In perhaps the biggest U.S. biotech launch ever, Seattle’s Fred Hutchinson Cancer Research Center (Fred Hutch), New York’s Memorial Sloan-Kettering Cancer Center (MSKCC) and Seattle Children’s Research Institute joined forces to establish Juno Therapeutics Inc. Arch Venture Partners and the Alaska Permanent Fund led the initial round – a whopping $120 million – through a partnership managed by Crestline Investors. The company, which already has multiple candidates in the clinic, will seek to develop a broad pipeline of cancer immunotherapeutics using technology that reprograms T cells to recognize cancer cells for a precision immunologic attack.
The Series A pales in comparison to the $600 million provided in 2011 by the Russian government and investors in London-based private equity firm Celtic Pharma Holdings to launch Pro Bono Bio. However, it was by far the largest disclosed initial round for a biotech this year and even outpaced most of the industry’s initial public offerings, topped only by Portola Pharmaceuticals Inc. at $122.1 million, PTC Therapeutics Inc. at $144.48 million, Agios Pharmaceuticals Inc. at $120.6 million and Ophthotech Corp. at $192.28 million. (See BioWorld Today, Sept. 13, 2011, May 23, 2013, June 21, 2013, July 25, 2013, and Sept. 26, 2013.)
The amount “eliminates the need to go for the B and the C and the D rounds” so the company can go straight to deeper pockets in strategic partnerships and crossover investors, said Robert Nelsen, Arch co-founder and managing director and a Juno co-founder. “We wanted to make sure that we had enough money to go broadly, in multiple clinical trials and in multiple approaches simultaneously, and also to be able to choose the time that we partner or go public.”
The round is sufficient to fund more than a dozen Phase I studies in 2014 and to continue, when merited, into Phase II trials, Nelsen said.
He gave credit to co-founder Larry Corey, president and director of Fred Hutch, as the mastermind of Juno, which is named for the mythical Roman goddess and warrior. Corey connected the dots among compelling Phase I data generated by cancer researchers at Fred Hutch and partner institution Children’s before reaching out to colleagues at MSKCC with the idea of forming a company around the cancer immunotherapy technology.
Other co-founders include Hans Bishop, CEO, former executive vice president and chief operating officer of Dendreon Corp., and Richard Klausner, former director of the National Cancer Institute. Juno’s founding scientists are Phil Greenberg and Stanley Riddell from Fred Hutch; Renier Brentjens, Isabelle Riviere and Michel Sadelain from MSKCC; and Michael Jensen from Seattle Children’s.
Without disclosing details of the transaction, Nelsen said the company’s structure aligned incentives among investors as well as the participating institutions, with buy-in from scientists as well as university technology transfer organizations.
“The unifying principal is that all of the scientists involved saw the vision that coming together would increase the probability of potentially [developing] therapies that would have a major impact on cancer – not just in liquid tumors but in solid tumors, over time,” Nelsen told BioWorld Today. Considering the complexity of cell therapy, “what got all of us excited was the idea of making very effective therapies that were more like products than services,” Nelsen said.
The three institutions showed commitment to the company at a level Nelsen characterized as unprecedented. “In 27 years of doing university spinouts, I haven’t seen this high level of institutional commitment from multiple, potentially competing institutions,” he said.
Although cancer immunotherapy is a broad field, Juno’s approach is to harness the potency of memory T cells, redirecting them to targets expressed on or in cancer cells. Using synthetic receptors and/or augmented natural antigen receptors, Juno’s T cell reprogramming technologies are designed to enable the creation of an anti-tumor immune response built from a patient’s own immune system.
Juno plans to build on that foundation by developing two distinct and complementary platforms, known as chimeric antigen receptors (CAR) and T-cell receptors (TCR). The CAR technology will target cell surface antigens expressed on cancer cells. The high-affinity TCR technology can detect alterations in intracellular proteins present in tumor cells.
“That approach is distinct and different from immunological approaches that other companies are using in the broad field of cancer immunology,” Bishop pointed out.
The breadth and depth of the program – with multiple shots on goal emerging from multiple academic institutions – represent additional differentiators, according to the CEO. Treatments emerging from the technologies offer the potential to reduce longer-term toxicities associated with chemotherapeutics. Plus, each product candidate has the potential to treat a variety of high-risk cancers.
If the approach succeeds, Juno could transform cancer therapy by inducing long-term remissions and reducing or altogether eliminating the need for surgery, radiation and chemotherapy.
Early findings in are stunning. A Phase I study applying the technology to 17 patients with acute lymphoblastic leukemia showed a complete response rate of 88 percent.
“In my career, I’ve certainly never seen such compelling early data in these very, very heavily pretreated, sick patients who go into these early trials,” Bishop told BioWorld Today, suggesting the potential for curative products to emerge from Juno’s pipeline.
The premise is so compelling that, according to Nelsen, additional money is sitting on the sidelines from existing and new investors, giving the company flexibility to extend its initial round, if needed.
“The mantra is to follow the data,” Nelsen said. “When you start looking at it, you’re compelled to join.”
Juno is based in Seattle, initially with some 20 employees, but the company expects to ramp up quickly. Long term, Juno plans to move directly to commercialization, at least in the U.S., with partnering as an optional strategy.
“It’s very important for us to stay an independent company that controls our destiny,” Bishop said.
In other financings news:
• Celldex Therapeutics Inc., of Hampton, N.J., said it is offering 6.5 million shares of its common stock in a proposed underwritten public offering. No pricing has yet been set and Jefferies LLC and Leerink Swann LLC are acting as the joint book-running managers and underwriters for the proposed offering.
• Clovis Oncology Inc., of Boulder, Colo., said it priced an underwritten public offering of 2 million shares of its common stock at a price to the public of $57.50 per share. All of the shares are being sold by certain existing stockholders who acquired the shares in connection with the company’s acquisition of EOS SpA. The selling stockholders have granted J.P. Morgan Securities a 30-day option to purchase up to an additional 300,000 shares of common stock from the selling stockholders to cover over-allotments, if any. The company said it will not receive any of the proceeds, and the total number of shares of its outstanding common stock will not change as a result of the offering.
• PaxVax Inc., of Menlo Park, Calif., said it completed a $22 million Series B financing round. The financing was led by Ignition Growth and joined by another existing investor, Ignition Ventures as well as new investors including Blue Haven Initiative. The company will use the new capital to continue to fund a recently initiated Phase III program for its single-dose oral cholera vaccine candidate, PXVX0200 (also known as CVD 103-HgR). Approximately 3,000 participants will be enrolled in this pivotal international program, which is comprised of cholera challenge, safety and immunogenicity studies. The studies are being conducted in the U.S., Australia and Canada for use of PXVX0200 as a traveler’s vaccine.