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Decipher Identifies a Molecular Subtype Most Likely to Benefit from Neoadjuvant KEYTRUDA Immunotherapy in Bladder Cancer Patients

On April 28, 2020 Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers, reported that patients with the molecular subtype Basal Claudin Low, identified by the Decipher Bladder test and studied in the PURE-01 clinical trial, received the most benefit in progression-free survival from neoadjuvant KEYTRUDA (pembrolizumab) immunotherapy in patients with muscle-invasive bladder cancer (MIBC) (Press release, Decipher Biosciences, APR 28, 2020, View Source [SID1234556724]).

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Identification of patients who benefit from immune checkpoint inhibitors, such as KEYTRUDA (a PD-1 inhibitor), is an unmet need in numerous disease settings for clinicians and pharmaceutical development teams. Currently, the use of KEYTRUDA is approved for patients with locally advanced or metastatic bladder cancer who are either platinum-ineligible or who have disease progression on platinum-based chemotherapy, and also for patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high risk, non-muscle-invasive bladder cancer. The PURE-01 clinical trial examined the use of KEYTRUDA prior to surgical removal of the bladder in platinum-eligible patients with non-metastatic MIBC.

"Identification of a predictive biomarker to a PD-1 inhibitor is essential for us to move the use of immunotherapy earlier in bladder cancer," said Andrea Necchi, MD, medical oncologist at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan. "The results of this study support the further examination of subtyping classifiers and their inclusion in ongoing and future immunotherapy clinical trials."

Standard of care for patients with MIBC is cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgical removal of the bladder, however, many patients suffer from comorbidities prohibiting the use of NAC, resulting in low utilization. Immunotherapy is a promising alternative, as demonstrated in the PURE-01 clinical trial, with rates of response and progression-free survival with neoadjuvant KEYTRUDA similar to rates reported for NAC.

In the PURE-01 clinical trial, the Basal Claudin Low molecular subtype represented 13% of patients with a unique tumor profile and RNA expression enriched for immune activity. These patients demonstrated exceptional improvement in two-year progression-free survival. Other Basal Claudin Low patients treated with the standard of care NAC had significantly worse outcomes with ~ 50% rate of disease progression.

The study, led by Dr. Necchi and titled "Impact of Molecular Subtyping and Immune Filtration on Pathological Response and Outcome Following Neoadjuvant Pembrolizumab in Muscle-Invasive Bladder Cancer," was published in the peer-reviewed journal European Urology on March 9, 2020. Additionally, the website UroToday published a "Beyond the Abstract" commentary by Dr. Necchi highlighting the findings from the study.

About Decipher Bladder

Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis from transurethral resected bladder cancer specimens. It was developed in bladder cancer patients with muscle-invasive disease who face the question of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy. The assay results are reported as one of five molecular subtypes (Luminal, Luminal-Infiltrated, Basal, Basal Claudin Low or Neuroendocrine-like), each of which has distinct biological composition, clinical behavior and predicted benefit from NAC.

CytoSorbents to Report Q1 2020 Operating and Financial Results

On April 28, 2020 CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported that it will report Q1 2020 financial results after the market close on Tuesday, May 5, 2020 (Press release, Cytosorbents, APR 28, 2020, View Source [SID1234556723]).

CytoSorbents’ management will host a live conference call and presentation webcast that will recount both operational and financial progress during Q1 2020 followed by a question and answer session.

Conference Call Details:

Date:

Tuesday, May 5, 2020

Time:

4:45 PM Eastern

Toll Free:

877-451-6152

International:

201-389-0879

Conference ID:

13701769

Live Presentation Webcast:

View Source

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: View Source

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at View Source

BioEclipse Receives FDA Clearance of Investigational New Drug Application for CRX100

On April 28, 2020 BioEclipse Therapeutics (BioEclipse), a private clinical-stage biopharmaceutical company developing first-in-class, curative immuno-oncology therapeutics, reported that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for the Company’s lead drug candidate, CRX100 (Press release, BioEclipse Therapeutics, APR 28, 2020, View Source [SID1234556722]). This multi-mechanistic cancer immunotherapy is delivered intravenously to target and destroy multiple cancer types and to prevent disease recurrence. BioEclipse plans to initiate a Phase 1 clinical trial of its patented CRX100 in therapy-refractory solid tumors in 2020.

