On September 12, 2024 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported both the development and the clinical validation of TNBCDX, the first genomic test designed specifically for patients with early-stage TNBC (Press release, REVEAL GENOMICS, SEP 12, 2024, View Source [SID1234646550]). This dual milestone will be presented at the ESMO (Free ESMO Whitepaper) Congress 2024 in Barcelona (Spain).

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TNBCDX represents a significant advancement in the management of TNBC, a subtype of breast cancer that is particularly challenging to treat due to its lack of hormone receptors and HER2 expression. This disease is typically treated with neoadjuvant multi-agent chemotherapy regimens that include taxanes, anthracyclines, cyclophosphamide, carboplatin, and pembrolizumab. However, these therapies often pose significant toxicities for patients and can lead to a considerable financial burden and increased use of healthcare resources.

Meanwhile, less intensive systemic therapies involving taxanes and carboplatin without anthracyclines and pembrolizumab are showing outstanding outcomes in selected patients. In this context, a biomarker such as TNBCDX was needed to guide treatment decisions and safely identify patients who could benefit from de-escalation of therapy.

Across two independent validation studies with 418 patients, the TNBCDX scores showed a strong association with pathological complete response (pCR), distant disease-free survival (DDFS), and overall survival (OS), providing a more refined risk stratification. Notably, the TNBCDX test outperformed tumor-infiltrating lymphocytes (TILs) in predicting both pCR and survival outcomes.

The first validation study, ADAPT-TN, led by Dr. Nadia Harbeck and Dr. Oleg Gluz of the West German Study Group, was a phase II prospective neoadjuvant trial (WSG-ADAPT TN Trial, NCT01815242) that enrolled patients diagnosed with stage I–III TNBC. The study involved a treatment regimen of nab-paclitaxel combined with either gemcitabine or carboplatin. Patients who did not achieve a pCR were given additional anthracycline-based chemotherapy. The second validation study, MMJ-CAR-2014-01 (NCT01560663), led by Dr. Miguel Martin, is an ongoing prospective, multicenter, nonrandomized trial in Spain investigating the antitumor activity of neoadjuvant carboplatin and docetaxel in early-stage TNBC. This study includes patients with stage I–III TNBC, treated with six cycles of carboplatin and docetaxel.

Dr. Miguel Martin, Chair of Medical Oncology at the Hospital General Universitario Gregorio Marañón in Madrid, and a recognized leader in breast cancer, will present the findings during the ESMO (Free ESMO Whitepaper) session scheduled for 10:50 a.m. on September 14th, 2024, at Barcelona Auditorium.

"The development and validation of TNBCDX are significant achievements in the field of precision oncology for TNBC. This test will enable oncologists to tailor treatments more effectively, offering new hope for individuals managing this aggressive form of breast cancer," commented Dr. Miguel Martin. He added, "The ability of TNBCDX to provide critical genomic insights, with a special focus on the immune system, marks an important step forward in the treatment of TNBC."

Dr. Patricia Villagrasa, CEO and Co-founder of REVEAL GENOMICS, added, "The introduction of TNBCDX into clinical practice will transform the treatment landscape for those diagnosed with TNBC. We are committed to ensuring global access to this important diagnostic tool."

About the TNBCDX Test
TNBCDX is the first genomic test designed specifically for patients with early-stage TNBC. The test integrates clinical variables with key tumor and immune biological factors across 15 genes to provide a comprehensive risk assessment, guiding treatment decisions in a clinical setting. TNBCDX includes two scores: a risk score and a pCR (pathological complete response) likelihood score. Additionally, the test measures the levels of ERBB2 to ensure that the tumor is accurately classified as TNBC.

TNBCDX is currently available in a Research Use Only (RUO) format. The company is in the process of standardizing the assay, with plans to offer it through the Biomedical Diagnostic Center (CDB) at Hospital Clínic by 2025.

