ASCO - 2025 Oncology Research Portfolio

SANFORD ONCOLOGY CLINICAL RESEARCH SCOPE

Sanford Health is the largest rural health system in the U.S., dedicated to transforming the health care experience and providing access to world-class health care in America’s heartland.

45 Hospitals

9 Countries

2 Phase 1 Centers (Sioux Falls, Fargo)

1 Transplant Center (Fargo)

4 Cancer Centers (Sioux Falls, Fargo, Bismarck, Bemidji)

3 MNCCTN Sites (Thief River Falls, Worthington, Bemidji)

75+ Open Pediatric Oncology Clinical Trials

275+ Open Adult Oncology Clinical Trials

6 Primary Performance Sites

Clinics/Hospitals

DISCOVERY IS THE FOUNDATION OF MEDICINE. WITHOUT IT, MEDICINE WOULD NOT EXIST. A SMALL QUESTION CAN GROW INTO AN ENORMOUS AMOUNT OF KNOWLEDGE.

HENCE, RESEARCH IS THE CORE OF WHAT WE DO. RESEARCH PREVENTS KNOWLEDGE FROM BECOMING STAGNANT AND ALLOWS MEDICINE TO CONTINUE TO EVOLVE.

- Daniel Almquist, MD Hematologist/Oncologist

SANFORD RESEARCH PROGRAM

From understanding the fundamentals of disease to developing the next generation of treatments, our team is on the path of innovation and bringing the world closer to a future where powerful healing overcomes any obstacle.

Primary Performance Sites

• Sioux Falls, SD

• Fargo, ND

• Bismarck, ND

• Bemidji, MN

• Worthington, MN

• Thief River Falls, MN

Comprehensive Program

State-of-the-art Research Facility

60,000-square-foot open collaborative research bay Advanced Therapeutics Program

Dedicated group of physician investigators, advanced practice providers, nurse navigator and research team

AAHRPP-accredited

In-House

Institutional Review Board

Maintains the highest ethical standards in protecting participants

Oncology Trials in 2025

• Over 6,300 analytical cases annually

• 5,494 total oncology enrollments:

• 5,321 NCI-funded

• 92 industry-sponsored

• 81 investigator-initiated

Biosafety Committee

Registered with the NIH and serves to review all research being conducted by Sanford Health involving recombinant or synthetic nucleic acids

Sanford BioBank

63,867 enrollments and 812,300 total research samples

Blood and Bone Marrow Transplant (BMT) Program

Offering autologous and allogenic BMTs. CAR-T cell therapy was added in 2023

BUILDING A ROBUST CANCER CLINICAL TRIALS PROGRAM IS CRITICAL TO ENSURE THAT ACCESS TO TRIALS IS AVAILABLE FOR THOSE IN HISTORICALLY UNDERSERVED AREAS.

– Lora Black, RN, MPH Vice President, Clinical Research Sanford Health

PROGRAM

NATIONAL CANCER INSTITUTE COMMUNITY ONCOLOGY RESEARCH PROGRAM (NCORP) SITE

Supported by the National Cancer Institute’s (NCI’s) Division of Cancer Prevention and Sanford Health

• One of 46 community-based research sites

• Approximately 70 clinical trials open for adults and 10 clinical trials open for children at any given time

• Offers the unique opportunity to conduct clinical research in community practice and to evaluate oncology care models through cancer care delivery research (CCDR) trials

PIs: Daniel Almquist, MD (adult)

Samuel Milanovich, MD (pediatrics)

CANCER PATIENTS SHOULD BE ABLE TO PARTICIPATE IN TRIALS AND HAVE ACCESS TO STATE-OF-THE-ART CARE CLOSE TO HOME, REDUCING BARRIERS SUCH AS TIME AWAY FROM THEIR FAMILY AND VITAL SUPPORT SYSTEMS. BY EXPANDING TRIAL AVAILABILITY, WE CAN MINIMIZE THEIR BURDENS.

