On June 20, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported that 29 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, JUN 20, 2023, View Source [SID1234632813]). With the addition of sites in Hungary, Poland, and Bulgaria in March 2023, THIO-101 has rapidly increased the number of patients enrolled and dosed with THIO. Thirteen sites were activated with another two new additional sites ready to open in the coming weeks.

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THIO is a first-in-class cancer telomere targeting agent administered in sequence with a checkpoint inhibitor (CPI). The main objectives of the THIO-101 trial are to evaluate the safety, tolerability, and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy. The trial dosed its first patient in Australia in July 2022 and expanded to include European patients in March 2023.

"We are very pleased with the progress of enrollment in Europe. Since our last update, we have more than doubled the number of patients dosed to 29, bringing us closer to our target of 184 patients planned to be treated in the trial. With a large number of lung cancer cases in Europe, we anticipate a robust rate of enrollment in the upcoming weeks," stated Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.

"With rapid enrollment in the trial, we project a substantial number of patients completing 3-6 months of treatment by the fall which will allow us a preliminary evaluation of the treatment efficacy," added Mihail Obrocea, MD, MAIA’s Chief Medical Officer.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose selection Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of an immune checkpoint inhibitor allowing for immune activation and PD-1 sensitivity to take effect. The trial is testing the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor 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 agent and a priming immune system agent and (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an 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. THIO is being 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.

On June 20, 2023 Simulations Plus, Inc. (Nasdaq: SLP) ("Simulations Plus"), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, reported the acquisition of Immunetrics, Inc. ("Immunetrics"), a modeling and simulation company focused on accelerating drug development in oncology, immunology, and autoimmune diseases, areas that are among the fastest growing therapeutics (Press release, Simulations Plus, JUN 20, 2023, View Source [SID1234632812]).

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Under the terms of the Agreement, Simulations Plus agreed to pay the shareholders of Immunetrics cash consideration at closing in the amount of $15.5 million, including a $1.8 million hold-back, plus two future earn-out payments in the aggregate amount of up to $8 million based on the revenue performance of Immunetrics through December 31, 2024. Following the close of the transaction, Immunetrics will be a wholly-owned subsidiary of Simulations Plus and will continue to operate under the Immunetrics name.

The acquisition strengthens the already-robust quantitative systems pharmacology ("QSP") expertise at Simulations Plus and expands the range of therapeutic areas addressed by its software and services. QSP is a rapidly growing field of biomedical research that aims to model the mechanisms behind disease progression and quantify the pharmacokinetics (movement of drugs through the body) and pharmacodynamics (the body’s biological response to drugs) of pharmaceuticals using mathematical computer models. QSP models are highly sophisticated and cost-intensive to build. With this acquisition, Simulations Plus is augmenting its established QSP offerings in a highly attractive field with additional proven models that can be rapidly deployed.

By adding Immunetrics’ QSP services and software capabilities, Simulations Plus has increased the therapeutic areas addressed by its QSP models by more than 50% and introduced new areas of service to existing and potential clients. The acquisition is consistent with the company’s disciplined strategy to grow a portfolio of complementary and innovative software platforms and services.

The acquisition of Immunetrics leverages Simulations Plus’ existing infrastructure by expanding its therapeutic resources into largely underserved areas, including immunology and oncology.

"Today’s announcement marks the beginning of a transformative offering in QSP for our clients," said Shawn O’Connor, Simulations Plus CEO. "Immunetrics brings proven QSP technology, a strong reputation in the market, and an incredibly talented team that we believe will provide us with a leading position in a rapidly growing field. Together, we intend to deliver valuable software solutions to help our clients provide optimized treatments to patients with speed and safety."

"We have been purposeful in our approach to company growth, investing in R&D and personnel, as well as making strategic acquisitions over the years. When we made the decision to expand into the QSP space in 2017, we acquired DILIsym Services and leveraged their expertise to expand into new therapeutic areas. Now, with the addition of Immunetrics, we will be able to provide support for an even greater range of therapeutic areas in a field with tremendous growth opportunity," O’Connor concluded.