Pamela Contag, Ph.D., founder and CEO of BioEclipse, stated, "Our first IND clearance represents a significant milestone for BioEclipse, and validates the groundbreaking potential of our cancer immunotherapy, CRX100. This first-in-class immunotherapy may conquer the challenges of resistant and recurrent cancers by both killing primary tumors and metastatic disease along with the generation of a durable immune response against the patient’s tumor. With funds raised in the Series A-1 financing, we plan to initiate the first clinical trial of CRX100 and take further steps to achieve our mission to bring a new generation of targeted therapies to cancer patients with few treatment options."

Dr. Contag continued, "These are exciting times for our team and our company. However, as we prepare to advance CRX100 into the clinic, we must acknowledge that we do so amid extraordinary circumstances with the COVID-19 outbreak placing immense pressure on our healthcare system. As we move ahead with the CRX100 clinical trial, the safety and well-being of the patients, and their families, as well as the medical personnel administering the trial is paramount."

CRX100 was developed with technology exclusively licensed from Stanford University, and has the potential to provide a curative therapy to patients with hard-to-treat malignancies that span a broad range of both solid and liquid tumors. The drug combines activated immune cells with a tumor selective oncolytic virus. When used separately in patients, these two approaches display limited efficacy as cancer therapies, as described by previous clinical research. By combining these two approaches, CRX100 is designed so the immune cells carry the virus to the cancer cells and then the two work synergistically to eradicate the tumors. An additional element of the combination CRX100 therapy is mediation of an immune response against the patient’s tumor cells that can potentially limit the growth of new disease.

The BioEclipse activated immune cells preinfected with a selective oncolytic virus have been studied extensively in animal models using mice across several cancer indications, including ovarian, breast, prostate, Non-Hodgkin’s Lymphoma, hepatocellular carcinoma, colon, glioblastoma, neuroblastoma and lung. Data from these nonclinical studies demonstrate that the therapy appears to work in both solid and liquid tumors, and that a long-term immune response was generated against even hard-to-kill metastatic cancers.

"We have an urgent need for more effective treatments especially for patients with disease refractory to standard treatments," said Oliver Dorigo, M.D., Ph.D., Director of Gynecologic Oncology at Stanford University Medical Center. "CRX100 has the potential to be effective not only in women with ovarian cancer, but in many other tumor types with an otherwise poor prognosis. This new immunotherapy is based on meticulous scientific studies and brings new hope to our patients and their families."

The planned open-label Phase 1 dose-escalation study is designed to determine the safety, tolerability and pharmacokinetic (PK) properties of CRX100 in adult subjects with solid tumors that are relapsed, refractory or intolerant to standard care, or refusing standard therapies. The study may include patients with multiple cancer types and can enroll up to 24 patients. The study’s primary endpoint will measure the frequency of treatment-emergent adverse events and dose-limiting toxicities in each subject following dose administration. More information on the study can be accessed at www.clinicaltrials.gov (NCT04282044).

BioEclipse will collaborate with Spannerwerks, LLC, a professional services firm focused on assisting biopharmaceutical companies with the development and launch of new products, to prepare for the upcoming Phase 1 clinical trial for CRX100. The firm worked with BioEclipse to complete the IND filing for CRX100.

"CRX100 is an important step forward in cancer immunotherapy and we are proud to work with BioEclipse as it advances this technology out of the laboratory and into the clinic," said Dara Lockert, Executive Director of Spannerwerks.

Immunovia Reports First Quarter Interim Report January – March 2020

On April 28, 2020 Immunovia reported that first quarter interim report for January – March 2020 (Press release, Immunovia, APR 28, 2020, View Source;march-2020-301048485.html [SID1234556721]). It is available on Immunovia’s website.

"During Q1 2020, Immunovia worked hard and continued to make great strides towards IMMray PanCan-d’s launch and the sales start of the first test for early diagnosis of pancreatic cancer, in spite of the COVID-19 global pandemic.

Work on the verification study proceeded as planned and we received all the blood samples from our KOL network. In January, our commercial team prepared detailed plans for the launch and in March and April these plans were adapted significantly to accommodate the COVID-19 situation. This included making in-person activities, such as conferences and the patient organization meetings that were canceled, into digital activities, etc.

In January, Immunovia welcomed a new Senior VP Sales NA (North America), Michael Pettigrew, to the team. Michael brings with him a very successful track record in product launches and sales growth in life science, along with unique leadership qualities. He is an important addition to Immunovia.

