On December 15, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported a collaboration with QIMR Berghofer Medical Research Institute, one of Australia’s foremost cancer research centres, to explore novel uses of paxalisib in solid tumours (Press release, Kazia Therapeutics, DEC 15, 2022, View Source [SID1234625311]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The research project is led by Professor Sudha Rao, a leading expert in transcriptional biology, particularly as it applies to the function of the immune system in cancer. Professor Rao’s laboratory works closely with pharmaceutical companies and with clinicians to explore innovative approaches to cancer treatment.

The collaboration is ongoing and will build on initial research that has already led to the filing of a patent, including the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer.

Key Points

Paxalisib is a member of a class of drugs known as PI3K inhibitors. The direct anti-cancer effects of PI3K inhibitors are well demonstrated, and five therapies have been approved by the US FDA to date.

Professor Rao’s research identifies an entirely separate effect of PI3K inhibition: as a modulator of the immune microenvironment within and around the tumour. Administration of PI3K inhibitors such as paxalisib, at doses and frequencies different to those conventionally used, appears to activate the immune system in the tumour, making it more susceptive to immunotherapy.

The research opens up an important opportunity for paxalisib in combination with drugs such as Keytruda (pembrolizumab, Merck) and Opdivo (nivolumab, Bristol Myers Squibb) for the treatment of diseases such as breast cancer and lung cancer. If proven effective in clinical trials, such combinations may have the potential to improve outcomes for patients.

•
It is anticipated that the results of the research will be published in 1H CY2023, and discussions are ongoing regarding potential translation to clinical trials in CY2023.

"These are very promising data," commented Professor Rao, Principal Investigator on the project. "In treatment-resistant pre-clinical models of breast cancer, paxalisib has shown encouraging results in inhibiting both the primary tumour burden and metastasis by reinvigorating the immune system within the tumour microenvironment. We look forward to continuing our research, and hopefully seeing this work lead to a clinical trial in due course."

"Professor Rao’s team are working at the leading edge of cancer research, and we are enormously grateful for their work on paxalisib," said Dr James Garner, CEO of Kazia. "An important part of our recent strategy for the drug has been to expand its field of opportunity outside of cancers of the brain. This work, which has primarily focused on breast cancer, but which has applicability to other solid tumours, builds on some promising data we previously shared which demonstrated the potential of paxalisib in melanoma. We look forward to working with the QIMR Berghofer team to take this research to the next stage."

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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