Exelixis initiated dose-escalation stage of first human Phase 1 study of XB628
Invenra 'announced that its collaboration partner, Exelixis (EXEL), has initiated the dose-escalation stage of the first-in-human Phase 1 clinical study of XB628 in participants with recurrent advanced or metastatic solid tumors. XB628 is a first-in-class bispecific antibody natural killer cell engager that targets NK group 2 member A, an inhibitory receptor on NK cells, and programmed cell death-ligand 1. The molecule was discovered in part through a collaboration between Exelixis and Invenra.'
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Business Wire
13 hours ago
- Business Wire
ASCO Report of Pioneering Treatment of Lymphopenia with Significant Overall Survival Benefit in Advanced Pancreatic Cancer
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced results presented at ASCO 2025 of the first known treatment for lymphopenia with ANKTIVA and CAR-NK therapy. This data supports that reversal of lymphopenia, a well-established root cause of early mortality in patients with cancer across all tumor types, correlates with significant improved survival. While anemia and neutropenia have long been addressed by agents like Epogen and Neupogen, no therapy has ever existed for lymphopenia—until now. ANKTIVA (nogapendekin alfa inbakicept-pmln), an IL-15 superagonist approved in April 2024 for BCG-unresponsive non-muscle- invasive bladder cancer carcinoma in situ with or without papillary disease, represents the first lymphocyte-stimulating agent (LSA) capable of expanding lymphocytes critical for immunogenic cell death, such as natural killer (NK) and T cells. These findings emphasize the need for a therapy to overcome treatment induced lymphopenia with higher mortality as presented at ASCO 2025 by several institutions (Abstract # 8054, Satoskar et al. and Abstract # 2663, Saleh et al.) In a single-arm QUILT-88 clinical trial of 86 participants with third-to-sixth-line metastatic pancreatic cancer with very high tumor burden (CA19-9 levels exceeding 34,000 IU/ml), for which no therapy currently exists, patients received ANKTIVA subcutaneously in combination with off-the-shelf, ex-vivo infusion of CAR-NK cells (PD-L1 t-haNK) and low dose immuno-modulating chemotherapy. This first reported study of treating lymphopenia demonstrated significant differences in median overall survival in subjects whose lymphopenia was reversed (Absolute Lymphocyte Count: ALC ≥ 1,000). In 67 out of 86 subjects, reversal of lymphopenia was achieved and median overall survival was significantly prolonged compared to those who remained in severe lymphopenia with P-value 0.005, HR: 0.46 (0.26, 0.80) in Figure 1. In subjects with lymphopenia rescue and a lower tumor burden (less than the median CA19-9 of 34,000 IU/mL), the median overall survival in these very advanced metastatic pancreatic cancer patients exceeded 10 months (Figure 2). These findings of improved survival in pancreatic cancer patients with lower tumor burden point to the potential of further prolonged overall survival in pancreatic cancer patients if treated in the first line or neoadjuvant stages of disease. Highlighting the importance of lymphopenia reversal, Oncologist published a peer-reviewed paper titled ' Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate,' demonstrating that in a patient with 2nd line metastatic pancreatic cancer treated with the full Cancer BioShield platform—including ANKTIVA, CAR-NK cells (PD-L1 t-haNK), and antigen-targeting adenoviruses—remained in remission for over six years and maintains a high quality of life at the date of this release. The expanded access authorization announced yesterday enables patients across all solid tumor types who have exhausted first-line therapy including chemotherapy, radiation, or immunotherapy to receive Anktiva as a lymphocyte stimulating agent to protect the immune system from the lymphogenic adverse effects of current standards of care. The ASCO Annual Meeting 2025 materials from ImmunityBio can be found below: Association of lymphopenia rescue and CA19-9 levels with overall survival following IL-15 superagonist N-803 and PD-L1 t-haNK chemo-immunotherapy for 3rd line or greater metastatic pancreatic cancer. Abstract Text: Poster PDF: About the Cancer BioShield™ Platform The Cancer BioShield platform is a first-in-class immunotherapy strategy designed to restore immune competence by reversing lymphopenia—the loss of functional immune cells caused by cancer itself and by conventional treatments such as chemotherapy, radiation and immunotherapy. At its core is ANKTIVA® (nogapendekin alfa inbakicept-pmln), an IL-15 agonist approved for BCG-unresponsive non-muscle-invasive bladder cancer CIS with or without papillary disease, activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells, restoring lymphocyte levels critical for immunosurveillance, immunogenic cell death, and long-term tumor control. The platform employs a multi-modal approach: In-vivo stimulation: Subcutaneous administration of ANKTIVA expands NK and T cells, boosting anti-tumor immunity. Ex-vivo targeted cytotoxicity: Off-the-shelf PD-L1 t-haNK CAR-NK cells are engineered to target and eliminate PD-L1–expressing tumor cells and immunosuppressive neutrophils (myeloid-derived suppressor cells), enhancing anti-tumor specificity and reducing immune evasion. Memory Cytokine-Enriched Natural Killer (M-ceNK) cell therapy: M-ceNK cells are developed via cytokine activation and expansion of autologous and allogeneic NK cells collected through apheresis, potentially