B-Cell Malignant Neoplasm

As early data show how T cell engagers — originally developed for cancers — can potentially treat a range of autoimmune diseases, GSK is buying its own molecule from Chimagen Biosciences. The UK pharma is paying $300 million upfront to acquire global rights to Chimagen’s antibody CMG1A46 in a deal that comes with another $550 million in milestones. GSK said it plans to test the T cell engager in autoimmune diseases like lupus erythematosus and lupus nephritis. The deal comes after Merck paid $700 million to Curon in August for a CD3xCD19 bispecific antibody that could treat B cell cancers and autoimmune diseases. Lupus is a disease area that GSK is familiar with, having developed and commercialized the lupus treatment Benlysta. Chimagen is already testing CMG1A46 in early-stage clinical trials in the US and China for leukemia and lymphoma, and GSK said it plans to begin a Phase 1 study in lupus in 2025. The company was founded in 2016 by Zhenhao Zhou and Jie Zhang to develop multi-specific antibodies, and is based in Shanghai. CMG1A46 was the biotech’s only compound in clinical studies, but it has other preclinical candidates in its pipeline. The experimental treatment is a trispecific antibody that binds to the proteins CD19 and CD20 on B cells, as well as CD3 on T cells. The idea is that the T cells can go after the uncontrolled B cells that play a big role in the disease. Drug developers are looking at both T cell engagers and cell therapies as potential treatment options for various autoimmune diseases. In cancer, however, safety concerns have followed the drug class. GSK said that the antibody has a “low affinity for CD3, which could lower toxicities typically associated with TCEs.”

Plus, news about Interius BioTherapeutics, Hope Medicine, PMV Pharmaceuticals, Epitopea, Alyssum Therapeutics and a new dementia trial accelerator in the UK: Bayer exercises option to develop heart drug with Dewpoint Therapeutics : The companies, which first teamed up in 2019, now plan to develop a therapy for dilated cardiomyopathy, a heart muscle disease. Bayer is paying $424 million in upfront and milestone payments. — Jaimy Lee Viking Therapeutics is already thinking about an obesity launch: The company plans to meet with the FDA before the end of the year to discuss Phase 3 plans for its subcutaneous GLP-1/GIP receptor agonist, VK2735, according to remarks made by CEO Brian Lian on Wednesday’s earnings call. Viking is already in conversation with manufacturers, and Lian said he’s confident the company will be able to supply “a blockbuster-sized product at the appropriate time.” Viking is also launching a Phase 2 trial this quarter for an oral version of VK2735. Lian described the experimental oral medicine as more of an “add-on” to the portfolio, while the subcutaneous version would be the “anchor piece.” — Nicole DeFeudis Interius BioTherapeutics doses first ever patient with in vivo CAR-T: The biotech gave an in vivo CAR-T therapy to a patient enrolled in a Phase 1 study of INT2104, which it’s developing for B cell cancers. The trial, which is being run in Australia, is the first test of its kind. Umoja Biopharma has said it plans to dose a patient in its US-based study of its own in vivo CAR-T therapy by the end of this year . — Lei Lei Wu Hope Medicine touts interim data for endometriosis treatment: The company’s monoclonal antibody, dubbed HMI-115 , demonstrated statistically significant improvement in endometriosis pain at 12 weeks. The Phase 2 trial enrolled 142 female patients in the US, Poland and China. The mean dysmenorrhea pain score was reduced by 42%, and non-menstrual pelvic pain score was reduced by 50%. Hope CEO Nathan Chen said the company plans to “move quickly” toward global Phase 3 trials. — Katherine Lewin PMV Pharmaceuticals discontinues early-stage cancer trial: Citing toxicities and limited clinical benefit, the company abandoned its Phase 1b study assessing rezatapopt and Merck’s Keytruda. It had been testing the combo in patients with advanced solid tumors harboring a TP53 Y220C mutation. PMV said enrollment for a Phase 2 trial evaluating rezatapopt as a monotherapy for patients with TP53 Y220C and KRAS wild-type advanced solid tumors is still on track. — Katherine Lewin Epitopea closes $31M pre-Series A: With today’s round, the cancer biotech has raised more than $45 million. The funds are set to go toward its preclinical discovery work in solid tumors and clinical development plans for its RNA-based immunotherapies. — Katherine Lewin Alyssum Therapeutics emerges from stealth with $26M Series A: The Cambridge, MA-based biotech’s lead asset is AT-1965, a clinical-stage small molecule CMTR2 inhibitor. This round was led by co-founder Patrick Soon-Shiong and Accel, Famy and Navam Capital. — Katherine Lewin UK government pours £20M into dementia trial accelerator: The new initiative aims to increase the number of participants in late-stage dementia studies to the tens of thousands and “address pharma-identified roadblocks” to running the trials. The Dementia Trials Accelerator’s objectives include creating a biomarker toolbox and extending trial enrollment to community settings. — Ayisha Sharma

