On September 1, 2022 Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, reported outstanding outcomes for the Galen Breast solution in diagnosing multiple cancer types and further expansion of its AI portfolio for breast cancer diagnosis (Press release, Ibex Medical Analytics, SEP 1, 2022, View Source [SID1234618922]). The CE-Marked AI solution is generally available as Ibex partners with laboratories, hospitals and health systems across Europe to deploy Galen Breast into their routine workflow, supporting improved quality and efficiency in the diagnosis of breast biopsies.

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!

Breast cancer is the most common malignant disease in women worldwide, with over two million new cases each year. As such, accurate and timely diagnosis is key to guiding treatment decisions by oncologists and improving patient survival rates.

Over the last several years, rapid advances in personalized medicine have resulted in a growing complexity of cancer diagnosis. Coupled with the increase in overall cancer incidence and a global decline in the number of pathologists, these trends have led to growing workloads imposed on pathology departments. Clearly, there is a growing need for automated solutions and decision-support tools that help pathologists detect cancer to the utmost accuracy more rapidly.

Galen is Ibex’s integrated diagnostics platform supporting pathologists in the diagnosis of breast, prostate, and gastric biopsies. Galen is the most widely deployed AI technology in pathology, and laboratories, hospitals and health systems worldwide already use it as part of their everyday practice. The combination of a skilled pathologist together with the accuracy, speed and objectivity provided by Artificial Intelligence has the potential to improve the quality of diagnosis, user experience, operational efficiency, and ultimately patient outcomes.

Galen Breast demonstrated excellent outcomes in a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. The study evaluated the performance of pathologists who used Ibex AI for diagnosing breast biopsies and compared them to pathologists who used only a microscope across multiple types of breast cancer including invasive and in-situ carcinoma as well as rare subtypes, such as metaplastic, mucinous, and other types of breast cancer. The study results showed very high accuracy and utility of Galen Breast across multiple scanning and staining platforms, and established its potential for improving the quality of diagnosis, compared to using a microscope alone. The full study results will be presented by Judith Sandbank, MD, Director of the Pathology Institute at Maccabi Healthcare Services5 and one of the principal investigators in the study, at the European Congress of Pathology which takes place in Basel, Switzerland, between September 3-7 (Ibex presents at booth no. 1).

Previous studies on Galen Breast established its AI algorithm’s accuracy in detecting cancer, distinguishing between multiple subtypes such as ducal and lobular carcinomas, grading DCIS (ductal carcinoma in-situ) and identifying rare tumors. Moreover, the solution successfully detected clinically important cancer-related and non-cancer features, including tumor infiltrating lymphocytes, angiolymphatic invasion, microcalcifications and more1,2. Galen also enables automated pre-ordering of the breast immunohistochemistry (IHC) panel and other tests which may help shorten the turnaround time for diagnosis of cancer cases, maximizing efficiency gains for laboratories and enabling patients to start treatment earlier3. Ibex is also working to expand its technology to support improved prognosis of breast cancer, by providing automated quantification of HER2, Ki67, ER and PR receptors in immunohistochemistry stained slides as part of its product portfolio. These innovative AI algorithms are intended to assist pathologists in their diagnosis which may help further enhance diagnostic efficiency and enable more accurate and objective scoring of breast biomarkers, allowing for improved treatment decisions and patient care.

"We are impressed with the successful study outcomes and the performance of Galen Breast, that was evaluated in a diagnostic setting which is identical to how our pathologists review cases in their daily routine," said Anne Vincent-Salomon, MD, Director of Pathology at Institut Curie and one of the principal investigators in the study4. "Our team demonstrated that when pathologists use Ibex’s AI technology they achieve very high accuracy levels in diagnosing breast cancer over a broad range of subtypes, with higher quality than when using a microscope alone. With these results, and as more and more laboratories transition to digital pathology workflows, I look forward to seeing Artificial Intelligence broadly adopted in the field."

"AI is going to be a critical adjunct to diagnostic pathology going forward. Pathologists reviewing whole-slide images, in combination with an AI algorithm, will provide better diagnoses and better care than either a pathologist alone or AI alone," said Stuart Schnitt, MD, Chief of Breast Oncologic Pathology at the Dana-Farber/Brigham and Women’s Cancer Center and Professor of Pathology at Harvard Medical School4. "AI has already demonstrated its value in helping pathologists improve the quality of breast cancer diagnosis and reduce misdiagnosis, and I am impressed with the outcomes of this new study, demonstrating the robustness and utility of Ibex AI in a primary diagnosis setting. I look forward to seeing the impact this solution will have on the overall performance of pathology departments and patient outcomes, as it becomes widely adopted."

