Latest news with #TIGIT
Yahoo
29-05-2025
- Business
- Yahoo
Cancer drugmaker iTeos to shut down
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company's assets and intellectual property rights. ITeos has for years struggled to develop a cancer treatment that sufficiently impressed investors and its pharmaceutical partners. Two weeks ago, it said it was shelving its most advanced drug prospect, a TIGIT-targeting treatment developed with GSK. The immuno-oncology developer is the latest biotechnology company considering merger prospects or liquidatation of its assets this year. Others such as Cargo Therapeutics and Third Harmonic Bio have made their own plans to dissolve. Investors are increasingly scrutinizing 'zombie' biotechs, pressuring their executive teams to shut down and return capital to shareholders after their primary development efforts fail. Typically, struggling companies have turned to mergers or pivoted to new programs to justify holding onto their cash reserves. Activist investors and analysts have argued they should give that money back to their investors instead. A new investment fund launched in April with the intention of liquidating billions of dollars in cash "trapped" on the balance sheets of nearly 300 public biotechs whose share prices have fallen significantly. 'Cash that was raised through an efficient capital process to fund specific projects ... is now being allocated by a few insiders and spent on programs that investors are not willing to support,' Cantor Fitzgerald analyst Eric Schmidt wrote in a February note explaining how the goals of executive teams and investors can diverge in the wake of clinical setbacks. He specifically highlighted biotechs Cargo, BioAge Labs and Keros Therapeutics. ITeos fits a similar mold. It developed an immunotherapy with Pfizer in the mid-2010s, but the pharma giant handed back rights to development in 2018 after the drug's promise faded. A few years later, iTeos brokered a deal with GSK to develop a so-called TIGIT drug for use in combination with cancer immunotherapies. Testing of that candidate was stopped in mid-May after study results showed the drug regimen failed to significantly delay tumor progression in non-small cell lung cancer. Data showed a 'trend below the meaningful threshold' for drug responses in study participants with other cancers, iTeos said. At the time, iTeos CEO Michel Detheux said: 'We believe the best path forward is to promptly evaluate a full range of strategic alternatives to unlock the value of our assets.' According to a regulatory filing Wednesday, iTeos plans to spend as much as $24.7 million in severance and other layoff costs, as well as another $11.1 million to wind down clinical development activities and terminate leases and other contracts. It expects to complete that by the third quarter of 2025. As of March 31, iTeos held $156.5 million in cash and cash equivalents. Recommended Reading iTeos, GSK to shelve TIGIT drug after study setback Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-05-2025
- Business
- Yahoo
Arcus Biosciences Announces New Employment Inducement Grants
HAYWARD, Calif., May 27, 2025--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today announced that the Compensation Committee of the Company's Board of Directors granted two new employees options to purchase a total of 13,400 shares of the Company's common stock at an exercise price per share of $9.02, which was the closing price on May 23, 2025, and restricted stock units to acquire a total of 13,400 shares of the Company's common stock. The equity awards were granted pursuant to the Company's 2020 Inducement Plan, which was approved by the Company's Board of Directors in January 2020 pursuant to the "inducement exception" under NYSE Listed Company Manual Rule 303A.08. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, A2a/A2b receptors, CD39 and AXL. For more information about Arcus Biosciences's clinical and preclinical programs, please visit Inducement PR Source: Arcus Biosciences View source version on Contacts Investor Inquiries: Pia EavesVP of Investor Relations & Strategy(617) 459-2006peaves@ Media Inquiries: Holli KolkeyVP of Corporate Communications(650) 922-1269hkolkey@ Maryam BassiriAD, Corporate Communications(510) 406-8520mbassiri@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-05-2025
- Business
- Yahoo
Compugen Ltd (CGEN) Q1 2025 Earnings Call Highlights: Strategic Advances Amid Revenue Decline
Cash Balance: Approximately $103.7 million as of March 31, 2025. Revenue: Approximately $2.3 million for Q1 2025, compared to $2.6 million in Q1 2024. R&D Expenses: Approximately $5.8 million for Q1 2025, compared to $6.4 million in Q1 2024. G&A Expenses: Approximately $2.4 million for both Q1 2025 and Q1 2024. Net Loss: Approximately $7.2 million or $0.08 per share for Q1 2025, compared to $7.3 million or $0.08 per share in Q1 2024. Cash Runway: Expected to fund operating plans into 2027. Warning! GuruFocus has detected 3 Warning Signs with CGEN. Release Date: May 19, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Compugen Ltd (NASDAQ:CGEN) has initiated a sub-trial for their anti-PVRIG antibody COM701 in ovarian cancer, targeting an unmet medical need. The company has a strong cash position with a runway extending into 2027, supporting their clinical and research activities. Compugen Ltd (NASDAQ:CGEN) is advancing its early-stage and