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Vaxart to Present at the 2021 Cantor Virtual Global Healthcare Conference on Thursday, September 30

On September 20, 2021 Vaxart, Inc. (NASDAQ: VXRT) reported that Chief Executive Officer Andrei Floroiu and Chief Scientific Officer Dr. Sean Tucker will present at the 2021 Cantor Virtual Global Healthcare Conference at 10:40 a.m. ET on Thursday, September 30, 2021 (Press release, Vaxart, SEP 20, 2021, View Source [SID1234588055]).

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The presentation will be available by clicking here and on Vaxart’s website. The Company will also participate in one-on-one meetings during the conference.

Vaxart’s oral tablet COVID-19 vaccine is "The Pill that Moves the Needle" and the only oral COVID-19 vaccine whose potential is backed by clinical data. The Company’s oral tablet COVID-19 vaccine candidate has completed phase I trials and will enter phase II clinical trials this year.

PharmAbcine to Participate in BIO-Europe 2021

On September 20, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next generation antibody therapeutics, reported that the Company will virtually participate in the 27th annual BIO-Europe which will take place from October 25 – 28, 2021 (Press release, PharmAbcine, SEP 20, 2021, View Source [SID1234588053]).

BIO-Europe is Europe’s largest annual partnering conference serving the global life science industry. It attracts a wide range of business leaders, including senior executives of leading biotech companies, business development teams from large and midsize pharmaceutical companies, investors and other industry experts. This year, more than 3,500 executives from over 1,000 life sciences companies around the world are expected to participate in the event.

During the event, PharmAbcine’s business development team will conduct one-to-one partnering meetings with biotech companies around the world to broaden its global network, explore mutual interests, and identify recent trends in drug development market. Also, the Company will present a pre-recorded video which will be made available on-demand. The video will feature Dr. Jin-San Yoo, CEO of PharmAbcine, who will introduce the Company’s core technology and give updates on the R&D progress of the main pipelines such as olinvacimab, PMC-403, and PMC-309.

Olinvacimab, an anti-VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) fully human antibody, is the Company’s leading pipeline and is undergoing multiple global clinical trials. In early September 2021, PharmAbcine initiated a Phase II olinvacimab and pembrolizumab combo study for the treatment of mTNBC (metastatic Triple-Negative Breast Cancer) in Australia. Also, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients at multiple sites in both US and Australia and two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM in Australia are still ongoing.

PMC-403 is a novel TIE2-activating fully human antibody designed to stabilize and repair damaged blood vessels in a variety of diseases. PMC-403 is currently in development for treating AMD (Age-related Macular Degeneration), DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy) which are common abnormal vascular-related eye diseases. The Company expects PMC-403 to enter global clinical trials for both ophthalmology and oncology in 2022.

PMC-309 is a novel anti-VISTA (V-domain Ig Suppressor of T cell Activation) antagonizing antibody in development for the treatment of various tumor types. VISTA plays a pivotal role in maintaining the immunosuppressive environment around the tumor cells and is expressed primarily on MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). Blocking VISTA pathways activates T cells’ immune responses and leads to better anti-tumor effects. PMC-309 is expected to enter a global clinical trial in 2022.

To request a partnering meeting with PharmAbcine, register for the event here.

Lipocine to Present at The Cantor Fitzgerald Virtual Global Healthcare Conference

On September 20, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that the Company will present at the Cantor Fitzgerald Virtual Global Healthcare Conference (Press release, Lipocine, SEP 20, 2021, View Source [SID1234588051]). The conference will be held virtually. Presentation details are below.

Cantor Fitzgerald Virtual Global Healthcare Conference September 27-30, 2021

Presentation time: September 30, 2021 starting at 1:20 p.m. EST
Webcast link: View Source

The webcast of this presentation will also be available on Lipocine’s corporate website under "Events and Presentations" in the Investors section or using the webcast link above. The webcast will be available on Lipocine’s website for 90 days.

miR Scientific Presents Groundbreaking Data on the Exceptional Accuracy of its Prostate Cancer Liquid-Biopsy Test

On September 20, 2021 miR Scientific reported that Data presented from a cross-validation study at the American Urological Association’s (AUA) 2021 Annual Meeting confirms that the miR Sentinel Prostate Cancer Test can detect and risk-classify prostate cancer at the molecular level with predictive accuracy of over 90%, based on a single urine sample (Press release, miR Scientific, SEP 20, 2021, View Source [SID1234588048]). This validation study follows and confirms the data on more than 1,400 patients published in The Journal of Urology in September 2020.

When comparing the results of the miR Sentinel Prostate Cancer Test to systematic core needle biopsy in men presenting with initial suspicion of prostate cancer, the latest validation study demonstrated a 93% concordance between the two methods of screening and detection regarding the classification of clinically significant cancer. This 93% sensitivity of the miR Sentinel Prostate Cancer Test sets a new bar for detecting and classifying prostate cancer. The data further demonstrate the strong negative predictive value of the miR Sentinel Prostate Cancer Test with results showing the test correctly identified 96% (371/387) of men as having non-clinically significant cancer.

