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In Brief This Week: Ginkgo Bioworks, Caris Life Sciences, MDxHealth, and More

NEW YORK – Selecta Biosciences and Ginkgo Bioworks said this week that they are collaborating to design novel and improved enzymes for the treatment of orphan and rare diseases. The firms plan to use Selecta's ImmTOR platform to develop therapies that reduce unwanted immune responses in combination with Ginkgo's high-throughput enzyme discovery, design, and screening capabilities. Under the terms of the agreement, Ginkgo is eligible to earn upfront R&D fees and milestone payments, including in the form of Selecta common stock; clinical and commercial milestone payments of up to $85 million in cash; and downstream payments in the form of royalties on sales.

Caris Life Sciences said this week that the Caris Precision Oncology Alliance and NCI's Center for Cancer Research will collaborate on precision medicine research initiatives. As part of the collaboration, Caris will make its suite of comprehensive molecular profiling offerings available to NCI researchers, and will link molecular testing results into an electronic medical records database to create a more complete dataset of combined patient outcomes and molecular information. Further, Caris said, joining the POA network will enable the NCI faculty and researchers to conduct clinical and translational research collaboratively across the alliance, to participate in all ongoing research activities across POA tumor groups, and to generate and publish clinical outcomes data that impacts cancer care across the US.

The POA currently includes 55 cancer centers and academic institutions, including 24 NCI-designated cancer centers.

MDxHealth said this week that it is launching a registered initial public offering of 3,750,000 American Depositary Shares, each representing 10 of the company’s ordinary shares, with no nominal value per share. The company filed for an IPO of ADSs with a proposed maximum aggregate offering price of $30 million earlier this month.

In connection with the offering, MDxHealth intends to grant the underwriters a 30-day option to purchase additional ordinary shares, which may be in the form of ADSs, in an aggregate amount of up to 15 percent of the total number of ordinary shares offered in the IPO.

MDxHealth’s ordinary shares are currently listed on Euronext Brussels under the symbol MDXH. The company has made an application to list the ADSs on the Nasdaq Capital Market under the same symbol.

Piper Sandler and Oppenheimer are acting as lead bookrunning managers, BTIG is acting as a lead manager, and KBC Securities USA is acting as a co-manager for the offering.

Southern Oncology Specialists this week partnered with bioinformatics firm Deep Lens to expand its clinical trial offering using Deep Lens' artificial intelligence platform, Viper. Southern Oncology Specialists system hopes to attract more clinical trials to its practice and help match patients with trials at diagnosis using the platform. Viper will prescreen all patients included in Southern Oncology Specialists’ EMR system and will incorporate data from pathology feeds and molecular data feeds from Caris Life Sciences, Guardant Health, Foundation Medicine, and Tempus. The platform is being provided at no cost to the practice.

Centogene said this week that the first patient has been enrolled in EFRONT, an observational study to understand the prevalence of genetic mutations in patients with frontotemporal dementia. The study, which is supported by Alector, uses Centogene's rare disease biobank and database, along with its network of physicians, and plans to enroll more than 3,000 FTD patients at centers in Belgium, Germany, Greece, Italy, Portugal, Spain, and Turkey. Centogene will provide genetic testing for the study, and patients with mutations in progranulin will have the option to enroll in Alector's Phase III INFRONT-3 clinical trial of AL001, an investigational drug designed to increase progranulin levels.

Curi Bio, a Seattle-based provider of human stem cell-based platforms for disease modeling and drug discovery, and Nexel, a South Korean developer of induced pluripotent stem cell, or iPSC, technology, said this week that they’ve formed a joint venture called Celogics to develop and commercialize human iPSC-derived cell products for drug discovery, drug safety testing, and biological research. Celogics will provide Nexel's iPSC-derived cell products, including Cardiosight-S cardiomyocytes, to the US and global markets, and will launch a Seattle-based iPSC production facility to support rapid growth and iPSC contract development and manufacturing services. Celogics will also develop and commercialize next-generation iPSC-derived cell products, the companies said.

Genetic Technologies this week announced results for its first quarter of fiscal year 2022, reporting cash receipts of A$850,000 ($625,430).

