Sargramostim

Zenocutuzumab offers meaningful and durable antitumor activity, substantially reduced toxicity and no treatment‑limiting safety concerns, distinguishing it favorably from existing standards of care LEXINGTON, Mass., July 2, 2026 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announced that results from the cholangiocarcinoma cohort of the eNRGy trial (NCT02912949) have been published in the Journal of Clinical Oncology (JCO).1 These data supported the recent U.S. Food and Drug Administration (FDA) approval of BIZENGRI® (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. The approval was expedited by PTx's receipt of a Commissioner's National Priority Voucher (CNPV) underscoring the urgent unmet need in this patient population. "The FDA approval of BIZENGRI and the publication of these data in the Journal of Clinical Oncology highlight the clinical relevance of the eNRGy trial and reinforces our commitment to advancing therapies for patients with unmet medical needs, including those with NRG1 fusion-positive cholangiocarcinoma. The JCO publication further supports the therapeutic potential of zenocutuzumab in this rare population, which has historically experienced limited treatment options and poor outcomes with chemotherapy." — Fiona Garner, Executive Director, Clinical Development, Partner Therapeutics Data in NRG1 + Cholangiocarcinoma The eNRGy trial is a multicenter, open-label, phase 2 study evaluating zenocutuzumab in adults with advanced solid tumors harboring NRG1 gene fusions. Data published in JCO include 22 patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma, of whom 19 were evaluable for efficacy. Most patients were pre-treated, with a median of one prior line of therapy (range up to 6). Notably, RNA-based next-generation sequencing (NGS) identified 100% of NRG1 fusions, compared with 29% detected by DNA-based testing. The investigator-assessed overall response rate (ORR), defined as the proportion of patients with tumor shrinkage or disappearance, was 36.8%. Median duration of response was 7.4 months, and median progression-free survival was 9.2 months. The clinical benefit rate was 57.9%, defined as the percentage of patients achieving a complete or partial response or stable disease lasting longer than 6 months. Zenocutuzumab was generally well tolerated. Most treatment-related adverse events were grade 1-2, with diarrhea (27.3%), fatigue (18.2%), and nausea (13.6%) being reported most frequently. No patients discontinued treatment due to treatment-related adverse events. "The FDA approval of zenocutuzumab and the publication of these data represent important progress for patients with NRG1 fusion–positive cholangiocarcinoma. Limited efficacy and poor tolerability of second-line chemotherapy remain a significant clinical challenge in the treatment of patients with advanced cholangiocarcinoma. Zenocutuzumab provided meaningful tumor responses, durable clinical benefit, and a favorable tolerability profile. These findings also underscore the critical importance of comprehensive molecular testing—particularly tissue-based RNA sequencing—to reliably identify NRG1 gene fusions and ensure patients are matched with appropriate targeted therapy." — James M. Cleary, MD, PhD, Director, Clinical Research, Division of Gastrointestinal Oncology, Dana-Farber Cancer Institute; and senior author. FDA Approval in Three NRG1 + Solid Tumors BIZENGRI was first FDA approved under accelerated approval in 2024 for advanced, unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma for patients harboring an NRG1 gene fusion on or after systemic therapy. In May 2026, BIZENGRI received FDA approval for advanced, unresectable or metastatic cholangiocarcinoma for patients harboring an NRG1 gene fusion on or after systemic therapy. Additionally, zenocutuzumab is included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for non-small cell lung cancer, pancreatic adenocarcinoma, and cholangiocarcinoma. For more information on the eNRGy trial and zenocutuzumab-zbco, please visit . About NRG1 + Cholangiocarcinoma Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with an all-stage 5-year overall survival of less than 15%. NRG1 gene fusions occur in fewer than 1% of cholangiocarcinoma cases. NRG1 fusions typically occur in patients who are otherwise driver negative, leaving affected patients, many of whom are younger adults, without approved targeted therapy. Standard cytotoxic regimens carry substantial toxicity, and second-line options such as FOLFOX produce objective responses in only approximately 5% of patients. About NRG1 Gene Fusions NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activating downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1. About BIZENGRI (zenocutuzumab-zbco) INDICATIONS BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.* BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.* BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. *This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Important Safety Information BOXED WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception. WARNINGS AND PRECAUTIONS Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough. In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion. Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions. Interstitial Lung Disease/Pneumonitis BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis. In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated. Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed. Left Ventricular Dysfunction BIZENGRI can cause left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment. In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event. Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI. Embryo-Fetal Toxicity Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose. ADVERSE REACTIONS NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI (n=99). Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each). In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27%), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transferase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%). NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI (n=39). There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure. In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transferase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%). NRG1 Gene Fusion Positive Advanced, Unresectable or Metastatic Cholangiocarcinoma Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive cholangiocarcinoma who received BIZENGRI (n=22). In patients with NRG1 gene fusion positive cholangiocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased magnesium (59%), increased alanine aminotransferase (50%), fatigue (46%), decreased platelets (46%), decreased hemoglobin (41%), increased aspartate aminotransferase (41%), increased alkaline phosphatase (41%), decreased phosphate (41%), diarrhea (41%), abdominal pain (36%), musculoskeletal pain (36%), increased gamma-glutamyl transferase (36%), increased bilirubin (32%), decreased potassium (32%), decreased sodium (32%), nausea (27%), cough (27%), increased activated partial thromboplastin time (aPTT) (27%), dyspnea (23%), decreased appetite (23%), and decreased albumin (23%). Please see full Prescribing Information, including BOXED WARNING. About Partner Therapeutics Partner Therapeutics, Inc. (PTx), an integrated biotechnology company, focuses on development and commercialization of therapeutics to improve health outcomes in cancer and serious diseases, as well as global health security threats. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. PTx's portfolio includes zenocutuzumab-zbco (BIZENGRI®) and sargramostim (US: LEUKINE®; EU: IMREPLYS®; and with Nobelpharma Co. Ltd for JAPAN: SARGMALIN®). Visit . Reference: 1. Cleary JM, Springfeld C, Arnold D, et al. Efficacy and tolerability of zenocutuzumab in advanced NRG1 fusion-positive cholangiocarcinoma: Results from the eNRGy phase 2 trial. J Clin Oncol. 2026. doi:10.1200/JCO-25-03128 NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. BIZENGRI® is a registered trademark of Merus B.V., a wholly owned subsidiary of Genmab A/S. Under an agreement with Merus, PTx has exclusive rights to develop, manufacture, and commercialize zenocutuzumab-zbco for the treatment of NRG1+ cancer in the U.S. and provide the product on a named-patient basis for this use outside of the U.S. pending future regulatory developments. PARTNER THERAPEUTICS®, LEUKINE®, and IMREPLYS® are registered trademarks owned by Partner Therapeutics, Inc. ©2026 Partner Therapeutics, All rights reserved. SOURCE Partner Therapeutics, Inc. 21% more press release views with Request a Demo

Cross-Agency Discussion Highlights Interest in Oral Formulation as Field-Deployable Medical Countermeasure SAN ANTONIO, May 19, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO), a late-stage innate immunotherapeutics company, today announced that it presented Entolimod for acute radiation syndrome (ARS) to senior officials from the U.S. Department of War and the Biomedical Advanced Research and Development Authority (BARDA) in a joint briefing held on May 14, 2026. The session was Valion Bio's second engagement with senior Department of War officials, following the Company's April 28, 2026, Pentagon briefing on Entolimod. We believe the cross-agency engagement reflects continued U.S. government interest in Entolimod as a differentiated medical countermeasure for radiological threats. Agency discussion included a specific interest in an oral formulation of the Company's lead candidate, which would offer operational advantages over injectable agents in mass-casualty scenarios and support broader field deployment for the warfighter. and national stockpile integration. "This second engagement, requested by the DoW, at senior levels of the Department of War, conducted jointly with BARDA, reflects the increasing interest of Entolimod within the national radiological preparedness conversation," said Michael K. Handley, Chief Executive Officer of Valion Bio. "Cross-agency interest at