On July 20, 2023 Sathgen Therapeutics, a division of a leading chemicals conglomerate in India – Godavari Biorefineries Limited (GBL), reported the completion of the first cohort in a Phase 1 clinical trial for their first-in-class New Chemical Entity, MSP008-22 (Press release, Sathgen Therapeutics, JUL 20, 2023, https://www.prnewswire.com/news-releases/sathgen-therapeutics-announces-dosing-of-the-first-patient-cohort-with-msp008-22-a-novel-anti-cancer-drug-301881833.html [SID1234633345]). The clinical trial program is managed by Clinexel Life Sciences, a renowned contract research organization in the health sector.

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Sathgen Therapeutics aims to develop MSP008-22 for difficult-to-treat cancers, starting with triple negative breast cancer (TNBC) and prostate cancer as proof-of-principle. MSP008-22 effectively targets treatment-resistant cancer cells in preclinical models, and demonstrates an excellent safety profile with no serious adverse events in the first patient cohort.

Professor Sendurai Mani, Associate Director, Legorreta Cancer Center, Brown University, and Scientific Co-Founder, Sathgen Therapeutics, stated, "TNBC is responsible for 30% of breast cancer-related deaths. The lack of estrogen and progesterone receptors and HER2 expression makes it challenging to treat using conventional hormone therapy. MSP008-22 will address this significant unmet need for TNBC patients."

Dr. Sangeeta Srivastava, Executive Director, GBL, and CSO, Sathgen Therapeutics, said, "A major milestone for us, this clinical trial marks our first program to enter clinical development. MSP008-22 is our lead candidate for treating TNBC and prostate cancer, and enhances the efficacy of standard-of-care chemotherapy."

Mr. Samir Somaiya, Chairman and MD, GBL, and Executive Co-Founder, Sathgen Therapeutics, highlighted, "At GBL, research is the cornerstone of our enterprise, creating continuous value for society. We are dedicated to pioneering drug discovery to generate sustainable advantages. The trial represents a crucial milestone in our mission to help patients with hard-to-treat cancers."

Dr. Deepa Arora, CEO, Clinexel, explained, "The successful completion of the first cohort of this study (NCT05478486) in patients with advanced solid tumours without any adverse events is very encouraging. We are working to bring a safe and effective oral therapy to benefit patients with TNBC or prostate cancer."

On July 20, 2023 SN Bioscience Co. Ltd. (CEO Park Young-hwan) reported that the US FDA had granted an orphan drug designation for small cell lung cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development (Press release, SN BioScience, JUL 20, 2023, View Source [SID1234633344]). SNB-101 is the world’s first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the US (NCT04640480) and Korea, and the IND for phase 2 has been filed after phase 1 clinical trial in Korea.

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SNB-101 showed excellent efficacy in animal small cell lung cancer models, and based on this, it has been designated as an orphan drug by the US FDA after application in April and review. Small cell lung cancer accounts for 15-20% of all lung cancers with a very poor prognosis. The current standard treatment (first-line treatment) is classic drugs, Cisplatin + Etoposide. However, as there are very limited options for second-line treatment and others, it is an area with very high medical unmet needs.

Orphan drug designation is a program where the FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. SN Bioscience expects the designation as an orphan drug to accelerate the development of SNB-101, which is being developed as a treatment for orphan drugs including small cell lung cancer.

Orphan drug designation provides the qualified drug developers with various benefits such as exclusive rights for 7 years from the date of marketing approval, tax credits for R&D costs, assistance on clinical trial design for clinical development, exemption from review application fees, and priority review support.

On July 20, 2023 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the execution of the Assignment Agreement (the "Agreement") with Cleave Therapeutics, Inc. ("Cleave"), pursuant to which CASI obtained all rights and global intellectual property rights related to CB-5339, a novel VCP/p97 inhibitor, as well as all remaining CB-5339 drug substance and drug product (Press release, CASI Pharmaceuticals, JUL 20, 2023, View Source [SID1234633343]). Additionally, CASI will assume responsibility of the United States ("US") CB-5339 Investigational New Drug ("IND") application.

