On July 10, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has dosed the final patient and completed recruitment into the Phase III pivotal study ZIRCON (Zirconium in Renal Cancer Oncology, NCT03849118) of its investigational renal (kidney) cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) (Press release, Telix Pharmaceuticals, JUL 10, 2022, View Source [SID1234616573]). This global study has dosed 300 patients to date, exceeding the target enrolment of 252 patients, announced on 8 March 2022.

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TLX250-CDx, which has received "Breakthrough Designation" from the U.S. Food and Drug Administration (FDA)1, is being developed as an imaging agent for use in the characterization of indeterminate renal masses previously identified on computed tomography (CT) or magnetic resonance imaging (MRI) as clear cell renal cell cancer (ccRCC) or non-ccRCC.

The detection of renal masses is increasing due to widespread use of cross-sectional imaging. Many of these are small renal masses and represent a diagnostic challenge as current imaging cannot reliably distinguish benign or malignant lesions from renal cell carcinoma, leading to invasive biopsy or partial nephrectomy to confirm the diagnosis. These procedures are not always necessary and can lead to complications2. It is estimated that up to 80% of small renal masses are malignant3.

If the study is successful, TLX250-CDx may provide a non-invasive method to aid in diagnosis and staging of ccRCC and the identification of metastatic disease through whole body imaging, ultimately leading to improved patient management by minimizing the need for surgical intervention for diagnosis and guiding treatment decisions.

In addition to its potential use as a diagnostic and staging tool, Telix is considering the potential for TLX250-CDx to also be used as an active surveillance tool for patients not deemed surgical candidates.

Brian M Shuch, MD, Director of the Kidney Cancer program at UCLA said: "We may well be on the cusp of a paradigm shift in how we manage renal masses. The incidence of small renal masses is increasing, yet there is currently no imaging tool that can effectively diagnose or stage clear cell renal cancer. Most patients are scheduled for the operating room without a firm diagnosis and often surgery is found to be unnecessary. Should this study report positive results, it may provide the non-invasive imaging tool to aid in accurate diagnosis that patients and clinicians have been waiting for. Congratulations to Telix for completing this ambitious international trial."

Renal cell carcinoma (RCC) is the deadliest of all urological cancers with a late-stage 5-year survival rate of 14%4. ccRCC is the most common sub-type and accounts for approximately 80% of all renal cell carcinoma cases5. RCC is also an increasingly frequent cancer, having more than doubled in incidence in the developed world over the last 50 years.6 Worldwide, there were more than 400,000 new cases in 2020, and >175,000 people died from their disease.7

TLX250-CDx will be available in selected countries to eligible patients under an Expanded Access Program (EAP) (also known as early access, pre-approval access or emergency use), in accordance with Telix’s Compassionate Use Policy and subject to jurisdictional regulatory requirements.8

Dr Colin Hayward, Telix’s Chief Medical Officer said, "The completion of this trial will bring us a step closer to commercialization for this diagnostic imaging agent which may address a significant unmet need in the diagnosis and management of ccRCC. It also builds on Telix’s commitment to urologic oncology, with the potential of delivering a major new imaging indication. This milestone could have not been achieved without the support of our many collaborators including the 36 clinical sites who participated in the trial, our global manufacturing teams and the associated auxiliary team who have supported this study. Most of all we wish to thank the patients who have volunteered to participate in this study."

ZIRCON is a confirmatory, prospective, open-label, multi-centre phase III study to evaluate sensitivity and specificity of 89Zr-TLX250-CDx PET/CT imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IDRM), scheduled for partial or total nephrectomy. Telix expects to report the outcome from the ZIRCON study in 2H, 2022.

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is an investigational product being developed by Telix for the purpose of non-invasive detection of clear cell renal cancer in patients with "indeterminate renal masses" (IDRMs) are, typically identified based on CT or MRI imaging and are an increasing medical dilemma as more scans are performed and more IDRMs are identified. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the characterization of indeterminate renal masses previously identified on CT or MRI as ccRCC or non-ccRCC. , ccRCC is the most common and aggressive form of kidney cancer.

About the ZIRCON Study

ZIRCON (Zirconium Imaging in Renal Cancer Oncology, NCT03849118) is an international multicentre Phase III study at 34 sites in Europe, Australia, Turkey, Canada and the United States. ZIRCON is a prospective imaging trial in renal cancer patients undergoing kidney surgery with the objective of determining the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic "standard of truth" determined from surgical resection specimens.

