On February 15, 2022 ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximize patient health reported an abstract comparing concurrent measures using ImpediMed’s SOZO Digital Health Platform and dual x-ray absorptiometry (DXA) for assessing bone mineral content in cancer patients was accepted for poster presentation at the 39th Annual Miami Breast Cancer Conference on 3-6 March 2022 in Miami Beach, Florida, USA (Press release, ImpediMed, FEB 15, 2022, View Source [SID1234608159]).

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The abstract, titled, "The Routine Use of Bioimpedance Spectroscopy Measurements in the Clinic as a Surrogate for Bone Mineral Content in Oncology Patients: Practical Application of the SOZO Device," analyzes data collected using both SOZO and DXA in healthy participants and cancer patients.

The Miami Breast Cancer Conference draws the multidisciplinary cancer care team for in-depth discussion about current topics and technologies for breast cancer care. The poster will be presented to registered attendees in-person and online. Abstracts will be published online following the conference in the journal Oncology.

"The Miami Breast Cancer Conference is run by leaders in breast cancer care from every oncology specialty," commented Richard Carreon, Managing Director and CEO of ImpediMed. "This is the ideal venue to present the new data evaluating SOZO to assess changes in bone in cancer patients during and after treatment. We continue to stay focused on lymphedema in the near term while exploring new ways to use SOZO in caring for cancer patients as part of our long-term oncology growth strategy."

Expanding the use of SOZO to help care for cancer patients is central to ImpediMed’s growth strategy in the oncology marketplace. Lymphedema provides a strong entry point for adoption of SOZO into oncology practices. Developing new indications creates opportunity to expand SOZO utilization by placing additional SOZO devices and adding new licenses to existing devices. New indications also support the strategy for building large corporate accounts, many of which have interest in co-development and regulatory clearance for new ways to use SOZO to benefit their cancer patients and improve health economics.

There are 16.9 million cancer survivors in the US and approximately 32 million worldwide. The majority of survivors are women with early-stage breast cancers and men with nonmetastatic prostate cancers. These patients frequently receive hormonal manipulation therapies that can significantly impact their bone mineral content. These patients have a higher risk bone fractures potentially leading to hospitalization and death.

About SOZO Digital Health Platform

SOZO, the world’s most advanced, noninvasive bioimpedance spectroscopy (BIS) device, delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds. Using ImpediMed’s BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. Results are available immediately online for easy data access and sharing across an entire healthcare system. The FDA-cleared, CE-marked and ARTG-listed digital health platform aids in the early detection of secondary lymphedema, provides fluid status for patients living with heart failure, and can be used to monitor and maintain overall health – all on a single device.

On February 15, 2022 Paige, the global leader in AI-based diagnostic software in pathology, and Mindpeak, the European leader for AI-based software for image analysis in pathology, reported a distribution partnership, which will enable pathologists to use Mindpeak’s BreastIHC* within the Paige Platform (Press release, Paige AI, FEB 15, 2022, View Source [SID1234608158]). Mindpeak’s BreastIHC is an AI software that reliably and accurately detects, classifies and quantifies breast cancer cells. This partnership enhances the utility of the Paige Platform by providing real-time results for routine breast cancer immunohistochemistry (IHC) biomarkers.

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The detection and quantification of IHC markers is an important step in treatment planning for breast cancer. Mindpeak’s BreastIHC is the first-ever plug-and-play AI solution for reliable HER2, Ki-67, estrogen (ER) and progesterone receptor (PR) quantification, without the need for complex set-up and calibration procedures. The product helps to differentiate between tumorous and non-tumorous structures on a single-cell basis, improving the specificity of the scoring.

"By combining MindPeak’s products for IHC with Paige’s AI products for H&E, our partnership will allow pathologists to drive efficient routine clinical cancer diagnostics in breast cancer," said Andy Moye, Ph.D., Chief Executive Officer at Paige. "We are excited to offer Mindpeak’s industry-leading BreastIHC directly within the Paige Platform to improve patient care. We believe integrating our products will drive the adoption of digital pathology technologies more broadly."

Paige Platform is a comprehensive digital pathology software platform that is inclusive of a viewer and storage capabilities and is compatible with existing digital pathology solutions, including most scanners, monitors, and laboratory information systems (LIS).

"This partnership brings us a big step closer to our shared goal of making pathological diagnosis of breast cancer quicker, more accurate and more reproducible," said Felix Faber, CEO at Mindpeak. "I am extremely excited that we will combine our respective strengths in analyzing H&E and IHC-stained tissue samples to make this vision of utilizing AI within pathology a reality."

