On June 6, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported further details regarding presentations relating to its proprietary percutaneous hepatic perfusion (PHP) system at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7, 2022, in Chicago, Illinois and virtually (Press release, Delcath Systems, JUN 6, 2022, View Source [SID1234615626]).

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Initial CHOPIN Trial Results

The goal of the CHOPIN trial is to study the safety and potential synergistic effects of systemic immunotherapy ipilimumab plus nivolumab (IPI+NIVO) when combined with Delcath’s proprietary liver-targeted PHP treatment in metastatic uveal melanoma patients. The poster presented initial safety and efficacy results from the Phase 1b portion of the trial which enrolled seven patients who were treated with two courses of six-weekly PHPs (melphalan 3mg/kg, max 220mg) combined with four courses IPI+NIVO three-weekly escalating the dosing from 1mg/kg each IPI+NIVO (cohort 1) to IPI 1mg/kg + NIVO 3mg/kg (cohort 2). The poster reports a Best Overall Response of 1 complete response, 5 partial responses and 1 stable disease accounting for an Objective Response Rate of 85.7%. At a median follow up time of 20.2 months, 4 patients have an ongoing response. Currently the median progression free survival is 22.4 months, and all patients are still alive.

"Initial CHOPIN data suggests that combining Delcath’s proprietary PHP liver targeted therapy with systemic immunotherapy is tolerated and can potentially achieve promising overall disease control rates in patients that otherwise would have limited treatment options. Uveal melanoma predominantly metastasizes to the liver and to date, the efficacy of immunotherapy in achieving meaningful disease control rates in this setting has been limited," said Johnny John, MD Delcath’s Senior Vice President of Clinical Development and Medical Affairs. "We are excited by the results of the Phase 1b portion of the study and look forward to the additional study of this this combination therapy to address both hepatic and extra hepatic lesions and meaningfully alter the course of this disease."

Updated FOCUS Trial Results

Updated efficacy and safety results from the single-arm phase 3 FOCUS trial in metastatic uveal melanoma including Overall Response Rate (ORR), median Duration of Response (mDOR), Disease Control Rate (DCR), median Progression Free Survival (mPFS) and Overall Survival (OS) data were presented that were largely consistent with prior presentations. In addition, predefined exploratory analyses comparing PHP to a Best-Alternative-Care (BAC) arm enrolled prior to the trial’s protocol amendment to a single-arm study were included.

Updated values reflect the latest data from clinical sites. OS data continues to mature with a final, predefined analysis expected in May 2023, two years after the study’s last treatment. As of last analysis the FOCUS trial results are as follows:

A 36.3% ORR in the Treated Population, including 8% Complete Responses (CR) with a mDOR of 14 months. A DCR of 73.6%, a median PFS of 9.03 months and a median OS of 19.25 months.
PHP analyses against the BAC arm yielded statistically significant (p<0.05) results on ORR (36.3% vs. 12.5%), DCR (73.6% vs. 37.5%) and mPFS (9.03 months vs. 3.12).
While OS data continues to mature, as of the last analysis, the median OS for the PHP arm is 19.25 months vs. 14.49 months for BAC (HR=0.70, p=0.14). Final analysis expected in 2023.
Retrospective Quality of Life Analysis

This abstract reported on a retrospective analysis in the change of Quality of Life (QoL) using the Functional Assessment of Cancer Therapy – General scores for 13 PHP treated patients at the University of Southampton. The analysis found no significant difference in QoL score on discharge post procedure versus baseline (prior to treatment) and noted a trend for overall improved QoL on day 28 from baseline.

Additional details about these three PHP-related ASCO (Free ASCO Whitepaper) presentations can be found below:

Title: Safety and efficacy of combined melphalan percutaneous hepatic perfusion (M-PHP) and ipilimumab plus nivolumab (IPI+NIVO) in metastasized uveal melanoma: First results of the phase Ib part of the CHOPIN trial.
Session Title: Melanoma/Skin Cancers
Session Date and Time: June 6, 2022, 1:15-4:15 PM CDT (Display)
Abstract Number: 9560
Presenter: Thaïs M.L. Tong Leiden University Medical Center, Department of Medical Oncology/Radiology, Leiden, Netherlands

