On April 21, 2023 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the Company will be showcasing its Focal One Robotic High Intensity Focused Ultrasound (HIFU) platform at the upcoming Annual Meeting of the American Urological Association (AUA), the largest gathering of urologists worldwide, which will be held April 28th through May 1st in Chicago, IL (Press release, EDAP TMS, APR 21, 2023, View Source [SID1234630389]).

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The Company will be having its largest presence ever at this year’s AUA meeting. Focal Therapy, and the Focal One HIFU platform will be represented in several topics during both plenary presentations and instructional courses throughout the meeting. Presentations will be given by leading academic urologists describing the key advantages of using HIFU therapy with its ability to meet accepted oncological standards for the management of prostate cancer while preserving sexual function and urinary control for patients. With the growing clinical acceptance of focal therapy in the management of prostate cancer, EDAP will also provide presentations delivered by several key thought leaders throughout the meeting in their booth along with hands-on Focal One simulated cases demonstrations. Additionally, EDAP will be featured in the Hands-on Ultrasound Skills Training AUA Accredited Course with the ExactVu Micro-ultrasound platform under the guidance of expert faculty.

"This year’s AUA meeting will highlight the growing adoption of EDAP’s Focal One HIFU platform in the management of prostate cancer," said Ryan Rhodes, Chief Executive Officer of EDAP USA. "Since last year’s meeting, use of Focal One therapy has continued to expand and is now widely recognized as an important technology for the comprehensive management of prostate cancer alongside other notable therapies. As Focal One use grows, major global medical meetings such as the AUA provide EDAP with a unique opportunity to reach a global physician audience to showcase the benefits of our technology and to further help physicians understand the important role and use of Robotic Focal HIFU from experienced colleague users."

About American Urological Association (AUA) Meeting

The AUA Annual Meeting is the world’s foremost meeting of urologists. It attracts more than 11,000 practicing physicians and healthcare professionals to the largest gathering of urological professionals worldwide. With over 300 technical exhibitors, more than 90 educational courses, and over 2,000 accepted abstracts, it delivers the latest in urologic medicine – providing needed tools to healthcare professionals as they continue to improve patient care. Additional information on the meeting can be found at View Source

On April 21, 2023 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ian Taylor, Ph.D., Chief Scientific Officer, and Sean Cassidy, Chief Financial Officer, will participate in a fireside at the Stifel Targeted Oncology Day on Wednesday, April 26 at 11:30 a.m. ET (Press release, Arvinas, APR 21, 2023, View Source [SID1234630388]).

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A live audio webcast of the fireside chat will be available here and on the Events & Presentations section of the Investors & Media section of the Company’s website.

On April 21, 2023 PDS Biotechnology presented its investment presentation (Presentation, PDS Biotechnology, APR 21, 2023, View Source [SID1234630386]).

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On April 21, 2023 Nerviano Medical Sciences Srl, a member of NMS Group and a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported to be selected as Plenary Session highlights of the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting 2023 for the data from the First-In-Human study of NMS-03592088 – a novel, potent inhibitor of FLT3, KIT and CSF1R (Press release, Nerviano Medical Sciences, APR 21, 2023, View Source [SID1234630385]). The Phase 1 clinical trial data were presented during an oral scientific session on 16 April.

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NMS-03592088 is an orally available compound that showed superior preclinical activity with respect to first and second generation FLT3 inhibitors and demonstrated a good potency on resistance mutation F691L identified as cause of relapse in patients treated with selective FLT3 inhibitors. NMS-03592088 is currently being explored in MKIA-088-001 trial, a multi-center Phase 1/2 study to evaluate safety, tolerability and efficacy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML).

The Phase 1 portion of the study was a 3+3 design dose escalation with NMS-03592088 administered daily for 21 of 28 days (schedule A) or continuously (schedule B). As of January 26, 44 R/R AML or CMML patients were treated across doses from 20 to 360 mg/day in schedule A or from 120 to 250 mg/day in schedule B. 41 patients had AML and 3 patients had CMML. 24 AML patients were FLT3 positive with FLT3-ITD mutations representing the most common genetic alteration and the majority of them had received at least one prior FLT3 inhibitor (87.5%).

NMS-03592088 showed manageable safety with no maximum tolerated dose characterized. Overall, the most frequent treatment-emergent related adverse events were nausea (any grade, 20.5%), vomiting (13.6%), asthenia (11.4%). A dose-dependent trend of reversible myasthenic syndrome was also characterized.

In terms of clinical benefit, the data showed a dose-dependent trend for response. 5 out of 12 evaluable patients with FLT3 positive AML treated at dose ≥ 300 mg achieved an investigator-assessed response. All these patients had received prior midostaurin and 2 had received prior midostaurin and prior gilteritinib. Two patients with response were able to withdraw from study to receive HSCT. Overall, the duration of response ranged from 1.3-7.9 months.

In summary, NMS-03592088 showed clinical efficacy in patients with FLT3 positive R/R AML, including patients who have failed prior FLT3 inhibitors. These results, together with the manageable safety observed, warrant further development which is now being explored in Phase 2 trial.

"We are pleased to see that NMS-03592088 demonstrates antileukemic activity in FLT3 positive AML patients since these patients are at high risk for poor outcomes" was noted by Lisa Mahnke, MD, PhD, Chief Medical Officer for Nerviano Medical Sciences.

"We believe that despite availability of FLT3 targeted agents there is still need for more effective treatments, including those for patients that have failed current FLT3 inhibitors" according to Hugues Dolgos, PharmD, CEO, Nerviano Medical Sciences.

A copy of today’s presentation "NMS-03592088, a novel, potent FLT3, KIT and CSF1R inhibitor with activity in FLT3 positive acute myeloid leukemia patients with prior FLT3 inhibitor experience" is available at this link: View Source

On April 21, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported that Dr. Milton Werner, Ph.D., President & Chief Executive Officer of Inhibikase, and Joseph Frattaroli, Chief Financial Officer of Inhibikase, will deliver a presentation at the 2023 Planet MicroCap Showcase being held on April 25-27, 2023 in Las Vegas, Nevada (Press release, Inhibikase Therapeutics, APR 21, 2023, View Source [SID1234630384]).

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Presentation Details:

Event: Planet MicroCap Showcase 2023
Presentation Date: Wednesday, April 26, 2023
Presentation Time: 1:00pm PT
Location: Horseshoe Hotel & Casino, Track 5 Company Presentations