On August 1, 2023 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global preclinical and clinical research services provider that offers end-to-end oncology R&D solutions, reported an agreement to adopt BioVolume’s leading 3D imaging and thermal technology as their primary means of capturing efficacy results (Press release, Champions Oncology, AUG 1, 2023, View Source [SID1234633581]). Through this multi-year agreement Champions Oncology will incorporate BioVolume’s cutting-edge thermal and 3D imaging platform into its broad portfolio of in vivo preclinical offerings. In alignment with Champions’ consistent focus on delivering the highest quality data and scientific excellence, the adoption of BioVolume technology will enable the achievement of greater accuracy, reduced variability, and the generation of reliable insights to advance oncology drug development programs across different therapeutic modalities.

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!

BioVolume is advancing global preclinical oncology by providing greater study accuracy and helping strengthen drug filings for clinical trials with a digital record of preclinical efficacy. Specifically, BioVolume detects, segments, and measures subcutaneous tumor growth in rodents. By providing traceable imaging for each volume measurement alongside the additional capture of tumor height, ensures greater reproducibility of study data and offers a statistically significant reduction in variability compared to calipers which rely on manual measurement. In silico modeling of BioVolume data demonstrates that reducing variability can decrease the chance of missing a therapeutic effect by a factor of seven in comparison to existing caliper-based processes.

Maria Mancini, Chief Operating Officer at Champions Oncology said, "We are excited to announce our partnership with BioVolume. Adopting innovative technologies to digitize preclinical lab processes is critical to generating new breakthroughs in cancer research. The partnership will enable us to provide full transparency in study data collection and analysis, more accurate and consistent data, and greater scientific confidence to the pharma and biotech research community."

"Champions Oncology and BioVolume are both forward-looking companies committed to advancing science, and we look forward to working together to enable faster, smarter, and more confident decisions to be made in the identification and development of new cancer therapeutics," said Karl Turley, BioVolume Chief Operating Officer. "Cancer research is affected by a reproducibility crisis, and we believe our unique imaging platform will help tackle this challenge by transforming reproducibility in preclinical efficacy assessments."

On August 1, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that Scott Hutton, Chief Executive Officer of Biodesix, will present and host in-person 1×1 investor meetings at the Canaccord Genuity 43rd Annual Growth Conference, which will be held from August 7-10, 2023 (Press release, Biodesix, AUG 1, 2023, View Source [SID1234633579]).

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!

Canaccord Genuity 43rd Annual Growth Conference
Fireside Chat Date: Wednesday, August 9, 2023
Fireside Chat Time: 4:00 PM ET
Location: InterContinental Boston, Boston, MA

The fireside chat will be webcast live and available for replay under "News & Events" in the Investors section of Biodesix’s website at Biodesix.com.

On August 1, 2023 – Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported interim data from Stage 2 of the Company’s Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) (Press release, Bio-Path Holdings, AUG 1, 2023, View Source [SID1234633578]). Prexigebersen continues to be well-tolerated and has now shown compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, which exceed outcomes with frontline therapy. The protocol for the Phase 2 study allows Bio-Path to conduct an interim efficacy analysis on each cohort at its discretion. Additional data will become available as final efficacy reviews are conducted.

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!

"We are delighted to report these positive interim data as they represent a potential breakthrough for these very sick patients who face a complicated disease with limited treatment options," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Based on these favorable results, we plan to file for regulatory designations that could accelerate our ability to bring this potentially lifesaving therapeutic to patients with the greatest of unmet medical needs."

Stage 2 of the Phase 2 clinical trial is a multi-center, open label study designed with three patient cohorts that offer Bio-Path three pathways to registration:

• Newly diagnosed AML patients treated with prexigebersen in combination with decitabine plus venetoclax;
• Refractory/relapsed AML patients treated with prexigebersen in combination with decitabine plus venetoclax; and
• Refractory/relapsed AML patients, resistant or intolerant to venetoclax, treated with prexigebersen in combination with decitabine.