– Jenna Hove, RN, BSN Director, Clinical Research

– Kathy Lancaster, BA Director, Clinical Research

AWARDS & RECOGNITION PROGRAM

NCI Connect NATIONAL CANCER INSTITUTE

New prospective cohort of 200,000 adults in the U.S., designed to further investigate the etiology of cancer and cancer outcomes, which may inform new approaches to precision prevention and early detection

Minnesota Cancer Clinical Trials Network

One of five health systems selected in collaboration with the Mayo Clinic Cancer Center and University of Minnesota Masonic Cancer Center

Launching preventive and therapeutic clinical trials at three Sanford Health outreach centers in Worthington, Thief River Falls and Bemidji

NCORP Network SANFORD NCORP OF THE CENTRAL PLAINS

Recognized with an award for overall accrual to cancer control and treatment trials

Certificate of Excellence

NCI CHILDREN’S ONCOLOGY GROUP (COG)

Recognized for the timely activation of CCDR studies, submission of data and for the quality of data submitted

National Accreditation Program for Breast Centers

American College of Radiology (ACR)

NRG Main Member Status

QOPI Certification Program

Commission on Cancer (CoC)

Alliance Member Status

College of American Pathologists (CAP)

National Consortium of Breast Centers

Designated Comprehensive Breast Imaging Center (CBIC)

12 GASTROINTESTINAL

14 GENITOURINARY

16 GYNECOLOGIC ONCOLOGY

18 HEAD AND NECK, MELANOMA AND RARE TUMORS

20 HEMATOLOGY

BREAST

FOCUS GROUP BREAST

Edith Sanford Breast Center

• Established in 2016 through a generous lead grant

• Leading the way in offering women the latest in national and international clinical trials

Integrated Team Approach

• Multidisciplinary review of cases

• Weekly tumor boards to review new and challenging cases

• Research staff presence at tumor boards to evaluate clinical trial eligibility

• Dedicated nurse navigators embedded in the clinic to allow for more timely diagnosis and coordination of services

Key Clinical Trials

Merck MK3475-B49

• Phase 3, randomized, double-blind study

• Compares the efficacy of adding pembrolizumab to chemotherapy in HR+ and HER2+ metastatic breast cancer

PIs: Christopher Sumey, MD, and Amit Panwalkar, MD

CTSU S2212 (SCARLET)

• Phase 3 randomized study

• Compares early-stage, TNBC-receiving, anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab vs taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab

PI: Daniel Almquist, MD

Novartis CLEE011O12001 (Adjuvant WIDER)

• Phase 3, open-label single-arm study to test the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy

• Invasive breast cancer for HR-positive, HER2-negative breast cancer patients

PIs: Allison Watson, MD, PhD, and Anu Gaba, MD

Celcuity CELC-G-301 (VIKTORIA-1)

• Phase 3, open-label, randomized two-part study

• Compares gedastolisib in combination with palbociclib and culvestrant to standard care therapies in HR-Positive, HER2-negative advanced breast cancer patients

PIs: Allison Watson, MD, PhD, and Anu Gaba, MD

Alliance A012103 (OptimICE-PRC)

• Phase 3 randomized study

• De-escalation trial of therapy in early-stage TNBC patients who achieve pCR after neoadjuvant chemotherapy with checkpoint inhibitors

PI: Daniel Almquist, MD

CURRENT STUDIES IN STARTUP OR ACTIVELY RECRUITING PARTICIPANTS

AN IMPORTANT GOAL OF OUR RESEARCH PROGRAM IS TO HELP PATIENTS IN REMOTE COMMUNITIES GET ACCESS TO AND BENEFIT FROM TOMORROW’S TREATMENTS TODAY.

– Amit Panwalkar, MD

FOCUS GROUP GASTROINTESTINAL

Disease Associated Working Group

Enterprise-wide scheduled meetings with GI physicians discussing clinical practice as well as research opportunities and clinical trials

Integrated Team Approach

• Multidisciplinary review of cases

• Weekly tumor boards to review new and challenging cases

• Integration of clinical research staff to evaluate and offer clinical trial selection to every qualified patient

• Specialized nurse navigators embedded into the gastrointestinal program, offering guidance to each patient from diagnosis through treatment

Systemwide Gastrointestinal Steering Committee

CURRENT STUDIES IN STARTUP OR ACTIVELY RECRUITING PARTICIPANTS

Key Clinical Trials

Sapience Therapeutics ST316-101

• Phase 1/2 dose-escalation and expansion study

• Evaluating ST316 in subjects with selected advanced unresectable and metastatic solid tumors

PI: Steven Powell, MD

CCTG-CO32 (NEO-RT Trial)

• Phase 3 randomized trial

• Evaluating neoadjuvant chemotherapy, excision and observation vs chemoradiotherapy in early rectal cancer

