Selecta Biosciences to Participate in Cantor Virtual Global Healthcare Conference

On September 21, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Company’s Management will participate in a fireside chat and one-on-one investor meetings at the Cantor Virtual Global Healthcare Conference to be held September 27-30, 2021 (Press release, Selecta Biosciences, SEP 21, 2021, View Source [SID1234588087]).

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Details on the conference be found below.

Cantor Virtual Global Healthcare Conference
Format: Fireside chat and one-on-one investor meetings
Date: Monday September 27, 2021
Presentation Time: 3:20 p.m. EST
Webcast: Click Here

An archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

BioCryst to Present at 2021 Cantor Virtual Healthcare Conference

On September 21, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported that the company will present at the 2021 Cantor Virtual Healthcare Conference on Tuesday, September 28, 2021 at 2:00 p.m. ET (Press release, BioCryst Pharmaceuticals, SEP 21, 2021, View Source [SID1234590064]).

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Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com.

Puma Biotechnology to Present at the Cantor Virtual Global Healthcare Conference

On September 21, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 8:00 a.m. EDT on Tuesday, September 28, at the 2021 Cantor Virtual Global Healthcare Conference (Press release, Puma Biotechnology, SEP 21, 2021, View Source [SID1234590089]).

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A webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

Vivoryon Therapeutics N.V. Reports H1 2021 Financial Results and Operational Progress

On September 21, 2021 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported financial results for the first six months of 2021 and provided an update on clinical and corporate progress (Press release, Vivoryon Therapeutics, SEP 21, 2021, View Source [SID1234588088]).

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"In the first half of 2021, we made significant progress towards bringing our lead candidate varoglutamstat to patients suffering from Alzheimer’s disease. Despite the ongoing pandemic, recruiting into our European Phase 2b study VIVIAD is on track and we’re particularly excited about the initiation of our complementary Phase 2 study VIVA-MIND in the US. Furthermore, by entering into a strategic regional partnership with Simcere, we have made substantial headway towards making varoglutamstat available to AD patients in China in the future," said Dr. Ulrich Dauer, CEO of Vivoryon. "Beyond AD, we are pleased to see our diverse preclinical pipeline of oral small molecule inhibitors maturing in a number of indications with exceptionally high medical need."

Corporate Highlights and R&D Updates
Varoglutamstat

Vivoryon’s US Phase 2a/b VIVA-MIND study for varoglutamstat in patients with early AD is being initiated as planned. VIVA-MIND is a combined Phase 2a/b study expecting to enroll 180 patients into the Phase 2a adaptive dose finding part, with an interim futility analysis planned for H1/2023. If predefined criteria are fulfilled, the trial is stage-gated into the Phase 2b part, enrolling an additional 234 patients treated at the selected dose for ³72 weeks. The primary endpoint for this study is CDR-SB (clinical dementia rating scale – sum of boxes), an established approvable endpoint measuring a combination of cognitive abilities and activities of daily living. The VIVA-MIND study is sponsored by Vivoryon and the study director is Dr. Howard Feldman, Professor of Neurosciences and Director of the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California San Diego School of Medicine. The study is coordinated by the ADCS, and supported by the National Institute on Aging (NIA), part of the National Institutes of Health (NIH) (NIA award number R01AG061146). The study’s first site is now approved to initiate screening of its first participant.
On June 29, 2021, Vivoryon and Simcere Pharmaceutical Group Ltd announced that they have entered into a strategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat AD in Greater China. The agreement grants Simcere a regional license to develop and commercialize varoglutamstat (PQ912), Vivoryon’s Phase 2b-stage N3pE amyloid-targeting oral small molecule glutaminyl cyclase (QPCT) inhibitor with disease-modifying potential for AD, as well as the Company’s preclinical monoclonal N3pE‑antibody PBD-C06 in the Greater China region.
Enrollment into the ongoing European Phase 2b VIVIAD study in patients with mild cognitive impairment (MCI) and mild AD is on track, with an interim safety readout anticipated in mid-2022. A number of additional study centers were opened to balance the effects of COVID-19 related patient and staff protection policies implemented at German study sites. Details on the study led by Prof. Dr. Philip Scheltens, University Medical Center, Amsterdam, were recently published in a peer-reviewed journal as Vijverberg et al., Alzheimer’s Research & Therapy (2021) 13:142 (View Source).
Patent Portfolio

Throughout the first half of 2021, Vivoryon has significantly expanded its patent portfolio with eight additional patents granted for the Company’s small molecule inhibitors and antibody-based medicines in development to treat AD and other diseases with exceptionally high medical need. Year to date (as of September 21, 2021) a total of 14 additional patents have been granted.
Corporate Developments

On June 28, 2021, Vivoryon held its 2021 Annual General Meeting as a virtual event. All items presented for resolution by the Board of Directors were approved with a large majority and can be found on the Company’s website.
On April 15, 2021, Vivoryon hosted a virtual event covering next steps in AD treatment options with leaders and experts in the field. The interactive session covered discussions surrounding current hurdles and exciting, novel approaches to the challenging AD space, including varoglutamstat, the Company’s small molecule inhibitor of QPCT designed to target all three hallmarks of AD: amyloid-beta, tau, and neuroinflammation.
On April 1, 2021, Florian Schmid joined Vivoryon as Chief Financial Officer. He joined the Company from InflaRx, where he served as Director Finance & Controlling. Prior to Vivoryon Mr. Schmid led the Global Deal & Business Support department at T‐Systems International GmbH. He began his career as certified Tax Advisor and Public Accountant at Arthur Andersen and Ernst & Young. Mr. Schmid holds a business degree from the Ludwig‐Maximilian‐University, Munich.
Financial Results for the First Six Months of 2021
In the first two quarters of 2021, research and development expenses amounted to EUR 9,456 k (H1 2020: EUR 6,380 k). This increase was mainly driven by higher expenses for production (H1 2021: EUR 4,194 k, H1 2020: EUR 1,876 k), expenses for share-based payments (H1 2021: EUR 464 k, H1 2020: EUR 3 k) and higher costs associated with basic research projects in connection with Meprin (H1 2021: EUR 220 k, H1 2020: nil) and cancer (H1 2021: EUR 162 k, H1 2020: nil).

