On December 15, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or the "Company"), a clinical-stage biopharmaceutical company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported positive initial patient data from the VITALIZE Phase 2B trial evaluating its lead DPX product, MVP-S, in combination with pembrolizumab in patients with relapsed, refractory Diffuse Large B Cell Lymphoma ("r/r DLBCL") who received at least three previous lines of treatment (Press release, IMV, DEC 15, 2022, View Source [SID1234625310]). Detailed results will be presented in a podium presentation at the Immuno-Oncology 360° conference to be held in New York City on February 7-10, 2023.

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"The initial clinical data from the VITALIZE trial are encouraging and the accelerating recruitment in this study reflects a growing interest for this therapeutic combination in DLBCL," said Dr. Matthew Matasar, Chief of Blood Disorders at Rutgers Cancer Institute of New Jersey and RWJBarnabas Health, and primary investigator of the VITALIZE trial. He added: "We find it remarkable that we have seen complete responses in this trial in patients that were refractory to prior cellular therapy and other advanced therapies."

"Positive initial results for the VITALIZE trial are an important development milestone for MVP-S" said Andrew Hall, CEO of IMV "Alongside other compelling cancer vaccine data announced this week, these data on MVP-S highlight renewed interest in the potential for cancer vaccines as a therapeutic class."

Andrew Hall added "A well-tolerated, easy-to-administer therapy, such as MVP-S, that provides durable clinical benefit is meaningful for patients who have already been subject to aggressive, toxic treatment regimens. Clinical activity in a highly refractory patient population may represent a path to registration in DLBCL."

About the VITALIZE Study

The VITALIZE Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess IMV’s lead candidate, MVP-S, in combination with pembrolizumab with or without cyclophosphamide. Across the arms of this study, the combination will be evaluated in up to 102 subjects with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy.

The primary endpoint is Objective Response Rate (ORR), centrally evaluated per Lugano (2014) and measured by the number of subjects per arm achieving a best clinical response of Partial or Complete Response (PR+CR) during the 2-year treatment period. All subjects will be evaluated for their baseline PD-L1 expression. Exploratory endpoints include evaluation of cell-mediated immune response, tumor immune cell infiltration, and other biomarker analyses.

On December 15, 2022 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutic research and technology company, reported financial results for second quarter fiscal year 2023, which ended October 31, 2022 (Press release, ImmunoPrecise Antibodies, DEC 15, 2022, View Source [SID1234625309]).

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"Our focus on accelerated revenue development and the sales integration of our in silico capabilities using innovative and unique HYFT-based technology was continued in the second quarter. With relevant outputs and advancements in drug discovery, IPA has quickly pushed the frontiers of cutting-edge innovation, building upon our already top-ranked global CRO," stated Dr. Jennifer Bath, CEO of IPA. "Along with continued corporate growth, we remain intently focused on maximizing shareholder value and we continue to swim against the tide of the downward market trend. However, we are not content. We have immense objectives, and we’re determined to work nonstop until we achieve them."

Second Quarter Fiscal Year 2023 Financial Summary*

(All comparisons are to the period ended October 31, 2021)

IPA achieved revenue of $5.2 million during the three months ended October 31, 2022, an increase of 9.8% compared to the three months ended October 31, 2021.
During the three months ended October 31, 2022, research and development expense increased to $4.6 million from $3.0 million during the three months ended October 31, 2021. The increase in research and development costs is primarily attributable to spend associated with clinical manufacturing of the Company’s PolyTope antibody combination therapy.
As of October 31, 2022, IPA held cash of $15.1 million.

*Expressed in Canadian dollars, unless otherwise indicated.

Financial Results

Revenue

IPA achieved revenue of $5.2 million during the three months ended October 31, 2022, a 9.8% increase from the three months ended October 31, 2021. Growth was primarily driven by increases in protein manufacturing and IPA’s B cell Select platform.

Research & Development

During the three months ended October 31, 2022, research and development expenses increased to $4.6 million, from $3.0 million during the three months ended October 31, 2021. The increase in research and development costs is primarily attributable to spend associated with clinical manufacturing of IPA’s PolyTope antibody combination therapy. Additional research and development expenses included salaries and benefits (including share-based compensation) of $0.3 million, and depreciation expense of $0.1 million.

Liquidity and Capital Resources

As of October 31, 2022, IPA held cash of $15.1 million as compared to $30.0 million as of April 30, 2022, and had working capital of $15.4 million.

