With partner Bristol-Myers Squibb Co. handling all costs for lead antibody ALD518 in autoimmune disease, Alder BioPharmaceuticals Inc. can apply the $38 million it just raised in Series D financing to its internal pipeline.
Randall Schatzman, president and CEO of Alder, said that when he approached his board about doing the Series D round, the Bothell, Wash.-based biotech's bank account was already "quite flush with cash."
Even though it's been more than four years since Alder's $40 million Series C financing, the biotech got $85 million up front from BMS in 2009 as part of a billion-dollar deal for autoimmune disease rights to ALD518. (See BioWorld Today, Jan. 14, 2008, and Nov. 11, 2009.)
Still, it's "best to go out and raise money when you have money," Schatzman said.
And beyond that, Alder's scientists had made progress not only in advancing ALD518 for cancer-related complications, where Alder hung on to rights, but also in bringing along new antibodies to new targets. "It was excitement about those targets" that drove the financing discussions, Schatzman told BioWorld Today.
New investor Novo Ventures led the Series D round, which included participation by existing investors Sevin Rosen Funds, Ventures West, WRF Capital, H.I.G. Ventures, Delphi Ventures and TPG Biotech.
Proceeds will support a variety of Alder's internal clinical programs, all with antibody candidates based on its better-faster-cheaper yeast-based manufacturing system.
While BMS advances ALD518 through Phase IIb for rheumatoid arthritis, Alder is conducting Phase II trials with the IL-6-targeted antibody in acute graft-vs.-host disease (GvHD) and oral mucositis.
GvHD, in which immune cells attack donated tissue, occurs in almost half of blood cancer patients undergoing bone marrow transplants, while oral mucositis increases mortality in patients with head and neck cancers because doctors must often stop chemotherapy treatment until the painful wounds heal.
ALD518 may be applicable for other cancer-related complications, too. A Phase II trial in lung cancer showed the drug improved cancer-related anemia and cachexia. The straightforward regulatory paths for GvHD and mucositis prompted Alder to prioritize those two programs, but Schatzman said the biotech is in discussions with the FDA regarding the best way to move the other programs forward as well.
Behind ALD518, Alder is advancing ALD403 against calcitonin gene-related peptide (CGRP) for migraine. Small-molecule programs at Boehringer Ingelheim GmbH and Merck & Co. Inc. validated the target, but ran into bioavailability and side effect issues that Alder's antibody aims to avoid.
The biotech said it's seen good preclinical data and plans to move ALD403 into the clinic this month.
Also in Alder's pipeline is ALD306, an antibody targeting PCSK9 for cardiovascular dyslipidemias. It's a popular target Amgen Inc. and Regeneron Pharmaceuticals Inc. have similar programs but Schatzman said Alder is in the process of narrowing down its lead candidate and will make sure its antibody is differentiated from the competition.
Migraine and cardiovascular disease are attractive to Alder because they're areas in which antibodies haven't played a role in the past and which can't support the high prices antibodies claim in cancer and autoimmune disease. Hence Alder's scalable, low-cost approach to making full-length antibodies could provide an advantage.
Such a platform also might provide an advantage in the rapidly evolving biosimilars space, which Schatzman said Alder is keeping a close eye on. But Mark Litton, Alder's chief business officer, noted that Alder's approach would actually be better for bio-betters, since biosimilars require the manufacturing to be the same as with the innovator product.
For now, Alder is staying focused on its internal pipeline. The Series D financing gives the biotech the flexibility to carry the products through Phase II, Schatzman said. After that, "hopefully we'll achieve another deal that looks a lot like the BMS deal," he said.
In other financings news:
RepliCel Life Sciences Inc., of Vancouver, British Columbia, said it closed a $754,001 private placement of 502,667 units priced at $1.50 apiece. Each unit consisted of one common share and one common share purchase warrant. An initial tranche of 66,304 units for gross proceeds of $99,456 closed Feb. 29, and a second tranche of 876,042 units for gross proceeds of $1.3 million closed March 29. The funds will be used for general working requirements. RepliCel is developing autologous cell transplantation technology to treat hair loss. Shares (OTCBB:REPCF) were down 2 cents, to close at $2.11 Thursday.