About

Dr. Julie Anne Lynne Gemmill, DO, MS is an Assistant Professor of Medicine at Stony Brook University Hospital. She cares for patients with gastrointestinal and breast cancers and non-malignant (benign) hematologic conditions. Additionally, she serves as the Associate Program Director for the Hematology & Oncology Fellowship Program. Dr. Gemmill received her Bachelor of Science degree from New York University with honors and completed an Intramural Research Training Award Program Fellowship at the National Institutes of Health (NIH) prior to medical school. She earned her Doctor of Osteopathic Medicine and Master of Science degrees from the New York Institute of Technology College of Osteopathic Medicine, where she also received an Academic Medicine Scholarship. Her residency training was in Internal Medicine, followed by fellowship training in Hematology and Medical Oncology at Stony Brook University Hospital, where she served as Chief Resident and Chief Fellow.

Research topics

• Medicine
• Internal medicine
• Endocrinology
• Oncology
• Surgery
• Physical therapy

Selected publications

• A phase 1b/2 study on the efficacy and safety of BXQ-350, a first-in-class sphingolipid metabolism modulator, in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal carcinoma.

  Journal of Clinical Oncology · 2026-01-10

  article

  TPS273 Background: Ceramides and sphingosine-1-phosphate (S1P) are key bioactive signaling molecules. Ceramides are proapoptotic and mitigate chemoresistance. Conversely, S1P promotes cancer cell proliferation, activates multiple oncogenic pathways, and stimulates immuno-suppressor cell populations promoting a pro-tumoral microenvironment. Several studies in colorectal cancer patients have shown high levels of ceramides are associated with improved survival, while high S1P levels are associated with a poor prognosis. Hence, modulation of sphingolipid metabolism could be a promising therapeutic approach. BXQ-350 is a nanovesicle of Saposin C, an allosteric activator of sphingolipid metabolism, that lowers systemic S1P and increases C18 ceramide. BXQ-350 was investigated in a Phase 1 dose-escalation safety study in cancer patients with advanced solid malignancies (NCT02859857). BXQ-350 was safe and well-tolerated (no DLT, no MTD). Methods: BXQ-350 is being investigated in a Phase 1b/2 study in combination with mFOLFOX7 and Bevacizumab in newly diagnosed mCRC patients (NCT05322590) to assess the efficacy and safety of BXQ-350. Design of the Phase 1b (open label study): A safety dose escalation part to establish the RP2D: patients will initially receive 1.8 mg/kg BXQ-350 in combination with mFOLFOX7 and Bevacizumab. If safe (no MTD), dose of BXQ-350 will be increased to 2.4 mg/kg and 9 additional patients will be entered at this dose level. If safe, then this dose will be the RP2D and 21 additional patients will be enrolled, completing a 30-patient expansion cohort. Efficacy will then be evaluated for all patients entered at the RP2D. Primary objectives of the Phase 1b are to assess safety, identify RP2D, and assess preliminary efficacy of BXQ-350 in this combination. A secondary objective is to determine if BXQ-350 decreases CIPN. Design of the Phase 2, a double-blinded, placebo-controlled study: Eligible patients (up to 160 patients) will be randomized in a 1:1 fashion to receive either BXQ-350 or placebo with mFOLFOX7 + Bevacizumab. Primary and secondary objectives include efficacy, safety and CIPN incidence. Enrollment in the Phase 1b dose escalation portion is completed. After review of the safety results, the DSMB approved enrollment of the expansion cohort, with a planned 30 patients at the Phase 2 dose. Primary endpoints are Cumulative Oxaliplatin Dose, ORR and Safety. Secondary endpoints are OS, PFS, DCR, CIPN, PK/PD and biomarkers. Clinical trial information: NCT05322590 .

  PublisherDOI

• BXQ-350 efficacy and safety evaluation in first line mCRC patients: A phase 1b/2 study of BXQ-350, a first-in-class sphingolipid metabolism modulator, in combination with mFOLFOX7 plus bevacizumab in newly diagnosed metastatic colorectal carcinoma.

