Emerging Drug Developer: Altor BioScience

Altor BioScience readies itself for Phase II

To understand Altor BioScience's niche in the cancer field, you need to take a look at its lead program: ALT-801.

Researchers took a cancer therapy, IL-2, and genetically fused it to a soluble T-cell receptor (TCR) which guides it to a p53 tumor-associated antigen, combining an attack on the tumor by the therapeutic as well as the stimulated immune system.

"That's our platform; using soluble T cell receptors against cancer and virally-infected cells," says Peter Rhode, Ph.D., vice president of research and development at the Miramar, FL-based developer. "We've been working on that since the mid-90s." And Altor believes that approach can work against cancer, viral infections and autoimmune diseases.

"You have these targets that T cells recognize as peptide antigens derived from proteins inside the cell," explains Rhode, "so that T cells through their T cell receptors can recognize the presentation of peptide antigens on the cell surface by MHC/HLA complexes. It opens up a new level of targeting that antibodies can't address."

"IL-2 is an approved drug for melanoma and renal cell carcinoma," he adds. But it has a bad toxicity profile, with patients being given doses three times a day for a week and then take a week off before undergoing a fresh round of treatment. Altor believes its approach will let doctors reduce doing to once a day and lower the dosage regimen to provide patients with the beneficial aspects of IL-2 without the toxicity. And that can lead to durable responses, essentially curing a percentage--perhaps five to 10 percent--of patients.

Altor's lead therapy is in an early-stage, dose-escalating clinical trial that has treated nine out of 10 patients in an expanded look at maximum tolerated dose for a total of 26 treated patients. That study should be wrapped in two months with data available in three months.

"By the end of 2009, we're planning to initiate a Phase II trial in metastatic melanoma and renal cell carcinoma," adds Rhode. "We're also looking at additional Phase II trials" as researchers explore therapeutic potential among a range of targets including head and neck cancer and also prostate cancer.

Altor was created as a spin-off from Sunol, which in turn had spun off from Baxter with both antibody technology as well as the TCR technology now in the clinic. The investors later decided to give Altor the TCR technology and kept the antibody work in Sunol, which was later sold off in pieces.

Altor has raised $19.5 million through three rounds of financing, including a still-open Series C. But the developer has also been effective in winning $5.6 million in grants from Small Business Innovation Research awards, a Bill & Melinda Gates Foundation grant and more.

"We're actively applying for additional grant awards," says Dr. Dean Taylor, the head of business development. "There's a total opportunity for us to pull in another $10 million in grants and SBIR funding. Our plan is to hold off doing a major round of funding so we can still be eligible for SBIR money."

If that funding strategy works as planned, Altor will be in a position to add to the 21 staffers on the payroll as it expands its clinical trials and research work. And Taylor is also working on developing new partnerships for Altor.

"We are looking for companies that might be interested in partnering ALT-801 and some of our other products behind it in the pipeline," says Taylor, who joined Altor in March. A pact could extend to other p53 targeting molecules and "if a large pharma is interested in acquiring the entire platform, we would consider that as well."

Altor inherited rights to a Sunol antibody product outlicensed to Biosynexus to prevent and treat staphylococcal infections. Altor stands to earn royalties if the late-stage therapy is approved. Two other cancer therapies, ALT-802 (a p53 TCR/IgG fusion) and ALT-803 (a p53 TCR/IL-15 fusion), are in the preclinical stage.   

ALT-836 is in a phase II placebo-control trial for acute lung injury/acute respiratory distress syndrome. Altor had previously developed this antibody at Sunol and licensed it back from Genentech last year.

"It would be nice if we had a deal sometime this year," adds Taylor. But we wouldn't have to have it this year. We'd like to have a partnership for the p53 platform or some of our other programs in the next year or year and a half."

Emerging Drug Developer: Altor BioScience
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