SMC Bio Looks to Heal Bones With Carbohydrates, Not Stem Cells
The secret to regenerative medicine doesn’t really lie in a lab dish with stem cells, or some engineered protein that stimulates tissue growth, at least to the folks at one Bay Area biotech startup. The big regenerative medicine opportunity at SMC Biotechnology comes from an unlikely source—carbohydrates from pig intestines.
SMC Bio, a little Redwood City company started in 2010 with technology from Singapore’s A*STAR research center, is betting that these certain carbohydrates, added to surgical sponge, might help bones heal better after spine surgery, or after a traumatic accident. On a bootstrap budget of less than $1 million, and with a network of former Genentech and Scios/Johnson & Johnson executives doing the planning, SMC Bio believes it has gathered enough data from animal studies to give its drug/device combo idea a shot in clinical trials being prepped for 2014.
SMC traces its origins to technology from the labs of Simon Cool and Victor Nurcombe at A*STAR. The idea in a nutshell is that certain variations of heparan sulfate—long chained sugar molecules—can help promote bone healing by binding with a protein called bone morphogenic protein-2 (BMP-2). The complex sugar molecules of interest are fished out of the mucosal lining of pig intestines, just like the well-known blood-thinning agent heparin.
Scientists have long known that BMP-2 plays an important role in healing after an injury to the bones. The traditional approach in biotech would be to make a genetically engineered copy of that protein, put it in a vial, and make it an injectable drug, says SMC co-founder and CEO Michael Crockett. But such an injection runs the risk of putting too much of a certain protein in the body, and causing side effects from runaway growth, like cancer, or development of bone tissue in muscle. Medical device giant Medtronic (NYSE: MDT) has such a protein-based product called Infuse that has stirred controversy as critics have questioned its risks and overuse, as you can see from this April story from the Milwaukee Journal Sentinel.
Rather than go down the road of making another engineered protein, SMC believes the carbohydrates are often what’s lacking at the injured site, which is already teeming with naturally produced growth factors like BMP-2. By adding its carbohydrates to the site of injury, SMC is looking to enhance the bone healing signals that are already coming from the interaction between BMP-2 and adult stem cells.
The product profile here is pretty clear. SMC’s job is to isolate the certain heparan-sulfate variants it wants from the pig intestines, and put them on a collagen sponge that a doctor will place at a wounded site during back surgery, or during an orthopedic procedure to repair broken bones. By doing it this way, SMC has gotten its technology classified as a medical device rather than as a drug for FDA regulatory purposes, which should shave a year of time and cost off its development plan, Crockett says.
“When your financing doesn’t come from venture capital or private equity, you have to figure out other ways to grow value in the company,” he says.
Crockett, a former Genentech and Scios manager, first got exposed to the idea that became SMC back in 2009 when he and his wife moved to Singapore, as part of her work for Genentech at a manufacturing facility there. He did some consulting there for the technology licensing arm of A*STAR, and became familiar with the research of Cool and Nurcombe. When he moved back to California in 2010, A*STAR and Crockett hashed out a deal that provided an exclusive license to a platform technology so he could start the company.
The data thus far to support SMC’s idea is still quite preliminary. The company has completed a study in rabbits that suggests it can spark a similar bone healing effect with its SMC-103 product candidate as scientists saw with a BMP-2 injection. Rabbits are an important experimental model for bone healing, Crockett says, but SMC’s next step is to show it can confirm the results in weight-bearing bones from a higher species like a sheep.
If those results can be replicated, the manufacturing for SMC should be relatively straightforward, and much cheaper than it would be to make an engineered protein, Crockett says. The carbohydrates are also quite rugged molecules, meaning they can withstand extremes in temperature and acidity, unlike relatively fragile protein molecules that need to handled with care. The durability of the carbohydrates raise the possibility that they can be delivered in a variety of ways, beyond the original collagen sponge, Crockett says.
Over the past year, Crockett says SMC’s plans have come into much clearer focus, in terms of timelines, budgets, and the regulatory requirements it will need to meet to advance this product candidate. He was brimming with can-do attitude when we spoke earlier this week, confident that he has found the people with money and expertise that will be needed to get SMC’s first clinical trials underway in 2014.
And while a million things can go wrong in any trial, he’s betting that SMC has hit upon a lower-risk approach to regenerative medicine than some of the better-known approaches with stem cells or engineered proteins.
“Instead of injecting growth factors or stem cells in the body, we’re using what’s already there,” Crockett says. “We’re just enhancing the body’s natural process, enhancing bone healing. We’re not accelerating the natural process, which can probably cause something harmful.”