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Associated Press
7 days ago
- Business
- Associated Press
Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer
Pasritamig, a first-in-class bispecific T-cell-engaging antibody, shows potential in mCRPC with outpatient dosing designed for the community setting Data show low rates of treatment-related adverse events, signaling human kallikrein 2 (KLK2) as a novel, highly specific target CHICAGO, June 1, 2025 /PRNewswire/ -- Johnson & Johnson announced today new data from a Phase 1 study evaluating pasritamig (JNJ-78278343), a first-in-class bispecific antibody that activates T-cells to harness the body's immune system against prostate cancer cells, showing promise in patients with advanced disease who have progressed after multiple lines of therapy. These first data on pasritamig, from the first-in-human study, demonstrate that pasritamig appears well-tolerated and exhibits a promising antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC), highlighting the potential of KLK2 as a novel target for T-cell engagement in advanced disease.1 These data were presented as an oral presentation (Abstract #5017) at the 2025 American Society of Clinical Oncology Annual Meeting and published simultaneously in The Journal of Clinical Oncology. Pasritamig is a novel T-cell engager designed to bind both CD3 on T-cells and KLK2—a prostate-specific antigen with minimal expression outside of the prostate. Pasritamig activates T-cells by binding to CD3 and directing them to KLK2- expressing tumor cells, engaging the body's immune system to specifically target these cancerous cells. This differentiated approach aims to deliver a targeted treatment for patients with advanced prostate cancer, while potentially reducing the high-grade toxicities historically associated with T-cell engagers. 'These first-in-human results for pasritamig are highly encouraging, demonstrating that KLK2 is a viable target for T-cell engagers in metastatic castration-resistant prostate cancer,' said Capucine Baldini*, M.D., Ph.D., Drug Development Department (DITEP), Institut Gustave Roussy, and presenting author. 'The data show a promising safety profile, with manageable adverse events and no AEs leading to treatment discontinuations or ICANS observed, with 40 percent of patients having no treatment-related AEs at all. Given the limited treatment options for mCRPC, these findings support further investigation of pasritamig and the role of KLK2-targeted T-cell therapies as a potential new approach for patients with aggressive disease.' 'Metastatic castration-resistant prostate cancer remains one of the most difficult stages of prostate cancer to treat, particularly for patients who haven't responded well to previous treatments,' said Jeff Infante, M.D., Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine. 'This investigational approach underscores our commitment to developing innovative and practice-changing medicines that are well-tolerated and can be easily administered in community practice settings.' The Phase 1 first-in-human study ( NCT04898634 ) evaluated 174 patients with ages ranging from 36 to 89 years old and on average having received four prior therapies (range 1-13). The recommended phase 2 dose (RP2D) of pasritamig was 3.5mg on day 1, 18mg on day 8, 300mg intravenously on day 15 and then once every six weeks. The RP2D safety group also included patients treated once every three weeks as the toxicity profiles were very similar. The RP2D efficacy group only included patients treated at the RP2D once every six weeks.1 Within the RP2D safety group (n=45), treated once every three or six weeks, 100 percent had previously received androgen receptor pathway inhibitors, 75.6 percent had undergone taxane chemotherapy, and 37.8 percent had been treated with Lutetium 177 vipivotide tetraxetan prostate-specific membrane antigen radioligand therapy.1 The most common treatment- related adverse events (TRAEs) were Grade 1/2 infusion-related reactions (24.4 percent), Grade 1 cytokine release syndrome (CRS) presenting as fever only (8.9 percent, no steroid or tocilizumab was administered) and no reports of higher grade CRS. No TRAEs leading to treatment discontinuation or dose reduction were reported and no immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. Grade 3 TRAEs were infrequent with 4.4 percent of patients reporting transient AST/ALT increases and neutropenia. There were no dose-limiting toxicities reported. The favorable safety profile of the RP2D regimen enabled convenient outpatient administration on a patient-friendly, once-every-six-weeks schedule.1 Of the patients in the RP2D efficacy group (n=33), treated once every six weeks, 42.4 percent achieved a 50 percent or greater reduction in their prostate-specific antigen (PSA) levels