  Journal of Clinical Oncology · 2026-01-10

  article

  242 Background: BXQ-350 is a first-in-class biologic nanovesicle of Saposin C, an allosteric activator of sphingolipid metabolism, that lowers systemic S1P and increases C18 ceramide. Several studies in colorectal cancer patients have shown high levels of ceramides are associated with improved survival, while high S1P levels are associated with a poor prognosis. BXQ-350 was investigated in a Phase 1 dose-escalation safety study in patients with advanced solid malignancies (NCT02859857). BXQ-350 was safe and well-tolerated (no DLT, no MTD). Methods: BXQ-350 is being investigated in a Phase 1b/2 study in combination with mFOLFOX7 and Bevacizumab in newly diagnosed mCRC patients (NCT05322590) to assess the efficacy and safety of BXQ-350. Design of Phase 1b/2 open label study: Safety dose escalation to establish RP2D: patients initially receive 1.8 mg/kg BXQ-350 in combination with mFOLFOX7 and Bevacizumab. If safe (no MTD), dose of BXQ-350 increased to 2.4 mg/kg and 9 additional patients entered at this dose level. If safe, then this dose is RP2D and 21 additional patients enrolled, completing 30-patient expansion cohort. Efficacy evaluated for all patients entered at RP2D. Primary objectives of Phase 1b/2 are to assess safety, identify RP2D, and assess preliminary efficacy of BXQ-350 in this combination. Secondary objective is to determine if BXQ-350 decreases CIPN. Results: Total of 34 evaluable patients were enrolled in the Phase 1b/2 trial. 32 patients have completed primary treatment period (6 months of SoC treatment plus BXQ-350). 5 patients are currently still receiving BXQ-350 in the Extended Treatment period. BXQ-350 combined with SoC in this population showed the following results: 94% patients reached 8 Cycles or more of Oxaliplatin without Oxaliplatin being halted due to CIPN; Improvements in Cumulative Oxaliplatin Dose (COD) and Relative Dose Intensity (RDI) with reduced dose vacations compared to natural history of Oxaliplatin in this population; Decreased intensity of CIPN with reduced incidence of Grade 2 or above CIPN and delayed time of CIPN onset; and DCR, ORR and mPFS compare favorably to natural history of Oxaliplatin in this population Conclusions: BXQ-350 was safe and well tolerated in combination with SoC. Ongoing monitoring of patients suggests BXQ-350 when added to SoC may provide additional clinical benefits in this population as compared to natural history of these patients, both in terms of increasing COD & RDI as well as amelioration of CIPN. Clinical trial information: NCT05322590 .

  PublisherDOI

• Bxq-350 in combination with FOLFOX7 and bevacizumab: Evaluation of effect on oxaliplatin-induced CIPN—A phase 1b/2 trial to assess the efficacy and safety of BXQ-350, a first-in-class sphingolipid metabolism modulator, in newly diagnosed metastatic colorectal carcinoma.

  Journal of Clinical Oncology · 2026-01-10

  article

  105 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a significant side effect associated with many cancer drugs and is highly prevalent in mCRC patients receiving oxaliplatin-based regimens. CIPN can severely impact quality of life (QoL) and may require dose vacation, reduction or interruption. CIPN pathology is complex and not completely understood; preclinical and clinical data have shown inflammatory (IL-6, Il-8, IL-10) and immune involvement as well as elevated levels of sphingolipids, a class of bioactive signaling molecules. BXQ-350 is a nanovesicle formulation of Saposin C, an allosteric activator of sphingolipid metabolism that normalizes dysregulated sphingolipid metabolism by lowering S1P, GM3 and GluCer levels while it increases ceramide level, promoting a return to homeostasis. In a single agent Phase 1 study, BXQ-350 was safe and well-tolerated and showed signs of activity. Among patients with PFS > 6 months, there were 4 recurrent CRC patients: 1 is still on study after 7 years. One patient self-reported an improvement of their pre-existing CIPN symptoms after BXQ-350 administration; this observation was confirmed in 4 of 10 patients with established CIPN at the time of enrollment. Methods: BXQ-350 is being investigated in a Phase 1b/2 study in combination with mFOLFOX7 and Bevacizumab (SoC) in newly diagnosed mCRC patients (NCT05322590). Primary objectives are to assess safety and preliminary efficacy of this combination, and to determine cumulative oxaliplatin dose. Secondary objectives include intensity, frequency and time to onset of CIPN. Results: The Phase Ib trial enrolled 33 oxaliplatin dosing evaluable patients; all patients completed the primary treatment period (6 months of SoC treatment plus BXQ-350). Amongst the 33 patients, 19 completed the full 12 Cycles of oxaliplatin dosing, 28 completed at least 8 Cycles with only 2 patients having dosing halted before Cycle 8 due to CIPN. There were no reported Grade 4 and only 3 reported Grade 3 CIPN AEs, all occurred after Cycle 12. Analysis of Neurofibrillary Light Chain (NfL) biomarkers suggests concordance with physician and patient reported outcomes. Conclusions: Results show that BXQ-350 was safe and well tolerated in the combination. Data suggest that BXQ-350 may provide additional clinical benefits and may reduce intensity or delay onset of CIPN, allowing for increased cumulative dosing of oxaliplatin and relative dose intensity in 1L mCRC. Clinical trial information: NCT05322590 .

