On November 6, 2023 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the third quarter of 2023 and provided a corporate update (Press release, Aclaris Therapeutics, NOV 6, 2023, View Source [SID1234637007]).

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"Throughout the first three quarters of this year, I believe our company has performed remarkably well in terms of executing across our clinical development programs," stated Doug Manion, M.D., Chief Executive Officer of Aclaris. "Most importantly, we are rapidly approaching the topline data read-outs for our two most advanced clinical programs, zunsemetinib in rheumatoid arthritis this month and ATI-1777 in atopic dermatitis around the end of this year. This level of high-quality execution is further exemplified as we advance ATI-2138 in patients with ulcerative colitis, and we’re pleased to collaborate with Washington University as they advance ATI-2231 in patients with advanced solid tumor malignancies."

Research and Development Highlights:

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
Currently being developed as a potential treatment for immuno-inflammatory diseases
Rheumatoid Arthritis (ATI-450-RA-202): This Phase 2b placebo-controlled dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in patients with moderate to severe rheumatoid arthritis (RA) completed enrollment in June 2023. Aclaris continues to expect topline data this month.
Psoriatic Arthritis (ATI-450-PsA-201): This Phase 2a placebo-controlled trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily) in patients with moderate to severe psoriatic arthritis (PsA) is ongoing. Aclaris continues to expect topline data in the first half of 2024.
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor:
Currently being developed as a potential treatment for mild to severe atopic dermatitis (AD)
Atopic Dermatitis (ATI-1777-AD-202): This Phase 2b vehicle-controlled trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in patients with mild to severe AD completed enrollment in September 2023. Aclaris continues to expect topline data around the end of 2023.
ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor:
Currently being developed as a potential treatment for ulcerative colitis; Aclaris is also exploring additional indications for other T cell-mediated autoimmune diseases
Healthy Volunteers (ATI-2138-PKPD-102): This two-week Phase 1 MAD (multiple ascending dose) trial to investigate the safety, tolerability, PK and PD of ATI-2138 in healthy volunteers has been completed. Based on analysis of the PK, PD and safety, Aclaris is progressing ATI-2138 into Phase 2a clinical development in ulcerative colitis, which it expects to initiate in early 2024. Aclaris reported the data in September 2023.
Preliminary data from the MAD trial demonstrated:
ATI-2138 was generally well tolerated at all doses tested in the trial;
ATI-2138 had dose proportional PK; and
a dose-dependent inhibition of both ITK and JAK3 exploratory PD biomarkers, with near maximal inhibition achieved at the 30 mg total daily dose.
ATI-2231, an investigational oral MK2 inhibitor compound:
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer. Aclaris is also currently exploring options to use ATI-2231 as a potential treatment for immuno-inflammatory diseases.
This is the second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and is designed to have a long plasma half-life.
Aclaris is supporting Washington University in a first-in-human investigator-initiated Phase 1a trial of ATI-2231 in patients with advanced solid tumor malignancies. Aclaris expects clinical development activities to be initiated in the second half of 2023.
Financial Highlights:

Liquidity and Capital Resources

As of September 30, 2023, Aclaris had aggregate cash, cash equivalents and marketable securities of $187.0 million compared to $229.8 million as of December 31, 2022.

Aclaris continues to anticipate that its cash, cash equivalents and marketable securities as of September 30, 2023 will be sufficient to fund its operations through the end of 2025, without giving effect to any potential business development transactions or financing activities.

