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 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the United States Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for ERAS-801, an orally available small molecule epidermal growth factor receptor (EGFR) inhibitor specifically designed to have high central nervous system (CNS) penetration for the treatment of recurrent glioblastoma multiforme (rGBM) (Press release, Erasca, DEC 17, 2021, View Source [SID1234639381]). The company has also entered into a collaboration with the Global Coalition for Adaptive Research (GCAR) to determine the feasibility of the evaluation of ERAS-801 as part of the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) trial.

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"We are pleased with the pace at which our ERAS-801 program is advancing. Filing this IND a quarter ahead of schedule and receiving FDA clearance allows us to begin potentially helping patients sooner," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "GBM is a rapid and aggressive malignancy for which patients have limited treatment options and a median overall survival of 17 months after diagnosis. Aberrant EGFR signaling is implicated in approximately 125,000 patients with GBM worldwide annually. ERAS-801’s profile of strong CNS penetrance and broad activity against EGFR amplifications driven by both oncogenic EGFR variants and wildtype EGFR has the potential to address significant unmet need in this patient population. We look forward to initiating our THUNDERBBOLT-1 Phase 1 trial evaluating ERAS-801 in patients with recurrent GBM in the first quarter of 2022."

Dr. Lim continued, "We are honored to enter into an early collaboration with GCAR, a leading nonprofit sponsoring the innovative GBM AGILE trial, which uses a streamlined, patient-centric approach to identify and advance the most effective treatment options for GBM more rapidly. GBM AGILE, an adaptive clinical trial that evaluates multiple drugs against a common comparator, is a seamless, international Phase 2/3 trial that we believe supports a clear registrational path in the United States and other key markets. Our early involvement with GCAR and the GBM Knowledge Network made up of industry leaders further reinforces the therapeutic promise of ERAS-801. We look forward to working together with GCAR and the GBM AGILE team to explore the robust potential of ERAS-801 in patients with GBM who are in much need of better treatment options."

ERAS-801 was designed and developed by a renowned team of cancer researchers—David Nathanson, Ph.D., Michael Jung, Ph.D., and Timothy Cloughesy, M.D. ERAS-801 was licensed from Katmai Pharmaceuticals, Inc.

About GBM AGILE
GBM AGILE is an international, innovative, long-standing platform trial designed to identify and advance effective therapies more rapidly through response adaptive randomization, data connectivity, and a seamless Phase 2/3 design. Conducted under a master protocol, the trial design allows simultaneous evaluation of multiple candidates as monotherapy or in combination against common controls. The operational infrastructure enables a more efficient and expedited approach to testing new therapies for GBM with the intent of lowering the cost, time, and number of patients required to evaluate potentially effective therapies. Data from the GBM AGILE trial has the potential to be used as the foundation for a new drug application (NDA) with the FDA and/or any comparable submission with other health authorities.

About ERAS-801
ERAS-801 is a highly potent, selective, reversible, and orally available small molecule EGFR inhibitor with significantly enhanced CNS penetration. In animal models, ERAS-801 had a 3.7:1 brain-to-plasma ratio and a Kp,uu (partition coefficient that measures unbound drug concentration) that was up to four times higher than approved EGFR inhibitors, indicating a higher concentration of unbound drug in the brain compared to the blood. At clinically relevant exposures, ERAS-801 demonstrated a survival benefit in nine out of 10 (90%) EGFR amplified glioblastoma patient-derived models tested and had statistically significantly higher brain penetrance and prolonged survival compared to approved EGFR tyrosine kinase inhibitors.

About THUNDERBBOLT-1
THUNDERBBOLT-1 will evaluate the safety, tolerability, and preliminary efficacy of ERAS-801 as a monotherapy in patients with recurrent GBM. The dose escalation portion will determine the recommended dose, which will then be used during the dose expansion portion to further evaluate the efficacy and safety of ERAS-801. Future sub-studies of THUNDERBBOLT-1 will potentially explore ERAS-801 in combination with other agents and in broader patient types. Dosing of the first patient in THUNDERBBOLT-1 is anticipated in the first quarter of 2022.

