Bionomics Announces Plans to Conduct U.S. Initial Public Offering

On August 2, 2021 Bionomics Limited (ASX: BNO,OTCQB: BNOEF), (Bionomics) a global, clinical stage biopharmaceutical company, reported that it plans to conduct a registered initial public offering of American Depositary Shares (ADSs) in the United States and a concurrent listing of ADSs on Nasdaq (Press release, Bionomics, AUG 2, 2021, View Source [SID1234585559]). The number of ADSs and price of the proposed offering have not yet been determined. The proposed offering is expected to commence after the U.S. Securities and Exchange Commission completes its review process of a registration statement relating to the proposed offering (the Registration Statement) that the company intends to file, and subject to market and other conditions, including the effectiveness of the Registration Statement and shareholder approval under Australian Securities Exchange (ASX) Listing Rule 7.1. Each ADS would represent a certain number of fully paid ordinary shares in Bionomics.

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No final decision has been made in respect of the Nasdaq listing and there can be no assurance as to the occurrence, timing or completion of such a listing. Following any Nasdaq listing Bionomics shares would continue to trade on ASX.

This press release is being made pursuant to and in accordance with Rule 135 under the U.S. Securities Act of 1933, as amended. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

Micronoma Wins Bio-IT World Innovative Practices Award

On August 2, 2021 Micronoma, the first cancer detection biotech company to diagnose cancer at an early stage with microbiome-driven liquid biopsy technology, reported that they are the recipient of the Bio-IT World Innovative Practices Award (Press release, Micronoma, AUG 2, 2021, View Source [SID1234585508]). This elite awards program highlights outstanding examples of how technology innovations and strategic initiatives can advance life sciences research, from basic biomedical research to drug development and beyond.

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Micronoma’s microbiome-driven liquid biopsy method uses machine learning to examine thousands of microbiome plasma features to discover, validate, and translate microbial-derived biomarkers into an early cancer detection method. The award from Bio-IT World recognizes that this process is designed to improve the chances of survival of cancer patients by discovering the disease in its earliest stages, including at stage I of the disease, when tumor size is still at its smallest.

"We are honored to receive the Bio-IT World Innovative Practices Award and to be in such great company with our fellow awardees," said Sandrine Miller-Montgomery, CEO of Micronoma. "This recognition from Bio-IT World adds to an incredible year of discovery and collaboration for Micronoma, and gives even more energy to our team to continue to work hard and fast to save lives."

Bio-IT World explained that the 2021 awards, which recognize work completed during 2020, are particularly noteworthy. "This has been a uniquely demanding season for the industry, but once again the Bio-IT World community has excelled and delivered innovation and solutions to serve both researchers and patients," said Allison Proffitt, Bio-IT World editorial director.

Grand prize awards were granted last week to Micronoma and two other winners including Regeneron Pharmaceuticals and Duke Cancer Institute with University of California, San Francisco. Micronoma will join these highly talented recipients in presenting its innovative work at the 2021 Bio-IT World Conference & Expo in Boston in September. The event will be held both online and in-person.

Sandrine Miller-Montgomery, Micronoma’s CEO, will present Micronoma Behind the Scenes Science and Technology: Using the Microbiome to Detect Early-Stage Cancer during the Genome Informatics track on Tuesday, Sept. 21, 2021.

Cardinal Health completes sale of Cordis business to Hellman & Friedman

On August 2, 2021 Cardinal Health (NYSE: CAH) and Hellman & Friedman (H&F) reported the completion of the previously announced sale of Cardinal Health’s Cordis business to H&F (Press release, Cardinal Health, AUG 2, 2021, View Source;Friedman/default.aspx [SID1234585529]). The sale price of approximately $1 billion includes the buyer’s assumption of certain liabilities and the seller’s retention of certain working capital accounts.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide.

"We appreciate H&F’s partnership throughout the transaction, and we are excited about Cordis’s future under H&F’s ownership," said Mike Kaufmann, CEO of Cardinal Health. "As we shared previously, this divestiture demonstrates our disciplined portfolio evaluation approach, and we remain committed to investing in our strategic growth areas."

"We are thrilled to begin this next chapter for Cordis and value the partnership with Cardinal Health through the transition," said Shar Matin, CEO of Cordis. "We believe that an independent Cordis company, combined with an innovative approach to bring differentiated products to market, will allow us to create incremental value for teammates, customers and investors."