PI: Daniel Almquist, MD

Alliance A022102

• Phase 3 randomized trial

• Comparing mFOLFIRINOX +/- nivolumab to FOLFOX +/- nivolumab in first-line metastatic HER2-negative gastroesophageal adenocarcinoma

PI: Daniel Almquist, MD

NRG-GI008 (CIRCULATE-US)

• Colon adjuvant chemotherapy based on evaluation of residual disease

PI: Daniel Almquist, MD

THE IMPROVEMENT SEEN IN PATIENT OUTCOMES AS A RESULT OF ADVANCES IN TREATMENT WAS ONE OF THE MAIN REASONS I BECAME ON ONCOLOGIST. IT IS ESSENTIAL THAT WE CONTINUE TO PARTICIPATE IN CLINICAL RESEARCH TO IMPROVE THE LIVES OF ALL PATIENTS WITH CANCER.

– Jarrett Failing, MD

Hematologist/Oncologist

FOCUS GROUP GENITOURINARY

Integrated Team Approach

• Multidisciplinary review of cases

• Weekly tumor boards to review new and challenging cases

• Integration of clinical research staff to evaluate and offer clinical trial selection to every qualified patient

• Specialized nurse navigators embedded into the genitourinary program, offering guidance to each patient from diagnosis through treatment

900+

GENITOURINARY CANCER CASES IN 2025

Key Clinical Trials

Alliance A031701

• Phase 2 study

• Comparing gemcitabine + cisplatin chemotherapy in patients with muscle-invasive bladder cancer with preservation for those patients whose tumor harbors deleterious DDR gene alterations

PI: Daniel Almquist, MD

Alliance A032103 (MODERN)

• Integrated Phase 2/3 and Phase 3 trial

• MRD-based optimization of adjuvant therapy in urothelial cancer

PI: Daniel Almquist, MD

Amgen 509-20180146

• Phase 1 study

• Evaluates the safety, tolerability, pharmacokinetics and efficacy of AMG 509 in metastatic castration-resistant prostate cancer (CRPR)

PI: Christopher Sumey, MD

Merck MK-6482-022 ccRCC

• Compares belzutifan (MK-6482) and pembrolizumab (MK-3475) vs a placebo and pembrolizumab in the adjuvant treatment of clear cell renal cell carcinoma (ccRCC) after nephrectomy

PI: Christopher Sumey, MD

Amgen 509-20230005

• Phase 3, randomized, multicenter, open-label trial

• Evaluating the efficacy and safety of xaluritamig (AMG 509) vs investigator’s choice of cabazitaxel androgen receptor directed therapy (ARDT) in subjects with metastatic castration-resistant prostate cancer (mCRPC)

PIs: Jarrett Failing, MD, and Christopher Sumey, MD

400+

GYNECOLOGIC ONCOLOGY

CASES IN 2025

FOCUS GROUP

GYNECOLOGIC ONCOLOGY

Integrated Team Approach

• Multidisciplinary review of cases

• Weekly tumor boards to review new and challenging cases

• Research staff presence at tumor boards to evaluate for clinical trial eligibility

• Specialized nurse navigators embedded into the gynecologic oncology program, offering guidance to each patient from diagnosis through treatment

Sanford Teleoncology Program

• Achieved approval through the Gynecologic Oncology Group to enroll patients in underserved areas into various clinical trials through teleoncology

• Uses audiovisual conferencing technology to remotely connect patients to cancer specialists for consultations, second opinions, and patient monitoring and counseling

• Currently utilized in 15 locations

Key Clinical Trials

GOG-3096/DS6000-109

• Phase 2/3 randomized multicenter trial

• Evaluating raludotatug deruxtecan (R-DXd), a CDH6-directed antibody-drug conjugate, in subjects with platinum-resistant, high-grade ovarian, primary peritoneal or fallopian tube cancer

PI: Maria Bell, MD

NRG-GY036

• Phase 3 trial

• One vs two years of maintenance on olaparib with or without bevacizumab in patients with BRCA1/2 mutated or homologous recombination deficient (HRD+) ovarian cancer after 1L platinum-based chemotherapy

PI: Maria Bell, MD

IMUNON Ovation-3

• Phase 3 randomized trial

• Evaluating the safety and efficacy of intraperitoneal IMNN-001 administered in combination with standard neoadjuvant and adjuvant chemotherapy in newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer

PI: Maria Bell, MD

GOG-3105/BNT323-01

• Phase 3, randomized, open-label, multicenter trial

CURRENT STUDIES IN STARTUP OR ACTIVELY RECRUITING PARTICIPANTS

• Comparing BNT323/DB-1303 vs investigator’s choice of chemotherapy in previously treated patients with HER2-expressing recurrent endometrial cancer

