On July 16, 2024 Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, reported that its multimodal immune profile score (IPS) algorithmic test is now available for research use only (RUO) (Press release, Tempus, JUL 16, 2024, View Source [SID1234644904]). IPS is the first offering of a larger immunotherapy-based portfolio being developed at Tempus to bring next-generation algorithmic diagnostics to the immuno-oncology space. Additionally, Tempus is collaborating with other partners, like Cleveland Clinic, to bring additional immunotherapy-focused algorithmic tests to this growing portfolio, leveraging clinical, laboratory, genomic, and transcriptomic data to identify patients that may respond to immunotherapy.

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Tempus’ IPS is a pan-cancer, laboratory developed test (LDT) that assesses a combination of immunotherapy-related biomarkers from prior DNA and RNA test results to calculate an IPS from 0-100 and a classification of either IPS-Low or IPS-High. IPS results can support patient stratification across pan-cancer cohorts to help inform who may or may not respond to immunotherapy. The IPS test is available today to life sciences partners for research use only, and is intended to be available as an add-on option for clinicians ordering Tempus’ xT and xR at the end of the year. Tempus is performing a retrospective, real-world study to evaluate the prognostic and the predictive utility of IPS in advanced pan-cancer patients treated with immune checkpoint inhibitors (ICI) and will be releasing data later this year.

In addition to developing and launching IPS, Tempus has licensed a machine-learning-based algorithmic test developed by Timothy A. Chan, MD, PhD, Cleveland Clinic. As described in Nature Biotechnology, the test demonstrates an ability to predict the efficacy of immune checkpoint blockade based on patient-specific biological, laboratory, genomic, and clinical factors, and adds to our expanding immunotherapy specific biomarker portfolio.

"Immune checkpoint inhibitors continue to have an incredible impact on patient outcomes, and we are excited to continue building a portfolio of AI-enabled diagnostics and tools to better equip clinicians in understanding which patients may benefit from these kinds of therapies," said Halla Nimeiri, MD, Chief Development Officer at Tempus. "The IPS test is our first multimodal algorithm to be introduced in the immunotherapy space, and we are excited to advance this field by providing critical insights that inform patient care."

"It’s a great pleasure to collaborate with Tempus on developing artificial intelligence powered models for better identification of patients who may respond to cancer immunotherapies," said Timothy A. Chan, MD, PhD, Department Chair of Immunotherapy and Precision Oncology and Professor of Medicine at Cleveland Clinic. "We look forward to working together with Tempus to bring multimodal immunotherapy response prediction assays to patients."

Tempus’ AI-enabled platform generates the type of rich multimodal data required to develop a novel class of predictive algorithms that can be introduced in the clinic to support personalized patient treatment selection. The IPS and Cleveland Clinic immune response tests joins a growing suite of algorithmic tests offered by Tempus, including Homologous Recombination Deficiency (HRD), Tumor Origin (TO), dihydropyrimidine dehydrogenase (DPYD), and PurISTSM. Each of these tests is designed to predict specific biological signals or clinical endpoints, ultimately supporting clinicians and life science partners as they seek to make more informed decisions for patients.

For more information on IPS, reach out to Tempus at tempus.com/contact-us.

On July 16, 2024 CatalYm reported the completion of a $150 million Series D financing (Press release, Catalym, JUL 16, 2024, View Source [SID1234644888]). The oversubscribed round was led by new investors, Canaan Partners and Bioqube Ventures, and joined by Forbion’s Growth Opportunities Fund ("Forbion Growth"), Omega Funds and Gilde Healthcare. Existing investors Jeito Capital, Brandon Capital Partners, Novartis Venture Fund and Vesalius Biocapital III also participated in the round. The proceeds will fund the expansion of the company’s broad Phase 2b development of visugromab into randomized Phase 2b studies in select checkpoint naïve frontline and second-line treatment settings. Visugromab has already demonstrated outstanding anti-tumor activity in combination with checkpoint inhibitor treatment.

