Latest news with #CLL
Medscape
18 hours ago
- Health
- Medscape
Genetics or Microenvironment: What Drives CLL Progression?
MILAN — Is chronic lymphocytic leukemia (CLL) progression primarily driven by genetic mutations or by external cues from the tumor microenvironment? Despite major strides in targeted therapies, CLL remains incurable, prompting renewed scrutiny of whether intrinsic genetic alterations or extrinsic cellular forces hold the key to more effective, lasting treatment. This central question took the spotlight at the 2025 European Hematology Association (EHA) Annual Congress, sparking a lively debate among leading CLL researchers. Most therapies have targeted intrinsic molecular features of leukemic cells, such as BCL2 and BTK. But the lack of robust responses to immunotherapy suggests that external factors such as the tumor microenvironment may also play a role. 'The debate dates back to at least 1999,' said session chair Silvia Deaglio, MD, PhD, director of the Immunogenetics and Transplant Biology Service, City of Health and Science of Turin, Italy in an interview with Medscape Medical News . 'That year, two landmark papers showed that mutations in IGHV [immunoglobulin heavy chain variable region] genes were a favorable prognostic marker, supporting a genetic model. But those same studies also identified an unfavorable prognostic marker in a molecule linked to how CLL cells interact with their environment, suggesting a role for the microenvironment as well.' Genetic Drivers Take Center Stage Eugen Tausch, MD, PhD, researcher at the University of Ulm, Germany, argued in favor of genetics as the primary driver. 'All CLLs have at least one genetic driver, and IGHV mutation status is a fundamental and stable biomarker,' he said. This mutation status affects multiple cellular mechanisms, including immune evasion, anti-apoptotic signaling, and B-cell receptor function. It also modulates how cells respond to cues from their environment, reinforcing the need to consider IGHV when studying microenvironmental influences. But IGHV is just one piece of the puzzle, Tausch added. More than 200 genetic drivers have been identified in CLL. Roughly 90% of cases harbor at least one gene mutation or chromosomal aberration that affects DNA repair, cell cycle regulation, metabolism, RNA processing, and intracellular signaling. 'These alterations have clear clinical implications,' he said. 'Resistance to BTK and BCL2 inhibitors often arises through mutations at the drug-binding site, establishing a direct link between genetics and therapy failure.' Understanding and tracking clonal genetic evolution is thus key to risk stratification, treatment planning, and anticipating disease trajectory, he concluded. The Microenvironment's Role in Early Disease Although CLL has long been seen as a genetically driven malignancy, new data suggest a more nuanced picture in which the tumor microenvironment influences early clonal dynamics. 'We know mutations drive disease progression, especially under therapeutic pressure, but the triggers of these mutations are less clear,' said John Gribben, MD, DSc, Hamilton Fairley Professor of Medical Oncology at Barts Cancer Institute, Queen Mary University of London, UK, who argued in favor of the microenvironment. Accumulation of mutations with age, oxidative stress, antigenic stimulation, and rare inherited factors have all been proposed, but these likely act in concert with tumor microenvironment signals to promote early clonal expansion, he explained. In lymph nodes and bone marrow, CLL cells interact with a milieu of stromal and nurse-like cells, dysfunctional T cells, and dendritic cells, along with a variety of cytokines and chemokines. Recent studies have shown that early clonal evolution primarily occurs in lymph nodes and is associated with a suppressed T-cell inflammatory response. A small subpopulation of lymph node-activated CLL cells engages with the microenvironment to drive disease progression and possibly influence mutation patterns. Moreover, therapies that disrupt microenvironmental interactions have shown efficacy by blocking B-cell receptor signaling and impairing chemokine-mediated trafficking. Even while advocating for the microenvironment's role, Gribben proposed a hybrid model. 