Phase Ib Trial of CAR-T Hepatic Artery Infusions Followed by Selective Internal Radiation Therapy (SIRT) With Yttrium-90 Sir-Spheres® for CEA-Expressing Liver Metastases

This is an open label fixed dose phase Ib of anti-CEA CAR-T cells hepatic artery infusions and yttrium-90 SIR-Spheres in patients with CEA-expressing liver metastases.

Start Date01 Apr 2015

Sponsor / Collaborator

Roger Williams Realty Corp.

[+1]

NCT00002681

/ CompletedPhase 1/2IIT

Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia or lymphoma cells. Combining these two therapies may be an effective treatment for leukemia and lymphoma.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy plus interleukin-2 in treating patients who have leukemia or lymphoma.

Start Date01 Jul 1995

Sponsor / Collaborator

Roger Williams Realty Corp.

[+2]

100 Clinical Results associated with Roger Williams Realty Corp.

0 Patents (Medical) associated with Roger Williams Realty Corp.

701

Literatures (Medical) associated with Roger Williams Realty Corp.

01 Mar 2025·Journal of Geriatric Oncology

Characteristics of older patients undergoing major oncological surgery: Insights from the Geriatric Surgery Verification Program

Article

Author: Kwon, Steve ; Espat, N Joseph ; Vognar, Lidia ; Somasundar, Ponnandai ; Salehi, Omid ; Abi Chebl, Joanna ; Calvino, Abdul Saied ; Zhao, Irving

INTRODUCTIONStudies outlining the unique burden of geriatric medical conditions and syndromes among older adults undergoing major oncological surgery are lacking, along with understanding of the goals of care for this population.MATERIALS AND METHODSWe conducted a single-institutional review of the initial 50 patients who enrolled in the American College of Surgeons' Geriatric Surgery Verification Program (GSV) program implemented for those ≥65 years undergoing major oncological surgery during the year 2023. Patient variables were categorized into four domains - somatic, functional, psychological, and social. The impact of GSV was analyzed by comparing the GSV cohort to historical controls from 2021 using patients' goals of care as the outcome of interest.RESULTSThe mean age of participants was 75.4 years (± 7.5). They were mostly White (72 %), English-speaking (78 %), with similar distribution of sex (54 % female). In the somatic category, nearly 40 % were at moderate to high nutrition risk and 61.5 % had a Geriatric 8 score of ≤14. In the functional category, 34.7 % used a cane or walker, 6.4 % had history of falls, and 22.4 % had some degree of frailty. In the psychological category, >70 % reported some degree of depression. Delirium risk factors were identified in 43 % of the patients. In the social category, more than half (54.3 %) of patients were never married, widowed, or divorced. Financial distress screening was positive in 23.3 %. In regard to goals of care, most patients (79.3 %) reported wanting to maintain independence while only 37.9 % reported extending life as primary concern. Using a composite adverse outcome (CAE) variable incorporating 30-day mortality and institutionalization 30-days after discharge as surrogate for these goals, we found that GSV group had an 8.0 % 30-day CAE rate compared to 28.9 % in the historical controls (p = 0.01).DISCUSSIONWe found high proportions of patients with low G8 score, frailty, perioperative risk of falls and delirium, lack of social support, and financial distress. To meet the care goals of this population, a comprehensive geriatric surgery program is essential to preoperatively capture and mitigate risk factors.

01 Feb 2025·Journal of Surgical Research

Relationship of Time to First Therapy and Survival Outcomes of Neoadjuvant Chemotherapy Versus Upfront Surgery Approach in Resectable Pancreatic Ductal Adenocarcinoma

Article

Author: Pena, Paola ; Abdelfattah, Thaer ; Sammartino, Cara J ; Espat, N Joseph ; Kwon, Steve ; Somasundar, Ponnandai ; Sousa, Aryanna ; Al Masad, Qusai ; Calvino, Abdul S