About TNBC
TNBC accounts for approximately 15-20% of all breast cancer diagnoses. Unlike other breast cancer subtypes, TNBC does not express estrogen receptor, progesterone receptor, or HER2, making it more difficult to treat with conventional therapies. TNBC is known for its aggressive nature and poor prognosis; however, it also exhibits substantial biological and clinical heterogeneity, underscoring the need for more precise diagnostic and therapeutic approaches.

On September 12, 2024 OmRx Oncology, or "OmRx," a new biopharmaceutical venture with investment from Scripps Research, launched with a Phase 2 clinical asset in-licensed from Gilead Sciences, Inc. and a vision for expanding access to immunotherapy in countries where biologic checkpoint inhibitors are often unaffordable and unavailable to patients (Press release, OmRx Oncology, SEP 12, 2024, View Source [SID1234646549]).

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The clinical-stage asset, OX-4224, discovered and initially developed by Gilead Sciences, is an investigational oral immune checkpoint inhibitor that targets the PD-1/PD-L1 pathway and will be evaluated by OmRx for the treatment of patients with non-small cell lung cancer (NSCLC). OmRx in-licensed the Phase 2-ready asset and plans to develop it for patients in countries where an oral small molecule would present a more affordable, accessible, and potentially equally effective option to traditional antibody checkpoint inhibitors such as Keytruda and Opdivo.

OmRx is wholly focused on advancing this clinical-stage program, first as a monotherapy in low and middle-income countries, and eventually, globally for potential all-oral combination therapies. OmRx’s mission to serve patients in low and middle-income countries is shared by Scripps Research, which actively supports a significant number of R&D initiatives addressing global health needs. The company is led by a high-caliber team with expertise in cancer R&D, clinical development, entrepreneurship, and corporate development. The OmRx team includes Dr. William Lee, Ph.D., who serves as Chairman and brings 30 years of experience from his tenure as the former Executive Vice President of Research at Gilead Sciences.

"Immune checkpoint inhibitor monoclonal antibodies represent one of the most important treatment advances in cancer in the past two decades, but they are essentially unavailable to cancer patients outside of the major commercial markets. Oral checkpoint inhibitors, meanwhile, could have important advantages over antibodies – they would not require infusions or infusion centers, dosing and patient exposure could be rapidly modulated in the case of immune-related side effects, and they would be significantly cheaper to manufacture," said Isy Goldwasser, CEO, OmRx. "With the launch of OmRx we can advance a promising oral checkpoint inhibitor that could bring immunotherapy to more people in an affordable way with the goal of reducing the worldwide cancer burden."

OX-4224 will initially be studied as a second-line monotherapy in patients with metastatic NSCLC whose tumors express PD-L1. The Phase 2 randomized, open-label study in India will establish safety and efficacy of OX-4224 in subjects with NSCLC who have not received immune checkpoint inhibitors.

"One of the highlights of my career was overseeing the discovery of a small molecule that blocked the PD-1/PD-L1 immune checkpoint and by doing so, could impact cancer therapy globally," said Dr. William Lee, Chairman, OmRx. "I am extremely grateful to the Scripps team for sharing this vision and investing in OmRx. If OX-4224 demonstrates the safety and efficacy projected, it will make a difference for patients everywhere, and especially in resource-constrained countries like India."

OX-4224 is an investigational product and statements regarding the potential benefits and future development of this investigational product are forward-looking and subject to risks and uncertainties.

On September 12, 2024 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported the U.S. Food and Drug Administration’s ("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") is scheduled to take place on Thursday, November 7, 2024 (Press release, IceCure Medical, SEP 12, 2024, View Source [SID1234646548]). The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.

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"This public forum transparency ensures key stakeholders, including women with early-stage low risk breast cancer, their doctors and payors, can exchange views and data regarding the potential benefits of minimally invasive cryoablation with ProSense as an alternative to surgery," stated IceCure’s CEO, Eyal Shamir. "Following the Advisory Panel, we anticipate that the FDA will make a decision regarding marketing clearance of ProSense by early 2025."

The Advisory Panel will include breast surgeons, interventional radiologists and industry representatives from the regulatory community. The vast body of data available on ProSense as a treatment for early-stage low risk breast cancer will be reviewed by the Advisory Panel, including results from the Company’s ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense cryoablation, followed by adjuvant endocrine therapy, were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported. The Advisory Panel is expected to make its recommendations at the conclusion of the meeting, at which time the FDA will commence its review process.