'Genetic lesions set the stage, but microenvironmental forces shape their emergence and survival. Early on, extrinsic factors dominate. Later, clonal evolution and genetic resistance take over.' A New Paradigm of Coexistence Both speakers emphasized the need to move beyond binary models of CLL progression. 'The data support a dynamic interplay,' Deaglio told Medscape Medical News . 'The long-term coexistence between leukemic cells and their environment in CLL alters both cell behavior and immune function.' She noted that the T-cell compartment becomes tolerogenic, showing expansion of regulatory T cells and memory effector cells, among other markers. The debate also touched on the progression from monoclonal B-cell lymphocytosis to CLL and on Richter transformation, reinforcing the need for an integrated understanding of intrinsic and extrinsic disease drivers. Deaglio underlined that researchers are now exploring whether treatment-resistant patients could benefit from new drugs or combinations and whether therapy could eventually be administered for fixed durations rather than continuously until progression. 'Progression is genetically driven,' said Deaglio. 'But single-cell sequencing shows that some leukemic cells carry the features that enable future expansion a long time before the disease is diagnosed. Why some clones grow while others do not may depend on the environment they find themselves in.' Gribben concluded, 'To treat CLL effectively, and maybe reach a cure, we'll need to combine immune-based approaches with current targeted therapies.' Deaglio reported no relevant financial relationships. Tausch reported industry affiliations with AbbVie, BeiGene, Lilly, AstraZeneca, Roche, and Janssen-Cilag. Gribben reported research funding from AstraZeneca, BMS/Celgene, and Janssen; clinical trials with AbbVie, Celgene, Epizyme, Gilead, Genmab, Janssen, Merck, MorphoSys, Pharmacyclics, Regeneron, Roche/Genentech, and Takeda; consultancy for AbbVie, Amgen, AstraZeneca, BeiGene, BSM/Celgene, Janssen, Kite Gilead, and Takeda; and honoraria from AbbVie, AstraZeneca, BeiGene, BSM/Celgene, Janssen, Kite Gilead, and Novartis.
Associated Press
3 days ago
- Health
- Associated Press
GeoVax Highlights Positive Immune Response Results From GEO-CM04S1 in CLL Patients at the European Hematology Association 2025 Meeting
GEO-CM04S1 Demonstrates Superior T Cell Responses Compared to mRNA Vaccine in Phase 2 Trial Among Immunocompromised Patients ATLANTA, GA - June 17, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today highlighted new clinical data presented at the 2025 European Hematology Association (EHA) Hybrid Congress, which took place June 12-15 in Milan, Italy. The data were featured in a poster presentation by Alexey V. Danilov, M.D., Ph.D., Associate Director of the Toni Stephenson Lymphoma Center and Professor in the Department of Hematology and Hematopoietic Cell Transplantation at City of Hope Comprehensive Cancer Center in Duarte, California. The poster titled 'MVA-Based GEO-CM04S1 Vaccine Results in Improved Cellular Immune Response in Patients with Chronic Lymphocytic Leukemia (CLL) Compared with mRNA-Based Vaccine: Initial Results of a Phase II Randomized Study', detailed findings from an ongoing randomized Phase 2 clinical trial (NCT05672355), and highlighted interim results showing superior cellular immune responses induced by GEO-CM04S1 compared to those induced by an authorized mRNA-based COVID-19 vaccine in CLL patients, a population known to exhibit suboptimal protective responses to COVID-19 and other vaccines due to immune dysfunction. Key Findings from the Study 'These findings reinforce the clinical and immunologic advantages of our multi-antigen approach,' said Kelly T. McKee, Jr., M.D., Chief Medical Officer of GeoVax. 'GEO-CM04S1's robust cellular response in immunocompromised individuals, especially patients with hematologic malignancies like CLL, provides further validation of our MVA platform's potential to address critical gaps in COVID-19 protection.' About GEO-CM04S1 GEO-CM04S1 is a next-generation COVID-19 vaccine based on a synthetic Modified Vaccinia Ankara (MVA) vector. Unlike single-antigen vaccines, it expresses both the Spike (S) and Nucleocapsid (N) proteins of SARS-CoV-2, aiming to provide broader, cross-reactive, and more durable immunity. The vaccine is currently being evaluated in three Phase 2 clinical trials across various patient populations, including immunocompromised individuals and healthy adults. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: Forward-Looking Statements This release contains forward-looking statements regarding GeoVax's business plans. The words 'believe,' 'look forward to,' 'may,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'should,' 'plan,' 'could,' 'target,' 'potential,' 'is likely,' 'will,' 'expect' and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Company Contact: [email protected] 678-384-7220 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected]
