SL-279252 / Shattuck - LARVOL DELTA

First-in-human, phase 1 dose escalation study of SL-279252, a hexameric PD1-Fc-OX40L fusion protein, in patients with advanced solid tumors and lymphoma. (PubMed, Invest New Drugs) - P1 | "Trial register number NCT03894618. Trial registration date 28-March-2019."

Journal • P1 data • Fatigue • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Oncology • Solid Tumor • CD4 • CD8 • PD-1 • TNFSF4

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1 | N=49 | Completed | Sponsor: Shattuck Labs, Inc. | Active, not recruiting ➔ Completed | N=87 ➔ 49

Enrollment change • Metastases • Trial completion • Anal Carcinoma • Cervical Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • ALK • EGFR • MSI

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1 | N=87 | Active, not recruiting | Sponsor: Shattuck Labs, Inc. | Trial primary completion date: Jul 2023 ➔ Dec 2023

Trial primary completion date • Anal Carcinoma • Cervical Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • ALK • EGFR • MSI

Development of an integrated method to quantify receptor occupancy for agonist immunotherapeutics that stimulate target cells to migrate from the peripheral blood (SITC 2021) - P1 | "SL-172154 (SIRPα-Fc-CD40L) and SL-279252 (PD1-Fc-OX40L) are two bi-functional fusion proteins in phase I clinical trials (NCT04406623 and NCT03894618)...An integrated assessment, termed ‘receptor engagement’, was developed to derive RO both on circulating cells and those that rapidly marginated. When CD40+ or OX40+ cells returned to the blood, they remained drug-bound, indicating that the compounds may piggy-back on target cells into tissues."

Oncology • CD40LG • PD-1 • SIRPA

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1 | N=87 | Active, not recruiting | Sponsor: Shattuck Labs, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Anal Carcinoma • Cervical Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • ALK • EGFR • MSI

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1 | N=87 | Recruiting | Sponsor: Shattuck Labs, Inc. | Trial completion date: Dec 2022 ➔ Oct 2023 | Trial primary completion date: Nov 2022 ➔ Jul 2023

Metastases • Trial completion date • Trial primary completion date • Anal Carcinoma • Cervical Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • ALK • EGFR • MSI

Shattuck Labs Reports Fourth-Quarter and Full-Year 2022 Financial Results and Provides Business Updates (GlobeNewswire) - "Completed Phase 1 Dose Escalation Clinical Trial of SL-279252 in Advanced Solid Tumors and Announces Discontinuation of Clinical Development of the SL-279252 Program....Our internal benchmark for continued program development of SL-279252 was response rates equal or exceeding 20% in the 12 and 24 mg/kg cohorts. We did not observe an overall response rate necessary to justify continued development in a very difficult PD-1 relapsed/refractory patient population, and we are announcing the discontinuation of clinical development of SL-279252."

Discontinued • Trial status • Oncology • Solid Tumor

Shattuck Labs Provides Corporate Update and Highlights Upcoming Key Milestones in 2023 (GlobeNewswire) - "Clinical Milestones Expected in 2023: SL-172154: Initial data from Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in platinum-resistant ovarian cancer expected 2H’2023; SL-279252: Go/no-go decision from the Phase 1 dose-escalation clinical trial of SL-279252 in advanced solid tumors or lymphoma in 1Q’2023."

P1 data • Pipeline update • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

Shattuck Labs Reports First Quarter 2021 Financial Results and Recent Business Highlights (GlobeNewswire) - "IND filings for SL-172154 in hematologic malignancies anticipated in the second half of 2021...SL-279252: Initiation of one or more dose-expansion cohorts expected in the second half of 2021."

IND • New trial • Hematological Malignancies • Oncology

Phase 1 dose escalation and dose expansion study of an agonist redirected checkpoint (ARC) fusion protein, SL-279252 (PD1-Fc-OX40L), in subjects with advanced solid tumors or lymphomas (SITC 2021) - P1 | "Trends for PK/PD effects at ≥1 mg/kg suggests dose exploration in PD-L1 expressing cancers is warranted beyond 6 mg/kg. Trial Registration NCT03894618"

Clinical • IO biomarker • P1 data • Eye Cancer • Hematological Malignancies • Lymphoma • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • CD4 • PD-1 • PD-L1

Shattuck Labs Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Business Highlights (GlobeNewswire) - P1 | N=87 | NCT03894618 | Sponsor: Shattuck Labs, Inc. | "SL-279252 was well tolerated across a dose-range of 0.0001 mg/kg through 6.0 mg/kg, and dose-dependent margination of CD4+OX40+ T cells was the primary pharmacodynamic effect observed and had not plateaued through the 6.0 mg/kg dose level. Monotherapy anti-tumor activity was observed at doses of 1.0 mg/kg and higher, including a confirmed partial response in a PD-1 and CTLA-4 inhibitor experienced ocular melanoma patient who remained on therapy for over 12 months....Additional dose-escalation data from the trial are expected in the second half of 2022."

P1 data • Oncology • Solid Tumor

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1 | N=87 | Recruiting | Sponsor: Shattuck Labs, Inc. | Trial completion date: Apr 2022 ➔ Dec 2022 | Trial primary completion date: Feb 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Anal Carcinoma • Cervical Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • ALK • EGFR • MSI

Shattuck Labs Announces Preliminary Clinical Data from Ongoing Phase 1 Clinical Trials of ARC Fusion Proteins SL-172154 and SL-279252 (GlobeNewswire) - P1, N=40; NCT04406623; P1, N=87; NCT03894618; Sponsor: Shattuck Labs, Inc; "For SL-172154 (SIRPα-Fc-CD40L), initial monotherapy Phase 1 dose-escalation data show favorable safety and tolerability for a CD40 agonist, high levels of CD47 target occupancy and CD40 target engagement, and escalating pharmacodynamic activity in heavily pretreated, platinum resistant ovarian cancer patients. For SL-279252 (PD1-Fc-OX40L), anti-tumor activity has been observed in heavily pretreated patients, including one confirmed partial response (PR), and a second unconfirmed PR, both in patients with PD-1/L1 inhibitor pretreated non-cutaneous melanoma. Both SL-172154 and SL-279252 have been well tolerated, and a recommended Phase 2 dose has not yet been identified."

