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University of Louisville Health Adopts Paige AI-enabled Cancer Detection Software for Enhanced Cancer Detection

On December 15, 2021 Paige, the global leader in AI-based diagnostic software in pathology, reported that University of Louisville (UofL) Health, a leading academic health system based in Louisville, Kentucky, has deployed a full suite of Paige AI-enabled digital pathology software to improve diagnostic confidence, efficiency, and patient care during routine cancer diagnosis (Press release, Paige AI, DEC 15, 2021, View Source [SID1234597240]).

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UofL Health is one of the first health systems in the U.S. to implement Paige Prostate, the first and only AI-based pathology product to receive FDA approval for in vitro diagnostic (IVD) use in detecting cancer in prostate biopsies. UofL Health will also deploy Paige’s FullFocus as their digital pathology case management tool and digital pathology image viewer, and Paige Breast to elevate pathologists’ ability to diagnose cancer.

With cancer cases on the rise globally, AI technologies have the potential to help pathologists work more confidently and efficiently. AI can act as a second pair of eyes for pathologists, helping them to quickly spot very small, almost imperceptible regions of cancer in a tissue sample that may be challenging to recognize with the naked eye. This can translate into better accuracy in cancer diagnosis and ultimately better clinical management for patients.

"We are proud to be one of the first health systems in the U.S. to adopt an AI-enabled digital pathology software platform which offers an enhanced look at tissues and acts as a built-in second opinion in our routine diagnostic processes," said Dibson Dibe Gondim, M.D., Director of Pathology Informatics, Assistant Professor of Pathology and Laboratory Medicine, Associate Residency Program Director of Anatomic Pathology, and Director of Genitourinary Pathology at the University of Louisville School of Medicine. "Leveraging the Paige Platform and AI tools, such as Paige Prostate, will help us increase efficiency and diagnostic confidence for our patients and improve our pathology workflows."

Additionally, UofL Health will leverage Paige’s Software Development Kit, an open platform that enables institutions to deploy customized laboratory developed tests for digital pathology, to deploy AI algorithms to assist in operational efficiencies and image analysis that were developed in-house.

"Completing our deployment at University of Louisville Health is an exciting milestone for Paige as we help hospital systems adopt digital, AI-based technologies to make their existing workflows more accurate and efficient," said Andy Moye, Ph.D., Chief Commercial Officer at Paige. "We are proud to offer a robust portfolio of AI-enabled digital pathology technologies backed by the FDA. We are also excited to see how the University of Louisville is utilizing the Paige Software Development Kit to achieve near-term clinical impact, and we hope this will be the first of many research applications adopting our open technology to improve patient care."

Outside of the U.S., Paige Prostate is CE-marked for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK. FullFocus is FDA cleared and CE-marked. The products are otherwise available for research use only in other territories.

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Asher Bio Showcases Versatility and Broad Applicability of Cis-Targeting Technology for Precision Immunotherapies at Antibody Engineering Conferences

On December 15, 2021 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported an overview of its cis-targeting platform and growing pipeline of highly differentiated precision immunotherapies (Press release, Asher Biotherapeutics, DEC 15, 2021, View Source [SID1234597237]). The update follows presentations by Asher Bio on its cis-targeting technology at PEGS Europe: Protein & Antibody Engineering Summit, held November 2-4, 2021 in Barcelona, and the Antibody Engineering & Therapeutics (AET) Conference, held December 12-16, 2021 in San Diego .

"We were delighted to present additional details on our cis-targeting technology at recent scientific conferences," said Andy Yeung, Ph.D., Chief Technology Officer and Founder of Asher Bio. "Our platform enables us to build a broad pipeline of potentially best-in-class precision immunotherapies, each of which engages both an immunomodulatory receptor and a specific target on the same cell. By focusing our potent immunomodulators selectively on only the desired immune cell type, we believe we can deliver improved clinical outcomes, offering patients more efficacious medicines that carry a reduced risk of off-target toxicities. Importantly, our approach can be applied systematically to target multiple classes of immunomodulators to a diverse set of immune cell types, creating numerous opportunities to generate new immunotherapies for a range of cancers, autoimmune and infectious diseases."

As outlined in Asher Bio’s presentations at PEGS Europe and AET, the company’s proprietary cis-targeting platform yields immunotherapies that selectively activate specific immune cell subsets, in order to avoid the pleiotropic effects that characterize the systemic delivery of existing cytokines and immunotherapies. Asher Bio is applying its modular toolkit, which includes a library of targeting arms and engineered cytokines that can be readily recombined to generate new molecules, to rapidly build and de-risk a portfolio of drug candidates for treatments in multiple disease areas.