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Visugromab is a humanized monoclonal antibody engineered to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15), which acts as a key regulator of immune resistance to cancer therapies. CatalYm recently reported impressive follow-up results from its ongoing "GDFATHER" Phase 1/2a trial (GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 1/2a) (NCT04725474) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024 in Chicago. The data showed that treatment with visugromab combined with the anti-PD-1 antibody, nivolumab achieves deep and durable anti-tumoral activity, including several complete responses in anti-PD-1/PD-L1 relapsed/refractory patients with non-small cell lung cancer (NSCLC), urothelial cancer (UC) or hepatocellular carcinoma (HCC).

"This substantial raise and strong syndicate recognize our achievements as a company and emphasize the excellent results of visugromab and our broad Phase 2b clinical program. We continue to demonstrate visugromab’s potential to induce cancer remission depth and durability across multiple solid tumor indications emphasizing the substantial role visugromab could play in a novel anti-cancer therapy regimen," said Phil L’Huillier, Managing Director and Chief Executive Officer at CatalYm. "We are building significant momentum for CatalYm’s development strategy and look forward to the support of these high-profile new and existing international investors, who share our vision of breaking immunosuppressive barriers to improve therapeutic outcomes."

In conjunction with the close of the financing, Colleen Cuffaro, Partner at Canaan, Jon Edwards, Managing Partner at Bioqube Ventures and Otello Stampacchia, Managing Director and Founder at Omega Funds, will join the CatalYm Board of Directors. Stefan Luzi, Partner at Gilde Healthcare will join as Board Observer.

"The recent data presented at ASCO (Free ASCO Whitepaper) highlight visugromab’s highly differentiated therapeutic profile and validate the ability of Phil and his team to expeditiously execute on the company’s clinical plan," commented Colleen Cuffaro, Partner at Canaan Partners. "As the company advances into expanded Phase 2b development, we are excited to provide our strategic guidance on the company’s trajectory toward changing the current treatment regimens for hard-to-treat solid tumor indications."

Jon Edwards, Managing Partner at Bioqube Ventures added: "We were initially drawn to the exciting biology around GDF-15 and found CatalYm to be at the forefront of the field. We believe this approach has the potential to significantly increase durability and deepen responses, unlocking the full potential of I/O treatments. We are excited to support this fantastic team, and syndicate, in running robust clinical studies in a variety of promising indications."

Founded in 2016 with support from Forbion Ventures Fund III and BGV, CatalYm is a leader in the development of a new class of cancer treatments aiming to prevent or reverse cancer resistance to checkpoint inhibition, chemotherapy and other targeted treatments. The approach neutralizes GDF-15, a critical immunosuppressant used by tumor cells to survive. With its broad Phase 2b development plan, the company targets high-need solid tumor indications including NSCLC, UC, HCC and bladder cancer where existing and acquired resistance are a major problem. CatalYm is now in preparations to launch further randomized, controlled studies in several major cancer indications in combination with checkpoint inhibitors and standard-of-care in first- and second-line treatment in the first half of 2025.

On July 16, 2024 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, and Biocytogen (HKEX: 02315), a global biotech company focused on the discovery of novel antibody therapeutics, reported a research collaboration and exclusive option and license agreement (Press release, Biocytogen, JUL 16, 2024, View Source [SID1234644905]).

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The agreement grants SOTIO the option to license multiple fully human bispecific antibodies generated with Biocytogen’s proprietary RenLite platform, which SOTIO will use to develop next-generation antibody-drug conjugates (ADCs) targeting solid tumors. The agreement also includes an option for SOTIO to leverage Biocytogen’s proprietary ADC platform. Biocytogen will be eligible to receive upfront, development, and commercial milestones and royalties on net sales on a product-by-product basis.

"SOTIO’s powerful ADC platform brings together multiple technologies, allowing us to tailor our therapeutics to meet the needs of specific cancer types. Specifically, exploiting bispecific targeting in the context of our ADC approaches to improve precision targeting and overcome tumor heterogeneity is particularly appealing," said Martin Steegmaier, Ph.D., chief scientific officer of SOTIO. "This agreement with Biocytogen complements our existing collaborations with Synaffix, LigaChem, and NBE-Therapeutics, providing SOTIO with access to fully human antibodies from Biocytogen’s state-of-the-art in vivo discovery platform. With the first targets for a bispecific program already selected, we are well-positioned to expand our ADC pipeline and the therapeutic possibilities for patients with solid tumors."