this level signals that policymakers recognize the strategic importance of a differentiated, dual-tissue radiation countermeasure, and the specific focus on a potential oral formulation underscores the operational realities of field deployment and stockpile readiness that our platform is positioned to address." Entolimod is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling to stimulate bone marrow and protect gastrointestinal tissues following ionizing radiation exposure — a dual-tissue mechanism not available in currently stockpiled countermeasures. Unlike Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), which target hematopoietic recovery alone, Entolimod addresses the gastrointestinal damage that is often the limiting factor for survival at higher radiation doses. Valion Bio is working to advance both injectable and oral transmucosal formulations of Entolimod to support a broad range of deployment scenarios. The May 14 briefing follows prior Valion Bio engagements with BARDA, the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Company's selection for the Department of War's Tech Watch program. To date, over $140 million has been invested in the Entolimod program, including approximately $35.6 million in non-dilutive U.S. government funding. The compound has been evaluated in 42 non-human primate studies and administered to approximately 300 human subjects, demonstrating a well-characterized safety and efficacy profile. "The current geopolitical environment continues to elevate radiological preparedness on the national security agenda, and we are seeing that reflected in the depth and frequency of our engagement with U.S. government stakeholders," Mr. Handley continued. "Our objective is straightforward: to ensure that Entolimod — and an oral formulation positioned for mass casualty and warfighter applications — is recognized and supported at the levels required to translate its differentiated profile into deployed national capability." The Company has received FDA Fast Track and Orphan Drug designations for Entolimod in acute radiation syndrome and is advancing the program toward a Biologics License Application under the FDA's Animal Rule. Strategic and Competitive Positioning Cross-agency convergence: Joint Department of War and BARDA engagement signals coordinated interest across biodefense and biomedical preparedness functions. Oral formulation focus: An oral medical countermeasure for ARS would expand operational deployment options for stockpiling, field use, and mass casualty response. Differentiated mechanism: TLR5 agonist provides dual-tissue cytoprotection versus single-target G-CSF therapies. Regulatory pathway: Animal Rule framework supports development for biodefense applications. Government validation: Approximately $35.6 million in prior federal funding and ongoing multi-agency engagement. About Entolimod for Acute Radiation Syndrome Entolimod (CBLB502) is a recombinant deletion variant of Salmonella FliC flagellin engineered to activate TLR5 selectively. Upon engagement, Entolimod likely triggers NF-κB-dependent signaling to stimulate G-CSF, PI3K, and IL-6 production, among others, to promote multi-tissue cytoprotection, and inhibit apoptosis in radiosensitive hematopoietic and gastrointestinal tissues. The compound has demonstrated survival benefit as both a radioprotectant and a radiomitigant in controlled non-human primate studies under the FDA's Animal Rule. About Valion Bio, Inc. Valion Bio, Inc. (Nasdaq: VBIO), the new corporate identity of Tivic Health Systems, Inc., is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The Company's lead candidate, Entolimod for acute radiation syndrome (ARS), has been extensively studied and has demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule. Entolimod is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Entolimod for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Valion Bio is also advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Valion Bio's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development and manufacturing organization (CDMO) that provides biomanufacturing services to third-party biotech companies. Valion Bio also leverages Velocity Bioworks' manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes, and supply chain security. For more information, visit . Forward-Looking Statements This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim, "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Valion Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the continued interest of BARDA and other U.S. government agencies in Entolimod; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; changes to the company's business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Valion Bio's filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026, under the heading "Risk Factors", as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law. Investor + Media Contact: Rich Cockrell CG Capital [email protected] SOURCE Valion Bio, Inc. 21% more press release views with Request a Demo