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SOPHiA GENETICS Launches New Solution to Advance Chronic Lymphocytic Leukemia Care, in Collaboration with IDIBAPS

biotech, biotechnology, cell, gene, tissue | June 10, 2022

SOPHiA_GENETICS_Launches
SOPHiA GENETICS (Nasdaq: SOPH), the Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) of Barcelona, and the Spanish Diagnóstica Longwood today announced from the European Hematology Association Congress in Vienna that they have combined their expertise to develop a new Chronic Lymphocytic Leukemia (CLL) solution to advance CLL care. This collaboration will unify the wide variety of current guideline recommendations into one single application aiming to improve CLL characterization and CLL research practices in Iberia.

SOPHiA GENETICS has already facilitated the analysis of one million genomic profiles through the SOPHiA DDM™ Platform, including a significant amount of onco-hematological-related diseases such as acute myeloid leukemia and lymphomas. The Platform computes a wide array of genomic variants needed to continually hone machine learning algorithms designed to accurately detect rare and challenging cases.  The growing number of users of the SOPHiA DDM™ community can share and access insights by pulling the relevant signals detected from the noise, ultimately saving time and helping to make better-informed decisions.

The new CLL solution allows for progress of Chronic Lymphocytic Leukemia research using genomic analysis. This could lead to better detection of the disease, which accounts for 25-30% of all leukemia cases in Western countries and affects yearly more than 100,000 people globally[1], and ultimately improve patient care. Thanks to the SOPHiA DDM™ Platform and IDIBAPS, hematopathologists can now access guidelines for the mutational status of TP53, immunoglobulin (IG) gene rearrangements and their somatic hypermutation status, while benefitting from the identification of 23 CLL-specific genes for SNVs, InDels and CNVs including NOTCH1, SF3B1, ATM, IGLV3-21, BTK, PLCG2, BCL2, del13q14, and trisomy 12, all in one single NGS workflow.

The new CLL solution has already been used in routine in Spain, with further opportunities throughout the country, and in Latin America through Diagnóstica Longwood's distribution channels.

We are proud to work together with some of the most renowned experts in the field of Chronic Lymphocytic Leukemia research around the world. This partnership is a great example of how combining advanced data analytics with emerging CLL strategies can move the possibilities of data-driven medicine forward." 

Lara Hashimoto, Chief Business Officer at SOPHiA GENETICS.

It is a great satisfaction to see how thanks to the partnership with SOPHiA GENETICS and Diagnóstica Longwood we will be able to transfer into clinical practice the relevant information generated for so many years in the research of CLL using a simple and robust assay." 

Elías Campo, principal investigator and director of IDIBAPS.

About SOPHiA GENETICS
SOPHiA GENETICS (Nasdaq: SOPH) is a healthcare technology company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-based SaaS platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products and services are currently used by more than 790 hospital, laboratory, and biopharma institutions globally.

About IDIBAPS
The August Pi i Sunyer Biomedical Research Institute (IDIBAPS) is a biomedical research center of excellence that addresses the most common diseases in our environment. It is a public consortium comprising the Catalan Government (Generalitat de Catalunya), the Hospital Clínic Barcelona, the Faculty of Medicine and Health Sciences at the University of Barcelona and the CSIC Institute of Biomedical Research of Barcelona.

About 1,500 professionals are organized in a hundred research groups. IDIBAPS undertakes translational research. It focuses on ensuring that the questions that arise at the patient's bedside have a response in the laboratory, and that advances made in the laboratory are promptly applied to patients. With over 1,200 articles published annually, it is the leading biomedical research center in Spain.

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Globenewswire | April 05, 2023