clinical immuno-oncology pipeline, focusing on innovative therapies. Partnership with AstraZeneca is progressing, with multiple Phase 3 trials initiated, potentially leading to significant revenue opportunities. The company is exploring novel mechanisms of action in their early-stage pipeline, aiming to enhance anticancer immunity. Revenues for the first quarter of 2025 decreased compared to the same period in 2024. The company reported a net loss of approximately $7.2 million for the first quarter of 2025. There is uncertainty in the TIGIT landscape, with previous Phase 3 failures impacting market sentiment. The success of Compugen Ltd (NASDAQ:CGEN)'s TIGIT program is contingent on positive outcomes from upcoming Phase 3 trials. The competitive landscape in ovarian cancer is evolving, with new therapies potentially impacting Compugen Ltd (NASDAQ:CGEN)'s strategy. Q: Merck's KEYNOTE-B96 Phase 3 study in pembrolizumab for platinum-resistant ovarian cancer was successful. How might this impact your strategy in ovarian cancer? A: Michelle Mahler, Chief Medical Officer: The study is in a different setting, but it shows benefit from adding an immune checkpoint inhibitor. If our study demonstrates activity, it could open opportunities to combine COM701 in broader populations. Q: What is your interpretation of Roche's SKYCRAPER-01 data, and how does it affect your confidence in TIGIT antagonism? A: Eran Ophir, Vice President - Research, Drug Discovery: Despite the failure, we see numerical activity in TIGIT trials. The Fc active format may have contributed to high discontinuation rates. We believe Fc inactive antibodies, like ours, may offer safety and efficacy advantages. Q: Do you plan to collect data on tumor microenvironment features in the COM701 study? What PFS benefit would be clinically meaningful in the maintenance setting? A: Michelle Mahler, Chief Medical Officer: We will collect data on the tumor microenvironment but won't disclose details. An improvement of around three months in progression-free survival would be clinically meaningful. Q: Have you observed activity of COM701 in PD-L1 positive patients, and what are your thoughts on PD-1 VEGF bispecifics? A: Michelle Mahler, Chief Medical Officer: We see activity in both PD-L1 positive and negative patients. Eran Ophir, Vice President - Research, Drug Discovery: VEGF increases T cell infiltration, complementing PVRIG biology. Fc inactive TIGIT may be preferable for combinations due to safety concerns. Q: What are your thoughts on the potential synergy between TIGIT, PD-1, and VEGF inhibitors? A: Eran Ophir, Vice President - Research, Drug Discovery: VEGF can enhance T cell infiltration, aligning with PVRIG biology. While we haven't published data, combining with Fc inactive TIGIT could be advantageous due to safety profiles. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
13-05-2025
- Business
- Yahoo
iTeos Reports Topline Interim Results from GALAXIES Lung-201 Study of Belrestotug + Dostarlimab in First-Line, PD-L1 High Non-Small Cell Lung Cancer Patients
– GALAXIES Lung-201 did not meet established criteria for clinically meaningful improvements in progression free survival – Based on totality of data, iTeos and GSK have agreed to terminate the belrestotug development program – iTeos has initiated a targeted review of strategic alternatives to maximize shareholder value WATERTOWN, Mass. and GOSSELIES, Belgium, May 13, 2025 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today reported topline results from an updated interim analysis of GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos' development partner GSK assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC). The GALAXIES Lung-201 data continued to demonstrate clinically meaningful improvements in the trial's primary endpoint of objective response rate (ORR), however the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression free survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy. Additionally, an interim analysis of the GALAXIES H&N-202 Phase 2 trial showed a trend below the meaningful threshold for ORR in the belrestotug combination cohorts vs. dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma. Based on these results, iTeos and GSK have made the decision to terminate the belrestotug development program and end the collaboration. All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial is ending. GSK is communicating with investigators, institutional review boards, ethics committees, and health authorities about next steps for appropriate management of currently enrolled patients. The Company is taking immediate steps to preserve capital and has initiated a targeted process to identify opportunities that preserve and maximize shareholder value. iTeos has engaged TD Cowen to advise on this process. 'We are truly disappointed by the results from GALAXIES Lung-201,' said Michel Detheux, Ph.D., president and chief executive officer of iTeos. 'Following the analysis of the TIGIT data generated to-date with GSK, we have made the mutual decision to discontinue development of all ongoing TIGIT studies. We are grateful to all patients, caregivers, and investigators involved in the GALAXIES studies and believe it is important to share these data with the scientific community at an upcoming medical meeting in order to advance our collective understanding of immuno-oncology and TIGIT.' 