with a median rPFS of 7.9 months (95 percent confidence interval [CI] 2.9, not estimable [NE]) and 21.2 percent of patients continuing therapy. Treatment with pasritamig showed durable disease control and rPFS that compares favorably to historical data in heavily pretreated patients with mCRPC.1 Metastatic castration-resistant prostate cancer occurs in a significant portion of prostate cancer patients, with many progressing despite initial therapies.2 Overall survival from diagnosis of mCRPC patients ranges from 13.5 to 31.6 months, and lower in patients who have progressed on therapy.3 Treatment options remain limited, underscoring the urgent need for safer and more effective therapies.4 About Pasritamig (JNJ-78278343) Pasritamig (JNJ-78278343) is an investigational T-cell-engaging bispecific antibody (bsAb) targeting human kallikrein 2 (KLK2) on prostate cancer cells and CD3 on T-cells. This approach is being evaluated in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC), a patient population with limited treatment options. About Metastatic Castration-Resistant Prostate Cancer (mCRPC) Metastatic castration-resistant prostate cancer (mCRPC) is a challenging and aggressive stage of prostate cancer where the disease progresses despite androgen deprivation therapy.2 Patients often experience metastasis to bones and lymph nodes, leading to poor outcomes and limited treatment options, including chemotherapy and second-line hormone therapies.5 The median overall survival ranges from 13.5 to 31.6 months depending on the site of metastasis, with a typical range of 15–36 months across the broader population.3,6 Survival rates can vary significantly depending on factors such as prior treatment history, disease burden, and response to therapy. The need for more effective treatments is critical, as the disease continues to impact a large number of men globally, with mCRPC being responsible for a substantial number of prostate cancer-related deaths. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of JNJ-78278343. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Source: Johnson & Johnson *Dr. Capucine Baldini has provided consulting, advisory, and speaking services to Johnson & Johnson; Dr. Baldini has not been paid for any media work. 1 Baldini, C., et al. Phase 1 Study Results of Pasritamig (JNJ-78278343) in Metastatic Castration-Resistant Prostate Cancer. 2025 American Society of Clinical Oncology Annual Meeting. June 2025. 2 Scher, H. I., et al. (2016). 'Treatment of castration-resistant prostate cancer: Current and future strategies.' Nature Reviews Clinical Oncology, 13(10), 577-590. 3 Wallace KL, Landsteiner A, Bunner SH, Engel-Nitz NM, Luckenbaugh AN. Increasing prevalence of metastatic castration-resistant prostate cancer in a managed care population in the United States. Cancer Causes Control. 2021;32(12):1365-1374. doi:10.1007/s10552-021-01484-4 4 Ravi P, Mateo J, Lorente D, et al. Clinical prognostic factors and management of metastatic castration-resistant prostate cancer: a population-based study. PLoS One. 2015;10(10):e0139440. doi:10.1371/ 5 Ryan, C. J., et al. (2015). 'Abiraterone acetate in metastatic prostate cancer: A new era.' Journal of Clinical Oncology, 33(10), 1051-1060. 6 Kawahara, T., Saigusa, Y., Yoneyama, S. et al. Development and validation of a survival nomogram and calculator for male patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate and/or enzalutamide. BMC Cancer 23, 214 (2023). View original content to download multimedia: SOURCE Johnson & Johnson
Associated Press
28-05-2025
- Business
- Associated Press
ASCO 2025: XOFIGO® (radium-223 dichloride) Combination Data Showcases Clinical Benefits in Metastatic Castration-Resistant Prostate Cancer with Bone Metastases
WHIPPANY, N.J.--(BUSINESS WIRE)--May 28, 2025-- New data from two clinical trials evaluating XOFIGO ® (radium-223 dichloride) in patients with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases will be presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting on June 3, 2025. The studies in prostate cancer treatment with XOFIGO, offer potential new insights for patients with mCRPC with bone metastases. XOFIGO is indicated for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease. 1 It is the first and only alpha emitting radiopharmaceutical that treats bone metastases in mCRPC approved by the U.S. Food and Drug Administration (FDA). An analysis from the pivotal Phase III PEACE III trial, evaluating XOFIGO in combination with enzalutamide, an androgen receptor pathway inhibitor (ARPI), showed that adding six cycles of XOFIGO to enzalutamide improved prostate-specific antigen (PSA) and alkaline phosphatase (ALP) response rates. 2 Notably, PSA response rates ≥90% at 6 and 12 months were 50.5% and 54.9%, respectively, in the combination arm compared to 34.1% and 37.6%, respectively, in the enzalutamide arm alone. 