Absci Corporation a generative AI drug creation company, and M2GEN, an oncology bioinformatics company with the most advanced lifetime-consented clinicogenomics data to accelerate discovery research, today announced a partnership to create new cancer medicines and bring them to market at unprecedented speed. Absci’s generative AI drug creation platform will tap into M2GEN’s clinical and molecular data set, ORIEN AVATAR® (AVATAR), to accelerate the creation of therapeutics for a range of malignancies and patient profiles, bringing AI drug creation to the fight against cancer. A key challenge in creating effective cancer treatments is finding specific antigens that can be targeted by immunotherapies. M2GEN’s AVATAR database represents a valuable resource for discovering such antigens. Absci will use its reverse immunology technology to first search the database for antibodies from patients with exceptional immune responses, then computationally re-assemble antigen-antibody pairs as promising starting points for drug development. This partnership brings together AI drug creation technology and oncology bioinformatics to potentially reduce the time and cost to create better cancer treatments. Absci’s Integrated Drug Creation™ platform unites generative AI and wet-lab capabilities to screen billions of cells per week, allowing it to go from AI-designed antibodies to lab-validated candidates in as little as six weeks. As the nexus between patients, researchers, and the pharmaceutical industry, M2GEN is uniquely positioned and equipped with the richest clinicogenomic data set, and a lifetime patient-consented Total Cancer Care® (TCC) protocol, to accelerate drug discovery and development and transform how cancer is treated. M2GEN’s real-world data set comes from its Oncology Research Information Exchange Network® (ORIEN) partners, an alliance of 18 cancer centers across more than a dozen U.S. states. “M2GEN and its ORIEN partners are premier leaders in the field of oncology data research and bring a wealth of unique data sets to our generative AI platform that may enable us to ultimately shave years off the drug discovery process,” said Sean McClain, CEO of Absci. “This is an important leap forward to better understand individualized protein-protein interactions on cancer cells, moving us toward delivering on the promise of personalized medicine.” The cornerstone of ORIEN is the lifetime-consented TCC protocol, one of the first longitudinal cancer patient databases of its kind, with over 360,000 patients enrolled nationwide. TCC enables patient monitoring throughout their treatment journey, with the goal to transform how cancer is treated. M2GEN and ORIEN research-facilitated projects are monitored by a multi-institution governing body, which includes scientists and research leaders from network members, to ensure adherence to privacy protocols and best practices. “Absci’s recent breakthrough creating de novo antibodies changed the idea of what’s possible for drug discovery,” said Jim Gabriele, CEO of M2GEN. “This was just one of the things that excited us about partnering together. Their AI-led approach to targeting biologics to make the drug discovery process more efficient and dramatically impact patients’ lives made them an ideal partner,” said Gabriele. “Together, by utilizing our real-word data, we plan to advance personalized cancer treatments in pursuit of a cure.” This partnership maintains Absci’s momentum building one of the largest repositories of patient data in the industry to train its generative AI platform for protein drug creation. The company recently partnered with St. John’s Cancer Institute to train on their datasets to discover medicines faster. About Absci Absci is a generative AI drug creation company that combines AI with scalable wet lab technologies to create better biologics for patients, faster. Our Integrated Drug Creation™ platform unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimizing multiple drug characteristics important to both development and therapeutic benefit. With the data to learn, the AI to create, and the wet lab to validate, Absci can screen billions of cells per week, allowing it to go from AI-designed antibodies to wet lab-validated candidates in as little as six weeks. Absci’s vision is to deliver breakthrough therapeutics at the click of a button, for everyone. Absci's headquarters is in Vancouver, WA, its AI Research Lab is in New York City, and its Innovation Center is in Zug, Switzerland.

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Omega Therapeutics Announces Clinical Supply Agreement to Evaluate the Combination of OTX-2002 and Atezolizumab in Hepatocellular Carcinoma

Globenewswire | March 31, 2023

Omega Therapeutics, Inc. a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenetic mRNA medicines, today announced a clinical supply agreement with Roche to evaluate OTX-2002, its lead candidate in development for the treatment of MYC-driven hepatocellular carcinoma (HCC), in combination with Roche’s anti-PD-L1 therapy, atezolizumab, as part of Omega’s Phase 1/2 MYCHELANGELO™ I clinical trial. “This agreement with Roche represents continued execution of our clinical trial strategy and the next step toward realizing the transformative potential of OTX-2002, a first-in-class epigenomic controller designed to pre-transcriptionally downregulate the MYC oncogene, a historically undruggable target,” said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. “In preclinical studies, OTX-2002 demonstrated synergistic antitumor activity with existing standard of care therapies for HCC, including anti-PD-1 and anti-PD-L1 immune checkpoint inhibitors, with minimal impact on safety and tolerability. Through the combination of two orthogonal treatments, OTX-2002 and atezolizumab, a leading anti-PD-L1 therapy, we aim to simultaneously disrupt multiple drivers of cancer progression with the goal of improving treatment outcomes. With Roche’s support and partnership, we look forward to assessing the ability of this novel combination approach to enhance antitumor immune response in patients with advanced HCC.” The ongoing Phase 1/2 MYCHELANGELO I trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a monotherapy (Part 1) and in combination with standard of care therapies in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. Preliminary data from the Phase 1 monotherapy dose escalation portion of the study are anticipated in 2023. Under the terms of this agreement, Roche will supply atezolizumab and Omega will evaluate the combination as part of the overall conduct of the trial. About Omega Therapeutics Omega Therapeutics, founded by Flagship Pioneering, is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenetic mRNA medicines. The Company's OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA medicines, Omega Epigenomic Controllers™(OECs), target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through unprecedented precision epigenomic control. Omega’s approach enables pre-transcriptional control of most human genes including historically undruggable, intractable, and difficult to treat targets. Omega’s pipeline of OEC candidates spans a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.are Diseases and Orphan Drugs from the Accreditation Commission for Health Care. PANTHERx is now a five-time winner of the prestigious MMIT Patient Choice Award, including the 2022 honor. PANTHERx is headquartered in Pittsburgh, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.