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CB-5339 is an oral, second-generation, small molecule valosin-containing protein (VCP)/p97 inhibitor, designed to disrupt protein homeostasis, DNA damage response and other cellular stress pathways. In a Phase 1 clinical trial in patients with acute myeloid leukemia and myelodysplastic syndrome, the drug was well tolerated in 55 patients and demonstrated signs of clinical activity. Two patients remain on CB-5339 under compassionate use protocols at two leading US cancer centers.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "CB-5339 is a first in class small molecule drug candidate that represents a promising opportunity to selectively target VCP/p97 in various malignancies. We are encouraged by the early clinical data in the phase 1 study of CB-5339 in patients with AML and MDS. CB-5339 is a complementary addition to our growing portfolio of approved and investigational therapies in oncology."

On July 20, 2023 Rarecells reported its breakthrough publication, written in partnership with the team of Dr. Azra Raza from Columbia University Irving Medical Center, revealing for the first time the presence of circulating giant cancer cells (CGCCs) in patients with Myelodysplastic Syndrome (MDS) at risk of developing acute myeloid leukemia (AML) (Press release, RARECELLS, JUL 20, 2023, View Source [SID1234633342]).

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The Medical Oncology journal article, entitled "Circulating cancer giant cells with unique characteristics frequently found in patients with myelodysplastic syndromes (MDS)", reports results of a collaborative study using Rarecells’ highly sensitive proprietary ISET technology to isolate circulating Giant Cells.

MDS are incurable blood diseases that have the potential to transform into AML. The research study identified tumor markers on circulating Giant Cells in MDS patients, proving their cancer nature. These tumor markers were not present in the circulating Giant Cells of healthy subjects.

"Giant Cells have demonstrated important links to the development of cancer and may be the culprit of cancer formation and recurrence," said Patrizia Paterlini-Brechot, Emeritus Professor at University Paris Cité and President of Rarecells. "We are excited to be working with Dr Raza and her team and developing new knowledge which has the potential to improve the way we treat liquid cancers."

"This paper is the culmination of several years of collaborative research. It is an important contribution to the field of Giant Cells and to the field of liquid cancers. Understanding the origins of cancer and finding "the first cancer cells" is essential to saving patient lives through early detection and development of more precise and targeted treatments " said Dr. Raza, author of the best-selling book The First Cell and the Human Costs of Pursuing Cancer to the Last.

On July 20, 2023 Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, reported that the company will present its clinical results in the form of Proffered Paper presentation at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Jacobio Pharmaceuticals, JUL 20, 2023, View Source [SID1234633341]). The presentation details are as follows:

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Presentation Number: 4838

Title: Glecirasib (KRAS G12C inhibitor) in Combination with JAB-3312 (SHP2 inhibitor) in Patients with KRAS p.G12C Mutated Solid Tumors

"We are extremely excited to have the opportunity for an oral presentation at 2023 ESMO (Free ESMO Whitepaper) Congress, and we hope our data will shed light on clinical development of SHP2 inhibitors in solid tumors. On behalf of Jacobio, we extend our sincere appreciation to the patients and investigators who participated this crucial study, and we are committed to advancing the global development of SHP2-based treatment regiments in cancer patients." Said Andrea Wang-Gillam, M.D., Ph.D., Chief Medical Officer of Jacobio.

Studies have shown that SHP2 inhibitor is one of the most optimal partners for KRAS G12C inhibitor in non-small cell lung cancer (NSCLC). Jacobio previously presented preclinical results of the above combination at the 2022 ESMO (Free ESMO Whitepaper) Asia Congress, demonstrating the combination of JAB-21822 and JAB-3122 synergistically inhibited tumor growth in multiple KRAS G12C inhibitor-resistant models. This suggests that the combination of JAB-21822 and JAB-3312 may overcome resistance to KRAS G12C inhibitor in cancer patients.

ESMO Congress 2023 will be held in Madrid, Spain, from October 20 to October 24. For more information, please visit the official website of the ESMO (Free ESMO Whitepaper): View Source

About Glecirasib
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. This includes a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer.

About JAB-3312

JAB-3312 is a highly selective SHP2 allosteric inhibitor with the best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with Glecirasib and other agents in China, the United States and Europe.