The primary objective of the study is to assess whether prexigebersen in combination with decitabine plus venetoclax provides higher response rates than decitabine plus venetoclax in AML patients and whether prexigebersen in combination with decitabine provides higher response rates than decitabine alone in AML patients.

Data Highlights

Fourteen newly diagnosed patients were evaluable in Cohort 1 and treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. All patients in this cohort (median age 75) were adverse risk by 2017 European LeukemiaNet (ELN) guidelines (n=10) or secondary AML (n=4). Prexigebersen was well-tolerated, and adverse events (AEs) were generally consistent with decitabine and venetoclax treatment and/or for AML. Twelve of the fourteen evaluable patients (86%) achieved complete remission (CR/CRi) and two (14%) achieved partial remission (PR). In total, 100% of the evaluable patients had a response to treatment. The complete remission rate (CR/CRi) of (86%) for the evaluable patients in Cohort 1 is significantly higher than complete remission (CR/CRi) rates (62%) for newly diagnosed patients treated with the frontline combination treatment of decitabine and venetoclax. This result is further highlighted by the high-risk rating of Bio-Path’s Cohort 1 evaluable patients and the inclusion of secondary AML patients (29%), both of which are classes of patients with very difficult to treat disease.

Fourteen refractory/relapsed evaluable AML patients in Cohort 2 were treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. All patients in this cohort (median age 56.5) were adverse risk by 2017 ELN guidelines (n=11) or secondary AML (n=2). Prexigebersen was well-tolerated, and AEs were generally consistent with decitabine and venetoclax treatment and/or for AML. Eight of the fourteen evaluable patients (57%) achieved complete remission (CR/CRi), two (14%) achieved partial remission (PR) and three (22%) achieved stable disease. In total, 93% of the evaluable patients had a response to treatment. The complete remission rate (CR/CRi) of (57%) for the evaluable refractory and relapsed patients in Cohort 2 is significantly higher than complete remission (CR/CRi) rate (21%) for refractory/relapsed patients treated with the combination treatment of decitabine and venetoclax. As with newly diagnosed patients in Cohort 1, this result is further highlighted by the high-risk rating of Bio-Path’s Cohort 2 evaluable patients and the inclusion of secondary AML patients (15%).

Next Steps

Efficacy data from the initial interim analysis of Cohort 1 and Cohort 2 are compelling and show that prexigebersen-based combination therapy was not only safely administered in Cohort 1 and Cohort 2 to high-risk newly diagnosed and refractory/relapsed AML patients considered unsuitable for standard chemotherapy, but also demonstrated efficacy signals significantly better than current therapies. This is particularly encouraging as refractory/relapsed patients are a challenging population in which current treatment options are suboptimal.

As a result of the interim review, Bio-Path has demonstrated superiority of prexigebersen combination therapy in treating AML patients and currently plans to pursue U.S. Food and Drug Administration (FDA) expedited programs for Fast Track and Breakthrough Therapy designations. Fast Track Designation is designed to expedite the development and review of drugs to treat serious conditions and to fulfill an unmet medical need. Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that may demonstrate substantial improvement over available therapies.

The next steps for Bio-Path are to conduct an administrative review to affirm the cohorts that will continue with enrollment. Nineteen patients had been chosen as an initial sample size for a cohort to provide interim efficacy data, however, the protocol for the Phase 2 allows Bio-Path to conduct interim efficacy analysis sooner at its discretion.

Operations in the United States are expected to remain unchanged with an expected six to ten treatment sites. In addition, Bio-Path is evaluating whether to seek to expand Stage 2 of the Phase 2 clinical trial by pursuing operations in Europe, as it believes there are more potential patients for Stage 2 of the Phase 2 clinical trial there, which could meaningfully enhance enrollment and accelerate completion of clinical trial milestones.

About Prexigebersen (BP1001)

Prexigebersen is a neutral liposome incorporated with nuclease-resistant, hydrophobic Pethoxy antisense oligodeoxynucleotides targeted to Grb2 mRNA. Grb2 is an adaptor protein that links oncogenic tyrosine kinases with downstream kinases, such as ERK and AKT, which are critical to cell proliferation and survival.

