Sangamo Therapeutics Inc (NASDAQ: SGMO) is climbing this morning with gains of more than 12% early on. While the company hasn’t issued any news today, it looks like a post-holiday data release that took place late last week is the catalyst driving the stock. Here’s what’s going on:
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SGMO Stock Rises On Data Release In PFE Collaboration
Sangamo Therapeutics and Pfizer, Inc. (NYSE: PFE) have been working on an investigational gene therapy known as SB-525. On Friday of last week, following the Fourth of July holiday, the companies issued a press release, announcing updated data.
Considering the timing of the release, it makes sense that a number of investors didn’t see the news until this morning. So, it seems as though today’s gains are simply following on due to the news that was released last week.
In the release, SGMO and PFE provided updated results from the Phase 1/2 Alta study. In the study, the companies are investigating SB-525 gene therapy as a potential option for severe hemophilia A.
According to the data, the treatment is proving to be generally well tolerated. Moreover, the data suggest a dose-dependent increase in Factor VIII activity levels. In fact, the company said that the first two patients treated rapidly achieved normal levels of FVIII activity. SGMO and PFE also said that there were no reported bleeding events and that the response continues to be durable at 24 weeks.
The companies went on to explain that two more patients were recently treated. These patients are demonstrating FVIII activity kinetics that seem to be consistent with the first two patients.
The data released Friday follows data from 10 patients in smaller-dose cohorts being presented. Accross all cohorts, patients realized a dose-dependent increase in FVIII levels and a dose-dependent reduction in the use of FVIII replacement therapy.
Moreover, the results seem to suggest a strong safety and tolerability profile, coupled with strong durability. In fact, the firt two patients treated with in the lowest dose cohort showed durable responses through weeks 52 and 32.
In a statement, Adrian Woolfson, M.D., Ph.D., Executive Vise President of R&D at SGMO, had the following to offer:
The initial results of the Alta study presented at ISTH demonstrate that SB-525 has the potential to be a predictable and reliable treatment that may bring clinical benefit to patients with hemophilia A.
The results show that SB-525 is well tolerated, that Factor VIII levels in the first two patients in the 3e13 vg/kg cohort reached normal, sustained levels as measured using a chromogenic assay, and that variability of Factor VIII activity is low, both within each patient and within each dose cohort. We look forward to continuing to follow these patients to further understand the durability of response to SB-525 gene therapy and to working with Pfizer to potentially advance a registrational study.
The above statement was followed up by Seng Cheng, Senior Vice President and Chief Scientific Officer at the Rare Disease Research Unit at PFE. Here’s what he had to say:
We are encouraged by the initial clinical data suggesting safety, tolerability, and efficacy of SB-525 and are beginning preparations, including manufacturing, to potentially advance into a registrational study. We are also encouraged by our interactions with regulators and by the FDA’s recent RMAT designation.
If FVIII levels are sustained, and patients continue to have no bleeding episodes and remain off factor replacement therapy, we believe that this gene therapy may potentially represent a transformative treatment paradigm for severe hemophilia A.
This Is Significant News
For Sangamo Therapeutics, the news released Friday is incredibly positive. First and foremost, a collaboration with Pfizer is a big win. The company is a global pharmaceutical giant that knows the ins and outs of bringing a drug through development and to approval. The positive data release further validates the work that the two companies are doing.
It’s also worth mentioning that the Hemaphilia market is a massive one. In fact, experts at Grand View Research expect the market to grow to be worth nearly $17 billion annually by the year 2026.
Considering that SGMO has a market cap of just $1.45 billion, even accessing a small portion of this market could prove to be a substantial value add for the company.
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