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June 2, 2020 Bioscience Notebook

Branford’s Sema4, Tangen tackle Covid testing; Azitra drug lands key FDA designation

IMAGE | Pixabay.com

A genomic testing firm with a lab in Branford said it is teaming with the state to expand COVID-19 testing and help employers reopen offices and return employees to work.

Under a partnership announced Monday, Stamford-based Sema4 said it is expanding virus testing capacity at its Branford lab to 10,000 a day and expects to process 5,000 antibody tests daily by the end of June. Officials have pointed to expanded testing as a key component of a successful reopening of the economy. 

The company is also offering a digital platform for employers who are managing back-to-work programs. This includes portals to register employees, track samples and report results.

The collaboration comes amid news that the state has fallen short of a goal to conduct and process 50,000 tests a week by the end of May, according to the Hartford Courant. The state has said it needs to conduct 100,000 tests a week by June 20 to proceed with Phase 2 of the state’s reopening. 

“Sema4 is playing a critical role in supporting the state with testing capacity,” Lt. Col. Chistopher Chabot, who leads Connecticut’s COVID testing program, said in a statement Monday. He said the partnership “will make a significant difference in keeping many of our residents safe.”

Sema4 said Monday its latest state partnership builds on testing it has been doing since April, when it began performing tests for some 30 Connecticut health-care facilities. 

The additional capacity will allow for more virus and antibody tests for state employees, first responders, nursing home residents, patients at primary care facilities and others, Sema4 said. 

The company is accepting saliva, nasal swab and oral swab samples collected by a health-care provider or authorized collection site, and is awaiting U.S. Food & Drug Administration authorization to accept saliva collected at home. Results are available in 24 hours for viral tests and 48 hours for antibody tests. There is no out-of-pocket cost for Connecticut residents.

Viral tests used by the company are manufactured by PerkinElmer, while antibody tests are run on the Abbott Alinity system. Both have received emergency use authorization from the U.S. Food & Drug Administration. 

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In other COVID-19 testing news, Branford’s Tangen Biosciences Inc. said last week that it had inked a partnership with a Delaware company to include Tangen’s hand-held molecular testing device in that firm’s portable disease surveillance lab kit.

The kit developed by LabWare Inc. resembles a small suitcase and includes all components needed to enable patient registration and testing in the field, according to Tangen.

Using Tangen’s device, called GeneSpark, patient specimens will be tested immediately and both patient details and results will be transferred electronically via the cloud to public health labs and the Centers for Disease Control in less than 30 minutes, the company said.

Tangen originally developed GeneSpark to detect anthrax under a 2017 $10.3 million contract with the U.S. Department of Health & Human Services’ Biomedical Advanced Research & Development Authority (BARDA). 

The diagnostics firm received another federal contract last month for a COVID-19 test to be used with the system. Reports valued that contract at $696,000.

The company said it is now working on a Flu/COVID-19 panel that can detect Flu A, Flu B and COVID-19 simultaneously from a single patient sample in one processing run, allowing people with flu-like symptoms to know which infection they have.  

“We believe the combined COVID-19 and Flu A/B test will be a critical surveillance tool for respiratory illness management,” said Tangen President and CEO Richard Birkmeyer, in a statement.

Tangen said it is also looking for partners on a sepsis panel as well as an antimicrobial resistance panel it is developing. 

Last week, New Haven BIZ reported that Jonathan Rothberg’s Homodeus Inc., another shoreline bioscience company, expects to bring its inexpensive, at-home COVID testing device to market this summer.

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Branford dermatology biotech Azitra Inc.’s treatment for a genetic skin condition has been granted “rare pediatric disease” status by the FDA.

The FDA gives the label to treatments for severe or life-threatening diseases affecting a limited number of people who are 18 or younger.

The special designation makes Azitra eligible for a voucher allowing a speedier review for another one of its products, should its drug, ATR-12,  be approved. The voucher can also be sold to another drug company. 

Azitra, which recently relocated to the shoreline from the UConn Technology Incubation Program (TIP) in Farmington, is developing an ointment for Netherton Syndrome (NS), a rare condition marked by severely inflamed, itchy and scaly red skin. 

One in 10 infants born with the condition die within the first year of life. Those who survive are at higher risk of infection and allergy, according to Azitra. 

Current treatments have limited effectiveness and can cause serious side effects, said Azitra President and CEO Richard Andrews.

Azitra’s drug uses its microbiome technology, which harnesses the good bacteria that live on the skin to treat disease. It’s designed to live on the skin and provide continuous delivery of a protein missing in patients with NS, the company said. 

Azitra expects to apply for FDA approval to begin human testing by the end of the year.

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After raising $145 million in venture capital in a Series B round last month, New Haven rare disease biopharma Rallybio has added another former Alexion executive to its growing team.

The company, founded in 2018 by three former Alexion executives, said last week it has hired Róisín Armstrong to head development of its recently unveiled lead drug, RLYB211, which treats a rare condition that causes uncontrolled bleeding in newborns.

Armstrong most recently served as vice president and global medicine team leader at Alexion, where she led teams in the development and registration of new treatments for rare and ultra-rare neurology indications. She previously held a succession of leadership roles at Pfizer. 

Rallybio opened a New Haven headquarters at 234 Church St. early this year after outgrowing its space at UConn’s Technology Incubation Program in Farmington. It currently has 16 employees.

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Guilford artificial intelligence-based drug discovery firm InveniAI LLC said the non-profit TB Alliance will use its AI and machine learning platform to find and advance new treatments for tuberculosis.

Approximately 10 million people develop active TB worldwide each year and 1.5 million die, making it the world’s top infectious disease killer, according to InveniAI.

“Immunomodulatory approaches have proven successful for treating many infectious diseases and have gained momentum for those diseases with an immune component,” said InveniAI President and CEO Krishnan Nandabalan in a statement. “There are several pathways, targets and drugs that represent a fertile ground to apply AI and ML to create novel concepts efficiently, rapidly and at scale.”

InveniAI shares a parent company with New Haven’s BioXcel Therapeutics Inc., which uses artificial intelligence to repurpose older drugs and discover new ones.

Contact Natalie Missakian at news@newhavenbiz.com

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