On June 3, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of data reinforcing the clinical utility of the Decipher Prostate genomic classifier for helping to guide the timing and intensity of therapy in men experiencing prostate cancer recurrence following radical prostatectomy (RP) (Press release, Veracyte, JUN 3, 2022, View Source [SID1234615519]). The findings, from an ancillary study of the prospective open-label, multicenter, randomized phase 3 SAKK 09/10 trial conducted at 28 centers in Belgium, Germany, and Switzerland, appear in Annals of Oncology.

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It is estimated that more than 40 percent of men with intermediate- or high-risk prostate cancer may experience a biochemical disease recurrence after RP, which is characterized by rising levels of serum prostate-specific antigen (PSA). For men who experience a rising PSA, determining the optimal timing to initiate salvage radiotherapy (SRT) and whether to add androgen deprivation therapy (ADT) to SRT is challenging. This decision is important in part because the side effects of ADT when given concurrently with SRT are often difficult for patients to manage and are associated with long-term cardiovascular impact of hormone therapy.

"Each year in the United States, tens of thousands of men are diagnosed with biochemically recurrent prostate cancer, yet conventional clinical measures such as PSA and Gleason score are often insufficient to predict which of them will do well with SRT alone and who will need more intensive therapy to improve their oncologic outcomes," said Elai Davicioni, Ph.D., Veracyte’s medical director for urology. "The data from this study suggest that the Decipher Prostate genomic classifier can help fill this gap by providing objective information to guide customized treatment planning in the postoperative setting."

Researchers in the Swiss Group for Clinical Cancer Research (SAKK) and collaborating cancer centers assessed the clinical outcomes and Decipher Prostate genomic risk for 226 prostate cancer patients from the SAKK 09/10 trial, which randomized patients to standard vs. dose-escalated SRT. This study involved men experiencing a rise in PSA following RP, all of whom received SRT without the addition of ADT. Patients in the Decipher Prostate analysis were followed for a median of 6.3 years.

Findings suggest that Decipher Prostate can identify the patients who are at highest risk of cancer progression following RP and would benefit from earlier, more intensive treatment. Patients with a high Decipher score were more than twice as likely than those with a lower Decipher score to experience biochemical and clinical progression, and to receive long-term salvage hormone therapy. Additionally, patients with high Decipher scores had markedly improved outcomes when treated with SRT when the PSA burden was still low as compared to late SRT, when PSA levels have already risen.

"These findings add meaningfully to the existing literature supporting the use of the Decipher Prostate RP test in postoperative decision-making. Decipher Prostate RP is the only genomic test backed by evidence from randomized Phase 3 trials and we look forward to our continued collaboration with the SAKK team, with studies aimed at further elucidating the subset of men that benefit most from dose-escalation," said Dr. Davicioni.

About Decipher Prostate

Decipher Prostate is a 22-gene, microarray-based genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis (Decipher Prostate Biopsy) and after surgical removal of the prostate (Decipher Prostate RP). The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes. Decipher Prostate is available as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service. This test has not been cleared or approved by the FDA.

On June 3, 2022 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported new clinical data from an investigator-sponsored Phase 2 trial evaluating bavituximab combined with chemoradiation and adjuvant temozolomide in newly diagnosed glioblastoma (GBM) patients (Press release, OncXerna Therapeutics, JUN 3, 2022, View Source [SID1234615518]). The data, which show that the trial met its primary endpoint, will be featured in a poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place both virtually and in-person at the McCormick Place Convention Center in Chicago, Illinois.

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Bavituximab is a potentially first-in-class phosphatidylserine (PS) inhibitor designed to reverse immune suppression. The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP)-funded Phase 2 investigator-sponsored trial that will be featured in the ASCO (Free ASCO Whitepaper) poster was an open-label, single-arm study in newly diagnosed IDH wild-type GBM patients that was designed to evaluate the safety and efficacy of bavituximab combined with chemoradiation and adjuvant temozolomide. Per the trial protocol, success on the primary endpoint was defined as a twelve-month overall survival rate (OS-12) of greater than or equal to 72% in evaluable patients.

"Novel approaches are needed to treat GBM, as the current standard-of-care of chemoradiation and temozolomide has historically provided an OS-12 of only 60%," said Elizabeth Gerstner, M.D., Mass General Cancer Center, the study’s lead investigator. "The Phase 2 results being presented at ASCO (Free ASCO Whitepaper) suggest bavituximab modulates the immunosuppressive GBM microenvironment, demonstrating its on-target effects. The OS-12 of evaluable patients exceeded both the study’s pre-specified criteria and the historical benchmark. Improved survival also correlated with positive changes in tumor immune cell gene expression and reductions in cerebral blood flow, which indicates that bavituximab was a contributor to treatment response and supports continued clinical evaluation in GBM."