2 The analysis also showed that for XOFIGO in combination with enzalutamide the median time to ALP normalization was 1.97 months compared to 4.47 months in the enzalutamide arm (HR 1.42; 95% CI, 1.13-1.80). 2 The analysis follows the presentation of the full results from the PEACE III trial, presented as a late-breaking abstract during the Presidential Symposium at ESMO 2024. 3 The results demonstrated that the addition of XOFIGO to enzalutamide significantly increased radiological progression-free survival (rPFS) among patients with mCRPC with bone metastases, with a 31% reduction in the risk of progression or death (HR 0.69; 95% CI, 0.54-0.87; p=0.0009) compared to enzalutamide alone. 3 At the preplanned interim analysis conducted at 80% of the overall survival (OS) events, the hazard ratio (HR) for OS was 0.69 (95% CI 0.52-0.90; p=0.0031). The safety results were consistent with the established safety profile of XOFIGO, although authors noted the importance of administering bone protective agents (BPAs) to avoid fractures. 3 The trial was a collaboration between the European Organization for Research and Treatment of Cancer (EORTC), Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and French UNICANCER Urogenital Tumor Study Group (GETUG). The results were consistent with the established safety profile of XOFIGO. Grade 3 or higher treatment emergent adverse events (TEAE) were recorded in 65.6% of patients in the combination arm compared to 55.8% of patients who received enzalutamide alone. 2 The most frequent Grade 3 or higher TEAEs in the combination arm were hypertension (34%), fatigue (6%), fracture (5%), anemia (5%) and neutropenia (5%). 2 Fractures (either treatment-emergent or post-treatment, symptomatic or pathologic, or with or without BPA use) were reported in 24.3% of patients in the combination arm and in 13.4% of patients in the enzalutamide arm. 2 'The PEACE III trial has provided us with valuable insights into the benefits of combining XOFIGO with enzalutamide for patients with metastatic castration-resistant prostate cancer with bone metastases,' said Dr. Murilo Luz, Urologic Oncologist, The Mount Sinai Hospital, New York and trial investigator. 'This analysis highlights that the combination therapy achieved improvements on PSA and ALP, beyond the known radiographic progression free survival benefit. We are encouraged by these results with this potential compelling therapeutic option, which could provide an additional treatment option for patients.' Data from the Phase II COMRADE trial were also presented at the ASCO 2025 Annual Meeting. Results demonstrated that the combination of olaparib with XOFIGO significantly improved radiographic progression-free survival (rPFS) in mCRPC patients compared to XOFIGO alone, with a median of 8.6 months versus 4.0 months (HR 0.51; 80% CI, 0.37-0.70; 2-sided p=0.005). 4 56% of patients in the olaparib with XOFIGO and 35% of patients in the XOFIGO arms had grade ≥3 treatment-related adverse events, the most common adverse events on the olaparib with XOFIGO and XOFIGO arms were anemia (22.0%/18.0%), lymphocyte decrease (30.5%/9.1%), platelet decrease (6.8%/3.6%), and neutrophil decrease (5.1%/7.3%), respectively. 4 'The results from the PEACE III and COMRADE trials underscore our dedication to exploring combinations, such as XOFIGO with enzalutamide or olaparib. We are hopeful these results will introduce another treatment option for patients with mCRPC and bone metastases who have not progressed viscerally,' said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. About PEACE III (EORTC GUCG-1333) The PEACE III trial is an international, randomized, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. A total of 446 patients were randomized 1:1 to receive either XOFIGO 55 kBq/kg as an intravenous injection monthly for six cycles in combination with enzalutamide 160mg orally daily or enzalutamide 160mg orally daily. The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event. This trial was a collaboration with several cancer cooperative groups: EORTC, CTI, CUOG, LACOG, and GETUG. About COMRADE II COMRADE is an open-label, randomized Phase II investigator-initiated trial in patients with metastatic castration resistant prostate cancer with bone metastases treated with a combination of olaparib, a PARP inhibitor, and XOFIGO compared to XOFIGO alone, 120 patients were randomized 1:1 to receive either olaparib plus XOFIGO or XOFIGO alone. The primary endpoint was radiographic progression-free survival (rPFS). About XOFIGO ® (radium-223 dichloride) Injection 1 XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Important Safety Information for Xofigo ® (radium-223 dichloride) Injection Warnings and