TRPH-222 / Triphase Accelerator Corporation, Catalent, BMS - LARVOL DELTA

RESULTS FROM A PHASE I PHARMACOKINETIC (PK) AND SAFETY STUDY OF TRPH-222, A NOVEL CD22-TARGETING ANTIBODY-DRUG CONJUGATE, IN PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (R/R NHL) (EHA 2022) - "TRPH-222 monotherapy resulted in robust and durable CRs in FL across dose levels where patients were able to discontinue TRPH-222 while remaining in remissions. Collectively, these characteristics of TRPH-222 are favorable for further development in the indolent lymphoma setting either as monotherapy or in combination with other anti-tumor agents in B-cell lymphoma patients."

Clinical • P1 data • PK/PD data • Diffuse Large B Cell Lymphoma • Dry Eye Disease • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Ophthalmology • Thrombocytopenia • CD22

Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Triphase Research and Development III Corp. | Recruiting ➔ Completed | N=120 ➔ 32 | Trial completion date: Aug 2022 ➔ Nov 2021

Enrollment change • Trial completion • Trial completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Triphase Accelerator Announces Positive Updated Phase 1 Data with TRPH-222 in Non-Hodgkin’s Lymphoma (GlobeNewswire) - P1 | N=120 | NCT03682796 | Sponsor: Triphase Research and Development III Corp. | "Triphase Accelerator...announced updated results from its Phase 1 multi-center, open-label, monotherapy study of TRPH-222 in heavily pre-treated patients with relapsed and/or refractory (R/R) B-cell non-Hodgkin’s lymphoma (NHL)....Seven complete responses (CR: 5 FL, 1 DLBCL, 1 MCL) and three partial responses (PR: 2 FL, 1 TFL) have been observed at doses from 0.6 to 10 mg/kg. Five patients with metabolic CRs that were confirmed after 3 additional cycles are now off treatment and continue in CR; 3 patients remain in CR with responses maintained for up to 25 months."

P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Highlighting the Phase I Pharmacokinetics & Safety Study of TRPH-222 in Patients with Relapsed/ Refractory B-cell Non-Hodgkin Lymphoma (ADC London 2022) - "Summarise the SMARTag technology and Phase I study design Review of the safety and efficacy of TRPH-222 in R/R NHL Presenting our thoughts on future directions for ADCs using novel payload linkers and moving beyond cytotoxic payloads"

Clinical • P1 data • PK/PD data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] Phase I Pharmacokinetic (PK) & Safety Study of TRPH- 222 in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (ADC-USA 2021) - "Summarize the SMARTag technology and Phase 1 study design Review of the safety and efficacy of TRPH-222 in R/R NHL Presenting our thoughts on moving ADCs beyond the delivery of cytotoxic payloads"

Clinical • P1 data • PK/PD data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] Catalent’s SMARTag® Technology: Differentiated Solutions for Optimal ADCs (ADC-USA 2021) - "6 CRs and 2 PRs among 22 patients were achieved by TRPH-222, a CD22-targeted SMARTag conjugate, in the dose-escalation stage of a Phase 1 trial for R/R B-cell lymphoma. We are using new linkers to achieve proprietary high DAR ADCs featuring topoisomerase I inhibitor payloads. We have demonstrated conjugate stability—even with cleavable linkers—to deliver efficacy with improved tolerability and a wider therapeutic window."

Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD22

[VIRTUAL] A Phase I Pharmacokinetic (PK) and Safety Study of Trph-222 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R NHL): Dose-Escalation Results (ASH 2020) - "TRPH-222 monotherapy is well tolerated through dose-escalation to 10 mg/kg, with a low incidence of AEs commonly associated with ADCs such as thrombocytopenia, neutropenia, and peripheral neuropathy. The most common AEs included low grade and manageable ocular findings consistent with known epithelial keratopathy of ADCs bearing microtubule inhibitors. These data, together with 100% CD22 receptor occupancy observed at all dose levels, and CRs/PRs observed at doses levels less than 10 mg/kg, support further assessment of TRPH-222 monotherapy in an expansion cohort currently enrolling R/R FL and DLBCL patients."