providing long-term immune memory and sustained cytotoxic capacity. Together, these components offer a comprehensive, novel, immune-restoring therapeutic platform aimed at not only expanding effector immune cells but also overcoming tumor-mediated immune suppression to support long-term disease control. The platform's effectiveness can be tracked through universally utilized, simple complete blood count (CBC): increases in absolute lymphocyte count (ALC) reflect ANKTIVA's lymphocyte-stimulating activity, while reductions in the neutrophil-to-lymphocyte ratio (NLR) demonstrate PD-L1 t-haNK's immunosuppressive neutrophil targeting. Low ALC and high NLR levels are laboratory measurements that have been extensively reported as predictive biomarkers of poor prognosis with early mortality across all tumor types 5,6. The data presented by ImmunityBio for the first time demonstrates that improving ALC and NLR correlates with significant enhanced overall survival and clinical benefit. About Lymphopenia and Absolute Lymphocyte Count (ALC) Lymphopenia—the loss of key immune cells such as NK, CD4+, and CD8+ T cells—is a common side effect of chemotherapy 1, radiation 2,3, and some immunotherapies 4. Unlike anemia and neutropenia, which have FDA-approved treatments like EPO and Neupogen, no therapy previously existed to treat this immune cell depletion. Lymphopenia weakens the immune system, increases infection risk, and is linked to early death across many cancer types 5. Low Absolute Lymphocyte Count (ALC) is a recognized poor prognostic marker. ANKTIVA ® is the first approved therapy to restore lymphocyte levels by activating and expanding NK and T cells—without increasing immunosuppressive T regulatory cells 7. More information on lymphopenia could be found on Twitter/X @DrPatSoonShiong articles here: References: Ray-Coquard I, et al. Lymphopenia as a prognostic factor for overall survival in advanced carcinomas, sarcomas, and lymphomas. Cancer Res. 2009 Jul 1;69(13):5383-91. doi: 10.1158/ Epub 2009 Jun 23. PMID: 19549917; PMCID: PMC2775079. Chen D, et al. Absolute Lymphocyte Count Predicts Abscopal Responses and Outcomes in Patients Receiving Combined Immunotherapy and Radiation Therapy: Analysis of 3 Phase 1/2 Trials. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):196-203. doi: 10.1016/ Epub 2020 Feb 7. Pike LRG, et al. The Impact of Radiation Therapy on Lymphocyte Count and Survival in Metastatic Cancer Patients Receiving PD-1 Immune Checkpoint Inhibitors. Int J Radiat Oncol Biol Phys. 2019 Jan 1;103(1):142-151. doi: 10.1016/ Epub 2018 Sep 15. PMID: 30227198. Lee, Y.J., et al. Peripheral lymphocyte count as a surrogate marker of immune checkpoint inhibitor therapy outcomes in patients with non-small-cell lung cancer. Sci Rep 12, 626 (2022). Ménétrier-Caux C., et al. Lymphopenia in Cancer Patients and its Effects on Response to Immunotherapy: an opportunity for combination with Cytokines? J Immunother Cancer. 2019 Mar 28;7(1):85. doi: 10.1186/s40425-019-0549-5. PMID: 30922400; PMCID: PMC6437964. Templeton AJ, et al. Prognostic role of neutrophil-to-lymphocyte (NLR) ratio in solid tumors: a systematic review and meta-analysis. J Natl Cancer Inst. 2014 May 29;106(6):dju124. doi: 10.1093/jnci/dju124. PMID: 24875653. FDA ANKTIVA Label, April 2024 - About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding clinical trial data and potential results and implications to be drawn therefrom, the expectation that the EAP described herein will enable access to ANKTIVA for patients across all solid tumor types who have exhausted first-line therapy including chemo, radiation or immunotherapy, the RMAT designation as previously reported and potential results therefrom and regulatory submissions in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, the belief that improving ALC levels and NLR levels correlates with enhanced overall survival and clinical benefit, the belief that reversal of lymphopenia correlates with improved survival, clinical trial and expanded access program enrollment, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's Cancer BioShield platform, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents for the prevention or reversal of lymphopenia, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents across multiple tumor types and indications and for potential applications beyond oncology, potential regulatory pathways and the regulatory review process and timing thereof, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that has the potential to change the paradigm in cancer care, and ImmunityBio's approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as 'anticipates,' 'believes,' 'continues,' 'goal,' 'could,' 'estimates,' 'scheduled,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'predicts,' 'indicate,' 'projects,' 'is,' 'seeks,' 'should,' 'will,' 'strategy,' and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, (ii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iii) risks and uncertainties regarding commercial launch execution, success and timing, (iv) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (v) whether clinical trials will result in registrational pathways and the risks, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio's ability to retain and hire key personnel, (x) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiv) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio's business are described under the heading 'Risk Factors' in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on May 12, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof.
