Galera’s leading drug candidate is Avasopasem Manganese (GC4419), which is in Phase 3 testing to prove its impact on mucous infections that plague some head and neck cancer radiology patients. The drug converts irritating superoxides to harmless hydrogen peroxide. The Food and Drug Administration has given it Fast Track and Breakthrough Therapy designations to speed it to market.
Last fall, Galera raised $70 million in equity, plus $80 million in cash commitments to be repaid from future sales, from a multinational coalition of biotech investors led by Clarus Ventures, Cambridge, Mass.
At the time, CEO Mel Sorensen said the company would use its money for clinical trials and sales and marketing staff. Sorensen, a GlaxoSmithKline veteran, previously headed Ascenta Therapeutics, which he sold to Sanofi for $398 million in 2010.
“In general, if you have a treatment that’s working, it’s best to take it as far as you can on your own" without selling to big drug companies, Sorensen told The Inquirer in September 2018. “We want to get this on the U.S. market as soon as possible.”
In October, gene therapy developer Cabaletta Bio Inc. of Philadelphia netted $66 million after selling its first shares (CABA) on the Nasdaq at $11 each. The stock closed at its initial price Thursday.
Cabaletta is building and testing engineered T-cell genetic therapies targeting patients with B-cell medicated autoimmune diseases, targeting mutant cells that harm a patient’s ability to fight diseases, while sparing healthy ones.
The treatment is based on the Chimeric Antigen Receptor (CAR) T-cell engineering technology licensed by the University of Pennsylvania. Cabaletta’s founders include Penn professors Michael Milone, Aimee Payne, and Steve Nichtberger, who serves as CEO.
The company had raised $88 million over the last two years from private investors, using some proceeds to speed its Investigational New Drug applications to the FDA, and to start clinical trials focused on patients with mucosal pemphigus vulgaris (mPV), a rare condition in which painful blisters grow on patients’ mucous membranes.
Cabaletta’s founders hope the technology, if successful against mPV, might contribute to treatments against other autoimmune diseases such as MuSK-positive myasthenia gravis and mucocutaneous PV. Hemophilia A is also a target.
Nichtberger, who has led the Life Sciences and Management capstone course on health-care company formation at the Wharton School, previously ran the human tissue-growing firm Tengion, which built a Norristown-area production facility that was idled after clinical trials failed. The site is now the home of research and manufacturing for Tmunity, the gene therapy developer started by Penn professor Carl June and his partners.