On April 12, 2021 Lonza reported an expansion to its popular PyroTec PRO Automated Robotic Solution for endotoxin testing (Press release, Lifescience Newswire, APR 12, 2021, View Source [SID1234577978]). The new PyroWave Reader add-on has been designed specifically for use with the sustainable PyroGene Recombinant Factor C (rFC) Assay. This brings a third test type option to the platform, allowing QC microbiologists to choose the endotoxin test method best suited for their testing needs. The PyroTec PRO Solution, now compatible with Lonza’s PYROGENT-5000 Turbidimetric LAL (Limulus Amebocyte Lysate) Assay, Kinetic-QCL Chromogenic LAL Assay and the PyroGene rFC Assay, expands the options available for streamlined, automated endotoxin testing.

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The PyroWave Reader add-on is built upon the original release of the PyroTec PRO Automated System that includes two absorbance readers for traditional LAL-based assays. Able to easily accommodate different assay types in the same run and powered by the world-class WinKQCL Endotoxin Analysis Software, this complete system further increases the efficiencies and data integrity gained from automated endotoxin testing.

The PyroGene rFC Assay is an animal-free method for endotoxin detection that works through a single enzymatic step. It has been shown to be equivalent to other photometric endotoxin methods that use LAL to detect endotoxins according to the parameters listed in the USP chapter <1225> "Validation of Compendial Procedures". These parameters include linearity, specificity, precision, accuracy, and limit of detection.

The need for accurate and dependable endotoxin testing technology continues to grow, especially with the pharmaceutical industry increasingly focusing on the development of innovative biotherapeutics that carry a higher risk of endotoxin contamination. Through process optimization and automation of routine manual tasks, the PyroTec PRO Automated Robotic Solution enables users to streamline and improve the performance of the QC laboratory, increasing lab efficiency and productivity. Automated endotoxin testing can also substantially reduce the potential for human error, enhancing the accuracy, reliability, and traceability of results.

On April 12, 2021 Recursion Pharmaceuticals, a Phase 2-ready biotech using AI to develop therapies for various indications, reported terms for its IPO on Monday (Press release, Recursion Pharmaceuticals, APR 12, 2021, View Source [SID1234577955]).

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The Salt Lake City, UT-based company plans to raise $306 million by offering 18 million shares at a price range of $16 to $18. Insiders Baillie Gifford and Mubadala Investment intend to purchase up to $125 million worth of shares in the offering. At the midpoint of the proposed range, Recursion Pharmaceuticals would command a market value of $3 billion.

Central to Recursion’s mission is the Recursion Operating System, which combines an advanced infrastructure layer to generate proprietary biological and chemical datasets, and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that the company uses to explore foundational biology and navigate to new biological insights. While the company is advancing 37 programs, its most advanced programs include one candidate targeting oncology and three targeting rare genetic disorders, all of which are expected to enter Phase 2 or 2/3 trials within the next four to five quarters.

Recursion Pharmaceuticals was founded in 2013 and booked $4 million in revenue for the 12 months ended December 31, 2020. It plans to list on the Nasdaq under the symbol RXRX. Goldman Sachs, J.P. Morgan, BofA Securities, SVB Leerink, Allen & Company and KeyBanc Capital Markets are the joint bookrunners on the deal. It is expected to price during the week of April 12, 2021.

On April 12, 2021 Cardiff Oncology, Inc. (the "Company") Presented its corporate slide presentation (Presentation, Cardiff Oncology, APR 12, 2021, View Source [SID1234577946]).

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On April 12, 2021 Treovir, an immuno-oncology company that is developing and plans to commercialize G207 for recurrent glioblastoma in children, reported that G207, an oncolytic HSV immunotherapy, was well tolerated with evidence of clinical effectiveness in a phase 1 study of 12 pediatric patients with recurrent high-grade glioma (Press release, Treovir, APR 12, 2021, View Source [SID1234577943]). Data from the phase 1 study (NCT02457845) are being presented by Gregory Friedman, M.D., professor in the Department of Pediatrics at the University of Alabama at Birmingham, during Week 1 of the virtual AACR (Free AACR Whitepaper) Annual Meeting 2021, held April 10-15. Data from this trial have been published in the New England Journal of Medicine.

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In the Phase 1 dose-escalation study, 12 pediatric patients 7 to 18 years of age with progressive high-grade glioma received an infusion of G207 alone or G207 in combination with radiation. No dose-limiting toxic effects or serious adverse events were attributed to G207 by the investigators and only 20 grade 1 adverse events were possibly related to G207. Radiographic, neuropathological, or clinical responses were seen in 11 patients. The median overall survival was 12.2 months (95% confidence interval, 8.0 to 16.4). The overall survival rate was more than double the typical survival rate for children with high-grade glioma. Some 36 percent of the patients thus far have survived longer than 18 months, surpassing the expected survival for newly diagnosed children with high-grade glioma. Additionally, G207 markedly increased the number of tumor-infiltrating lymphocytes for at least nine months after infusion effectively turning immunologically "cold" tumors "hot".