Key data and conclusions from the ASCO (Free ASCO Whitepaper) poster include:

Efficacy data in evaluable patients (N = 33, median age of 59)

OS-12: 73% (95% confidence interval: 59% – 90%)
Median progression-free survival (PFS): 6.9 months (95% confidence interval: 6.2 – 9.7 months)
Median overall survival (OS): 15.4 months (95% confidence interval: 13.3 – 23.6 months)
Disease control rate: 91% (30/33)
Overall response rate: 12% (4/33)
Safety findings:

The studied combination was generally well tolerated. There were eight grade 3 or 4 adverse events (AEs) and no grade 5 AEs observed.
Immune profile and MRI assessments:

A statistically significant reduction of pro-tumor, immunosuppressive, myeloid-derived suppressor cells (MDSCs) was observed post-treatment
Tumor samples from patients with longer PFS and OS showed a significantly positive shift in myeloid-related gene expression
The studied combination was shown to have anti-angiogenic effects as evidenced by a post-treatment decrease in relative cerebral blood flow
Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics, commented, "Confirming the on-target effect of bavituximab in modulating the GBM immune microenvironment is a significant finding that suggests combining bavituximab with an immune checkpoint inhibitor is a reasonable potential next step in its development. Incorporating our Xerna TME panel prospectively in a future study may further enable us to understand which patients would most likely benefit from this treatment approach as well as bavituximab’s potential to significantly improve outcomes in a setting where new treatment options are desperately needed. We look forward to discussing these latest Phase 2 data with key thought leaders as we assess next steps for bavituximab in GBM."

The Xerna TME Panel is OncXerna’s novel RNA gene expression-based diagnostic panel. It uses a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). By utilizing the Xerna TME Panel, OncXerna aims to match a specific patient’s tumor with the drugs best suited to treat that tumor.

The ASCO (Free ASCO Whitepaper) poster (# 368), entitled, Phase 2 Trial of Bavituximab with Chemoradiation and Adjuvant Temozolomide in Newly Diagnosed Glioblastoma, will be presented during the ASCO (Free ASCO Whitepaper) Annual Meeting’s "Central Nervous System Tumors" poster session, which is taking place on June 5, 2022, beginning at 8:00 a.m. CT (9:00 a.m. ET). Following its presentation at the conference, a copy of the poster will be available on the OncXerna website here.

About the Phase 2 Trial

This study is one of three investigator-sponsored studies funded through a collaboration between the NCCN ORP and OncXerna Therapeutics. The investigator-sponsored study was led by Elizabeth Gerstner, M.D., Mass General Cancer Center. The Phase 2 trial was an open-label, single-arm study designed to evaluate the safety and efficacy of bavituximab with chemoradiation and adjuvant temozolomide in adult patients with newly diagnosed glioblastoma. The trial included 33 evaluable patients who were treated with bavituximab weekly, temozolomide daily, and chemoradiotherapy in accordance with hospital guidance. The primary endpoint of the trial was OS-12, with the trial’s pre-specified statistical analysis plan indicating an OS-12 greater than or equal to 72% would result in the null hypothesis being rejected. Secondary endpoints included progression-free survival, overall survival, radiographic response, and toxicity assessments. Exploratory assessments evaluated the immune profile in tumor tissue and peripheral blood mononuclear cells with treatment and the impact of treatment on relative cerebral flood flow. For more information, see ClinicalTrials.gov Identifier: NCT03139916.

About Bavituximab

Bavituximab is an antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling. The mechanism of action of bavituximab is to block tumor immune suppression signaling from PS to multiple immune cell receptor families (e.g., TIMs and TAMs). This biology is relevant across multiple types of solid tumors. A Phase 2 clinical trial is evaluating the combination of bavituximab with KEYTRUDA to test the hypothesis that relieving immunosuppression can enhance responses to checkpoint inhibitors. Bavituximab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced gastric cancer.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About the Xerna TME Panel

The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.

On June 3, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported data from a Phase 1 study demonstrating efficacy proof-of-concept of the Company’s lead program, ST101, in patients with refractory solid tumors (Press release, Sapience Therapeutics, JUN 3, 2022, View Source [SID1234615517]). The data will be presented in a poster discussion session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 5, 2022.

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ST101, a first-in-class peptide antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). The primary objectives of the Phase 1 clinical study were to evaluate the safety and tolerability of ST101 and to determine the recommended Phase 2 dose. Secondary and exploratory objectives included pharmacokinetics (PK), preliminary efficacy (RECIST 1.1), and pharmacodynamic (PD) evaluation. The study used a 3+3 dose-escalation design, with once-weekly IV infusion dosing of ST101 at 0.5, 1, 2, 4, 6, 9 mg/kg or a flat dose of 500 mg.