Title: FOCUS Phase 3 Trial Results: Percutaneous Hepatic Perfusion (PHP) With Melphalan for Patients With Ocular Melanoma Liver Metastases (PHP-OCM-301/301A)
Session Title: Melanoma/Skin Cancers
Session Date and Time: June 6, 2022, 1:15-4:15 PM CDT (Display) and 4:30-6:30 PM CDT (Discussion)
Abstract Number: 9510
Presenter: Dr. Jonathan Zager, Director of Regional Therapies and Chief Academic Officer, Moffitt Cancer Center; Professor and Chair, Department of Oncologic Sciences, USF Morsani School of Medicine.

The Poster will be available at View Source

Title: Temporal evolution in quality-of-life following melphalan percutaneous hepatic perfusion for patients with metastatic uveal melanoma.
Session Title: Melanoma/Skin Cancers
Abstract Number: e21520
Presenter: Ganesh Vigneswaran University of Southampton, Southampton, United Kingdom

Visit the ASCO (Free ASCO Whitepaper) Annual Meeting website for further information regarding the conference.

On June 6, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported the presentation of safety results from the ongoing Phase I clinical study of CCX559, the Company’s highly potent, orally administered PD-L1 checkpoint inhibitor, in patients with advanced solid tumors during a poster session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, ChemoCentryx, JUN 6, 2022, View Source [SID1234615642]).

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In the ASCO (Free ASCO Whitepaper) poster titled, Results From an Ongoing Phase 1 Dose-Escalation Study of CCX559, an Orally Administered Small Molecule PD-L1 Inhibitor, in Patients With Advanced Solid Tumors (abstract #2593), ChemoCentryx reported patient baseline characteristics and safety data available from the ongoing study as of April 27, 2022, from the first 13 patients enrolled across four dose cohorts: 30 mg, 60 mg, 120 mg, and 180 mg.

The first-in-human Phase I study is assessing CCX559 in patients with a range of advanced solid tumors. Ten of the 13 patients enrolled have received at least two or more prior lines of systemic therapy. The primary objectives of the study are to evaluate the safety and tolerability, and to inform dose selection for the planned Phase Ib/II clinical trial.

To date, there have been no dose limiting toxicities (DLTs) or treatment-related serious or severe (≥ grade 3) adverse events (AEs) reported. Two patients receiving 120 mg once daily CCX559 presented with three probable immune-related AEs, which provides supportive evidence of immune activation. There have been no treatment-related AEs reported in more than one patient.

The ASCO (Free ASCO Whitepaper) poster also includes pharmacokinetic (PK) and pharmacodynamic (PD) data that build on the positive findings presented during the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April, providing evidence that CCX559 is pharmacologically active and 120 mg once daily is a therapeutically relevant dose. Results presented during ASCO (Free ASCO Whitepaper) indicate continued dose-dependent PK exposure at Day 1 for CCX559. The mean exposure at 120 mg (n=10) remains in line with preclinical projections and continues to increase at the 180 mg level (n=1). Consistent with approved antibody inhibitors of PD-L1, CCX559 demonstrates immunomodulatory activity in first cycle of treatment.

ChemoCentryx expects to present additional findings from this ongoing Phase I study at major oncology conferences through 2022. The tumor types being evaluated in the Phase I study are not known to be responsive to treatment with anti-PD-1/PD-L1 therapies, and the Company plans to advance CCX559 into a Phase Ib/II clinical trial to measure anti-tumor effects of CCX559 more directly during the second half of 2022.

About CCX559

CCX559 is a highly potent orally administered small molecule PD-L1 checkpoint inhibitor. Preclinical characterization has demonstrated that CCX559 blocks binding to PD-1 and CD80, and prevents PD-L1 inhibition of T cell activation. CCX559, when orally administered in animal models, demonstrated anti-tumor efficacy, including the ability to induce complete responses.

The PD-L1/PD-1 interaction is one of the major immune checkpoints that limits the ability of effector T cells to destroy cancer cells. As a potential next generation therapy, an orally administered small molecule inhibitor of PD-L1 could have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors, reduced immunogenicity, lack of Fc-mediated side effects and convenience of oral administration.

