BOSTON, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers, today announced the appointment of Alex Kane, MBA, as Senior Vice President, Investor Relations & Capital Markets, effective immediately. Mr. Kane brings 20 years of experience and a proven track record in investor relations, strategic communications, and equity capital markets across the life sciences sector. He joins P ...

New biomarker and immune data from the ongoing phase 2 trial with EVX-01 will be presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting The data will be the latest of many additions to EVX-01’s strong data packageTwo-year clinical efficacy data from the trial will be presented at the European Society for Medical Oncology (ESMO) 2025 congress on October 17, 2025 COPENHAGEN, Denmark, October 3, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializi ...

Core Insights - Merck has received FDA approval for KEYTRUDA QLEX, a new formulation for subcutaneous administration in adults for most solid tumor indications of KEYTRUDA [1] Company Summary - KEYTRUDA QLEX combines pembrolizumab with berahyaluronidase alfa-pmph, a variant of human hyaluronidase developed by Alteogen Inc [1] - The approval expands the administration options for KEYTRUDA, which is a significant product for Merck in oncology [1]

RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. One recommends approval of a new subcutaneous (SC) route of administration and a new pharmaceutical form (solution for injection) for KEYTRUDA® (pembrolizumab), which if approved would be marketed in ...

Company Overview - Pyxis Oncology, Inc. is a clinical-stage company focused on developing antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers [1][2] - The company is building therapeutics that have potential for both monotherapy and combination indications [2] Lead Candidate - The lead candidate, micvotabart pelidotin (MICVO), is currently being evaluated in ongoing Phase 1 clinical studies targeting multiple types of solid tumors [2] - The development focus is on treating patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) due to promising signals observed in this area [2] - A Phase 1/2 combination study of MICVO and Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), has been initiated for patients with R/M HNSCC and other advanced solid tumors [2] Upcoming Conferences - Lara S. Sullivan, M.D., President and CEO, will participate in several upcoming investor conferences, including: - 2025 Cantor Global Healthcare Conference on September 3, 2025, featuring a fireside chat and investor one-on-one meetings [4] - H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, also including a fireside chat and investor one-on-one meetings [4] - 2nd Annual ADC and Novel Conjugates Partnering and Investment Summit on September 9, 2025, with a company presentation [1][4]

Core Insights - IO Biotech reported significant advancements in its cancer therapy pipeline, particularly with the Phase 3 trial results for Cylembio, an immune-modulatory cancer vaccine for advanced melanoma [2][6][7] - The company plans to engage with the FDA regarding the trial results and potential submission of a Biologics License Application (BLA) [2][6] Recent Business Highlights - The company achieved clinical improvement in progression-free survival (PFS) in the Phase 3 trial of Cylembio combined with KEYTRUDA, although statistical significance was narrowly missed [6][7] - IO Biotech ended Q2 2025 with approximately $28.1 million in cash and cash equivalents, expecting this to fund operations into Q1 2026 [6][12] - Upcoming presentations at the Morgan Stanley Global Healthcare Conference and H.C. Wainwright Global Investment Conference are scheduled for September 2025 [6][7] Financial Results - For Q2 2025, IO Biotech reported a net loss of $26.2 million, compared to a net loss of $20.7 million in Q2 2024 [5][12] - Research and development expenses increased to $16.7 million in Q2 2025 from $15.8 million in Q2 2024, while general and administrative expenses rose to $6.5 million from $5.7 million in the same period [12][20] - The total comprehensive loss for Q2 2025 was $26.4 million, compared to $20.8 million in Q2 2024 [20] Clinical Trials Overview - The pivotal Phase 3 trial (IOB-013/KN-D18) enrolled 407 patients and evaluated Cylembio in combination with KEYTRUDA against KEYTRUDA alone for advanced melanoma [10][11] - The company is also conducting two Phase 2 trials: IOB-022/KN-D38 for advanced solid tumors and IOB-032/PN-E40 for resectable squamous cell carcinoma and melanoma [11][13] - Initial data from the ongoing Phase 2 trials is expected in the second half of 2025 [7][10] Company Background - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win platform [14] - The company is headquartered in Copenhagen, Denmark, with a US office in New York [14]

The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company's antigen presenting cell (APC) activator, eftilagimod alfa (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA® (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression (Tumour Proportion Score ...

