Arvinas advances breast cancer drug into clinical trials; Alexion’s Soliris OK’d in Europe for new disease
PHOTO | Contributed
Arvinas CEO John Houston
New Haven biotech Arvinas Inc. said Tuesday it has begun dosing patients in the first human trial of its experimental drug to fight an advanced form of breast cancer.
This is the second Arvinas drug to enter the clinic this year. The company began a Phase 1 trial on a drug targeting prostate cancer this past spring.
Like the prostate cancer drug, its latest candidate, ARV-471, is part of a new class of treatments called targeted protein degraders. It targets a type of protein known as an estrogen receptor, which plays a role in estrogen-receptor positive breast cancer. (The prostate cancer drug targets the androgen receptor.)
Both drugs use technology developed by Yale molecular scientist Craig Crews, in which small molecules called PROTACs (short for proteolysis-targeting chimeras) induce the body’s natural protein removal system to attack and remove the troublesome proteins. Crews founded the Science Park-based company in 2013.
“ARV-471 is a potent ER degrader that has demonstrated significant anti-tumor activity in preclinical models, and we are hopeful it will address an important need for patients with advanced ER positive breast cancer not adequately treated with current standards of care,” said Arvinas Chief Medical Officer Ronald Peck, MD.
The American Cancer Society estimates roughly 268,000 women in the U.S. will be diagnosed with invasive breast cancer in 2019, the majority of which are ER-positive.
The early-stage study will mainly look at the safety and tolerability of the drug in patients with locally advanced or metastatic ER positive/HER 2 negative breast cancer. Preliminary results are expected in 2020.
Later trials will investigate ARV-471 as both a stand-alone drug and in combination with other treatments, Arvinas said.
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Alexion Pharmaceutials, which has a large Elm City research presence, has once again expanded the reach of its blockbuster Soliris, announcing Tuesday it won European approval to market its flagship drug for a rare central nervous system condition.
The European Commission greenlighted Soliris for the new indication, neuromyelitis optica spectrum disorder (NMOSD), a rare, relapsing disease marked by attacks that cause progressive damage to the brain, optic nerve and spinal cord.
“In a disease marked by unpredictable relapses that each have the potential for irreversible consequences such as blindness or the inability to walk, the primary treatment goal is prevention of such attacks,” said John Orloff, MD, Alexion’s research and development chief.
Nearly all NMOSD patients treated with Soliris in a Phase 3 study were relapse free after 48 weeks, according to Alexion.
The approval is for patients who are positive for an antibody known as anti-aquaporin-4 (AQP4) and have a relapsing course of the disease, which is often misdiagnosed as multiple sclerosis.
Tuesday’s announcement had been expected, since a committee of the European Medicines Agency, an advisory body, recommended approval last month. Soliris received U.S. Food & Drug Administration approval for NMOSD in June.
Soliris is Alexion’s chief money maker, bringing in roughly $3.6 billion for the company last year, and is routinely listed as one of the world’s costliest drugs.
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Shelton-based anti-viral developer Nanoviricides Inc. is making headway on its topical cream for the shingles rash, but needs to raise more money to advance the drug into clinical trials, the company said in an annual report filed Friday.
The company, whose fiscal year ended June 30, closed out the year with $2.8 million in cash and cash equivalents, compared to $7.08 million at the end of fiscal 2018, according to a filing with the U.S. Securities and Exchange Commission (SEC).
Nanoviricides attributed the cash burn to continuing operating expenditures.
“Management is actively exploring additional required funding for its planned objectives through debt or equity financing,” the company said in announcing the year-end financial results.
The company posted a net loss of $8.42 million, or 12 cents a share in fiscal 2019, slightly less than the $8.56 million (13 cents a share) it lost a year earlier, according to the filing.
While running low on cash, Nanoviricides said that with $10.2 million in property and equipment assets (namely its manufacturing and R&D facility in Shelton) and no debt, it “continues to have a strong fiscal position as it is advancing its drugs towards human clinical trials.”
It said it remains “on course” to file an investigational new drug application with the FDA and start clinical trials on the shingles treatment in the coming year.
Founded in 2005, Nanoviricides is developing drugs to fight diseases caused by the herpes simplex virus and others.
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Guilford’s Bioasis Technologies Inc. said it has elevated Caroline Dircks to the position of chief operating officer.
Dircks has been senior vice president of research and development at the biotech since March 2018. She was formerly head of regional R&D operations for Bristol Myers-Squibb.
“After working directly with her this past year, Caroline has demonstrated excellent leadership skills and the drive to implement Bioasis’ growth and development strategy,” CEO Deborah Rathjen said in a statement.
Bioasis has developed technology to transport drugs across the blood-brain barrier, the brain’s filtering mechanism. The barrier makes some drugs which work elsewhere in the body ineffective on diseases in the brain.
The company is researching ways to use the technology for the treatment of certain brain cancers and rare neurological diseases.
Contact Natalie Missakian at news@newhavenbiz.com
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