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/.

On July 6, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported that it will host a data event on Thursday, July 27th, 2023 at 10:00 a.m. Eastern Time (Press release, UroGen Pharma, JUL 6, 2023, View Source [SID1234633090]). The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and will highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials.

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For ENVISION, UroGen will provide complete response rate (the primary endpoint) from approximately 240 patients who completed the study; and for ATLAS, the predecessor to ENVISION, UroGen will provide disease free survival (the primary endpoint) as well as complete response, durability, and safety data from approximately 280 patients that completed the study. The program will also feature Key Opinion Leaders and a panel discussion on the treatment of LG-IR-NMIBC.

Please register for the webinar under the Events & Presentations section of the Company’s Investor Relations site (View Source).

Following the live audio webcast, a replay will be available on the Company’s website (View Source).

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.

On July 6, 2023 Shorla Oncology (‘Shorla’), a U.S.-Ireland pharmaceutical company, reported that it has entered into a licensing agreement and strategic partnership with a U.K.-based innovative drug development and manufacturing company (Press release, Shorla Oncology, JUL 6, 2023, View Source [SID1234633088]). Under the terms of the agreement, Shorla will obtain an exclusive license from the developer to register and commercialize PIP-101, the first palatable oral solution of the related chemotherapeutic agent in the U.S.

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PIP-101 is an oral solution treatment that slows or stops the growth of certain forms of leukemia, such as acute lymphoblastic leukemia and chronic myeloid leukemia.

"We are excited to partner with and leverage the developer’s oral oncology liquid manufacturing expertise," said Sharon Cunningham, CEO and Co-founder of Shorla Oncology. "This commercial partnership is a strong endorsement of our commitment to bring to market differentiated oncology treatments to address key areas of unmet needs for patients."

Under the terms of the agreement, the developer will continue to manufacture PIP-101. Once Shorla has obtained approval of its New Drug Application (NDA), the company will be responsible for the timely launch, commercialization and sales of PIP-101 in the U.S.

"We look forward to a long-term relationship with the developer with not only PIP-101, but other treatments that are in the pipeline," said Orlaith Ryan, CTO and co-founder of Shorla Oncology. "We expect this partnership will take both companies to new heights and provide much-needed oncology treatments to patients with cancer."

The U.S. Food and Drug Administration recently approved Shorla Oncology’s Nelarabine Injection for the treatment of T-cell Leukemia, an aggressive blood and bone marrow cancer. Shorla also has plans to have three products on market and three or more in development by end of year 2024.