On September 4, 2024 Arsenal Biosciences, Inc. (ArsenalBio), a clinical stage programmable cell therapy company focused on engineering advanced CAR T-cell therapies for solid tumors, reported the close of an oversubscribed $325 million Series C financing round (Press release, ArsenalBio, SEP 4, 2024, View Source [SID1234646359]). The funding round included new investors ARCH Venture Partners, Milky Way Investments Group, Regeneron Ventures, NVentures (NVIDIA’s venture capital arm), Luma Group, funds and accounts advised by T. Rowe Price Associates, Inc., Rock Springs Capital, among others, with ongoing support from existing investors the Parker Institute for Cancer Immunotherapy (PICI), SoftBank Vision Fund 2, Bristol-Myers Squibb Company, Westlake Village BioPartners, Kleiner Perkins, Byers Capital, and Hitachi Ventures.

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Proceeds from the financing will be used to advance ArsenalBio’s lead programs through development as the company continues to build its pipeline of therapeutic candidates for solid tumor cancers based on its proprietary T cell engineering technology, including logic gating. The funds will also drive further innovation in developing tools and processes for identifying new candidate cell therapies, helping ArsenalBio remain at the forefront of the rapidly evolving field of cell therapy, and bringing it closer to its goal of addressing unmet needs across the oncology category.

"Our initial clinical trials and preclinical studies have shown the promise of our T cell engineering approach and have given us the confidence to broaden the application of our technology to address additional cancer types," said Ken Drazan, M.D., ArsenalBio’s co-founder, CEO and Chairman. "This new investment enables us to continue our development roadmap, scale up our manufacturing capabilities, and invest in new avenues for innovation in T cell medicine."

ArsenalBio’s robust pipeline includes potential therapies in development for ovarian, kidney, and prostate cancers, as well as other solid tumors being co-developed through a collaboration with Bristol-Myers Squibb Company. The fundraising follows ArsenalBio’s recent entry into clinic with its second T cell product candidate, AB-2100, being studied in a Phase 1/2 clinical trial for clear-cell renal cell carcinoma (ccRCC). The candidate has been granted Fast Track designation by the U.S. Food and Drug Administration.

On September 4, 2024 Tempus AI, Inc. (NASDAQ: TEM, "Tempus"), a technology company leading the adoption of AI to advance precision medicine and patient care, reported a multi-year collaboration with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases (Press release, Tempus, SEP 4, 2024, View Source [SID1234646358]). This collaboration leverages Tempus’ robust multimodal datasets in support of BioNTech’s next-generation oncology pipeline.

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Under this collaboration, Tempus is providing analytical support and computational biology expertise to BioNTech across its comprehensive research and development oncology pipeline. BioNTech will work collaboratively with Tempus to leverage Tempus’ real-world multimodal database to generate novel insights into the biological mechanisms supporting the discovery of new therapies and aiming to enhance the development of BioNTech’s clinical oncology pipeline.

"We are looking forward to collaborating with BioNTech to combine our real-world multimodal data and cutting-edge computational technology to help advance their differentiated oncology pipeline," said Ryan Fukushima, Chief Operating Officer of Tempus. "By applying Tempus’ extensive real-world multimodal data to BioNTech’s AI capabilities and multi-platform discovery engine, we believe we can generate a real impact by working to bring novel therapies to those cancer patients who could potentially benefit the most."

On September 4, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported they will collaborate with the Icahn School of Medicine at Mount Sinai on a precision medicine clinical study in multiple myeloma (MM) (Press release, BostonGene, SEP 4, 2024, View Source [SID1234646357]). The study aims to evaluate and improve cancer sequencing for the characterization of tumor molecular vulnerabilities and the identification of novel therapeutics, paving the way for developing targeted therapies and personalized treatment approaches for MM patients.

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Samir Parekh, MBBS, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and fellow researchers at Mount Sinai will utilize BostonGene’s CLIA-certified, CAP-accredited and NY State-approved next-generation sequencing technologies, including whole exome and whole transcriptome sequencing, to support clinical care and discovery efforts for patients with MM.

"Collaborating with BostonGene enables us to leverage their advanced next-generation sequencing to gain deeper insights into the molecular and immune characteristics of multiple myeloma," said Cesar Rodriguez, MD, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai. "This partnership will help us identify novel therapeutic targets and develop more effective, personalized treatment strategies for our patients. By recognizing the unique features a patient and their disease have, we may be able to select optimal regimens that may translate to better outcomes."

BostonGene’s cloud-based solutions, bioinformatics capabilities and analytical tools offer a robust platform for integrated analysis of the patient and their tumor. This comprehensive approach delivers data-driven results, transforming patient care and revolutionizing precision medicine practices.

"We are excited to partner with Mount Sinai on this study," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our AI-powered solutions and comprehensive analytical tools provide unparalleled insights into the molecular underpinnings of cancer and we are committed to advancing precision medicine to improve outcomes for multiple myeloma patients."

On September 4, 2024 Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company") reported that the Company will be sharing information on its proprietary AI/ML-powered SaMD, eyonis LCS, including recently announced data from the pivotal REALITY study, at Booth #2601 during the 2024 World Conference on Lung Cancer (WCLC), being held in San Diego, CA, USA, from September 7-10, 2024 (Press release, MEDIAN Technologies, SEP 4, 2024, View Source [SID1234646356]). The WCLC, the premier world conference on lung cancer, is organized by the International Association for the Study of Lung Cancer (IASLC), a global multidisciplinary association dedicated to eradication of all forms of lung cancers.

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eyonis LCS is designed to improving the detection and diagnostic accuracy of LDCT in lung cancer screening procedures. LDCT imaging is the standard of diagnostic care globally and is currently the only approved lung cancer screening modality in U.S. and Europe. The average five-year survival rate for all lung cancer patients is 18.6 percent because only 16 percent of lung cancers are diagnosed at an early stage2. Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%.

