On April 7, 2021 Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company exploiting synthetic lethality to develop a broad pipeline of precision medicines for the treatment of cancer, reported a global research collaboration with Novartis to discover and validate next generation DDR targets to enhance Novartis’ Radioligand Therapies (RLT) (Press release, Artios Pharma, APR 7, 2021, View Source [SID1234577665]).

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Under the three-year collaboration, Artios and Novartis will perform target discovery and validation, and Novartis will select up to three exclusive DDR targets, and receive worldwide rights on these targets to be utilized with its RLT’s.

Dr. Niall Martin, Chief Executive Officer at Artios Pharma, said: "This collaboration expands the reach of our discovery platform, leveraging our DDR expertise and target knowledge to enhance the potential of radioligand therapies. We are thrilled to work with Novartis, and this combined with our recent collaboration with Merck KGaA provides important validation of the power of the internal discovery capabilities at Artios. From a strategic perspective, this collaboration is an ideal fit which maximizes the application of our platform to areas beyond our current focus as we independently advance our pipeline of novel DDR candidates. We look forward to continued momentum as a clinical-stage precision medicine company, building upon our recently initiated Phase 1 study of ART0380, our potential best-in-class ATR inhibitor, with the expected entry of our first-in-class Pol Theta program into the clinic before year end."

Under the terms of the agreement, Novartis will make an up-front payment of US$20 million and provide near term research funding to support the collaboration. Artios will be eligible to receive discovery, development, regulatory and sales-based milestones, in addition to royalty payments on net sales of products commercialized by Novartis. The collaboration does not include Artios’ lead programs, ART0380, which is currently in clinical development, or ART4215, a first-in-class Pol Theta inhibitor.

Novartis’ RLT delivers targeted radiation to a specific subset of cancer cells, with minimal effect on surrounding healthy cells. RLT has been shown to improve overall survival and quality of life, particularly in the setting of cancers with bone metastases.

On April 7, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported abstracts accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will convene virtually on April 10-15 and May 17-21 (Press release, Tempus, APR 7, 2021, View Source [SID1234577701]). The research leverages Tempus’ unparalleled library of multi-modal data to facilitate discovery, development, and delivery of optimized therapeutic options for patients.

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"We’re proud to present our recent research that demonstrates the power and depth of our database," said Dr. Kim Blackwell, Chief Medical Officer at Tempus. "As evidenced by the collection of abstracts, we are utilizing data-driven tools that empower physicians to optimize patient care."

Tempus will present eight posters; including two in collaboration with outside investigators from Baylor College of Medicine, Harris Health Ben Taub Hospital, and the Dan L Duncan Comprehensive Cancer Center. Four of the abstracts accepted for poster presentation at AACR (Free AACR Whitepaper) 2021 are highlighted below and the complete list can be found at www.tempus.com/publications.

Incidence of Molecular Alterations in KRAS and Other Known Cancer Genes in Patients With Pancreatic Cancer Assessed With a Commercial Genomic Profiling Panel Compared to TCGA Results
Overview: Tempus’ xT LDT assay detected common alterations in genes such as KRAS, TP53, and SMAD4 in a Baylor College of Medicine pancreatic cancer cohort at a similar incidence to The Cancer Genome Atlas Program. Approximately 13% of pancreatic cancer patients had an alteration in the homologous recombination repair pathway. Lens, Tempus’ next-generation data exploration and analysis platform, allowed researchers to identify the incidence of targetable molecular alterations landscape in patients with pancreatic cancer.
Genomic Characterization and Monitoring Molecular Response to Treatment in African Americans (AA) Advanced Prostate Cancer (PC) Patients (Pts) via Next-Generation Sequencing (NGS); Real-world Experience in a Safety Net Hospital Oncology Clinic
Overview: Tempus’ xF liquid biopsy LDT assay allows for longitudinal monitoring of treatment response and resistance in patients with advanced prostate cancer. This study reported the incidence of key prostate cancer driver gene alterations, including TP53, SPOP, AR and BRCA2, in both the Ben Taub Hospital cohort and Tempus database, and revealed the value of longitudinal xF monitoring in 4 case studies: (1) Response to first line hormonal therapy, (2) Nonresponse to third line darolutamide, and (3) Two cases of response to pembrolizumab in MSI-H metastatic prostate cancer.
Comprehensive Validation of RNA Sequencing for Clinical NGS Fusion Genes and RNA Expression Reporting
Overview: Tempus sequenced both DNA and the whole-transcriptome RNA to improve coverage and provide the most comprehensive patient molecular profile. This study reported results from the clinical and analytical validation of fusion calling for improved gene rearrangement detection, and the analytical validation of RNA expression for research purposes. The orthogonal testing concordance for targeted fusions was 100%, with 99.9% sensitivity and 99.9% specificity, and for untargeted fusions, the overall concordance was 97%, with 97% sensitivity. The enhanced RNA-sequencing assay offers unbiased detection of common and novel fusions, as well as validated gene expression data for comprehensive research analyses.
Leveraging Clinical RNA Sequencing for Scalable Tumor Immune Repertoire Profiling
Overview: Characterizing tumor-infiltrating lymphocytes (TILs) by repertoire sequencing (rep-seq) at scale can help maximize patient benefit from data-driven treatment options. This study presents a scalable method for TIL rep-seq from whole-transcriptome RNA data in approximately 500 tumors from 38 cancer types. Results of this study were consistent with an orthogonal DNA-seq method and confirmed expected trends in receptor profiles across the cohort, including monoclonality of lymphocyte receptors in T-cell/B-cell-driven malignancies, high repertoire richness in TIL-high cancers (e.g., NSCLC) and low in TIL-low cancers (e.g., multiforme glioblastoma). This method can be seamlessly integrated for improved TIL characterization from routine RNA-sequencing.