Financial Results

Third Quarter 2023

Net loss was $29.3 million for the third quarter of 2023 compared to $20.0 million for the third quarter of 2022.
Total revenue was $9.3 million for the third quarter of 2023 compared to $19.0 million for the third quarter of 2022. The decrease was primarily driven by a one-time upfront payment under the non-exclusive patent license agreement with Eli Lilly and Company (Lilly) received in the third quarter of 2022.
Research and development (R&D) expenses were $23.9 million for the quarter ended September 30, 2023 compared to $23.7 million for the prior year period.
The $0.2 million increase was primarily the result of:
An increase in ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial and other preclinical activities; and
An increase in compensation-related expenses due to an increase in headcount.
The increases were partially offset by a decrease in zunsemetinib costs associated with the completion of the Phase 2a trial in patients with hidradenitis suppurativa.
General and administrative (G&A) expenses were $7.1 million for the quarter ended September 30, 2023 compared to $5.8 million for the corresponding prior year period. The increase was primarily due to increased compensation-related expenses due to an increase in headcount.
Licensing expenses were $7.3 million for each of the quarters ended September 30, 2023 and September 30, 2022, resulting from separate third-party contractual obligations related to the non-exclusive patent license agreement with Lilly.
Revaluation of contingent consideration resulted in a $1.7 million charge for the quarter ended September 30, 2023 compared to a charge of $2.2 million for the prior year period.
Year-to-date 2023

Net loss was $87.0 million for the nine months ended September 30, 2023 compared to $59.3 million for the nine months ended September 30, 2022.
Total revenue was $13.7 million for the nine months ended September 30, 2023 compared to $22.0 million for the nine months ended September 30, 2022. The decrease was primarily driven by a one-time upfront payment under the non-exclusive patent license agreement with Lilly received in the nine months ended September 30, 2022.
R&D expenses were $71.7 million for the nine months ended September 30, 2023 compared to $56.7 million for the corresponding prior year period.
The $15.0 million increase was primarily the result of higher:
Zunsemetinib development expenses, including costs associated with clinical activities for a Phase 2b trial for RA and a Phase 2a trial for PsA;
ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial and other preclinical activities; and
Compensation-related expenses due to an increase in headcount.
G&A expenses were $24.2 million for the nine months ended September 30, 2023 compared to $18.0 million for the prior year period.
The $6.2 million increase was primarily the result of higher compensation-related costs, including stock-based compensation, due to increased headcount and the impact of equity awards granted during the nine months ended September 30, 2023. Bad debt expense recorded from Aclaris’ determination that collection of amounts due from EPI Health are uncertain as a result of their filing for Chapter 11 bankruptcy protection also contributed to the increase.
Revaluation of contingent consideration resulted in a $0.6 million gain for the nine months ended September 30, 2023 compared to a gain of $2.4 million for the corresponding prior year period.

On November 6, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapiesfor cancer and autoimmune disease, reported the open-label safety lead-in of its integrated AIPAC-003 Phase II/III trial evaluating for the very first time 90mg of eftilagimod alpha (efti) in combination with paclitaxel has been completed with no safety or tolerability issues (Press release, Immutep, NOV 6, 2023, View Source [SID1234636977]).

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Six patients with metastatic breast cancer receiving this immuno-oncology chemotherapy (IO-chemo) combination, after exhaustion of all endocrine/CDK4/6 based therapies, tolerated the therapy very well and there were no dose limiting toxicities, as confirmed by the independent Data Monitoring Committee (IDMC) appointed for the trial. The IDMC recommended proceeding to the randomised Phase II portion of the trial.

The randomised (1:1) Phase II portion of the study will now open to include up to 58 evaluable patients with metastatic breast cancer receiving either 30mg efti or 90mg efti to determine the optimal biological dose. The evaluation of 90mg efti dosing in combination with paclitaxel is driven by efti’s excellent safety profile, along with the FDA’s Project Optimus initiative in oncology. Importantly the determination of the optimal biological dose is relevant for the whole efti program across all disease indications.

The integrated Phase II/III AIPAC-003 trial is evaluating efti, Immutep’s soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with standard-of-care paclitaxel for the treatment of metastatic hormone receptor positive (HR+), HER2-negative or HER2-low breast cancer and triple-negative breast cancer. It will take place at approximately 17 clinical sites across Europe and the United States of America. For more information on the trial, please visit clinicaltrials.gov (NCT05747794).

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy.

Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

On November 6, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported a clinical trial update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA) (Press release, Imugene, NOV 6, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/44c8291a-171d-e510-504e-2691967778cb/Phase_1_CF33_VAXINIA_Study_Update_Positive_Early_Signals.pdf [SID1234636976]).

