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Updated MDNA11 Clinical Data from the ABILITY-1 Study to be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025
Globenewswire· 2025-10-23 21:12
TORONTO and HOUSTON, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer and autoimmune diseases, announced today that updated MDNA11 clinical data will be presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025 taking place December 10-12, 2025, in London, United Kingdom. Updated clinical data from the Phase ...
X @Bloomberg
Bloomberg· 2025-10-23 20:45
US regulators approved GSK's blood cancer drug, a decision that will allow the company to bring the medicine back to the world’s biggest pharmaceutical market after questions about its effectiveness led to its withdrawal in 2022 https://t.co/X4muiEKfcL ...
Coya Therapeutics Announces Proposed Public Offering of Common Stock
Businesswire· 2025-10-23 20:31
Oct 23, 2025 4:31 PM Eastern Daylight Time Coya Therapeutics Announces Proposed Public Offering of Common Stock Share For more information about Coya, please visit www.coyatherapeutics.com. About COYA 302 HOUSTON--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya†or the "Company†), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, today announced that it intends to offer and sell ...
Zymeworks (NasdaqGS:ZYME) Update / Briefing Transcript
2025-10-23 20:32
Summary of Zymeworks Conference Call on ZW191 Phase One Trial Results Company and Industry - **Company**: Zymeworks - **Industry**: Biotechnology, specifically focused on antibody-drug conjugates (ADCs) for cancer treatment Key Points and Arguments Overview of ZW191 - ZW191 is an antibody-drug conjugate designed to target folate receptor alpha, utilizing a novel IgG monoclonal antibody conjugated to a topoisomerase I inhibitor, ZD-06519, with a drug-to-antibody ratio of eight [4][5] - The design aims to enhance tumor penetration and deliver high payload levels, particularly in tumors with low folate receptor alpha expression [5] Phase One Trial Design - The trial focuses on three primary tumor types: platinum-resistant epithelial ovarian cancer, serous or endometrial cancer, and adenocarcinoma non-small cell lung cancer [8] - Patients had a performance status of zero or one and were heavily pretreated, with a median of three prior treatments [10][11] Patient Demographics - 41 patients were treated, with approximately 70% having metastatic platinum-resistant ovarian cancer, 20% endometrial cancer, and 10% non-small cell lung cancer [10] - The patient population included a mix of Asian and Caucasian participants, with a significant number being heavily pretreated [9][10] Safety Profile - The trial reported minimal grade 3 or greater treatment-related adverse events, with only seven patients experiencing such events [12] - No serious treatment-related adverse events or deaths were reported, indicating a favorable safety profile [12][18] Efficacy Results - Preliminary data showed significant anti-tumor activity, with a 50% partial response rate in patients with gynecological cancers at doses between 6.4 mg/kg and 9.6 mg/kg [16][18] - Notably, ZW191 demonstrated efficacy in patients with low or negative folate receptor alpha expression, contrasting with other ADCs that require high expression for efficacy [14][15][16] Next Steps in Development - The maximum tolerated dose was determined to be 11.2 mg/kg, with plans to proceed with dose optimization at 6.4 mg/kg and 9.6 mg/kg [20] - Enrollment for the next phase of the study is expected to begin soon, focusing on refining the balance between efficacy and safety [20][21] Strategic Partnerships and Future Plans - Zymeworks aims to explore strategic partnerships to accelerate development and expand global reach, particularly for ZW191 and other pipeline ADCs [21][22] - The company is also considering combination therapies with existing treatments, such as bevacizumab, to enhance efficacy in earlier lines of treatment [71][86] Additional Insights - The design of ZW191 allows for a broader therapeutic window, supporting further investigation in advanced solid tumors [19] - The company is also looking into other preclinical candidates targeting novel antigens, indicating a robust pipeline beyond ZW191 [22][91] Important but Overlooked Content - The trial's design allows for the inclusion of patients regardless of prior mirvetuximab treatment, which may increase enrollment as the drug gains approval globally [25][26] - The efficacy observed in patients with low folate receptor alpha expression highlights a significant advantage of ZW191 over existing therapies, potentially expanding the treatment landscape for these patients [28][31] - The discussion around the mechanism of resistance for folate receptor alpha-based ADCs suggests that the payload's stability and the linker chemistry play crucial roles in the observed safety and efficacy [65][66] This summary encapsulates the critical aspects of the conference call, focusing on the development and potential of ZW191 in the oncology landscape.
