alextatug (ATRC-101) / Atreca - LARVOL DELTA

A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=87 | Terminated | Sponsor: Atreca, Inc. | Phase classification: P1b ➔ P1 | N=240 ➔ 87 | Trial completion date: Mar 2025 ➔ Nov 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Nov 2023; Sponsor Decision

Combination therapy • Enrollment change • Metastases • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Fallopian Tube Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • BRAF • MSI • TMB

A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies (clinicaltrials.gov) - P1b | N=240 | Active, not recruiting | Sponsor: Atreca, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Monotherapy • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Fallopian Tube Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • BRAF • MSI • TMB

Former Big Pharma darling Atreca axes lead drug, 40% of staff in last-ditch pivot to ADCs (FierceBiotech) - "With its cash running low and share price in the basement, the biotech has decided to stop work on its lead candidate, switch its focus to preclinical antibody-drug conjugates (ADCs) and lay off 40% of its staff....Having laid off 25% of its staff and dropped a near-clinical candidate over safety signals last year, Atreca disclosed its biggest pivot yet after the stock market closed Thursday. The biotech is suspending work on its early-phase antibody candidate ATRC-101 and almost halving its head count. Atreca had 90 full-time employees at the end of last year."

Commercial • Discontinued • Oncology • Solid Tumor

Interim update of the ATRC-101 phase 1b trial in advanced solid tumors. (ASCO 2023) - P1b | "ATRC-101 alone and in combination with pembrolizumab continues to be well tolerated with evidence of anti-tumor activity. Interim data support ongoing enrollment of pts with RNP+ve pre-tx tumors. Updated and new data including durability of disease control will be presented."

Metastases • P1 data • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Atreca Presents Data from Ongoing Phase 1b Study of ATRC-101 in Patients with Select Advanced Solid Tumors during Oral Abstract Session at the ASCO 2023 Annual Meeting (GlobeNewswire) - P1 | N=240 | NCT04244552 | Sponsor: Atreca, Inc. | "ATRC-101 has been generally well-tolerated. Treatment emergent adverse events of Grade ≥3 occurred in 27 (38%) participants and were deemed related to ATRC-101 in 2 (3%). None led to treatment discontinuation or dose reduction due to ATRC-101....Among the 17 participants with a high target expression at screening treated with monotherapy at the higher dose levels, disease control was observed in 59% (10 of 17 patients) including 9 (53%) patients with stable disease (SD) and one (6%) patient with a partial response (PR)....Longer progression-free survival was observed in patients with high target expression treated in the 3, 10 and 30 mg/kg dose cohorts."

P1 data • Oncology • Solid Tumor

Interim clinical update of the Phase 1b trial of ATRC-101 as monotherapy or in combination with pembrolizumab for select advanced solid tumors (SITC 2022) - P1b | "The latter participant had previously progressed during treatment with nivolumab. Trial Registration NCT04244552 Ethics Approval This trial was approved by the institutional review board or ethics committee as required for each participating site. View this table: View inline View popup Download powerpoint Abstract 717 Table 1 Cumulative safety data as of February 15, 2022"

Clinical • Combination therapy • IO biomarker • Monotherapy • P1 data • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD8

Atreca Reports First Quarter 2023 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Atreca reported additional data from the ongoing Phase 1b study of ATRC-101 monotherapy and in combination with pembrolizumab in patients with select solid tumor cancers, with ATRC-101 continuing to be well tolerated and clinical activity observed in multiple tumor types with a correlation observed between target expression and progression free survival. Atreca is enrolling additional patients at a dose level of 30mg/kg in both the Q3W monotherapy and combination therapy arms and expects to report additional data and provide details on its potential Phase 2 development plans by the end of 2023. Data from the Phase 1b study of ATRC-101 will be presented during an oral abstract session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. The oral abstract session will be held on June 4, 2023, from 9:45am – 12:45pm CDT."

P1 data • Pipeline update • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Atreca Announces Oral Presentation of ATRC-101 Phase 1b Study Data at ASCO 2023 Annual Meeting (GlobeNewswire) - "Atreca...announced that data from the Phase 1b study of ATRC-101 will be presented during an oral abstract session at the American Society of Clinical Oncology 2023 Annual Meeting, being held June 2-6, 2023 in Chicago, Illinois."

