On September 10, 2024 Curium, a world leader in nuclear medicine, reported that in Spain, PYLCLARI is now available for patients with prostate cancer (Press release, Curium Pharma, SEP 10, 2024, View Source [SID1234646470]). PYLCLARI (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings:

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Primary staging of patients with high-risk prostate cancer prior to initial curative therapy
To localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Benoit Woessmer, PET Europe CEO at Curium commented, "The availability of PYLCLARI in Spain is an important milestone for patients with prostate cancer and underscores our dedication to improving the choice of diagnostic PET radiopharmaceuticals. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are proud that the availability of PYLCLARI continues to grow and now covers seven countries including Austria, France, Germany, Greece, Italy, the Netherlands, and Spain."

In Spain, prostate cancer is one of the most common cancers among men with around 30,000 new cases diagnosed nationwide every year. PYLCLARI is being produced by Curium at two sites in Madrid and one site in Sevilla, ensuring timely and efficient distribution across the country.

On September 10, 2024 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported the presentation of a significant study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from September 13-17 (Press release, Lunit, SEP 10, 2024, View Source [SID1234646486]).

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While Nivolumab plus chemotherapy has recently been approved as a standard first-line treatment for advanced gastric cancer (AGC), its efficacy varies among patients. This variability underscores the critical need for reliable biomarkers to predict treatment response. Lunit’s study addresses this pressing need, potentially offering a new tool to optimize patient care and treatment decisions.

Conducted in collaboration with leading Korean medical institutions, the research showcases the potential of Lunit’s AI-powered histopathology analyzer, Lunit SCOPE IO, in predicting treatment response and guiding treatment decisions for AGC via assessment of immune phenotype.

The study analyzed H&E images from 585 AGC patients, with Lunit SCOPE IO classifying tumors into two immune phenotypes—inflamed (IIP) and non-inflamed—based on the presence and distribution of tumor-infiltrating lymphocytes (TILs) from hematoxylin and eosin (H&E) slides that are readily available from a standard clinical workup. This classification provided valuable insights into the tumor microenvironment and helped predict treatment response, particularly in cases where traditional biomarkers like PD-L1 may not provide a complete picture.

Key findings include:

1. Patients treated with Nivolumab+Chemotherapy showed significantly longer median progression-free survival (mPFS) compared to Chemotherapy alone (8.2 vs. 5.9 months).
2. The inflamed immune phenotype group, classified by Lunit SCOPE IO, was associated with more pronounced PFS benefits from Nivolumab+Chemotherapy:

IIP: 5.2 months longer PFS for Niv+Chemo (mPFS of 11.0 vs 5.8 months)
Non-IIP: only 1.4 months longer PFS for Niv+Chemo (mPFS of 7.3 vs 5.9 months)
3. The predictive value of IIP was consistent across different PD-L1 expression levels.
4. Multivariate analysis confirmed IIP as an independent factor for PFS in patients treated with Nivolumab+Chemotherapy.

"By demonstrating that our AI-powered immune phenotype analysis can predict treatment response independently of PD-L1 status, we’re opening new possibilities for tailoring treatments in AGC," said Brandon Suh, CEO of Lunit. "This is particularly significant because gastric cancer continues to be a leading cause of cancer-related deaths globally, representing 7.7% of all cancer cases. Our AI technology has the potential to enhance the precision of treatment decisions, potentially leading to more effective therapies and better quality of life for patients with AGC."

Please visit Lunit’s poster session at 1411P to discover more about our findings and the innovative capabilities of Lunit SCOPE IO.

Poster presentation featuring Lunit SCOPE IO at ESMO (Free ESMO Whitepaper) Congress 2024:

"AI-powered immune phenotype predicts favorable outcomes of nivolumab (niv) plus chemotherapy (chemo) in advanced gastric cancer (AGC): A multi-center real-world data analysis" (1411P, September 16, 12:00~13:00 PM)

On September 10, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, and Mary Beth Harler, M.D., Head, Research & Autoimmunity, will participate in a fireside chat at the Stifel 2024 Virtual Immunology and Inflammation Summit on Tuesday, September 17, 2024, at 9:00 a.m. EDT (Press release, IGM Biosciences, SEP 10, 2024, View Source [SID1234646471]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On September 10, 2024 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported the expansion of its in vivo chimeric antigen receptor macrophage and monocyte (together, "CAR-M") collaboration with Moderna, Inc. (Nasdaq: MRNA) to include the nomination of two targets for the treatment of autoimmune diseases (Press release, Carisma Therapeutics, SEP 10, 2024, View Source [SID1234646487]). Carisma retains all rights in autoimmune disease beyond the two nominated targets, which will be exclusively partnered with Moderna.

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Under this expanded collaboration, Carisma and Moderna will leverage Carisma’s proprietary CAR-M technology and Moderna’s mRNA/LNP platform to develop novel in vivo macrophage engineering approaches in the nominated autoimmune disease targets. Carisma will receive research funding and is eligible to receive development, regulatory, and commercial milestone payments, plus royalties on net sales of any products that are commercialized under the collaboration agreement. Carisma will be responsible for the discovery and optimization of development candidates, while Moderna will lead the clinical development and commercialization of therapeutics resulting from the agreement.

"We are excited to expand our collaboration with Moderna into the realm of autoimmune diseases," said Steven Kelly, President and Chief Executive Officer of Carisma. "The nomination of the two autoimmune targets is a significant milestone in our mission to harness the power of macrophages to treat a broader range of diseases. Our innovative CAR-M technology has the potential to revolutionize the treatment landscape for patients suffering from these debilitating conditions."

"We are excited to build on the progress of advancing in vivo CAR-M therapies with Carisma by expanding beyond oncology," said Lin Guey, PhD, CSO of Therapeutic Research Ventures, Moderna. "We continue to believe that the combination of our platform and Carisma’s deep myeloid biology expertise could lead to innovative treatments for patients."

The expanded collaboration between Carisma and Moderna underscores the potential of CAR-M technology to impact a diverse range of disease areas. The expansion will aim to bring transformative therapies to patients with cancer and autoimmune diseases, advancing the frontier of immunotherapy.

On September 10, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the upcoming Cantor Global Healthcare Conference being held in New York (Press release, Kura Oncology, SEP 10, 2024, View Source [SID1234646472]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a fireside chat at 1:20 p.m. ET / 10:20 a.m. PT on September 17, 2024.

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A live audio webcast of the fireside chat will be available in the investor section of Kura’s website at www.kuraoncology.com with an archived replay available following the live event.