Yahoo
3 days ago
- Yahoo
EXEL Reports Superior Efficacy Data From Kidney Cancer Study Cohort
Exelixis EXEL announced encouraging results from an expansion cohort of the early to mid-stage study of its next-generation oral TKI, zanzalintinib, in combination with either Bristol Myers' BMY Opdivo (nivolumab) or a fixed-dose combination of nivolumab and relatlimab (Opdualag) in patients with previously untreated advanced clear cell renal cell carcinoma (RCC). The phase Ib/II STELLAR-002 study is evaluating the candidate's safety and efficacy as a monotherapy or in combination with Opdivo, Opdualag, or the Opdivo/Yervoy combo in patients with advanced solid tumors. According to data from the expansion cohort of Exelixis' STELLAR-002 study, the combination of zanzalintinib with Bristol Myers' Opdivo demonstrated an objective response rate (ORR) of 63%, while the combination with Opdualag showed an ORR of 40%. Both treatment arms achieved a disease control rate of 90%. At a median follow-up of 20.1 months for the Opdivo arm and 15.9 months for the Opdualag arm, the 12-month duration of response was 73.4% and 74.1%, respectively. Median progression-free survival was reported as 18.5 months and 13 months for the Opdivo and Opdualag combinations, respectively. EXEL shares have risen 28.7% year to date against the industry's decline of 5.6%. Image Source: Zacks Investment Research The zanzalintinib/Opdivo combo has the potential to address the unmet medical need for RCC treatments. Based on the encouraging high rate of durable responses and long progression-free survival data observed, coupled with the lack of other effective therapies in the market, the company plans to further evaluate the regimen. Treatment-emergent adverse events (TEAEs) occurred in all patients, with common grade 3/4 events, including hypertension, diarrhea and liver enzyme elevations in both treatment arms. Two grade 5 TEAEs were reported per arm (none treatment-related). Study drug discontinuation due to TEAEs was observed in 8% and 20% of patients in the Opdivo and Opdualag combination arms, respectively. Exelixis shared additional data from several cohorts in the phase Ib/II STELLAR-002 study, evaluating different dose combinations of zanzalintinib with Bristol Myers' Opdivo or Opdualag in patients with advanced solid tumors. Colorectal and prostate cancers were most common among patients receiving zanzalintinib with Opdivo, while RCC was the most frequent tumor type in the Opdualag cohorts. The combination therapies showed a manageable safety profile consistent with the individual agents. Early safety, efficacy, and pharmacokinetic data supported the selection of the 100 mg zanzalintinib dose for the ongoing expansion cohorts. Please note that Bristol Myers' Opdivo is approved, both as a monotherapy and in combination with Yervoy, to treat a plethora of cancer indications in many countries, including the United States and the European Union. BMY's Opdualag is also currently approved in the United States and the EU for treating unresectable or metastatic melanoma. Exelixis, Inc. price-consensus-chart | Exelixis, Inc. Quote Exelixis currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Bayer BAYRY and Amarin AMRN, each carrying a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Bayer's earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 41.8%. BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. In the past 60 days, estimates for Amarin's loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 13.3%. AMRN's earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
The Verge
4 days ago
- The Verge
Young people sue Donald Trump over climate change
A group of young people — as young as 7 and as old as 25 — are suing the Trump administration to stop its assault on renewable energy and climate action. Executive orders President Donald Trump signed to promote fossil fuels amount to an 'unconstitutional' overreach of power, they allege in a complaint filed Thursday at a US District Court in Montana. The 22 plaintiffs also claim that by increasing pollution and denying climate science, the president's actions violate their Fifth Amendment rights to life and liberty. It's the latest high-profile case brought against governments by youth concerned about how fossil fuel pollution and climate change poses risks to their health and ability to thrive as they grow up. Two brothers, aged 11 and 7, 'were born into climate change-induced smoke seasons that did not