"Our mission to inclusively transform cancer management is further validated in this prospective study, demonstrating that the miR Sentinel Prostate Cancer Test is able to provide an accurate non-invasive means to identify the presence or absence of any prostate cancer and classify the molecular risk of disease becoming metastatic, and thereby lethal, prior to biopsy" says Sam Salman, Chairman and CEO of miR Scientific. "We believe that the accuracy, accessibility, and non-invasive features of our award-winning technology will impact the lives of millions of men and forever positively evolve the standard of care for urological cancers."

Cross-Validation Study Results

The data reported in this late-breaking abstract and presented by Laurence Klotz, MD, FRCSC at the AUA, is based on a study of 763 men over 45 years old, eligible for their first core needle biopsy. Pathology based on the core needle biopsy showed 354 (46%) were biopsy negative and 409 (54%) were biopsy positive. Of those 409 men found to have pathologic evidence of disease, 189 (25%) were classified as Grade Group 1 (GG1) representing non-clinically significant cancer, and 220 were classified as Grade Group 2 (GG2) or higher representing clinically significant cancer.

With just a urine liquid biopsy, the miR Sentinel Prostate Cancer Test identified 204 men with clinically significant cancer (intermediate or high risk), demonstrating 93% sensitivity (204/220) with the core needle biopsy. When evaluating men with non-clinically significant cancer, the miR Sentinel Prostate Cancer Test identified 371 out of 387 men, delivering 96% (371/387) sensitivity.

The data further examined the apparent false positive rate for clinically significant cancer by analyzing the sub-set of men who underwent both systematic biopsy and MRI-fusion biopsy, and who were negative on systematic biopsy. The data demonstrates >95% concordance been the positive MRI-guided biopsy and the miR Sentinel Prostate Cancer Test, indicating that the discordance between systematic biopsy results and the miR Sentinel Prostate Cancer Test are largely attributable to false negatives of biopsy.

Laurence Klotz, MD, FRCSC, Professor of Surgery at the University of Toronto, and Chief Medical Officer of miR Scientific LLC, said, "The key features of the test are the very high negative predictive value and the very high accuracy [in] identifying cancer. In addition to its quick turnaround, the test is highly scalable: the company will be able to perform a very large number of these tests right away."

Innovative Urine-based Liquid Biopsy

The miR Sentinel Prostate Cancer Test, which already received the Breakthrough Device Designation by the FDA, is a non-invasive molecular test based on the analysis of small non-coding RNAs (sncRNA) isolated from non-DRE urinary exosomes. It provides an innovative method to analyze sncRNAs derived from a simple, non-invasive urine specimen from age-eligible men. Using only the expression dynamics of these sncRNAs, a proprietary Statistical Classification Algorithm derives scores that classify patients according to the likelihood of being in the following four possible groups: no molecular evidence of prostate cancer; low-risk; intermediate-risk; or high-risk prostate cancer.

The miR Sentinel Prostate Cancer Test is expected to be commercially available in the United States and Puerto Rico at the end of this year.

Alvotech Provides Update on FDA Action Regarding AVT02, Proposed High-Concentration Biosimilar to Humira® (adalimumab)

On September 20, 2021 Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, reported that the FDA is deferring action on the application for AVT02, the company’s proposed biosimilar to Humira, until facility assessments can be completed (Press release, Alvotech, SEP 20, 2021, View Source [SID1234588041]). The FDA can defer action1 when no deficiencies have been identified and the application otherwise satisfies the requirements for approval, but an inspection(s) is necessary yet cannot be completed due to factors including travel restrictions. Alvotech continues to work with the FDA to coordinate the required inspection(s) in a safe and adequate manner.

Alvotech is the only known company that has both submitted a Biologics License Application(BLA) for a high-concentration biosimilar candidate to Humira, the most commonly utilized strength of the product on the market, and has successfully conducted a switching study in support of an FDA designation of interchangeability and correspondingly the potential for product substitution at the pharmacy level. Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT02 in the United States.

In addition to the positive top-line results seen in the switching study, Alvotech on Sept. 16, 2021 received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of AVT02 in the EU. The European Commission (EC) will consider the CHMP’s positive opinion when deciding to grant a marketing authorization for AVT02 at its October meeting.

The Biden Administration and the U.S. Department of Health and Human Services (HHS) have expressed support for the increased competition and healthcare savings generated by biosimilars and interchangeable biosimilars.

"The U.S. Government has made it clear that increasing the affordability of prescription drugs, through enhanced competition in biologic medicines, is a significant priority," said Mark Levick, CEO of Alvotech. Adding, "We strongly share the view that biosimilar medicines and interchangeable biosimilars present a unique opportunity to contribute to improving equity in healthcare"

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