'Since founding this company over a decade ago, I could not be prouder of the team we have built, the quality of science produced, and our collective commitment to improving the lives of cancer patients in need. However, given current market conditions and our appreciation of the responsibility to our valued shareholders, we believe the best path forward is to promptly evaluate a full range of strategic alternatives to unlock the value of our assets. With a strong balance sheet and a commitment to disciplined execution, we are well positioned to pursue opportunities that maximize shareholder value,' continued Dr. Detheux. About iTeos Therapeutics, Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium. About Belrestotug (EOS-448/ GSK4428859A) Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of adaptive and innate immune responses against cancer. As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC). Forward-Looking StatementsThis press release contains forward-looking statements. Any statements that are not solely statements of historical fact are forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to iTeos' steps to preserve capital and review and identify opportunities to maximize shareholder value. These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos' control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: risks relating to volatility and uncertainty in the capital markets for biotechnology companies; whether iTeos will be able to identify opportunities to maximize shareholder value and whether iTeos will be able to execute on such opportunities on attractive terms or timing, or at all; whether any capital preservation strategies undertaken will be effective; and those risks identified under the heading 'Risk Factors' in iTeos' Annual Report on Form 10-K for the period ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by iTeos which you are encouraged to review. Any of the foregoing risks could materially and adversely affect iTeos' business, results of operations and the trading price of iTeos' common stock. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements other than as required by law. CONTACT: For further information, please contact: Investor Contact: Carl Mauch iTeos Therapeutics, Inc. Media Contact: media@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
05-05-2025
- Health
- Medscape
Tiragolumab/Atezolizumab Shows No Benefit in NSCLC
A trial testing the combination of the anti-TIGIT antibody tiragolumab and atezolizumab vs atezolizumab in previously untreated programmed cell death ligand 1 (PD-L1)–high locally advanced unresectable or metastatic non–small cell lung cancer (NSCLC) failed to meet its primary endpoints. Although the SKYSCRAPER-01 trial did not meet its primary endpoints, numerical advantages observed with the tiragolumab/atezolizumab combination suggest that TIGIT remains a potentially valid target in NSCLC, said Solange Peters, MD, PhD, during her presentation of the new results at the American Association for Cancer Research (AACR) Annual Meeting 2025. 'More data are needed to identify the patient population who potentially could benefit from combining an anti–PD-L1 strategy with the inhibition of the TIGIT pathway,' she said during her talk. Peters, of the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, described the importance of checkpoint inhibitors in the management of advanced NSCLC without actionable genomic alterations, particularly in patients with high PD-L1 expression. However, she noted that most patients, 'probably more than 85%,' eventually experience disease progression. According to Peters, this high rate of progression despite treatment indicates an unmet need for new treatment options for this patient population. Peters explained that TIGIT, a T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine–based activation motifs domains, has emerged as a promising immune checkpoint target. TIGIT binds to poliovirus receptor (PVR), also called CD155, on cancer cells and antigen-presenting cells, inhibiting the immune activity of T cells and natural killer cells. 'In lung cancer cells, tumor-infiltrating lymphocytes, particularly exhausted CD8+ T cells, may express high levels of TIGIT and PD-1,' Peters noted during her presentation. 'Therefore, a human anti-TIGIT monoclonal antibody that blocks TIGIT binding to PVR could restore the interaction between CD226 and PVR, allowing activation of T cells and NK cells.' Study Design SKYSCRAPER-01 was a phase 3, double-blind, placebo-controlled, randomized trial that recruited patients between March 2020 and August 2021 at 122 sites across 20 countries. The study enrolled patients with previously untreated, locally advanced, unresectable, or metastatic NSCLC with high PD-L1 expression, good performance status (ECOG 0-1), and without EGFR / ALK alterations. Patients were randomized 1:1 to receive either tiragolumab 600 mg intravenously (IV) plus atezolizumab 1200 mg IV or placebo plus atezolizumab 1200 mg IV every 3 weeks until disease progression or loss of clinical benefit. The final analysis included 534 randomized patients. The primary endpoint was investigator-assessed progression-free survival (PFS) and overall survival (OS) in the primary analysis set, which included patients with PD-L1 tumor proportion score ≥ 50%, as determined with the 22C3 assay. Secondary endpoints included investigator-assessed objective response