"We are excited to announce this milestone results and enable breast pathologists to further adopt AI into their routine diagnosis of breast biopsies, following excellent outcomes in a clinical study" said Chaim Linhart, PhD, Co-founder and CTO of Ibex at Ibex Medical Analytics. "We believe that AI has an essential role to play in pathology and cancer diagnosis, extending beyond cancer detection to ultimately support pathologists across most of the diagnostic pathway, as demonstrated by the scope of clinical features available with Galen Breast, as well as the expansion toward automated quantification and scoring of breast biomarkers".

On September 1, 2022 Recursion (NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported its participation in the following investor conferences (Press release, Recursion Pharmaceuticals, SEP 1, 2022, View Source [SID1234618920]):

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!

Morgan Stanley Global Healthcare Conference — September 12 through September 14, 2022
Goldman Sachs Global Sustainability Forum — September 29, 2022

On September 1, 2022 bioAffinity Technologies, Inc., a cancer diagnostics company that develops noninvasive, early-stage diagnostics to detect cancer and diseases of the lung and is researching targeted therapies to treat cancer, reported that its initial public offering of 1,282,600 units of securities has been priced at $6.125 per unit (Press release, BioAffinity Technologies, SEP 1, 2022, View Source [SID1234618919]). Total gross proceeds from the offering is estimated to be $7,855,925 before deducting underwriting discounts and commissions and other estimated offering expenses.

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!

Each unit, which has no stand-alone rights and will not be certificated or issued as a stand-alone security, consists of one share of common stock, one tradeable warrant to purchase one share of common stock at an exercise price of $7.35 per share, and one non-tradeable warrant to purchase one share of common stock at an exercise price of $7.656 per share. Each warrant is immediately exercisable and will expire five years from the date of issuance. The shares of common stock and the tradable warrants may be transferred separately immediately upon issuance. In addition, bioAffinity has granted the underwriters a 45-day option to purchase up to 192,390 shares of common stock, and/or 192,390 tradeable warrants, and/or 192,390 non-tradeable warrants, or any combination of additional shares of common stock and warrants representing, in the aggregate, up to 15% of the number of the units sold in this offering to cover over-allotments in this offering.

The shares and the tradeable warrants will begin trading on September 1, 2022, on the Nasdaq Capital Market under the ticker symbols "BIAF" and "BIAFW," respectively. The Company intends to use the net proceeds for the commercialization of its diagnostic called CyPath Lung, a non-invasive test for the early detection of lung cancer that has completed a clinical trial showing 92% sensitivity and 87% specificity in detecting lung cancer in individuals at high risk who have lung nodules less than 2 centimeters. Proceeds also will be used for development of tests, additional clinical trials, regulatory filings, and for working capital and general corporate purposes.

WallachBeth Capital, LLC and Craft Capital Management, LLC are co-managers and co-book running managers for the offering.

bioAffinity’s registration statement relating to these securities was declared effective as of August 29, 2022, by the U.S. Securities and Exchange Commission. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, View Source and by contacting WallachBeth Capital, LLC, Attention: Capital Markets, 185 Hudson Street, Jersey City, NJ 07311, by telephone at 646-998-7608, or by email at [email protected]

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

On September 1, 2022 Fuzionaire, Inc. reported a collaborative research agreement with McGill University that will leverage the company’s proprietary alkali metal catalyst platform in creating novel heterocyclic, biologically active, silicon-containing scaffolds and new silicon-based drug candidates (Press release, McGill University, SEP 1, 2022, View Source [SID1234618918]).

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!

New silicon-containing scaffolds, where a carbon atom is replaced with a silicon atom, would enable a wide array of new silicon-based drug candidates that could have improved efficacy and safety as compared to their carbon-based counterparts.

Silicon is the second-most abundant element in the Earth’s crust. Belonging to the same group in the periodic table as carbon, silicon shares many of its properties, including biocompatibility and low toxicity. Because of slight structural differences, a carbon/silicon switch can modify the biological properties of a drug and potentially enhance its efficacy and safety. Existing drugs that are currently disfavored because of poor biochemical or pharmacokinetic properties could be converted into new silicon forms and used to treat a wide array of diseases.

To date, silicon has not been well-explored in drug development because it is difficult to synthesize silicon-containing structures. Consequently, there are only a small number of silicon-containing compounds under current investigation for pharmaceutical use.

As a platform for the incorporation of silicon into organic molecules, Fuzionaire’s alkali metal catalyst platform could help pave the way for a larger role for silicon in the discovery and design of future generations of pharmaceuticals.

