Liver metastases

QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on November 8, 2024, at 8:30 AM Eastern Time to discuss results for its third quarter ended September 30, 2024. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Friday, November 8, 2024 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-877-407-3982 International: 1-201-493-6780 Webcast: A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website here . About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT™ (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT ® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information , including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Contacts Investor Relations Contact: ICR Healthcare investorrelations@delcath.com

NEW YORK, Oct. 08, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics (MiNK, NASDAQ: INKT) a clinical-stage company pioneering the development of allogeneic off-the-shelf, invariant natural killer T (iNKT) cell therapies and Autonomous Therapeutics, Inc. (Autonomous), a leader developing first-in-class, disease-activated RNA medicines, announced a research collaboration aimed at effectively targeting and treating metastatic tumors. This collaboration will leverage Autonomous’ precision encrypted RNA™ (encRNA) technology and MiNK’s innovative iNKT cell therapies, MiNK-215 and agenT-797. The companies will evaluate these technologies in state-of-the-art metastatic solid tumor models. The goal is to develop novel therapies that effectively target metastatic cancer cells in patients while avoiding healthy cells—a challenge that existing cancer medicines have not been able to overcome. Based on the results, the companies plan to launch a Phase 1 clinical trial in patients with treatment-refractory metastatic solid tumors, including microsatellite stable (MSS) colorectal cancers. “This collaboration underscores the unique potential of both native and engineered iNKT cells, allowing us to explore cutting-edge approaches that could significantly enhance clinical responses and deliver better outcomes for patients,” said Dr. Jennifer Buell, President and Chief Executive Officer at MiNK. “MiNK-215 and agenT-797 are novel cell therapies designed to overcome the limitations of traditional immune checkpoint inhibitors. Recent preclinical models of MSS colorectal cancer with metastatic liver disease demonstrated that these iNKT cells have the potential to eliminate tumor cells effectively. By combining them with Autonomous Therapeutics' engineered RNA technology, we are confident that we can unlock even greater therapeutic possibilities and continue advancing our mission to transform the landscape of cell therapy.” Dr. Ariel Weinberger, Chief Executive Officer of Autonomous, added: “This exciting collaboration leverages the platform capabilities of our next-generation encrypted RNA technology and MiNK’s unique allogeneic cell therapy platform. AT313 is a preclinical encRNA candidate developed at Autonomous to enable the precision targeting of solid tumors, via cancer-activated therapeutic protein translation. Our aim is to develop novel medicines that pinpoint tumor cells in patients—by sensing and targeting the aberrant molecular signatures that define cancer replication. This would enable us to eliminate cancer cells in patients while sparing healthy and immune cells. It would also eliminate dose-limiting toxicities common to existing oncology medicines while significantly enhancing therapeutic efficacy—to dramatically improve Stage IV patient outcomes.” About MiNK-215 MiNK-215 is an investigational, off-the-shelf cellular immunotherapy, specifically designed to target immune resistance mechanisms and promote a potent anti-cancer immune response. Engineered to express CAR targeting the Fibroblast Activating Protein (FAP) protein prevalent in stromal cells within the tumor microenvironment, MiNK-215 also integrates soluble IL-15 for enhanced persistence (Michelet X et al, SITC 2022; Shan K et al, AACR 2023; Dijk MV et al, CICON 2023). In preclinical models resistant to immune checkpoint inhibitors, MiNK-215 has demonstrated remarkable efficacy, not only in eliminating tumor cells and FAP+ immune-suppressive cells but also facilitating the infiltration and persistence of proinflammatory cytotoxic T cells crucial for effective tumor elimination. About agenT-797 AgenT-797 is an investigational, off-the-shelf immune cell therapy product by MiNK Therapeutics, possessing anti-viral and immune-modulating properties. In a Phase 1 trial involving 54 patients with heavily