PI: Maria Bell, MD

GOG-3122/DS8201-854 (DESTINY)

• Phase 3, randomized, open-label trial

• Evaluating trastuzumab deruxtecan vs SOC (carboplatin in combination with paclitaxel) as adjuvant treatment in HER2-expressing endometrial cancer

PI: Maria Bell, MD

FOCUS GROUP HEAD AND NECK, MELANOMA AND RARE TUMORS

Active Biospecimen Repository

Multidisciplinary team heavily active in NCI studies

Key Clinical Trials – Head and Neck

WU-202108203

PALBO/CETUX

• Washington University Phase 3, randomized, open-label, multicenter trial

• Comparing palbociclib and cetuximab vs cetuximab monotherapy in patients with CDKN2A-altered, HPVunrelated head and neck squamous cell carcinoma who experience disease progression on a PD-L1 inhibitor

PIs: Steven Powell, MD, and Daniel Almquist, MD

WU-202501127 MINT-2

• Washington University Phase 2 trial

• Evaluating surgery followed by risk-directed post-operative adjuvant therapy for HPV-related oropharynx squamous cell carcinoma (The Minimalist Trial-2)

PIs: Steven Powell, MD, and Daniel Almquist, MD

AstraZeneca eVOLVE HNSCC D798EC00001

• Phase 3 study

• Evaluating volrustomig (MEDI5752) for participants with unresectable, locally advanced head and neck squamous cell carcinoma following definitive concurrent chemotherapy

PI: Steven Powell, MD

Key Clinical Trials – Melanoma

CTSU S2101

• Phase 2 study

• ImmunoMatch pilot study

• Comparing cabozantinib and nivolumab in participants with advanced solid tumors (IO refractory melanoma or HNSCC) stratified by tumor biomarkers

PI: Daniel Almquist, MD

ECOG-ACRIN EA7222

• Phase 3 randomized trial

• Doxorubicin and pembrolizumab vs doxorubicin alone for the treatment of undifferentiated pleomorphic sarcoma (UPS) and related poorly differentiated sarcomas

PI: Daniel Almquist, MD

FOCUS GROUP HEMATOLOGY

HEMATOLOGY CASES IN 2025

Integrated Team Approach

• Multidisciplinary review of cases

• Weekly tumor boards to review new and challenging cases

• Integration of clinical research staff to evaluate and offer clinical trial selection to every qualified patient

• Specialized nurse navigators embedded into the program, offering guidance to each patient

Center for International Blood and Marrow Transplant Research (CIBMTR) membership

Blood Disorder and Bone Marrow Transplant Program

• 6 dedicated hematologists

• 4 advanced practice providers

• Dedicated BMT pharmacist

• Dedicated research staff

• Currently performing autologous and allogenic transplants, tumor-infiltrating lymphocytes (TIL) therapy and chimeric antigen receptor T-cell (CAR-T) therapy

• Focus on providing multidisciplinary care with dedicated team

• State-of-the-art cellular processing lab on campus

Dedicated space for BMT patients

• Positive pressure rooms with HEPA filters

• Dedicated infusion space for visits and treatment post-transplant to protect patients

• Dedicated apheresis space, learning space and red blood cell exchange space

CURRENT STUDIES IN STARTUP OR ACTIVELY RECRUITING PARTICIPANTS

Key Clinical Trials

Pfizer-C107 MagnetisMM-32

• Phase 3 open-label study

• Evaluating elranatamab monotherapy vs elotuzumab, pomalidomide and dexamethasone (EPd) or pomalidomide, bortezomide and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in participants with relapsed/refractory multiple myeloma after prior anti-CD38 directed therapy

PI: Seth Maliske, MD

Merck MK2140-010 (waveLINE-010)

• Phase 3, randomized, open-label, multicenter study

• Evaluating zilovertamab vedotin (MK-2140) in combination with R-CHP vs R-CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL)

PI: Jonathan Bleeker, MD, and Seth Maliske, MD

LUNG CASES IN 2025

FOCUS GROUP LUNG

Integrated Team Approach

• Multidisciplinary review of cases

• Weekly tumor boards to review new and challenging cases

• Integration of clinical research staff to evaluate and offer clinical trial selection to every qualified patient

