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US FDA Grants Orphan Drug Designation of SN Bioscience’s Nano Anti-Cancer Drug ‘SNB-101’ for Small Cell Lung 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.

CASI Pharmaceuticals Acquires Global Intellectual Property Rights to Cleave Therapeutics’ VCP/P97 Inhibitor CB-5339

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.

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."

Rarecells, Inc. announces a breakthrough publication on Circulating Giant Cancer Cells detected in patients with MDS

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]).

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.

Jacobio Pharma to Present Data of Glecirasib in Combination with JAB-3312 at the 2023 ESMO Conference

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:

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.

Theratechnologies Announces 1-for-4 Reverse Stock Split

On July 20, 2023 Theratechnologies Inc. ("Theratechnologies", the "Company", or "we") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that its Board of Directors approved a consolidation of the issued and outstanding common shares of the Company’s share capital on the basis of one (1) post- consolidation share for each four (4) pre-consolidation shares issued and outstanding (the "Consolidation") (Press release, Theratechnologies, JUL 20, 2023, View Source [SID1234633337]).

The Consolidation will be effective July 31, 2023, subject to applicable regulatory approvals, including the Toronto Stock Exchange (the "TSX") and the Nasdaq Stock Market ("NASDAQ"). No shareholder approval will be required for the Consolidation to come into effect. The Company expects its common shares will begin trading on the TSX and the NASDAQ on a consolidated basis on or about July 31, 2023.

No fractional common share will be issued in connection with the Consolidation and, in the event that a shareholder would otherwise be entitled to receive a fractional share upon such Consolidation, the number of common shares to be received by such shareholder will be rounded up (if the fraction is half a share or more) or down (if the fraction is less than half a share) to the nearest whole common share, provided that no shareholder shall hold less than a single common share as a result of the Consolidation. As at July 19, 2023, the Company had 96,807,309 common shares issued and outstanding, and the Company expects to have approximately 24,201,835 common shares issued and outstanding upon completion of the Consolidation.

Shareholders who hold their common shares electronically either in direct registered book-entry form via a direct registration system advice/statement ("DRS") with Computershare Trust Company of Canada ("Computershare"), the Company’s transfer agent, or in "street name" through an intermediary like a bank, broker or other nominee, will not need to take any action as the Consolidation should automatically be reflected in the transfer agent’s records and on such shareholders’ next account statement. Intermediaries may have specific procedures for processing the Consolidation, including the treatment of fractional shares.

Shareholders holding paper stock certificates will be sent by Computershare a letter of transmittal which will enable them to exchange their old share certificates for a DRS representing the number of new post-Consolidation common shares they hold. Until surrendered, each stock certificate representing pre-Consolidation common shares will be deemed for all purposes to represent the number of whole post-Consolidation common shares to which the shareholder is entitled as a result of the Consolidation.

Rationale for the Consolidation

On March 7, 2023, the Company announced it had received a notification letter from the NASDAQ advising the Company that it was not in compliance with Listing Rule 5550(a)(2), as the bid price of the Company’s common shares on the NASDAQ had closed at less than US$1.00 per share over the prior 30 consecutive business days (the "Minimum Bid Price Requirement"). In accordance with its Listing Rules, NASDAQ afforded the Company a 180-day period ending August 30, 2023, to regain compliance with the Minimum Bid Price Requirement.

The Consolidation is being implemented by the Company with the objective of increasing the trading price of its common shares and to allow the Company to regain compliance with the Minimum Bid Price Requirement of the NASDAQ and maintain a listing on the NASDAQ which accounts for a large part of the trading in the Company’s common shares.

The Company anticipates that the Consolidation will have a neutral economic effect on shareholders and holders of securities convertible into or exercisable to acquire common shares or correlated with the price thereof, except to the extent the Consolidation will result in fractional common shares.

Proportionate adjustments will be made to the exercise price of outstanding stock options, warrants and other instruments linked to the common shares and the number of common shares underlying such options, warrants and equity-linked instruments to maintain the same economics associated with such instruments post-Consolidation.