DeTIL-0255 / Nurix Therap - LARVOL DELTA

NX-DeTIL-0255-201: A Study of DeTIL-0255 in Adults With Advanced Malignancies (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: Nurix Therapeutics, Inc. | N=50 ➔ 5 | Trial completion date: Jul 2026 ➔ May 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ May 2023; Sponsor Decision

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Cervical Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

NX-0255 AND NX-1607, SMALL MOLECULE INHIBITORS OF CBL-B, ARE EFFICACIOUS IN COMBINATION WITH ADOPTIVE CELL THERAPY OR RITUXIMAB IN PRECLINICAL MOUSE MODELS OF LYMPHOMA (ICML 2023) - P1, P1b | "We have initiated a clinical trial with NX-1607 (NCT05107674) in patients with advanced cancer including solid tumors and malignant lymphoma, including large B cell lymphoma. Nurix has also completed the safety run-in portion of a Phase 1 trial evaluating NX-0255 in the production of an investigational drug-enhanced TIL therapy, DeTIL-0255 (NCT05107739)."

Combination therapy • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD8

Universal Expansion of CBL-B-inhibited Tumor Infiltrating Lymphocytes, DeTIL-0255, from Women with Ovarian Cancer: Process Validation (SITC 2022) - P1 | "Conclusions OC DeTIL-0255 demonstrate a favorable phenotype amenable for ACT. A Phase 1 clinical study of DeTIL-0255 in women with recurrent/platinum resistant OC is ongoing ( NCT05107739 )."

Clinical • IO biomarker • Hematological Malignancies • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • B3GAT1 • CD4 • CD8 • IL2 • LAG3 • PD-1

The CBL-B inhibitor, NX-0255, enhances human drug enhanced tumor infiltrating lymphocyte (DeTIL) expansion and T cell function in full-scale runs (SITC 2022) - P1 | "We have initiated a clinical trial with DeTIL-0255 in patients with gynecologic malignancies. NCT05107739"

IO biomarker • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Solid Tumor • CD4 • CD69 • CD8 • ENTPD1 • GZMB • IFNG • IL2

NX-DeTIL-0255-201: A Study of DeTIL-0255 in Adults With Advanced Malignancies (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Nurix Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cervical Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Phase 1 adoptive cell therapy using drug-enhanced, tumor-infiltrating lymphocytes, DeTIL-0255, in adults with advanced malignancies (SITC 2022) - P1 | "The study is expected to enroll ~54 patients in ~10 sites across the United States. NCT05107739 Trial Registration NCT05107739 Ethics Approval The study obtained institutional review board(s) approval, and participants gave informed consent before taking part."

Clinical • P1 data • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • CD69 • CD8 • ENTPD1

A novel small molecule inhibitor of CBL-B shows potent antitumor activity in combination with Pmel-1 adoptive cell transfer in an aggressive mouse melanoma model (SITC 2022) - "Methods We have developed two highly potent small molecule inhibitors of CBL-B to increase T-cell antitumor function both in vitro (NX-0255) and in vivo (NX-1607). Treatment with NX-1607 induces a more favorable T cell phenotype compared to IL-2 treatment and is well tolerated. The observed antitumor effects of NX-1607 support its potential use in combination with cell-based therapeutics."

Combination therapy • IO biomarker • Preclinical • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Solid Tumor • CD8 • GZMB • TNFRSF9

Nurix Announces DeTIL-0255 Scientific Presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) and Successful Completion of DeTIL-0255 Phase 1 Safety Run-in (GlobeNewswire) - "The results presented in this poster demonstrate that production of ACT supported by ex vivo use of NX-0255 combined with in vivo oral treatment with NX-1607: Increases the antitumor activity of the transferred T cells when compared to ACT alone and Induces a more favorable anti-tumor activity phenotype of the adoptively transferred T cells compared to treatment with IL-2."