* Mindpeak’s BreastIHC is available in the EU as a CE-IVD marked medical device. Outside the EU, BreastIHC is Research Use Only, not for use in diagnostic procedures.

On February 15, 2022 OncoBeta GmbH reported that the first patients have registered into the world-first International Registry that is capturing data-driven treatment results for NMSC treatments (Press release, OncoBeta, FEB 15, 2022, View Source [SID1234608156]).

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The first-of-its kind International Registry was launched by OncoBeta via specialist health solutions partner Avion Medical in November 2021 to collect real-world patient data for three mainstay treatments of NMSC. Its goal is to identify optimal methods of treating the disease that can be applied internationally.

The International Registry is an easy-to-use platform for physicians and will capture data observing how treatments and innovative approaches influence long-term patient outcomes. The Registry also has an important focus on patient-reported outcomes such as quality of life and comfort of treatment.

The first patients have been recorded into the online registry that follows the treatment journey, from the initial disease assessment to treatments and ongoing assessments. Not only that, but there is an opportunity for patients to contribute their feedback and record their experiences via a questionnaire that includes impact on quality of life as well as comfort score through the OncoBeta WeBe mobile app.

Dr Gerhard Dahlhoff, Medical Director at OncoBeta, says, "To date, no unified reportage on NMSC and its treatments is available to the international medical community. The Registry aims to rectify this shortfall in our understanding of the disease treatment. The WeBe app has been designed so it is easy to use for the patient and the physician, which is critical in ensuring participation and the delivery of robust data. The patient data collection will provide key insights from the patient’s perspective about their treatment and the disease."

An international committee made up of multi-disciplinary clinicians from South Africa, Australia, Italy and Germany is leading the data collection and outputs of the registry. Paolo Castellucci, Nuclear Medicine Physician at S. Orsola, Bologna, and chairman of the International Registry, says, "I’m excited to be involved in an International Registry that will be the first to capture robust, long-term data that will reveal patterns of care, identify which treatment provides the best long term outcomes for patients."

Shannon D Brown III, CEO at OncoBeta GmbH, says, "We are thrilled to see the first patients being registered in the International Registry. By working with clinicians around the world, the Registry will draw from a larger sample size to identify important insights and establish best practices in the treatment of NMSC."

Participation in the International Registry for Non-Melanoma Skin Cancer Treatment is by invitation only. Physicians that would like to become part of the Registry and offer Rhenium-SCT treatment at your centre, contact [email protected]

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans. The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.1

The Rhenium-SCT is a painless*, single session†, non-invasive therapy providing for unparalleled aesthetic results, even in cases otherwise considered difficult to treat.2-4 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, personalised 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†4. Scar-free healing4 of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment4.

On February 15, 2022 Medivir reported that Year-End Report, January – December 2021 (Press release, Medivir, FEB 15, 2022, View Source;year-end-report-january–december-2021-301482292.html [SID1234608155])

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October – December

Financial summary for the quarter

Net turnover amounted to SEK 13.9 (1.5) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -23.5 (-10.6) million. Basic and diluted earnings per share amounted to SEK -0.44 (-0.46) and SEK -0.44 (-0.46) respectively.
Cash flow from operating activities amounted to SEK -5.4 (-1.0) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 221.2 (70.0) million.
Significant events during the quarter

In October, the Board of Directors appointed Jens Lindberg as new CEO of Medivir. Jens Lindberg has extensive experience from the pharmaceutical industry and the field of Oncology. He joins from Sedana Medical where he has been VP Commercial Operations and acting CEO.
IGM Biosciences, Inc. initiated its clinical study in solid cancers with birinapant (IGM-9427) in combination with IGM’s DR5 agonist antibody IGM-8444. The purpose of this first clinical trial with the combination is to evaluate safety and tolerability.
In November, results from an investigator-initiated phase II clinical trial of remetinostat in patients with squamous cell carcinoma were published.
In December, it was announced that the first patient with hepatocellular carcinoma had started treatment with fostroxacitabine bralpamide (MIV-818) in the phase 1b / 2a combination study.
January – December

Financial summary for the period

Net turnover amounted to SEK 25.5 (13.9) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -59.5 (-38.5) million. Basic and diluted earnings per share amounted to SEK -1.20 (-1.75) and SEK -1.20 (-1.75) respectively.
Cash flow from operating activities amounted to SEK -48.7 (-58.1) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 221.2 (70.0) million.
Significant events after the end of the period

In January, it was announced that the WHO had selected fostroxacitabine bralpamide as the official generic name for the patented candidate drug MIV-818, which is in clinical development in primary liver cancer.
Jens Lindberg assumed his position as CEO of Medivir on January 24, 2022.
Conference call for investors, analysts and the media

The Year-End Report January – December 2021 will be presented by Medivir’s CEO, Jens Lindberg.

