On February 26, 2024 Lirum Therapeutics, Inc. ("Lirum"), an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases, reported that it will present positive data on LX-101, a novel clinical-stage targeted therapy directed to the insulin growth factor-1 receptor (IGF-1R), in patients with high IGF-1R tumor expression at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress in Paris, France on Monday, February 26th at 5:15 PM CET (11:15 ET) (Press release, Lirum Therapeutics, FEB 26, 2024, View Source [SID1234651604]).

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Lirum’s presentation "LX-101, a novel, clinical-stage, payload-bearing IGF-1R targeted therapy demonstrates activity in patients with high IGF-1R tumor expression" will be presented in the Hall Bordeaux at the Palais des Congrès. The poster presentation covers patient outcomes in the previous Phase 1a studies with LX-101, with a focus on those patients that we determined to have high IGF-1R tumor expression. Of the 19 patients treated with LX-101, 4 were considered high IGF-1R expressers. Of these 4 patients, 3 were evaluable for response, and 2/3 (67%) of these patients experienced disease control/response, including the one patient who had an objective response at the highest dose. The poster presentation is available on the Lirum website (www.lirumtx.com) under the Investors and Media tab.

Given the promising results, including that patients with high IGF-1R expressing tumors can be clinically sensitive to LX-101, Lirum is planning new clinical trials with LX-101 focused on oncologic indications, both pediatric and adult, that carry well-established ties to the IGF-1/IGF-1R pathway. Lirum is also developing LX-101 in certain autoimmune diseases, including thyroid dye disease, where IGF-1R has been clinically and commercially validated.

On February 26, 2024 Orion reported its annual report (Presentation, Orion, FEB 26, 2024, View Source [SID1234643767]).

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On February 26, 2024 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, targeted therapeutics for the treatment of fibrotic disease and cancer reported that Lisa Anson, Chief Executive Officer, and Peter Collum, Chief Financial Officer, will be presenting in-person at the TD Cowen 44 th Annual Health Care Conference in Boston, MA, on Wednesday 6 March at 9:50am ET. Alongside the presentation, the Company will also be available for one-to-one meetings (Press release, Redx Pharma, FEB 26, 2024, https://www.redxpharma.com/2024/02/26/redx-to-present-at-cowen-health-care-conference/ [SID1234640602]).

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The presentation will be webcast live and can be accessed via the following link: https://wsw.com/webcast/cowen154/redx.l/2263774

Following the event, a recording will be made available on the investor section of the Company’s website at: View Source

On February 26, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and Co-founder, will present at the following investor conferences in March (Press release, In8bio, FEB 26, 2024, View Source [SID1234640482]):

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TD Cowen 44th Annual Health Care Conference
Company presentation
Monday, March 4, 2024, at 9:50 am ET

2nd Annual H.C. Wainwright Cell Therapy Virtual Conference
Virtual company presentation
Tuesday, March 26, 2024

A live webcast and replay will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

On February 26, 2024 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported an update on the positive results of OSE-279 in the Phase 1/2 clinical evaluation in advanced solid tumors at the 2024 ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress (ESMO TAT) held in Paris, France (February 26 – 28, Abstract #368; FPN 30P) (Press release, OSE Immunotherapeutics, FEB 26, 2024, View Source [SID1234640481]).

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Silvia Comis, Head of Clinical Development and Regulatory Affairs of OSE Immunotherapeutics, comments: "We are very pleased to share this positive update on the preliminary efficacy and safety results from a Phase 1/2 study assessing the therapeutic potential of our proprietary high affinity anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors. These new results and additional signal of efficacy with a high anti-tumor response rate in difficult-to-treat patients, highlight the value of OSE-279 as a potential strong anti-PD1 therapy and encourage further clinical development in the future in pre-identified cancer niche indications, with still high unmet medical needs. In parallel to OSE-279 monotherapy development, new cohort testing combinations with other OSE drug candidates, including cancer vaccine, are being explored."

The ESMO (Free ESMO Whitepaper)-TAT communication reported on the positive results from the Phase 1/2 clinical trial (NCT05751798) evaluating OSE-279 monotherapy in patients with advanced solid tumors, with no therapeutic option available.

The updated data show a good pharmacokinetic/pharmacodynamic (PK/PD) and manageable safety profile in line with previous anti-PD1 development and with a high signal of efficacy in the first 20 patients representing 13 different tumor types. Four confirmed ongoing partial responses (PR) with 600 mg every six weeks (q6w), with a response rate of 36%, were reported in patients with anal squamous cell carcinoma, undifferentiated pleomorphic sarcoma, oncocytic thyroid cancer, and alveolar soft part sarcoma. One still ongoing confirmed PR (81% reduction of target lesions) has been observed in a patient with hepatocellular carcinoma after one single dose of OSE-279 300 mg. Five stable diseases (SD) were reported at multiple dose levels. Treatment is ongoing in seven patients. Pharmacokinetic (PK) showed dose-proportionality and favorable exposure. Receptor occupancy (RO) was maintained. At 600 mg q6w, no dose-limiting toxicities (DLTs) were reported in 10 patients. Further to the recommendation of a Phase 2 dose (RP2D) of 300 mg q3w, the dose of 600 mg q6w has been selected as the second RP2D.

OSE-279 is a high affinity humanized anti-PD1 monoclonal antibody blocking both PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells and tumor microenvironment. Overexpression of PD-L1 and PD-L2 on tumor and myeloid cells in the tumor microenvironment is a mechanism of tumor immune escape.

Given the advantages of owning a proprietary and protected high affinity anti-PD1 antagonist antibody, OSE Immunotherapeutics has developed a global intellectual property strategy protecting OSE-279 until at least 2039. This has been achieved through recent grants of patents in the U.S., various European countries, China, Japan, Korea, Australia, and Mexico to date. These patents protect the original antibody sequences of OSE-279 associated with its innovative biological and manufacturing properties.

The first-in-human open label Phase 1/2 dose escalation and expansion study, initiated in December 2022, aims to determine the Maximum Tolerated Dose (MTD) and/or the RP2D of OSE-279 as a monotherapy in advanced solid tumors with two possible administration regimens. Secondary objectives include assessment of OSE-279’s antitumor activity, evaluation of the safety profile, pharmacokinetic and receptor occupancy or pharmacodynamic profile (NCT05751798).