On August 9, 2024 Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), reported the enrollment of the first patients in a US pivotal study of its AI-based image analysis module for lung cancer (Press release, Invenio, AUG 9, 2024, View Source [SID1234645695]). The ON-SITE study, a multicenter study in bronchoscopy combining Stimulated Raman Histology with Artificial Intelligence for rapid lung cancer detection, is in collaboration with Johnson & Johnson Enterprise Innovation Inc. and will be conducted at multiple centers including The University of Texas MD Anderson Cancer Center, Corewell Health, Memorial Sloan Kettering Cancer Center, and University of North Carolina at Chapel Hill.

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Lung cancer is the leading cause of cancer-related deaths in the United States. This has led to the institution of large-scale screening programs for high-risk patients, which results in an estimated 3.1 million new primary lung nodules identified each year. Despite major sector investment in minimally-invasive biopsy technology, obtaining adequate tissue for biomarker and treatment determination remains a challenge. For this reason, bronchoscopy guidelines recommend rapid-on-site tissue evaluation (ROSE) for lung biopsies.

"ROSE requires that a cytologist or highly trained cytotechnician be physically present in the procedure room, and thus it is not available at many centers performing lung biopsy due to resource limitations," said Jason Akulian, MD, Director of Interventional Pulmonlogy at UNC, "we are excited by the NIO’s potential to extend the benefits of ROSE to the proceduralist when the service is not available."

The NIO Laser Imaging System allows rapid imaging of fresh tissue biopsies in the treatment room. Sample preparation does not require staining or sectioning and can be performed by the existing OR-staff. NIO Slides are also designed to allow retrieval of the sample for downstream analysis. NIO images are natively digital and can be shared in near real-time. The ON-SITE study aims to develop and validate an AI-based image analysis module for the NIO Laser Imaging System that is intended to assist physicians in the detection of cancer in bronchoscopic lung biopsies in situations where ROSE is not available for the sample type.

"Artificial intelligence aiding healthcare may seem utopic, but the future is coming. While still investigational, the promise of fast, in-room, accurate identification of tissue that is suspicious for cancer has the potential to ultimately lead to improved outcomes, a beneficial cost/benefit profile, and personalized treatments," said Gustavo Cumbo-Nacheli, MD, pulmonologist at Corewell Health and one of the site PIs for the ON-SITE study.

"Enrolling the first patient in the ON-SITE study is an important milestone for Invenio, as we aim to develop the first FDA-cleared AI to identify cell/tissue morphology suspicious for cancer in lung biopsies," said Jay Trautman, PhD, co-founder and CEO of Invenio Imaging. "Near real-time image analysis on the NIO Laser Imaging System completes the end-to-end solution for streamlined intraoperative histology."

On August 9, 2024 GenScript Biotech Corporation, a leading global technology and service provider of life science R&D and manufacture, reported its first half 2024 financial results for the six months ended June 30, showcasing impressive revenue growth, significant improvements in gross profit, and strategic advances across its business segments (Press release, GenScript, AUG 9, 2024, https://www.genscript.com/genscript-biotech-reports-first-half-2024-results.html [SID1234647130]). GenScript is also deepening its commitment to environmental, social, and governance (ESG) practices, marking a significant step towards sustainable development.

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Sherry Shao, GenScript’s rotating CEO, said, "In the first half of 2024, the Group showcased strong market adaptability and growth potential. With a diversified business strategy, exceptional innovation, and efficient operations, GenScript not only maintained solid profitability in the life sciences sector but also saw promising growth in cell therapy product sales. Our subsidiary, Bestzyme, has also outperformed the industry, thanks to years of hard work from the team. While the CDMO sector has been under pressure due to current investment challenges, we’re starting to see signs of recovery. We’re ready to accelerate our business in the second half of the year. GenScript will continue to strengthen its core competencies across all business lines and foster synergies across divisions to achieve shared growth with our global partners."

Strong Financial Performance
During the Reporting Period, GenScript generated revenue of approximately US$561.4 million, reflecting a robust 43.5% increase from US$391.3 million in the Prior Period. This growth was largely driven by the cell therapy segment, which saw a remarkable 156% increase, reaching approximately US$280.3 million compared to US$109.5 million previously. On the other hand, revenue from the non-cell therapy business was around US$281.1 million.

Gross profit surged to approximately US$307 million, a 75.4% increase from US$175 million in the Prior Period. The cell therapy segment was a key contributor to this growth, with its gross profit soaring by 323.4% to approximately US$175.3 million.

Improved Loss and Adjusted Net Loss
GenScript’s loss for the Reporting Period narrowed to approximately US$215.6 million, compared to US$245.8 million in the Prior Period. The adjusted net loss saw a significant improvement, decreasing to approximately US$69 million from US$162 million.

For the non-cell therapy business, the adjusted net profit before eliminations was approximately US$29.2 million, a 13.1% decrease from US$33.6 million. Meanwhile, the adjusted net loss for the cell therapy business before eliminations narrowed to approximately US$98.3 million from US$195.7 million.