P1 data • Fallopian Tube Cancer • Gynecologic Cancers • Melanoma • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Shattuck Labs to Host Conference Call and Webcast Highlighting Data Presented at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "During the event, the company will highlight dose-escalation data for SL-172154 (SIRPα-Fc-CD40L)...in platinum-resistant ovarian cancer patients, and dose-escalation data for SL-279252 (PD1-Fc-OX40L)...in patients with advanced solid tumors or lymphoma."

P1 data • Gynecologic Cancers • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

Shattuck Labs Reports Third Quarter 2021 Financial Results and Recent Business Highlights (GlobeNewswire) - "Corporate Updates: Shattuck and Takeda Mutually Agree to Termination of Collaboration Agreement: In November 2021, Shattuck and Takeda mutually agreed to termination of the Collaboration Agreement for SL-279252 and SL-115154, originally executed in 2017. Shattuck is no longer required to satisfy any remaining performance obligations, the Company will not make any payments to or receive any future milestone or royalty payments from Takeda, and all options to license and rights of first negotiation held by Takeda under the Collaboration Agreement were terminated."

Licensing / partnership • Oncology

Shattuck Labs Reports Third Quarter 2021 Financial Results and Recent Business Highlights (GlobeNewswire) - P1, N=87; NCT03894618; Sponsor: Shattuck Labs, Inc.; "Initial data from ongoing SL-279252 (PD1-Fc-OX40L) phase 1 dose-escalation clinical trial in advanced solid tumors demonstrate evidence of anti-tumor activity at the 36th Annual SITC Meeting....SL-279252 was well-tolerated in heavily pretreated subjects with refractory solid tumors with no maximum tolerated dose reached. A total of 16 patients were treated at doses of 1 mg/kg or higher on schedule 1. Best response was one confirmed partial response (iPR) (ocular melanoma, four prior systemic regimens, including PD-1 and CTLA-4 inhibitors) in a patient who remained on treatment for more than one year, and stable disease (iSD) in 12 patients (including 1 unconfirmed iPR)."

P1 data • Melanoma • Oncology • Solid Tumor

Shattuck Labs to Present Clinical Data on SL-172154 and SL-279252 and Preclinical Data on SL-9258 at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Shattuck Labs, Inc...announced it will present four posters at SITC’s 36th Annual Meeting being held Wednesday, November 10, 2021 to Sunday, November 14, 2021."

Clinical data • P1 data • Preclinical • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor

Shattuck Labs Reports Second Quarter 2021 Financial Results and Upcoming Phase 1 Dose Escalation Data for SL-172154 and SL-279252 (GlobeNewswire) - "Because very few of the patients treated to date are known to express PD-L1 within the tumor, Shattuck plans to enroll patients with known PD-L1 positive tumors in the additional dose level cohorts. The Phase 1 trial is an open label, multi-center, dose escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-279252 as monotherapy in patients with advanced solid tumors...An abstract containing data from the dose-escalation cohorts through 6.0 mg/kg has been submitted to the SITC Annual Meeting, to be held in November 2021."

P1 data • Trial status • Oncology • Solid Tumor

Shattuck Labs Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Highlights (GlobeNewswire) - "...Phase 1 Clinical Trial of SL-172154 in Ovarian Cancer:...Initial Phase 1 dose-escalation data from the trial are expected in the second half of 2021....Phase 1 Clinical Trial of SL-172154 in Head and Neck or Skin Squamous Cell Carcinoma: Initial Phase 1 dose-escalation data from the trial are expected in the first half of 2022....Phase 1 Clinical Trial of SL-279252: Phase 1 dose-escalation data from the trial are expected in the second half of 2021."

P1 data • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Shattuck Labs Reports Third Quarter 2020 Financial Results and Recent Business Highlights (GlobeNewswire) - “The Phase 1 trial will initially evaluate the safety, tolerability, and anti-tumor effects of SL-172154 in patients with ovarian cancer. Initial Phase 1 dose escalation data from the trial are expected in the second half of 2021. The Company is continuing to enroll patients in its Phase 1 clinical trial evaluating SL-279252…Phase 1 dose escalation data from the trial are expected in the second half of 2021.”

Enrollment status • P1 data • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

Shattuck Labs Announces Closing of $118 Million Series B Financing (Businesswire) - "The proceeds from the financing will be used to support the continued clinical development of SL-172154 (SIRPα-Fc-CD40L), a wholly-owned fusion protein that combines CD47 inhibition with CD40 co-stimulation, and SL-279252 (PD1-Fc-OX40L), Shattuck’s lead PD1 asset being developed in collaboration with Takeda Pharmaceuticals. Shattuck anticipates adding another clinical program in 2021 and continuing the development of an innovative pipeline of compounds for the treatment of cancer…"

Clinical • Financing • Oncology

Shattuck Labs, Inc. announces initiation of phase 1 clinical trial of SL-279252 (PD1/OX40L) (Businesswire) - "Shattuck Labs, Inc...that patients are being treated in its Phase 1 dose escalation and expansion clinical trial of its molecule SL-279252 (PD1/OX40L), a bi-functional fusion protein (https://clinicaltrials.gov/ct2/show/NCT03894618)....This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and anti-tumor activity of SL-279252 in patients with advanced solid tumors or lymphomas."

Trial status