pre-treated solid tumors, agenT-797 appears to overcome resistance to immune checkpoint inhibitors, with durable disease stabilization in multiple solid tumors and a confirmed response in chemotherapy and anti-PD-1 refractory gastric cancer (Carneiro et al, 2024 Oncogene). agenT-797 is being evaluated in an investigator sponsored Phase 2 trial in 2L gastric cancer, led by Dr. Yelena Janjigian, Chief of GI Oncology at Memorial Sloan-Kettering Cancer Center and supported by Stand Up to Cancer. About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels. About Autonomous Therapeutics, Inc. Autonomous Therapeutics is pioneering a new class of RNA medicines (encRNA) for difficult-to-treat indications in oncology and infectious disease. Autonomous has developed a proprietary pipeline of more than 10 encRNA candidates targeting indications from pandemic influenza to metastatic cancers. The company’s encRNA pipeline includes next-generation immunotherapies such as AT313, a cancer-activated RNA prodrug designed to precisely eliminate solid tumor cells. Autonomous’ partners and funders have included: the Defense Advanced Research Projects Agency (DARPA), the National Institutes of Health (NIH), the Office of the Secretary of Defense (OSD), Third Kind Venture Capital (3kVC), and BLUE KNIGHT™, a joint initiative between the Biomedical Advanced Research and Development Authority (BARDA) and Johnson & Johnson Innovation – JLABS. About encrypted RNA™ encRNA is a new class of RNA invented at Autonomous to enable the development of precision medicines against virtually any disease driven by aberrant nucleic acid expression or protein translation. Autonomous’ encRNA therapeutics leverage the molecular signatures of a targeted disease as intracellular logic gates—to drive precision therapeutic protein translation in targeted cells. Each encRNA candidate is designed to differentiate between healthy and diseased cells across a patient and to translate therapeutic proteins solely in diseased cells. encRNA candidates are modular and can be programmed with multiple logic gates for potential patient-specific sensitivity and specificity. In proof-of-concept studies, Autonomous has demonstrated the preclinical safety and efficacy of encRNA candidates in animal models, with the potential to completely eradicate immunologically “cold” solid tumors via precision immunotherapy. Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, anticipated benefit, plans and timelines of iNKT cells and encrypted RNA, as well as the collaboration between MiNK and Autonomous Therapeutics. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K, Form 10-Q and the S-1 Registration Statement filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK and Autonomous undertake no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. MiNK Investor Contact 917-362-1370 investor@minktherapeutics.com MiNK Media Contact 781-674-4428 communications@minktherapeutics.com

--Encouraging progression-free survival data in overall population; continued follow-up needed to allow data to mature further, especially in low ctDNA subgroup where events accrue more slowly --21% relative risk reduction of progression or death with GRANITE vs. control in all treated population (HR=0.79 [95% CI, 0.42-1.50])-- -- 38% relative risk reduction of progression or death with GRANITE vs. control in low ctDNA subgroup (HR=0.62 [95% CI, 0.23-1.70]) -- -- Strength of neoantigen specific T cell responses in GRANITE patients appears to associate with progression-free survival -- GRANITE was generally well-tolerated with no treatment discontinuations due to adverse events– -- Overall survival data expected in 2H 2025 -- Sept. 30, 2024 -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced encouraging interim Phase 2 data from the ongoing Phase 2 study evaluating GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer (MSS-CRC). The randomized, controlled study is designed to evaluate the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression-free survival (PFS) data show an encouraging benefit for GRANITE patients (HR=0.79 [95% CI, 0.42-1.50]). As expected, the greatest benefit was observed in the 50% of patients with lower disease burden at study entry, as measured by circulating tumor DNA (ctDNA) at study baseline. (HR=0.62 [95% CI, 0.23-1.70]). Continued follow-up is needed to fully assess GRANITE effects and determine whether a plateau of improved PFS (indicating durable clinical benefit) is achieved. The most recent ctDNA assessments for the 20 patients who remain without disease