On October 13, 2022 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its third quarter 2022 financial results on Thursday, October 27, 2022 (Press release, Insmed, OCT 13, 2022, View Source [SID1234622012]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Thursday, October 27, 2022 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (844) 200-6205 (U.S.) or (929) 526-1599 (international) and referencing access code 889963. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 2 hours after its completion through November 26, 2022, by dialing (866) 813-9403 (U.S.) or (+44) 204-525-0658 (international) and referencing access code 035584. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

On October 13, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that it will present two scientific posters at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting in Boston, MA, November 8-12, 2022 (Press release, Transcenta, OCT 13, 2022, View Source [SID1234622011]): one related to Claudin18.2 and PD-L1 expression in gastric/gastro-esophageal adenocarcinoma, relevant for TST001 (Osemitamab) clinical development and the other on TST005 (PD-L1/TGF-β bifunctional antibody) trial in progress.

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The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Through educational programs that foster scientific exchange and collaboration, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere.

Details of the poster presentations are as follows:

Title: Prevalence of Claudin18.2 and PD-L1 Expression in Chinese Gastric/Gastroesophageal Junction Adenocarcinoma
Abstract#: 105
Date & Time: Nov. 10, 2022, 9 a.m.–9 p.m. (EST)
Presenter: Dr. Caroline Germa, MD
First Author: Linlin Mao, PhD

Title: A phase 1, first in human, open-label, dose escalation and dose expansion study of TST005 in patients with locally advanced or metastatic solid tumors
Abstract#: 771
Date & Time: Nov. 10, 2022, 9 a.m.–9 p.m. (EST)
First Author: Anthony Tolcher, MD

Full text of the abstracts will be released on the SITC (Free SITC Whitepaper) website at 8:00 a.m. EST, November 7, 2022, and the posters will be available on Transcenta’s website (View Source) on November 12, 2022.

About TST001 (Osemitamab)

TST001 (Osemitamab) is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC") and complement-dependent cytotoxicity ("CDC") activities and potent anti-tumor activities in tumor xenograft models. TST001 (Osemitamab) is the second most advanced Claudin18.2 targeting antibody being developed globally. TST001 (Osemitamab) is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 (Osemitamab) kills Claudin18.2 expressing tumor cells by mechanisms of ADCC and CDC. Leveraging advanced bioprocessing technology, the fucose content of TST001 (Osemitamab) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001 (Osemitamab). Clinical trials for TST001 (Osemitamab) are ongoing in the U.S. and China (NCT04396821, NCT04495296/CTR20201281). TST001 (Osemitamab) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) cancer.

About TST005

TST005 is the second bi-functional anti-PD-L1 and TGF-β trap fusion protein entering the global clinical stage. It simultaneously targets two immuno-suppressive pathways, transforming growth factor -β (TGF-β) and programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system. TST005 consists of a high affinity PD-L1 antibody fused with an engineered TGF-β Receptor Type II protein in its C-terminal. TST005 lacks FcR binding activity and thus has reduced FcR mediated killing of PD-L1 expressing effector T cells. TST005’s high PD-L1 binding activity and enhanced TGF-β trap stability enables the targeted delivery of TGF-β trap into PD-L1 expressing tumors, thereby minimizing off-target toxicities of systemic inhibition of TGF-β signaling. TST005 displayed potent activity in vitro in reversing TGF-β induced T-cell suppression. In multiple syngeneic tumor models, TST005 induced significant increase of CD8+ T-cell infiltration into PD-L1 expressing tumors and displayed dose-dependent tumor growth inhibition in tumor model not sensitive to PD-(L)1 treatment due to high level TGF-β. TST005 is well tolerated in non-human primates and displayed a linear PK profile. TST005 is a potentially differentiated bi-functional immunotherapy candidate with improved therapeutic window. TST005 is being investigated in a FIH trial in the US and China (NCT04958434/CTR20221397).

