A Branford diagnostics biotech that developed a hand-held device to detect organisms that cause infectious diseases is expanding its footprint in the shoreline town with a planned move to a new 16,200-square-foot facility.
A spokeswoman for Tangen Biosciences Inc. said the six-year-old company will move its 24 employees from a 2,700-square-foot space at 780 Main St. to the larger location at 20 Commercial St. in August.
The move follows the company’s closing last spring on a $9 million Series A funding round, led by state venture-capital arm Connecticut Innovations (CI). Current and new stockholders also participated, including VC23, Axiom and Leading Edge Ventures.
Tangen is using the proceeds to advance its portable molecular diagnostics platform — which it calls TangenDx — through the federal regulatory approval process, with the goal of a commercial launch in 2020, the spokeswoman said.
Tangen expects to begin two infectious-disease trials on the platform this year.
Daniel Wagner, senior managing director for CI, said the quasi-public agency was impressed with the TangenDx technology, which the company touts as cheaper, faster and more sensitive than existing molecular diagnostic systems.
“The future of diagnostics lies in decentralized testing, and TangenDx will bring high-quality molecular testing out of the traditional laboratory setting into doctors’ offices, pharmacies and health-care providers in areas with limited infrastructure,” Wagner said in a statement.
The company also announced an expansion of its management team, tapping Keith Kardos, as acting vice president of clinical affairs and Anne Cavanaugh as finance director. Kardos formerly served as vice president of R&D at OraSure Technologies, while Cavanaugh cofounded publicly traded Strategic Diagnostics Inc.
They join CEO Richard C. Birkmeyer, who was brought on last November.
In 2017, the company won a federal contract worth up to $9.4 million to develop a diagnostic test for Anthrax.
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New Haven-based ReNetX Bio Inc. is recruiting patients for the first human trial of its breakthrough drug that aims to reverse the damage caused by spinal-cord injuries.
The U.S. Food & Drug Administration in June greenlighted the company’s Investigational New Drug (IND) application for its lead drug candidate, AXER-204, for the treatment of spinal cord injuries, which affect roughly 300,000 people in the U.S.
AXER-204 works by blocking certain proteins that inhibit the regrowth of neurons. There is currently no approved treatment to restore sensory or motor function after injury, the company said.
In a statement, ReNetX CEO Erika R. Smith said the company is “excited to advance an entirely new approach for patients to restore function to damaged nerve fibers in the central nervous system.”
Founded in 2010 as Axerion Therapeutics, the Yale spinoff is based on research by Stephen Strittmatter, MD, the Vincent Coates Professor of Neurology at Yale University.
The Phase 1 trial will be conducted in patients at leading spinal-cord injury treatment centers around the country, said ReNetX. It will examine the drug’s safety, tolerability, efficacy and how it is distributed throughout the body.
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On the heels of a $13.4 million venture-capital funding round, New Haven’s Cybrexa Therapeutics said it has landed a federal grant worth up to $2.3 million to advance its lead cancer drug.
The startup has received a $300,000 initial payment from the National Institutes of Health’s Fast Track Small Business Innovation Research (SBIR) Grant, a company spokeswoman said Monday. It has the potential to reap another $2 million based on meeting certain milestones.
Launched in 2016 by serial entrepreneurs Per Hellsund, Kevin Didden and Kevin Rakin, the Science Park-based company has developed technology that sends cancer-fighting agents directly into tumor cells while sparing healthy tissue.
Cybrexa CEO Per Hellsund
“This SBIR grant represents an important external validation of the core technology that Cybrexa is developing,” said cofounder and scientific advisor Ranjit Bindra, MD, a professor at Yale School of Medicine.
Cybrexa will use the funding to support development of CBX-11, which pairs its tumor-targeting technology with rucaparib, an existing cancer treatment known as a PARP inhibitor. Used in combination with chemotherapy, the drug could potentially result in fewer toxic side effects, according to the company.
Cybrexa expects to begin human trials early next year.
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Alexion Pharmaceuticals Inc. has racked up its third regulatory approval for its newest drug, Ultomiris, this time from health regulators in the European Union.
Alexion announced last week that the European Commission has approved Ultomiris, the company’s follow-up to its blockbuster drug Soliris, to treat adults with the ultra-rare blood disease paroxysmal nocturnal hemoglobinuria (PNH).
The news follows an approval in June by Japanese regulators to allow the company to market the drug in Japan. The U.S. Food & Drug Administration greenlighted the treatment last December.
PNH is a debilitating disease that can cause blood clots throughout the body, resulting in organ damage, stroke, heart attack and premature death.
The EU approval is for adult PNH patients with hemolysis (the destruction of red blood cells) with clinical symptoms of high disease activity, as well as for adult patients who are clinically stable after having been treated with Soliris for at least six months, Alexion said.
Like Soliris, Ultomiris inhibits c5, an immune system protein overactivated in PNH patients, but requires fewer infusions than its predecessor, reducing the treatment burden for patients, according to the company.
Alexion expects Ultomiris will replace Soliris as the new standard treatment for the disease.
Contact Natalie Missakian at news@newhavenbiz.com