INTRODUCTIONEvidence demonstrating overall survival benefit of neoadjuvant chemotherapy (NAC) followed by surgical resection over upfront surgical resection for resectable pancreatic ductal adenocarcinoma (PDAC) has been mixed. The time to first therapy (TTFT) variable has not been studied as a contributing factor.METHODSA nationwide retrospective analysis using the National Cancer Database to evaluate patients with clinical stage T1 and T2 PDACs from 2010 to 2020. Cox proportional hazards model was used to evaluate the impact of NAC followed by definitive surgery compared to upfront surgery on overall survival with and without TTFT.RESULTSTotal of 43,174 patients were included-9874 patients with clinical stage T1 and 33,300 patients with T2 PDACs. There were increasing trends in the NAC approach from 2.9% in 2010 to more than 25% by 2020 and decreasing trends in the upfront surgery approach from 69.34% in 2010 to 31.87% by 2020. There were significant differences in TTFT according to the treatment choice with upfront surgery group having a significantly shorter TTFT-proportion of those receiving first treatment within the first week was 24.32% in the upfront surgery compared to 4.22% in the NAC group. In the adjusted cox regression without the TTFT variable, there was a 25% higher rate of death in the upfront surgery compared to the NAC group (hazard ratio 1.25, 95% confidence interval 1.19-1.30). When the adjusted regression was performed with addition of a TTFT interaction term, there was survival disadvantage of upfront surgery approach in patients whose TTFT occurred after 1 wk, but not in those with TTFT occurring in less than 1 wk (hazard ratio 1.01, 95% confidence interval 0.86-1.17).CONCLUSIONSOur study emphasizes the importance of incorporating TTFT variable when comparing NAC versus upfront surgery approach in PDAC. Future studies comparing NAC to upfront surgery in resectable PDAC should consider incorporating the TTFT variable.

01 Jan 2025·Annals of Surgical Oncology

Negative Impact of Systemic Therapy on Survival in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Low-Grade Metastatic Appendiceal Adenocarcinoma

Article

Author: Calvino, Abdul S. ; Espat, N Joseph ; Stillman, Mason ; Calvino, Abdul S ; Kwon, Steve ; Espat, N. Joseph ; Somasundar, Ponnandai

BACKGROUNDDespite studies demonstrating that patients with peritoneal metastases from low-grade appendiceal adenocarcinoma (AA) do not respond well to systemic chemotherapy (SC), patients frequently undergo combination of SC with cytoreductive surgery/hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) regardless of grade.METHODSA nationwide retrospective analysis using the National Cancer Database evaluated patients with AA with peritoneal metastasis from 2016 to 2021. Cox proportional hazards model was used to evaluate the impact of SC in addition to CRS/HIPEC on overall survival (OS) stratified by tumor grade.RESULTSA total of 1,449 patients were included: 481 low-grade, 428 intermediate-grade, and 540 high-grade tumors. Clinical variables, such as age, sex, and comorbidity index, were similar across tumor grades. Cytoreductive surgery/hyperthermic intraperitoneal chemotherapy without SC was utilized in 65.73% of low-grade cases compared with 41.01% in intermediate-grade and 11.11% in high-grade cases. Systemic chemotherapy was utilized alone in 17.74% and with CRS/HIPEC in 16.53% of low-grade cases. In adjusted survival analysis, addition of SC to CRS/HIPEC was associated with worse OS for patients with low-grade AA (hazard ratio [HR] 2.77, 95% confidence interval [CI] 1.18-6.50) but not for intermediate (HR 1.65, 95% CI 0.82-3.35) and high-grade tumors (HR 1.18, 95% CI 0.67-2.45). The addition of time to definitive surgery variable nullified the negative impact of adding SC to CRS/HIPEC in low-grade AA (HR 1.76, 95% CI 0.68-4.53).CONCLUSIONSNegative OS impact of SC may be mediated by delays in effective surgical/intraoperative therapy. If CRS/HIPEC is planned for patients with metastatic low-grade AA, avoiding SC may facilitate earlier surgical intervention and improve survival.

News (Medical) associated with Roger Williams Realty Corp.

15 Aug 2024

·www.businesswire.com

Bicara Therapeutics Expands Board of Directors with Appointments of Mike Powell, Ph.D., and Christopher Bowden, M.D.