Clene (NasdaqCM:CLNN) Conference Transcript
2025-10-23 20:12
Clene (NasdaqCM:CLNN) Conference October 23, 2025 03:10 PM ET Company ParticipantsMorgan Brown - CFOKimberly Ann - President and CEORob Etherington - CEORob EtheringtonHello, everybody. Thanks for joining us again. This is Rob Etherington. Happy to be involved with the Emerging Growth Conference. I'm the CEO of Clene Inc., and I'm joined by Morgan Brown, our CFO. We have a few moments here of update because a lot has been going on at Clene Inc. You see here the classical forward-looking statements that you' ...
Iovance Biotherapeutics to Host Third Quarter 2025 Financial Results and Corporate Updates Webcast on Thursday, November 6, 2025
Globenewswire· 2025-10-23 20:05
SAN CARLOS, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will report its third quarter 2025 financial results and corporate updates before market on Thursday, November 6, 2025. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update on November ...
INOVIO to Participate in the Stephens Biotechnology Virtual Fireside Chat Conference
Prnewswire· 2025-10-23 20:05
Accessibility StatementSkip Navigation PLYMOUTH MEETING, Pa., Oct. 23, 2025 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, today announced that it will participate in a virtual fireside chat at the upcoming Stephens Biotechnology Virtual Fireside Chat Conference. During the conference, members of INOVIO's management team will also be conductin ...
Qualigen Therapeutics Partners with BitGo to Execute First Multi-Asset C10 Treasury Allocation
Globenewswire· 2025-10-23 20:05
New York, NY, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Qualigen Therapeutics Inc. (NASDAQ: QLGN) (“Qualigen”, “QLGN” or “Company”), a publicly-trading technology company majority owned by Faraday Future, today announced a strategic partnership with BitGo, the digital asset infrastructure company, to support its C10 treasury strategy, which accumulate and compound a market-cap-weighted basket of the world’s top 10 crypto assets (excluding stablecoins). Through this partnership, Qualigen will leverage BitGo’s holist ...
BioLife Solutions to Report Third Quarter 2025 Financial Results and Business Update on November 6, 2025
Prnewswire· 2025-10-23 20:03
Accessibility StatementSkip Navigation To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at https://www.biolifesolutions.com/earnings. In addition, the conference call will be accessible by dialing toll-free 1-833-630-0431 or 1-412-317-1808 for international callers. A webcast replay will be available approximately two hours after the call and will be archived on https://investors.biolifesolutions.com/ for 90 days. About BioLife SolutionsBioLife Solutions is a l ...
X4 Pharmaceuticals Announces Proposed Underwritten Public Offering
Globenewswire· 2025-10-23 20:01
Core Viewpoint - X4 Pharmaceuticals has initiated an underwritten public offering of its common stock and pre-funded warrants, aiming to raise funds for the development of mavorixafor and other corporate purposes [1][2]. Group 1: Offering Details - The public offering includes an option for underwriters to purchase an additional 15% of the shares offered at the public offering price [1]. - The offering is subject to market conditions, and there is no guarantee regarding its completion or the terms [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to the pivotal Phase 3 development of mavorixafor for chronic neutropenic disorders, as well as for general administrative expenses, capital expenditures, and working capital [2]. Group 3: Company Background - X4 Pharmaceuticals focuses on developing therapies for rare hematology diseases, with mavorixafor being a key product currently marketed in the U.S. as XOLREMDI® [5]. - The company is conducting a global pivotal Phase 3 clinical trial (4WARD) for mavorixafor in patients with chronic neutropenic disorders [5].