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Bexion Pharmaceuticals, Inc. Announces First Patient Dosed with BXQ-350 in the RETRO Clinical Study

On October 18, 2022 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing biologics for the treatment of cancer and neuropathy, reported that the first adult patient has been dosed in the Pilot Proof of Concept Pharmacokinetic/Pharmacodynamic (PK/PD) Study in Cancer Patients (RETRO) (Press release, Bexion, OCT 18, 2022, View Source [SID1234622157]). The study will examine the effects of BXQ-350 on cancer patients exposed to Oxaliplatin and/or Taxane-based chemotherapy exhibiting chemotherapy-induced peripheral neuropathy (CIPN) symptoms.

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"We are delighted with the news that the first patient has been dosed in our Phase 1 RETRO study. This study is a natural follow-on to data reported from our recent Phase 1 solid tumor study in cancer patients, in which patients reported potential reduction of existing CIPN symptoms," said Scott Shively, Chief Executive Officer of Bexion Pharmaceuticals. "CIPN is an enormous problem in which over 700,000 surviving cancer patients per year in the US alone have peripheral neuropathies caused by their prior chemotherapy. We are targeting to have initial data read-out from this study in 3Q2023."

The aim of this pilot proof-of-concept study is to assess PK/PD relationships in cancer patients with CIPN symptoms to determine the impact BXQ-350 has on ceramide, S1P, and inflammatory cytokine levels; thereby potentially reducing the intensity and/or duration of CIPN, improving quality of life, and establishing these signaling molecules as biomarkers in future studies.

The trial is being conducted at CTI Clinical Research Center in Cincinnati, Ohio. The plan is to enroll twenty patients. Interested patients can find more information here: View Source

Biohaven Announces Launch of Public Offering of Common Shares

On October 18, 2022 Biohaven Ltd. (NYSE: BHVN) ("Biohaven") reported that it has commenced a public offering of 20,000,000 of its common shares pursuant to a registration statement on Form S-1 (the "Registration Statement") filed with the Securities and Exchange Commission (the "SEC") (Press release, Biohaven Pharmaceutical, OCT 18, 2022, View Source [SID1234622156]). Biohaven expects to grant the underwriters a 30-day option to purchase up to an additional 3,000,000 common shares. Biohaven intends to use the net proceeds received from the offering for general corporate purposes.

J.P. Morgan Securities LLC is acting as book-running manager in the offering.

The proposed offering will be made only by means of a prospectus. A copy of the preliminary prospectus relating to this offering, when available, may be obtained from the following source: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected].

The Registration Statement has been filed with the SEC but has not yet become effective. The securities may not be sold nor may offers to buy be accepted prior to the time the Registration Statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

PIVALATE ACHIEVES POSITIVE PHASE 2 DATA IN BRAIN METS TRIAL

On October 18, 2022 Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, reported that Imperial College London’s F-18 Pivalate (RAD 101) has achieved successful Phase 2a data in patients with brain metastases, having shown significant tumour uptake that was consistent and independent from the tumour origin (Press release, Radiopharm Theranostics, OCT 18, 2022, View Source [SID1234622155]).

A full presentation of the results will take place at the 34th EORTC/AACR/NCI symposium in Barcelona (26-28 October 2022). The study was funded by the Medical Research Council and will also be published in a peer-reviewed journal in due course.

"We are very pleased to see a new molecule and an innovative mode of action showing significant results in brain cancer metastases," said Radiopharm’s CEO & Managing Director Riccardo Canevari.

"The team at Imperial College London, led by Professor Eric Aboagye, did a tremendous job. F-18 Pivalate and its potential therapeutic variations, currently under development, represent a promising theranostic approach to target brain metastases and potentially other brain tumours.

"These positive and encouraging results will inform F-18 Pivalate accelerated future development and we are looking forward to starting conversations with medical experts and regulatory agencies."