During 2021, ChemoCentryx initiated a first-in-human Phase I dose escalation study to evaluate the safety, tolerability, PK and PD of CCX559 in patients with various types of advanced cancer. During the second half of 2022, the Company plans to advance CCX559 into a Phase Ib/II clinical trial to measure anti-tumor effects of CCX559 more directly.

On June 6, 2022 Genuv Inc., a clinical-stage biotechnology company focused on innovative drug discovery for central nervous system disorders and advanced antibody therapies, and Nanocarry Therapeutics, a private company developing a new class of therapeutics capable of crossing the Blood-Brain Barrier (BBB), reported an agreement to collaborate on the development of an experimental drug to treat metastatic lung cancer (Press release, Genuv, JUN 6, 2022, View Source [SID1234615659]). Specifically, this collaboration will further develop GNUV201 to treat metastatic tumors in the brain, using Nanocarry’s AxS platform to cross the BBB.

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GNUV201 is an experimental, novel anti-PD-1 monoclonal antibody developed with Genuv’s proprietary antibody development platform Shine Mouse. GNUV201 exhibits strong cross-reactivity to both human and mouse PD-1, increasing the likelihood that animal models of disease are predictive of human clinical results. The experimental drug candidate also demonstrates superior binding affinity compared to Keytruda and Opdivo. The goal is to deliver this powerful cancer-fighting experimental antibody to treat metastatic tumors in the brain from non-small cell lung cancer (NSCLC).

"Genuv is excited to partner with Nanocarry to explore the potential of pairing their platform with our GNUV201 antibody to deliver cancer-fighting medicine directly to metastatic brain tumors," said Sungho Han, Ph.D., founder and CEO of Genuv. "We believe our collaboration could provide proof-of-concept for the first-ever brain-penetrating anti-PD-1 antibody. If we are successful, it may open up the possibility of expanding this therapy to other brain tumor types."

Revital Mandil Levin, Ph.D., cofounder and CEO of Nanocarry Therapeutics, said, "This project is an exciting opportunity to enable Genuv’s novel anti-PD-1 antibody treatments to reach its full potential, by accessing the brain. We look forward to partnering with Genuv for the development of this experimental treatment with our engineered nanoparticles and to bring new hope to patients in need."

The two firms have applied for a grant from the Korea-Israel Industrial R&D Foundation (KORIL-RDF) to support an initial feasibility study including in vitro and in vivo studies to explore targeting the brain with antibodies to treat tumors.

On June 6, 2022 OriCell Therapeutics Co., Ltd (OriCell), a leading innovative biopharmaceutical company pioneering novel oncology cell therapies for the unmet medical needs in in hematology and oncology, reported the positive results from Phase I POLARIS study, an investigator-sponsored study evaluating Ori-CAR017, an autologous GPRC5D-directed CAR-T cell, in patients with relapsed/refractory multiple myeloma at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, OriCell Therapeutics, JUN 6, 2022, View Source [SID1234615675]).

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Single Infusion of OriCAR-017 Demonstrates an Early, Deep and Durable Responses at All Dose Levels in Heavily Pretreated RRMM Patients, including Patients Who Relapsed from BCMA CAR-T Therapy.
Overall Response Rate(ORR) was 100% with Complete Response (CR)/ stringent Complete Response (sCR) rate of 60%，including Five patients with prior BCMA CART therapy achieved 2 sCR, 2 VGPR and 1PR. Patient medium follow up time 175 days (range 35-281). All patients were progression free without additional therapy at data cutoff. Results Highlights a Major Advance for OriCAR-017 Future Potential in RRMM Setting, regardless prior BCMA Targeted Therapy.
No Dose Limiting Toxicities (DLTs) or Serious Adverse Events (SAE) was observed. No Immune effector Cell Associated Neurotoxicity Syndrome(ICANS). Only Grade 1/2 Cytokine Release Syndrome(CRS). Most common Grade 3/4 AE was cytopenia, mainly due to lymphodepleting chemotherapy.
"We are delighted to share the FIH data from our Phase I POLARIS study, we strongly believe these data has demonstrated our advantages from the proprietary platforms for CAR-T optimization structure. Next step, we will be focusing on filling an IND with the NMPA and FDA for Ori-CAR017." said Dr. Helen Yang, Chairman and CEO of OriCell. "We look forward to continue developing novel cell therapies, to provide patient with better treatment option in the future."

