On August 22, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that a new analysis from the post-market, prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test NCT03766958) will be presented at the 6th Annual Conference of the American Association for Bronchology and Interventional Pulmonology (AABIP) (Press release, Biodesix, AUG 22, 2023, View Source [SID1234634612]). The data will be presented by principal investigator of the ORACLE study, Michael Pritchett, DO, MPH, on Thursday, Aug. 24, 2023 in a live poster presentation in Chicago, IL.

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The Nodify XL2 test is designed to identify likely benign lung nodules that can be monitored with computed tomography (CT) scans instead of costly invasive procedures. The primary endpoint of the ORACLE study demonstrated that patients with benign lung nodules managed with the test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group.

The analysis to be presented at AABIP investigated the effect of improved identification of benign lung nodules on the remaining patients who received a diagnostic biopsy. Prior to implementation of the Nodify XL2 test, 49% of patients receiving a biopsy had a lung cancer diagnosis compared to 74% when the test was used in clinical decision making, representing a 51% relative increase in the cancer diagnosis rate.

"Finding a suspicious lung nodule can create fear and anxiety for patients, whether it is found through lung cancer screening or an incidental finding from imaging for general medical purposes," said Dr. Pritchett. "It is very encouraging that the Nodify XL2 test is helping physicians avoid unnecessary invasive procedures on benign lung nodules and prioritize patients with a higher risk of lung cancer. These results offer peace of mind to both patients and providers as they navigate the diagnostic plan."

On August 21, 2023 Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as "Sumgen Biotech") reported that it has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its Class 1 innovative therapeutic biological product SG1827 for injection (Press release, Sumgen Biotech, AUG 21, 2023, View Source;a=nav&id=351 [SID1234656272]). The indication is for the treatment of advanced malignant solid tumors.

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One of the main mechanisms of action for SG1827 is to provide co-stimulatory signals for T cell activation. This plays a crucial role in promoting the recognition of and attack to tumors by immune cells, and it helps improve the clinical efficacy of immunotherapies such as anti-PD-1/PD-L1 antibody treatment. Early research has shown that SG1827, both as a monotherapy and in combination with other immune checkpoint antibodies, exhibits significant anti-tumor activity. Furthermore, no obvious cytokine release reactions have been observed, indicating good safety profiles.

Dr. Ming Lv, founder of Sumgen Biotech, stated: "SG1827 is one of Sumgen Biotech’s most important pipeline layouts in the ‘post-PD-1 era,’ and is the company’s ninth project to enter the clinical phase. SG1827 has a clear pharmacological mechanism, definite efficacy, and good safety. In the early stages of R&D, targeted molecular design was used to significantly optimize its PK characteristics and improve the developability. This not only puts SG1827 in a leading position in the global R&D competition for the same target but also gives it the potential to become a "Best in Class" drug. We will actively advance the clinical development of SG1827, striving to benefit more cancer patients as soon as possible."

On August 21, 2023 GenScript reported 2023 interim results (Presentation, GenScript, AUG 21, 2023, https://www.genscript.com/gsfiles/IPO/2023%20Interim%20Results%20Final.pdf?101034653 [SID1234644731]).

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On August 21, 2023 Hanmi Pharm reported that the company has taken the first step toward clinical trials of BH3120, a double-antibody anticancer drug candidate it is developing as its next-generation pipeline (Press release, Hanmi, AUG 21, 2023, View Source [SID1234638486]).

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According to the Ministry of Food and Drug Safety (MFDS), Hanmi received approval for a phase 1 clinical trial of BH3120 on Friday. Hanmi plans to confirm the safety and efficacy of BH3120 in patients with advanced or metastatic solid tumors. Only Seoul National University Hospital has registered for it so far.

BH3120 is an immunotherapy candidate developed by the R&D Center of Hanmi Pharm Group’s subsidiary in China, Beijing Hanmi Pharm. BH3120 is a bispecific antibody that targets PD-L1 and 4-1BB based on Hanmi Pharm’s bispecific antibody platform "Pentambody."

The phase 1 trial will be conducted as a global clinical trial. In April, Hanmi Pharma and Beijing Hanmi Pharm submitted a phase 1 IND (Investigational New Drug Application) for BH3120 to the U.S. Food and Drug Administration. The phase 1 study has yet to be listed on Clinical Trials, a clinical trial information site of the National Institutes of Health (NIH).

Hanmi Pharm and Beijing Hanmi Pharm disclosed the nonclinical results of BH3120 in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 in April last year. At this year’s AACR (Free AACR Whitepaper), the companies said they had confirmed excellent safety in primate studies.

According to the AACR (Free AACR Whitepaper) presentation, BH3120 is a bispecific immunoglobulin G (IgG) antibody with differently designed binding affinities to PD-L1 and 4-1BB, demonstrating superior anticancer activity in a dose-dependent manner when administered alone and a strong synergistic effect when combined with a PD-1 inhibitor, resulting in the disappearance of cancerous tissue.

In cancer tissues with PD-L1 overexpression, the immune response by 4-1BB activation is expressed, whereas in normal tissues with low PD-L1 expression, the immune activity signal is hardly observed, showing a clear decoupling of immune activity between cancer and normal tissues.

Based on these characteristics of BH3120, Hanmi Pharm and Beijing Hanmi Pharm expect to confirm a balanced profile between safety and anticancer effectiveness by minimizing hepatotoxicity and other systemic side effects, which have been recognized as toxic in the field of 4-1BB-activated antibodies.

The Hanmi Pharm Group, which celebrated its 50th anniversary this year, is strengthening its commitment to developing its new drugs through R&D. The group has recently begun to improve its affiliates by establishing mid- and long-term strategies and reorganizing leadership, announcing an ambition to reach 5 trillion won ($3.8 billion) in total sales in 2032.

On August 21, 2023 Carina Biotech (Carina), a cell therapy immuno-oncology company, reported a poster presentation from preclinical studies of its LGR5-targeting CAR-T platform in colorectal cancer at the 8th CAR-TCR Summit that will take place in Boston, Massachusetts from 29 August – 1 September 2023 (Press release, Carina Biotech, AUG 21, 2023, View Source;utm_medium=rss&utm_campaign=press-release-carina-biotech-to-present-preclinical-data-at-8th-car-tcr-summit [SID1234634676]).

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"We are thrilled to continue to share our preclinical data related to our LRG-5 targeted autologous CAR-T platform in colorectal cancer at the upcoming 8th CAR-TCR Summit," said Deborah Rathjen, PhD, Carina’s Chief Executive Officer. "We are encouraged by the data evidenced in our preclinical studies, further supporting our LGR5 CAR-T cell candidate, CNA3103. These data were crucial in the selection of CNA3103 for a Phase 1/2a clinical trial in patients with advanced colorectal cancer and we are pleased to report that patient screening has commenced."

Poster Presentation Details
Title: LGR5-targeting CAR-T cells – The road to the clinic.
Lead Author: Deborah A. Rathjen CEO, Carina Biotech Limited, Adelaide, South Australia
Session Date and Time: Thursday 31 August 2023 from 3:30 PM ET – 4:30 PM ET
Location: Exhibition Hall D
Poster Board Number: 131