Precautions: Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients' oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo Secondary Malignant Neoplasms: Xofigo contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%). Please see the fullPrescribing Informationfor Xofigo (radium 223 dichloride). About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and XOFIGO are registered trademarks of Bayer. Find more information at Our online press service is just a click away: Follow us on Facebook: Follow us on X: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References View source version on CONTACT: Media Contacts: Polina Miklush, Tel + 862.431.8817 Email:[email protected] KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: ONCOLOGY FDA HEALTH CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Bayer Copyright Business Wire 2025. PUB: 05/28/2025 08:15 AM/DISC: 05/28/2025 08:13 AM
Associated Press
23-05-2025
- Business
- Associated Press
Syncromune® Inc. Announces Publication of Abstract on SYNC-T® Therapy SV-102 Phase 1 Data for Metastatic Prostate Cancer at ASCO 2025 Annual Meeting
Study Demonstrated 87% Overall Response Rate in Metastatic Prostate Cancer Patients Treated with SYNC-T, a First-in-Class In Situ Personalized Immunotherapy Platform Abstract published on podium presentation that will take place during the 'Developmental Therapeutics - Immunotherapy' session on May 31, 2025, from 3:00 – 6:00pm CT at McCormick Place, Chicago FORT LAUDERDALE, Fla. and WEST DES MOINES, Iowa, May 23, 2025 (GLOBE NEWSWIRE) -- Syncromune® Inc., a clinical-stage biopharmaceutical company developing SYNC-T, an in situ platform combination immunotherapy optimized for solid tumor cancers, today announced the publication of an abstract that will be presented orally at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The abstract shares Phase 1 clinical results from a trial of SYNC-T Therapy SV-102 in patients with metastatic castration-resistant prostate cancer (mCRPC). The data demonstrate that SYNC-T Therapy achieved an overall response rate (ORR) of 87%, including a complete response (CR) rate of 53%, in patients with metastatic castration-resistant prostate cancer or who had refused hormonal therapy. SYNC-T was well-tolerated with predominantly low-grade treatment-emergent adverse events (TEAEs). 'These data mark a significant step forward in our effort to bring a new kind of immunotherapy to the treatment of solid tumors,' said Charles J. Link, M.D., Adjunct Professor, Lankenau Institute for Medical Research and Executive Chairman of Syncromune and senior author of the study. 'Prostate cancer has long been considered resistant to immunotherapy, and the response rates we're seeing with SYNC-T in this trial appear both meaningful and encouraging. For patients who have failed conventional options, these results offer real hope, and we look forward to delivering more details during our upcoming podium presentation at this year's ASCO meeting.' Notably, a complete radiographic resolution of bone and soft tissue metastases was observed in all eight patients demonstrating a CR, highlighting SYNC-T's potential to address one of the most challenging manifestations of mCRPC. More details concerning time to response, duration of response, progression free survival and overall survival will be presented at the symposium. These encouraging clinical results have led to further study of SYNC-T Therapy SV-102, now being evaluated in a U.S., multicenter, Phase 2a trial (LEGION-100) for patients with mCRPC. Details of the upcoming oral presentation at the ASCO meeting can be found below: Presentation Details: Title: Clinical responses to SYNC-T therapy: In situ personalized cancer vaccination with intratumoral immunotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC) Abstract Number: 2504 Presenter: Ricky T. Tong, M.D., Ph.D., Clinical Assistant Professor, Lankenau Institute for Medical Research, part of Main Line Health Date: May 31, 2025 Time: 4:12pm CT Session Title: Developmental Therapeutics – Immunotherapy Location: McCormick Place, Chicago, IL About Syncromune® and SYNC-T® Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, a potentially first-in-class platform immunotherapy designed to address major unmet needs and treatment challenges of incurable metastatic solid tumor cancers. SYNC-T is an in situ personalized cancer therapy engineered to synchronize the location of three components critical to T cell activation and an anti-tumor immune response: tumor antigens, immune cells, and our multi-target biologic drug. SYNC-T features a novel proprietary device delivery system that is optimized for combination drug/device immunotherapy. First, the system lyses a portion of a target tumor to rupture tumor cells and release tumor antigens into the tumor microenvironment (TME) that help to activate the immune system. Next, the