The conference call will also be streamed via a link on the website: www.medivir.com

The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message

On January 24, 2022, I took over as CEO of Medivir and after my first time on the job, it is clear to me why the company managed to deliver so well on business goals in 2021. We have an extremely competent and experienced team that works dedicatedly with both our cutting-edge project fostroxacitabine bralpamide (MIV-818) and with the business development for our other assets. I hope to be able to contribute to the further strengthening of our delivery capacity in the future. Under the leadership of the company’s former CEO Yilmaz Mahshid, today a board member of Medivir, and our CFO Magnus Christensen, who has been the company’s interim CEO since May, Medivir has made significant progress in 2021.

Medivir’s drug development focuses on a very promising and proprietary clinical project, fostroxacitabine bralpamide (formerly MIV-818), with a clear therapeutic target, where the unmet medical needs remain extremely large, despite recent clinical advances. Fostroxacitabine bralpamide has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action means that it does not directly compete with other treatment options but instead enables combination treatments with other drug alternatives in hepatocellular carcinoma (HCC). Liver cancer is the third leading cause of cancer-related deaths worldwide and HCC is the most common form of cancer that arises in the liver. The effect of today’s medications is often limited and mortality remains at a high level.

After the end of the year, MIV-818 received the official generic name fostroxacitabine bralpamide from the World Health Organization WHO, something we see as an important step towards a product for the treatment of HCC.

The clinical development program for fostroxacitabine bralpamide has passed a number of milestones during the year. In April, it was announced that the top-line results from the monotherapy part of the phase Ib study were positive with a good safety and tolerability profile. They were later presented in more detail at the ESMO (Free ESMO Whitepaper) Congress in September and aroused great interest. In May, the design for the next step, the phase 1b/2a combination study with fostroxacitabine bralpamide for liver cancer, was presented. The regulatory approval from the British Medicines & Healthcare products Regulatory Agency (MHRA) for the study was obtained at the end of August, and from the South Korea Ministry of Food and Drug Safety (MFDS) in November.

In December, the first patient with HCC was dosed in the phase 1b/2a combination study with fostroxacitabine bralpamide, which is given in combination with two other medicines, either with Lenvima, a tyrosine kinase inhibitor, or with Keytruda, an anti-PD-1 checkpoint inhibitor. Lenvima and Keytruda (approved in the USA) are currently approved as mono therapy treatments of HCC.

The licensing agreement with IGM Biosciences, Inc., which gives IGM the global and exclusive rights to develop birinapant, could potentially provide milestone payments up to a total of approximately USD 350 million as well as tiered royalties up to "mid-teens". At the time of signing in January 2021, Medivir received USD 1 million, and when IGM in early November initiated a phase I clinical trial in solid cancers with birinapant in combination with its own DR5 agonist antibody IGM-8444, it was followed by an additional USD 1.5 million. Of course, we look forward to IGM’s continued clinical development of birinapant.

Also for remetinostat, a number of steps forward made during the year should be noted. Positive results from the investigator-initiated phase II clinical trial of remetinostat in patients with squamous cell carcinoma were published in November in the scientific journal JAMA Dermatology. Promising results from the investigator-initiated phase II study with remetinostat for basal cell carcinoma were published in August in the scientific journal Clinical Cancer Research. Through a renegotiated multi-party agreement, Medivir was able to further strengthen the business development potential for remetinostat in August.

Business development and collaborations are central to Medivir’s success. Birinapant is a good example of this and we see opportunities for remetinostat and MIV-711, but also in other smaller projects. In early 2021, a licensing agreement was entered into with Ubiquigent for the preclinical research program USP7.

Thanks to the financing that was successfully carried out at the beginning of the year and provided the company with approximately SEK 223 million before transaction costs, we are entering 2022 with resources and business development opportunities that provide good conditions for continuing the clinical development program for our cutting-edge project fostroxacitabine bralpamide. Our goal is to make it an effective drug for liver cancer that makes a real difference for patients and for healthcare, and thus also for our shareholders. I look forward to keeping you informed about Medivir’s continued development.

On February 15, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that interim data from the single center Phase III randomized MIRAGE trial, led by UCLA, comparing MRIdian MRI-guided vs. CT-guided SBRT for localized prostate cancer, will be featured at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, held February 17-19 in San Francisco (Press release, ViewRay, FEB 15, 2022, View Source [SID1234608154]). Interim analysis of the primary endpoint signaled superiority of MRIdian MRI-guided SBRT with a significant reduction in acute grade ≥2 GU toxicity in men receiving MRI-guided SBRT over those receiving CT-guided SBRT.