Segment Highlights
Life-Science Services and Products: Revenue in this segment grew by 9.6% to approximately US$222.4 million, driven by major upgrades in platforms and automation, especially in molecular biology, peptide, and protein technologies. Enhanced manufacturing efficiency in Singapore, Mainland China, and the U.S., along with strong commercial operations in the U.S. and Europe, fueled this growth. Adjusted gross profit increased by 8.5% to approximately US$119.9 million, maintaining a stable margin. Adjusted operating profit rose significantly by 23.8% to approximately US$47.8 million.
Biologics Development Services: This segment saw a revenue decline of 37.9% to approximately US$40.4 million, impacted by reduced demand and increased competition. Adjusted gross profit fell by 69.7% to approximately US$5.9 million, with the adjusted gross profit margin decreasing to 14.7%. Adjusted operating loss widened to approximately US$18.9 million, driven by higher operating costs related to U.S. expansion and strategic investments. The Company plans to refine pricing strategies and enhance global market presence to address these challenges.
Industrial Synthetic Biology Products: Revenue increased by 43.4% to approximately US$26.1 million, driven by a market rebound and growing demand in Mainland China and beyond. Adjusted gross profit rose by 52.8% to approximately US$11 million, with the adjusted gross profit margin improving to 42.2%. Adjusted operating profit improved to approximately US$2.3 million, reflecting higher capacity utilization and process improvements.
Cell Therapy: Revenue from the cell therapy segment grew by 155.7% to approximately US$280.5 million. This growth was fueled by collaboration revenue from CARVYKTI sales under the Janssen Agreement and increased license revenue from agreements with Janssen and Novartis Pharma AG. The adjusted operating loss narrowed to approximately US$119.4 million from US$205.9 million. The Company invested approximately US$196.3 million in research and development, focusing on cilta-cel and solid tumor programs, and incurred approximately US$52.4 million in adjusted selling and distribution expenses and US$49.1 million in adjusted administrative expenses.
Deepening ESG Commitment
In addition to its financial achievements, GenScript is advancing its commitment to sustainability and ESG practices. This year, the Company officially joined the United Nations Global Compact (UNGC), underscoring its commitment to adhere to ten sustainable development principles and drive more responsible, inclusive, and sustainable global business practices.

The Group has also been recognized for its ESG performance, ranking in the top 35% in EcoVadis’ sustainability assessments. This recognition highlights the Company’s efforts in environmental protection, labor rights, supply chain management, fair operations, and the execution of sustainable development strategies. Further demonstrating its dedication, the Company has joined the Science Based Targets initiative (SBTi) and submitted its Science-Based Targets Commitment, reflecting its proactive stance on global climate change and commitment to aligning with the Paris Agreement’s temperature goals.

In environmental management, GenScript is focused on optimizing its carbon footprint through international certifications such as ISO 14064, ISO 14001, and ISO 50001. These certifications enhance energy efficiency and cut greenhouse gas emissions. Additionally, the Company has earned ISO 27001 certification, ensuring top-notch data security and customer privacy protection.

On August 9, 2024 C&Cure (CEO Min Jeong-jun and Park Jung-gon), an anticancer drug development company in Gwangju Metropolitan City, reported the company has developed a new concept of immunotherapy using bacteria for treating cancer (Press release, CNCure, AUG 9, 2024, View Source [SID1234649035]).

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According to C&Cure on the 9th, the company created bacteria for treating cancer by genetically engineering salmonella, E. coli, and Vibrio.

The independently developed salmonella strain has removed more than 70 genes that are harmful to the human body, reducing toxicity by more than 1 million times.

The company explains that this non-toxic salmonella has a strong affinity for cancer tissue.

When injected into the body, it has the characteristic of overproliferating in cancer tissue by more than 100,000 times more than in normal tissue.

The C&Cure research team genetically engineered the non-toxic salmonella to produce cytolysin A, a cell-lytic protein of E. coli, and flagellin B, a flagellar protein of Vibrio, in cancer tissue.

A company official said, "As a result of experiments on mouse models transplanted with various types of cancer, the fused salmonella dramatically changed the cancer immune microenvironment and caused an anticancer immune effect," adding, "It suggested that it can effectively treat not only primary cancer but also metastatic cancer."

With this technology, C&Cure is going through the clinical trial new drug approval process with the U.S. Food and Drug Administration ( FDA ). It is also conducting mammalian toxicity tests in accordance with standards. CEO Min Jeong-jun, director of Chonnam National University Hospital in Hwasun, and Professor Hong Young-jin of Chonnam National University College of Medicine, chief technology officer, conducted this research with support from the Ministry of Science and ICT’s Immunotherapy Innovation Platform Project and mid-level research project.

On August 9, 2024 GenScript reported its first quarter 2024 results (Presentation, GenScript, AUG 9, 2024, https://www.genscript.com/gsfiles/IPO/2024%2dInterim%2dResults%2dEN.pdf?v=0%2e2?1018088532 [SID1234647131]).

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On August 9, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,857,143 American Depositary Shares (ADSs), having an exercise price of $1.75 per ADS, issued by Can-Fite in January 2023 and November 2023 (Press release, Can-Fite BioPharma, AUG 9, 2024, View Source [SID1234645674]). The ADSs representing ordinary shares issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form F-3 (File No. 333-276000) and Form F-1 (File No. 333-269485). The closing of the offering is expected to occur on or about August 12, 2024, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, Can-Fite will issue new unregistered warrants to purchase up to 5,714,286 ADSs. The new warrants will have an exercise price of $2.25 per ADS, will be immediately exercisable until the five-year anniversary from the date of issuance with respect to 2,987,012 new warrants and the twenty-month anniversary from the date of issuance with respect to 2,727,274 new warrants.

The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $5.0 million, prior to deducting placement agent fees and offering expenses. The Company intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act"), and, along with the ADSs issuable upon exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Can-Fite has agreed to file a registration statement with the SEC covering the resale of the shares of ADSs issuable upon exercise of the new warrants.

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