Under the terms of the agreement, Biocytogen is eligible to receive upfront and potential milestone payments worth up to $325.5 million, plus low single-digit royalties on net sales. SOTIO and Biocytogen will collaborate closely during the research phase of the bispecific programs. SOTIO will be responsible for non-clinical and clinical development, manufacturing, and commercialization of the ADC products.

"We are eager to deploy Biocytogen’s cutting-edge tools for antibody discovery to support SOTIO’s exciting ADC development plans," said Yuelei Shen, Ph.D., president and chief executive officer of Biocytogen. "Our unique RenMice platforms allow us to discover fully human antibodies with high affinity, low immunogenicity, and favorable developability. We look forward to working with SOTIO to advance novel therapeutics that have the potential to improve cancer treatment."

On July 16, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported improved performance of its key building block, EvaxMHC, within its AI-Immunology platform, at the 32nd Intelligent Systems for Molecular Biology (ISMB) conference taking place in Montreal, Canada, from July 12-16, 2024 (Press release, Evaxion Biotech, JUL 16, 2024, View Source [SID1234644889]).

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A key feature in developing effective AI-designed personalized and precision vaccines is the ability to accurately predict which small fragments, known as peptides, of pathogens or cancer cells are displayed on the surface of cells by Major Histocompatibility Complex (MHC) molecules. This display allows the immune system to recognize and eliminate the threat. Evaxion’s EvaxMHC building block predicts which peptides are more likely to be presented by MHC molecules, thereby aiding vaccine target discovery and facilitating the development of effective vaccines.

Christian Kanstrup, Evaxion’s CEO, comments: "Our results demonstrate significant improvements in the prediction of peptide-MHC interactions, particularly for MHC class II molecules, which have historically been difficult to predict accurately. With this advancement on AI-Immunology we now have a more reliable and effective tool for designing personalized and precision vaccines for cancer and infectious diseases. The improved EvaxMHC building block is used in the ongoing Phase 2 trial with Evaxion’s lead vaccine candidate, the personal cancer vaccine EVX-01."

Key highlights showcased at the presentation:

A state-of-the-art deep-learning framework was utilized, enhancing the accuracy of peptide-MHC predictions

Our approach includes three new strategies: Creating a unified representation for both MHC class I and -II molecules, utilizing a deep transformer encoder-decoder architecture, and adopting a generative adversarial network (GAN) pretraining mechanism

The updated EvaxMHC building block led to improved vaccine designs demonstrated in preclinical studies
About AI-Immunology
AI-Immunology is a scalable and adaptable artificial intelligence technology platform at the forefront of vaccine discovery for infectious diseases and cancers. By integrating the collective power of proprietary AI models PIONEER, EDEN, RAVEN, and ObsERV, the platform can model the complexity of the patient’s immune system. AI-Immunology advanced computational modeling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionizing the landscape of immunotherapy by offering a holistic and personalized approach to combat fast-evolving pathogens and malignant cells.

On July 16, 2024 Orum Therapeutics ("Orum" or the "Company"), a clinical-stage private biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported a global, multi-target license and option agreement whereby it granted Vertex Pharmaceuticals ("Vertex") (Nasdaq: VRTX) rights to conduct research using Orum’s Dual-Precision Targeted Protein Degradation (TPD²) technology for the discovery of novel targeted conditioning agents for use with gene editing (Press release, Orum Therapeutics, JUL 16, 2024, View Source [SID1234644906]).

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Following the research period for each target, Vertex will have the option to obtain a worldwide, exclusive license to research, develop, manufacture, and commercialize DACs developed with Orum’s TPD² technology for that target. Under the terms of this agreement, Orum will receive an upfront payment of $15 million and is eligible to receive additional option payments and milestones potentially totaling up to $310 million per target for up to three targets, as well as tiered royalties on potential future global annual net sales. Vertex is responsible for all research, development, and commercialization.

"Vertex is a leader in discovering and developing innovative medicines, including being the first to receive FDA approval of a CRISPR/Cas9 gene-edited therapy, and we are pleased they’ve selected Orum’s TPD² technology to discover novel targeted conditioning agents," said Sung Joo Lee, Ph.D., CEO and founder of Orum Therapeutics. "This agreement with Vertex creates the potential to treat patients in a novel indication space with our leading targeted protein degradation approach for an exciting new therapeutic class of degrader-antibody conjugates."