The Melbourne, Australia-based firm said that during the quarter ended Sept. 30, it acquired and integrated EasyDNA for $4 million, and the new company became a primary channel for an increase in cash receipts during the quarter. The company also said that a cash balance of A$15.7 million at the end of the quarter will provide it with 24 months of runway post integration of EasyDNA, including revenue contributed by EasyDNA.

During the recently completed quarter, net cash used for operations was A$1.9 million and was due mainly to an increase in R&D and operating expenses as the firm executes on its commercialization strategy.

Genetic Technologies added that it has submitted a validation package to the Australian National Association of Testing Authorities for its Genetype MultiTest assay, a predictive panel risk test that the firm said covers common cancers that account for approximately 70 percent of annual morbidities. A phase one launch will include breast cancer, colorectal cancer, prostate cancer, ovarian cancer, coronary artery disease, and type 2 diabetes.

PerkinElmer said this week that GenWorks Health will exclusively distribute its newborn and prenatal screening portfolio in India. Terms of the deal were not disclosed. The deal will improve access to reproductive health solutions, especially in private hospitals and clinics, PerkinElmer said.

Separately, the Waltham, Massachusetts-based company also said this week that its board has declared a regular quarterly dividend of $.07 per share of common stock, payable on Feb. 11, 2022, to all shareholders of record at the end of business on Jan. 21, 2022.

Anitoa Systems said this week that its Maverick line of qPCR instruments has been registered and listed with the US Food and Drug Administration as a Class II 510(k)-exempt medical device. According to the company the platform can provide a test result in about 45 minutes using standard RT-PCR chemistry. It is available in 4-, 6-, and 16-well formats, all of which feature a proprietary low-light sensitive, complementary metal-oxide-semiconductor four-channel fluorescence optics system for multiplexed DNA detection, as well as cloud-based software for data storage and retrieval.

LUNGevity Foundation this week launched an online patient resource, called Lung Cancer Patient Gateways, which helps patients find treatment information, educational resources, and patient and caregiver support. The first resource LUNGevity is launching is the KRAS Patient Gateway, to help patients learn about KRAS mutations, find specialists and clinical trials, and join KRAS-specific patient and caregiver communities. Over the next six months, LUNGevity will launch five other gateways including resources for different types of lung cancer such as non-small cell and small cell lung cancer, and tumors driven by mutations in genes such as ALK, EGFR, ROS1, MET, NTRK, BRAF, and RET.

Montreal-based Optina this week announced it has raised C$24.8 million ($20.1 million) in a Series A financing round. The financing will primarily support a pivotal study for its Awair cerebral amyloid status test for suspected Alzheimer's disease and the development of a platform for the early detection of systemic diseases, the firm said.

Celemics of South Korea said this week that it has signed an agreement to supply Sangon Biotech, a Chinese genetic analysis company, with its BTSeq (Barcode-Tagging Sequencing) technology. Under the terms of the one-year agreement, Celemics will provide Sangon with BTSeq kits for at least 100,000 reactions, as well as bioinformatics software.

In a filing with the US Securities and Exchange Commission last week, Thermo Fisher Scientific closed a previously priced offering of $5.85 billion aggregate principal amount of five types of senior notes. The company said it expects net proceeds from the sale of approximately $5.82 billion, after deducting underwriting discounts and estimated offering expenses. 

Thermo Fisher said it intends to use the net proceeds to pay a portion of the cash consideration for its pending acquisition of PPD. The company agreed in April to pay $17.4 billion for the clinical research services provider, plus the assumption of approximately $3.5 billion of net debt.

Exagen announced this week that its flagship Avise CTD and Avise Lupus tests are now contracted covered services with Inland Empire Health Plan, making Avise diagnostic testing available to more than 1.4 million members as an in-network benefit.

10x Genomics this week announced a new facility in Singapore that will begin operations later this year. The 53,000-square-foot center is 10x's first manufacturing facility outside the US and will also serve as the firm's commercial hub for the Asia Pacific region. It will include a biosafety level 2 lab for training customers.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.