On December 17, 2021 Deep Lens and Ventura County Hematology Oncology Specialists reported that they have entered into a strategic agreement that will expand clinical trial opportunities for patients in the Ventura county area (Press release, Deep Lens, DEC 17, 2021, View Source [SID1234597436]). As part of this collaboration, Ventura County Hematology Oncology Specialists will integrate Deep Lens’ artificial intelligence (AI) based clinical trial matching solution and other services to identify patients for trials faster and more effectively. Ventura County Hematology Oncology Specialists is a comprehensive cancer center serving patients across Ventura and the surrounding coastal communities. Deep Lens is a digital healthcare company that leverages AI to improve inefficiencies in the oncology clinical trial recruitment process.

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"Our clinical trial program is an integral part of our overall offering to patients, as we believe that everyone should have access to novel therapies in development that have the potential to change the course of their disease," said Lynn Kong, MD, of Ventura County Hematology Oncology Specialists. "However, as many new therapies have become increasingly more targeted to address specific markers or mutations, the trials to support them have become more complex. Unfortunately, this means that identifying patients for trials is more labor intensive and timelines are often shortened, making it difficult for staff to enroll the right patients at the right time. We look forward to leveraging Deep Lens’ technology and services so that we can continue to provide our patients with every resource possible to treat their disease."

More than 15,000 oncology clinical trials are actively recruiting patients; however, fewer than 1 in 30 patients participate in a clinical trial. Limited trial site resources make it time-consuming to identify eligible patients, especially as trial protocols increase in complexity. Deep Lens supports care teams by automating the identification of potentially eligible patients at the time of diagnosis and easily matching them to relevant trials.

"We are thrilled to welcome the Ventura team into our network of community-based oncology practices. The majority of patients diagnosed with cancer are treated by community oncologists, and it is critical to bring more trials to this setting so that patients can receive access to novel therapies in a comfortable, familiar environment, without having to travel or commute to larger medical centers," said Tyrone Richardson, vice president, provider sales at Deep Lens. "Ventura is a great example of a community oncology practice that prioritizes clinical research and we’re delighted that we can add value to their program and help more of their patients receive stellar, cutting- edge care."

Deep Lens’ software will pre-screen patients from Ventura County Hematology Oncology Specialists’ EMR (OncoEMR) and integrate molecular data feeds from Guardant Health and Foundation Medicine, as well as all pathology feeds to automatically identify qualified patients for clinical trials. Deep Lens’ pre-screening and clinical trial matching solution is provided at no cost to oncology practices.

Deep Lens is working with a significant number of community oncology practices representing every region in the U.S. It is estimated that approximately 85 percent of cancer patients are diagnosed and treated at local, community-based oncology practices. Deep Lens is committed to expanding important oncology research by making trials more accessible to a larger and more diverse population within these local community settings.

On December 17, 2021 DisperSol Technologies LLC reported that it is has entered into a research collaboration with Ajax Therapeutics, Inc. to apply its KinetiSol technology to enhance the bioavailability of an Ajax drug candidate in development for the treatment of hematologic malignancies (Press release, Ajax Therapeutics, DEC 17, 2021, View Source [SID1234597435]).

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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

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"Ajax is taking an innovative approach to developing a pipeline of selectively targeted small molecules and we look forward to applying our proprietary KinetiSol technology to help enhance the bioavailability of one of these promising drug candidates," said Dr. Edward Rudnic, CEO of DisperSol Technologies. "This collaboration is another example of our partnering strategy with our KinetiSol technology platform to help improve the bioavailability of next generation targeted therapies to provide new treatments for patients in need."

On December 17, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it has reached its target enrollment of 12,750 patients in ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter), a registrational study to evaluate the performance of its LUNAR-2 blood test to detect colorectal cancer (CRC) in average-risk adults (Press release, Guardant Health, DEC 17, 2021, View Source [SID1234597434]). Subject to positive study results, the number of patients currently enrolled in ECLIPSE is targeted to support a premarket approval (PMA) submission to the U.S. Food and Drug Administration in 2022.

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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

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"Colorectal cancer screening rates have remained stubbornly low due to the nature of current screening methods. New modalities in colorectal cancer screening, such as a routine, accurate blood test like the one being studied in the ECLIPSE study, has the potential to increase screening rates dramatically," said AmirAli Talasaz, Guardant Health co-CEO. "Reaching this significant enrollment milestone highlights our ability to successfully run one of the largest cancer screening studies of its kind and gives us tremendous confidence in initiating large registrational studies in other cancer types, including the SHIELD screening study to detect lung cancer. It is also a testament not just to our team’s perseverance, but also to the commitment of our clinical researchers and the generosity of those enrolled in the study."

