On March 21, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported that the European Commission has granted Orphan Drug Designation to AU-011, its first VDC product candidate, for the treatment of uveal melanoma (Press release, Aura Biosciences, MAR 21, 2022, View Source [SID1234610486]). The designation of uveal melanoma includes choroidal melanoma as well as melanomas of the iris and the ciliary body. Choroidal melanoma represents approximately 90% of uveal melanomas.

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"There are currently no approved drug therapies for the treatment of early-stage choroidal melanoma, and receiving Orphan Drug Designation from EMA underscores the unmet need that AU-011 could fill for patients with this life-threatening disease," said Mark De Rosch, Ph.D., Chief Operating Officer and Head of Regulatory Affairs. "We have alignment with U.S. and European agencies on our pivotal program and are on track to initiate this program before the end of 2022."

The European Commission grants Orphan Drug Designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union (EU) and when no satisfactory method of diagnosis, prevention, or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

AU-011 was previously granted Orphan Drug Designation for the treatment of uveal melanoma by the U.S. Food and Drug Administration.

About AU-011

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in clinical development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparin sulphate proteoglycans (HSPGs), which are modified and overexpressed on the tumor cell surface of malignant cells in the choroid and AU-011 delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma is currently in Phase 2 clinical development and the company plans to expand the clinical program into choroidal metastasis.

On March 21, 2022 RNAGene Inc., a South Korean biotech which specializes in the development of mRNA (messenger ribonucleic acid)-based therapeutics, reported that it has signed a Collaborative Research Agreement with PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics (Press release, RNAGene, MAR 21, 2022, View Source [SID1234610504]).

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Under the agreement, both companies will collaborate to develop next-generation mRNA-based antibody therapeutics by utilizing the proprietary mRNA platform from RNAGENE.

Unlike the existing antibody treatments, in which antibodies are artificially produced from external cell lines, mRNA-based therapies involve administration of mRNA in patients so that patients’ own cells can produce the encoded therapeutic antibody.

"The Company entered this agreement because this partnership gives us an extraordinary opportunity to expand our development strategy and discover new possibilities in the mRNA therapeutic area," said Dr. Jin-San Yoo, CEO of PharmAbcine. "Through this collaboration, both parties will explore new potentials between the two platforms and develop a new therapeutic approach to help patients with unmet medical needs."

"One of the key strengths of mRNA therapy is that it is simple and cost-effective because there is no need to produce antibodies externally in a facility," said Dr. Woo Gil Lee, CEO of RNAGENE. "We are delighted to have PharmAbcine, one of the leading antibody-based therapeutic companies, as a partner for this collaborative research, and we are confident that our advanced mRNA technology platform will help create alternative therapeutic options in oncology field."

On March 21, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported the launch of EDGE, an innovative platform that allows pathologists to access developing AI models intended to identify specimens with potentially actionable biomarkers using a single hematoxylin and eosin stain (H&E) slide (Press release, Tempus, MAR 21, 2022, View Source [SID1234610487]). With access to over 50 petabytes of de-identified multimodal data, Tempus is developing AI models with the aim to identify patients who would benefit from additional testing and may qualify for targeted therapies, including those in clinical trials, earlier in their cancer care journey.

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The model portfolio, called Tempus HistogenomicsTM, features digital pathology algorithms that are being developed to use a single, whole slide H&E image to predict the potential of biomarkers, such as microsatellite instability (MSI) or homologous recombination deficiency (HRD) status, in patients whose samples are not ordinarily sequenced.

Tempus is creating a network of pathology labs, called NAPA, across the country that can access the company’s growing portfolio of investigational AI models designed to identify patients that are more likely to have targetable biomarkers. In addition, Tempus is collaborating with some of the world’s leading pharmaceutical and biotech companies to leverage the EDGE platform and NAPA network to identify unique biomarkers and co-develop novel AI applications.

"We believe there is a unique opportunity to advance patient care by integrating digital pathology AI tools into our daily clinical practice," said Matthew Leavitt, MD, CEO of PathNet Labs, a national network of digital pathology practices. "This collaboration will carefully validate safe-use clinical applications of Tempus Histogenomics, directly comparing these algorithms with conventional ancillary testing methodologies while seeking to empower our pathologists with computational tools that can assist in identifying patients most likely to benefit from new therapies."

"EDGE is one of the many ways in which we will leverage our AI-enabled platform and library of multimodal data, including our diverse matched digital pathology and molecular datasets, to more effectively identify the right treatments for the right patients even earlier in their treatment journey," said Abdul Hamid Halabi, GM and SVP of Translational AI at Tempus. "This platform will bring actionable AI to pathologists’ fingertips and support them in identifying optimal therapeutic paths for patients, while also facilitating the discovery of new biomarkers for researchers developing new, targeted therapies."

