On March 10, 2020 Sysmex Inostics has reported the test to provide additional key information for investigation of the validity of ctDNA for molecular monitoring and recurrence surveillance for breast cancer patients who are receiving novel therapies (Press release, Sysmex Inostics, MAR 10, 2020, View Source [SID1234555386]).

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!

In addition to a high detection rate even for patients with very low frequency mutations, the SafeSEQ Breast Cancer Panel has now also demonstrated the ability to delineate true changes in the level of ctDNA from random sampling or technical variation. This is in contrast to other liquid biopsy methods which report mutations detected along with the ratio of mutant molecules to wildtype molecules (mutant allele frequency, MAF), but are unable to relate changes in MAF to changes in the disease status of the patient with confidence. For instance, clinical data presented at San Antonio Breast Cancer Symposium (SABCS) demonstrated the importance of accurate detection of ctDNA with SafeSEQ testing to monitor tumor response in breast cancer patients receiving neoadjuvant treatment.

As a highly refined clinical development diagnostic, the SafeSEQ breast cancer panel has demonstrated exquisite sensitivity for detecting mutations in ESR1, which are known to arise in patients with estrogen receptor-positive breast cancer who have progressed on adjuvant hormone therapy. Extensive ESR1 ctDNA testing by Sysmex Inostics’ OncoBEAM enhanced digital PCR has shown that these mutations occur at very low frequencies in circulation. Patients who are receiving an investigational ESR1-directed therapy as part of a clinical trial may exhibit an ESR1 mutation well below 1% MAF at baseline which could then decrease further, sometimes below 0.1% MAF, several months after initiation of therapy. Using a traditional qualitative ctDNA next generation sequencing-based test would not only make detection of these low-frequency mutations difficult, but it would also not be possible to determine whether this reduction in MAF represents a true decrease in ctDNA that could reflect a clinical response. This is because the reduction in MAF may result from an increase in wildtype DNA rather than a decrease in tumor-derived DNA, and the magnitude of change in MAF may be within the range of random variation that is inherent to the assay. Quantitative ctDNA detection is also important for other clinical applications such as monitoring tumor response for patients receiving neoadjuvant treatment as illustrated by SafeSEQ data presented at the recent San Antonio Breast Cancer Symposium, Poster P6-10-05.

The updated SafeSEQ Breast Cancer Panel can overcome these challenges by determining whether the change in the absolute number of ESR1 mutant molecules detected at each timepoint, irrespective of the wildtype background, is sufficient to suggest a true biological cause such as a clinical response. This ability for true quantitative mutation detection is based on a rigorous linearity validation study and is especially important given the increasing interest in ctDNA-based monitoring and surveillance to support rapid advancements in therapies for breast cancer patients.

"Without quantitatively measuring ctDNA in a way that is specific for the patient’s disease and instead employing qualitative methods based on mutant allele frequency that have traditionally been used for tissue analysis, you’re neglecting some of the unique aspects of ctDNA testing that can make it an extremely powerful tool for clinical development," noted Matt Ryder, Sysmex’s Associate Director of Biomarkers & Companion Diagnostics. "We are confident that the SafeSEQ Breast Cancer Panel is now one of the most informative tests available to support development of novel therapies for breast cancer, and we look forward to helping our pharma partners explore the clinical validity of ctDNA-based therapeutic monitoring and recurrence surveillance."

The updated SafeSEQ Breast Cancer Panel is available now for use as a clinical trial assay in Sysmex Inostics’ Baltimore-based CLIA laboratory.

On March 9, 2020 Immune Therapeutics, Inc. (OTC Pink: IMUN) ("Immune" "IMUN" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of therapies for the treatment of autoimmune diseases, inflammatory diseases and cancer reported an update on the pending 1000-to-1 reverse stock split and name change of Immune Therapeutics (Press release, Immune Therapeutics, MAR 9, 2020, View Source [SID1234555308]).

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!

Immune Therapeutics originally submitted the reverse and name change request for a corporate action to FINRA and paid the applicable fees on November 27, 2019. Since then, the company has responded in a timely fashion to all of FINRA’s requests for further information, and we continue in our efforts to work diligently and cooperatively with FINRA to process the reverse and name change. FINRA requested a copy of the File-stamped articles of amendment from the state of incorporation approving the name change and reverse split which can be found by clicking on the following link.

The Company approved the amended Articles of Incorporation and filed them with the State of Florida Division of Corporation, on February 20, 2020; the State of Florida accepted and approved the 1000-to-1 reverse split leaving 458,019 shares issued and outstanding. Please note that the Company has no control of the FINRA approval process and as such the timing of any decisions our not in the Company’s control.

Michael K. Handley, CEO of Immune, said, "We had hoped the process of implementing the reverse and name change would have occurred sooner, but we are confident and fully committed to seeing the reverse and name change through. Furthermore, I would personally like to thank all of our shareholders for their patience in this process. We realize this delay may have eroded shareholder confidence, however, based on the extensive review by FINRA, we are optimistic that their approval may be given soon, at which time we will inform shareholders immediately. I would like to thank our shareholders on behalf of Immune and myself for standing behind us as we continue to work in your interests with a commitment to improving shareholder value and bringing lifesaving drugs to the market."