  PublisherDOI

• Metastatic breast cancer through the Oncotype DX Breast Recurrence Score®: insights from a small cohort study

  Breast Cancer Research and Treatment · 2025-05-28

  article1st authorCorresponding
  PublisherDOI

• BXQ-350: A phase 1b/2 placebo controlled, double blinded study on the efficacy and safety of BXQ-350 in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal carcinoma (mCRC).

  Journal of Clinical Oncology · 2024-01-20 · 3 citations

  article

  TPS224 Background: Ceramides and sphingosine-1-phosphate (S1P) are key bioactive signaling molecules. Ceramides are proapoptotic and mitigate chemoresistance. Conversely, S1P promotes cancer cell proliferation, activates multiple oncogenic pathways, and stimulates immuno-suppressor cell populations promoting a pro-tumoral microenvironment. Several studies in colorectal cancer patients have shown high levels of ceramides are associated with improved survival, while high S1P levels are associated with a poor prognosis. Hence, modulation of sphingolipid metabolism could be a promising therapeutic approach. BXQ-350 is a nanovesicle of Saposin C, an allosteric activator of sphingolipid metabolism, that lowers systemic S1P and increases C18 ceramide. BXQ-350 was investigated in a Phase 1 dose-escalation safety study in an cancer patients with advanced solid malignancies ( NCT02859857 ). BXQ-350 was safe and well-tolerated (no DLT, no MTD). Also, 13 patients (~17.8% of evaluable patients) had a clinical benefit up to cycle 6 and beyond (PR, SD). Among patients with PFS > 6 months, there were 4 recurrent CRC patients: 1 patient had a PFS of ~12 months, 2 of ~18 months, and 1 is still on study after 6 years. Furthermore, there were signs that BXQ-350 may alleviate symptoms of CIPN as 4 out of 10 patients with chronic CIPN at time of enrollment experienced an improvement of their symptoms. Methods: BXQ-350 is being investigated in a Phase 1b/2 study in combination with mFOLFOX7 and Bevacizumab in newly diagnosed mCRC patients (NCT05322590) to assess the efficacy and safety of BXQ-350. Design of the Phase 1b (open label study): A safety dose escalation part to establish the RP2D: patients will initially receive 1.8 mg/kg BXQ-350 in combination with mFOLFOX7 and Bevacizumab. If safe (no MTD), dose of BXQ-350 will be increased to 2.4 mg/kg and 9 additional patients will be entered at this dose level. If safe, then this dose will be the RP2D and 21 additional patients will be enrolled, completing a 30 patient expansion cohort; Efficacy will then be evaluated for all patients entered at the RP2D. Primary objectives of the Phase 1b are to assess safety, identify RP2D, and assess preliminary efficacy of BXQ-350 in this combination. A secondary objective is to determine if BXQ-350 decreases CIPN. Design of the Phase 2, a double-blinded, placebo-controlled study: Eligible patients (up to 160 patients) will be randomized in a 1:1 fashion to receive either BXQ-350 or placebo with mFOLFOX7 + Bevacizumab. Primary and secondary objectives include efficacy, safety and CIPN incidence. Enrollment in the Phase 1b dose escalation portion is completed. After review of the safety results, the DSMB approved enrollment of the expansion cohort, with a planned 30 patients at the Phase 2 dose. Available Phase 1b data will be presented. Clinical trial information: NCT05322590.

  PublisherDOI

• FOLFOX Induced Interstitial Lung Disease

  2024-04-30 · 1 citations

  articleSenior author
  PublisherDOI

• Abstract PS5-37: The feasibility of obtaining oncotype DX breast recurrence score® results from metastatic sites of patients with hormone receptor positive metastatic breast cancer