In December 2021, Tempus announced a collaboration with the Data Science and Oncology teams at Janssen Research & Development LLC (Janssen) aimed at jointly creating algorithms intended to further patient pre-screening efforts for specific cancer indications, including biomarker-selected cohorts, for Janssen’s clinical trials. Tempus also announced a strategic collaboration with AstraZeneca last year, which intends to utilize Tempus’ AI-enabled platform and multimodal data to advance novel therapeutic programs across AstraZeneca’s diverse oncology pipeline.

On March 21, 2022 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, reported that the companies have signed a large-scale manufacturing agreement for the main drug intermediate in the supply of clinical material for its investigational drug candidate, Cantrixil (Press release, Oasmia, MAR 21, 2022, View Source [SID1234610469]).

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Cantrixil, an intraperitoneally administered drug in development for the treatment of late-stage ovarian cancer, was licensed by Oasmia from the Australian pharmaceutical company Kazia in 2021, having successfully completed a Phase I trial. Ovarian cancer is one of the most aggressive cancers and is difficult to treat in advanced stages. The Phase I study of Cantrixil demonstrated the potential for it to provide prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cancer cells to standard chemotherapy. Oasmia is now preparing for the initiation of a Phase II trial of Cantrixil in advanced ovarian cancer.

Under the terms of the agreement, Lonza will provide kilogram-scale synthesis, purification, and stability testing of Cantrixil, and deliver cGMP batches of drug substance for clinical supply. Oasmia will leverage Lonza’s extensive experience and expertise in manufacturing highly-potent API (HPAPI). The drug substance will be manufactured at Lonza’s recently expanded production facility at Nansha, China. The manufacturing is expected to begin later in March 2022.

Kai Wilkinson, Chief Technical Officer at Oasmia, commented: "We are excited to have partnered with Lonza, a global leader in drug manufacturing. The manufacture of Cantrixil is planned to be performed in three steps and this agreement is the first and most crucial step in us securing the clinical drug supply for its development."

Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules, Lonza, added: "Our team has extensive experience with supporting the development and manufacture of challenging molecules. We are looking forward to collaborating with Oasmia to advance this promising drug candidate in the clinic."

On March 21, 2022 Integrated DNA Technologies’ xGen NGS portfolio launch in December, MLL, the Munich Leukemia Laboratory, one of the leading research and diagnostic laboratories for leukemias and lymphomas, reported the global genomics solutions provider’s Align Program (Press release, INTEGRATED DNA TECHNOLOGIES, MAR 21, 2022, View Source [SID1234610488]).

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The addition of MLL bolsters the program’s roster of preferred sequencing providers who are united in a shared mission to advance genomics research. MLL’s extensive experience in the sequencing of exomes, genomes, and transcriptomes, coupled with IDT’s robust xGen portfolio of NGS solutions spanning library preparation, hybridization capture, amplicon sequencing, and library normalization, provides cutting-edge products and services to support researchers’ NGS workflow needs.

"Accelerating the next research discovery continues to drive the genomics industry, and unlocking efficiencies and breaking down barriers can be keys to success," said Rajan Kapadia, IDT’s VP of Global Sales and Marketing. "IDT builds meaningful partnerships with its Align Program members to open access to innovative NGS tools and technologies for the research community, and we’re proud to add MLL to our growing roster of preferred providers. Working in lockstep with our partners in science, together we can empower researchers and help advance their important work."

MLL is well known for its extremely high level of expertise in NGS, which it now offers with its sequencing label, MLLSEQ, to researchers beyond the healthcare system. MLLSEQ offers a wide range of sequencing experience and capacities from wet labs to informatics. Services span from genomes to exomes to RNA sequencing, along with detailed bioinformatic processing and visualization of the data generated.

"We are very pleased to be part of IDT’s Align Program as its first partner in Europe," said Manja Meggendorfer, head of molecular genetics at MLL. "Partnering with IDT to advance genomics research was an easy decision, as the company’s work uniquely aligns with our mission. As whole exome sequencing, RNA sequencing, and oncology translational research continue to grow in demand, we are excited to work alongside IDT to deliver the sequencing needs of the scientific community and look forward to the new discoveries to come."

IDT is a leader in gene reading, writing, and editing, and delivers innovative, high-performing NGS solutions to enable research and discovery. IDT’s comprehensive NGS offerings feature customization, complexity and scalability that break down barriers for scientists and provide them confidence in their results.

Launched in 2021, the IDT Align Program broadens access to services and solutions that help move genomics research forward. The program unites some of the most comprehensive genomic sequencing servicers in the world who are aligned in a shared mission of collaboration and dedicated to breaking down research barriers. Align Program members help to ensure accessibility of NGS tools and resources for researchers who need sequencing tailored to their specific research. For a list of members and program benefits, visit IDT Align | IDT (idtdna.com).