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Iovance Biotherapeutics Completes Biologics License Application (BLA) Submission for Lifileucel in Advanced Melanoma

Globenewswire | March 27, 2023

Iovance Biotherapeutics, Inc. a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel. Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous effort in completing the first BLA submission for Iovance. Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.” The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. Following a successful pre-BLA meeting with the FDA, Iovance is pursuing accelerated approval in this indication. Iovance also reached agreement with the FDA regarding the registrational trial design for the Phase 3 TILVANCE-301 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma. TILVANCE-301 is intended to support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is also designed to support registration for lifileucel in combination with pembrolizumab as therapy for advanced melanoma in the frontline setting. Startup activities for TILVANCE-301 are ongoing and the trial is expected to be well underway at the time of potential accelerated approval for lifileucel in advanced post-anti-PD-1 melanoma. Marc Hurlbert, Ph.D., CEO of the Melanoma Research Alliance (MRA), said, “MRA congratulates Iovance for completing the BLA submission and moving closer toward making TIL therapy an option for people with advanced melanoma who have progressed following prior treatments. We hope for an FDA approval as quickly as possible for patients with significant unmet need who have no approved treatment options.” Following receipt of the complete rolling BLA submission for lifileucel, the FDA has 60 days to determine the acceptability of the BLA for review. The rolling BLA allowed Iovance to submit portions of the BLA to the FDA on an ongoing basis, enabling the FDA to begin review as early as possible as documents were received. The rolling BLA submission and eligibility for priority review are benefits available under the FDA’s guidance on expedited programs for serious conditions, which allow for an expedited six-month review from the time of BLA acceptance. In addition, the FDA previously granted a regenerative medicine advanced therapy (RMAT) designation for lifileucel in advanced melanoma. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer.

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Absci Partners with Bioinformatics Company M2GEN to Accelerate Drug Creation for Oncology

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Absci Corporation a generative AI drug creation company, and M2GEN, an oncology bioinformatics company with the most advanced lifetime-consented clinicogenomics data to accelerate discovery research, today announced a partnership to create new cancer medicines and bring them to market at unprecedented speed. Absci’s generative AI drug creation platform will tap into M2GEN’s clinical and molecular data set, ORIEN AVATAR® (AVATAR), to accelerate the creation of therapeutics for a range of malignancies and patient profiles, bringing AI drug creation to the fight against cancer. A key challenge in creating effective cancer treatments is finding specific antigens that can be targeted by immunotherapies. M2GEN’s AVATAR database represents a valuable resource for discovering such antigens. Absci will use its reverse immunology technology to first search the database for antibodies from patients with exceptional immune responses, then computationally re-assemble antigen-antibody pairs as promising starting points for drug development. This partnership brings together AI drug creation technology and oncology bioinformatics to potentially reduce the time and cost to create better cancer treatments. Absci’s Integrated Drug Creation™ platform unites generative AI and wet-lab capabilities to screen billions of cells per week, allowing it to go from AI-designed antibodies to lab-validated candidates in as little as six weeks. As the nexus between patients, researchers, and the pharmaceutical industry, M2GEN is uniquely positioned and equipped with the richest clinicogenomic data set, and a lifetime patient-consented Total Cancer Care® (TCC) protocol, to accelerate drug discovery and development and transform how cancer is treated. M2GEN’s real-world data set comes from its Oncology Research Information Exchange Network® (ORIEN) partners, an alliance of 18 cancer centers across more than a dozen U.S. states. “M2GEN and its ORIEN partners are premier leaders in the field of oncology data research and bring a wealth of unique data sets to our generative AI platform that may enable us to ultimately shave years off the drug discovery process,” said Sean McClain, CEO of Absci. “This is an important leap forward to better understand individualized protein-protein interactions on cancer cells, moving us toward delivering on the promise of personalized medicine.” The cornerstone of ORIEN is the lifetime-consented TCC protocol, one of the first longitudinal cancer patient databases of its kind, with over 360,000 patients enrolled nationwide. TCC enables patient monitoring throughout their treatment journey, with the goal to transform how cancer is treated. M2GEN and ORIEN research-facilitated projects are monitored by a multi-institution governing body, which includes scientists and research leaders from network members, to ensure adherence to privacy protocols and best practices. “Absci’s recent breakthrough creating de novo antibodies changed the idea of what’s possible for drug discovery,” said Jim Gabriele, CEO of M2GEN. “This was just one of the things that excited us about partnering together. Their AI-led approach to targeting biologics to make the drug discovery process more efficient and dramatically impact patients’ lives made them an ideal partner,” said Gabriele. “Together, by utilizing our real-word data, we plan to advance personalized cancer treatments in pursuit of a cure.” This partnership maintains Absci’s momentum building one of the largest repositories of patient data in the industry to train its generative AI platform for protein drug creation. The company recently partnered with St. John’s Cancer Institute to train on their datasets to discover medicines faster. About Absci Absci is a generative AI drug creation company that combines AI with scalable wet lab technologies to create better biologics for patients, faster. Our Integrated Drug Creation™ platform unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimizing multiple drug characteristics important to both development and therapeutic benefit. With the data to learn, the AI to create, and the wet lab to validate, Absci can screen billions of cells per week, allowing it to go from AI-designed antibodies to wet lab-validated candidates in as little as six weeks. Absci’s vision is to deliver breakthrough therapeutics at the click of a button, for everyone. Absci's headquarters is in Vancouver, WA, its AI Research Lab is in New York City, and its Innovation Center is in Zug, Switzerland.

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Omega Therapeutics Announces Clinical Supply Agreement to Evaluate the Combination of OTX-2002 and Atezolizumab in Hepatocellular Carcinoma

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Globenewswire | March 27, 2023

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