  Cancer Research · 2021-02-15

  article1st authorCorresponding

  Abstract Background: Identifying when to start CDK4/6 inhibitors or use chemotherapy in hormone receptor positive (HR+) metastatic breast cancer (MBC) remains challenging. The 21-gene Oncotype DX Breast Recurrence Score® test is validated to predict chemotherapy benefit in early stage HR+ breast cancer but has not been studied for use in the MBC setting.Objective: To assess the feasibility of obtaining Recurrence Scores from metastatic sites after standard of care biopsy in HR+, HER2 negative patients and correlate Recurrence Score results from matched primary breast cancer when available. Methods: A total of 48 metastatic biopsies were retrieved retrospectively from the residual tissue of patients with primary HR+, HER2 negative breast cancer. This included 36 from bone and 12 from other sites [liver (7), lung (1), rectum (1), brain (1), skin (2)]. Slides were sent to Genomic Health Inc. for RNA isolation and Recurrence Score result determination using standardized protocols. Recurrence Score results were available for 18 matched primary and metastatic biopsy samples. The percent success rate for Recurrence Score result was determined for the various metastatic sites and results compared between matched primary and metastatic site. Results: Recurrence Score results were obtained in 48% of metastatic biopsies (23 of 48 samples) including bone (17), liver (4), lung (1), and skin (1). Reasons for Recurrence Score failure included insufficient RNA (17), poor quality RNA (1), failed QC (4), and other (3). The mean Recurrence Score from the 23 metastatic sites was 35 (range: 1–66). Notably, 70% (16/23) of successful metastatic biopsies yielded Recurrence Scores in the high-risk range (>25). None of the 23 metastatic biopsies gained HER2 by RT-PCR. Among the 18 paired samples, higher recurrence score results were observed in all but three of the metastatic biopsy samples with mean Recurrence Score results of 20 (range 7 to 41) for the primary and 35 (range 1-66) for the metastatic site. For paired samples, 72% of metastatic biopsies yielded Recurrence Scores >25 compared to 17% of primary sample. Primary Recurrence Scores were not predictive of metastatic scores (r2=0.052). Estrogen receptor (ER) expression status was conserved in 87% whereas progesterone receptor (PR) was lost in 69% of the metastatic lesion. Among the pairs, 5 had de novo metastatic disease. In these, the Recurrence Score was higher in the metastatic biopsy in each case compared to the matched primary (mean 36 versus 23, respectively). Among de novo cases, there was 100% concordance in ER positive and HER2 negative expression and only 60% concordance in PR expression between primary and metastatic sites. Conclusion: Using standard of care metastatic biopsy samples, a Recurrence Score result was successfully generated in 48% of samples including bone. This small series demonstrates wide variability in Recurrence Score results in metastatic disease with overall higher scores, common loss of PR, and minimal correlation to matched primary disease. Further examination of the potential significance of the Recurrence Score for treatment decisions in the metastatic setting requires additional tissue sampling during biopsy as insufficient RNA was the primary reason for failure. Citation Format: Julie Anne L Gemmill, Patricia Thompson, Rebecca Batiste, Caterina Vacchi-Suzzi, Christina Preece, Jules Cohen, Lea Baer, Carolyn Mies, Michelle Turner, Christy A Russell, Alison Stopeck. The feasibility of obtaining oncotype DX breast recurrence score® results from metastatic sites of patients with hormone receptor positive metastatic breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS5-37.

  PublisherDOI

• Managing dermatologic changes of targeted cancer therapy.

  PubMed · 2020-04-29 · 1 citations

  article

  Failure to control these dermatologic changes can lead to lower dosages of cancer agents or an interrupted course of Tx. These steps can help you to head off trouble.

  Publisher

• Anti-PD-1-Related Exacerbation of Interstitial Lung Disease in a Patient with Non-Small Cell Lung Cancer: A Case Presentation and Review of the Literature

  Cancer Investigation · 2020 · 8 citations

  1st authorCorresponding
  • Medicine
  • Oncology
  • Internal medicine

  Immunotherapy is standard first-line therapy for advanced non-small cell lung cancer (NSCLC) either alone or in combination with chemotherapy. Despite significant benefits, immune checkpoint inhibitors (ICI) can cause toxicities within any organ, termed immune related adverse events. Pneumonitis is a potentially life-threatening complication of ICIs. Currently, there are no established guidelines for use of ICIs in patients with underlying autoimmune or interstitial lung disease (ILD) and few studies have been published. We present a case of first-line ICI-chemotherapy in a patient with metastatic NSCLC and ILD who suffered treatment related lung toxicity and acute worsening ILD, which lead to his death.

  PublisherDOI

• Hypothalamic-Pituitary-Adrenal Axis Responses in Women with Endometriosis-Related Chronic Pelvic Pain

  Reproductive Sciences · 2020 · 23 citations

  • Medicine
  • Internal medicine
  • Endocrinology
  PublisherOA PDFDOI

Frequent coauthors

• Pamela Stratton

  National Institutes of Health

  23 shared

• Ninet Sinaii

  National Institutes of Health Clinical Center

  20 shared

• James H. Segars

  Johns Hopkins Medicine

  16 shared

• George P. Chrousos

  Children's Hospital Agia Sophia

  13 shared

• Barbara J. Stegmann

  12 shared

• I. Khachikyan

  National Institutes of Health

  10 shared

• Mary Lou Ballweg

  7 shared

• R. Nandagopal

  Washington State University Spokane

  6 shared

Education

• B.S.

  New York University

• M.S.

  New York Institute of Technology College of Osteopathic Medicine

• M.D.

  New York Institute of Technology College of Osteopathic Medicine