ITV News
4 days ago
- Health
- ITV News
New leukaemia treatment hailed as ‘milestone' for patients
Scientists have hailed a 'milestone' in leukaemia care for patients after a UK trial found a chemotherapy-free approach to treatment may lead to better outcomes for some patients. The groundbreaking UK-wide trial could reshape the way the most common form of leukaemia in adults is treated. Researchers from Leeds wanted to assess whether two targeted cancer drugs could perform better than standard chemotherapy among patients with chronic lymphocytic leukaemia (CLL). They led the Flair trial, which took place at 96 cancer centres across the UK. Flair trial is a milestone. We have shown that a chemotherapy-free approach can be not only more effective but also more tolerable for patients Dr Talha Munir Some 786 people with previously untreated CLL were randomly assigned to receive standard chemotherapy; a single targeted drug, ibrutinib, or two targeted drugs taken together, ibrutinib and venetoclax, with treatment guided by personalised blood tests. They found that after five years, 94% of patients who received ibrutinib plus venetoclax were alive with no disease progression. This compares with 79% for those on ibrutinib alone and 58% for those on standard chemotherapy, according to the study, which has been published in the New England Journal of Medicine and presented to the European Haematology Association congress in Milan, Italy. Meanwhile 66% of patients on the new combination had no detectable cancer in their bone marrow after two years, compared with none of the people who received ibrutinib alone and 48% on chemotherapy. Ibrutinib is a type of drug known as a cancer growth blocker. It works by stopping signals that cancer cells use to divide and grow. And venetoclax blocks the functions of a protein found in CLL cells. Experts said that the new treatment regime was also tolerated better than traditional treatments. Dr Talha Munir, consultant haematologist at Leeds Teaching Hospitals NHS Trust, who led the study said: 'Flair trial is a milestone. 'We have shown that a chemotherapy-free approach can be not only more effective but also more tolerable for patients. 'By tailoring individualised treatment based on how well the cancer responds, we're moving into an era of truly personalised medicine.' Catherine Whitfield, 63, from Farnley, West Yorkshire, was diagnosed with CLL in 2018 after she noticed symptoms including bleeding gums, constant illness and neck pain. She signed up to the trial, which was co-ordinated by the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds and sponsored by the University of Leeds. She said: 'After three years of treatment, I am still MRD negative – that means no cancer cells.' 'I lost my husband to cancer. I have seen how hard it could be. 'My first thought after my diagnosis was, I will never see my grandchildren being born and growing up. 'Now I have two grandchildren, Drew and Alaia, and they are a delight and highlight the joys of a healthy life'. Ms Whitfield added: 'The way this trial was explained, it just made sense. 'Also, the thought of chemotherapy was scary to me. The trial felt right. And it was.' Dr Iain Foulkes, executive director of research and innovation at Cancer Research UK, which funded the trial along with AbbVie, and Johnson and Johnson, said: 'The results of the Flair trial show that we can provide kinder, more targeted treatment for chronic lymphocytic leukaemia, which gives people with CLL more precious time with their loved ones. 'We're hopeful that the results of the Flair trial will power new treatment options for leukaemia and other blood cancers, thanks to the efforts of researchers at in Leeds and across the UK working together on this trial.' Chronic lymphocytic leukaemia is the most common form of leukaemia in adults. There are about 4,000 new CLL cases in the UK every year.