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As announced last week, the trial has now cleared cohort 4 of the intravenous (IV) arm of the monotherapy dose escalation study, as well as IV cohort 2 of the combination study where VAXINIA is administered with checkpoint inhibitor drug pembrolizumab (KEYTRUDA). Cohort 5 of the IV arm for the monotherapy dose escalation is now open as is IV cohort 3 of the combination study.

As of 31 October 2023, 34 patients have been dosed with VAXINIA during the continuing dose escalation phase comprised of 16 patients intratumorally and 18 patients intravenously as either monotherapy or in combination with pembrolizumab. Twenty-five patients were evaluable (received at least their first scan at day 42) and seven patients have their first scan still pending. Of the evaluable patients the BOR (best overall response) are 1 Complete Response (CR), 1 Partial Response (PR), 16 Stable Disease (SD), showing patients had control and stability of their cancer and 8 progressive disease (PD) as measured by iRECIST and RECIST criteria
Importantly early results from 6 patients with gastrointestinal cancers who received CF33-hNIS alone including 2 colorectal cancer, 2 bile duct, 1 pancreatic and 1 liver cancer showed positive treatment effects, with a disease control rate (all CR, PR and SD) of 75%
Trial expansion is planned for 10 patients with bile duct cancers

Imugene MD & CEO Leslie Chong said: "Phase 1 trials are generally designed to look for safety, tolerability and early response signals to determine the optimal dose for further development. The early positive response data we are seeing at the mid-dose level in hard-to-treat bile duct cancer suggests that VAXINIA may be a potent anti-cancer drug as we interrogate higher dose levels. With no adverse safety signals, thus allowing us to dose higher, VAXINIA will have a very high therapeutic window which is valuable in oncology drug development."

Notably one patient with bile duct cancer, treated IT with mid-dose level displayed pseudoprogression (see below) with a 49% increase in tumour burden after two cycles of therapy. However, by the 4th cycle they achieved a Complete Response (iCR) with no known recurrence in over 200 days. A second patient with bile duct cancer, who previously progressed on prior drug therapies, achieved Stable Disease (SD) for > 4 months upon receiving IV-administered CF33-hNIS.

Bile duct cancers are difficult to treat and typically respond poorly to immunotherapy drugs. Pseudoprogression is a phenomenon in which the cancer initially appears to be growing, largely due to the cancer cells being infected by the virus then followed by infiltration of cancer fighting immune cells. However, it is usually followed by a decrease in tumour burden when the therapy takes effect. This phenomenon can benefit patients receiving immunotherapy but often leads to premature discontinuation of treatment owing to the false impression the cancer is growing.

The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Overall, the study aims to recruit cancer patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.

On November 5, 2023 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported studies for its innovative immunotherapeutic molecules at the SITC (Free SITC Whitepaper) 2023 Annual Meeting, including KG2A/NKG2C dual-targeting antibody ES015-2, a high affinity LILRB1 specific blocking antibody ES008-a, and the first-in-class anti-CD39/TGF-βRII bifunctional fusion protein ES014 (Press release, Elpiscience, NOV 5, 2023, View Source [SID1234636979]).

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Study Highlights:

Title: Selective delivery of TGFβ "trap" to CD39-expressing immune and stroma cells reshapes tumor microenvironment and rejuvenates antitumor immunity
Abstract Number: 453

CD39-Adenosine and TGFβ are two key immune suppressive pathways within the tumor microenvironment (TME). TGFβ, in contrast to its biphasic effects on tumor cells, acts on stromal cells and immune cells in the TME, which commonly express high levels of CD39, to promote tumor progression. CD39-targeted TGFβ "trap" is thus more likely to effectively inhibit tumor progression. Our study showed that ES014, a bifunctional antibody–ligand trap which comprises an antibody targeting CD39 fused to a TGFβ receptor II ectodomain, can inhibit TGFβ activity and lead to cancer killing in ex vivo models.

A phase I clinical study is ongoing to primarily investigate the safety, tolerability, and preliminary clinical activity of ES014 in patients with advanced solid tumors.