On December 16, 2021 Neogene Therapeutics, Inc., a preclinical stage biotechnology company pioneering a new class of fully individualized T cell receptor (TCR) therapies to treat cancer, reported the appointment of Raphaël Rousseau, M.D., Ph.D. as Chief Medical Officer (Press release, Neogene Therapeutics, DEC 16, 2021, View Source [SID1234597282]). Dr. Rousseau brings more than 20 years of extensive experience in oncology drug development, including engineered T cell therapies, in both academia and the biotechnology industry. He joins Neogene’s executive team and will be based in its U.S. headquarters in Santa Monica.

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"We’re thrilled to welcome Raphaël at this crucial and exciting time in our company’s growth. He is a strong leader, who has led teams across all phases of development and has successfully built and executed multiple global clinical programs," said Carsten Linnemann, Ph.D., President, Chief Executive Officer and co-founder of Neogene. "Raphael’s broad experience with cell therapy and neo-antigen targeting drug modalities will be critical in helping us to diversify our pipeline and advance our programs into the clinic with the goal of bringing T cell therapies to patients across a broad spectrum of solid tumors."

Dr. Rousseau most recently served as Executive Vice President, Head of Product Development, and Chief Medical Officer at Gritstone bio, where he was responsible for the company’s global clinical development strategies and expansion of its neoantigen-based immunotherapies. He led the buildout of the clinical development organization and execution of Gritstone’s clinical strategy including conducting several phase 1 and phase 2 clinical trials. Prior to Gritstone bio, Dr. Rousseau served as the Global Franchise Head of Pediatrics at Genentech and Roche, where he successfully led a global development and study management team and served as the Chair of the Development Review Committee for early and late-stage pediatric asset reviews. While at Genentech, he oversaw the clinical development of the company’s oncology portfolio from first-in-human to registrational trials for several pediatric hematology and oncology indications. Prior to joining industry, Dr. Rousseau was a Professor of Medical and Pediatric Oncology at the Université Claude Bernard in Lyon, France, and the head of the pediatric translational research program at Léon Bérard Cancer Center. There, he created and led the first European academic consortium for the conduct of a phase 1 study using CD19-targeting CAR T cells for the treatment of pediatric high-risk leukemias. Earlier in his career, Dr. Rousseau was a fellow at Baylor College of Medicine in Houston, where he worked with Dr. Malcolm Brenner at the Center for Cell and Gene Therapy. Dr. Rousseau received a Ph.D. in Therapeutic Biotechnologies from the Université Denis Diderot and an M.D. from the Université René Descartes in Paris. He is board certified in pediatrics and has a sub-specialty certification in pediatric hematology-oncology.

"I’m proud to be joining the Neogene team, which has been making great strides in the field of neoantigen-directed T cell therapy, and excited about helping advance our pioneering research into the clinic to potentially help patients who currently have limited treatment options," said Dr. Rousseau. "This is a field that I am extremely passionate about, and I am excited to apply my expertise in successfully advancing these promising therapies into clinical trials as we work to change the solid cancer treatment paradigm."

On December 16, 2021 InveniAI LLC, a global leader in applying Artificial Intelligence (AI) and Machine Learning (ML) to transform drug discovery and development, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that expanded their longstanding relationship with a new, multiple drug discovery agreement (Press release, Kyowa Hakko Kirin, DEC 16, 2021, View Source [SID1234597306]). The collaboration will provide Kyowa Kirin with access to InveniAI’s AI Innovation Lab and AI Technology Platform, AlphaMeld, to expand the scope of Kyowa Kirin’s drug discovery programs.

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The agreement builds on an ongoing partnership between InveniAI and Kyowa Kirin that began in 2018. The collaboration enables Kyowa Kirin to access InveniAI’s AI technology platform, AlphaMeld, its AI Innovation Lab, and a dedicated team of experts to drive drug discovery efforts across Kyowa Kirin’s therapeutic areas, platforms, and modalities. InveniAI and Kyowa Kirin are now standing at the intersection of state-of-the-art biotechnology and digital technology. Both scientists will work together more interactively to generate innovative drug candidates.

Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin, said, "We are excited about the strategic expansion of our partnership, as it is designed to seamlessly integrate InveniAI’s AI capabilities with our therapeutic platforms to facilitate the discovery of valuable new therapies for patients. Our collaboration, to date, is a testament to the importance of a data-driven approach, and through our partnership with InveniAI, we are embracing the undeniable advantage of technology-aided drug discovery and development."