On July 8, 2022 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that effective as of July 7, 2022, the Company closed the Phase 2 study (CP-MGA271-06) evaluating the investigational regimen of enoblituzumab (Fc-optimized B7-H3-directed monoclonal antibody) in combination with either retifanlimab (anti-PD-1 monoclonal antibody) or tebotelimab (PD-1 × LAG-3 bispecific DART molecule) in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) (Press release, MacroGenics, JUL 8, 2022, View Source [SID1234616572]).

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The decision to discontinue the study was based on an internal review of safety data, which included the occurrence of seven fatalities potentially associated with hemorrhagic events in both arms of the study (of 62 total patients treated). Six of the seven fatal events observed in the CP-MGA271-06 study were assessed by investigators as secondary to disease progression and/or unrelated to the study treatment, and one event was assessed as possibly related. Fatal tumor-related hemorrhages and airway obstruction are known risks in patients with SCCHN. The incidence of fatal events observed in the study that were potentially hemorrhagic in origin was higher than what has been reported for this patient population in the medical literature (i.e., 1 – 3.6% as per Argiris, et al., J Clin Oncol. 2019 Dec 1, 37(34):3266) and in the context of a risk : benefit analysis, prompted the Company’s decision to close the study. Accordingly, the Company informed investigators and the U.S. Food and Drug Administration (FDA) of the study closure and instructed investigators that no additional patients in the study were to be enrolled or receive further treatments as of July 7, 2022.

MacroGenics continues to investigate and monitor these events, and an analysis of the data is ongoing. There were no hemorrhagic events or coagulopathies observed in nonclinical toxicology studies of enoblituzumab, and the incidence of any fatal hemorrhage reported in earlier studies of enoblituzumab evaluated in over 340 patients across a broad range of tumor types was less than 1%.

"Our top concern in conducting clinical trials is the safety of study participants," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We were surprised by the emergence of these events in first-line SCCHN patients, as we had not observed any such events in an earlier, smaller study in patients with later-line SCCHN disease who were treated with enoblituzumab in combination with an anti-PD-1 antibody. Similar safety events have not been reported in patients treated with MGC018, our B7-H3-targeted ADC molecule, and the decision to close the CP-MGA271-06 study does not impact our ongoing MGC018 study activities. We’d like to thank all patients, their families and caregivers who participated in the CP-MGA271-06 study."

About Enoblituzumab
Enoblituzumab is an investigational anti-B7-H3 monoclonal antibody that incorporates an immunoglobulin G1 fragment crystallizable (Fc) domain designed to enhance Fcγ receptor-mediated antibody-dependent cellular cytotoxicity. B7-H3, a protein in the B7 family of immune regulator proteins, is widely expressed by a number of different tumor types and may play a key role in regulating the immune response to various types of cancer.

About Retifanlimab
Retifanlimab is an investigational anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics retains the right to develop the molecule in combination with product candidates from its pipeline.

About Tebotelimab
Tebotelimab is an investigational, bispecific DART molecule designed to block PD-1 and lymphocyte-activation gene 3 (LAG-3) checkpoint molecules to sustain or restore the function of exhausted T cells.

On July 8, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, applauds the recently reported that Centers for Medicare and Medicaid Services (CMS) Calendar Year 2023 Physician Fee Schedule proposal, which considers follow-up colonoscopy to an at-home test as a preventive service (Press release, Exact Sciences, JUL 8, 2022, View Source [SID1234616571]). If adopted, the rule would eliminate all cost to Medicare patients for a follow-up colonoscopy after a positive at-home colorectal cancer screening test. Additionally, CMS has proposed covering the service for individuals 45 years of age or older who participate in Medicare, which aligns with the previous recommendation from the United States Preventive Services Task Force (USPSTF) and the American Cancer Society. The final CMS rule is expected to be published in the fall of this year and take effect on January 1, 2023.

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"Colorectal cancer is the most preventable, yet least prevented cancer, because approximately 44 million average risk adults remain unscreened in the United States," said Kevin Conroy, Chairman and CEO of Exact Sciences. "Exact Sciences supports the CMS proposal to encourage wider utilization of non-invasive colorectal cancer screening tests, which has the potential to close the screening gap by reducing barriers to screening, prevention and earlier detection for individuals aged 45 and older."

