On October 10, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), reported that two upcoming investigator-initiated trials (IIT) were presented at the North American Neuroendocrine Tumor Society (NANETS) 2023 Symposium in Montreal, Canada, which was held October 4-6, 2023 (Press release, Perspective Therapeutics, OCT 10, 2023, https://perspectivetherapeutics.com/press-releases/perspective-therapeutics-vmt-%CE%B1-net-protocols-presented-at-the-north-american-neuroendocrine-tumor-society-nanets-2023-symposium/ [SID1234635816]).

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Presentation One: Phase 1 Trial of Pb-212-VMT-alpha-NET in Select Metastatic or Inoperable Somatostatin Receptor Positive Tumors

Summary: This presentation detailed the planned protocol for the IIT Phase 1 trial of Pb-212-VMT-alpha-NET in patients with metastatic or inoperable somatostatin receptors positive (SSTR+) tumors to investigate if this new treatment can improve management of patients naïve to prior radioligand therapy. The study is an open-label, single arm, single-center, phase 1 trial evaluating the safety, tolerability, and pharmacokinetic properties of the alpha-emitting, systemic radioligand therapy agent Pb-212-VMT-alpha-NET in five different SSTR+ tumors: gastrointestinal neuroendocrine tumors (GI-NET), pheochromocytoma and paraganglioma (PPGL), small cell lung cancer (SCLC), renal cell carcinoma (RCC), and head and neck (H&N). Enrollment for this study is expected to commence in the first quarter of 2024.

Presenter: E. Mena, MD, National Cancer Institute, National Institutes of Health

Presentation Two: Phase 1/2 Trial of Pb-212-VMT-alpha-NET in GI Neuroendocrine Tumors and Pheochromocytoma/Paraganglioma Previously Treated with Radioligand Therapy

Summary: This presentation detailed the planned protocol for the IIT Phase 1/2 trial designed to determine if such a new treatment can improve management of patients who have progressed on beta-emitting radioligand therapy. This study is an open-label, single arm, single-center, Phase 1/2 study evaluating the safety, tolerability, and pharmacokinetic properties of the alpha-emitting, systemic radioligand therapy agent Pb-212-VMT-alpha-NET in somatostatin receptors (SSTR+) metastatic GI neuroendocrine tumors (GI-NETs) and pheochromocytoma/paraganglioma (PPGL) tumors. Enrollment for this study is expected to commence in the first quarter of 2024.

Presenter: J. Del Rivero, MD, National Cancer Institute, National Institutes of Health

"There are currently no approved targeted radiopharmaceuticals for NETs patients outside of the gastroenteropancreatic indication," said Chief Executive Officer Thijs Spoor of Perspective Therapeutics. "We are excited to expand clinical studies to a wider range of cancer types in order to potentially expand therapeutic options for patients with these difficult to treat tumors."

"We are delighted to have the NIH conduct these studies to investigate the safety and efficacy of [212Pb]VMT-alpha-NET in these expanded patient populations." said Chief Medical Officer Markus Puhlmann, MD MBA, of Perspective Therapeutics. "These clinical studies are evaluating [212Pb]VMT-alpha-NET in a wide range of neuroendocrine tumors, where the unmet need is greatest."

The presentation abstracts can be accessed on the conference website at View Source The presentations will also be made available on the Company’s website at www.perspectivetherapeutics.com.

About neuroendocrine tumors

Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are approximately 175,000 people living with this diagnosis.

About VMT-α-NET

VMT-α-NET is a clinical stage targeted alpha particle therapy (TAT) radiopharmaceutical being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, which are a rare and difficult-to-treat type of cancer. VMT-α-NET incorporates Perspective Therapeutics’ proprietary lead-specific chelator (PSC) to bind Pb-203 for SPECT imaging, and Pb-212 for alpha particle therapy.

On October 10, 2023 Oxford Vacmedix (OVM), the UK-based biopharma company focused on the development of vaccines to treat cancer reported the publication of a key research paper on its lead cancer vaccine, OVM-200 (Press release, Oxford Vacmedix, OCT 10, 2023, View Source;utm_medium=rss&utm_campaign=publication-highlights-the-importance-of-survivin-the-cancer-treatment [SID1234635815]). The paper, in the online journal Advanced Therapeutics, comprehensively reviews the rationale for targeting survivin, the advances in vaccine design using OVM’s novel recombinant overlapping peptide (ROP) platform and the compelling preclinical results for OVM-200 being used both alone and in combination with an immune oncology agent.

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OVM-200 targets survivin, a protein overexpressed by cancer cells that allow unregulated growth and stimulates an immune response. The vaccine is in a Phase 1 trial which is both the first time OVM-200 has been used in people and also the first time any ROP based vaccine has been tested in the clinic. The Phase I trial of OVM-200 is focused on safety and on establishing an immune response in advanced cancer patients in three cancer indications – non small cell lung cancer (NSCLC), prostate cancer and ovarian cancer. Patients are being treated at five leading hospitals in the UK. To date twelve patients have been treated at four dose levels in Phase 1a, the dose escalation part of the trial – the initial results show very good safety and a strong immune response. A further 24 patients are being treated in Phase 1b.