• Specialized nurse navigators embedded into the lung program, offering guidance to each patient from diagnosis through treatment

Key Clinical Trials

BMS CA245-0001

• Phase 3, randomized, double-blind, multicenter trial

• BMS-986489 in combination with carboplatin plus etoposide vs atezolizumab with carboplatin plus etoposide as 1L therapy in extensive-stage SCLC

PIs: Thandiwe Gray, MD; Allison Watson, MD, PhD, and Mark Gitau, MD

Merck MK2870-009

• Phase 3, randomized, open-label study

• Evaluating MK-2870 vs platinum doublets in participants with EGFR-mutated, advanced non-squamous non-small cell lung cancer who have progressed on prior EGFR tyrosine kinase inhibitors

PIs: Steven Powell, MD, and Mark Gitau, MD

Alliance A151216 (ALCHEMIST)

• Screening trial

• Looking at adjuvant lung cancer enrichment marker identification and sequencing in NSCLC of any histologic subtype and candidate for platinum doublet chemotherapy

PI: Daniel Almquist, MD

NRG LU007 (RAPTOR)

• Phase 2/3, randomized study

• Extensive stage SCLC

• Compares radiation therapy (RT) versus RT and atezolizumab

PI: Daniel Almquist, MD

SWOG LungMAP

• Master screening protocol

• Evaluating biomarker-driven therapies and immunotherapies in previously treated NSCLC

PI: Daniel Almquist, MD

Merck MK3475-U01 (KEYMAKER)

• Phase 1/2 umbrella study

• Rolling arms of investigational agents, pembrolizumab and chemotherapy alone or in combination in participants with NSCLC

PIs: Jeffrey Wiisanen, MD, and Steven Powell, MD

Iovance IOV-LUN-202

• Phase 2 multicenter study

• Evaluating autologous tumor-infiltrating lymphocytes (LN145) in patients with metastatic non-small cell lung cancer

PI: Steven Powell, MD, and Dan Almquist, MD

Merck MK2870-019

• Phase 3, randomized, open-label study

• Comparing adjuvant pembrolizumab with or without MK-2870 in participants with resectable stage 2 to 3b (N2) NSCLC who do not achieve pCR after neoadjuvant pembrolizumab with platinum-based doublet chemotherapy followed by surgery

PIs: Mark Gitau, MD, and Steven Powell, MD

Sanford Children’s Hospital and Clinics

Sanford Health has been participating in pediatric oncology clinical trials for over 40 years

FOCUS GROUP PEDIATRICS

NCI Children’s Oncology Group

Sanford Health is a member of the largest childhood cancer research organization in the world with over 100 clinical trials. We have at least 30 Phase 2 and Phase 3 COG studies currently open and we were recognized for being a top-accruing NCORP site for adolescent and young adult (AYA) enrollments on COG trials.

PIs: KayeLyn Wagner, MD, and Samuel Milanovich, MD

Disease Associated Working Group

Enterprise-wide scheduled meetings with pediatric oncology team to discuss clinical practice as well as research opportunities and clinical trials

Pediatric Tumor Board

Discuss and review new and challenging pediatric oncology cases

Distinguished Program

• Only pediatric oncology group in the Dakotas and western Minnesota

• Only hemophilia treatment centers in the Dakotas

• Accredited pediatric cancer center by the ACS Commission on Cancer

ASCO TAPUR Study Molecular Tumor Board

Samuel Milanovich, MD – Member

Pediatric Cancer Data Commons Team

Aggregates diverse datasets to facilitate pediatric cancer research

Kirk Wyatt, MD – Co-investigator

Key Clinical Trials

A Natural History Study of Non-Neoplastic Hematologic Disorders (ATHN Transcends)

• A cohort study of the safety, effectiveness and practice of treatment in people with non-neoplastic hematologic disorders

PI: Samuel Milanovich, MD, and Jordan Fritch, MD

Sickle Treatment Outcomes Research in the Midwest (STORM 2.0)

• Collaborative effort to implement quality improvement projects and provider education initiatives to enhance access and delivery of care and outcomes

• Sickle cell disease in the Midwest

PIs: Jordan Doss, MD, and Samuel Milanovich, MD

SH Pediatric Oncologic Predisposition Study (POPS)

• Prospective genetic testing study

• Evaluates the number of pediatric oncology patients with AML, ALL, lymphoma, myelodysplastic syndrome or aplastic anemia that have a genetic predisposition to cancer