progression (per RECIST) were supportive of potential benefit from treatment with GRANITE: 12 of 13 GRANITE patients had stable ctDNA titers below the assay limit of quantitation (LOQ); 4 of 7 control patients exhibited the same characteristic. “We are excited by the potential of GRANITE to extend both progression-free and overall survival in a disease where relentless progression is the rule with existing therapies,” said Andrew Allen, MD, PhD, Co-Founder, President & CEO of Gritstone bio. “The field of neoantigen-targeting immunotherapy is evolving rapidly, and the focus is shifting to patients with lower volume disease. Notably, patients with newly diagnosed metastatic disease who have low ctDNA at study entry and thereby relatively low disease burden, could benefit from this type of immunotherapy. Success for immunotherapy typically manifests as an elevated plateau in PFS and overall survival Kaplan-Meier curves, and we may be seeing this in our low disease burden population. We need more time to let these data mature. The most recent ‘low and stable’ ctDNA measurements in most GRANITE patients are encouraging since that pattern is not typically seen in patients about to develop disease progression. The potential PFS benefit observed in MSS-CRC, a notoriously ‘cold’ tumor, suggests opportunity for even greater effects in tumors more typically amenable to immunotherapy.” Dr. Allen continued, “These data support further exploration of GRANITE in frontline MSS-CRC and in other low burden (neo)adjuvant settings. With this new dataset in hand, we continue to actively explore several strategic and funding alternatives to rapidly advance our innovative immunotherapy for the benefit of patients.” Concurrently, Gritstone announced that it has engaged Raymond James as its financial advisor to support the Company in exploring and reviewing potential value-maximizing strategies. Gritstone does not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until its Board of Directors has approved a definitive action or otherwise determined that further disclosure is appropriate or required by law. Data cut as of August 19, 2024 104 patients were randomized 1:1 in the study: 69 patients (39 GRANITE arm, 30 control arm) are included in the treated analysis below. Demographics and clinical characteristics were balanced between arms (stage, sidedness, presence of liver metastases), with the vast majority (80%) of patients having liver metastases in the treated analysis. Thirty-five patients did not advance to study treatment after oxaliplatin, most commonly due to withdrawing consent (n=15), disease progression (n=8), and other reasons (n=12) (12 in GRANITE arm; 23 in control arm). Interim data demonstrated an emerging PFS benefit to all GRANITE recipients (study not statistically powered for PFS) 21% relative risk reduction of progression or death with GRANITE vs. standard of care (SOC) control in all treated population (HR=0.79 [95% CI, 0.42-1.50]) 33% (13/39) GRANITE and 23% (7/30) of control patients remain on study and free of progression Last ctDNA assessment is below the assay LOQ in 12/13 GRANITE and 4/7 control patients Clinical benefit was most notable in patients with low disease burden (defined as patients with ctDNA equal to or below the trial population median value at study entry) 38% relative risk reduction of progression or death with GRANITE vs. SOC control with low ctDNA subgroup (HR=0.62 [95% CI, 0.23-1.70]) Low baseline ctDNA is a likely prognostic and predictive factor Immune data were consistent with clinical activity Functional neoantigen-specific T cells were observed in all 16/16 GRANITE patients tested by ELISPOT Association of PFS and peak ex vivo ELISPOT responses was apparent, suggesting that ex vivo ELISPOT may be a surrogate for PFS GRANITE demonstrated a favorable safety and tolerability profile No patients discontinued study treatment due to an adverse event (AE) Common adverse events were the mild systemic and local effects associated with any potent vaccine, i.e. transient flu-like illness One treatment-related serious AE (fatigue) occurred in the GRANITE arm (patient continued GRANITE treatment without recurrence upon recovery) Gritstone plans to review the PFS data with FDA in the coming months and agree on next steps to advance GRANITE, including a potential Phase 2 or 3 trial using ctDNA levels as eligibility criteria. Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. www.gritstonebio.com The content above comes from the network. if any infringement, please contact us to modify.