"Since our founding, we progressed our three most advanced programs – all of which leverage our discoveries in IL-2 and other cis-targeted cytokines for the treatment of oncology – through preclinical proof-of-concept, demonstrating the reproducibility of our approach and providing the foundation for us to build a portfolio of potentially best-in-class immunotherapies," said Ivana Djuretic, Ph.D., Chief Scientific Officer and Founder of Asher Bio. "We look forward to building on this momentum as we advance our existing programs toward the clinic and apply our proprietary cis-targeting technology to discover, develop and, ultimately, deliver novel molecules with the potential to restore hope, health and happiness to many more patients."

The presentations at PEGS Europe and AET provide additional detail on Asher Bio’s cis-targeting technology and support the company’s emerging pipeline of cis-targeted immunotherapies:

Asher Bio’s lead program, AB248, is a fusion protein that selectively activates the interleukein-2 (IL-2) receptor pathway on CD8+ T cells. In preclinical studies, AB248 has demonstrated highly compelling anti-tumor activity across multiple mouse tumor models, showing superior efficacy and tolerability compared to wild-type IL-2 and other not-α IL-2 therapies currently in clinical development. Asher Bio expects to file an investigational new drug application with the U.S. Food and Drug Administration in the third quarter of 2022.
Beyond AB248, Asher Bio is advancing two additional programs for the treatment of cancer, both of which have achieved preclinical proof of concept:
A cis-targeted cytokine that selectively activates STAT3 signaling in CD8+ T cells, promoting cytotoxicity, memory cell differentiation and survival, all of which are signals potentially complementary to the proliferation signal provided by IL-2 and STAT5 activation.
A CAR-T cis-targeted IL-2 that selectively expands CAR-Ts post-adoptive transfer, supporting better engraftment, peak expansion and persistence, all of which have been correlated with improved clinical efficacy and outcomes.
The scientific overview presented at PEGS Europe and AET is now available in the "Presentations and Posters" section of Asher Bio’s website: View Source

Mythic Therapeutics Launches with New Approach to Improving Antibody Drug Conjugate Performance, Backed by $103 Million in Series B Financing

On December 15, 2021 Mythic Therapeutics reported its launch to develop smarter and safer antibody-drug conjugates (ADCs) with an oversubscribed Series B financing round of $103 million (Press release, Mythic Therapeutics, DEC 15, 2021, View Source [SID1234597235]). Viking Global Investors led the round, along with new investors including Venrock Healthcare Capital Partners, Foresite Capital, Perceptive Advisors, and Highside Capital. Existing Mythic investors participating in the round include Venrock, First Round Capital, OMX Ventures, Lifeforce Capital, and Refactor Capital. The proceeds from Mythic’s Series B will finance the lead program through first-in-human clinical studies in lung cancer and fund pipeline development.

"We are thrilled to partner with this distinguished group of investors," said Alex Nichols, PhD, co-founder, President, and CEO of Mythic Therapeutics. "This financing validates the FateControl approach and supports our efforts to achieve expanded use of Mythic’s ADCs within and across indications, translating to improved outcomes for patients with unmet medical needs."

Although the development history of ADCs spans more than four decades, the clinical benefit of ADCs has so far remained limited to a subset of diseases and targets with optimal biological characteristics, such as high levels of target expression. Mythic has developed a breakthrough approach to expand the role of ADCs in precision medicine by dramatically improving ADC therapeutic index against a broad set of molecular targets and patient profiles.

"To date, approaches to improve the performance of ADCs have focused primarily on innovation in one of three dimensions: linker and payload chemistries, conjugation technology, and new target biology," said Brian Fiske, PhD, co-founder and Chief Scientific Officer of Mythic Therapeutics. "Mythic seeks to improve the clinical performance of ADCs by introducing a new dimension of ADC technology focused on manipulating the fate of ADCs within the cell."

ADCs are designed to specifically deliver a therapeutic payload to a target tissue or disease site. However, studies have demonstrated that the vast majority of payload is ultimately released non-specifically throughout the body, causing systemic toxicity and reducing efficacy. Mythic’s FateControl technology increases the amount of ADC that is internalized by the target tissue while reducing payload release in non-targeted tissues, thereby improving therapeutic index independent of the linker and payload. Mythic’s lead program in lung cancer has the potential to drive a multi-fold expansion of the number of lung cancer patients eligible for treatment using ADCs; the company plans on developing a pipeline of products incorporating its platform technology.