PI: Catherine Nelson, DO

CURRENT STUDIES IN STARTUP OR ACTIVELY RECRUITING PARTICIPANTS

Merck MK3475-051

• Phase 1/2 study

• Evaluating pembrolizumab in children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma (KEYNOTE-051)

PIs: Samuel Milanovich, MD, and KayeLyn Wagner, MD

Merck MK9999-U01

• Phase 1/2 study

• Sub-study 01A: Evaluating the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors

• Sub-study 01C: Evaluating the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants with Relapsed Refractory Solid Tumors

• Sub-study 01D: Evaluating the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Population with Relapsed or Refractory Solid Tumors

PIs: Samuel Milanovich, MD, and KayeLyn Wagner, MD

ASCO TAPUR Review Board

Samuel Milanovich, MD, Anu Gaba, MD, and Steven Powell, MD – Members

JCO Precision Oncology

Steven Powell, MD, Associate Editor

Steering Committee

Meets quarterly to improve strategies for gaining access to clinical trials that support genomic alterations and for the development of levels of evidence criteria

FOCUS GROUP PRECISION ONCOLOGY

Enterprise-Wide Multidisciplinary Genomic Tumor Board

• Collaborative team of researchers, pathologists, genetic counselors, oncologists and functional genomics experts with experience in cancer and genetics develops a personalized care plan using genomic testing results

• Meets twice a week with an average of 10 cases formally presented each month

• Dedicated nurse navigator

• Collaboration with Sanford World Clinic sites including Costa Rica and Ireland

Key Clinical Trials

Community Oncology Use of Molecular Profiling to Personalize the Approach to Specialized Cancer Treatment at Sanford (SH COMPASS)

• Enterprise-wide tracking of genomic testing use, collaborative testing review and subsequent treatment

• Focuses on delivering cancer treatment options tailored to a patient’s genomic profile

PI: Steven Powell, MD

ASCO Targeted Agent and Profiling Utilization Registry (TAPUR)

• Non-randomized clinical trial

• Evaluates the safety and efficacy of FDA-approved, targeted anticancer drugs prescribed for advanced cancer with a potentially actionable genomic alteration

PIs: Steven Powell, MD, Anu Gaba, MD, and Peter Kurniali, MD

ECOG-ACRIN EAY191 ComboMATCH Molecular Analysis for Combination Therapy Choice

• Non-treatment ComboMATCH registration trial, an informatics component for specimen and genomic data management, and multiple ComboMATCH treatment trials

PI: Daniel Almquist, MD

TEMPUS Aries TP-CA-007

• A biobank registry platform study in oncology

PI: Daniel Almquist, MD

THROUGH OUR ADVANCED CANCER THERAPEUTICS PROGRAM, WE ARE ABLE TO OFFER OUR PATIENTS NOVEL TREATMENTS WHEN THEY MAY NOT HAVE OPTIONS AVAILABLE ELSEWHERE.

– Steven Powell, MD, FASCO Chief Research Physician, Sanford Health, Sioux Falls region Head of Enterprise Oncology Research Medical Oncologist

FOCUS GROUP EARLY PHASE

Advanced Therapeutics Program

Program Highlights

• 6 physician investigators

• 2 dedicated advanced practice providers

• Dedicated nurse navigator

• Dedicated research team

• 2 procedure rooms

• Spacious recovery room

• Opportunity for an overnight stay or extended lodging during trial participation

• State-of-the-art research lab for specimen collection and processing

*Early phase clinical trials are given priority in the study start-up process

Recognized as a Regional Referral Hub

Physicians within and outside of Sanford Health refer cancer patients to Sanford Health

Key Clinical Trials

Sapience Therapeutics ST316-101

• Phase 1/2 dose-escalation and expansion study

• Evaluating ST316 in subjects with selected advanced unresectable and metastatic solid tumors

PI: Steven Powell, MD

Seagen SGNB6A-001

• Phase 1, open-label, multicenter study

• Evaluates the safety, tolerability, pharmacokinetics and antitumor activity of SGN-B6A as monotherapy, in combination with pembrolizumab, and in combination with pembrolizumab and chemotherapy in adults with multiple disease-specific cohorts

PI: Steven Powell, MD

Amgen 20240124

• Phase 1b study

• Evaluating the safety, tolerability, pharmacokinetics and efficacy of tarlatamab in combination with YL201 with or without anti-PD-L1 in subjects with extensive stage small cell lung cancer