Conference Call:

Date: Thursday, December 15, 2022

Time: 10:30 am Eastern time

On December 15, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported positive results from ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode), an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer (CRC) in average-risk adults (Press release, Guardant Health, DEC 15, 2022, View Source [SID1234625307]).

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The test demonstrated 83% sensitivity in detecting individuals with CRC. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. This test also demonstrated 13% sensitivity in detecting advanced adenomas. Based on these study results, Guardant Health plans to complete its premarket approval submission to the U.S. Food and Drug Administration (FDA) in the first quarter of 2023. These results exceed the performance criteria set forth by the Centers for Medicare & Medicaid Services (CMS) for reimbursement.1

In this study, two configurations of a multimodal blood-based screening test were evaluated independently – a cell-free DNA (cfDNA)-only test and a cfDNA test with protein biomarkers. The announced results were derived from the cfDNA-only test, which outperformed the cfDNA test with protein biomarkers.

In addition to the strong clinical performance, blood-based screening has been shown to significantly enhance adherence to CRC screening in a real-world setting. Among the initial 8,000 individuals for whom the test was ordered during a routine visit with their physician, 90% completed the test.2 This is in stark contrast with adherence rates ranging from 43%3 to 66%4 for other non-invasive stool tests. Screening rates remain stagnant and well below the Centers for Disease Control and Prevention’s goal of 80%.5 By providing accurate and convenient screening via a simple blood draw, the company’s blood-based screening test has the potential to significantly improve screening rates and help save lives.

"Over 49 million eligible people in the U.S. remain unscreened for colorectal cancer. We are confident that a high-sensitivity blood test can play a critical role in improving screening adherence rates by offering an accurate and convenient blood test to those reluctant to get screened," said AmirAli Talasaz, Guardant Health co-CEO. "These results demonstrate, for the first time, that a blood test can indeed achieve high-sensitivity detection for colorectal cancer, a disease that was thought to be difficult to detect in blood. And as groundbreaking as these results are, colorectal cancer is just the beginning. Fueled by this success, we will expand this test to detecting many other cancer types, including lung cancer, the leading cause of death from cancer."

"Colorectal cancer is curable if detected early, but rates of adherence to screening remain too low with current screening options. There is a significant unmet need for a convenient, highly accurate screening test to improve these rates," said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School. "The topline results from ECLIPSE are very encouraging and support the use of a blood-based test as a screening option that has the potential to dramatically improve colorectal cancer screening rates by overcoming barriers associated with current testing methods."

Investor Call

Company management will be webcasting a corresponding conference call beginning at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

About ECLIPSE

ECLIPSE is a prospective registrational study to evaluate the performance of Guardant Health’s blood test in detecting signs of CRC compared to a screening colonoscopy in average-risk adults between the ages of 45 and 84 from across the U.S.

For more informationabout the ECLIPSE study (NCT04136002), visit www.clinicaltrials.gov. Full study data will be submitted to a peer-reviewed publication.

ECLIPSE diverse study representation

Designed to reflect a diverse population of the U.S., the ECLIPSE study included more than 200 clinical trial sites in rural and urban communities across 34 states. Study data includes 13% Black, 15% Hispanic and 7% Asian American populations. Enrollment among Black Americans was above average for a clinical trial, which is important given the disproportionate impact of CRC on the black community.6

Adherence to CRC screening is particularly poor among medically underserved populations, including those with low income and racial and ethnic minority populations. Only 59% of individuals age 50 and older who are Hispanic and 65% of individuals who are Black/African American are up to date with recommended screenings, compared to 68% of individuals who are white.7

ECLIPSE study locations included community hospitals, private clinics, gastroenterology clinics and academic medical centers. In addition, numerous strategies were implemented to increase representation from underserved communities that have lower CRC screening rates, including mobile phlebotomy, transportation/rideshare assistance and language translation services.

On December 15, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer, will present at the 41st Annual J.P. Morgan Healthcare Conference occurring January 9-12, 2023 in San Francisco (Press release, Gritstone Oncology, DEC 15, 2022, View Source [SID1234625303]). The presentation will take place on Thursday, January 12, 2023 from 9:45 – 10:25 AM Pacific Time in Elizabethan A conference room.

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A webcast of the presentation will be available at View Source An archived replay will be accessible for 30 days following the event.

On December 15, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the company’s Board of Directors granted five employees nonqualified stock options to purchase an aggregate of 46,950 shares of its common stock with an exercise price of $2.69, which is equal to the closing price of Gritstone’s common stock on December 6, 2022, the date of the grant (Press release, Gritstone Oncology, DEC 15, 2022, View Source [SID1234625302]). These stock options are part of an inducement material to each of the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.