On April 6, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported it has completed the acquisition of Asuragen, Inc. The transaction included initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones (Press release, Bio-Techne, APR 6, 2021, View Source [SID1234577614]). The Asuragen acquisition adds a leading portfolio of best-in-class molecular diagnostic and research products, including genetic screening and oncology testing kits, molecular controls, a Good Manufacturing Practice (GMP)-compliant 50,000 square foot manufacturing facility and a CLIA-certified laboratory, plus a team with deep expertise navigating products through the global diagnostic regulatory environment. Bio-Techne sees multiple growth synergies as a result of this acquisition, including capabilities in productizing lab-developed tests and commercializing innovative molecular products for broader market adoption. Bio-Techne also gains an attractive pipeline of expanded carrier screening panels for various pathologies recognized by The American College of Obstetricians and Gynecologists (ACOG) as areas of concern for prospective new parents. Following this acquisition, Bio-Techne now has a global workforce of more than 2,400 team members.

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On April 6, 2021 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development reported that Panna Sharma, President and CEO of Lantern Pharma, will participate in the 20th Annual Needham Healthcare Conference, to be held virtually on April 12-15, 2021 (Press release, Lantern Pharma, APR 6, 2021, View Source/news/press-releases/detail/46/lantern-pharma-to-participate-in-the-virtual-20th-annual" target="_blank" title="View Source/news/press-releases/detail/46/lantern-pharma-to-participate-in-the-virtual-20th-annual" rel="nofollow">View Source [SID1234577629]).

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Mr. Sharma will participate in a fireside chat moderated by Needham & Company’s Alexander Salisbury on Thursday, April 15, at 12:45 pm ET and hold one-on-one meetings with investors throughout the four-day event.

The live event will be accessible on View Source and will be archived for 90 days. Investors interested in scheduling a meeting with Mr. Sharma should contact their Needham & Company representative or Lantern Pharma investor relations.

On April 6, 2021 Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, reported the European Commission (EC) has granted orphan designation to BNZ-1 for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer (Press release, Bioniz Therapeutics, APR 6, 2021, View Source [SID1234577646]). BNZ-1 has previously been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). Bioniz recently completed a phase 2 study of BNZ-1 in CTCL in the United States and intends to initiate a phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory CTCL (rCTCL). Bioniz expects the phase 3 to begin enrolling the second half of 2021.

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"The currently approved therapies to treat CTCL are not ideal given the limited efficacy and safety concerns and are typically tolerated by patients only for a limited time due to many side effects that are associated with these treatments," said Nazli Azimi, Pharm.D., Ph.D., Founder, President, and CEO of Bioniz Therapeutics. "With our lead product candidate, BNZ-1, we have completed several significant milestones, including positive efficacy data from our phase 2 study, guidance from the FDA on our phase 3 trial design, and now orphan designation in the U.S. and EU. BNZ-1 has the potential to be a significant treatment for CTCL."

Orphan designation from the EC provides incentives for companies to develop medicines intended for the treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating and where no satisfactory treatment is currently authorized. The prevalence of the condition must not exceed more than five in 10,000 people in the European Union (EU). In addition to being eligible for a 10-year period of marketing exclusivity in the EU upon product approval, orphan designation provides fee waivers, protocol assistance, and eligibility for marketing authorization under the centralized procedure granting approval in all EU countries.

About Refractory Cutaneous T-cell Lymphoma (rCTCL)
Cutaneous T-cell lymphomas (CTCLs) are a rare, aggressive, heterogeneous group of non-Hodgkin’s lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.

About BNZ-1
The company’s lead product candidate, BNZ-1, is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL and autoimmune diseases. Bioniz is also planning a phase 2 study of BNZ-1 for the treatment of alopecia areata, which is also driven by unregulated T-cell biology.