Immunetrics CEO, Steven Chang, added, "We are excited to join Simulations Plus and work together with our new colleagues to further expand and standardize the use of QSP in drug development. We complement one another in areas of QSP applications and share a commitment to scientific rigor and positive client outcomes. I believe we are far greater together than the sum of our parts and will achieve significantly more as one unified organization."

The acquisition comes at a time when QSP use in the drug development process is becoming more prevalent. "QSP is no longer an emerging field—12 years after the term was coined, it has become a critical component of drug development," noted Brett A. Howell, President of DILIsym Services, a division of Simulations Plus. "We are seeing it change the way companies run their drug discovery process, accelerating it while simultaneously reducing the likelihood of costly clinical trial failures down the line. The number of QSP-related FDA filings has also been on the rise, as the FDA and other regulatory agencies recognize the value of QSP modeling and predictions. We are excited to join forces with our new colleagues from Immunetrics and provide broader and deeper support to our clients."

After completion of the Immunetrics acquisition, Simulations Plus now has the capability to offer clients QSP modeling software and services solutions for 20 therapeutic areas that include:

Acute myeloid leukemia (AML)

Atopic dermatitis

Cardiac wound healing and fibrosis

Cardiovascular disease

Complement pathway diseases

Drug-induced acute kidney injury

Drug-induced liver injury from small molecules

Gout

Hypertension

Idiopathic pulmonary fibrosis (IPF) and interstitial lung disease (ILD)

Inflammatory bowel diseases (ulcerative colitis and Crohn’s disease)

Multiple myeloma (MM)

Non-alcoholic fatty liver disease (NAFLD)

Non-alcoholic steatohepatitis (NASH)

Non-small cell lung cancer (NSCLC)

Psoriatic arthritis/psoriasis

Renal diseases and interplay with the cardiovascular system

Rheumatoid arthritis (RA)

Systemic lupus erythematosus

Type 2 diabetes/metabolism

Many of Simulations Plus’ existing and new QSP models are suited for applications in additional therapeutic areas with minor modification. The company will also continue developing new models in collaboration with clients and other partners.

Excel Partners, an investment bank with offices in New York and Los Angeles, acted as exclusive financial advisor to Simulations Plus in connection with this transaction. Procopio served as legal counsel to Simulations Plus in connection with this transaction. K&L Gates served as legal counsel to Immunetrics.

On June 20, 2023 The Lubrizol Corporation reported the licensing of its novel excipient polymer technology, Apisolex excipient, to Welton Pharma (Welton) (Press release, The Lubrizol, JUN 20, 2023, View Source [SID1234632811]). The license allows Welton to use the Apisolex excipient worldwide to develop and commercialize a novel formulation of SN-38 to treat colorectal and associated gastro-intestinal cancers.

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Introduced to the market last year, the patented Apisolex excipient is a polyamino-acid polymer designed for parenteral applications. The use of the Apisolex excipient has been proven to increase the solubility of active pharmaceutical ingredients (APIs) by as much as 50,000-fold with the goal of increasing the API’s efficacy in the body. Lubrizol continues to invest in expanding the reach of the Apisolex excipient in the market and nurturing relationships with drug product manufacturers that are facing insoluble API challenges.

Kevin Song, Ph.D. Global Marketing Director, Lubrizol Life Science Health said, "We are continuously innovating to solve challenges for our customers and partners. By delivering differentiated solubility-enhancing solutions to the market, we enable the acceleration of life changing drug products to patients who need them."

Welton is looking to bring life-saving solutions for the treatment of colorectal cancer that impacts 1.9 million people worldwide (2020)1. Combining Welton’s formulation expertise and Lubrizol’s Apisolex excipient, Welton plans to develop a novel formulation of SN-38 to overcome its solubility challenges in water, which has hindered its clinical development. Welton seeks to develop a stable, ready-to-use formulation having higher bioavailability and shorter infusion time to enhance the clinical outcome for cancer patients. In the next 12 months, Welton will focus on advancing their lead formulation with the Apisolex excipient into nonclinical testing and developing plans for the first in-human studies.

Kevin Sill, Ph.D., Welton CEO and cofounder said, "We are thrilled to have access to both this critical excipient and the expertise of Lubrizol. We will be relying on the strong patent protection of the Apisolex excipient, coupled with supply and supporting data as we advance our product."