delivery system facilitates the infusion of our proprietary multi-target biologic drug directly into the tumor. This synchronization of location approach is designed to unite the three critical components together in the TME and lymphatics where the immune system optimally functions. The combination therapy targets numerous mechanisms of cancer, promoting in situ immune activation while also battling immune suppression and minimizing systemic drug exposure. The goal is to activate T cells, empowering the immune system to recognize and attack the patient's cancer throughout the body and defend with immune memory. Our lead candidate, SYNC-T Therapy SV-102 for metastatic castration-resistant prostate cancer (mCRPC), is being evaluated in a U.S., multicenter, Phase 2a trial. For more information, please visit Corporate Contact Danielle Hobbs EVP, Corporate Communications Syncromune, Inc. [email protected] Media Contact Mike Tattory LifeSci Communications [email protected]
Yahoo
18-02-2025
- Business
- Yahoo
ORIC® Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Updates
Reported encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with androgen receptor inhibitors in patients with mCRPC Entered into clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations Expects to report seven data readouts across ORIC-114 and ORIC-944 clinical programs over the next 18 months, with potential initiation of registrational trials in 2H25 and early 2026 Cash and investments of $256 million expected to fund operating plan into late 2026 SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Feb. 18, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter and year ended December 31, 2024. "2024 was a year of significant advancements across several areas," stated Jacob M. Chacko, M.D., president and chief executive officer. "Key achievements included initiation of multiple cohorts for ORIC-114 in non-small cell lung cancer and ORIC-944 in metastatic castration-resistant prostate cancer. We also established three strategic partnerships with major pharmaceutical companies, expanded our leadership team's expertise, and secured $125 million in financing, which extends our cash runway into late 2026. We anticipate seven data readouts in the next year and a half and are working towards potential registration studies for ORIC-114 in the latter half of 2025 and for ORIC-944 in early 2026." 2024 Key Accomplishments ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor Entered into a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous (SC) amivantamab for the 1L treatment of patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Initiated a cohort to evaluate ORIC-114 monotherapy for the 1L treatment of patients with NSCLC harboring EGFR exon 20 insertion mutations. Announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 and the selection of two provisional recommended phase 2 doses; after which, initiated dosing of patients across three expansion cohorts in the Phase 1b trial of ORIC-114 in patients with mutated NSCLC, including 2L EGFR exon 20 insertion (EGFR exon 20 inhibitor naïve), 2L+ HER2 exon 20 insertion, and 2L+ EGFR atypical mutations. Presented preclinical data demonstrating potential best-in-class properties, including potency and selectivity, of ORIC-114 to treat NSCLC harboring EGFR exon 20 insertion mutations and other atypical EGFR mutations at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. ORIC-944: a potent and selective allosteric inhibitor of PRC2 Reported encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with metastatic castration resistant prostate cancer (mCRPC). Initiated dosing of ORIC-944 in combination with ERLEADA® (apalutamide) and in combination with NUBEQA® (darolutamide) in mid-2024 in the ongoing Phase 1b trial for prostate cancer. Entered into clinical trial collaboration and supply agreements with Johnson & Johnson and Bayer to support the ongoing Phase 1b trial of ORIC-944 in combination with AR inhibitors for the treatment of mCRPC. Reported initial Phase 1b single agent data for ORIC-944 in metastatic prostate cancer supporting advancement into combination development and demonstrating the potential as a best-in-class PRC2 inhibitor, including a clinical half-life of ~20 hours, robust target engagement, no signs of CYP autoinduction that was observed with first-generation PRC2 inhibitors, and a generally well-tolerated safety profile. Presented preclinical data at the 2024 AACR Annual Meeting demonstrating superior drug properties and synergy data in prostate cancer models, reinforcing the promise of ORIC-944 as a potential best-in-class treatment for combination with AR inhibitors. Corporate Highlights: Strengthened cash position and runway with a $125 million private placement financing from new and existing healthcare specialist