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2023 Interim Results Presentation

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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Hanmi begins clinical trial of dual antibody immunotherapy BH3120

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]).

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.

PRESS RELEASE: Carina Biotech to Present Preclinical Data at 8th CAR-TCR Summit

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]).

"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

FloraStilbene™ Demonstrates Synergy with Conventional Chemotherapy and Immunotherapy in Reducing Triple Negative Breast Cancer

On August 21, 2023 Therapeutic Solutions International, Inc. (TSOI) reported that its breast cancer immunotherapy spin-off company, Res Nova Bio, released data showing synergistic suppression of breast cancer growth when used in combination with anti-PD1 and anti-CTLA4 antibodies, which represent clinically used checkpoint inhibitors such as Keytruda and Yervoy, respectively (Press release, Res Nova Bio, AUG 21, 2023, View Source [SID1234634608]). Additionally, the Company demonstrated that FloraStilbene administration increased efficacy of the standard chemotherapies Taxotere and Cytotoxan which are used in breast cancer.

"I have witnessed first-hand the devastating suffering, both mental and physical, that patients with advanced breast cancer go through"

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The data were filed in a patent application covering adjuvant use of FloraStilbene in radiotherapy, oncolytic virus therapy, adoptive cellular therapy, chimeric antigen receptor therapy, chemotherapy and immunotherapy.

"I have witnessed first-hand the devastating suffering, both mental and physical, that patients with advanced breast cancer go through," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The findings announced today are a major accomplishment in our development of non-toxic immunotherapies of breast cancer. By leveraging similarities between pregnancy and cancer we have successfully been able to turn the abortion pill, a drug associated with death, into something that potentially saves lives."

Studies have shown that the abortion pill reduces activity of the cytokine TGF-beta1,2, which is involved in protecting the fetus from the maternal immune response, as well as protecting cancer cells from immunity of the body3. At a cellular level immature dendritic cells, which are found in both cancer and pregnancy seem to be stimulated to maturation by treatment with the abortion pill4.

"I congratulate Ms. Famela Ramos and her team who has already initiated treating advanced breast cancer patients with ValloVax and is now rapidly racing towards the clinic with FloraStilbene," said Timothy Dixon, President, and CEO of Therapeutic Solutions International. "The fact that Res Nova already has secured a manufacturing and distribution partner for FloraStilbene, Cure Stat5 supports our hope of rapidly entering the clinic and perhaps even accelerated sales through a 505b2 mechanism."

"At Res Nova Bio we are fixated on providing hope for patients who currently have very limited hope," said Famela Ramos, President, and CEO of Res Nova Bio. "Knowing the detailed mechanisms of action of our products ensures not only solid intellectual property protection but also respect and credibility of potential acquisition partners and regulators. I am thankful to our scientific team and collaborators for their unceasing dedication to patients and shareholders."

Lunit Backs the Potential of Tertiary Lymphoid Structures Analysis as an Emerging Biomarker for Lung Cancer Treatment – to be presented at WCLC 2023

On August 21, 2023 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported the presentation of a groundbreaking study at the 2023 World Conference on Lung Cancer (WCLC 2023), to be held in Singapore on September 9-12 (Press release, Lunit, AUG 21, 2023, View Source;to-be-presented-at-wclc-2023-301905588.html [SID1234634607]).

Co-led by Lunit, Northwestern University Feinberg School of Medicine, Ascension Saint Francis Hospital, and Lincoln Medical and Mental Health Center, the study explores the use of Lunit SCOPE IO – an AI-powered H&E analyzer which identifies Tertiary Lymphoid Structures (TLS) within the tumor microenvironment (TME) – to forecast immunotherapy treatment outcomes in lung cancer. The study builds on recent academic findings that the presence of TLS can serve as a predictive marker for the effectiveness of immuno-oncology treatment.

A total of 85 patients with non-small cell lung cancer (NSCLC) who received immune checkpoint inhibitors (ICI) were analyzed for the study. According to the study, the utilization of Lunit SCOPE IO for TLS evaluation yielded clinically significant correlations with patients’ overall survival (OS). 25 patients with detected TLS had notably prolonged overall survival compared to 60 patients without TLS. This correlation remained consistent irrespective of PD-L1 expression, a known biomarker for treatment response in NSCLC patients.

These findings underscore the potential of AI-based TLS analysis as a biomarker for predicting treatment response in NSCLC patients.

"Through rigorous collaboration and cutting-edge technology, our study illuminates a promising path toward better predicting lung cancer treatment outcomes. The potential of TLS analysis via Lunit SCOPE IO in predicting immunotherapy response represents a meaningful step forward in better understanding cancer biology, and making AI analysis of the TME an actionable part of cancer care," said Brandon Suh, CEO of Lunit.

Lunit SCOPE IO was developed with a dataset of thousands of Hematoxylin and Eosin (H&E) stained whole-slide images derived from 18 different types of cancer from patients around the world.