Request a sample of the Apisolex excipient today by visiting www.apisolex.com.

On June 20, 2023 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported upcoming presentations by the Company and a collaborator at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, to be held June 24 – 27, 2023 in Chicago, Ill (Press release, Blue Earth Therapeutics, JUN 20, 2023, View Source [SID1234632810]). Presentations on investigational clinical and preclinical studies of therapeutic applications of radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) technology are being made at the conference. They include early clinical experience and a preclinical evaluation of 177Lu-rhPSMA-10.1, currently being investigated by Blue Earth Therapeutics as a potential PSMA-targeted therapeutic radiopharmaceutical candidate for the treatment of prostate cancer.

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NOTE: Currently, therapeutic radiohybrid (rh) PSMA compounds are investigational and have not received regulatory approval. Presentations noted by "*" discuss results that are investigational and are not approved by the FDA.

Investigational 177Lu-rhPSMA-10.1

Poster presentations

NOTE: Poster presentations are available Saturday, June 24, 2023, from 6:00 – 8:00 PM CT and throughout the meeting in the Science Pavilion. Times for Meet the Author sessions are below.

Monday, June 26, 2023

Title:

*Improved therapeutic index with the novel PSMA-ligand 177Lu-rhPSMA-10.1 compared to 177Lu-PSMA I&T – an intrapatient comparison

Presenter:

Ralph Bundschuh, MD, PhD, Nuclear Medicine, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany

Session Title:

MTA04-A12 Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A

Session Time:

11:15 – 11:45 AM CT

Area:

Science Pavilion Pod 12: Oncology Clinical Therapy & Diagnosis

Program ID:

346

Tuesday, June 27, 2023

Title:

*Enhanced therapeutic response to 177Lu-rhPSMA-10.1 in pre-clinical models of prostate cancer

Presenter:

Caroline Foxton, Ph.D., Blue Earth Therapeutics, Oxford, UK

Session Title:

MTA 06-B10 Meet the Author: Neurosciences/Oncology Basic & Translational – Group B

Area:

Science Pavilion Pod 10: Oncology Basic and Translational

Session Time:

1:00 – 1:30 PM CT

Program ID:

621

Blue Earth Therapeutics invites participants at the 2023 SNMMI Annual Meeting to learn more about its clinical program in the Medical Affairs information booth of its sister company, Blue Earth Diagnostics, at Booth 6025. For full session details and scientific presentation lists, please see the SNMMI online program here. Information about Blue Earth Diagnostics presence at SNMMI is available here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.

On June 20, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported that the Company has received €1.5 million in non-dilutive funding from Bpifrance – Direction Régionale de Nantes (Press release, OSE Immunotherapeutics, JUN 20, 2023, View Source [SID1234632809]). The "R&D Innovation Loan" program aims at supporting the development of a companion diagnostic for the pivotal Phase 3 clinical trial of Tedopi in NSCLC second line treatment.

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The funding from Bpifrance aims at accelerating the development of an innovative companion diagnostic test based on a simple blood sample. The companion diagnostic is a unique test for a predictive immunological biomarker to identify patients with HLA-A2 genotype who are biological responders to Tedopi. The companion diagnostic will be used for the enrolment of the patient subpopulation in the upcoming registration pivotal Phase 3 of Tedopi. The objective of this final clinical development stage is to confirm the efficacy and safety of Tedopi in second line treatment post-immune checkpoint inhibitor (ICI) failure in HLA-A2 positive NSCLC patients.

NSCLC accounts for 85% of all lung cancers and the HLA-A2 phenotype represents about 45% of the population. Based on selection of patients after ICI failure data, the targeted population for Tedopi in second line is hence considered as rare with high unmet medical needs. Up to 100,000 patients per year are estimated to potentially benefit from Tedopi in 7 major markets across the US, Europe, China and Japan. Tedopi has obtained an orphan drug status designation in the United States and is considered as a precision medicine in Europe for HLA-A2 positive patients.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We warmly thank Bpifrance – Direction Régionale de Nantes for funding the development of this unique companion diagnostic test to accelerate the final clinical development phase of our cancer vaccine Tedopi in preparation to support the regulatory registration in advanced NSCLC for the HLA-A2 patient subpopulation".