Prof. He Huang, M.D., Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University said: "Multiple Myeloma (MM) remains incurable with extremely low overall survival for relapsed/refractory patients. Therapies using newer targets are urgently needed. The data presented at ASCO (Free ASCO Whitepaper) 2022 demonstrated that OriCAR-017 is a safe and effective treatment for patients with RRMM who received multiple lines of therapy, especially those who relapsed after BCMA-targeted therapy. I look forward to advancing the research of Ori-CAR017, a first-in-class autologous GPRC5D-directed CAR-T cell, with OriCell, so that patients can benefit from clinical results as soon as possible."

On June 6, 2022 TriSalus Life Sciences, an interventional immunotherapy company on a mission to extend and improve the lives of patients with liver and pancreatic tumors, reported that it will present a series of events at the Society of Interventional Radiology (SIR) 2022 Annual Scientific Meeting, held June 11-16, 2022, at the Boston Convention and Exhibition Center (Press release, TriSalus Life Sciences, JUN 6, 2022, View Source [SID1234615767]).

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The TriSalus clinical leadership team will be on-site to discuss the company’s FDA-cleared TriNav Infusion System as well as ongoing research with the interventional radiology (IR) community, including two presentations on new pre-clinical data that inform the company’s immunotherapeutic platform approach.

The company is pioneering an integrated platform approach that aims to overcome immunosuppression and delivery barriers by combining an investigational toll-like receptor 9 agonist, SD-101, with innovative drug delivery technology. The TriNav Infusion System utilizes the Pressure-Enabled Drug Delivery (PEDD) method of administration with SmartValve to overcome intratumoral pressure and improve delivery of therapeutic agents during outpatient interventional radiology procedures.

Additional activities, including a Monday evening reception, are highlighted below.

ON-SITE TRISALUS SPOKESPERSONS

Steven C. Katz, MD, FACS, Chief Medical Officer

David B. Jaroch, PhD, Senior Principal Scientist

Alexander Y. Kim, MD, Director of Interventional Oncology Clinical Strategies

Mikael Trollsas, PhD, Senior Vice President of Research and Development

CONFERENCE ACTIVITIES

Sunday, June 12 – Tuesday, June 14

TriNav Exhibition, Booth #605

Visit Booth #605 to see a replica of the TriNav Infusion System and learn how the device is engineered to improve tumor response, increase therapeutic delivery, and target tumors more precisely.

Sunday, June 12

Hands-on Workshop, Interventional Oncology: Embolization, 3:00 – 4:30pm ET, Exhibit Hall C

During this interactive workshop, attendees can experience what makes the TriNav Infusion System different from standard delivery approaches.

Monday, June 13

Taste of New England: An Evening Reception, Presented by TriSalus Life Sciences, 6:30-8:00pm ET

Westin Boston Seaport – Marina Ballroom II

Join the TriSalus team for an evening networking and education reception, complete with New England favorites. (Media RSVP for the event by emailing [email protected].)

Wednesday, June 15

(Scientific Sessions listed below are part of the SIR 2022 CME-accredited scientific program and not a TriSalus-sponsored activity.)

Scientific Session: IO Frontiers 2, 3:18-3:27pm ET, Room 253B

Abstract Title: Improved Delivery of a TLR-9 Agonist to Liver Tissue by Intravascular Pressure Enabled Drug Delivery (PEDD) Compared with Direct Needle Injection

Hear TriSalus Senior Principal Scientist David B. Jaroch, PhD highlight promising results from a pre-clinical study comparing local injection of labeled SD-101 into hepatic tissue versus using the PEDD method.

Scientific Session: Venous Disease and Sampling, 4:21-4:30pm ET, Room 258A

Abstract Title: Comparison of Pancreatic Tissue Uptake of Oxaliplatin Delivered by Systemic Circulation and by Pancreatic Retrograde Venous Infusion (PRVI)

TriSalus Senior Principal Scientist David B. Jaroch, PhD will present on the development of a trans-venous approach for regional treatment of pancreatic tumors, using a catheter capable of modulating pressure and flow within the organ to promote drug uptake.