Professor Aboagye, from Imperial College London and the lead inventor of 18-F Pivalate, added: "This technology, when compared to the current clinical standard in PET imaging, has showed superior imaging performance in several cancers. We’re very pleased to see this interim data further confirms its potential."

Radiopharm acquired an exclusive worldwide licence for the Pivalate platform technology from Cancer Research Technology Limited and Imperial College London, and has a Sponsored Research Agreement on new analogues with Professor Aboagye.

GE Healthcare Announces Collaboration to Advance Digital Transformation of Pathology

On October 18, 2022 GE Healthcare and Tribun Health reported that they have entered a collaboration with the intent to provide digital pathology departmental solutions that give healthcare providers a more holistic view of patient records (Press release, GE Healthcare, OCT 18, 2022, View Source [SID1234622154]). The alliance intends to bring a data management solution by interfacing Tribun’s Health Suite data into GE Healthcare’s solution, such as GE Healthcare’s vendor neutral archive (VNA), Edison Datalogue. It is expected to focus on making digital pathology images and results an integrated part of the imaging patient record within the VNA; the availability of more accurate pathology reports in less time, created with the assistance of artificial intelligence (AI) provided by Tribun’s Health Suite; and fostering collaboration among pathologists and clinicians through availability of data in a consolidated location. Having pathology information is critical, especially in oncology, to enable collaboration, while improving the speed of diagnosis.

The market is rapidly evolving towards data-driven healthcare. In addition, the shortage of clinicians and increase in oncology cases globally are driving the need for development of AI to support early detection of cancers1.

"The oncology care pathway is one of the most complex with multiple steps involving a variety of specialists, complex tools, frequent decisions and large data sets," said Nalinikanth Gollagunta, CEO of Enterprise Digital Solutions at GE Healthcare. "With this digital pathology collaboration, we continue our journey towards simplifying the oncology care pathway with improved data management, the digitization of pathology and streamlined data access. Tribun Health is an important collaborator to achieve this objective and build on GE Healthcare’s enterprise approach to bringing clinical depth and AI at the point of care."

GE Healthcare and Tribun Health provide complementary solutions to streamline the oncology care pathway across the enterprise and support clinical teams delivering the best care to their patients. Edison Datalogue is GE Healthcare’s solution to unify and intelligently manage patient data, images and enterprise imaging content. The Tribun Health Suite is a leading AI-powered end-to-end computational pathology for diagnostics, prognosis and drug development. Tribun was awarded the 2022 Best in KLAS award for Digital Pathology solutions with extensive experience and has many large installations worldwide. Adding the pathology suite enables GE Healthcare to offer a full solution for patient data management.

"I am delighted with the implementation of this partnership with GE Healthcare which builds on existing relationships between our companies," said Jean-François Pomerol, CEO at Tribun Health. "It will allow us to offer our customers a solution that interfaces easily between CaloPix, the reference solution for digital pathology, and GE’s Enterprise Imaging products. This will promote interoperability of healthcare data, cooperation between clinicians and help to further clinical research."

Isoray Medical, Inc. and Viewpoint Molecular Targeting, Inc. Announce Investor Webcast on October 19, 2022 at 4:15 p.m. EDT

On October 18, 2022 Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy, and Viewpoint Molecular Targeting, Inc., a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported they will hold an investor webcast Wednesday, October 19, 2022, at 4:15 p.m. EDT (Press release, IsoRay Medical, OCT 18, 2022, View Source [SID1234622153]). The presentation will provide an overview of Viewpoint’s pipeline along with a review of data presented at this year’s European Association of Nuclear Medicine conference which concludes on October 19 in Barcelona, Spain. Speakers on the call will include Isoray CEO Lori Woods, Viewpoint Molecular Targeting CEO Thijs Spoor, Viewpoint Molecular Targeting CSO and co-founder Michael K. Schultz PhD, Geoffrey Johnson MD, PhD, lead investigator on TIMAR1, Vikas Prasad MD, director of clinical theranostics at the Mallinckrodt Institute of Radiology at Washington University in St. Louis.