On July 11, 2023 Hummingbird Diagnostics GmbH, a leader in reading blood-based small RNAs for early disease detection and characterization, reported a publication in the Journal of Thoracic Oncology following a poster presentation at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting on the miLung small RNA blood test for early-stage lung cancer detection (Press release, Hummingbird Diagnostics, JUL 11, 2023, View Source [SID1234633185]).

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The results of the study provide clear evidence for the viability of a small RNA-based blood test as an alternative to low-dose computed tomography (LDCT) screening, which could be deployed in a primary care setting for early-stage lung cancer detection. Screening was performed on stabilized whole blood samples from 1,384 individuals meeting National Lung Screening Trial (NLST) lung cancer eligibility criteria (age 55-74, pack-years ≥30) by leveraging ultra-deep small RNA sequencing. A newly discovered 18-small RNA signature (miLung) was validated as a molecular biomarker for lung cancer in an independent cohort of 441 individuals1. The miLung small RNA blood test is noninvasive and identifies specific small RNAs, molecular biomarkers associated with lung cancer in whole blood samples that can be drawn at the point of care.

"We have developed a sensitive yet robust analysis using small RNA tumor markers to detect early-stage lung cancer," remarked Bruno Steinkraus, PhD, Chief Scientific Officer of Hummingbird Diagnostics. "Our approach integrates tumor-derived and immune system-derived small RNAs into unbiased machine learning to inform early-stage lung cancer detection."

The multicenter study was performed in collaboration with Dr. Amita Sharma at Massachusetts General Hospital, Professor Alexander Bankier at Beth Israel Deaconess Medical Center, Professor Martin Reck at LungenClinic Grosshansdorf, Professor Clemens Aigner of University Medicine Essen and Professor Klaus Rabe of LungenClinic Grosshansdorf amongst others.

"Early cancer detection remains the most effective strategy to reduce mortality associated with lung cancer," commented Jochen Kohlhaas, Founder and Chief Executive Officer of Hummingbird Diagnostics. "We envision the miLung test as a non-invasive alternative to LDCT scans for use in primary care settings to improve participation in screening, and potentially reduce gender- and race-based disparities in access to lung cancer screening."

The ASCO (Free ASCO Whitepaper) poster presentation titled "Early detection of lung cancer using small RNAs" can be found here.

The article can be found on the Journal of Thoracic Oncology’s website here.

1 Sikosek T and Horos R et al. Early Detection of Lung Cancer using small RNAs. Journal of Thoracic Oncology (2023), doi: View Source

On July 11, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported updates on disease control data in the Part A safety lead-in of its ongoing THIO-101 phase 2 trial, evaluating THIO in sequential combination with cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, JUL 11, 2023, View Source [SID1234633184]).

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Of the first 11 patients enrolled in THIO-101 to complete at least 1 post baseline response assessment, 9 (82%) met the primary endpoint of disease control (defined as a Complete Response, Partial Response, or Stable Disease per RECIST 1.1). All patients enrolled have previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor (CPI) and platinum-based chemotherapy for advanced NSCLC. No new safety analysis was conducted at this time.

"The 82% disease control rate observed so far with this combination is highly encouraging, especially in the heavily pre-treated population with previous immune CPI resistance, where typically the Disease Control Rates are in the 25-35% range. This preliminary data aligns with our pre-clinical data which showed that THIO, followed by an immune checkpoint inhibitor, greatly slowed and reduced tumor progression when compared to treatment with CPI alone. We look forward to continue the monitoring of these patients and evaluate disease control rates on a longer time frame with the next response assessment phases," said Vlad Vitoc, MAIA’s Chief Executive Officer.

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.

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 potential immune system activation effects in NSCLC patients by administering THIO in sequential combination with Regeneron’s anti-PD1 therapy, Libtayo (cemiplimab), allowing for immune activation and PD-1 sensitivity to take effect. The trial will test 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 (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.

On July 11, 2023 IconOVir Bio, Inc. (IconOVir), a clinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported that the first patient has been dosed in a Phase 1 dose escalation and expansion clinical trial evaluating intravenously (IV) administered ICVB-1042 for the treatment of advanced solid tumors (Press release, IconOVir Bio, JUL 11, 2023, View Source [SID1234633183]).

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"We are delighted to begin clinical evaluation of ICVB-1042, our potentially best-in-class OV and the first product candidate to emerge from our portfolio," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir. "We founded IconOVir to pioneer the next generation of OVs to improve the care and treatment of people living with solid tumors, with the ultimate mission of curing cancer and restoring life to patients everywhere. The initiation of this Phase 1 trial marks an important step toward achieving that goal and I look forward to working with our clinical partners to enroll and execute this study."

