1stOncology™: Cancer Intelligence Service – Page 5752 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

MimiVax Announces Positive Final Data from the Phase IIa Study of SurVaxM for Newly Diagnosed Glioblastoma Published Today in the Journal of Clinical Oncology

On December 15, 2022 MimiVax reported the published manuscript of the now completed Phase IIa study of SurVaxM, a cancer vaccine, in newly diagnosed glioblastoma (nGBM) in the Journal of Clinical Oncology, authored by researchers from several prominent US cancer centers (Press release, MimiVax, DEC 15, 2022, View Source;utm_medium=rss&utm_campaign=survaxm-glioblastoma-phase-2a-data-published [SID1234625314]). Glioblastoma is a rare disease with severe unmet medical need. SurVaxM was developed to bring a paradigm shift to a field with few advancements in recent years. The current study found that 51% of nGBM patients receiving SurVaxM had survived at least 2 years and 41% had survived 3 years, considerably higher rates than has been seen historically from standard care.

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!

This multi-center, open label, single arm, phase IIa trial in adult patients with nGBM was approved by the institutional review boards at each of the participating hospitals [NCT02455557]. All participants signed an informed consent prior to participation and study related tests. Patients were enrolled and treated at the following institutions: Roswell Park Comprehensive Cancer Center (which also served as the central trial site), Beth Israel Deaconess Medical Center, Cleveland Clinic, Dana-Farber Cancer Institute and Massachusetts General Hospital.

Of 63 patients enrolled, 60 (95.2%) remained progression-free 6 months after diagnosis to successfully reach the study primary endpoint. Additional endpoints of median Progression Free Survival (mPFS) of 11.4 months and median Overall Survival (mOS) of 25.9 months, measured from first dose of SurVaxM. SurVaxM was shown to stimulate survivin-specific cytotoxic T-cells and produce anti-tumor antibody responses which correlated with survival. Patients with the strongest antibody responses had a mOS of 43.1 mos. SurVaxM appeared to be safe and well-tolerated and may represent a promising new therapy emerging for nGBM.

"These promising results seen in the Phase IIa study compare favorably to the historical contemporary outcomes seen in glioblastoma. Additionally, we are excited about the benefit that was seen in both in the methylated [temozolomide-sensitive] and unmethylated [temozolomide-resistant] patients. There has also been significant interest in the randomized Phase IIb ongoing study." –Manmeet Ahluwalia, MD, MBA; Fernandez Family Foundation Endowed Chair in Cancer Research, Chief of Medical Oncology, Deputy Director and Chief Scientific Officer at Miami Cancer Institute, part of Baptist Health South Florida.

A follow-up Randomized, Blinded Placebo-Controlled Phase IIb Clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 10 cancer centers across the USA (enrolling at Roswell Park Comprehensive Cancer Center, Miami Cancer Institute, Cleveland Clinic, Dana-Farber Cancer Institute, Overlook Medical Center, Norton Cancer Institute, Fred Hutchinson Cancer Center, Texas Oncology, NYU Langone and UCSF Medical Center). See clinical trials.gov for enrollment details and locations.

"We are finally starting to see immunotherapy having an impact upon difficult to manage diseases like glioblastoma and are excited to be able to contribute in a meaningful way to cancer care to provide hope for glioblastoma patients" –Michael Ciesielski, PhD; Chief Executive Officer, MimiVax

"Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma." J Clin Oncol, Dec. 15, 2022 Manuscript is available online for free open-access at: View Source

Trials for SurVaxM were graciously supported by Roswell Park Comprehensive Cancer Center and the Roswell Park Alliance Foundation.

Kintara Therapeutics Receives Orphan Drug Designation for VAL-083 for Treatment of Diffuse Intrinsic Pontine Glioma (DIPG)

On December 15, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for VAL-083 for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and highly-aggressive childhood brain cancer (Press release, Kintara Therapeutics, DEC 15, 2022, View Source [SID1234625312]).

The FDA’s ODD program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people. ODD provides the sponsor of the drug with development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

"This is another important step for us in evaluating VAL-083 as a treatment for brain tumors in addition to our lead indication of glioblastoma," said Robert E. Hoffman, Kintara’s President and CEO. "We will continue with our clinical advancement of the drug candidate with our objective of delivering a much-needed new treatment that can benefit patients."

KAZIA LAUNCHES PRECLINICAL COLLABORATION WITH QIMR BERGHOFER MEDICAL RESEARCH INSTITUTE AND ANNOUNCES PATENT FILING

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]).

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."

IMV Inc. Announces Initial Data from the Ongoing Phase 2B VITALIZE Trial in Patients with r/r DLBCL

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.

"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.

IPA Reports Financial Results and Recent Business Highlights for Second Quarter Fiscal Year 2023

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]).

"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