PIs: Steven Powell, MD, and Daniel Almquist, MD

BMS CA254-0001

• Phase 1/2a

• First-in-human, open-label study

CURRENT STUDIES IN STARTUP OR ACTIVELY RECRUITING PARTICIPANTS

• BMS-986517 as a monotherapy in adult participants with advanced solid tumors

PI: Steven Powell, MD

BMS CA233-000

• Phase 1/1b trial

• Evaluating BMS-986484 as monotherapy and combination therapy in participants with advanced solid malignancies

PI: Steven Powell, MD

UNDERLYING EVERY HUMAN DISEASE IS A BIOLOGICAL PROCESS THAT HAS GONE AWRY. DISCOVERING THOSE MECHANISMS AND THEIR MANIFESTATION IN DISEASE TO GENERATE NOVEL TREATMENTS LIES AT THE CORE OF ALL THAT WE DO.

– Michael Kareta, PhD

Associate Scientist, Genetics and Genomics

Sanford Health

FOCUS GROUP TRANSLATIONAL RESEARCH

Sanford Center for Cancer Biology Research

Awarded multiple grants through the National Institutes of Health’s Centers of Biomedical Research Excellence (CoBRE):

• Phase 1: A nearly $11.5 million grant to develop the infrastructure to support a group of basic science and translational cancer researchers

• Phase 2: A five-year, nearly $11.7 million grant to translate laboratory research into clinical trials for head and neck

• Phase 3: A $6.2 million grant to continue building research expertise in cancer biology

• Pilot awards include:

• Wenfeng An, PhD, South Dakota State University – “Preclinical Study of a Novel Vaccine Against Head and Neck Cancer”

• Francisco Bustos, PhD, Sanford Research – “Defining the Cellular Impact of Neurodevelopmental Disorder-Associated UBA7 Mutations”

• Michael Kareta, PhD, Sanford Research – “Enhancing the Immunogenicity of Small Cell Lung Cancer”

• Safiya Khurshid, PhD, Sanford Research – “Metabolic Starvation in Osteosarcoma Drives MYL6 Splicing to Promote Metastasis”

• Kurt Warnhoff, PhD, Sanford Research – “Molybdenum Cofactor Homeostasis in Human Cells”

TRANSCEND Collaborative Translational Science Engaging North Dakota

Clinical and translational research development program (CTR-D) to expand C&T research focused on health problems in North Dakota.

• Elevates clinical and translational research across North Dakota, offers training and assistance to grow investigators, and makes an impact on the health of North Dakotans

• Three ongoing collaborative projects engaging Sanford Health clinicians with academic partners

Core Facilities

Located at the research centers in Sioux Falls, South Dakota, and Fargo, North Dakota, Sanford Research’s core facilities are led by highly trained staff and provide expertise, advanced techniques and cutting-edge technology for basic, translational and clinical research.

Translational Hub

• Coordination of Rare Disease at Sanford (CoRDS)

• Translational Core and Biobank

Technical Hub

• Biochemistry Core

• Flow Cytometry Core

• Functional Genomics and Bioinformatics Core

• Histology and Imaging Core

Animal Hub

• Animal Behavior Core

• Animal Research Support Services

• Experimental Therapeutics and Screening Facility (ETSF)

Data Hub

• Data Exchange Core

• Research Design and Biostatistics Core

Key Clinical Trials

SH CD8+ T Cells in TME

• Prospective specimen collection study that aims to uncover how CD8+ T Cells dysfunction, driven by exhaustion and senescence, limits immune response in colon cancer.

PI: Robert Sticca, MD

CTR CRC OBESITY

• Prospective specimen collection study

• Investigates novel pathways that accelerate the formation of benign and malignant tumors in obese and overweight patients for therapeutic strategies to prevent and treat obesity-associated colorectal cancer

PI: Jonathan Bleeker, MD

SH UICT

• Prospective specimen-collection study

• Aims to build a repository of blood, tissue, saliva and stool specimens and epidemiological data for continued research into the understanding of solid tumor cancers and the improvement of treatments

PI: Steven Powell, MD

SH TME

• Prospective specimen collection study

• Aims to validate a novel patient-derived 3D model as a tool to predict patient response to therapy to determine effective treatments and avoid treatment with drugs that ovarian cancer patients will be resistant to

PI: Pilar de la Puente, PhD

CTR PCA Bone Metastasis Testbeds

• Prospective specimen collection study

• Development of humanoid testbeds of prostate cancer at bone, lymph and liver metastases to recapitulate the environment for the purpose of testing drug therapies