rate (ORR) and investigator-assessed duration of response (DOR) in the primary analysis set, as well as OS in the secondary analysis set (patients with PD-L1 tumor cell ≥ 50%, as determined using the SP263 assay). No Significant Benefit With Tiragolumab Plus Atezolizumab At the data cutoff in March 2022, the median investigator-assessed PFS was 7.0 months with tiragolumab plus atezolizumab vs 5.6 months with placebo plus atezolizumab (hazard ratio [HR], 0.78; 95% CI = 0.63-0.97; P = .02). Although there was a slight numerical difference in the median PFS between the groups, this difference did not meet the prespecified significance threshold of P < .01. At the final OS analysis (data cutoff September 2024), the median OS was 23.1 months with tiragolumab plus atezolizumab vs 16.9 months with placebo plus atezolizumab (HR, 0.87; 95% CI = 0.71-1.08; P = .22). Patients in the tiragolumab plus atezolizumab arm showed a higher ORR (45.8% vs 35.1%) and longer median DOR (18.0 months vs 14.6 months). Peters said that although the primary endpoints of investigator-assessed PFS and OS were not met, 'numerical improvements in both PFS and OS with tiragolumab plus atezolizumab versus placebo plus atezolizumab suggest potential antitumor activity of combination PD-L1/TIGIT targeting in NSCLC.' Safety Profile Safety analysis revealed increased toxicity with combination therapy. The median treatment duration was 7.5 months in the experimental arm vs 5.5 months in the control arm. The rates of any-grade toxicity, adverse events related to any treatment, adverse events leading to treatment withdrawal, and immune-related adverse events were all higher in the experimental arm than in the control arm. The most frequent adverse events in the tiragolumab plus atezolizumab arm were pruritus, rash, decreased appetite, cough, and anemia. Immune-mediated adverse events observed in more than 5% of patients included rash, hepatitis, hypothyroidism, infusion-related reactions, hyperthyroidism, adrenal insufficiency, and pneumonitis. Expert Perspective: What Went Wrong? In his discussion session, Ramaswamy Govindan, MD, of Washington University School of Medicine, St. Louis, provided context for the SKYSCRAPER-01 results, which he described as 'disappointing.' Govindan compared SKYSCRAPER-01 with the earlier phase 2 CITYSCAPE study, which yielded positive results and provided the rationale for the phase 3 trial. 'If you look at the combination arm, the response rates in SKYSCRAPER-01 are a little lower, the PFS is half of what was seen in the CITYSCAPE study, and OS is much less impressive,' he said. On the contrary, the atezolizumab arm in the two trials was 'roughly the same.' Govindan pointed out several differences between the populations in the two studies, including a higher proportion of participants with liver and brain metastases and a greater proportion of men in the SKYSCRAPER-01 study. He also highlighted the sample size issue, noting, 'Although the CITYSCAPE results were promising, findings were based on a small number of patients.' He further explained that the study had a population of 67, and only about half had PD-L1 ≥ 50%. Govindan stated that variations in cohort sizes and characteristics, as well as differences in tumor biology and the tumor microenvironment, also could have contributed to the discrepancies in the findings of the two studies. Future Directions for TIGIT Inhibitors Despite these setbacks, both Peters and Govindan emphasized that the TIGIT pathway remains an interesting target, with other TIGIT inhibitors still under development, including domvanalimab, rilvegostomig, and belrestotug. Govindan also said that not all TIGIT inhibitors are the same and that there is a controversy in the TIGIT field about 'whether we should keep' the fragment crystallizable region of the monoclonal antibody (Fc) 'active,' meaning able to engage Fc receptors and potentially trigger antibody-dependent cellular cytotoxicity, or 'inactive,' meaning engineered to minimize Fc receptor engagement. Govindan also discussed the importance of biomarker development, noting, 'We should look at biomarkers before we say that TIGIT-targeted therapies do not work.' He explained that in the CITYSCAPE study, an agnostic approach was used, and transcriptomic studies showed tumor-associated macrophages, Tregs, and monocytes as potential biomarkers of response. He added that 'tumors that were enriched in macrophages, monocytes, and Tregs did well with the TIGIT combination,' suggesting that these could serve as markers for better patient selection. Peters reported financial relationships with Lausanne University/Centre Hospitalier Universitaire Vaudois (employment), AbbVie, Amgen, Arcus, AstraZeneca, Bayer, BeiGene, BioNTech, BerGenBio, Bicycle Therapeutics, Biocartis, Biolnvent, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly and Company, F-Star, Foundation Medicine, Genmab, Genzyme, Gilead Sciences, GSK, HUTCHMED, Illumina, Incyte, Ipsen, iTeos Therapeutics, Janssen, Qlucore, Merck Sharp & Dohme, Merck Serono, Merrimack, Mirati, Nuvation Bio, Nykode Therapeutics, Novartis, Novocure, PharmaMar, Promontory Therapeutics, Pfizer, Regeneron, Roche/Genentech, Sanofi, Seattle Genetics, Takeda, and Zymeworks. Govindan reported financial relationships with Washington University School of Medicine (employment) and Amgen, Verastem, MOMA Therapeutics, and Prelude Therapeutics.