Professor Shisong Jiang, Founder and Chief Scientific Officer of OVM, said:

"We are very pleased this research paper has been published. It shows not just the rationale for selecting survivin as a target and for the design of our ROP vaccines but also our convincing preclinical results with OVM-200. We look forward to the completion of Phase 1 and to being able to combine OVM-200 with immune oncology agents in Phase 2, to help patients with advanced cancer."

Dr Mark Tuthill, Principal Investigator for the trial at the Oxford University Hospitals NHS Trust added;

"We are very excited by the Phase 1a results from the trial of OVM-200 and look forward to being able to progress with the trial. We are very pleased to be working with the team at OVM and to have the opportunity to see how these vaccine treatments can benefit patients. We strongly believe that cancer vaccine will play a major role in the future, potentially in combination with immune-oncology agents."

On October 10, 2023 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported an amendment to our existing clinical collaboration and supply agreement with Novartis Institutes for BioMedical Research, Inc. ("Novartis") to increase the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients (Press release, Olema Oncology, OCT 10, 2023, View Source [SID1234635814]).

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"The amendment announced today significantly increases the size of our ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib, in collaboration with Novartis," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "With the Phase 1b dose escalation portion now successfully completed, we are currently in Phase 2 dose expansion at the 120 mg dose of palazestrant in combination with 600 mg of ribociclib. We believe that this expanded study now has the potential to generate a clinical dataset sufficient to support the regulatory pathway for a first-line pivotal trial."

Olema first signed a clinical collaboration and supply agreement with Novartis in July 2020, the agreement was amended and restated in January 2022, and focuses on the evaluation of the safety, tolerability and efficacy of palazestrant in combination with Novartis’ proprietary cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor ribociclib and/or Novartis’ proprietary phosphatidylinositol 3-kinase (PI3Ka) inhibitor alpelisib in patients with metastatic ER+ breast cancer. The amendment adds approximately 30 patients to be enrolled in the cohort expansion phase of the palazestrant clinical study in combination with ribociclib.

On October 10, 2023 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported preliminary financial and operational highlights for the third quarter ended September 30, 2023, as well as a reorganization designed to accelerate the Company’s path to profitability (Press release, NanoString Technologies, OCT 10, 2023, View Source [SID1234635813]).

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"Our teams delivered strong revenue results for the third quarter, with preliminary results exceeding consensus estimates and the high end of our guidance range," said Brad Gray, President and CEO of NanoString. "In addition, we began important steps to deliver on our commitment to improve our financial profile."

"As part of our Company’s evolution and with a focus toward achieving profitability, we have decided to reorganize our research and development and manufacturing operations. As part of this reorganization, we expect to reduce expenses by more than $15 million on an annualized basis," continued Mr. Gray. "While we are confident these changes focus our investments on the activities that are best for NanoString’s future success, we will have to part ways with many wonderful colleagues. I would like to thank our team for their commitment, innovation and hard work."

"With strong revenue growth and improved working capital, we were able to reduce our cash burn by about 50% over the prior quarter," said Thomas Bailey, Chief Financial Officer of NanoString. "We expect our reorganization will further reduce our expenses and net operating loss in the fourth quarter and 2024."

Preliminary Third Quarter Financial Results
•Revenue is expected to be over $48 million, representing year on year growth of more than 60%, above the upper end of our guidance range of $45 to $47 million and above the consensus revenue estimate of approximately $46 million
•Spatial biology revenue is expected to be approximately $29 million, above the upper end of our guidance range of $27 to $28 million and above the consensus revenue estimate of approximately $27 million
•nCounter revenue, inclusive of all service and other revenue, is expected to be approximately $19 million, at the upper end of our guidance range of $18 to $19 million and in line with the consensus revenue estimate of approximately $19 million
Third Quarter Highlights
Spatial Biology
•Accelerated CosMx shipments during Q3, resulting in Q3 spatial biology instrument revenue growth of approximately 348% year-over-year
•Successfully defended sizeable CosMx SMI instrument order book, fulfilling or retaining approximately 95% of cumulative orders as of September 30, 2023
Operating Expenses and Cash
•Commenced implementing a reorganization of the Company’s research and development and manufacturing departments and activities, which is expected to eliminate approximately 110 positions from the Company and reduce expenses by over $15 million on an annualized basis. A charge of approximately $5 million is expected to be incurred in the fourth quarter of 2023 primarily as a result of severance and support being provided to transitioning employees
•Reduced use of cash to approximately $20 million during the third quarter, as compared to about $37 million in the second quarter, with further improvement expected in the fourth quarter and in 2024
These preliminary results are based on management’s initial analysis of operations for the quarter ended September 30, 2023 and are subject to further internal review.
Third Quarter Conference Call
The Company plans to release full operating results for the third quarter of 2023 after the close of trading on Monday, November 6, 2023. Company management will host a conference call beginning at 4:30pm ET to discuss those results and provide updated financial guidance.
Investors and other interested parties should register for the conference call in advance by visiting View Source Following registration, an email confirmation will be sent that includes dial-in details and unique conference call codes for entry. Registration is open throughout the call but to ensure connection for the full call, registration in advance is recommended.
The link to the webcast and audio replay will be made available at the Investor Relations website: nanostring.com.
A replay of the call will be available beginning November 6, 2023, at 7:30pm ET through midnight on November 13, 2023. To access the replay, dial (800) 770-2030 or (647) 362-9199 and reference Conference ID: 72369. The webcast will also be available on the Company’s website for one year following the completion of the call.