PI: Parth Vyas, MD

SIOUX FALLS, SOUTH DAKOTA

Sanford Cancer Center

1309 W. 17th St. Sioux Falls, SD

SIOUX FALLS, SOUTH DAKOTA INVESTIGATORS

Maria Bell, MD

Gynecology

Jonathan Bleeker, MD

Gastrointestinal, Precision Oncology

Keely Hack, MD

Breast

Michele Lohr, MD

Radiation Oncology

Kevin Byrd, MD

Gynecologic Oncology

Jordan Doss, MD

Pediatric Hematology & Oncology

Miroslaw Mazurczak, MD

Breast, CNS, NCORP

Steve McGraw, MD

Radiation Oncology

Jordan Fritch, MD

Pediatrics

Catherine Nelson, DO

Pediatrics

Ryan Nowak, MD

Radiation Oncology

Christopher Sumey, MD

Lung, Genitourinary, Precision Oncology

Steven Powell, MD

Precision Oncology, Early Phase, Head and Neck

KayeLyn Wagner, MD

Pediatrics

Na Smith, MD

Radiation Oncology

Travis Snyders, MD

Hematology, Precision Oncology

Allison Watson, MD, PhD

Breast

FARGO, NORTH DAKOTA

INVESTIGATORS

FARGO, NORTH DAKOTA

Mohammad Ali, MD

Surgical Oncology

Anu Gaba, MD

Breast, Precision Oncology

Daniel Almquist, MD

Gastrointestinal, Lung, Head and Neck, Precision Oncology

Mark Gitau, MD

Gastrointestinal, Lung, Head and Neck, Precision Oncology, Rare Tumor

Melissa Babcook, MD, PDH

Hematology & Oncology

Jessica Benjamin-Eze, DO

Pediatric Hematology & Oncology

Mahendra Gupta, MD Gynecologic, Lung

Lauren Hernandez, DO

Pediatric Hematology & Oncology

Jarrett Failing, MD Melanoma

Ash Jensen, MD

Radiation Oncology

Andrea Kaster, MD

Breast

Elliot Lawrence, MD

Radiation Oncology

Seth Maliske, MD

Hematology & Oncology

Haritha Mopuru, MD

Hematology & Oncology

Sommer Nurkic, MD

Radiation Oncology

Oluwatobi Odetola, MD

Hematology & Oncology

Kiarash Mashayek, MD

Surgical Oncology

Samuel Milanovich, MD

Pediatrics

Colette Pameijer, MD

Surgical Oncology

Amit Panwalkar, MD

Breast, Gynecologic, Lung

FARGO, NORTH DAKOTA INVESTIGATORS

Richard Sheppard, MD

Hematology & Oncology

Robert Sticca, MD

Surgical Oncology

Andrew Terrell, MD

Head and Neck

Shelby Terstriep, MD

Breast

Matthew Tinguely, MD

Gastrointestinal

Radhakrishna Vegunta, MD

Hematology & Oncology

Jeff Wiisanen, MD

Hematology & Oncology

Kirk Wyatt, MD

Pediatrics

Sanford Medical Center

300 N. Seventh St.

Bismarck, ND

BISMARCK, NORTH DAKOTA INVESTIGATORS

Thandiwe Gray, MD

Hematology & Oncology

Alexander Johnson, MD

Hematology & Oncology

Matthew McGee, MD

Hematology & Oncology

Kafi Thomas, MD

Hematology & Oncology

Peter Kurniali, MD

Hematology & Oncology

Aaron Luebke, MD

Hematology & Oncology

Edward Wos, DO

Hematology & Oncology

Sanford Joe Lueken Cancer Center

1233 54th St. NW

Bemidji, MN

BEMIDJI, MINNESOTA

Gastrointestinal, Lung, Head and Neck, Precision Oncology

sanfordresearch.org/clinicalresearch

Radiation Oncology

Pediatrics

INVESTIGATORS

Hematology & Oncology

3001 Sanford Parkway

Thief River Falls, MN

INVESTIGATORS

WORTHINGTON, MINNESOTA

Jonathan Bleeker, MD

Gastrointestinal, Precision Oncology

Keely Hack, MD

Breast

Allison

Mazurczak, MD

Breast, CNS, NCORP

sanfordresearch.org/clinicalresearch

Watson, MD, PhD

Breast

Worthington

1018 6th Ave.

Worthington, MN