Epizyme hits the biotech IPO queue with rapid R&D plan for cancer drugs

Epizyme wants to go public as the company plans on taking the fast lane to develop small molecules for genetically defined cancers. The Cambridge, MA-based biotech company has proposed to raise up to $69 million in a public debut, with plans to spend proceeds from the deal on advancing clinical trials for its top candidates against cancer-related epigenetic enzymes.

Epizyme (a 2011 Fierce 15 company) comes to the IPO table amid a renaissance in cancer drug development. Rather than taking 10 years or more to develop a drug, companies have sped through development with oncology programs based on early clinical findings. For instance, according to Epizyme's SEC filing, the FDA approved Zelboraf from Roche ($RHHBY)/Genentech and Pfizer's ($PFE) Xalkori within 5 years of the start of Phase I clinical trials for those anti-cancer drugs.

Clearly, Epizyme wishes for a speedy development schedule for its two lead candidates known as EPZ-5676, which is covered in a partnership with Celgene ($CELG), and EPZ-6438, which was discovered through a collaboration with Eisai. Only EPZ-5676, which targets the DOT1L histone methyltransferase enzyme, has begun clinical development. In September, Epizyme launched a Phase I study of the candidate in patients with a lethal subtype of acute blood cancer known as mixed lineage leukemia (MLL), for which there are no approved drugs. However, the company says it has dosed just three patients in the escalation phase of the Phase I study, and the company has yet to report any human evidence that it's got a breakthrough on its hands.

"If we see early evidence of a therapeutic effect in either of these trials, we plan to meet with regulatory authorities to discuss the possibility of an expedited clinical development and regulatory pathway for the applicable program," the company says in its filing for the IPO.

The biotech has partnered with Abbott ($ABT) on a companion diagnostic for its lead candidate and tapped Roche for a test to find patients suitable for its second candidate EPZ-6438. The agreement with Abbott was announced today.

Epizyme, founded in 2007, wrapped up calendar 2012 with cash and equivalents of $98 million. It's raised $61.9 million through three rounds of venture financing, and its largest institutional shareholders include New Enterprise Associates (25.1%), Kleiner, Perkins, Caufield & Byers (20.1%), Bay City Capital (15.5%), Celgene (14.5%) and MPM Capital (12.8%). The company has also raised about $120 million in non-dilutive partnership money form Celgene, Eisai and GlaxoSmithKline ($GSK).

It's been busy for initial public offerings in biotech in 2013, during which at least 5 drug developers have wrapped up the deals and several more are in the running, putting the deal flow for 2013 on pace to outmatch the 10 completed maiden offerings of biotech companies last year. Yet many life sciences outfits have failed to fetch their asking prices in the deals, settling for lower share prices to complete their IPOs.

- here's the S-1

Special Reports: Epizyme - 2011 Fierce 15 | Top 10 biotech IPOs of 2012