On October 30, 2025 Takeda reported Financial Report For the Quarter Ended September 30, 2025 (Presentation, Takeda, OCT 30, 2025, View Source [SID1234661412]).

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On October 30, 2025 Merck & Co reported third quarter 2025 financial results (Presentation, Merck & Co, OCT 30, 2025, View Source [SID1234661408]).

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On October 30, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported it will present new preclinical and translational data from multiple investigational programs at two scientific conferences in November – the World ADC Conference in San Diego, California, and PEGS Europe, in Lisbon, Portugal.

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At these global forums, SOTIO will highlight progress across its next-generation antibody-drug conjugates (ADCs) and immunocytokine pipeline, which is advancing toward new treatment options for patients with solid tumors in areas of unmet medical need. Topics of the presentations include:

SOT106, a novel ADC targeting LRRC15 for the treatment of mesenchymal tumors, with a particular focus on soft tissue sarcoma and osteosarcoma. Preclinical data demonstrate a high therapeutic index and strong anti-tumor activity, supporting its potential best-in-class profile.
SOT109, SOTIO’s lead CDH17-targeting ADC for gastrointestinal cancers, including colorectal and other GI malignancies. Preclinical findings show robust efficacy and a favorable safety profile, reinforcing best-in-class therapeutic potential.
SOT201, a cis-acting PD-1/IL-15 mutein-based immunocytokine designed to target and reinvigorate exhausted T cells in the tumor microenvironment while maintaining a systemic immune balance. SOT201 is currently under clinical evaluation in the Phase 1 VICTORIA-01 study in patients with advanced metastatic cancers.
"These data reflect the significant progress we are making across our pipeline and the strength of our scientific foundation," said Radek Špíšek, M.D., Ph.D., chief executive officer of SOTIO. "By integrating deep insights into cancer biology with next-generation therapeutic modalities, we aim to provide new therapies for diseases with high unmet medical need."

World ADC oral presentation details:

Title: "Exploring Novel Pharmacology & Translational Aspects of SOT106 Targeting LRRC15 in Solid Tumors"
Session: Pharmacology track
Presenter: Lenka Palova Jelinkova
Date & Time: November 3, 2025, 10:30am PT

Title: "Advancing a Preclinical Pipeline of ADCs Targeting Gastrointestinal Cancers"
Session: Preclinical track
Presenter: Amy Jensen-Smith
Date & Time: November 5, 2025, 3:00pm PT

PEGS Europe oral presentation details:

Keynote Presentation Title: "SOT109: A CDH17 Targeting ADC with Best-in-Class Potential Activity for the Treatment of CRC and Other GI Cancers"
Session: Engineering Antibody-Drug Conjugates
Presenter: Radek Špíšek
Date & Time: November 12, 2025, 1:50pm CET

Title: "Preclinical Pharmacology and Translational Aspects of a Cis-Acting PD-1/IL-15 Mutein-Based Immunocytokine SOT201"
Session: Next-Generation Immunotherapies
Presenter: Anna Jirovec
Date & Time: November 13, 2025, 5:10pm CET

Presentation materials will be available upon request following the live presentations.

(Press release, SOTIO, OCT 30, 2025, View Source [SID1234657189])

On October 30, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that the first patient has been treated in a Phase 2 clinical trial investigating FL115 in combination with Bacillus Calmette-Guérin (BCG). The study will assess the anti-tumor effect of the combination therapy, including Complete Response Rate and Duration for carcinoma in situ (CIS) NMIBC patients, and Disease Free Survival and Relapse Free Survival for papillary (Ta/T1) NMIBC patients.

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FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. The start of the Phase 2 clinical trial builds on positive data from the Phase 1 trial where FL115 demonstrated favorable safety and efficacy in the same patient population. As a monotherapy at the recommended dose for expansion, 4/6 patients achieved responses longer than 3 months, of which 2 patients achieving responses longer than 9 months. This dose of FL115 in combination with BCG will be investigated in the Phase 2 trial.

"Dosing the first patient in our Phase 2 trial for FL115 marks a defining moment for Forlong, as we advance our lead candidate further into clinical development and continue to validate the potential of our synthetic immunology platforms," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "FL115 stands out with favorable safety and preliminary efficacy observed in multiple Phase 1 clinical studies in advanced solid tumors and NMIBC. With FL115 interim data for advanced solid tumor to be presented as Late Breaking Abstract on Nov 8 at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025), this trial gives us the opportunity to further validate FL115 as potential Best-in-class IL-15 superagonist, and bring new treatment options for cancer patients in need."

The Phase 2 clinical trial plans to enroll three arms: BCG unresponsive CIS NMIBC patients, BCG unresponsive high risk papillary NMIBC patients, and BCG naïve medium/high risk NMIBC patients. The trial will be conducted at over 15 investigator sites in China.

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, OCT 30, 2025, View Source [SID1234657188])

On October 30, 2025 Synthekine Inc., an engineered cytokine therapeutics company, reported that data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented in a late-breaking oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025 taking place in National Harbor, MD., from November 7-9, 2025. In this study, STK-012 is being evaluated in combination with standard-of-care pembrolizumab + chemotherapy in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC) patients. The company will also present new preclinical data on combinations of STK-012 and T cell engagers.

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"We are excited to present our first clinical data in first-line, PD-L1 negative nonsquamous NSCLC patients from the ongoing trial of STK-012, our lead program and a novel approach to biasing IL-2," said Debanjan Ray, chief executive officer of Synthekine. "PD-L1 negative patients comprise approximately one-third of the nonsquamous NSCLC population, and these patients receive significantly reduced benefit from standard-of-care chemoimmunotherapy versus PD-L1 positive patients. We look forward to sharing these results with the scientific community, and the further development of STK-012 in this setting in our SYNERGY-101 study, a global, randomized Phase 2 trial which is currently ongoing."

Details are as follows and available on the SITC (Free SITC Whitepaper) online itinerary:
(Please note that the late-breaking clinical data will be shared both as an oral presentation and a poster.)

Title: Initial Phase 1a/1b Results of STK-012, an α/β IL-2 Receptor Biased Partial Agonist, with Pembrolizumab, Pemetrexed, and Carboplatin in 1L PD-L1 Negative Non-Squamous NSCLC
Session Title: Clinical Oral Abstract Session 2
Session Date & Time: Saturday, November 8, 2025, 2:00 PM ET
Location: Gaylord National Resort and Convention Center, Potomac Ballroom
Abstract Number: 1345

Title: Initial Phase 1a/1b Results of STK-012, an α/β IL-2 Receptor Biased Partial Agonist, with Pembrolizumab, Pemetrexed, and Carboplatin in 1L PD-L1 Negative Non-Squamous NSCLC
Session Title: Exhibits and Poster Reception
Session Date & Time: Friday, November 7, 2025, 5:35 PM – 7:00 PM ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Poster Board Number: 1345
Abstract Number: 1345

Title: STK-012, a First-in-Class α/β IL-2 Receptor Biased Partial Agonist Enhances the Anti-Tumor Efficacy of Bispecific Antibodies
Session Title: Exhibits and Poster Reception
Session Date & Time: Saturday, November 8, 2025, 5:10 PM – 6:35 PM ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Poster Board Number: 682
Abstract Number: 682

Copies of the presentation and posters will be available on Synthekine’s website following presentation at the meeting.

(Press release, Synthekine, OCT 30, 2025, View Source [SID1234657187])