Preclinical • Oncology • Solid Tumor

Nurix Announces DeTIL-0255 Scientific Presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) and Successful Completion of DeTIL-0255 Phase 1 Safety Run-in (GlobeNewswire) - "Nurix also announced the successful completion of the safety run-in portion of the ongoing Phase 1 trial of DeTIL-0255 in patients with advanced gynecologic malignancies and revealed that it has received feedback from the FDA regarding the potential combination of DeTIL-0255 with the oral CBL-B inhibitor NX-1607....Pending successful completion of Nurix’s NX-1607 Phase 1a dose escalation trial, we envision expanding the use of NX-1607 as a single agent in selected indications in 2023."

FDA event • Trial status • Gynecologic Cancers • Oncology • Solid Tumor

A phase 1 adoptive cell therapy using drug-enhanced, tumor-infiltrating lymphocytes, DeTIL-0255, in adults with advanced malignancies. (ASCO 2022) - P1 | "Key eligibility criteria include measurable disease, a resectable lesion for TIL harvest, ≥2 prior lines of therapy, and an Eastern Cooperative Oncology Group performance status 0 or 1. The study is expected to enroll ̃54 patients in ̃10 sites across the United States."

Clinical • P1 data • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Targeted Protein Degradation • CD69 • CD8 • ENTPD1

Nurix Therapeutics Reports Third Quarter Fiscal 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Upcoming Program Highlights - DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Nurix anticipates providing a clinical update from the run-in portion of the DeTIL-0255 Phase 1 study by the end of 2022."

P1 data • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer

Nurix Therapeutics Announces Six Poster Presentations at the Upcoming Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting (GlobeNewswire) - "'Our presentations at SITC highlight the versatility of our targeted protein modulation platform and applications of our first-in-class CBL-B inhibitors which include both an orally administered agent, NX-1607, and our infused DeTIL-0255 cell therapy,' said Arthur T. Sands, M.D., Ph.D., president, and chief executive officer of Nurix. 'With respect to NX-1607, we are excited to present the initial biomarker data from our Phase 1 trial in patients with advanced malignancies."

Biomarker • P1 data • Preclinical • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Ovarian Cancer • Solid Tumor

Nurix Therapeutics Will Present Trial in Progress Posters for Three Clinical Programs at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (GlobeNewswire) - "Nurix Therapeutics, Inc...announced that the company will present clinical trial design details for three of its wholly-owned investigative therapies, NX-2127, DeTIL-0255 and NX-1607, each currently in Phase 1 development, at the Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting is being held from June 3-7, 2022 in Chicago, IL and virtually."

P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Nurix Therapeutics Doses First Patient in Phase 1 Clinical Trial of DeTIL-0255, a Drug-Enhanced Cell Therapy for the Treatment of Patients with Solid Tumors (GlobeNewswire) - "Nurix Therapeutics...announced that the first patient has been dosed in its Phase 1 clinical trial of DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte therapy and the lead candidate in its cellular therapy portfolio. The trial is designed to evaluate the safety and efficacy of DeTIL-0255 in patients with advanced gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer....Nurix expects to provide a clinical update from the safety run-in portion of the Phase 1 study in the second half of 2022."

P1 data • Trial status • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer

Nurix Therapeutics Presents New Preclinical Data Supporting NX-2127 and DeTIL-0255 Clinical Programs at the American Association for Cancer Research Annual Meeting (GlobeNewswire) - "These presentations showing the unique activity of two proprietary small molecule protein modulators...NX-0255,provide clear scientific rationale supporting our ongoing clinical programs for...DeTIL-0255 for solid tumors. We plan to provide clinical updates from both programs in the second half of 2022.”Additional details include: Mice treated with T-cells cultured with a combination of NX-0255 and IL-2 demonstrated superior anti-tumor activity and survival vs. T cells cultured with NX-0255 or IL-2 alone. T-cells cultured with NX-0255 persisted longer in circulation. The addition of NX-0255 increased the frequency and absolute numbers of less exhausted CD8+ memory T-cells, increasing their in vivo persistence and ability to infiltrate the tumor."