exist for older generations' Two brothers, aged 11 and 7 and named 'J.K.' and 'N.K.' in the suit, 'were born into climate change-induced smoke seasons that did not exist for older generations and which compromise their health,' the complaint says. They grew up mostly in Montana but now live in Southern California, and the suit says wildfire smoke has encroached on their lives from state to state. J.K. was born with an abnormal mass of lung tissue and 'experienced nosebleeds, sore throats, headaches, tiredness, coughing, trouble breathing, and eye irritation from wildfire smoke,' according to the suit. N.K. has 'frequent' upper respiratory infections that have led to emergency room visits. They've both missed school days and camp because of feeling sick from smoke and soot in the air from wildfires, it says. Greenhouse gas emissions from fossil fuels trap heat, and rising temperatures have contributed to longer fire seasons in the western US. With hotter, drier conditions, the area burned by forest fires in the western US doubled between 1984 and 2015. 'Every additional ton of [greenhouse gas] pollution and increment of heat Defendants cause will cause J.K. and N.K. more days of poor air quality, more smoke, and thus, more harm to their lives, health, and safety,' the complaint adds. In recent years, scientists have been trying to better understand the long-term health impact of wildfire smoke, which previously hadn't been studied as thoroughly as pollution from other sources thought to be more consistent problems, like factories and highways. Now, chronic exposure to wildfire smoke is a growing concern. Wildfire smoke is considered a neurotoxin estimated to be more harmful than other common air pollutants, but its effects on the body can vary depending on what kinds of materials burn and how chemicals released by the fire interact with other substances in the atmosphere. After campaigning on a promise to ' drill, baby, drill ' and accepting more than $75 million in contributions from oil and gas interests, Trump signed executive orders on his first day in office declaring a purported 'national energy emergency,' directing federal agencies to 'unleash' domestic fossil fuel production and promote the use of gas-powered vehicles over EVs. He signed another executive order to 'reinvigorat[e]' the coal industry in April. Coal releases more planet-heating pollution when burned than other fossil fuels and has struggled to compete with cheaper sources of electricity. The plaintiffs are seeking injunctive relief to block implementation of those executive orders and to declare them unconstitutional. They also claim that Trump lacks the authority to erode environmental protections passed by Congress under the Clean Air Act. The administration's efforts to impede scientific research and remove climate information from federal websites amounts to 'censorship' and denies plaintiffs access to resources they might otherwise be able to use to minimize risks they face from climate change, the suit alleges. In response to the lawsuit, White House assistant press secretary Taylor Rogers said in an email to The Verge, 'The American people are more concerned with the future generations' economic and national security, which is why they elected President Trump in a landslide victory to restore America's energy dominance. Future generations should not have to foot the bill of the lefts' radical climate agenda.' The plaintiffs, who hail from Montana, Oregon, Hawai'i, California, and Florida, are represented by the nonprofit law firm Our Children's Trust, which has also represented young people in similar climate cases. A federal appellate court dismissed another case that youth filed against the Obama administration in 2015 over fossil fuel pollution causing climate change, and the US Supreme Court ended that legal battle this year when it declined to hear an appeal. But there have also been some wins. A group of youth reached a settlement last year with the state of Hawai'i and its Department of Transportation that commits them to a plan to reach zero greenhouse gas emissions from transportation by 2045. J.K. and N.K. were also plaintiffs in a climate suit filed against the state of Montana. Last year, Montana's Supreme Court upheld a district judge ruling affirming their right to a clean and healthy environment and rejecting policies that had barred officials from considering the consequences of climate change when permitting new energy projects.