In regard to Immune’s drug programs, the Company has made great progress to the restructuring and advancement of its Lodonal and MENK programs, and will release detailed updates shortly on both these and its business development activities. In the interim, Immune would like to announce it has assisted Cytocom in with the advancement of their Crohn’s therapy program with Lodonal by requesting a Type C meeting with the FDA. Immune and Cytocom expect to have the Type C meeting in the next several months and plan to receive guidance on the final steps to approving the drug for Crohn’s disease.

On March 9, 2020 Invicro LLC, a Konica Minolta Company reported it has entered into a strategic research partnership with industry leading pathologist, Dr. David Rimm, MD, PhD, at The Yale University School of Medicine to advance the development of Quanticell, Konica Minolta’s proprietary tissue biomarker detection technology (Press release, invicro, MAR 9, 2020, View Source [SID1234555325]).

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!

Invicro is a global provider of imaging biomarkers, core lab services, CAP-CLIA pathology services, advanced analytics and software solutions for drug discovery and development. Dr. Rimm is the Professor of Pathology and Medicine; Director of Pathology Tissue Services; and Director of Translational Pathology at Yale University.

Quanticell is an ultra-sensitive, quantitative, amplification-free technology that detects proteins at the cellular and subcellular level using photostable, highly bright phosphor-integrated dots (PIDs). This nanoparticle-based detection technology circumvents the limitations observed with traditional multiplex chromogenic and fluorescent-based assays, such as signal saturation, non-linearity and high background.

"With his unmatched knowledge and experience in anatomical pathology, product commercialization, and late-stage clinical trials, Dr. Rimm is a leading pioneer in the quantitative pathology space," said Dr. Ken Bloom, Chief Medical Officer for Advance Pathology Solutions for Invicro. "We could not be happier to have him as a scientific research partner. I am highly confident that his efforts will support the advancement of Quanticell for specific drug development initiatives."

Chromogenic-based Immunohistochemistry (IHC) is ubiquitously used in research and clinical practice, including companion diagnostics (CDx). Despite IHC’s wide use, underperforming assays often require additional molecular testing due to narrow detection range. With expertise in quantitative and digital pathology and having invented the AQUA technology for predicting response to therapies or recurrence in a myriad of disease indications, Dr. Rimm and his research team will evaluate a multitude of assay conditions to assess Quanticell’s technology performance for quantifying HER-2 expression across a much wider dynamic range.

"I am thrilled to be working on this cutting-edge technology that has the potential to revolutionize molecular drug target testing that will in turn maximize therapeutic efficacy and reduce undesired toxicity," said Dr. Rimm. "In previous studies performed in my laboratory, we have found that HER-2 protein expression spanned three logs of dynamic range and discovered DAB-based methods typically only show a linear range of one log, which we hypothesize can be addressed with Konica Minolta’s novel detection technology."

On March 9, 2020 Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway (Press release, Mylan, MAR 9, 2020, View Source [SID1234565288]).

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 BLA seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent or metastatic cervical cancer.

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Dec. 27, 2020.

Mylan and Biocon’s proposed biosimilar bevacizumab is expected to be the third biosimilar from the partnered portfolio for cancer patients in the U.S. It is currently available in India and other developing markets.

Mylan President Rajiv Malik commented: "As we continue toward our goal of expanding access to cancer treatments for oncology patients, the FDA acceptance of our application for proposed biosimilar bevacizumab is another important step forward to increase competition, drive health system savings and expand our growing oncology portfolio to provide a broad range of offerings. We’re encouraged by the results of our scientific program to date and look forward to advancing the review of our application."

Dr Christiane Hamacher, CEO, Biocon Biologics, said: "The US FDA’s acceptance of our BLA for a proposed biosimilar bevacizumab co-developed by Biocon Biologics and Mylan is an important milepost in our journey of enabling access to affordable cancer therapies for patients. Once approved, our proposed biosimilar bevacizumab will provide an affordable alternative to the branded biologic for the approved indications. Biocon Biologics’ strong R&D and manufacturing capabilities have enabled us to offer two key biosimilars to cancer patients in the U.S. and bevacizumab will further expand our oncology portfolio."

The BLA is supported by a global randomized, controlled phase 3 clinical trial to evaluate the efficacy, safety and immunogenicity of proposed biosimilar bevacizumab versus Avastin. The study included patients diagnosed with stage 4 non-squamous non-small cell lung cancer. Eligible patients were randomised to receive either the proposed biosimilar bevacizumab or Avastin along with carboplatin and paclitaxel for up to six cycles (18 weeks). After which the patients continued to receive monotherapy until week 42. Additionally, patients benefitting from the treatment continued on bevacizumab monotherapy. The primary endpoint was overall response at week 18, using RECIST 1.1. Secondary endpoints included safety, progression free survival and overall survival at week 18 and 42.

A total of 671 patients were randomized. At week 18, the study met the primary endpoint and the 90% confidence interval for the best ORR (objective response rate) ratio was within the pre-specified equivalence margin. The safety which included immunogenicity was found to be similar to Avastin.

About the Biocon and Mylan Partnership
Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Our proposed biosimilar bevacizumab is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

On March 9, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC QB: IPATF) reported that it wishes to settle up to $796,875 of previously issued debentures including interest by issuing up to 1,328,125 Shares at a price of $0.60 per Share (the "Debt Settlement") (Press release, ImmunoPrecise Antibodies, MAR 9, 2020, View Source [SID1234555310]). The purpose of the Debt Settlement is to reduce the ongoing debt obligations of the debentures and is subject to the approval of the TSX Venture Exchange.

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!