ICVB-1042 is a chimeric oncolytic adenovirus, rationally designed with genomic modifications to confer tumor selective replication, broad tropism and enhanced tumor cell killing, as well as allow for either IV or intratumoral delivery. In preclinical studies, ICVB-1042 has been shown to infect and kill a broad range of tumor cells, including head and neck, bladder, lung and breast, suggesting that it could have potential utility in a wide range of solid tumor indications.

"Leveraging our proprietary platforms, we engineered and combined novel mutations to create ICVB-1042, the first OV with the potential to be delivered systemically, without sacrificing potency or tumor selectivity," said Julie Maltzman, M.D., Chief Medical Officer of IconOVir. "Preclinical data suggest that ICVB-1042 offers a highly differentiated profile relative to currently marketed or OVs in development, which may translate into more effective anti-cancer activity across a range of difficult-to-treat tumors. We expect to know from early data whether ICVB-1042 can be effectively delivered IV to drive viral replication in the tumor, which would provide strong mechanistic support for our approach. We look forward to reporting initial safety data later this year, with potential biological proof-of-concept in the first half of 2024 and we are pleased that our first patient tolerated ICVB-1042 therapy well."

About the Phase 1 Clinical Trial

IconOVir’s Phase 1 clinical trial is an open-label study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and biological and clinical activity of ICVB-1042 in patients with relapsed or refractory solid tumors. The goal of the study is to establish a maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). Once the MTD is reached, or a RP2D is established, IconOVir intends to open expansion cohorts in advanced solid tumors. Biological activity will be measured by viral replication in the tumor. Clinical response will be assessed by immune Response Evaluation Criteria in Solid Tumors (iRECIST) version 1.1. To learn more about the first-in-human trial of ICVB-1042, please visit www.clinicaltrials.gov (NCT05904236).

On July 11, 2023 CEL-SCI Corporation (NYSE American: CVM) reported new data from a biomarker analysis of its pivotal Phase 3 study in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 10, 2023 in Montreal, Canada, in the presentation titled "Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study" (Press release, Cel-Sci, JUL 11, 2023, View Source [SID1234633182]). The Leukocyte Interleukin Injection (LI) [aka Multikine*] talk, was delivered by Philip Lavin, PhD, lead biostatistician for over 80 regulatory approvals/clearances who has also served on multiple U.S. Food and Drug Administration (FDA) review panels. Dr. Lavin is the lead biostatistician for CEL-SCI’s IT-MATTERS study.

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Tumor cell PD-L1, also known as PD-L1 (Programmed Death-Ligand 1), a protein that plays a crucial role in immune system regulation, is a target pathway for immune checkpoint inhibitors, a major class of oncology drugs. These work by blocking the interaction between tumor cell PD-L1 and the PD-1 receptor. The global PD-L1/PD-1 therapeutics market was valued at $34.8 billion in 2022 and includes two drugs approved for head and neck cancer, specifically unresectable recurrent or metastatic SCCHN, Keytruda and Opdivo.

While pembrolizumab (Keytruda) and nivolumab (Opdivo) are approved for use in recurrent and metastatic head and neck cancer, CEL-SCI’s Phase 3 data showed that Multikine prolonged overall survival in the lower risk for recurrence advanced primary head and neck cancer patients and more so in a subset comprising >70% of the lower-risk patients (all had low levels (defined as TPS<10) of tumor cell PD-L1 expression).

"This data is of great interest in that, in our opinion, they suggest Multikine can be effective in extending life in patients who are generally not well served by checkpoint inhibitors. A combination of Multikine and drugs like Keytruda or Opdivo may in fact extend the reach of coverage in this hard-to-treat disease and thus help more patients, indicating a promising new treatment path," stated CEL-SCI CEO Geert Kersten. "Our immediate opportunity is in head and neck cancer, yet these latest results also point to potential in other solid tumors as well. We are interested in running such combination studies."

The AHNS presentation focused on biomarker analysis, specifically featuring tumor cell PD-L1, from tumor specimens that were collected from nearly half of the patients in CEL-SCI’s pivotal Phase 3 study.