Phase 1 Study Results:

As of May 5, 2022, 25 patients with multi-metastatic disease that were refractory to standard therapy received a median of 8 weeks of treatment
Three patients show ongoing clinical benefit:
One confirmed PR lasting more than 51 weeks in a patient with cutaneous melanoma
Eight patients with varying histologies had stable disease lasting 9-81+ weeks (2 ongoing)
No DLTs, dose modifications, or serious adverse events (SAEs) related to ST101
Pharmacokinetics and pharmacodynamics support the selection of a 500 mg flat dose as the recommended Phase 2 dose
Dr. Alice Bexon, Sapience’s Chief Medical Officer, commented, "We remain extremely pleased with the safety and efficacy ST101 has demonstrated in Phase 1, with evidence of clinical benefit across the whole dose range explored, particularly at higher doses and in patients with melanoma. The Phase 2 expansion portion of the study is going very well, with all cohorts enrolling, and a confirmed partial response in a patient with recurrent glioblastoma, which is very exciting. We believe that ST101’s unique mechanism of action targeting C/EBPß represents a potentially transformative approach to treating cancer."

+indicates ongoing treatment

SD=stable disease
PR=partial response

Details of the poster presentation at ASCO (Free ASCO Whitepaper) 2022 are as follows:

Abstract Number: 3014
Title: Efficacy proof-of-concept from a phase 1 study of a novel therapeutic peptide, ST101, targeting the oncogenic transcription factor C/EBPβ in patients with refractory solid tumors
Session Title/Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Type: Poster Discussion Session
Date/Time: June 5, 2022, 2:30 PM CDT

Abstracts and full session details can be accessed through the ASCO (Free ASCO Whitepaper) meeting planner: Abstracts | ASCO (Free ASCO Whitepaper) Annual Meeting

About ST101 and the Phase 1-2 Study
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 expansion. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a confirmed partial response in a patient with recurrent GBM. Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On June 3, 2022 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported encouraging preliminary safety and efficacy results from its Phase 1B study of unesbulin (PTC596) in advanced leiomyosarcoma (LMS) patients (Press release, PTC Therapeutics, JUN 3, 2022, View Source [SID1234615516]). The results demonstrated that treated patients achieved an 18.2 percent objective response rate and a 51.5 percent disease control rate. In addition, unesbulin was generally well tolerated. The results from the dose escalation study which evaluated unesbulin in combination with dacarbazine (DTIC), will be presented on Saturday, June 4, during the Sarcoma Oral Abstract Session beginning at 1:15 p.m. CDT at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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"The results demonstrated with unesbulin in LMS patients are very promising," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. "Leiomyosarcoma is an aggressive soft tissue sarcoma that has significant high unmet medical need, especially for those patients who have relapsed or are refractory to current treatments. We are excited to bring a new chemical entity to the fight against cancer."

The primary objectives of the study were to determine the recommended Phase 2 dose (RP2D) of unesbulin in combination with DTIC and to characterize the safety profile of the combination. In addition, the secondary objectives included progression free survival and duration of response. Unesbulin 300 mg taken twice a week in combination with DTIC 1,000 mg/m2 every 21 days was established as the RP2D.

"Leiomyosarcoma is a particularly aggressive tumor type that desperately requires new treatment options for patients," said Brian Van Tine, M.D., Ph.D., Sarcoma Program, Washington University and lead clinical investigator. "The preliminary results demonstrate promising early efficacy in patients with advanced leiomyosarcoma."

Based on the preliminary data from the Phase 1B study, PTC has initiated the SUNRISE LMS study. SUNRISE LMS is an international, placebo-controlled, registration-directed study comparing the efficacy and safety of unesbulin and DTIC versus placebo and DTIC in patients with advanced LMS who have received ≥1 prior line of systemic therapy. The study is ongoing (ClinicalTrials.gov identifier: NCT05269355).

About Unesbulin (PTC596)
Unesbulin is an investigational oral tubulin binding agent that arrests tumor cells in G2/M phase, including cancer stem cells, through the action of inhibiting tubulin polymerization. Unesbulin was discovered through PTC’s proprietary discovery platform.

About Leiomyosarcoma
Leiomyosarcoma (LMS) is a rare and aggressive cancer found in smooth muscle tissue. LMS is one of the more aggressive sarcoma subtypes representing 10 to 28 percent1 of all soft tissue sarcomas and has a high risk of recurrence leading to decreased disease-specific survival.2 Approximately 4,000 patients are diagnosed each year in the United States and there is a 2:1 incidence in females compared to males.3

On June 3, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will present at the 2022 Jefferies Global Healthcare Conference on Friday, June 10, 2022 at 9:00 AM ET in New York, New York (Press release, Fate Therapeutics, JUN 3, 2022, View Source [SID1234615515]).

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A live webcast, if recorded, of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.