Highlights:

ES014 binds and neutralizes both CD39 and TGFβ.
ES014 promoted killing of tumors from NSCLC patients in ex vivo MPE model.
ES014 inhibits Treg differentiation and TGFβ-induced CD39 expression on T cells.
ES014 promotes T cell survival.
Title: ES015-2, a first-in-class NKG2A and NKG2C dual-targeting antibody, demonstrated potent anti-tumor immune response
Abstract Number: 498

The inhibitory receptor NKG2A and the activating receptor NKG2C modulate the function of NK and CD8 T cells by recognizing the same ligand HLA-E. NKG2A is selectively expressed on lymphocytes with cytolytic function, and the NKG2C "engager" has the potential to generate a strong antitumor response against various tumors. Inhibiting NKG2A and HLA-E alone was not as effective as had been expected in both mouse tumor models and in clinical trials. Our NKG2A/NKG2C dual targeting antibody ES015-2 can inhibit NKG2A function yet promoting NKG2C action, leading to superior anti-tumor response.

Highlights:

ES015-2 is a NKG2A/NKG2C dual targeting antibody.
ES015-2 can completely block the interaction of NKG2A/CD94 with HLA-E, thereby inhibits HLA-E-induced NKG2A inhibitory signaling.
Ligation of ES015-2 effectively potentiates the activation of NKG2C+ NK cells and T cells.
Title: ES008-a, a high affinity LILRB1 specific blocking antibody activates multiple immune cells to fight cancers
Abstract Number: 510

LILRB1 is the most broadly expressed member of LILRB family on various immune cells. Blocking LILRB1 augments macrophage phagocytosis of tumor cells, restores cytotoxic function of NK cells, and enhances tumor cell killing by effector CD8+ T cells. The high affinity LILRB1 specific blocking antibody ES008-a can activate multiple immune cells to fight cancers.

Highlights:

ES008-a is a high affinity LILRB1-specific blocker that can completely block HLA-G/LILRB1 and HLA-A2/LILRB1 interactions.
ES008-a promotes NK cell-mediated destruction of tumor cells.
ES008-a synergizes with CD47/SIRPα inhibitors in enhancing macrophage phagocytosis of tumor cells.

On November 4, 2023 TriSalus Life Sciences Inc., (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported additional Phase 1 clinical data during the late-breaker oral presentation session at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting (Press release, TriSalus Life Sciences, NOV 4, 2023, View Source [SID1234636980]).

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The PERIO-01 Phase 1 study for uveal melanoma with liver metastases (UMLM), studied SD-101 delivered via PEDD with the TriNav Infusion System in combination with intravenous checkpoint inhibitors. The data presented today at SITC (Free SITC Whitepaper) demonstrate that SD-101 is well tolerated when given by the PEDD method and is associated with immunologic effects both within the liver and systemically, which may enable better outcomes with systemic checkpoint inhibition. The Progression-Free Survival (PFS), Disease Control Rate (DCR), and ctDNA molecular response data in PERIO-01 patients in combination with nivolumab are encouraging for UMLM and for other indications under development. At the optimal biologic dose of SD-101 (2 mg) in combination with nivolumab (n=7), the median PFS was 11.7 months with an 81% DCR.

"We are encouraged to see that SD-101 is well tolerated when given by PEDD, in association with immunologic effects within the liver and systemically, which may enable better outcomes with systemic checkpoint inhibition," said Steven C. Katz, M.D., FACS, Chief Medical Officer at TriSalus. "The PFS and ctDNA molecular response data in PERIO-01 patients in combination with nivolumab are promising for UMLM and as well as for other indications that we are pursuing."

"The results of PERIO-01 highlight the importance of getting the biology right and not just pushing a drug to its maximum tolerated dose. The biological effects of SD-101 are best at the lowest dose tested, revealing tumor microenvironment reprogramming and inflammatory cell trafficking from normal to metastatic liver tumors," said Sapna Patel, M.D., director of the uveal melanoma program at The University of Texas MD Anderson Cancer Center. "This is not seen at higher doses of SD-101, and these findings ensure we are entering the next phase with the optimal dose in combination with checkpoint inhibition, for patients with metastatic uveal melanoma."