On August 1, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a publicly-traded clinical-stage oncology company, reported that it will present posters on its gamma secretase inhibitors AL102 and AL101 at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, to be held in Madrid, Spain 20-24 October 2023 (Press release, Ayala Pharmaceuticals, AUG 1, 2023, View Source [SID1234633577]).

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!

Poster Presentation Details
Title: Phase 2 Results from the RINGSIDE Phase 2/3 Trial of AL102 for Treatment of Desmoid Tumors
Presenter Prof. Robin Jones (The Institute of Cancer Research and Royal Marsden, UK)
Presentation # 1929P
Abstract # 4578

Title AL101 therapy in patients with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC): Final ACCURACY trial results and meta-analysis of clinical outcomes
Presenter Renata Ferrarotto MD (M.D. Anderson Cancer Center, Houston TX)
Presentation # 903P
Abstract # 4549
About AL102

AL102 is an investigational small molecule gamma secretase inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2/3 RINGSIDE clinical studies in patients with progressing desmoid tumors. AL102 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL102 from Bristol-Myers Squibb Company in November 2017. AL102 was granted U.S. Food and Drug Administration (FDA) Fast Track Designation for the potential treatment of desmoid tumors.

About AL101

AL101 is a novel, injectable, potent and selective small molecule gamma secretase inhibitor. It is currently being studied in the Phase 2 ACCURACY trial for the treatment of patients with recurrent/metastatic adenoid cystic carcinoma (R/M ACC).The FDA granted Orphan Drug Designation and Fast Track Designation for AL101 for the potential treatment of ACC.

On August 1, 2023 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare diagnostic solutions development company, reported the receipt of notification by the United States Patent & Trademark Office of several patent allowances (Press release, AXIM Biotechnologies, AUG 1, 2023, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-receives-notice-of-u-s-patent-allowance-for-three-separate-patents-including-its-rapid-point-of-care-neutralizing-antibody-test [SID1234633576]).

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!

AXIM has been developing a proprietary diagnostic platform that can be adapted to test for a variety of analytes including, for example, SARS-Cov-2, Lactoferrin, IgE, Lacritin, MMP-9. This innovative platform allows clinicians to detect with greater speed and accuracy different conditions that, e.g., allow for point of care testing of viruses, diseases, and conditions such as Dry Eye Disease. The platform capability can also be applied to rapid testing for vaccine candidates, including COVID vaccines and a potential Fentanyl vaccine. AXIM’s proprietary platform can also be used to enable point-of-care detection for one or more cancers using a unique cancer biomarker, QSOX1-L.

The first patent application recently allowed relates to COVID and other neutralizing antibody (Nab) testing and treatment. The allowance confirms that AXIM was a pioneer in developing a rapid point of care Nab test and its novelty. Additionally, the company was notified by the USPTO of a second patent allowance for systems and methods for rapid diagnostic for various cancers. The invention relates to the discovery by AXIM scientists of a unique biomarker for cancer, QSOX1-L. A third patent allowance was received for a point-of-care apparatus and methods for detecting cancer that uniquely uses electrochemical or impedance spectroscopy (EIS).

These allowances have increased the depth of AXIM’S IP portfolio to include 13 patent applications, including the above allowed applications, that cover AXIM’s innovative platforms and technologies. The Company see’s significant value in its IP portfolio whereas it may look to either further develop the covered technologies or license the IP to larger healthcare organizations, both creating significant upside value of the organization.

"These allowances further validate both the novelty and underlaying science of our diagnostic technologies," said John Huemoeller II, CEO of AXIM Biotechnologies. "While we continue to manufacture and ship our FDA-cleared diagnostic assays to customers through our commercialization partner, we have simultaneously continued to expand our value proposition through innovations in diagnostics field, that are now protected under the USPTO. We see our growing IP portfolio as a major opportunity for the organization, with an unrealized market value which probably exceeds the company’s current market capitalization. For instance, while the original SAR COVID-19 virus which plagued the world in recent years received extensive attention from the medical community, our now protected assay methodology can be applied to any future mutations or new SARS viruses or vaccines."