P1 data • Oncology • Solid Tumor

Atreca Reports Fourth Quarter and Full-Year 2022 Financial Results and ATRC-101 Data Update (GlobeNewswire) - "Additional data from the ongoing study will inform a future decision concerning whether to advance ATRC-101 into Phase 2 studies and in which indications. Atreca expects to report additional data from the Phase 1b study and provide details on its potential Phase 2 development plans by the end of 2023....APN-497444 (‘444) is an Atreca-discovered antibody targeting a novel, tumor-specific glycan.... Atreca expects to nominate a clinical candidate from the program in 2023 and is targeting an IND submission in late 2024....APN-346958 (‘958)...Atreca and Xencor expect to name a candidate from the program in 2023 and target an IND submission by early 2025."

IND • New P2 trial • P1 data • Oncology

[VIRTUAL] Cooperation between checkpoint inhibitors targeting the PD-1 / PD-L1 axis and ATRC-101, a novel clinical-stage candidate for the treatment of solid tissue malignancies (SITC 2020) - P1b | "Conclusions In situ studies suggest the target of ATRC-101 may co-locate with PD-L1, and in vivo studies indicate that ATRC-101 administration increases PD-L1 transcripts and PD-1-positive infiltrates in mouse tumor. Altogether, our data support studies to combine ATRC-101 with agents targeting PD-1 in the clinical treatment of solid tissue malignancies."

Checkpoint inhibition • Clinical • IO Biomarker • Oncology • Solid Tumor • CD8

Atreca Reports Third Quarter 2022 Financial Results and Provides Pipeline Update (GlobeNewswire) - "Atreca continued enrolling patients in its ongoing Phase 1b study of ATRC-101 based on ATRC-101 target expression in archival or newly obtained biopsies. To-date, 67 participants have been enrolled across the monotherapy and pembrolizumab combination cohorts of the study. The Company has taken steps to accelerate enrollment in the trial, including initiating additional trial sites and streamlining enrollment criteria. Atreca now expects to present updated monotherapy and combination data from the trial in the first quarter of 2023."

Enrollment status • P1 data • Oncology • Solid Tumor

First-in-human results with the novel tumor-targeting antibody ATRC-101: phase 1b study in patients with solid tumors (SITC 2021) - P1b | "Trial sites have been activated to test ATRC-101 in combination with pembrolizumab, and combination with chemotherapy is also planned. Trial Registration Trial Registration: NCT04244552"

Clinical • P1 data • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8

Atreca Announces Poster Presentations at Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Atreca...announced two poster presentations at the SITC 2022 Annual Meeting, being held November 8-12 in Boston, Massachusetts....The ATRC-101 poster presentation is a trial-in-progress update and will not include new clinical data."

Clinical protocol • Preclinical • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mobilization of innate and adaptive antitumor immune responses by the RNP-targeting antibody ATRC-101. (PubMed, Proc Natl Acad Sci U S A) - "Preclinical data suggest a mechanism of action in which ATRC-101 activates myeloid cells of the innate immune system, leading to an adaptive immune response that yields its antitumor activity. These data have led to an ongoing phase 1 trial in patients with advanced solid tumors."

Journal • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Atreca Announces Publication in PNAS: “Mobilization of Innate and Adaptive Antitumor Immune Responses by the RNP-Targeting Antibody ATRC-101” (GlobeNewswire) - "Atreca...announced the peer-reviewed publication of preclinical data demonstrating how its lead product candidate, ATRC-101, activates the immune system and drives tumor destruction...The PNAS publication details the discovery and preclinical development of ATRC-101, which was identified via a target-agnostic process evaluating antibodies produced by the plasmablast population of B cells in a patient experiencing an antitumor immune response during treatment with checkpoint inhibitor therapy."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Atreca Reports Fourth Quarter and Full-Year 2021 Financial Results and ATRC-101 Data Update (GlobeNewswire) - P1 | N=190 | NCT04244552 | Sponsor: Atreca, Inc. | "Among participants treated at the higher dose levels who were evaluable for target expression and response, stable disease (SD) (n=6), PR (n=1) or CR (n=1) was observed in 8 of 12 (66%) with a screening H-score ≥ 50 (high)....A confirmed CR was observed in a melanoma participant (H-score high) in the pembrolizumab combination cohort who had progressed on prior anti-PD-1 and combined BRAF/MEK inhibitor therapy. In the monotherapy cohorts, a participant with non-small cell lung cancer (H-score high) achieved PR with 48% reduction in tumor burden, and a participant with colorectal cancer (H-score unknown) experienced a 29% reduction."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

Preclinical evaluation of pegylated liposomal Doxorubicin or Doxorubicin with mATRC-101 in the EMT6 syngeneic mouse model (SITC 2021) - "Exposure to Doxorubicin or PLD in EMT6 tumor-bearing mice increased mATRC-101 immunoreactivity in the tumor, in a dose-dependent manner Moreover, mATRC-101 immunoreactivity in normal tissues was not influenced by Doxorubicin or PLD. Taken together, these findings support clinical evaluation of the combination of ATRC-101 and doxorubicin."