On October 10, 2023 NanOlogy LLC, a clinical-stage oncology company, reported that initial safety and clinical outcomes from a Phase 2 clinical trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) in locally advanced pancreatic cancer (LAPC) were published online ahead of print in Pancreas and two posters were presented at the ninth AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer in Boston reporting downstaging and immune data from the trial (Press release, NanOlogy, OCT 10, 2023, View Source;utm_medium=rss&utm_campaign=interim-results-from-a-nanology-phase-2-clinical-trial-of-its-intratumoral-investigational-drug-in-the-treatment-of-locally-advanced-pancreatic-cancer [SID1234635812]).

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The research article entitled Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome provides safety and response data from dose escalation and 2-injection cohorts. Clinical investigators included Neil Sharma, MD, Simon Lo, MD, Mohamed Othman, MD, and Antonio Mendoza-Ladd, MD.

"Pancreatic cancer is among the most lethal cancers with 5-year survival of only 12%," said lead investigator and author, Neil Sharma, MD. "The interim results from this study, particularly the potential for downstaging and immunomodulation, are encouraging and warrant expanded studies to further evaluate the clinical benefit of neoadjuvant IT LSAM-PTX in combination with standard of care therapy."

The dose escalation/expansion trial (NCT03077685) enrolled 54 subjects across four clinical sites in three cohorts including one-injection escalation (n=10), two-injection expansion (n=25), and four-injection expansion (n=19). The research article reports data from evaluable subjects in the first two cohorts while the third is pending final readout. Highlights include:

Most treatment-emergent adverse events (84%) were mild to moderate and considered related to underlying disease and comorbidities. No confirmed treatment-related severe adverse events or pancreatitis were reported. The most common adverse events were abdominal pain and nausea. Plasma paclitaxel levels attributed to LSAM-PTX were unremarkable throughout the study.
In the 2-injection cohort, 8 of 22 (36%) evaluable subjects were downstaged from nonresectable to resectable disease. Six subjects underwent surgery with five R0 resections and one R1 resection. Mean survival increased in resected subjects to 35 months versus 19 months for nonresected subjects.
Tissue was available pre/post LSAM-PTX treatment for immunophenotypic profiling via multiplex immunofluorescence from the 6 subjects undergoing resection. Despite pancreatic cancer being considered a "cold" tumor, favorable antitumor immunomodulation was observed with increases in concentrations of immune effector cells and NK cells along with decreases in concentrations of immune suppressor cells.
In evaluable subjects from the 2-injection cohort, disease control rate was 82% (18/22) at 3 months and 94% (16/17) at 6 months.
Additionally, two posters presented downstaging and immune data from the Phase 2 trial following IT LSAM-PTX at the recent AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer.

The first poster (B004) entitled: "EUS guided local administration of large surface area microparticle paclitaxel with neoadjuvant chemotherapy in locally advanced pancreatic cancer: A single center experience" was presented by Harishankar Gopakumar, MD (University of Illinois College of Medicine).

Data were collected prospectively on 6 of 13 (46%) LAPC subjects in the second cohort of the trial who received 2 monthly endoscopic ultrasound-guided fine needle injections (EUS-FNI) of LSAM-PTX in addition to neoadjuvant chemotherapy at Parkview Health and subsequently underwent surgery from 2018 to 2019.
EUS-FNI of LSAM-PTX, added to neoadjuvant chemotherapy, was safe and resulted in a significant reduction in tumor volume, significant tumor necrosis on pathology exam, and favorable changes in TME immunophenotypic configuration.
The preliminary results suggest that adding LSAM-PTX to neoadjuvant chemotherapy could increase the rate of downstaging of LAPC to resectable disease and improve clinical outcomes.
The second poster (A048) entitled: "Enhancing the immune response in locally advanced pancreatic cancer (LAPC) with intratumoral of large surface area microparticle paclitaxel (LSAM-PTX)" was presented by Andrew Hendifar, MD (Cedars-Sinai Medical Center).

Blood samples were collected before and after treatment for flow cytometry analysis from 14 subjects in the third cohort of the trial who received 4 monthly EUS-FNI of LSAM-PTX in addition to prior or current SOC therapy.
Immunophenotyping of blood from LAPC subjects treated with IT LSAM-PTX demonstrates peripheral immunomodulation to a phenotype associated with anti-tumor immune effects, including favorable immunosurveillance, and is consistent with changes found in the TME in resected tissues. Immunosuppressive cell types typically associated with poor clinical outcomes were reduced at six months.
Anti-tumor immunomodulation without immunosuppression suggests that IT LSAM-PTX may be amenable to combination with immunotherapy.