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The poster, titled "Magnetic resonance imaging-guided versus computed tomography-guided stereotactic body radiotherapy for prostate cancer (MIRAGE): Interim analysis of a phase III randomized trial" and authored by Amar Kishan, MD., Associate Professor and Chief of the Genitourinary Oncology Service at UCLA, will be showcased on Thursday, February 17 from 11:30 AM PT to 1:00 PM PT as part of the Prostate Cancer poster session. Following the poster session, Dr. Kishan (@AmarUKishan) will host a LIVE Twitter Q&A to answer questions about the interim findings. Those interested can join the conversation and post their questions using #MIRAGEQ&A.

The interim analysis of data from 100 patients eligible for evaluation (51 in the CT group and 49 in the MRI group) showed a statistically significant reduction in acute grade ≥2 GU toxicity in men receiving MRI-guided SBRT (47.1 percent in the CT group vs. 22.4 percent in the MRI group) and a significant reduction in acute grade ≥2 gastrointestinal (GI) toxicity in men receiving MRI-guided SBRT (13.7 percent in the CT group vs. 0 percent in the MRI group). Acute grade ≥2 GU toxicity can include adverse events range from frequent, urgent, or painful urination to pelvis pain, bladder spasms, or blood in the urine. Acute grade ≥2 GI toxicity can include adverse events ranging from diarrhea, discharge, or rectal/abdominal pain to abdominal distention or obstruction.

Patient-reported outcomes were measured using the International Prostate Symptom Score (I-PSS) and Expanded Prostate cancer Index Composite (EPIC-26). Patient reported urinary and bowel function metrics were better preserved at the 1-month time point with MRI-guidance, though this difference dissipates at the 3-month time point, potentially due to management of side effects.

"Beyond a reduction in the standardized metric of physician-scored toxicity, we also saw differences in one-month patient-reported urinary and bowel function metrics favoring the MRI-guidance arm. These data are highly indicative of less radiation dose being delivered to sensitive structures, such as the bladder, urethra, and rectum, with MRI-guidance," said Dr. Kishan. "Potential explanations for the magnitude of these results can be attributed to the real-time tissue tracking of actual anatomy and automatic gating of beam delivery, which thereby allows for tighter contours and treatment of smaller volumes. The high dose regions are significantly smaller for patients receiving MRI-guided SBRT."

Given the large primary endpoint signal seen, the study protocol was amended to reduce the projected sample size from 300 to 154, requiring half the number of patients while still maintaining 89 percent power to demonstrate superiority. Accrual of the MIRAGE trial (NCT04384770) was completed as of October 2021 and a final analysis for the primary endpoint is anticipated in early 2022.

"While the final results are still being analyzed, it is evident from our interim analysis that the benefit provided by MRI-guidance over CT-guidance for the delivery of SBRT for localized prostate cancer is projected to be large enough that we were able to cut the projected size of our trial in half. In fact, by the time this interim analysis was done, we had already enrolled enough patients to close the trial successfully," said Dr. Kishan. "In anticipation of the highly positive result implied by this interim analysis, we have now shifted to routinely offering MRI-guided SBRT at UCLA."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.

Nearly 18,000 patients have been treated with MRIdian. Currently, 48 MRIdian systems are installed at hospitals around the world where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts, and presentations. For a list of treatment centers, please visit: View Source

Disclaimer:
The opinions and clinical experiences discussed herein are specific to the featured physicians and are for information purposes only. Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations. Results of treatment presented in this press release are not indicative of typical or future results.

Safety Statement
The MRIdian Linac System is not appropriate for all patients, including those who are not candidates for magnetic resonance imaging. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be severe. Treatment sessions may vary in complexity and duration. Radiation treatment is not appropriate for all cancers. You should discuss the potential for side effects and their severity as well as the benefits of radiation and magnetic resonance imaging with your doctor to make sure radiation treatment is right for you.

Conflicts of Interest: Amar Kishan, M.D. discloses research funding from the Department of Defense, the National Institutes of Health, the Jonsson Comprehensive Cancer Foundation, the Prostate Cancer Foundation, and the American Society for Radiation Oncology. He also discloses research support, not related to this study, from ViewRay, Inc. AUK discloses consulting fees from ViewRay, Inc. and Varian Medical Systems, Inc. Dr. Kishan also discloses low-value stock held in ViewRay Inc.