Preclinical • Oncology • Solid Tumor

Atreca Reports Third Quarter 2021 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Enrollment in the monotherapy portion of the Phase 1b trial of ATRC-101 is ongoing at 30 mg/kg and Atreca plans to report additional monotherapy data in mid-2022....Enrollment has commenced in a Phase 1b combination cohort evaluating ATRC-101 with pembrolizumab. Another combination cohort with pegylated liposomal doxorubicin ('PLD') is expected to begin enrolling patients following completion of ongoing monotherapy cohorts, including those following a Q2W dosing schedule which better aligns with the standard PLD regimen. Atreca plans to report additional monotherapy data in mid-2022 and pembrolizumab combination data in 3Q22."

Enrollment status • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Atreca Announces Poster Presentations at the Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - “Atreca, Inc….announced two poster presentations at the SITC 2021 Annual Meeting, which is being held November 10-14, 2021 in Washington, D.C.”

P1 data • Preclinical • Oncology • Solid Tumor

[VIRTUAL] Cooperation between checkpoint inhibitors targeting the PD-1 / PD-L1 axis and ATRC-101, a novel clinical-stage candidate for the treatment of solid tissue malignancies (SITC 2020) - P1b | "Conclusions In situ studies suggest the target of ATRC-101 may co-locate with PD-L1, and in vivo studies indicate that ATRC-101 administration increases PD-L1 transcripts and PD-1-positive infiltrates in mouse tumor. Altogether, our data support studies to combine ATRC-101 with agents targeting PD-1 in the clinical treatment of solid tissue malignancies."

Checkpoint inhibition • Clinical • IO Biomarker • Oncology • Solid Tumor • CD8

[VIRTUAL] First-in-human phase Ib study of ATRC-101, an engineered version of a patient-derived antibody targeting a tumor-restricted ribonucleoprotein complex. (ASCO 2020) - P1b | "Secondary objectives are to characterize the pharmacokinetic profiles of ATRC-101 and to assess antitumor activity as determined by RECIST 1.1 and lymphocytic infiltration in the tumor microenvironment. Research Funding: Atreca, Inc."

Clinical • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Thoracic Cancer • CD8

[VIRTUAL] First-in-human phase 1b study of ATRC-101, a patient-derived antibody with a tumor-specific target, as monotherapy or in combination with pembrolizumab, in patients with solid tumors (AACR 2021) - P1b | "Trial registration NCT04244552. The study was approved by the institutional review board of each participating site."

Clinical • Combination therapy • Monotherapy • P1 data • Breast Cancer • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Atreca Reports Second Quarter 2021 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Phase 1b monotherapy dose expansion of ATRC-101 is ongoing at 30 mg/kg. A combination study evaluating ATRC-101 with pembrolizumab is active and another combination study with pegylated liposomal doxorubicin is expected to begin enrolling patients in 4Q21. Atreca expects to report additional monotherapy data in 1H22, pembrolizumab combination data in mid-2022 and chemotherapy combination data in late 2022."

New trial • P1 data • Oncology • Solid Tumor

Atreca Presents Initial Clinical Data from Phase 1b Trial of ATRC-101 in Select Advanced Solid Tumors (GlobeNewswire) - P1b, N=160; NCT04244552; Sponsor: Atreca, Inc; “Atreca, Inc…announced initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types that displayed greater than 50% target expression in preclinical studies…Disease control observed in the study was associated with target expression, as 3 of 6 (50%) of participants with evaluable response assessments and baseline tumor H-scores ≥50 achieved SD, compared with 1 of 9 (11%) evaluable participants with an H-score <50….Phase 1b monotherapy dose expansion is ongoing at 30 mg/kg, a combination study evaluating ATRC-101 with pembrolizumab is active and another combination study with pegylated liposomal doxorubicin is expected to begin enrolling patients in 4Q21. Atreca expects to report additional monotherapy data by mid-2022, pembrolizumab combination data in mid-2022 and chemotherapy combination data in late 2022.”

Enrollment status • P1 data • Oncology • Solid Tumor

Atreca to Host Webcast Presentation of Initial Clinical Data from Phase 1b Trial of ATRC-101 (GlobeNewswire) - “Atreca, Inc…announced it will host a webinar to present initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types on Thursday, July 29, 2021, at 8:00 a.m. ET.”

New P1 trial • Oncology • Solid Tumor