On June 20, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy treatment options for multiple cancers, reported that it has initiated clinical trial sites and commenced the enrollment period for its 212Pb-labeled therapeutic product candidates, VMT-α-NET and VMT01 (Press release, Perspective Therapeutics, JUN 20, 2023, View Source [SID1234632852]).

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"We are excited to have our first clinical sites on board for our two lead development programs and to commence the enrollment period for these promising product candidates in patients with melanoma and neuroendocrine tumors," said Thijs Spoor, Perspective’s Chief Executive Officer.

The first product candidate, VMT-α-NET, is a result of Perspective’s intensive in-house research and development efforts to develop a best-in-class radiopeptide. The molecule incorporates the Company’s proprietary chelator technology platform that enables radiolabeling with isotopes of lead (Pb) and shows superior preclinical results as compared to other ligands in its class. On the basis of this promising preclinical data, VMT-α-NET was awarded Fast Track designation under the FDA’s expedited development program. Targeting the somatostatin type receptor 2 (SSTR2) which is over-expressed on a range of different cancer types including neuroendocrine tumors, VMT-α-NET was designed to deliver potent alpha-particle radiation directly to the tumor. Investigators at Fortis Memorial Research Institute (FMRI) located in Gurgaon, India are excited about initial patient experiences in their investigator initiated compassionate use of VMT-α-NET, results of which are expected to be presented at a major medical meeting in Q3 of 2023. An IND-enabled imaging and radiation dosimetry trial utilizing VMT-α-NET is also currently enrolling patients at the University of Iowa, IA, and similar imaging work is occurring at University Hospital Carl Gustav Carus in Dresden, Germany.

Perspective Therapeutics’ trial is a Phase 1/2a Dose Escalation of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors (NCT05636618).
The second product candidate, VMT01, also delivers alpha-particle radiation to tumors by targeting the melanocortin 1 receptor (MC1R) present on melanoma cells. This product candidate has completed clinical imaging studies at Mayo Clinic, Rochester, and results will be presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting in Chicago being held from June 24 to 27, 2023. Recent published preclinical data from Perspective’s scientists show its potential to deliver durable complete responses in treatment-resistant models when combined with existing immunotherapy drugs used to treat melanoma.

Perspective Therapeutics has initiated a Phase 1/2a Dose Escalation trial of [212Pb]VMT01 Targeted Alpha-Particle Therapy for patients with MC1R Positive unresectable and metastatic melanoma (NCT05655312).
Both US trials will be supplied with finished drug product from Perspective’s GMP manufacturing facility in Coralville, IA. Additional CDMO manufacturing sites are expected to be brought online in the coming months to enable broader coverage for sites across the US. Isotope will be supplied using Perspective’s proprietary VMT- α-GEN 212Pb benchtop generator.

"These clinical trials represent a significant advancement in our relentless pursuit of innovative and potent treatments for cancer," said Markus Puhlmann, Chief Medical Officer at Perspective. "We know that despite recent improvements in therapies for neuroendocrine cancers and melanoma, many patients become refractory to treatment. The targeted alpha-particle therapies that are being developed at Perspective have the potential to revolutionize the treatment of these and many other cancers. We look forward to seeing the results emerge over the coming months."

Preliminary results from the initial cohorts for both trials are expected to be available by the end of 2023.

On June 20, 2023 Portage biotech presented its corporate presentation (Presentation, Portage Biotech, JUN 20, 2023, View Source [SID1234632827]).

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On June 20, 2023 Vizgen, the life science company dedicated to improving human health by visualizing single-cell spatial genomics information, reported publication of a study in the June issue of Nature Medicine conducted by Drs. Assaf Magen and Pauline Hamon in the Miriam Merad lab at the Icahn School of Medicine at Mount Sinai, in collaboration with Regeneron Pharmaceuticals, Inc (Press release, Vizgen, JUN 20, 2023, View Source [SID1234632814]). The spatial characterization described in this study was enabled by the company’s spatial transcriptomics MERSCOPE Platform, which simplifies and empowers the entire workflow from sample preparation through data visualization.

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The study, "Intratumoral dendritic cell–CD4+ T helper cell niches enable CD8+ T cell differentiation following PD-1 blockade in hepatocellular carcinoma," leveraged a large neoadjuvant PD-1 blockade trial in patients with hepatocellular carcinoma (HCC) to search for correlates of response to immune checkpoint blockade (ICB) within T-cell rich tumors. Integration of single-cell RNA and TCR sequencing, together with several imaging approaches suggested that T cell activation and expansion occurs predominately at the tumor site and is promoted by CXCL13+ CD4 T cells and mregDCs (mature dendritic cells that have captured tumor antigens). These data provide the closest cellular resolution of T cell diversity in PD-1 treated patients seen in HCC. These findings could be used to develop new therapies targeting these cellular triads.

"Vizgen was developed precisely for the type of work conducted in this study and it is immensely gratifying to see our spatial transcriptomics platform play an important role in evaluating and imaging gene panels and in understanding cellular role and function in this clinical trial, which could ultimately improve tumor response to treatment," said Terry Lo, President and CEO of Vizgen. "We look forward to the continued demonstration of Vizgen’s multiplexing, high resolution in situ MERSCOPE Platform’s potential in empowering future breakthrough biological discoveries."

Surgical resection is traditionally the preferred treatment for HCC, a rare, aggressive type of liver cancer that is only variably responsive to chemotherapy, and more than half of these tumors recur within 2 years. Neoadjuvant immune checkpoint blockade targeting the PD-1/PD-L1 axis has been successful in inducing pathological response and preventing recurrence in multiple tumor types, in part by driving the expansion of tumor-specific T cells, which may also induce systemic immunity and eliminate micrometastases. This neoadjuvant clinical trial for early-stage HCC patients, led by Drs. Thomas Marron and Myron Schwartz, in which treatment-naive patients received two doses of PD-1 blockade prior to surgery, observed a 30% pathological response rate, which prompted a more detailed investigation into the cellular and molecular pathways that promote an effective anti-tumor immune response.

"I am excited about the high quality of the data produced by this study and the important implications this has for HCC and cancer biology as a whole," said Jiang He, PhD, Scientific Co-founder and Senior Director of Scientific Affairs of Vizgen. "We hypothesize that this interaction between mregDCs, helper cells and T cells could be critical across multiple other cancers. We hope this is the first of many discoveries driving insight into PD-1 therapy and advancing our treatment of cancer patients."

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.