The Company released in August the definitive results from the first of the two pivotal eyonis LCS clinical studies, REALITY (Clinicaltrials.gov identifier: NCT0657623) evaluating the standalone performance of the medical device in characterizing cancerous vs non-cancerous patients (i.e. "performance at patient level"), and in detecting and characterizing suspicious versus malignant nodules. Despite the inclusion of many challenging LDCT images, the eyonis LCS SaMD achieved exceptional results and met all study primary and secondary endpoints with statistical significance and achieved an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as the primary endpoint for REALITY.

REALITY analyses were conducted on data from a cohort of 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose.

The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case (MRMC) study that will offer clinical validation of eyonis LCS to complement the analytical validation already achieved with REALITY. RELIVE is ongoing and scheduled for completion in the coming months, with an anticipated data read-out in Q1 2025. Median Technologies expects eyonis LCS regulatory filings in the US for FDA 510(k) clearance and in Europe for CE marking in H1 2025.

With eyonis LCS, Median Technologies is working to provide the U.S. and European lung cancer medical communities with a unique breakthrough software as medical device to help medical professionals expedite lung cancer screening programs. Increased accuracy with eyonis LCS can help save lives and reduce the distress and costs associated with unnecessary procedures.

About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic device that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to diagnose lung cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis LCS has been classified by regulators as "Software as Medical Device", or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in 2025. Separately, Median’s AI technology is being sold and deployed across cancer indications, via Median’s iCRO business unit, to companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.

About IASLC 2024 World Conference on Lung Cancer: The International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) is an immersive scientific meeting where over 5,000 leading experts, researchers, and oncologists gather to showcase cutting-edge advancements in lung cancer research, treatment modalities, and personalized therapies, fostering collaboration towards a world free from the burden of lung cancer. For more information about 2024 WCLC, visit View Source

On September 4, 2024 TippingPoint Biosciences, a therapeutic company focused on innovative drug discovery targeting the aberrant DNA in cancer cells, reported pre-seed investment from the Pediatric Brain Tumor Foundation, Sontag Foundation, Yuvaan Tiwari Foundation, and BrightEdge, the impact investment and venture capital arm of the American Cancer Society (Press release, TippingPoint Biosciences, SEP 4, 2024, View Source [SID1234646355]).

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The investments will support TippingPoint’s breakthrough work to target Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric brainstem tumor that is untreatable and terminal, usually within months of diagnosis. TippingPoint’s novel drug discovery platform is the first to target disease-specific interfaces in DNA packaging networks in cancer cells, also known as chromatin states, without affecting healthy states. Current approaches to address DNA packaging dysfunction target single chromatin factors that have broad functions across both disease and healthy cells, which leads to unwanted toxicities. Because TippingPoint’s platform is able to specifically target the unique chromatin interactions in disease, they have successfully applied their technology to target DIPG cancer cells in the laboratory, which cancer researchers regard as a significant breakthrough.

"We are committed to accelerating breakthrough treatments for DIPG and other fatal pediatric brain tumors," said Parvati Tiwari, President and Co-Founder of the Yuvaan Tiwari Foundation. "TippingPoint’s innovative approach to targeting complex chromatin interactions offers real hope for new therapies. We’re proud to back their efforts to transform the future of DIPG treatment."

"We are proud to support the work being done by Tipping Point to further the American Cancer Society’s mission to end cancer as we know it for everyone, said Alice Pomponio, VP, Innovation & Impact Investing / Managing Director, BrightEdge. It has been a privilege to support their journey from the beginning to where they are today, and we look forward to seeing a DIPG treatment benefit people with cancer in the future."

"There will be no cure for DIPG without collaboration, and we’re proud to come alongside other investors to back TippingPoint’s novel search for new treatment pathways," said Pediatric Brain Tumor Foundation President and CEO Courtney Davies. "We believe their research focus promises to be transformative."

The Sontag Innovation Fund, building on the reputation of the Sontag Foundation as one of the largest private funders of brain tumor research in North America, is thrilled with being part of TippingPoint’s efforts. "We are excited to help support TippingPoint and their effort to use an innovative screening platform to identify new potential therapeutic options for DIPG and other diseases" said Scott Davis, Managing Director of the Sontag Innovation Fund.

TippingPoint Bioscience’s founder, Dr. Laura Hsieh, formerly a post-doctoral researcher in Dr. Geeta Narlikar’s lab at the University of California San Francisco (UCSF), left the university to launch TippingPoint and accelerate the development of cancer therapeutics. TippingPoint raised its first investments in 2023, from early stage ventures like Mission BioCapital, ACS BrightEdge and SOSV’s IndieBio, and won four golden or platinum ticket awards in pitch competitions sponsored by major pharmaceutical companies including ONO Pharma, Astellas, and Abbvie.

Dr. Hsieh and the TippingPoint Biosciences team are currently conducting hit-to-lead studies to develop a new class of molecules for DIPG that are highly specific to the disease. They are diligently working to increase the potency and selectivity of their molecules so they can test them in mouse models in the near term with an eye on reaching first-in-human studies for DIPG patients in 4 years.

"We are honored to receive these investments to further our drug development efforts for such a devastating disease like DIPG. In order to make significant breakthroughs in complex diseases like DIPG and really make a difference in patient lives, big bets need to be made on paradigm-shifting technologies like ours. The support in capital, expertise and networks with patient advocates and world-class researchers goes a long way for TippingPoint to continue development of much-needed therapeutics for DIPG and other complex diseases," said Dr. Laura Hsieh, CEO and Founder of TippingPoint Biosciences.