On July 6, 2023 Tempus, a leader in artificial intelligence and precision medicine, reported a new collaboration to develop a companion diagnostic (CDx) test with TScan Therapeutics, a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of cancer patients (Press release, Tempus, JUL 6, 2023, View Source [SID1234633097]). The collaboration supports TScan’s screening protocol for its Phase 1 solid tumor clinical trial which is designed to enable customized mixtures of TCR-Ts to be administered to patients based on tumor antigen positivity and intact HLA expression.

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TCR-Ts genetically reprogram a patient’s immune system to recognize and fight their cancers. TScan plans to enroll patients with solid tumors including non-small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and cervical cancer. Up to 40% of these tumors lose half of their HLA genes, which is a frequent and overlooked cause of resistance to immunotherapies such as TCR-Ts. TScan is collaborating with Tempus to use the xT assay, Tempus’ 648-gene panel, to prospectively identify patients with HLA loss in the tumor to select TCR-Ts that recognize HLA genes still intact in the patient’s tumor.

"Utilizing the assay developed in collaboration with Tempus will help determine if the clinical trial participants’ tumors have undergone partial HLA loss and so will enable us to choose the most appropriate TCR-Ts that are customized for the patient’s tumor antigens and preserved HLA genes," said Debora Barton, M.D., Chief Medical Officer at TScan. "The breadth and depth of selection criteria in this study, including the Tempus companion diagnostic, has the potential to help a significant number of patients across multiple solid tumor types through identification of patients most likely to respond to TCR-T treatment."

"This CDx work is unique because we’re looking for information that’s not currently in the list of readouts you typically receive from next-generation sequencing of a solid tumor," said Michael Yasiejko, Executive Vice President at Tempus. "Tempus is uniquely positioned to develop a custom pipeline to extract information from standard tests that need to guide TCR-T therapy development and ultimately help identify patients that may benefit from these therapies."

On July 6, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported the publication of a review of the company’s clinical development program evaluating CMN-001, a dendritic cell-based immunotherapy electroporated with autologous tumor RNA to treat metastatic renal cell carcinoma (mRCC) (Press release, CoImmune, JUL 6, 2023, View Source [SID1234633095]). The review is published in Human Vaccines & Immunotherapeutics, a peer-reviewed journal sponsored by the International Society for Vaccines.

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"Engineering dendritic cells to treat cancer is a long sought-after goal for cell-based immunotherapies," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "CMN-001 is specifically designed to elicit an adaptive T-cell response against the antigens present in the patient’s own tumor tissue. With more than two decades of clinical experience with CMN-001, we are implementing lessons learned for a new study that reflects the changing landscape of therapies available to treat mRCC. We have an exciting opportunity to combine and sequence therapies with three distinct mechanisms of action and look forward to advancing this development program."

The publication, titled, "A review of the clinical experience with CMN-001, a tumor RNA loaded dendritic cell immunotherapy for the treatment of metastatic renal cell carcinoma," reviews the early clinical development of CMN-001, including a previously completed multicenter Phase 3 clinical trial that demonstrated synergy between CMN-001 and an mTOR blocker, everolimus, in a retrospective data analysis.

CoImmune has designed an ongoing randomized Phase 2b clinical trial that builds on the mechanism of action of CMN-001 and underlying immune and clinical outcomes observed. In this trial, CMN-001 is being combined with first-line checkpoint inhibition therapy and second line lenvatinib/everolimus in poor-risk mRCC patients. The trial is actively recruiting with plans to enroll 90 patients.

"Clinical trials employing antigen-loaded dendritic cells have been shown to be safe and provide positive clinical benefit in small proportions of patients, and we are looking for ways to improve the overall efficacy to attain durable clinical responses," said Mark DeBenedette, Ph.D., Vice President of Research and Development of CoImmune. "Based on the surprising benefit of everolimus as a subsequent second-line therapy revealed in a retrospective analysis of more than 90 patients – a benefit that only manifested if subjects were administered CMN-001 – we have a rationale for evaluating this combination further in poor-risk mRCC patients who have limited treatment options today."

On July 6, 2023 Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported the completion of patient enrollment for its Phase III bridging clinical trial of Hexvix, a drug used for the diagnosis of bladder cancer (Press release, Asieris Pharmaceuticals, JUL 6, 2023, View Source [SID1234633094]).

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The study is a prospective, self-controlled, multicenter Phase Ⅲ trial aimed at investigating the additional detection rate and safety of Hexvix and blue light cystoscopy (BLC) versus white light cystoscopy in patients with non-muscle invasive bladder cancer (NMIBC) including tumors with stage carcinoma in situ (CIS), Ta, and T1.

This study is led by Peking Union Medical College Hospital and the Chinese Academy of Medical Sciences. Professor Li Hanzhong, head of the Department of Surgery at Peking Union Medical College Hospital, serves as the Principal Investigator to lead a team of top experts in the field of bladder cancer in China to carry out this study. The company will closely track the subsequent progress of this clinical trial.

In January 2021, Asieris entered into a license agreement with Photocure ASA (Photocure, OSE:PHO), a bladder cancer specialty company based in Oslo, Norway, to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan.

In December 2021, Hexvix was put into pilot use in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province and the first prescription in China was issued at Hainan General Hospital, with the first patient operated successfully. It received approval from the National Medical Products Administration (NMPA) for phase III clinical trials in the first quarter of 2022 and was included in the real-world clinical data pilot program.

