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 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will present at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 10:30 a.m. ET (Press release, Tempest Therapeutics, JUN 6, 2022, View Source [SID1234615625]).

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To access the live or archived recording of the company presentation, please visit the investor section of the Tempest website at View Source

On June 6, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (US FDA) to evaluate its SAR-Bombesin product as an imaging agent in prostate cancer patients that are Prostate-Specific Membrane Antigen (PSMA)-negative (Press release, Clarity Pharmaceuticals, JUN 6, 2022, View Source [SID1234615624]).

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Receiving clearance from the FDA on the imaging trial with SAR-Bombesin is yet another significant milestone for Clarity. It shows our ability to develop cutting-edge theranostics from the lab, through preclinical studies and into clinical trials, with SAR-Bombesin being Clarity’s fourth IND across five products which are clear for investigation in the US."

This IND gives Clarity clearance to proceed with a US-based Phase II 64Cu SAR-Bombesin Positron Emission Tomography (PET) imaging trial in participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy (such as surgery or radiation).

SABRE, which derives from "Copper-64 SAR-Bombesin in Biochemical REcurrence of Prostate Cancer trial", is a multi-center, single arm, non-randomised, open-label trial in up to 50 PSMA-negative patients with known or suspected prostate cancer. The primary objectives of the trial are to investigate the safety and tolerability of 64Cu SAR-Bombesin, as well as its ability to correctly detect the recurrence of prostate cancer.

The SABRE trial builds upon the promising clinical data from the pilot trial assessment of 64Cu SAR-Bombesin in breast cancer led by Prof Louise Emmett of St Vincent’s Hospital Sydney. The data from this trial was recently presented at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting. The SABRE trial was developed in response to the strong demand for this product from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents or conventional imaging (such as CT and/or MRI). Their patients were successfully imaged with 64Cu SAR-Bombesin under a Special Access Scheme.

Approximately 20% of prostate cancers with BCR are PSMA-PET negative1-4. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product targets the Gastrin Releasing Peptide receptor (GRPr) found on prostate and many other cancers. As such, the product could offer valuable imaging and therapeutic options for not only PSMA negative patients, but also the large number of patients that have the target receptor on their cancers.

"We look forward to further progressing the development of SAR-Bombesin and hope it will provide a new and effective diagnostic option for prostate cancer patients. Building on the promising clinical and preclinical data acquired to date, we are also planning an IND submission for a theranostic trial in prostate cancer participants, using 67Cu SAR-Bombesin therapy paired with the imaging agent, 64Cu SAR-Bombesin. Combined with the clinical, environmental and logistical benefits enabled by the copper isotope pairing, SAR-Bombesin has potential to provide this large patient population with accurate and precise detection and treatment of prostate cancer. We anticipate the SABRE trial to commence shortly and the theranostic trial to commence in 2023," Dr Taylor added.

This announcement has been authorised for release by the Executive Chairman.

On June 6, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported a trial-in-progress poster describing the study outline of its Phase 1b clinical trial of PH-762, a self-delivering RNAi targeting PD-1, for the treatment of advanced melanoma at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which is being held June 3-7, 2022 in Chicago, IL (Press release, Phio Pharmaceuticals, JUN 6, 2022, View Source [SID1234615623]).

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Immunotherapy with antibodies targeting immune checkpoints, such as PD-1, has shown significant benefit in late stage melanoma patients. However, further improvements in therapeutic options are still needed. Treatment given as a first step prior to surgery, or neoadjuvant treatment, and local intratumoral (IT) injection are two alternative approaches for improving the outcome of immunotherapy for melanoma patients.

"We are pleased to share the details for the ongoing clinical trial of our lead product, PH-762. As the first-in-human study for an INTASYL immunotherapy compound, the initiation of this study earlier this year marks an important milestone for our broader pipeline and platform," said Dr. Simon Fricker, Phio’s VP of Research and Development. "Neoadjuvant therapy may stimulate significant responses that appear to be associated with a decrease in the risk of relapse after surgery. As there is currently no neoadjuvant standard of care for resectable advanced melanoma patients, neoadjuvant treatment with PH-762 provides an alternative therapeutic option to treat these patients."

IT administration of PH-762 to the tumor can stimulate a local immune response in the tumor microenvironment by silencing PD-1 and generating an immune response in distant untreated tumors. Studies conducted by the Company have shown potent silencing of PD-1 and a robust, dose-dependent inhibition of tumor growth. Further, IT injection of PH-762 also has the potential to minimize systemic effects and off-target toxicity, which has been seen with the use of antibodies.

The poster presented at ASCO (Free ASCO Whitepaper) outlines the design of the Phase 1b study with PH-762 for the treatment of patients with advanced melanoma. The clinical study is being conducted at the Gustave Roussy Institute, one of the largest cancer centers in Europe. The purpose of this study is three-fold: to evaluate the safety and pharmacokinetics of neoadjuvant use of PH-762 administered by IT injection in subjects with resectable advanced melanoma; to determine the recommended Phase 2 dose; and to determine the potential immunologic and pathologic tumor responses. Study treatment will feature a dose escalation of once weekly IT injections of PH-762 for four weeks prior to surgical excision of tumor lesion(s) after treatment with PH-762. Up to five dose levels will be tested in a serial fashion in cohorts of three or more subjects. A Bayesian optimal interval (BOIN) design will be employed to evaluate escalating doses of PH-762 to determine the maximum tolerated dose level and the dose of PH-762 will be normalized to tumor volume to ensure an equivalent local dose (tumor tissue concentration). Tumor changes will be evaluated per RECIST criteria, adapted for use with IT therapy, and by pathological response.

The poster being presented at ASCO (Free ASCO Whitepaper), titled, "A First-in-Human, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of Neoadjuvant Use of PH-762 Administered Intratumorally in Subjects with Advanced Melanoma" will be made available on the "Investors – Events and Presentations" section of the Company’s website (click here).

About PH-762

PH-762 activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing cancer cells. When PH-762 reduces PD-1 expression, the "brakes" on the immune system are released and activates the T cells to kill the cancer cells. PH-762 is being developed as a standalone drug therapy with local IT administration to a tumor. In addition, it is also being developed as a critical component of cellular immunotherapy, more specifically to improve tumor cell killing capability of adoptively transferred tumor infiltrating lymphocyte (TIL) therapy.

On June 6, 2022 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, reported that presentation of a poster at the ASCO (Free ASCO Whitepaper) Annual Meeting to be held from 3rd – 8th June 2022 (Press release, BerGenBio, JUN 6, 2022, View Source [SID1234615622]).

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The poster presentation provides clinical data from a Phase 1 dose escalation and expansion study of bemcentinib (BGB324) in combination with docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC). The data presented indicate that bemcentinib in combination with docetaxel shows evidence of anti-tumor activity, with 35% of patients achieving a partial response and 47% attaining stable disease, and a manageable safety profile in previously treated, advanced NSCLC.

Cristina Oliva, Chief Medical Officer at BerGenBio, commented: "While the data are limited, they suggest a mechanism by which treatment with bemcentinib could delay resistance to and potentiate the effects of chemotherapy treatment in NSCLC patients."

The full abstract is available on the ASCO (Free ASCO Whitepaper) website here: View Source