On July 3, 2023 CANbridge Pharmaceuticals, Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, reported that, based on the interim analysis recommendation of the independent data monitoring committee, it plans to continue the ongoing Phase 2 study of CAN008 in patients with newly diagnosed glioblastoma multiforme (GBM) in China to completion (Press release, CANbridge Life Sciences, JUL 3, 2023, View Source [SID1234633035]).

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"We are pleased that the independent data monitoring committee made the recommendation to continue the CAN008 Phase 2 glioblastoma multiforme trial in China, based on their analysis of the interim data," said James Xue, Ph.D., founder, chairman and CEO of CANbridge Pharmaceuticals Inc. "Glioblastoma is an intractable cancer with poor patient outcomes under standard-of-care. We look forward to continuing to develop CAN008 as a potentially new treatment for patients in China."

About the CAN008 Phase 2 Trial in glioblastoma multiforme (GBM)

The Phase 2 double-blinded study enrolled 119 subjects who were randomized 2:1 to receive intravenous CAN008 400 mg or placebo, in addition to standard-of-care chemoradiotherapy. All subjects underwent surgical excision of the GBM tumor prior to treatment. During the course of the study, they receive a 6-week course of triple therapy(temozolomide, radiotherapy and CAN008 or placebo), followed by a 1-month rest, then a 12-month course of dual therapy (temozolomide and CAN008 or placebo), and then monotherapy (CAN008 or placebo) until progression of disease, intolerability to treatment, death, or withdrawal. The primary endpoint is progression-free survival (PFS), and the secondary endpoint is overall survival (OS).

About CAN008

CAN008 (asunercept) is a CD95-Fc fusion protein that binds to the CD95 ligand and blocks the interaction between the ligand and the endogenous CD95 receptor. CAN008 has a unique dual mechanism of action, inhibiting both the invasive growth and migration of tumor cells, as well as T-cell apoptosis, which enhances immune recognition of the cancer. Earlier asunercept glioblastoma multiforme (GBM) clinical trial data showed favorable safety and tolerability, prolonged survival and improved quality-of-life.

Asunercept has been granted US FDA Orphan Drug Designation and Orphan Medicinal Product Designation by the European Medicines Agency (EMA) for GBM. It has also been accepted into the EMA’s PRIME (Priority Medicines) program, which provides support to medicines that could address unmet medical needs. In China, CAN008 has been classified as a Class 1 New Drug by the National Medical Products Administration. CANbridge holds the rights to develop and commercialize CAN008 for any indication in Greater China and is currently conducting a CAN008 Phase 2 trial in GBM in China.

On July 3, 2023 Lunit (KRX:328130.KQ), a global provider of AI-powered cancer diagnostics solutions, reported the publication of a study exploring the impact of medical AI solutions’ accuracy on radiologists’ diagnostic determination (Press release, Lunit, JUL 3, 2023, View Source;published-in-radiology-301868701.html [SID1234633033]). The study, conducted by Seoul National University Hospital from December 2015 to February 2021, was recently published in ‘Radiology,’ a renowned peer-reviewed journal in medical imaging.

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The study involved a cohort of 30 doctors, including 20 board-certified radiologists with 5 to 18 years of expertise and 10 radiology residents with 2 to 3 years of training. A total of 120 retrospectively collected chest radiographs were assessed, with 60 obtained from patients with lung cancer and the remaining 60 showing no abnormalities.

During the first session, the 30 readers were divided into two groups and analyzed 120 chest X-rays each without the assistance of AI. In the subsequent session, each group reinterpreted the images with the aid of either a high-accuracy or low-accuracy AI model.

The high-accuracy AI model utilized in the study was Lunit INSIGHT CXR, Lunit’s commercially available AI solution for chest X-ray analysis. In contrast, the low-accuracy model was trained using only 10% of the data available to Lunit INSIGHT CXR. The AUROC (area under the receiver operating characteristic curve), a commonly used metric for diagnostic accuracy, of Lunit INSIGHT CXR was 0.88, while the low-accuracy AI model only reached 0.77.

The study revealed that using the higher-accuracy AI model, Lunit INSIGHT CXR, significantly improved radiologists’ performance. The AUROC was remarkably advanced from 0.77 to 0.82 when assisted by the high-accuracy AI model.

Conversely, the radiologists from the other group did not experience any performance improvement when utilizing the low-accuracy AI model, as the AUROC remained at 0.75. Moreover, the group that employed the high-accuracy AI model demonstrated a higher susceptibility to AI suggestions. The radiologists accepted 67% of AI recommendations that contradicted the initial reading results, compared to 59% acceptance of the group that utilized the low-accuracy AI model.