"We are pleased to expand our collaboration with Kyowa Kirin, with whom we share a common philosophy of leveraging data and technology to de-risk drug development and deliver better therapies to patients more efficiently. By leveraging our longstanding relationship and combined capabilities – including drug discovery and development infrastructure, and a proven AI platform –we believe we can rapidly achieve this objective," said Krishnan Nandabalan, Ph.D., President and CEO, InveniAI LLC. "InveniAI is the only AI company with a track record that includes an AI-identified candidate that has undergone successful Phase 3 trials and an NDA submission, in addition to ten other programs at various stages of development. We remain excited about harnessing the potential of this platform for both industry partnerships and our internal drug portfolio."

Under the terms of the collaboration, InveniAI will receive a committed annual research funding fee for the duration of the collaboration term and obtain rights to receive milestone payments and royalties on sales from Kyowa Kirin.

About AlphaMeld
AlphaMeld is an AI-based platform powered by machine learning algorithms that accelerates innovation by identifying alpha signals for targets, drugs, and healthcare products and technologies. The platform generates testable hypotheses by leveraging the TranslationalEdge and ModalityFit AI tools we have developed that take into account an ideal mode of pharmacotherapy (antibody, protein replacement, siRNA, mRNA, small molecule, cell and gene therapy, and gene-editing modalities), disease severity, gene ontology, disease pathways, proteinopathies, standard of care, emerging innovation, and enabling technologies while factoring in medical, scientific, strategic, and commercial considerations. AlphaMeld operates in real-time and in a rapidly changing and diverse data environment.

On December 16, 2021 Aqemia, the next-gen pharmatech company leveraging artificial intelligence and quantum physics, and Servier, a global pharmaceutical group, reported that they have entered into a collaboration agreement that will use Aqemia’s technology to accelerate the discovery of small molecule therapeutic drug candidates on an undisclosed target in immuno-oncology (Press release, Servier, DEC 16, 2021, View Source [SID1234597340]). The agreement includes upfront payments and payments for potential milestones from the early-stage discovery and the clinical trials in developing the drug candidates resulting from this collaboration.

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This collaboration builds upon a successful pilot initiated in early 2021 by Servier to blind test the unique AI, quantum, and statistical physics technologies of Aqemia.

Aqemia will take responsibility for the AI-based design to deliver optimized molecules that fulfill several small molecule design goals. Unlike most AI-based technologies that need experimental data to train their algorithms prior to starting the design, Aqemia will tackle the project from the earliest stage of the drug discovery by generating its own data with quantum and statistical physics-based calculations.

Maximilien Levesque, CEO and co-founder of Aqemia, commented, "We are thrilled to initiate this new collaboration with Servier, following a successful pilot phase that demonstrated the value brought by Aqemia’s team and technology to the rapid discovery of innovative therapeutic molecules.". He added, "Our goal is to find innovative new drugs for many, many diseases at a massive scale, thanks to our unique platform, to change the lives of patients, and this collaboration with Servier is an important step in this direction."

"We are delighted to collaborate with Aqemia to accelerate the identification of novel bioactive compounds, combining Aqemia’s unique AI-driven technology and Servier’s expertise in medicinal chemistry and computer-aided drug design (CADD)," added Christophe Meyer, Head of Molecular Modeling and Chemoinformatics at Servier. "Both teams will work together in a collaborative mindset to leverage Aqemia’s generative technology and physics-based evaluation of binding free energy to design molecules optimized according to multi-criteria design objectives."

Olivier Nosjean, Head of Open Innovation and Scientific Affairs at Servier R&D concluded, "This collaboration with Aqemia is a concrete example of Servier working side by side with a start-up to create value for both parties, working jointly to accelerate therapeutic innovation for patients. This collaboration is the result of the Start-up @ Servier program, where an initial phase of joint work allows us to carry out a key study or pilot application of a technology, before entering into a classic collaboration. This is our first application of this Start-up @ Servier model, and we are very happy to see it take shape with Aqemia, which is such a promising collaboration."