Core Insights - Transgene and BioInvent are presenting updated data on BT-001, an oncolytic virus, at the ESMO Annual Meeting in October 2025 [1][2] - BT-001 is being evaluated in a Phase I/IIa study for its efficacy in treating advanced solid tumors [4] Group 1: Study Details - The study is a multicenter, open-label, dose-escalation trial assessing BT-001 as a monotherapy and in combination with pembrolizumab [4] - The Phase I part of the study has shown that BT-001 is well tolerated and has demonstrated initial efficacy, with clinical responses observed in 2 out of 6 refractory patients [3][4] - The treatment has converted "cold" tumors into "hot" tumors, inducing T-cell infiltration and PD(L)-1 expression in the tumor microenvironment [3] Group 2: Product Information - BT-001 is developed using Transgene's Invir.IO® platform and incorporates a Treg-depleting recombinant human anti-CTLA-4 antibody from BioInvent [3] - The collaboration between Transgene and BioInvent is a 50/50 partnership focused on the development of oncolytic viruses [3] Group 3: Company Background - Transgene specializes in designing and developing virus-based immunotherapies for cancer treatment, with a portfolio that includes multiple viral vector-based immunotherapeutics [6][8] - BioInvent focuses on discovering and developing novel immune-modulatory antibodies for cancer therapy, with several candidates in clinical programs [8]

Core Insights - Evaxion A/S will present two-year clinical efficacy data from its phase 2 trial of the personalized cancer vaccine EVX-01 at the ESMO Congress 2025 in Berlin [1][3] - EVX-01, developed using Evaxion's AI-Immunology™ platform, is currently being evaluated for advanced melanoma treatment, showing a 69% Overall Response Rate in interim data [2][4] - The phase 2 trial combines EVX-01 with MSD's KEYTRUDA® therapy, tailored to each patient's unique tumor profile [4][6] Company Overview - Evaxion is a clinical-stage TechBio company focused on AI-driven immunotherapies for cancer and infectious diseases [9] - The company utilizes its AI-Immunology™ platform to create personalized vaccines, aiming to enhance immune responses against tumors [6][9] - Evaxion's pipeline includes novel personalized vaccines for oncology and preclinical candidates for bacterial and viral diseases [9] Clinical Trial Details - The phase 2 trial of EVX-01 has shown promising results, with 67% of metastatic melanoma patients achieving objective clinical responses in earlier trials [7] - The upcoming presentation at ESMO will include data on T-cell responses and disease control over two years [5][6] - The trial emphasizes the correlation between AI predictions and immune responses, highlighting the platform's predictive capabilities [2][7]

Core Insights - Kazia Therapeutics Limited announced transformative preclinical research on paxalisib, highlighting its potential in treating triple-negative breast cancer (TNBC) [1][2] - The research indicates paxalisib can reprogram the tumor microenvironment and enhance immune response, showing synergy with immune checkpoint inhibitors [2][6] - The publication of this research supports the ongoing Phase 1b clinical trial of paxalisib in advanced breast cancer [4] Preclinical Research Findings - Conducted by Professor Sudha Rao at QIMR Berghofer Medical Research Institute, the study shows paxalisib's ability to remodel the TNBC tumor microenvironment, increasing CD4+ and CD8+ T cell infiltration and activation [2][6] - The combination of paxalisib with KEYTRUDA® (pembrolizumab) demonstrated significant antitumor activity, leading to robust tumor regression and prolonged survival in preclinical models [6] Clinical Development - Kazia has initiated a Phase 1b trial evaluating paxalisib in combination with checkpoint inhibitors and chemotherapy for advanced breast cancer, marking a significant step in clinical translation [5] - The company has previously conducted ten clinical trials for paxalisib, primarily focused on brain cancers, and is now expanding its application to solid tumors [5] Regulatory Designations - Paxalisib has received multiple designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions, indicating its potential therapeutic value [5] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program centered on paxalisib, a PI3K/Akt/mTOR pathway inhibitor [5]