PERIO-01 is an open-label, first-in-human Phase 1 trial of SD-101, administered by hepatic arterial infusion with TriNav using PEDD in UMLM. The study consists of dose-escalation cohorts of SD-101 (2, 4, or 8 mg) alone or with immune checkpoint inhibition. At the data cutoff as of September 29, 2023, 56 patients were enrolled, with each having received at least one dose of SD-101. Of the patients with available data, 16 patients (29%) were treatment-naïve and 40 (71%) had failed at least one prior line of therapy, including 8 patients (14%) on 3rd or greater line of treatment. SD-101 infused via PEDD in combination with systemic checkpoint inhibition was well tolerated, with an overall serious grade 3/4 adverse event rate related to treatment of 11% (n=56), and no such events at the optimal SD-101 dose level of 2 mg in combination with nivolumab (n=7). The most common adverse events overall were gastrointestinal (41%), fatigue (30%), and skin toxicity (27%), with the majority being minor.

Encouraging early efficacy signals were noted in the UMLM patients treated in PERIO-01. Overall, the ctDNA molecular response rate was 65% using specified time points (n=20), and 82% when analyzing the best on-treatment response (n=26). Clearance of ctDNA was noted in 59% of subjects when assessing the best on-treatment response. There was an 81% disease control rate at 2 mg SD-101 via PEDD with nivolumab (n=7). Across all subjects, two partial responses (≥30% decrease) and five minor responses (10-29% decrease) were documented as the best on-treatment response. The median progression free survival at the optimal dose of SD-101 via PEDD (2 mg) in combination with nivolumab was 11.7 months with a 1-year overall survival rate of 86% (n=7).

Among PERIO-01 patients who received SD-101 via PEDD in combination with intravenous nivolumab, there was evidence of increases in CD8+ T cells, CD4+ T cells, and natural killer cells within their liver metastases. Gene expression analysis by Nanostring revealed increased TLR signaling, interferon signaling, cytokine signaling, Th1 T cell activation, and lymphocyte activation. At the optimal SD-101 dose of 2 mg in combination with nivolumab, decreases in monocytic myeloid derived suppressor cells (MDSC), M2 macrophages, and regulatory T cells were found in liver metastases. Along with predicted immune changes within liver metastases, encouraging peripheral immune signals were detected. Increases in IFNγ, soluble IL2-receptor, IL-15, IL-18, T cell activation, and NK cell proliferation were found in the blood.

Dr. Katz added, "These data reflect additional validation of our innovative immunotherapy approach for liver and pancreas tumors. SD-101 was selected based on its mechanism of action, which has the potential to reverse immunosuppression in the liver and pancreas through depletion of MDSC in concert with broad stimulation of immune cells in the tumor microenvironment. TriSalus delivery systems, which use the PEDD method, are designed to overcome mechanical barriers to immunotherapy success, which may be underappreciated factors in limiting performance of TLR agonists in liver and pancreas tumors."

Overall, the data emerging from the PERIO-01 and PERIO-03 also presented at SITC (Free SITC Whitepaper) indicate immunologic changes are occurring within the liver and pancreas, with favorable safety profiles. Patients with liver metastases in the PERIO-01 study have had favorable outcomes despite pre-treatment.

All TriSalus presentations from SITC (Free SITC Whitepaper) is available here following their respective sessions.

About Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials

The Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials are studying an investigational class C toll-like receptor-9 agonist, SD-101, delivered intravascularly by TriSalus’ TriNav Infusion System (TriNav) using the Company’s proprietary Pressure-Enabled Drug Delivery (PEDD) method of administration in three Phase 1 trials.

The PERIO-01 Phase 1 clinical study for uveal melanoma with liver metastases (UMLM), is studying SD-101 delivered via PEDD with the TriNav in combination with intravenous checkpoint inhibitors.

The PERIO-02 trial is evaluating whether this same platform approach (PERIO-01) with SD-101 and PEDD can improve the performance of systemic checkpoint inhibitors in treating patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma.

The PERIO-03 study is an open-label, Phase 1/1b study of the pressure-enabled intrapancreatic infusion of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in adults with locally advanced pancreatic cancer.