New Haven biotech Arvinas Inc. said it has begun its first human trial on a groundbreaking drug that aims to fight prostate cancer by inducing the body to attack and remove a protein linked to the disease.
Arvinas announced Monday that it has begun dosing patients in a Phase 1 study of its drug ARV-110 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The so-called targeted protein degrader, part of an emerging field in the pharmaceutical industry, is believed to be the first of its kind to enter the clinic, according to CEO John Houston.
“We believe this is the first time a patient has been treated with this new class of targeted protein degraders and we look forward to furthering our understanding of ARV-110 as a potential treatment for men with mCRPC and the broader field of protein degradation,” Houston said in a statement.
The drug harnesses the body’s natural protein disposal system to go after a type of protein called an androgen receptor, which plays a role in the progression of prostate cancer, according to Houston.
The compound uses technology developed by Yale molecular scientist Craig Crews in which small molecules called PROTACs (short for proteolysis-targeting chimeras) induce the body to remove the troublesome proteins. Crews founded Arvinas in 2013 to commercialize the platform and is the company’s chief scientific advisor.
The clinical trial will include approximately 28-36 patients with progressive mCRPC, which is resistant to standard hormone therapy. It will chiefly be testing the drug’s safety and tolerability, as well as how it is absorbed, distributed, metabolized and excreted by the body.
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In a separate announcement Tuesday morning, Arvinas reported wider fourth-quarter and 2018 losses compared to a year ago, but the company still has plenty of cash from its initial public offering last September.
Arvinas attributed the higher losses to the costs of propelling ARV-110 and another drug that targets breast cancer toward clinical trials, as well as an expansion of infrastructure to prepare for becoming a publicly-traded company last year.
For the three-months ended Dec. 31, 2018, Arvinas posted a net loss of $16.1 million, compared to $4.7 million in the year-ago period.
For the year, Arvinas reported a net loss of $41.5 million, compared to $24 million in 2017.
R&D expenses rose to $14.6 million for the quarter, up from $6.7 million in the year-ago period, and climbed to $45.2 million for the year, up from $28.8 million in 2017. General and administrative expenses rose to $5.8 million for the quarter, compared to $1.2 million a year ago, and reached $12.9 million for the year, up from $3.5 million in 2017.
The company brought in $3.4 million in revenue for the quarter, up slightly from $2.6 million in the year-ago period. For the year, Arvinas generated $14.3 million in revenue, compared to $7.6 million in 2017. The company attributed the increase to its licensing deal with pharma giant Pfizer and the expansion of a 2017 deal with Genentech.
Arvinas ended the year with $187.8 million in cash, cash equivalents and marketable securities, compared to $39.2 million at the end of 2017. The increase follows the company’s initial public offering last September, which raised $114.6 million.
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Alexion Pharmaceuticals Inc. will pay $50 million up front — and potentially hundreds of millions more based on milestones — to a pair of small European biotechs as part of two separate deals to co-develop rare disease drugs.
Alexion, which has a major research presence in the Elm City, announced the partnerships with Sweden’s Affibody AB and Denmark-based Zealand Pharma last week.
Alexion said it will pay $25 million up front for the rights to Affibody’s anti-FcRn drug to treat rare autoimmune diseases. The company has also committed to additional milestone-based payments of up to $625 million and tiered low double-digit royalty payments.
Under the deal, expected to close this quarter, Alexion will lead joint clinical development of Affibody’s ABY-039, which is in early-stage clinical trials.
Meanwhile as part of the Zealand Pharma deal, Alexion will acquire global rights to up to four peptide therapies it will co-develop with the Copenhagen-based company. Zealand will lead the joint discovery and research efforts through the preclinical stage, and Alexion will take over when the drugs reach the clinic.
Alexion will pay Zealand Pharma $25 million up front for the first drug target along with a $15 million equity investment in the company, and hand over up to $610 million more based on development and sales-related milestones. Alexion also has the option to pay $15 million for each of the three additional drug targets and has agreed to smaller milestone payments and royalties compared to the first target.
Like Alexion, Zealand develops medicines targeting the complement system, a part of the immune system that is over-activated in people with certain diseases. Zealand’s therapies focus on drugs that can be self-injected subcutaneously (under the skin).
The deals are Alexion’s latest effort to diversify its drug pipeline and reduce its dependence on its blockbuster blood-disorder drug Soliris.
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New Haven’s BioXcel Therapeutics Inc. is seeking regulatory approval to expand to the U.K. a study of its lead immuno-oncology drug, part of a plan to grow its drug program globally.
The two-year-old company said Monday it has filed a Clinical Trial Application (CTA) with U.K. health authorities for BXCL701, which is in early-stage studies in the U.S. for the treatment of a rare form of prostate cancer known as tNEPC. The clinical trial is examining BXCL701, an innate-immune activator, in combination with Merck’s immuno-therapy drug Keytruda.
CEO Vihmal Mehta called the filing the “first milestone in the expansion of our footprint into major markets outside the U.S.” The company uses artificial intelligence to discover new drugs and repurpose older ones for new therapeutic uses.
Contact Natalie Missakian at news@newhavenbiz.com