The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before the meeting, at which time IceCure intends to share the link with shareholders via a press release.

About ProSense

The ProSense Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens that door to fast and convenient office-based procedure for breast tumors.

On September 12, 2024 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, reported an update that several world-renowned healthcare organizations have joined SOPHiA UNITY (Press release, Sophia Genetics, SEP 12, 2024, View Source [SID1234646547]). SOPHiA UNITY is the global consortium announced at ASCO (Free ASCO Whitepaper) by SOPHiA GENETICS that connects best-in-class healthcare institutions to fuel the next wave of innovation in oncology by making real-world data available for research.

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SOPHiA UNITY, the pioneering initiative by SOPHiA GENETICS, harnesses multimodal data and analytics to drive innovation from a global network. The bar for innovation in oncology is increasing as indications become more fragmented, more complex and requiring larger datasets. No single institution can address this challenge alone. SOPHiA GENETICS launched SOPHiA UNITY to meet this challenge, harmonizing high-quality, diverse, multimodal data at scale, leveraging the collective intelligence of leading research institutions.

Exactis Innovation in Montreal, Quebec, Canada, an organization of hospital partners dedicated to improving cancer survivorship through real-world data, as well as Institut Paoli-Calmettes in Marseille, France, one of the largest cancer centers in France, will be joining SOPHiA UNITY. In addition, Gemelli Hospital in Rome, Italy, named the best hospital in Italy in 2024, has expressed interest in joining the collaborative.

These organizations accompany inaugural member Memorial Sloan Kettering Cancer Center, a top cancer treatment and research institution. The SOPHiA UNITY network includes three countries and over 100,000 committed patient profiles with multimodal data.

"By uniting a critical mass of data and expertise through SOPHiA UNITY, we are empowering a global network of top-tier institutions to leverage real-world data to tackle the complexities of cancer. This initiative provides a new opportunity to advance oncology research with one of the most robust sources of diverse data available in the market to drive breakthroughs and improve patient outcomes worldwide," said Jurgi Camblong, PhD, Co-founder and CEO of SOPHiA GENETICS. "Together, we have the power to change the world."

Members benefit from participating in innovative global projects funded by industry and have access to the SOPHiA GENETICS AI-driven technology that increases efficiency of data curation, structuring and harmonization efforts. Collaborations made possible by SOPHiA UNITY pave the way for continued advancement of oncology research and data-driven medicine.

Members of SOPHiA UNITY can use SOPHiA CarePath which provides large-scale data insights from various modalities—including imaging, genomics, and pathology, as well as clinical notes and a diverse array of patient profiles. Data are safely and anonymously collected, harmonized and curated using SOPHiA GENETICS’ advanced AI-based technology and proprietary algorithms, delivering meaningful, data-driven insights.

On September 12, 2024 Medivir AB (NASDAQ Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that detailed and mature data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, September 16, 2024 (Press release, Medivir, SEP 12, 2024, View Source;lenvima-at-esmo-conference-and-to-host-a-webcast-on-september-16-302246468.html [SID1234646546]).

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The abstract, titled "Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) progressed on immunotherapy combinations. Results from a multi-center phase 1b/2a study." will be presented by Dr Hong Jae Chon, CHA Bundang Medical Center in Korea.

After the presentation Medivir will also host a webcast where Dr Chon and Dr Pia Baumann, Chief Medical Officer at Medivir, will present the data and answer questions. The webcast will take place on September 16, at 13.45 CET, and will be streamed via a link on the website: www.medivir.com/investors/presentations.

In addition to the presentation of phase 1b/2a data, Dr Chon with his experience of treating liver cancer patients, will provide additional context to the data by comparing with what can be expected with current clinical practice in second-line.

The poster and the presentation from the webcast will be available on Medivir’s website after the webcast.

For additional information, please contact:

Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: [email protected]

About fostrox

Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1,2. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.