BOSTON--( BUSINESS WIRE )--Bicara Therapeutics, a clinical-stage biotechnology company developing transformative bifunctional therapies for patients with solid tumors, today announced the appointments of Mike Powell, Ph.D., and Christopher Bowden, M.D., to the company’s board of directors. Dr. Powell currently serves as executive partner of Omega Funds and will serve as Bicara’s chairman of the board. Dr. Bowden is the former chief medical officer of Agios Pharmaceuticals and current chief medical officer of Remix Therapeutics and will serve as an independent director. “ Mike and Chris are distinguished biopharma industry leaders that have contributed to the approvals of multiple innovative oncology medicines. We are thrilled to welcome them to our board of directors,” said Claire Mazumdar, Ph.D., MBA, chief executive officer of Bicara Therapeutics. “ The combination of Mike’s four decades of pharmaceutical clinical development experience and Chris’ strategic medical and corporate expertise will be critical as we continue to advance ficerafusp alfa (BCA101) into late-stage development for recurrent/metastatic head and neck squamous cell carcinoma as well as other indications.” About Mike Powell, Ph.D. Dr. Mike Powell joined Omega Funds as executive partner in 2021 from Sofinnova Investments, where he served as managing general partner since 1997. Previously, Dr. Powell was Group Leader at Genentech from 1990 to 1997, where his focus was on drug delivery, CMC, and formulation of both small molecule and protein drug entities. Before this, he served as the director of product development for Cytel Corp, an immunology biotech company. Prior to this, he was senior scientist and project team leader at Syntex Research (Roche). Dr. Powell was the first person in the biotech industry to become a fellow of the American Association of Pharmaceutical Scientists (AAPS). He was previously board president of the AIDS Vaccine Advocacy Coalition, an advisor to the Institute for One World Health, IAVI, and the Bill and Melinda Gates Foundation, and an adjunct associate professor in the Department of Pharmaceutical Chemistry at the University of Kansas. Dr. Powell holds a Ph.D. in physical chemistry from the University of Toronto, and a postdoc in bio-organic chemistry at the University of California. About Christopher Bowden, M.D. Dr. Chris Bowden currently serves as the chief medical officer of Remix Therapeutics. Prior to Remix, Dr. Bowden served as a strategic advisor and chief medical officer of Agios Pharmaceuticals from 2014-2022. As chief medical officer at Agios, he oversaw clinical development that led to U.S. approvals for the IDH inhibitors IDHIFA™ and TIBSOVO™ in acute myeloid leukemia (AML), for TIBSOVO™ in cholangiocarcinoma and for PYRUKYND™ for adults with pyruvate kinase deficiency. Prior to joining Agios, Dr. Bowden was vice president of product development in oncology, franchise lead (signaling group) at Genentech, Inc. where he was responsible for the successful development of several novel targeted oncology medicines, including Zelboraf™ and Tarceva™. Dr. Bowden received his M.D. from Hahnemann University School of Medicine in Philadelphia after which he completed his internal medicine training at Roger Williams Medical Center and the Providence VA Medical Center, Rhode Island. He conducted his medical oncology fellowship at the National Cancer Institute Medicine Branch. Dr. Bowden is board certified in internal medicine and medical oncology. About Ficerafusp Alfa (BCA101) Ficerafusp alfa is a bifunctional antibody designed to inhibit the epidermal growth factor receptor (EGFR) and disable transforming growth factor beta (TGF-β) directly at the tumor site. This approach is designed with the intent to allow ficerafusp alfa to inhibit tumor proliferation, while restoring the cytolytic activity of the local immune cells. Ficerafusp alfa is currently being evaluated in a dose expansion phase of an open-label Phase 1/1b study in combination with pembrolizumab in HPV-negative patients with R/M HNSCC, advanced squamous non-small cell lung cancer (SqNSCLC), or squamous cancer of the anal canal (SCAC) and as a monotherapy for cutaneous squamous cell carcinoma (cSCC). About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biotechnology company developing bifunctional therapies engineered to combine the precision of well validated, tumor-targeting antibodies with the power of tumor microenvironment modulators. The Company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, offering the potential for synergistic therapeutic impact at the site of the tumor. Bicara’s lead product candidate, ficerafusp alfa, is a EGFR/TGF-β-trap bifunctional antibody in clinical development for multiple tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

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F105 ( HIV envelope protein gp120 )	HIV Infections More	Preclinical
Anti-CEA CAR-T cells(Roger Williams Medical Center) ( CEA )	Liver metastases More	Pending

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