Gregory Friedman, M.D., Principal Investigator of the study, said, "This is the first study utilizing delivery of a viral immunotherapy directly into brain tumors in children and the results indicate that G207 can be delivered safely into tumors located in all areas of the cerebrum in children. The key findings thus far are that the approach is safe and well tolerated, and the preliminary evidence of efficacy is very promising."

G207 is an oncolytic HSV engineered to infect only tumor cells. When infused into a tumor, the virus enters the tumor cells and replicates and kills the cells. In the process, G207 releases viral progeny that infect and kill nearby tumor cells. Furthermore, as demonstrated in the Phase 1 study for the first time, G207 induces a strong local immune response to harness the body’s immune system to further fight against the tumor cells.

"We are enthusiastic that the Phase 1 results appear to support the use of G207 as a safe and potentially effective therapy to treat pediatric high-grade gliomas," said Michael Christini, CEO of Treovir. "There are no approved therapies to treat these types of lethal tumors and it is our goal to develop G207 for glioma and other childhood brain cancers."

In collaboration with Dr. Friedman and the Pediatric Brain Tumor Consortium, Treovir is in the late stages of planning its Phase 2 clinical trial for G207 in recurrent high grade glioma (NCT 04482933). The Phase 2 trial is expected to start later in 2021. Additionally, G207 is being studied at UAB and Children’s of Alabama in recurrent pediatric brain tumors, including medulloblastoma, which arise in the cerebellum, the most common location for pediatric tumors to arise. (NCT 03911388)

"It is our goal that the Phase 2 study will support market approval of G207 to treat pediatric recurrent high-grade gliomas and our company’s mission is clear: We want to commercialize G207 and provide hope to the children and families who currently have no effective therapeutic options," stated Mr. Christini.

Brain tumors are the most common solid tumor in children, and aggressive types like glioblastoma have an extremely low survival rate: as low as 10% five years after diagnosis. Malignant high-grade glioma accounts for 8 to 10% of pediatric brain tumors and survival rates have not improved in 30 years. The median life expectancy of recurrent high-grade glioma is only 5.6 months.

The study was supported by the US FDA Orphan Products Clinical Trials Grants Program, Cannonball Kids’ Cancer Foundation, the Rally Foundation for Childhood Cancer Research, Hyundai Hope on Wheels, St. Baldrick’s Foundation, and the Kaul Pediatric Research Institute. Dr. Friedman has no financial or equity interest in Treovir and was not paid by Treovir for the Phase 1 study.

On April 12, 2021 Flagship Biosciences, the leader in data-centric pathology and tissue analysis, and Leap Therapeutics (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported a partnership to use a clinically validated tumor expression assay utilizing RNAscope and tissue image analysis (Press release, Leap Therapeutics, APR 12, 2021, View Source [SID1234577942]). In a poster shared this week at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, the companies presented data on the validation of a Dickkopf-1 (DKK1) RNAscope chromogenic in situ hybridization (CISH) assay and digital image analysis solution.

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DKK1 is a secreted modulator of Wnt signaling that is frequently overexpressed in tumors and associated with a poor prognosis for patients. DKN-01 is a humanized monoclonal therapeutic antibody that binds to and blocks the activity of DKK1 and has demonstrated clinical activity in gastric/gastroesophageal junction (G/GEJ) adenocarcinoma patients with elevated tumoral expression of DKK1 RNA. The companies have demonstrated that the DKK1 RNAscope assay and accompanying digital image analysis solution is specific, sensitive, accurate and reproducible according to Clinical Laboratory Improvement Amendments (CLIA) guidelines. The assay is currently being applied to prospectively identify G/GEJ patients with elevated tumoral expression of DKK1 for treatment with a DKN-01 plus tislelizumab combination (Leap Therapeutics; NCT04363801).

"CISH assays can be used for the interrogation of clinical samples when protein targets are not sufficient," said Flagship Biosciences CEO, Trevor Johnson. "However, reading these assays can be challenging for pathologists. At Flagship, our pathologist-driven image analysis generates unique cellular data profiles that allow for the kind of robust quantitative solution that Leap was looking for. Using our proprietary image analysis technology and patented, cell-based tissue analysis, we deliver the data-rich tissue interpretations to support therapeutic development."

"This is a robust laboratory developed test (LDT) that is superior to traditional DKK1 immunohistochemistry (IHC) by demonstrating improved specificity and sensitivity," said Michael Kagey, Ph.D., Senior Director of Translational Medicine. "Furthermore, the use of the digital image analysis algorithm to quantify DKK1 signal and support pathologist interpretation is a novel approach that reduces the risk of scoring bias."

To select patients for their clinical study, Leap Therapeutics sends samples from the United States and the Republic of Korea to Flagship’s centralized laboratory. Flagship conducts the RNAscope assay, image analysis, data analysis, and in-house pathologist review, providing the information needed to make clinical trial enrollment decisions.

"The DKK1 RNAscope LDT is an integral component of our clinical development strategy," said Douglas E. Onsi, President and CEO of Leap Therapeutics. "The rapid sample turnaround time from Flagship has allowed for the prospective screening of patients to support enrollment. We look forward to our continued partnership with Flagship."