Clinical • P1 data • PK/PD data • Diffuse Large B Cell Lymphoma • Dry Eye Disease • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Neuralgia • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Ophthalmology • Pain • Peripheral Neuropathic Pain • Thrombocytopenia • Transplantation

Triphase Accelerator Announces Positive Interim Results of Phase 1 Trial of TRPH-222 in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (GlobeNewswire) - P1, N=120; NCT03682796; Sponsor: Triphase Research and Development III Corp.; "Six complete responses (CR: 4 FL, 1 DLBCL, 1 MCL) and two partial responses (PR: 1 FL, 1 TFL) have been observed at doses from 0.6 to 7.5 mg/kg at the end of cycle 6. Five patients with CRs confirmed at the end of cycle 9 are now off treatment for up to 15 months while they continue to be in CR; patients are continuing to be followed for safety and response durability. The observed data, together with 100% CD22 receptor occupancy observed at all dose levels, and CRs/PRs observed at doses levels less than 10 mg/kg, support further assessment of TRPH-222 monotherapy in an expansion cohort currently enrolling R/R FL and DLBCL patients."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] TRPH-222: A Next-Generation ADC Targeting CD22 (PEGS 2020) - P1 | "TRPH-222 is a CD22-directed ADC, constructed via a novel, site-specific (SMARTag™) conjugation approach, resulting in highly controlled and reproducible drug loading. TRPH-222 is being studied in relapsed and/or refractory B cell lymphoma patients in a phase 1 clinical trial (NCT03682796); currently, the trial is enrolling patients in the dose-escalation phase, with promising tolerability, PK, and PD, as well as early signs of clinical efficacy in this single agent study."

Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] SMARTag® technology for the preparation of safe and efficacious site-specifically modified antibody-drug conjugates (ACS-Fall 2020) - "The lead SMARTag® ADC is TRPH-222, a CD22-targeting molecule featuring RED-106, a non-cleavable linker bearing a maytansine payload...A related ADC made using trastuzumab conjugated to RED-106 has shown improved tolerability and pharmacokinetics over ado-trastuzumab emtansine (T-DM1) in preclinical models of efficacy and toxicity. Similarly, a SMARTag® dual-release cleavable linker offers improved plasma stability and better tolerability relative to standard cleavable linker motifs as highlighted by data from monomethylauristatin E (MMAE) conjugates. With impressive manufacturability, simplified analytics, and improved tolerability relative to other approaches, SMARTag® technology offers a clinically-validated way to make better ADCs."

Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Triphase Accelerator and Catalent announce interim results of a dose escalation phase 1 clinical trial of TRPH-222 in patients with non-Hodgkin’s lymphoma (PRWeb) - P1, N=120; NCT03682796; Sponsor: Triphase Research and Development III Corp; "To date, results in 19 heavily pre-treated patients with non-Hodgkin’s lymphoma have been evaluated, with five confirmed to have had a complete response at TRPH-222 doses of 0.6 to 5.6 mg/kg. Tumor reductions have been observed in patients with both indolent and aggressive disease, and durable responses to date have been observed in follicular, diffuse large cell, and mantle cell lymphoma patients. The trial is currently ongoing with a 10 mg/kg dose cohort."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma (clinicaltrials.gov) - P1; N=120; Recruiting; Sponsor: Triphase Research and Development III Corp.; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Triphase Accelerator Initiates Phase 1 Clinical Trial of TRPH-222 in B-cell Lymphoma (GlobeNewswire, Triphase Accelerator) - “Triphase Accelerator Corporation…announced that Triphase Accelerator’s TRPH-222, an anti-CD22 antibody-drug conjugate (ADC) for the treatment of patients with lymphoma, has been dosed in the first patient in a Phase 1 clinical trial….The study is currently enrolling patients at sites in the U.S. and Canada, including Roswell Park Cancer Center, University of Pennsylvania.”

Clinical • Enrollment status • New P1 trial • New trial • P1 data