(Page 2 of 2)
correct the mutations and restore the ability of the p53 to suppress tumors.
The most advanced PMV drug candidate, PC14586, targets a specific p53 mutation called Y220C, a misfolding of the protein that the company says is associated with 1 to 1.5 percent of all cancers. PMV says its drug is designed to occupy a crevice in the protein created by the mutation. Last month, the company applied for FDA permission to begin human tests of the drug. A Phase 1/2 study, which the company says has the potential to serve as a pivotal study, is expected to begin in the second half of this year. PMV is developing other small molecules that correct structural mutations to p53 to restore the function of the protein.
Though p53’s role in cancer has been documented, the protein has proven to be an elusive drug target. Other companies in the hunt for a p53 therapy include Aileron Therapeutics (NASDAQ: ALRN), Actavalon, Aprea Therapeutics (NASDAQ: APRE), CDG Therapeutics, Boehringer Ingelheim, Daiichi Sankyo, Novartis (NYSE: NVS, and Roche.
PMV was co-founded by Arnold Levine, an emeritus professor at The Simons Center for Systems Biology at the Institute for Advanced Study in Princeton, NJ. The molecular biologist and colleagues at Princeton University are credited with discovering p53 in 1979. The company’s largest shareholders are InterWest Partners with a 20.5 percent stake and OrbiMed, which owns 20.4 percent. PMV has set a preliminary $100 million goal for its IPO, and has applied for a Nasdaq listing under the stock symbol “PMVP.”
—Prelude Therapeutics is looking to the public markets to finance clinical development of its pipeline of targeted, small molecule drugs for cancer. The Wilmington, DE-based biotech has three programs in early clinical development and three more that it plans to advance to human testing next year.
The two most advanced Prelude drug candidates are designed to block protein arginine methyltransferase 5 (PRMT5), a protein overexpressed in a number of different types of cancer. In its IPO filing, the company says it has encouraging early data from a Phase 1 test of PRT543, a small molecule being evaluated in solid tumors and blood cancers in patients who don’t respond to or can’t tolerate currently available therapies. A second compound, PRT811, is another PRMT5 inhibitor that the company has optimized for the brain. That drug is currently in Phase 1 testing in solid tumors, including the brain cancer glioblastoma.
Prelude’s third clinical-stage candidate, PRT1419, is designed to block the protein MCL1, which the company believes could have applications addressing blood cancers. Upregulation of this protein has been noted as a way that cancers acquire resistance to certain cancer drugs, including the AbbVie (NYSE: ABBV) blood cancer drug venetoclax (Venclexta). Prelude says a Phase 1 study later this year testing its drug in myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkin lymphoma, and multiple myeloma.
Since its launch in 2016, Prelude says it has raised $94.6 million. Prelude’s largest shareholders are OrbiMed and Baker Brothers, each holding a 37.1 percent stake, according to the filing. As of June 30, the company reported it had $29.7 million in cash. Prelude has set a $100 million goal for its IPO. It says it plans to use the IPO proceeds to continue early clinical development of its two lead compounds and to start a Phase 1 study testing PRT1419. The company will also use the cash to advance its preclinical compounds toward clinical trials. Prelude has applied for a listing on the Nasdaq under the stock symbol “PRLD.”
—Graybug Vision, a clinical-stage developer of eye disease drugs, set an $86.5 million target for its IPO. In its filing, the Redwood City, CA-based biotech says its technology releases a therapeutic in the eye at a controlled rate for up to 12 months. The company’s lead drug candidate, GB-102, is an injectable formulation of sunitinib (Sutent), a Pfizer cancer drug. Graybug is developing the drug as a once every six months treatment for the wet form of age-related macular degeneration (AMD), as well as for diabetic macular edema.
In a Phase 1/2a clinical trial enrolling wet AMD patients, Graybug says the drug was well tolerated. In about 88 percent of the patients, the drug showed evidence of controlling the disease for at least six months. A dose-ranging Phase 2b study is currently underway; preliminary data are expected in the first half of next year. Graybug says it will use the IPO proceeds to fund that study and to start a separate Phase 2b clinical trial in diabetic macular edema. The company says it will set aside some cash to start a pivotal study testing its lead drug candidate in wet AMD, and to start clinical testing of GB-104, a potential treatment for glaucoma.
Since incorporating in 2011, Graybug says it has raised about $134 million. The company’s largest shareholders are Deerfield and OrbiMed, holding 25.7 percent and 24.9 percent respectively, according to the filing. Graybug has applied for a Nasdaq listing under the stock symbol “GRAY.”
—Pulmonx, a commercial-stage medical technology, filed for an IPO to support sales and marketing of its product for severe emphysema patients. The Redwood City, CA-based company’s Zephyr Endobronchial Valve was approved by the FDA in 2018. The Pulmonx valve does not require surgery; it was designed for placement in a patient via a delivery catheter that the company also sells. The Zephyr is currently available in North America, Europe, and Asia. In 2019, Pulmonx reported $32.6 million in revenue, a 62.9 percent increase over the prior year.
Pulmonx’s IPO filing is its second attempt at a public offering this year. The company initially filed to go public in February, but withdrew those plans in May. In the paperwork filed late last week, Pulmonx set $86.2 million target for its IPO. The company has applied for a Nasdaq listing under the stock symbol “LUNG.”
|Want more Xconomy content? Subscribe today for free newsletters, event and webinar alerts, whitepapers, podcasts, and more.|