"Venrock was attracted by Mythic’s innovative strategy to overcome one of the most historically challenging obstacles to realizing the full potential of ADCs for patients," said Bryan Roberts of Venrock, a member of Mythic’s Board of Directors. "The progress this team has made in a short time reinforces our deep conviction in Mythic’s ability to develop a pipeline of safer and more effective ADCs, beginning with their lead program. We are delighted to be part of the Mythic story."

Leadership

Alex Nichols, PhD, Co-Founder, President, CEO, and Director
Brian Fiske, PhD, Co-Founder, Chief Scientific Officer, and Director
Sandra Poole, MASc, PEng, Chief Operating Officer
In addition to Alex and Brian, the Mythic Therapeutics Board of Directors is comprised of:

Bryan Roberts, PhD, Partner, Venrock
Josh Kopelman, Partner, First Round Capital
Peter Hecht, PhD, Co-Founder and CEO, Cyclerion; Co-Founder and former CEO, Ironwood Pharmaceuticals
Scientific Advisory Board

Douglas E. Williams, PhD, President and CEO, Codiak Biosciences
John Lambert, PhD, former EVP and CSO, ImmunoGen
Michael Vasconcelles, MD, Chief Medical Officer, Flatiron Health
Richard Gregory, PhD, former CSO, ImmunoGen and former head of R&D, Sanofi
Scott J. Dylla, PhD, Co-Founder and Former CSO, Stemcentrx

NOXXON to Participate in Banking and Investor Conferences in January and February 2022

On December 15, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that Aram Mangasarian, CEO of NOXXON, and Bryan Jennings, CFO of NOXXON, will participate and be available for meetings at several banking and investor conferences in early 2022 (Press release, NOXXON, DEC 15, 2021, View Source [SID1234597233]).

LifeSci Partners Corporate Access Event, January 5-7, 2022, digital event
Corporate Access Event organized by LifeSci Partners will feature more than 200 innovative publicly traded and privately held biotechnology, medical technology, pharmaceutical, life sciences, and digital health companies from across the globe. The event will include one-on-one meetings with company senior management teams and panel discussions featuring KOLs, CEOs, specialized investors, and healthcare experts highlighting the most relevant topics impacting the life sciences industry today. The NOXXON team will be available for meetings. Registration for the event is required.

H.C. Wainwright BIOCONNECT Virtual Conference, January 10-13, 2022, digital event
BIOCONNECT hosted by H.C. Wainwright aims to connect life sciences companies with a diverse roster of investors. NOXXON’s corporate video presentation will be available on demand from January 10 at 7:00 a.m. ET. The team welcomes meetings with the investment community during the conference. Registration for the event is required.

BIOMED EVENT 2022, January 26, 2022, Paris, France
The 7th edition of the BIOMED EVENT organized by INVEST SECURITIES, will host numerous European listed biotech/medtech companies and institutional investors. NOXXON’s CEO will be available for one-on-one and group meetings throughout the day. Registration for the event is required.

LSX World Congress, February 8-9, 2022, London, UK or February 14-25, 2022, digital event
The 8th LSX World Congress will gather the founders and CEOs of innovative start-ups through to big pharma and aims to provide platform for companies to share their cutting-edge research and technology. The Congress offers one-on-one partnering, connecting the biotech, healthtech and medtech industry c-suite with the sector’s most active investors, pharma and health technology BD&L teams, R&D leaders, KOLs and top tier service companies who are driving the sector forward. NOXXON’s in-person or virtual participation will be driven by the conditions imposed by the pandemic. More information about the event can be found here.

Avenue Therapeutics Announces Closing of Public Offering of Common Stock

On December 15, 2021 Avenue Therapeutics, Inc. (or the "Company") (NASDAQ: ATXI), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, reported the closing of its public offering of 1,910,100 shares of common stock at a public offering price of $1.07 (Press release, Avenue Therapeutics, DEC 15, 2021, View Source [SID1234597229]). The gross proceeds of the offering were approximately $2.0 million before deducting underwriting discounts, commissions and offering expenses. In addition, the Company has granted Aegis Capital Corp. a 45-day option to purchase up to an additional 286,430 shares of common stock to cover over-allotments, if any, at the public offering price, less the underwriting discount.

The common stock is trading on The Nasdaq Capital Market under the symbol "ATXI".

Aegis Capital Corp. acted as the sole book-running manager for the offering.

A registration statement on Form S-3 relating to common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on December 10, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.