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ERYTECH Announces the Hosting of a KOL Event as the TRYbeCA-1 Phase 3 Trial in Second-line Pancreatic Cancer Nears Complete Enrollment

On September 14, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the hosting of a Key Opinion Leader (KOL) Event to discuss the medical need in pancreatic cancer and the potential role of eryaspase in this setting (Press release, ERYtech Pharma, SEP 14, 2020, View Source [SID1234565150]).

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TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, has randomized more than 450 of the approximately 500 patients to be enrolled in the trial. The interim superiority analysis, to be conducted by the Independent Data Monitoring Committee when two-thirds of the events have occurred, is currently expected to take place around year-end 2020. Since the interim analysis does not include a test for futility, there will be two possible outcomes: (1) the trial will either continue toward a final analysis, expected in the second half of 2021, or (2) the trial will be stopped for superiority if the primary endpoint is met by demonstrating a significant improvement in overall survival (OS). In April 2020, the U.S. Food and Drug Administration (FDA) granted eryaspase Fast Track Designation as a potential second-line treatment of patients with metastatic pancreatic cancer.

On September 29, 2020 at 10:00 am ET, ERYTECH will host a call that will include a presentation by KOL Dr. Manuel Hidalgo, MD, Ph.D. (Weill Cornell Medicine/New York Presbyterian Hospital), who will discuss the current treatment landscape and unmet medical need in treating patients with pancreatic cancer, and an update by Erytech’s management on eryaspase and the TRYbeCA-1 trial. Dr. Hidalgo and management will be available to answer questions at the conclusion of the call.

INmune Bio, Inc. to Participate in Oppenheimer’s Fall Healthcare Life Science & Med Tech Virtual Investor Summit, on September 23, 2020.

On September 14, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the, "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported management will participate in Oppenheimer’s Fall Healthcare Life Science & Med Tech Virtual Investor Summit, on September 23, 2020 (Press release, INmune Bio, SEP 14, 2020, View Source [SID1234565146]).

Management will be available for virtual one-on-one meetings during the conference. To schedule a meeting with management, please contact your conference representative or [email protected].

Grail Files for IPO Ahead of Launching Multi-Cancer Liquid Biopsy Screening Test

On September 14, 2020 Grail, a spin out of genome sequencing firm Illumina,reported that it filed a preliminary prospectus for a $100 million initial public offering (IPO) last week with the U.S. Securities and Exchange Commission (SEC) (Press release, BioSpace, SEP 14, 2020, View Source [SID1234565137]). This move precedes the company’s anticipated 2021 launch of a multi-cancer liquid biopsy screening test for use in asymptomatic individuals over the age of 50.

The IPO will be used to fund new trials for its liquid biopsy test as well as a diagnostic aid for the test. Additionally, proceeds from the IPO will be used to advance other candidates and expand sales force and lab operations.

As of May 2020, the company has raised more than $1.9 billion in capital, thanks largely to support from third-party investors. These investors include ARCH Venture Partners, Sutter Hill Ventures and even Amazon.com founder Jeff Bezos via Bezos Expeditions. Illumina holds a 14.6% stake in the company with approximately 98.3 million shares.

Grail expects to launch their liquid biopsy product Galleri as a lab-developed test next year. Galleri relies on a targeted methylation sequencing panel to identify more than 50 types of cancer across different stages of disease. Additionally, the blood-based test is designed to help clinicians identify a cancer’s tissue of origin. The company is planning for commercialization of their product, and a premarket approval application for a next-generation version of the test has been scheduled for submission in 2023.

Clinical data, published in the Annals of Oncology, supported the test’s accuracy in identifying tissue of origin and specificity in detecting cancers across all stages. The study also found that the test featured a single false positive rate of <1%.