Below is an overview of AXIM’s patent portfolio:

SARS-Cov-2. Neutralizing Antibody Testing and Treatment. 1 Allowed Patent; 3 Utility Patent Applications.

The invention is a diagnostic test intended for semi-quantitative measurement of neutralizing antibodies in plasma, serum or whole blood of persons who have had recent or prior infection with SARS-CoV2 or have received a COVID-19 vaccine.

DRY EYE DISEASE

1. Tests for Human Monomeric Lacritin. 1 Utility Patent Application

The invention relates to a Rapid Point of Care test for Human Monomeric Lacritin. Lacritin is a tear protein that, in its monomeric form, autonomously promotes tearing and ocular surface survival. Lower concentrations of Lacritin may diagnose several eye diseases, including Blepharitis, Sjögren’s syndrome, Dry Eye Disease and other inflammatory conditions.

2. Tear Sample Collectors Systems and Methods. 1 Utility Patent Application

Tear fluid analysis contributes to the greater understanding of various ocular and systemic diseases and obtaining adequate samples for tear analysis requires effective collection methods. Most tear sample collectors on the market use capillary designs that are intimidating to the patient. The invention relates to a laminated and looped tear sample collector that is cost-effective, easy to use and soft and non-intimidating to the user and patient.

3. Use of Micromesh Materials in Diagnostic Devices. 1 Provisional Patent Application

When small sample sizes (0.1-2 microliters) are used, such as tears, there is a need for the sample to be spread out over application area for a proper flow. The invention allows dispersion of a small sample volume into mesh cells over a wide area controllable by the mesh size. This enables homogeneous sample dispersion over the entire sample application area.

CANCER DIAGNOSTICS

Systems and Methods for Rapid Diagnostic for Various Cancers. 1 Allowed Patent Application

QSOX1-L, a splice variant of QSOX1, has been identified as a novel biomarker of bladder cancer and possibly other cancers in serum. Proprietary antibodies have been generated that selectively detect only this variant and not others. QSOX1-L has been used to develop a rapid and cost-effective diagnostic test for bladder and possibly other urologic cancers from urine.

PLATFORM TECHNOLOGY

Molecules and Related Assays, Test Kits and Methods. 1 Utility Patent Application, 1 Provisional Patent Application.

The invention relates to the use of various recombinant proteins, test kits, test kit components and methods for detecting and measuring "binding antibodies" (for example, non-neutralizing antibodies) as well as "functional antibodies" (for example, neutralizing) in a single test and at the same time. Such test kit and method can advantageously improve the diagnosis and therapy of various diseases.

NEW DIAGNOSTIC TEST

Fentanyl Diagnostic Test. 1 Provisional Patent Application

Researches have reported that broadly neutralizing antibodies may prevent lethality from the fentanyl class of synthetic opioids. The University of Houston is developing a vaccine targeting the dangerous synthetic opioid fentanyl that could block its ability to enter the brain. The invention relates to a test that can measure neutralizing antibodies against fentanyl, either therapeutic or generated by anti-fentanyl vaccine. The test can be used to monitor the vaccine’s response and help decide when a booster is needed.

NEW TECHNOLOGY

Point of Care Apparatus and Methods for Detecting Cancer Using Electrochemical Impedance or Capacitance Spectroscopy 1 allowed patent. 1 Allowed Patent, 1 Utility Patent Application

The presence of cancer biomarkers or other analytes can be detected in the bodily fluid using EIS or ECS in devices, such as handheld point-of-care devices. The devices, as well as systems and methods, utilize using EIS or ECS in combination with an antibody or other target-capturing molecule on a working electrode. Imaginary impedance or phase shift, as well as background subtraction, also may be utilized.