Yahoo
12-06-2025
- Business
- Yahoo
Starton Therapeutics Announces Phase 2a Clinical Trial for Continuous Low-Dose Lenalidomide (STAR-LLD) in Multiple Myeloma Open for Enrollment
Gabrail Cancer & Research Center activated and open to screen patients, with Nash Gabrail, MD as lead investigator Second site, Regional Medical Oncology Center, also activated Recent Phase 1b clinical study results concluded continuous low dose lenalidomide provides meaningful efficacy and improved tolerability with no grade >3 drug-related hematologic toxicity PARAMUS, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. ('Starton'), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary continuous delivery technologies, announced today Gabrail Cancer Center (GCC) in Canton, Ohio is now activated and open for enrolling patients in its Phase 2a clinical trial evaluating their continuous low-dose lenalidomide, STAR-LLD, for the treatment of multiple myeloma (MM). Dr. Nash Gabrail, medical oncologist and founder of the Center, is the study's lead investigator. Regional Medical Oncology Center, located in Wilson, NC, has also opened as the trial's second active clinical site. 'We are excited to announce this major milestone in our mission to bring breakthrough therapies to patients. This marks the next phase of development for our lead candidate, STAR-LLD, and represents a significant step forward for the entire team," stated Pedro Lichtinger, Chairman and Chief Executive Officer of Starton Therapeutics. 'We expect this study to expand on what we observed in our prior Phase 1b study, that continuous low-dose lenalidomide provides meaningful efficacy and improved tolerability,' added Dr. Jamie Oliver, Starton's Chief Medical Officer. 'The expanded cohort and dose escalation will help us determine the most effective dose, with the goal of maintaining acceptable safety and tolerability.' Starton, which recently presented the results of the Phase 1b portion of the study at the 2025 American Association for Cancer Research, will assess the safety and tolerability of low-dose lenalidomide in heavily treated MM patients. Continuous SC infusion (STAR-LLD) in combination with dexamethasone and a protease inhibitor (PI) will be compared to oral lenalidomide (Revlimid®) in combination with dexamethasone and a PI. The study will include at least 24 patients randomized to STAR-LLD and oral lenalidomide (Revlimid®). Up to 45 additional patients may be enrolled to identify the optimal dose for a future registrational study (based on ORR vs dose vs Grade 3-4 toxicity). Starton anticipates opening approximately 10 clinical sites. About STAR-LLD STAR-LLD is a continuous delivery lenalidomide (LLD) in development to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD and 20% of animals in this cohort were tumor-free after 100 days, compared to a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity. About Starton Therapeutics Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer live better, for longer. Starton's proprietary technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit Forward Looking Statements All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding our plans and objectives for future operations and expectations about current and future clinical trials, constitute 'forward-looking statements.' Forward-looking statements are subject to numerous conditions and known and unknown risks and uncertainties that could cause our actual results or events to differ materially from those included within the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, and except as required by law, Starton undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise. Investor Relations Contact Alex StarrManaging Director LifeSci Advisors astarr@ in to access your portfolio
Yahoo
12-06-2025
- Business
- Yahoo
Schrödinger Reports Encouraging Initial Phase 1 Clinical Data for SGR-1505 at EHA Annual Congress
SGR-1505 was observed to have a favorable safety profile and was well tolerated, with encouraging preliminary efficacy in patients with relapsed/refractory B-cell malignancies Responses observed across a broad range of B-cell malignancies, including monotherapy responses in patients with CLL and Waldenström macroglobulinemia Management to host a webcast today at 8:00 a.m. ET MILAN, June 12, 2025--(BUSINESS WIRE)--Schrödinger, Inc. (Nasdaq: SDGR) today announced encouraging initial clinical data from its ongoing Phase 1, open-label, dose-escalation study of SGR-1505 in patients with relapsed/refractory B-cell malignancies. SGR-1505 was observed to be safe, well tolerated, and clinically active, with responses observed in multiple histologies, including in patients with chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM). These data are being presented in a poster presentation at the European Hematology Association Annual Congress. "We are very encouraged by the initial results from