"The promising results from this independent validation data set demonstrate the robustness of the test performance, including its ability to detect multiple cancer types, and its generalizability to broader populations due to a low false positive rate," according to a statement made by study author and investigator Minetta Liu, MD, Research Chair and Professor, Department of Oncology, Mayo Clinic. "In addition, the high accuracy in identifying the anatomic origin of the primary cancer, in conjunction with detection of a positive cancer signal in the blood, will allow providers to efficiently direct next steps for each individual’s diagnostic work-up and subsequent clinical care."

Grail noted in the SEC filing that the company has not yet generated any revenues to date. In 2019, Grail incurred a net loss of $244.9 million, encompassing research and development costs of approximately $158.9 million as well as general and administrative costs of $80.9 million.

In the IPO filing, Guardant Health, Exact Sciences, Freenome, Thrive Earlier Detection and ArcherDX were named as Grail competitors. These competitor companies have also tested liquid biopsies in trials comprising more than 100,000 participants. In an effort to set itself apart from these companies, Grail said that it doesn’t believe they "would have the financial resources to invest in population-scale clinical trials and rigorous analytics to compete with" Grail’s products.

According to a statement made by Grail about the IPO registration, the number of shares to be offered as well as the price range for the offering have not been determined. The company, based out of Menlo Park, CA, applied for Nasdaq listing under stock symbol "GRAL."

Nuvo Pharmaceuticals® to Webcast Live at Life Sciences Investor Forum September 17th

On September 14, 2020 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX: NRI); (OTCQX:NRIFF), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported Jesse Ledger, Nuvo’s President & Chief Executive Officer and Kelly Demerino, Nuvo’s Interim Chief Financial Officer will present live at LifeSciencesInvestorForum.com on September 17th (Press release, Nuvo Pharmaceuticals, SEP 14, 2020, View Source [SID1234565133]).

DATE:

Thursday, September 17, 2020

TIME:

1:30 p.m. ET

LINK:

https://bit.ly/30GjErk

This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.

It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates.

PharmAbcine Unveils Olinvacimab’s Positive Results from Phase Ib Combination Studies at KSMO 2020

On September 14, 2020 PharmAbcine Inc. (KOSDAQ: 208340ks) reported positive data from its two combination trials of olinvacimab, its leading clinical candidate in oncology, with MSD’s pembrolizumab at the 13th Annual Meeting of the Korean Society of Medical Oncology (KSMO 2020) (Press release, PharmAbcine, SEP 14, 2020, View Source [SID1234565132]).

The interim results from the two Phase Ib studies showed that olinvacimab & pembrolizumab, combo has an excellent safety profile in both recurrent glioblastoma multiforme (rGMB) and metastatic Triple-Negative Breast Cancer (mTNBC) patients. The results from the mTNBC study, in particular, demonstrated meaningful efficacy.

Both rGBM and mTNBC trials assessed dose-limiting toxicity (DLT) and safety, as the primary endpoint to establish a preliminary RP2D (Recommended Phase II Dose). The studies also measured ORR, DCR, PFS, and OS for efficacy as the secondary endpoint.

The data indicates that both combination therapies have an excellent safety profile. DLT, the most crucial factor that determines the safety and dosage, was not observed. In both trials, many patients showed manageable symptoms of fatigue, rash, or hemangioma in grade 1 or 2.

In terms of efficacy, the data from the mTNBC trial was more pronounced. Among 11 patients, 4 patients (36%) had PR (Partial Response) and 1 patient had CR (Complete Response), and the total of 5 patients had clinical benefits (PR+SD≥24weeks) from the combination therapy.

The rGBM trial showed that 4 patients (44%) had SD (Stable Disease), including 1 patient staying on SD over 12 cycles. The median OS (Overall Survival) was 7.2 months vs 4 months, the average life span of rGBM patients.

"The interim results provide a strong rationale to proceed the mTNBC combination trial to Phase II," said Dr. Jin-San Yoo, CEO of PharmAbcine. "Despite the encouraging data from the rGBM study, we plan to pursue Phase II with mTNBC only for more efficient use of our resources. We just added three molecules with first-in-class potential in our pipeline and we need to be more careful with our resource utilization."