Clinical • Preclinical • Oncology • Solid Tumor

Nurix Therapeutics to Present Preclinical Data from Its Novel BTK Degrader (NX-2127) and CBL-B Inhibitor (NX-0255) Programs at the American Association for Cancer Research Annual Meeting (GlobeNewswire) - "Nurix Therapeutics...announced that preclinical data supporting its NX-2127 and DeTIL-0255 clinical programs will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting, which is being held from April 8-13, 2022 in New Orleans, LA."

Preclinical • Oncology • Solid Tumor

A Study of DeTIL-0255 in Adults With Advanced Malignancies (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Nurix Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Upcoming Program Highlights: (i) Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in mid-2022; (ii) DeTIL-0255: Nurix anticipates dosing the first patient in the first half of 2022 and providing a clinical update from the run-in portion of the study in the second half of 2022."

Biomarker • P1 data • PK/PD data • Trial status • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Nurix Therapeutics Advances Clinical and Preclinical Pipeline and Outlines 2022 Catalysts (GlobeNewswire) - "Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in mid-2022; Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Nurix anticipates dosing the first patient in the first half of 2022 and providing a clinical update from the run-in portion of the study in the second half of 2022."

P1 data • Trial status • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

NX-0255, a small molecule CBL-B inhibitor, expands and enhances tumor infiltrating lymphocytes (TIL) for use in adoptive cancer immunotherapy (SITC 2021) - "Adoptive transfer of DeTIL-0255 may increase persistence and exhibit broader functional activity than conventional TIL, potentially conferring improved anti-tumor activity. Taken together, these data support the clinical development of DeTIL-0255 for the treatment of patients with cancer."

IO biomarker • Breast Cancer • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Solid Tumor • Vulvar Cancer • CCR7 • CD8 • GZMB • HAVCR2 • IL2 • IL7R • LAG3 • LAMP1 • PD-1 • TNFRSF9

Nurix Therapeutics Presents Beneficial Effects of CBL-B Inhibition on Human Tumor Infiltrating Lymphocytes at SITC Conference (GlobeNewswire) - "Compared to TIL, DeTIL-0255 demonstrated: Increased T cell expansion (p<0.001); Reduced expression of markers associated with T cell exhaustion such as PD-1, LAG-3 and TIM-3 (p<0.05); Increased cytotoxicity as measured by increased perforin, granzyme B, and the degranulation marker CD107a (p<0.001); Increased 4-1BB, a surrogate marker of tumor reactivity (p<0.05); and Increased T cell receptor diversity (p<0.05). Taken together, these findings support advancing DeTIL-0255 into human clinical trials as a potentially superior, drug-enhanced TIL product candidate."

Preclinical • Oncology

Nurix Therapeutics Announces IND clearance for DeTIL-0255, a drug-enhanced autologous T cell therapy for the potential treatment of a variety of solid tumors (GlobeNewswire) - "Phase 1 clinical trial initiation anticipated by year-end 2021...Nurix Therapeutics, Inc...announced that the Food and Drug Administration (FDA) has cleared Nurix’s Investigational New Drug Application (IND) for its lead cell therapy product candidate DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte (TIL) therapy...The Phase 1 trial of DeTIL-0255 is an open-label, non-randomized clinical trial anticipated to enroll up to 50 patients with gynecological malignancies following a safety run-in. "

IND • Trial status • Cervical Cancer • Gynecologic Cancers • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

A Study of DeTIL-0255 in Adults With Advanced Malignancies (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Nurix Therapeutics, Inc.

Clinical • New P1 trial • Cervical Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Nurix Therapeutics Reports First Quarter Fiscal 2021 Financial Results and Provides a Corporate Update (GlobeNewswire) - “Nurix anticipates initiating a Phase 1 trial for NX-1607 in the second half of 2021…Nurix anticipates initiating a Phase 1 trial for NX-5948 in patients with hematologic malignancies in the second half of 2021…Nurix anticipates initiating a Phase 1 trial for DeTIL-0255 in the second half of 2021.”

New P1 trial • Hematological Malignancies • Oncology • Solid Tumor