As initially reported in Nature, Fuzionaire’s patented technology enables the incorporation of silicon into organic molecules to create many previously unexplored organosilicon compounds. The synthetic technology is safe and based on an inexpensive potassium catalyst. This is in contrast with many other methods used for incorporating silicon, which often require expensive precious metal catalysts and have other practical limitations.

"The potential upside of using silicon in therapeutics has been recognized for decades, but progress in developing silicon drugs has been impeded, in part, by a lack of general methods to create organosilicon scaffolds," said Jean-Philip Lumb, PhD, Associate Professor of Chemistry at McGill. "With new chemistry, new possibilities are created."

"Silicon-based medicines will be an important part of the future of healthcare, and our goal is for our platform, and the library of scaffolds and pipeline of drug candidates developed with it, to help accelerate this future," said Nick Slavin, co-founder and CEO of Fuzionaire.

Fuzionaire’s collaboration with the Lumb Lab to make new silicon-containing scaffolds and drug candidates will begin with a focus on oncology.

The expertise of McGill and the Lumb Lab in silicon chemistry is longstanding. Since 2020, Fuzionaire affiliate Fuzionaire Diagnostics has been working with McGill in the development of a library of heteroaromatic silicon-fluoride acceptors, or HetSiFAs, as a platform to make diagnostic and theranostic radiopharmaceuticals.

On September 1, 2022 Moores Cancer Center at UC San Diego Health, the Office of Industry Relations and Alexandria Real Estate reported that the 18th annual Industry/Academia Next Generation Precision Oncology Symposium will be held Thursday, September 15, at The Alexandria at Torrey Pines (Press release, UC San Diego Moores Cancer Center, SEP 1, 2022, View Source [SID1234618917]). The Symposium serves as a forum for sharing scientific and medical advances in cancer research spanning multiple classes of therapies, with sessions focused on immuno-oncology, solid tumors and hematology/oncology.

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!

As part of the event, Kristen Hege, MD, Senior Vice President of Early Clinical Development, Hematology/Oncology & Cell Therapy at Bristol Myers Squibb, will be honored as the 2022 Duane Roth Achievement Award recipient. Dr. Hege is being recognized for her contributions to advancing cancer treatments over her career, including leading the development of Abecma (idecabtagene vicleucel), the first BCMA-directed CAR-T cell therapy approved by the FDA. In addition, Dr. Hege is a Clinical Professor of Medicine at the University of California San Francisco (UCSF), and continues to see patients with blood cancers.

"The Duane Roth Achievement Award is intended to recognize individuals who overcome significant challenges to improve the lives of patients with cancer," said Ida Deichaite, PhD, director of Moores Cancer Center’s Office of Industry Relations and organizer of the symposium. "This year we are proud to recognize Dr. Hege, whose tireless efforts have led to breakthrough therapeutic advances and who continues to engage directly with patients through her role at UCSF."

The Symposium is a forum for leaders in cancer research to present their latest data and translation of research into clinical applications and lifesaving treatment approaches for patients. The Symposium’s emphasis on translational oncology and drug development unites discovery and clinical development researchers, facilitating alliances and partnerships to ultimately accelerate curative therapies that advance global cancer care. Organizers encourage sharing of unpublished data to accelerate research dissemination and discussions that support exchange of knowledge.

Talks presented at the symposium include:

Presentations by researchers from oncology companies, including Bristol Myers Squibb, Dracen Pharmaceuticals, INHIBRx, Mirati Therapeutics, TRACON Therapeutics, and Viracta Therapeutics
Presentations by academic researchers at Moores Cancer Center and UC San Diego across multiple cancer types
About the Duane Roth Endowed Award Lecture

The Duane Roth Endowed Award Lecture is bestowed upon patient-focused leaders in health care whose work has overcome numerous scientific, financial, institutional, political and cultural obstacles to create new paradigms in research and treatment. Named after Duane Roth, an esteemed leader in the biotech industry who was tragically killed following a bicycle accident in 2013, the award is given to those who demonstrate his deep commitment to innovation and the patient. Past recipients include Dennis Carson, MD, UC San Diego; Susan Band Horwitz, PhD, Albert Einstein College of Medicine; Scott Gottlieb, MD, 23rd Commissioner of the Food and Drug Administration; Carl June, MD, University of Pennsylvania School of Medicine; Sandra Horning, MD, head of global product development and chief medical officer, Genentech; Dennis Slamon, MD, PhD, UCLA Jonsson Comprehensive Cancer Center; Brian Druker, MD, Knight Institute at Oregon Health and Science University; and Laura Esserman, MD, UCSF Helen Diller Family Comprehensive Cancer Center. Biographies of past winners and their accomplishments are available online.