Following the end of Q1 2020, we provided an update on the measures the company has taken and continues to take in order to support patients, employees and public health initiatives in response to the COVID-19 pandemic. We also announced other crucial preparations that Immunovia has made in response to COVID-19, such as securing inventories of critical consumables, the successful collection of samples for the verification study including the reallocation of extra blood samples to the efforts of securing all samples for the verification study. All this done to facilitate the uninterrupted continuation towards commercialization start.

We reiterate that Immunovia’s R&D laboratories and clinical laboratory in Lund, along with the production facilities are fully operational. They all have plans in place to help sustain operations in these unusual times."

– Excerpt from the CEO Mats Grahn’s comment on the report

First Quarter Interim Report for January – March 2020 Call Details:

Immunovia invites to a teleconference (in English) for investors, analysts and media on Tuesday, April 28th, 2020 at 16:30 CET.

Mats Grahn, CEO will present Immunovia and comment on the first quarter interim report for the period January – March 2020 followed by a Q&A session.

There will be an MP3-file available at Immunovia’s webpage under Investors/Financial Reports (View Source) for those who want to listen to the telephone conference afterwards. The file will be available within two hours after the conference has ended.

This information is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16:00 CET on April 28, 2020.

ArcherDX and UCL Present New Minimal Residual Disease Surveillance Data from their Collaboration at 2020 AACR Virtual Annual Meeting

On April 28, 2020 ArcherDX, Inc., UCL and the Francis Crick Institute reported new data from their research collaboration as part of the Cancer Research UK-funded UCL-sponsored TRACERx study (Press release, ArcherDX, APR 28, 2020, View Source [SID1234556720]). Based on the on-going collaboration between ArcherDX and UCL, utilizing ArcherDX’s AMPTM technology, the data demonstrated cancer circulating tumor DNA (ctDNA) monitoring for minimal residual disease (MRD) can detect relapse of non-small cell lung cancer (NSCLC) earlier than standard of care imaging surveillance in some instances. Post-operative timepoints were analyzed from 90 TRACERx patients. In patients whose cancer had relapsed and shed ctDNA, the ctDNA was detected at or before relapse with a median lead-time, or time from ctDNA detection to clinical relapse, of 164 days (range: 6 to 1,022 days) in the TRACERx study tracking a median of 200 variants per patient. Furthermore, in non-relapse patients, the assay demonstrated 99.3% clinical specificity within the research data set. Results from the analytical validation of a 50-variant version of the research assay demonstrated 100% specificity with detection down to 0.003% variant fractions at high cell-free (cfDNA) input levels.i

With more sensitive detection of ctDNA for MRD as a biomarker, it is possible for adjuvant clinical trials to be conducted in smaller and more relevant settings by only escalating therapy in patients who are set to relapse, thereby potentially reducing trial size, cost and time. The full results of the analysis will now be presented today at 2:30 p.m. ET during the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting (abstract #2025).i

"Specificity is a critical and under-appreciated requisite of frequent disease monitoring," said Christopher Abbosh, M.D., Principal Clinical Fellow, UCL. "Data from a 50-variant version of the research assay demonstrates a variant detection limit of 0.003% at high cfDNA input levels while maintaining 100% variant analytical specificity. Together, with our collaborators, we aim to establish an MRD approach to treating early-stage NSCLC in order to determine which patients are likely to relapse and overcome challenges associated with conventional adjuvant therapy trial design. We believe this approach will provide an opportunity to expand precision oncology into early-stage cancer, when the cancer is typically easier to cure."

ArcherDX’s Personalized Cancer Monitoring (PCM) development program is being developed by ArcherDX and is supported by a collaboration led by Professor Charles Swanton of UCL and the Francis Crick Institute to detect evidence of disease progression in lung cancer patients from cell-free ctDNA as part of the Cancer Research UK-funded UCL-sponsored TRACERx study. PCM applies Archer’s proprietary Anchored Multiplex PCR (AMP) technology to accurately detect exceedingly low levels of cancer-derived DNA from patient blood.

"There remains a stark unmet need to improve the current adjuvant standard of care and outcomes in patients with solid tumors," said Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX. "Key to reducing patient burden in cancer treatment is a minimally invasive assay that enables tracking disease recurrence at the earliest possible time point directly at the patient’s care setting. We are thrilled to collaborate with the UCL team, which aligns closely with ArcherDX’s mission to bring the right test to the right patient at the right time."

Lung cancer is one of the most common types of cancer worldwide and a leading cause of cancer-related death.ii NSCLC is the most common type of lung canceriii and has a complex genomic landscape.iv

About TRACERx Study
TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analysing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.