General and administrative expenses increased to EUR 2,337 k (H1 2020: EUR 1,138 k). This increase is largely attributable to costs for consulting (H1 2021: EUR 1,030 k, H1 2020: EUR 481 k) and expenses for share based payments (2021: EUR 464 k, 2020: nil). The increase in consulting costs resulted from the transformation of the Company’s legal form, subsequent adaption of administrative structures and preparations for potential future capital measures.

The Company did not generate any licensing revenues in the reporting period. Revenues deriving from the strategic regional licensing partnership with Simcere will be recognized starting in the third quarter of 2021.

Net loss of the period was EUR 11,671 k compared to EUR 7,572 k in the first half of 2020.

The Company held EUR 19,832 k in cash and cash equivalents as of June 30, 2021, compared to EUR 26,306 k as of December 31, 2020.

Conference Call and Webcast
Vivoryon will host a conference call and webcast today, September 21, 2021, at 3:00 pm CEST / 9:00 am EDT. A Q&A session will follow the presentation of the half year results.

Please dial in ten minutes prior to commencement.

A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/.

Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/.

The statement for the first six months of 2021 is available on the Company’s website www.vivoryon.com/investors-news/financial-information.

AUA2021 Presentation Highlights Results from a Phase 1/2 Clinical Trial of Intramural/Intravesical NanoDoce® Suspension in High-Risk Nonmuscle Invasive Bladder Cancer

On September 21, 2021 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that initial results from a Phase 1/2 clinical trial of intramural/intravesical (IMI/IVT) NanoDoce (large surface area microparticle [LSAM] docetaxel) suspension in high-risk nonmuscle invasive bladder cancer (hrNMIBC) were presented by Max Kates, MD (Johns Hopkins Medicine) at the American Urological Association annual meeting (AUA2021) via virtual platform on September 12, 2021 (Press release, NanOlogy, SEP 21, 2021, View Source;utm_medium=rss&utm_campaign=aus2021_presentation_highlights_pr [SID1234590065]).

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The oral presentation entitled Initial Results from a Phase 1/2 Trial of Large Surface Area Microparticle Docetaxel for High-Risk Non-Muscle Invasive Bladder highlighted safety and preliminary efficacy data from the multicenter dose-rising/confirmation clinical trial that enrolled 19 subjects. In addition to Dr. Kates, contributing clinical investigators were Ahmed Mansour, MD (UT Health San Antonio), Donald Lamm, MD (BCG Oncology), and Neal Shore, MD (Carolina Urologic Research Center).

Highlights from the presentation:

Overall, NanoDoce was well tolerated. Most treatment emergent adverse events were mild to moderate, and no severe adverse events were attributable to the study drug.
Systemic absorption of docetaxel was negligible and below the threshold for systemic toxicity in all subjects.
Across all doses and subjects (n=19), complete response (CR) at 3 months as 68% (13/19) and durability for responding subjects at 12 months was CR of 31% (4/13).
In the high-dose cohort (n=6), 6/6 maintained CR > 6 months with 4 subjects showing durability at 12 months, 1 subject showing recurrence, and 1 subject lost to follow up.
Tissue biopsies suitable for multiplexed immunofluorescence were obtained pre/post NanoDoce in 5 subjects. Analysis revealed directional increases in density of T Cells, macrophages (including PD-L1), and NK cells, and decreases in myeloid and MDSC cells.
NanoDoce (LSAM docetaxel) suspension is composed of large surface area microparticles of pure docetaxel designed for local administration and sustained drug release over time. In the dose-rising phase of the study (n=13), 3mg to 15mg of investigational drug were delivered IMI into and around the tumor resection bed post transurethral resection of bladder tumor (TURBT) followed by multiple periodic IVT of 50mg to 75mg. No dose limiting toxicities were encountered allowing target of 15mg IMI and 75mg IVT NanoDoce to continue into dose confirmation (n=6). Subjects were followed for up to one year. A separate study arm evaluated a post-TURBT single IMI/IVT administration of NanoDoce for safety over a 45-day period in 17 patients with muscle invasive bladder cancer. These data will be reported separately once final.

The American Cancer Society estimates 83,730 new cases of bladder cancer in the United States for 2021 with more than 20,000 presenting with hrNMIBC. For these patients, bladder removal often follows, which results in among the highest lifetime treatment costs and negative impact to quality of life of any cancer. NanOlogy is in planning of a later phase clinical trial in hrNMIBC.

In addition to this trial, NanOlogy clinical programs have advanced in lung, pancreatic, and other cancers. Data from preclinical and clinical studies in a variety of solid tumors have shown evidence of tumor kill, minimal local or systemic toxicity, and favorable antitumoral immune effects, which includes published preclinical research of NanoDoce synergy in combination with an immune checkpoint inhibitor.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts taxane API crystals into stable LSAMs of pure drug for tumor-directed therapy and sustained drug release. The taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, & US 10,993,927), Canada, Europe, Japan, Russia, and Australia all valid through June 2036, plus applications pending globally. These composition of matter patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, methods, and technology.