Moreover, the study findings highlighted that factors such as radiologists’ individual expertise, experience with AI, or attitudes toward AI had negligible impact on their reading performance in the second session. Instead, the accuracy of the AI model and the radiologists’ initial diagnostic accuracy emerged as the primary determinant shaping the final diagnostic determination.

These findings underscore the significance of the AI model’s performance when radiologists use AI as a second reader. Furthermore, the study demonstrates how such AI assistance can increase radiologists’ susceptibility to AI suggestions, ultimately contributing to more accurate diagnoses.

"The study backs that irrespective of radiologists’ individual characteristics, the utilization of high-performance AI significantly enhances diagnostic accuracy and fosters a greater acceptance of AI within medical practices," said Brandon Suh, CEO of Lunit. "At Lunit, we are committed to developing AI-powered solutions that not only improve patient outcomes but also augment the expertise of healthcare professionals. This publication is a testament to our dedication to advancing the field of cancer diagnostics through cutting-edge technology."

Radiology, owned and published by the Radiological Society of North America (RSNA), is a prestigious publication with a distinguished Impact Factor of 29.146, making it the number one ranked journal in the field of medical imaging.

On July 4, 2023 4SC AG (4SC, FSE Prime Standard: VSC) reported that the results from the RESMAIN Study evaluating resminostat (Kinselby) in maintenance treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) will be presented by Professor Dr. Rudolf Stadler at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 on Saturday, 23rd September 2023 at 9:10h CEST at The Leiden University Medical Center in the Netherlands (Press release, 4SC, JUL 3, 2023, View Source [SID1234633032]).

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On 23 May 2023 4SC AG informed the market that resminostat (Kinselby) had met the primary endpoint in the RESMAIN study and demonstrated a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo. The study confirmed the already well known safety profile of resminostat (Kinselby) in CTCL.

RESMAIN is a pivotal study, conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluating resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at 50 clinical centers in 11 European countries and 5 centers in Japan.

If approved by regulatory authorities, resminostat (Kinselby) would be the first histone deacetylase inhibitor approved in Europe for CTCL and the first and only drug approved for maintenance therapy in this disease, making it the Company’s most valuable asset. The positive outcome to RESMAIN creates an opportunity to either sell, license or partner 4SC’s resminostat program for commercialization worldwide (excluding Japan), where Yakult Honsha Co. Ltd, was granted an exclusive license for the development and marketing of resminostat in Japan in 2011.

Dr. Susanne Danhauser-Riedl, Chief Medical Officer of 4SC: "The RESMAIN study is the first randomised controlled trial that has proven the benefit of maintenance treatment in advanced CTCL, and we are very pleased to have successfully demonstrated the positive impact of using resminostat for patients enrolled in this study. We thank the investigators and their staff and in particular the patients that participated in the RESMAIN trial and made this success happen".

On July 3, 2023 IGM Biosciences, Inc. (NASDAQ: IGMS) reported the closing of its previously announced upsized underwritten public offering of 1,597,827 shares of its voting common stock and 9,000,000 shares of its non-voting common stock and including the full exercise of the underwriters’ option to purchase 1,589,673 shares of its voting common stock, at a public offering price of $8.00 per share (Press release, IGM Biosciences, JUL 3, 2023, View Source [SID1234633031]). All of the shares in the public offering were sold by IGM and delivered to purchasers on June 26, 2023, other than with respect to 5,625,000 shares of non-voting common stock, delivery of which occurred on July 3, 2023.

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Concurrent with the public offering, IGM closed the sale of 2,812,500 shares of its non-voting common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the Securities Act), to certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC at a sale price equal to $8.00 per share.

The public offering and the concurrent private placement resulted in gross proceeds for IGM of $120.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM.

BofA Securities, Jefferies, Stifel, and Guggenheim Securities acted as joint book-running managers for the public offering.

The securities in the public offering were offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 3, 2022 and declared effective on November 14, 2022. A final prospectus supplement and accompanying prospectus relating to the public offering was filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this public offering may also be obtained from: BofA Securities, Attention: Prospectus Department, NC1-0220-02-24, 200 North Tryon Street, Charlotte, North Carolina 28255-0001, or via email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

The shares of non-voting common stock sold in the concurrent private placement have not been registered under the Securities Act or under any state securities laws and, unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

On July 3, 2023 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported that senior management will participate in a fireside chat at Cowen’s 2nd Annual RNA Therapeutics Summit on Monday, July 10, 2023 at 11:00 a.m. E.T (Press release, Sarepta Therapeutics, JUL 3, 2023, https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-present-cowens-2nd-annual-rna-therapeutics [SID1234633028]). The fireside chat will be held virtually.

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The presentation will be webcast live under the Events & Presentations section of the investor relations section of Sarepta’s website at View Source and will be archived there following the presentation for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.