Multiple Presentations on Lead Development Candidate EVOLVE104 to Showcase Preclinical Safety and Efficacy Profile and Precision Therapeutic Strategy as Company Advances Program Toward Clinic for Solid Tumors Unveiling of CD20-Targeted EVOLVE205 Demonstrates Expanded EVOLVE Platform Development Offering a Differentiated Strategy for Hematologic Tumors BRANFORD, Conn., Oct. 23, 2024 (GLOBE NEWSWIRE) -- EvolveImmune Therapeutics, an immuno-oncology company developing first-in-category, multifunctional biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immune therapy agents, today announced that new preclinical data highlighting EVOLVE, the company’s novel costimulatory T cell engager platform, will be presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which is being held November 6-10, 2024, in Houston, Texas. The poster presentations will include the latest preclinical results for the company’s lead development candidate, EVOLVE104, being developed for the treatment of solid tumors. Additionally, the company will spotlight work designed to expand the potential of the EVOLVE platform by applying integrated CD2 co-stimulation to next-generation T cell engager formats. The EVOLVE platform uniquely unleashes potent, selective and integrated T cell co-stimulation, which amplifies and sustains the tumor killing capacity of these T cells. This approach bypasses low tumor immunogenicity, conditionally activates adaptive immunity and reduces T cell dysfunction to overcome therapeutic challenges in solid and hematologic tumors. By pairing its distinctive co-stimulation strategy with EvolveImmune’s deep insights in cancer cell biology, EVOLVE enables the discovery and development of first-in-category precision immuno-oncology agents with an enhanced likelihood of clinical success. In two poster presentations, EvolveImmune will highlight the latest preclinical safety and efficacy data for EVOLVE104, a novel multi-functional T cell engager with integrated CD2 co-stimulation which conditionally targets ULBP2/5/6. This will include evidence of a favorable safety and tolerability profile, and updated ULBP2/5/6 RNA and immunohistochemistry analyses across a range of solid tumor types to pinpoint cancers enriched for its expression and most likely to respond to EVOLVE104 therapy. Importantly, the expression pattern for ULBP2/5/6 suggests opportunities to clinically differentiate EVOLVE104 from several approved or investigational immunotherapies. EvolveImmune continues to progress its chemistry, manufacturing, and control (CMC) activities for EVOLVE104, with the goal of advancing the program into the clinic in 2025. In addition, the company will deliver an oral presentation highlighting the discovery and profiling of EVOLVE205, a highly potent CD20-targeted CD2 co-stimulatory T cell engager designed in a 2:1 bispecific format. Presented data will include promising initial preclinical activity for EVOLVE205, findings which demonstrate both its potential differentiation from approved CD20-targeted immunotherapies and the growing capability of the EVOLVE platform to serve as a backbone for emerging classes of T cell engager therapies. “The upcoming SITC conference offers an ideal forum for us to share our significant pipeline progress not only with EVOLVE104 but also our success in unlocking the broad potential of the EVOLVE platform to enable the design of next-generation T cell engagers capable of overcoming therapeutic limitations of current immuno-oncology treatments,” said Jay Fine, Ph.D., president of research and development at EvolveImmune. “Our robust preclinical work on EVOLVE104 continues to build optimism for the clinical potential of the program, and we look forward to completing IND-enabling activities and advancing the compound into first-in-human studies in the coming year. At the same time, our excitement around our foundational EVOLVE technology and its fully integrated CD2 co-stimulation has never been greater.” Details of the company’s SITC presentations are as follows: EVOLVE104 Poster Presentations: Title: EVOLVE104, a first-in-class novel ULBP2/5/6-targeting T cell engager with integrated CD2 co-stimulation, demonstrates a favorable preclinical safety and toxicity profile in cynomolgus monkeysAbstract Number: 1339Presenter: Antonio Ward, Ph.D.Session: Novel Single-Agent ImmunotherapiesSession Date/Time: Friday, November 8, 2024 from 9:00 a.m. – 7:00 p.m. CSTLocation: Poster Hall in Exhibit Halls A and B of the George R. Brown Convention Center Title: Precision oncology strategy for EVOLVE-104, a differentiated T cell engager for the novel solid tumor target ULBP2/5/6Abstract Number: 1326Presenter: Oksana Sergeeva, Ph.D.Session: Novel Single-Agent ImmunotherapiesSession Date/Time: Friday, November 8, 2024 from 9:00 a.m. – 7:00 p.m. CSTLocation: Poster Hall in Exhibit Halls A and B of the George R. Brown Convention Center EVOLVE205 Oral Presentation: Title: EVOLVE205, a highly potent 2:1 CD20-targeted CD2 co-stimulatory T cell engager engineered for the treatment of B cell malignancies and B cell autoimmune diseasesAbstract Number: 1137Presenter: Afsana Sabrin, Ph.D.Session: CAR-T Cells vs T-cell Engineering Bispecifics in Hematological MalignanciesSession Date/Time: Saturday, November 9, 2024 from 5:15 -6:35 p.m. CSTLocation: Level 3 - Grand Ballroom A of the George R. Brown Convention Center The EVOLVE205 presentation will also be included in the poster session at the pre-conference Immune Engineering Workshop on Thursday, November 7, as well as during the poster reception on Friday, November 8. Additional information on the 39th Annual Meeting of SITC is available through the conference website at: https://www.sitcancer.org/2024/home About EvolveImmune Therapeutics EvolveImmune Therapeutics, Inc. is an immunotherapy platform company developing first-in-category, multifunctional biotherapeutics designed to overcome cancer-driven immunodeficiency in a range of solid tumors and hematological cancers. First-in-human clinical trials are anticipated in 2025. The company is supported by a syndicate of top-tier life science industry investors including Pfizer Ventures, Solasta Ventures, Bristol Myers Squibb, Takeda Ventures, Inc., Yonjin Ventures and Elm Street Ventures. For more information, please visit: www.evolveimmune.com