funds. Expanded the leadership team with the appointment of industry veteran Keith Lui as Senior Vice President of Commercial and Medical Affairs. Anticipated Program Milestones ORIC anticipates the following upcoming data milestones: ORIC-114 (NSCLC): 1H 2025: 2L EGFR exon 20 and 2L+ HER2 exon 20 2H 2025: 2L+ EGFR atypical 1H 2026: 1L EGFR exon 20 Mid-2026: 1L EGFR exon 20 combination with SC amivantamab and 1L EGFR atypical ORIC-944 (mCRPC): 4Q 2025 / 1H 2026: Combination with AR inhibitors Fourth Quarter and Full Year 2024 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256 million as of December 31, 2024, which is expected to fund the current operating plan into late 2026. R&D Expenses: Research and development (R&D) expenses were $32.0 million for the three months ended December 31, 2024, compared to $24.5 million for the three months ended December 31, 2023, an increase of $7.5 million. For the year ended December 31, 2024, R&D expenses were $114.1 million compared to $85.2 million for the same period in 2023, an increase of $28.9 million. The increases were due to a net increase in external expenses related to the advancement of product candidates, as well as higher personnel costs, including additional non-cash stock-based compensation. G&A Expenses: General and administrative (G&A) expenses were $7.6 million for the three months ended December 31, 2024, compared to $6.9 million for the three months ended December 31, 2023, an increase of $0.7 million. For the year ended December 31, 2024, G&A expenses were $28.8 million compared to $25.6 million for the same period in 2023, an increase of $3.2 million. The increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation. About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers, and (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the continued clinical development of ORIC-114 and ORIC-944; statements regarding the potential best-in-class properties of ORIC-114 and ORIC-944; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-114, ORIC-944 and ORIC's other programs; the potential advantages of ORIC-114, ORIC-944 and ORIC's other programs; plans underlying ORIC's clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of registrational studies; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; and statements by the company's chief executive officer. Words such as 'believes,' 'anticipates,' 'plans,' 'expects,' 'intends,' 'will,' 'goal,' 'potential' and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC's product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC's operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC's license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC's product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC's reliance on third parties, including contract manufacturers and contract research organizations; ORIC's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled 'Risk Factors' in ORIC's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the 'SEC') on February 18, 2025, and ORIC's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Contact:Dominic Piscitelli, Chief Financial ORIC PHARMACEUTICALS, INC. CONDENSED BALANCE SHEETS(in thousands, except share and per share amounts) December 31, 2024 2023 Assets Current assets: Cash, cash equivalents and short-term investments $ 255,960 $ 208,187 Prepaid expenses and other current assets 6,290 4,410 Total current assets 262,250 212,597 Long-term investments - 26,852 Property and equipment, net 2,924 2,862 Other assets 8,968 9,696 Total assets $ 274,142 $ 252,007 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 1,548 $ 944 Accrued liabilities 23,298 19,514 Total current liabilities 24,846 20,458 Other long-term liabilities 6,174 7,461 Total liabilities 31,020 27,919 Total stockholders' equity 243,122 224,088 Total liabilities and stockholders' equity $ 274,142 $ 252,007 ORIC PHARMACEUTICALS, OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(in thousands, except share and per share amounts) Three Months Ended December 31, Twelve Months Ended December 31, 2024 2023 2024 2023 Operating expenses: Research and development $ 31,970 $ 24,481 $ 114,072 $ 85,172 General and administrative 7,600 6,947 28,823 25,608 Total operating expenses 39,570 31,428 142,895 110,780 Loss from operations (39,570 ) (31,428 ) (142,895 ) (110,780 ) Other income, net 3,263 3,098 15,048 10,083 Net loss $ (36,307 ) $ (28,330 ) $ (127,847 ) $ (100,697 ) Other comprehensive (loss) income: Unrealized (loss) gain on investments (343 ) 627 121 1,549 Comprehensive loss $ (36,650 ) $ (27,703 ) $ (127,726 ) $ (99,148 ) Net loss per share, basic and diluted $ (0.51 ) $ (0.49 ) $ (1.83 ) $ (1.96 ) Weighted-average shares outstanding, basic and diluted 70,652,013 57,464,041 69,727,940 51,450,848 Sign in to access your portfolio