The proposed CMS policy builds on President Biden’s Cancer Moonshot proposal to ensure equitable access to screening and prevention through at-home screening, particularly for colorectal cancer. The Administration’s focus on removing barriers to cancer prevention and early detection advances health equity within rural communities and communities of color that are especially impacted by the incidence of colorectal cancer. The proposed policy also builds upon the recent Department of Labor guidance that mandates coverage for follow-up colonoscopy for most commercial insurance plans.

"This proposal helps patients across the country who are seeking to complete the colorectal cancer screening process but can’t due to financial barriers. This is a huge victory for patients," said Anjee Davis, president, Fight Colorectal Cancer, a leading patient empowerment and advocacy organization.

Colon cancer is the third most common cancer in both men and women of all racesi and is on the rise for people younger than 50.ii Approximately 70 percent of people diagnosed with colon cancer have no family history.iii Despite efforts by leading medical and government organizations to raise awareness, approximately 44 million average-risk Americans aged 45-plus remain unscreened.iv

Exact Sciences is the maker of Cologuard, an FDA-approved, noninvasive stool-based DNA screening test for adults 45 and older who are at average risk for colon cancer. Since its launch in 2014, 9 million people have used Cologuard to screen for colon cancer at home.

On July 8, 2022 Median Technologies (ALMDT) (Paris:ALMDT) reported that the Company will be participating in the 2022 European Congress of Radiology (ECR), to be held in Vienna, Austria, July 13-17 (Press release, MEDIAN Technologies, JUL 8, 2022, View Source [SID1234616569]).

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The Company will give an industry presentation and a scientific paper presentation. Details of the sessions include:

Industry presentation: "Enabling lung cancer screening with iBiopsy AI-based software as medical device"

Session: AIX Theater
Date: July 13, 2022
Time: 3:25 pm – 3:45 pm CEST

Scientific paper presentation: RPS 1305-6 – "Development and validation of a machine learning based CADx designed to improve patient management in lung cancer screening programmes"

Session: RPS 1305 – Artificial intelligence (AI) in chest imaging: part 2
Categories: Artificial Intelligence & Machine Learning, Imaging Informatics, Chest, Oncologic Imaging
Date: July 15, 2022
Time: 10:30 am – 12:00 pm CEST

Median’s team will be available at booth #AI-29, Expo X1, AI-area to discuss the presentations and present the latest developments on iBiopsy LCS CADe/CADx SaMD from July 13 to 17, 9:00 am-5:00 pm.

The European Congress of Radiology (ECR) organized by the European Society of Radiology (ESR) is the premier European event in radiology and the second largest in the world. The congress conveys more than 20,000 with a split of more than 10,000 professional delegates (radiologists, technologists etc.), and ~8,000 industry participants (imaging modalities, PACS etc.). Radiology professionals from Europe and beyond attend to gather knowledge through educational courses, to see the latest innovations presented by technical exhibitors, and to discover groundbreaking research from scientific paper presentations. More about the ECR: View Source

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of innovative AI/ML-based Software as Medical Device, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).

On July 8, 2022 IMV Inc. ("IMV" or the "Company") (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported that on July 7, 2022, IMV Inc. (the "Company") received a letter from the Listing Qualifications Department of the Nasdaq Stock Market ("Nasdaq") indicating that, based upon the closing bid price of the Company’s common shares for the 30 consecutive business day period between May 23, 2022, through July 6, 2022, the Company did not meet the minimum bid price of US$1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (Press release, IMV, JUL 8, 2022, View Source [SID1234616568]). The Notice has no immediate effect on the listing of the Company’s common shares on the Nasdaq Capital Market.

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The letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or until January 3, 2023 (the "Compliance Period"), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A). In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common shares must maintain a minimum closing bid price of US$1.00 for at least ten consecutive business days during the Compliance Period.

In the event the Company does not regain compliance by the end of the Compliance Period, the Company may be eligible for an additional 180 calendar days to regain compliance. To qualify, the Company will be required to meet the continued listing requirement for the market value of its publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Company may be granted an additional 180 calendar days to regain compliance. However, if it appears to Nasdaq that the Company will be unable to cure the deficiency, or if the Company is not otherwise eligible for the additional cure period, the Company may face delisting.

The letter has no immediate impact on the Company’s business operations or listing of the Company’s common shares, which will continue to be listed and traded on The Nasdaq Capital Market, subject to the Company’s compliance with the other listing requirements of The Nasdaq Capital Market, as well as on the TSX.