Today, it is estimated that 1 in 3 adults in the U.S. does not adhere to national CRC screening recommendations even though regular screening for colorectal cancer has been shown to improve survival rates.1,2 Increasing screening rates to 80% from current levels could reduce the number of people diagnosed with CRC by 22% by 2030.3 However, current screening methods are time consuming and, in the case of a colonoscopy, invasive. LUNAR-2 is intended to improve CRC screening rates by offering a simple blood test that overcomes barriers associated with current testing methods and facilitates access to screening tests to more individuals and communities where access may be limited.

"Given the importance of this study and the size of the cohort, we’re grateful Guardant Health has been able to enroll 12,750 study participants in just over two years during a global pandemic," said William M. Grady, M.D., Professor, Clinical Research Division, Fred Hutchinson Cancer Research Center. "We look forward to evaluating the data from the ECLIPSE study to increase our understanding of blood-based screening in patients at average risk for colorectal cancer."

ECLIPSE is a prospective, multi-site registrational study to evaluate the performance of the company’s LUNAR-2 blood test to detect colorectal cancer in individuals aged 45-84 in the U.S. who are at average risk for colorectal cancer, including those who have historically been underrepresented in clinical research and identify as Native American and Black or African American. More details about ECLIPSE can be found at NCT04136002.

On December 17, 2021 Iktos, a company specialized in Artificial Intelligence for new drug design, and The Drug Discovery Unit (DDU), School of Life Sciences, The University of Dundee, focused on the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery, reported entering a collaboration to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of DDU’s drug discovery programs (Press release, Iktos, DEC 17, 2021, View Source [SID1234597433]). Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies, its AI-based retrosynthesis analysis and planning tool Spaya, and know-how complementing DDU’s drug discovery capabilities to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties.

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The DDU was established in 2006 to respond to a lack of drug targets identified for neglected tropical diseases being translated into therapeutics for diseases impacting the poorest people in the world. The DDU translates basic science into lead compounds to validate putative drug targets, to use as tools to investigate disease pathways and, when appropriate, advance to pre-clinical drug candidates for multiple diseases, e.g. TB and cancer.

Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. This technology automatically designs virtual novel molecules with all of the characteristics of a successful drug molecule. This approach, validated through Iktos’s other collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with greater freedom to operate.

Iktos has recently diversified its R&D efforts into the development of an AI technology for retrosynthesis. Identifying and selecting synthetic pathways is one of the most challenging and time-consuming tasks in synthetic and medicinal chemistry. Iktos has developed AI based retrosynthesis analysis and planning tool Spaya by harnessing the power of data-driven retrosynthesis algorithm for systematic exploration and prioritisation of synthetic routes for a desired compound in minutes.

Professor Paul Wyatt, Head of the DDU said, "We are thrilled to be working with Iktos to drive our projects towards drug candidates. Iktos AI platform combined with our own in-house computational and medicinal chemistry design teams provide a powerful combination for innovative new drug design."

"We are thrilled and proud to join forces with DDU with the aim to help in the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery," commented Yann Gaston-Mathé, President and CEO of Iktos. "Pleased to have earned DDU’s trust, we are confident that together with DDU and their established R&D partners, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The feedback from DDU’s research team will be highly valuable as we improve our product offerings. Our strategy has always been to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects."

On December 17, 2021, Oncternal Therapeutics, Inc. ("Oncternal") reported that it entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC (the "Agent"), pursuant to which Oncternal may offer and sell shares of Oncternal’s common stock having an aggregate offering price of up to $50,000,000 from time to time, in "at the market" offerings through the Agent (Filing, 8-K, Oncternal Therapeutics, DEC 17, 2021, View Source [SID1234597410]). Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from Oncternal of 3.0% of the gross proceeds of any shares of common stock sold under the Sale Agreement.

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Oncternal is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sale Agreement. No assurance can be given that Oncternal will sell any shares of common stock under the Sale Agreement, or, if it does, as to the price or amount of shares of common stock that it sells or the dates when such sales will take place.

In the Sale Agreement, Oncternal agreed to indemnify the Agent against certain liabilities, including under the Securities Act of 1933, as amended, or to contribute payments that the Agent may be required to make because of such liabilities.

The shares of common stock sold pursuant to the Sale Agreement will be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-254985), which became effective on April 15, 2021. Oncternal filed a prospectus supplement with the U.S. Securities and Exchange Commission on December 17, 2021 in connection with the offer and sale of shares of Oncternal’s common stock pursuant to the Sale Agreement.

A copy of the Sale Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the Sale Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sale Agreement.

A copy of the opinion of Latham & Watkins LLP relating to the validity of the shares of common stock that may be sold pursuant to the Sale Agreement is filed herewith as Exhibit 5.1.