our Phase 1 study in patients with relapsed/refractory B-cell malignancies. The data presented today, coupled with the differentiated preclinical and safety profiles observed in our previously completed study in healthy volunteers, further increases our conviction about the potential for SGR-1505 to be a best-in-class therapy," said Margaret Dugan, M.D., chief medical officer at Schrödinger. "Dose escalation is complete, and we look forward to discussing these results and our proposed recommended Phase 2 dose with the FDA later this year." "Despite recent advances in the treatment of B-cell malignancies, resistance to currently available therapies eventually results in treatment failure and disease progression for many patients," said Stephen Spurgeon, M.D., Associate Professor of Medicine, Oregon Health and Science University, and an investigator for the clinical study. "We know that MALT1 plays a critical role in key signaling pathways that drive cancer cell survival and proliferation, making it a promising target for a broad range of B-cell malignancies. Although these data are from an early-phase study, they suggest SGR-1505 demonstrates on-target activity resulting in potential clinical benefit. I look forward to seeing additional data as the study progresses, including response data in patients with aggressive histologies." "The positive data reported today represent a key milestone for Schrödinger and follow the clinical successes of programs advanced by collaboration partners and companies we have co-founded," said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. "These data reinforce the power of Schrödinger's platform to enable the rapid design of differentiated molecules and the impact that our computational approach can have on a drug discovery and development program." Major Takeaways from the Study As of the data cut-off date, May 13, 2025, 49 patients were enrolled and evaluable for safety, including 18 patients with CLL/SLL, nine with diffuse large B-cell lymphoma (DLBCL), six with Waldenström macroglobulinemia (WM), and five with marginal zone lymphoma (MZL). Patients had a median of four (range two-nine) prior lines of therapy, with the most common being Bruton's tyrosine kinase (BTK) inhibitors (55.1%), BCL-2 inhibitors (18.4%) and BTK+BCL-2 inhibitors (18.4%). SGR-1505 was well-tolerated with no dose-limiting toxicities or deaths due to treatment-emergent adverse events (TEAEs). Forty three percent of patients (n=21) experienced ≥ 1 treatment-related adverse event (TRAE), with the most common (≥ 10%) being rash (12%) and fatigue (12%). Ten patients (20%) experienced treatment-emergent serious adverse events (SAEs); one was treatment-related. All blood bilirubin increased TEAEs were asymptomatic, reported in patients with UGT1A1 polymorphisms and none were Grade 4. Inhibition of IL-2 is a pharmacodynamic biomarker for target engagement and an exploratory endpoint in the study. Preliminary data indicated that SGR-1505 inhibits T-cell derived IL-2 upon ex vivo stimulation achieving the PD target of ~90% inhibition in the majority of PD-evaluable participants treated at ≥ 150 mg QD and all Q12H doses at steady state. Preliminary efficacy data indicated SGR-1505 was clinically active as a monotherapy in a number of relapsed/refractory B-cell malignancies. Of the 49 participants, 45 patients had at least one follow-up disease assessment or disease progression and were evaluable for preliminary efficacy. The overall response rate (ORR) across all dose levels was 22% (n = 10/45). Thirteen of 49 patients had been on treatment for ≥120 days. Among patients with indolent disease, 3/17 CLL/SLL, 5/5 WM, and 1/5 MZL patients responded. The responses of the three CLL responders were independently reviewed and confirmed, and two had a partial response (PR) with lymphocytosis (PR-L). Two of three CLL patients with partial responses were double-exposed to BTK and BCL-2 inhibitors, and all WM patients were exposed to BTK inhibitors. The study recently began enrolling patients with aggressive lymphomas into the 300 mg QD and 100 mg Q12H cohorts. A PR was reported in one of four ABC-DLBCL patients. Study DesignThe Phase 1 dose-escalation study (NCT05544019) assessed SGR-1505 as a monotherapy treatment in patients with relapsed/refractory B-cell malignancies. The primary endpoint is the incidence and severity of adverse events and dose-limiting toxicities. Secondary endpoints include pharmacokinetic and pharmacodynamic measurements as well as objective response rate, duration of response and disease control rate. EHA Poster Presentation DetailsThe full abstract (#PS1569) can be found online at Poster Title: A Phase 1 study of SGR-1505, an oral, potent, MALT1 inhibitor for relapsed/refractory (R/R) B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL)Presentation Date and Time: Saturday, June 14, 2025, 6:30-7:30PM CST (12:30-1:30PM ET)Location: Poster Session 2 About SGR-1505SGR-1505 is an oral investigational MALT1 inhibitor being evaluated for the treatment of relapsed/refractory B-cell malignancies. MALT1 plays a central role in key signaling pathways that drive cancer cell survival and proliferation, making its location downstream of BTK in the NF-κB signaling pathway an attractive target for the development of novel therapeutics for a potentially broad range of B-cell malignancies. In preclinical studies, SGR-1505 was observed to be highly potent and selective, and has demonstrated anti-tumor activity in preclinical models both as a monotherapy and in combination with BTK and BCL-2 inhibitors. There is also emerging therapeutic rationale supporting MALT1 inhibition as a potential treatment for inflammatory and autoimmune disorders. SGR-1505 was designed using Schrödinger's computational platform at scale and was discovered approximately 10 months after the company started its MALT1 program. Schrödinger believes that SGR-1505 is currently the most advanced MALT1 inhibitor known to be in clinical development and has both first-in-class and best-in-class potential. A Phase 1 study in patients with relapsed/refractory B-cell malignancies is ongoing (NCT05544019). Webcast and Conference Call InformationSchrödinger will host a conference call on Thursday, June 12, 2025, at 8:00 a.m. ET to review the clinical opportunity for SGR-1505 and review the Phase 1 data presented at EHA. The live webcast can be accessed under "Events & Presentations" in the investors section of Schrödinger's website, To participate in the live call, please register for the call here. It is recommended that participants register at least 15 minutes in advance of the call. The archived webcast will be available on Schrödinger's website for approximately 90 days following the event. About SchrödingerSchrödinger is transforming molecular discovery with its computational platform, which enables the discovery of novel, highly optimized molecules for drug development and materials design. Schrödinger's software platform is built on more than 30 years of R&D investment and is licensed by biotechnology, pharmaceutical and industrial companies, and academic institutions around the world. Schrödinger also leverages the platform to advance a portfolio of collaborative and proprietary programs and is advancing three clinical-stage oncology programs. Founded in 1990, Schrödinger has approximately 800 employees operating from 15 locations globally. To learn more, visit follow us on LinkedIn and Instagram, or visit our blog, Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 including, but not limited to those statements regarding the potential advantages of Schrödinger's computational platform, the clinical potential and favorable properties of SGR-1505, its MALT1 inhibitor, and the potential for SGR-1505 to be used for the treatment of relapsed/refractory B-cell malignancies, including chronic lymphocytic leukemia, small lymphocytic leukemia, and Waldenström macroglobulinemia, and Schrödinger's plans to engage with regulators. Statements including words such as "aim," "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "goal," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would" and statements in the future tense are forward-looking statements. These forward-looking statements reflect Schrödinger's current views about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to the company and on assumptions the company has made. Actual results may differ materially from those described in these forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and important factors that are beyond Schrödinger's control, including the uncertainties inherent in drug development and commercialization, such as the conduct of research activities and the timing of and its ability to initiate and complete preclinical studies and clinical trials, whether results from preclinical and early clinical studies will be predictive of the results of later preclinical studies and clinical trials, whether initial data from clinical results will be predictive of the final results of the clinical trials, uncertainties associated with the regulatory review of clinical trials and applications for marketing approvals and the ability to retain and hire key personnel on its business and other risks detailed under the caption "Risk Factors" and elsewhere in the company's Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission on May 7, 2025, as well as future filings and reports by the company. Any forward-looking statements contained in this press release speak only as of the date hereof. Except as required by law, Schrödinger undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, changes in expectations or otherwise. View source version on Contacts Matthew Luchini (Investors) 917-719-0636Allie Nicodemo (Media) 617-356-2325 Sign in to access your portfolio