"Completing patient enrollment for the Phase III bridging clinical trial of Hexvix marks a significant milestone for Asieris Pharmaceuticals." said Dr. Linda Wu, Chief Development Officer of Asieris," We are thrilled to have reached this stage in the development of a drug that has the potential to revolutionize the diagnosis of bladder cancer. Our goal is to provide healthcare professionals with a more effective and reliable way for patient with bladder cancer."

On July 6, 2023 GeneQuantum Healthcare, a leader in the innovative bioconjugation technologies for ADC new drug development, reported the expansion of its partnership with a South Korean biotech company Aimed Bio (Press release, GeneQuantum Healthcare, JUL 6, 2023, View Source [SID1234633093]). This strategic collaboration aims to jointly develop up to five new ADC drugs to address unmet clinical needs.

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Since April of last year, GeneQuantum and Aimed Bio have been collaborating on the joint development of a FGFR3-targeting ADC named GQ1011/AMB302. The progress of this development was presented at the 13th World ADC 2022 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Annual Meeting. The published results showcased the exceptional anti-cancer effects of this FGFR3-targeting ADC in in vivo models of bladder cancer and glioblastoma. Safety evaluations conducted in monkey models also showed positive results. Encouraged by these development achievements, the two companies have made the decision to expand their partnership in the joint development of up to five additional ADCs.

Dr. Gang Qin, the founder and CEO of GeneQuantum, stated, "The innovative ADC drug GQ1011 developed in collaboration with Aimed Bio has demonstrated excellent preclinical druggability data, fully showcasing the wide applicability and competitive advantage of GeneQuantum’s leading site-specific conjugation and linker-payload technologies. GeneQuantum has always adhered to the vision of open collaboration and innovative empowerment for ecosystem construction. With an integrated and holistic innovative conjugation solution as the hub, we gather advantages and resources from all parties, breaking fundamental bioconjugate drug development barrier through wide cooperation. This enables us to focus on the development of high-quality innovative ADC drugs that better meet the growing unmet clinical demand and provide improved treatment options for patients worldwide. The collaboration with Aimed Bio in the development of a series of innovative ADC drugs fully embodies GeneQuantum’s core technology and integration of various high-quality innovative resources from both international and domestic upstream and downstream sectors, presents a promising outlook for the revolutionary ADC therapy innovation."

Dr. Do-Hyun Nam, Aimed Bio’s CTO, commented " Through our collaboration with GeneQuantum, we aim to optimize resources by leveraging big data analysis and addressing high unmet needs to identify novel targets. We will utilize our proprietary translation platform to develop the most effective ADC platforms together." Dr. Nam highlighted the potential of this collaboration to deliver innovative treatments for patients who has no other therapeutic options.

On July 6, 2023 Mustang Bio, Inc. ("Mustang" or the "Company") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, reported that members of its management team will participate in the 2nd In Vivo Engineering of Therapeutic Cells Summit, scheduled to take place from July 10-12, 2023, and the 8th Annual CAR-TCR Summit, scheduled to take place from August 29 – September 1, 2023, both in Boston, MA (Press release, Mustang Bio, JUL 6, 2023, View Source [SID1234633092]).

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Event details are as follows:

2nd In Vivo Engineering of Therapeutic Cells Summit

Date & Time: July 11, 2023, at 11:00 a.m. ET
Session: Developing Novel Routes of Administration & Delivery for More Targeted Biodistribution
Seminar Title: In Situ CAR T Cell Concepts
Speaker: James Edinger, Ph.D., Senior Vice President, Preclinical Sciences, Mustang Bio

For more information on the 2nd In Vivo Engineering of Therapeutic Cells Summit, please visit View Source

8th Annual CAR-TCR Summit

Date & Time: Tuesday, August 29, 2023, at 1:00 p.m. ET
Workshop D: Moving Beyond Ex Vivo: The Promise of In Vivo Engineered Cell Therapies
Speaker: James Edinger, Ph.D., Senior Vice President, Preclinical Sciences, Mustang Bio

Date & Time: Wednesday, August 30, 2023, at 12:00 p.m. ET
Track: Early-Stage Clinical Strategy
Session: Preparing for IND Submission to the FDA
Panel Discussion: Discussing Initial Considerations When Planning for IND Submission
Speaker: Lynn Bayless, MS, RAC, Vice President, Head of Regulatory Affairs, Mustang Bio

Date & Time: Wednesday, August 30, 2023, at 12:00 p.m. ET
Track: CMC & Analytics
Session: Optimizing Characterization to Better Predict Cellular Attributes
Panel Discussion: Exploring the Future of Cell Therapy Characterization to Ensure High Quality Products
Speaker: Edward Armstrong, Vice President, Quality, Mustang Bio

Date & Time: Wednesday, August 30, 2023, at 5:00 p.m. ET
Track: Early-Stage Clinical Strategy
Session: Sharing CD20-Directed CAR-T Clinical Data & Strategy
Speaker: Bruce Dezube, M.D., Senior Vice President, Head of Clinical Development, Mustang Bio

Date & Time: Thursday, August 31, 2023, at 2:00 p.m. ET
Track: Supply Chain & Logistics
Session: Addressing Chain of Identity & Custody Concerns to Improve Traceability
Discussion: Improving Traceability Throughout the End-to-End Cell Therapy Supply Chain
Speaker: Edward Armstrong, Vice President, Quality, Mustang Bio

For more information on the 8th Annual CAR-TCR Summit, please visit https://car-tcr-summit.com/.