On October 13, 2022 GE Healthcare’s Pharmaceutical Diagnostics business reported a long-term agreement with Chile-based mining company, Sociedad Quimica y Minera de Chile S.A. (SQM) (NYSE: SQM; Santiago Stock Exchange: SQM-B, SQM-A), to secure its supply of iodine, a key ingredient for contrast media products used in X-Ray and Computed Tomography (CT) procedures globally (Press release, GE Healthcare, OCT 13, 2022, View Source [SID1234622010]). The agreement will see SQM increase supply of iodine raw material year-on-year and is part of GE Healthcare’s broader commitment and investment plan to enable the production of 30 million more patient doses of iodinated contrast media annually by 2025.

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The growing global prevalence of chronic disorders has driven significant growth in CT procedures, leading to increased global demand for iodinated contrast media, used to enhance visualization of organs, blood vessels and tissues across clinical care pathways. GE Healthcare is also investing in production capacity to help meet this growing demand, including a new $30 million manufacturing line at its Cork, Ireland, contrast media production facility, which opens this week.

Kevin O’Neill, President and CEO, GE Healthcare Pharmaceutical Diagnostics, said: "We expect global demand for iodinated contrast media to double in the next 10 years. As an industry leader, we understand our responsibility to help meet this growing demand from customers and patients by investing in production capacity and securing higher volumes of iodine raw material. As one of the largest consumers of iodine globally we value our longstanding relationship with SQM, an important partner for us."

Pablo Altimiras, Executive Vice President of Iodine and Nitrates, SQM, said: "We’re pleased to continue our relationship with GE Healthcare – a key customer for us for more than 40 years. As one of the largest producers of iodine worldwide with approximately 24 percent of our production used for X-ray contrast media, we are committed to the iodine industry and will continue to improve quality and increase capacity to ensure the reliability of supply, which is essential to so many sectors, including healthcare."

GE Healthcare Pharmaceutical Diagnostics develops and manufactures imaging agents used to support over 100 million procedures per year, equivalent to three patient procedures every second. All stages of its contrast media manufacturing, from development of API to finished product, are managed entirely by GE Healthcare, adhering to current Good Manufacturing Practices (cGMP). With over 4000 employees globally and seven manufacturing sites, the business also develops and supplies radiopharmaceuticals used to support diagnosis, monitoring and treatment selection across Neurology, Cardiology and Oncology clinical pathways.

On October 13, 2022 Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, and aCGT Vector, a point-of-care cell and gene therapy-as-a-service (TaaS) company, reported a collaboration to improve manufacturing and analytic procedures used to develop personalized cell and gene therapies for cancer patients (Press release, Xcell Biosciences, OCT 13, 2022, View Source [SID1234622009]). Through this alliance, aCGT Vector will provide its point-of-care, GMP-licensed manufacturing platform to validate Xcellbio’s core next-generation manufacturing and analytical AVATAR AI technology for use in precision cancer treatment.

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"We are looking forward to working with the Xcellbio team and to utilizing the well-established AVATAR platform to further power our TaaS platform to deliver and deploy precision medicine proximal to patients," said Gary McAuslan, CEO and co-founder of aCGT Vector. "We believe our joint efforts will further accelerate the creation of automated, end-to-end cell therapy manufacturing and QC release platforms to streamline processing and optimize patient outcomes."

aCGT Vector’s enclosed, GMP-compliant manufacturing environment will demonstrate the use of Xcellbio’s AVATAR AI to support development and deployment of cell therapeutic procedures proximal to patients in the treatment of cancers. Through mimicking the tumor microenvironment (TME) ex vivo, AVATAR AI delivers unique capabilities to support the development of therapeutic products with improved potency and persistence as well as reduced cell exhaustion. Proprietary technology enables tight control and modulation of atmospheric pressures and oxygen concentrations in direct contact with the cell therapy product.

The AVATAR AI leverages the tight environmental control of the proven AVATAR product family, and pairs it with a specialized reader to enable real-time, label-free cell killing analysis of cell therapies targeting solid tumors. Focused on establishing next-gen immunotherapy testing workflows, the AVATAR AI system is currently in late-stage beta.

