On December 16, 2021 Denovo Biopharma LLC ("Denovo"), a pioneer in applying precision medicine to the development of innovative therapies, reported it discovered a novel genetic biomarker, Denovo Genomic Marker 7 (DGM7 TM), using its proprietary biomarker discovery platform (Press release, Denovo Biopharma, DEC 16, 2021, View Source [SID1234597358]). DGM7 has been shown to be associated with response to treatment of recurrent high grade glioma (HGG) with an investigational gene therapy combination treatment, DB107, via retrospective analysis. DB107 is an investigational combination product consisting Toca 511 (vocimagene amiretrorepvec) in combination with Toca FC (extended-release flucytosine, [5-FC]), which is part of the retroviral replicating vector (RRV) platform that was acquired from Tocagen in 2020.

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In addition to potentially being useful for selecting patients who may respond to DB107 therapy, the utility of this genetic biomarker may extend to the broader RRV platform. This RRV platform has the capability of carrying a wide variety of genes, in addition to the gene carried by DB107. Furthermore, this finding demonstrates that Denovo’s biomarker discovery platform has broad utility for such disparate drug modalities as small molecules and viral vectors.

Denovo’s biomarker platform has utility for disparate drug modalities such as small molecules and viral vectors.

"Biomarker-guided DB107 treatment brings a much needed treatment option to patients with recurrent high-grade glioma, a major unmet medical need with median survival less than a year," said Wen Luo, PhD, Denovo’s Chief Executive Officer and Chief Scientific Officer. "Denovo now has three biomarker-guided programs in active development using biomarkers discovered using its biomarker platform, which once again shows that it can deliver repeatable success."

About Denovo’s RRV Platform and DB107
DB107 is an innovative approach utilizing a proprietary gene therapy platform, RRV, combined with a prodrug, to selectively infect and kill cancer cells while stimulating a robust and durable anti-cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high-grade GBM and colorectal cancer, most recently in a randomized 403-patient Phase 3 trial. DB107 received Orphan Drug Designation in GBM from the FDA and EMA, and Fast Track Designation from the FDA.

About HGG and Glioblastoma
Most common type of HGG is Glioblastoma multiforme (GBM), which is also the most common type of adult primary malignant brain cancer, with 18,000 newly-diagnosed patients in the US and 13,000 deaths annually. Standard treatment for patients with newly diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The five-year survival rate of patients with GBM is less than five percent.

On December 16, 2021 Cothera Bioscience, the parent company of Percans Oncology, reported that it had successfully completed the first administration for the first patient in the Phase 1/2 clinical trial of CTB-02 for the treatment of pan-KRAS/BRAF mutant colorectal cancer in Australia (Press release, Cothera Bioscience, DEC 16, 2021, View Source [SID1234618850]).

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CTB-02 is a first-in-class targeted combination therapy discovered by the i-CR technology platform that has been independently developed by Cothera Bioscience and clinically verified for the treatment of KRAS/BRAF mutant colorectal cancer. CTB-02 has demonstrated strong inhibitory activity against KRAS/BRAF mutant colorectal cancer in multiple animal models, especially those based on patient transplanted tumor PDX. Colorectal cancer (CRC) is a common malignant tumor disease. According to the statistics, there were nearly two million new cases and one million deaths from this disease worldwide in 2020, among which there were about 560,000 new cases and 290,000 deaths in China. The incidence of colorectal cancer has been significantly increasing in China. KRAS mutation is the most important genetic variation in colorectal cancer, and has been detected in 40% of patients with metastatic colorectal cancer (mCRC). KRAS mutations may lead to sustained activation of the RAS-RAF-MEK pathway, resulting in tumor resistance to EGFR monoclonal antibodies. In CRC, KRAS mutations are significantly associated with resistance to EGFR-targeted drugs such as cetuximab. BRAF is a component of the RAS-RAF-MEK signaling pathway. About 10% of mCRC patients have BRAF activation mutations that are mutually exclusive with KRAS mutations. BRAF mutations, mostly the V600E subtype, have been demonstrated to be associated with a poor overall prognosis in studies.

"This is the first clinical trial of CTB-02," said Dr. Chun Jiang, cofounder of Cothera Bioscience and the executive vice president leading product development. "KRAS mutant colorectal cancer currently has no approved targeted therapies and there is a huge unmet clinical need. CTB-02 has presented an effect not only on KRAS G12C mutant colorectal cancer, but also on other KRAS mutations in cells as well as CDX and PDX animal experiments. We are fully committed to advancing this clinical trial and expect CTB-02 to lead to a breakthrough in the treatment of patients with KRAS/BRAF mutant colorectal cancer."

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."