In June of 2021, a Multikine study reported a statistically significant 14.1% absolute 5-year overall survival benefit in the intent to treat (ITT; n=923) subjects who were categorized as lower risk for recurrence (LR; n=380) per National Comprehensive Cancer Network (NCCN) guidelines and received Multikine followed by surgery and radiotherapy, as compared to control LR subjects who received only standard of care (SOC) (surgery plus radiotherapy), resulting in a near 4-year median overall survival advantage over control (101.7 vs 55.2 months). The Company is pursuing paths to marketing approval for Multikine in the treatment of head and neck cancer in the USA, Canada, the UK and the European Union.

Highlights of the data we presented at AHNS conference include:

A Kaplan-Meier lifetable for low tumor cell PD-L1 (defined as TPS <10) demonstrated a significant log rank test (2-sided p=0.034) favoring the Multikine plus Standard of care (SOC) group vs SOC alone; there was an absolute 20% survival advantage at 5-year favoring both Multikine plus SOC (~60% alive) vs SOC alone (~40% alive)
The PD-L1 low subgroup represents >70% of all LR subjects
Two-way and three-way interaction models for the LR population confirmed statistical significance favoring Multikine treatment regimen plus SOC vs SOC alone with a 0.6 hazard ratio for 3-way interaction and a 0.55 hazard ratio for the 2-way interaction vs 0.68 hazard ratio for the study LR population that contained all patients, not just those with low PD-L1 (TPS <10)
The data suggest potential benefits for combining Multikine with checkpoint inhibitors to further improve overall survival outcome in this hard-to-treat patient population.

On July 11, 2023 OncoBeta GmbH, a medical device company specialised in innovative epidermal radioisotope therapies, reported that the phase IV international multi-centre study designed to further evaluate the Complete Response Rate of patients with non-melanoma skin cancer after treatment with Rhenium-SCT is now fully recruited (Press release, OncoBeta, JUL 11, 2023, View Source [SID1234633181]).

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The EPIC-Skin study (Efficacy of Personalised Irradiation with Rhenium-SCT for the treatment of non-melanoma skin cancer) is based on the proven effect of the ß-emitter rhenium-188 in the treatment of basal cell (BCC) and squamous cell carcinomas (SCC)1,2. The study aims to further evaluate the efficacy of Rhenium-SCT as well as important Patient Reported Outcome Measures such as quality of life, treatment comfort and cosmetic outcomes.

Patients treated had a confirmed histopathology of stage I or II non-melanoma skin cancer. With the latest treatment round complete, all patients are now in the follow-up phase, which monitors quality of life, treatment comfort and cosmetic outcomes over the next 24 months. An interim analysis is expected to be published in mid 2023.

Professor Mike Sathekge, an internationally acclaimed researcher and current Head of Nuclear Medicine at Steve Biko Academic Hospital in Pretoria, South Africa, treated his first patient enrolled in EPIC-Skin in November 2022, and the latest patient marks the final treatment in the study.

An international multi-centre trial, the EPIC-Skin study is being conducted across five countries and seven major cities including Rostock, Vienna, London, Pretroria, Gold Coast, Perth and Sydney with more than 180 patients taking part.

There are more than 7.7 million cases of NMSC each year, and incidence rates are increasing globally.3,4 Traditional treatments for NMSCs predominantly involve surgery, which carries a risk of scarring or loss of function. Treatment with Rhenium-SCT employs a non-invasive superficial application of a paste containing ß-emitting particles directly to the lesion, which eliminate cancer cells without the need for surgery.2,5,6

Dr. Gerhard Dahlhoff, Medical Director at OncoBeta GmbH, stated: "We are excited to complete the final patient recruitment within EPIC-Skin as we will now start to receive data on the quality-of-life outcomes. With patients in study centres across Australia, Austria, Germany, United Kingdom and South Africa, we have a mix of patients, ethnicities, NMSC localisations and lesion characteristics which will enable us to even further evaluate the outcomes of treatment with Rhenium-SCT."

Shannon D. Brown III, CEO and Managing Director at OncoBeta GmbH, said, "The patient journey is often a difficult one, so it is critical that the medical community continues to improve and develop new treatment options for patients with NMSCs. The EPIC-Skin clinical study has the potential to influence and change the way we evaluate and fit NMSC treatments to the individual needs and requirements of patients."

ClinicalTrials.gov Identifier: NCT05135052

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans.4 The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.7

The Rhenium-SCT is a painless*, single session†, non-invasive‡ therapy that provides aesthetic results, even in cases otherwise considered difficult to treat.2,5,6 The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The Rhenium-SCT is a precise, personalised1,2 therapy that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient’s skin and the application is safe and simple for the applying physician. Most cases of NMSCs (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT in one single session.2,5,6† Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.