"With the tremendous promise of cell therapies and the current challenges in treating patients with solid tumors, there is more interest in both designing manufacturing conditions to optimize potency, persistence, and quality and in characterizing cell potency as a critical attribute in cell therapy manufacturing," said Brian Feth, co-founder and CEO at Xcellbio. "We are pleased to partner with aCGT Vector and to pair their manufacturing expertise with our unique approach to measuring and improving therapeutic potency. Together, our objective is to advance the development and deployment of cell therapies, such as CAR-T and tumor-infiltrating lymphocyte technologies, to treat solid tumors. We look forward to supporting aCGT and their initiatives, including the next-generation cell therapies for the cancer-focused HEALED Consortium."

On October 13, 2022 Iterative Scopes, a pioneer in precision-medicine technologies for gastroenterology, reported that it has partnered with One GI, a gastroenterology management services organization (MSO), to bring its AI Recruitment (AIR) technology to One GI’s clinical research (Press release, Iterative Scopes, OCT 13, 2022, View Source [SID1234622008]). Initially, One GI will use AIR at Gastro One, one of One GI’s clinical research sites in Memphis, Tennessee, with plans to expand to additional research sites within the One GI network. The implementation of AIR will aid in the recruitment of patients for clinical trials focused on inflammatory bowel disease (IBD).

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Both One GI and Iterative Scopes are fast-growing innovators in the gastroenterology space. One GI is a unique, rapidly expanding MSO that brings together community-based practices, including Gastro One, a network of six practices across Tennessee. The MSO currently has 40 sites within its network across Tennessee, Mississippi, Kentucky, Ohio, and Indiana. Iterative Scopes is a pioneer in the application of powerful, proprietary artificial intelligence tools to the practice of gastroenterology and drug development.

The partnership between the two organizations will allow One GI physicians to leverage the AI-based technology from Iterative Scopes to standardize the endoscopic scoring process for patients and identify likely eligible patients to enroll in IBD clinical trials. By initiating the collaboration at Gastro One, the organizations are taking initial steps to develop a hub and spoke recruitment model for One GI, which will democratize access to the novel IBD therapeutics for all patients, regardless of where they receive care.

"Our partnership with Iterative Scopes enables the delivery of innovative technology to community-based gastroenterology practices, demonstrating One GI’s commitment to physician-centered, patient-focused healthcare," said Robbie Allen, CEO of One GI. "Our ultimate mission is to power practices – regardless of their location – to deliver world class GI care, and implementing AIR will allow a broader array of patients to access potentially life-changing clinical trials."

"In addition to helping us offer the most advanced patient care, this partnership fuels the continuous growth of our research department so that we remain at the forefront of GI care, improving outcomes and patients’ lives," said Richard Aycock, MD, Gastro One senior physician. "Dr. Ziad Younes, a global leader in gastroenterology, is pioneering the program within our practices, and we’re enthusiastic about the potential to help advance the GI field even further."

AIR works to simplify the process of matching patients to clinical trials by helping gastroenterologists better understand disease severity more quickly and consistently. The technology uses computational algorithms integrated with existing colonoscopy imagery and videos to determine clinical trial eligibility, speeding up the clinical trial timelines and allowing more patients to access potentially life-changing treatments. The company’s technology automates scoring of a patient’s minimum threshold score of disease severity, as measured by the Mayo Endoscopic Score (MES), as an aid in determining their qualification for pre-screening for IBD clinical trials. Iterative Scopes has already partnered with multiple clinical research sites for IBD and is continuing to expand its reach with notable partners like One GI.

"Iterative Scopes’ mission is to democratize access to high quality care for patients struggling with IBD and other GI conditions, ultimately reducing healthcare disparities in clinical practice," said Sahir Raoof, VP of Business Development at Iterative Scopes. "We are thrilled to be partnering with Dr. Younes and One GI to drive clinical adoption of artificial intelligence to help us advance clinical trial recruitment in an effort to help bring novel therapeutics to IBD patients faster."