Cardinal Health plans to release its fourth-quarter and year-end financial results for its fiscal year 2021 on August 5 prior to the opening of trading on the New York Stock Exchange. The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

Castle Biosciences Collaborates with the Melanoma Research Foundation

On August 2, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported its continued collaboration with the Melanoma Research Foundation (MRF), a non-profit organization leading the melanoma community to transform melanoma from one of the deadliest cancers to one of the most treatable through research, education and advocacy (Press release, Castle Biosciences, AUG 2, 2021, View Source [SID1234585544]).

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MRF Miles for Melanoma and 2021 Galas:

The MRF Miles for Melanoma 5K run/walks are community events held across the United States, both virtually and in-person, to raise funds that support critical research for viable melanoma treatments. Participants include melanoma patients, survivors, caregivers and supporters. Castle Biosciences is a sponsor of the upcoming events taking place in Cleveland, St. Paul, Minn., Philadelphia, Boston and San Francisco.

Additionally, Castle Biosciences is a sponsor of the 2021 MRF galas, taking place in Chicago, Denver and New York, in celebration of courageous melanoma survivors and those in the medical community who are making a difference in the fight against melanoma through exemplary patient care, cutting-edge research or scientific leadership.

"The important work of the MRF to accelerate medical research while advocating for the melanoma community would not be possible without the generous support of corporate sponsors like Castle Biosciences," said Kyleigh LiPira, M.B.A., chief executive officer of the MRF. "We are grateful for their partnership and applaud their commitment to keeping patients at the forefront of their business."

"At Castle, we are committed to improving the lives of patients with skin cancer, and it is at the core of everything we do," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "So, we are proud to further our collaboration with the Melanoma Research Foundation. Their important work in the areas of research, advocacy and education is critical for patients living with melanoma and their families."

Hummingbird Bioscience Announces UK MHRA Approval for First-in-Human Phase 1 Trial of HMBD-001 in Advanced Cancers

On August 2, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, reported that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the clinical trial application (CTA) to initiate first-in-human phase 1 trial of HMBD-001 in patients with advanced cancers (Press release, Hummingbird Bioscience, AUG 2, 2021, View Source [SID1234585560]).

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HMBD-001 is a novel antibody with a unique, differentiated mechanism of action that fully inhibits HER3 activation of the MAPK/PI3K tumor growth signaling pathway. By binding to the HER3 dimerization interface, HMBD-001 blocks the formation of all HER3 dimers, regardless of NRG1 ligand-binding or HER2/EGFR overexpression. Pre-clinical studies in multiple HER3 cancer models, including those with NRG1-fusions, have shown that these differentiated properties of HMBD-001 result in robust and sustained tumor growth inhibition.

The phase 1 trial will be a multi-center, open-label, dose-escalation and -expansion study, to be conducted in two parts. First, the safety and tolerability profile and recommended phase 2 dose of HMBD-001 will be determined in patients with advanced tumors known to overexpress HER3. This will be followed by further evaluation of safety and preliminary anti-tumor activity of HMBD-001 as a monotherapy in biomarker-selected patients, including those with NRG1 fusions, as well as in combination with other selected targeted therapies. Under a clinical development partnership agreement, Cancer Research UK will be funding and conducting the phase 1 trial in the UK.

"This marks an exciting next step in our journey to deliver a potentially transformative therapy for hard-to-treat cancers that express HER3 and are resistant to standard of care treatments," said Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder of Hummingbird Bioscience. "Our platform technology was developed specifically to tackle biologically relevant yet extremely challenging targets for which research efforts to-date have yet to generate effective treatments. HMBD-001 is the first of our growing pipeline of rationally designed antibodies to obtain clinical trial approval, demonstrating the power of the platform to develop highly differentiated, precision therapies."

About HMBD-001
HMBD-001 is a anti-HER3 neutralizing antibody, with a novel mechanism of action that offers significant potential for clinical benefit. Previous attempts to block the HER3 receptor, a key player in the PI3K/MAPK signaling pathways that promotes cell division and tumor growth in cancer, have not proven to be effective. HER3 is activated by the binding of NRG1, which stabilizes a transient open conformation to allow it to form heterodimers with HER2/EGFR. In the presence of abundant HER2/EGFR, heterodimers can form without NRG1.

Pre-clinical studies have shown that HMBD-001 potently inhibits the formation of these heterodimers, blocking activation of the signalling pathway – and consequently, prevents tumor growth. Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel drug candidate into clinical trials for the treatment of HER3-driven cancers.