GEIS has shown that it is essential for many institutions to collaborate and accrue a large enough group of patients needed to timely evaluate promising new treatments. We are delighted that GEIS has chosen to study whether LIXTE’s lead clinical compound, LB-100, can significantly improve the anti-tumor activity of doxorubicin, the current clinical standard, an only marginally effective treatment for previously untreated ASTS. The clinical trial is expected to begin later this year or during the first quarter of 2023; up to 170 patients will be entered onto the trial, which is expected to be completed within two and a half years. This rapid rate of patient accrual is only possible through the collaborative efforts of GEIS oncologists."

Dr. Javier Martín-Broto, Coordinating Investigator of the trial, medical oncologist at the Fundación Jiménez Díaz University Hospital (Madrid) and GEIS Co-Founder, commented, "Although there has been an increase in overall survival in advanced sarcoma in recent years, this gain has not been accompanied by advances in first line therapy. Anthracyclines, and specifically doxorubicin, is still the standard initial treatment. The growing list of negative phase III trials indicates to us that sarcoma therapy is in crisis. It is true that sarcoma encompasses more than 60 different subtypes and, for some of them, substantial advances have emerged. But it is also true that the most frequent sarcoma subtypes desperately need a turning point. One promising topic of research is the combination of doxorubicin with drugs that are able to impair the mechanisms of DNA repair. LB-100 has demonstrated synergistic action in in vivo preclinical mesenchymal tumors. GEIS will lead a European initiative to conduct a Phase 1/randomized II trial exploring the combination of doxorubicin plus LB-100 in first line of advanced soft tissue sarcomas."

Dr. Kovach added, "We believe that authorization of this trial by AEMPS should facilitate approval of other LB-100 protocols in EU countries.