SAN DIEGO, Aug. 23, 2018 /PRNewswire/ -- Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, today announced that it has raised $150 million in a Series C financing. This round, as with previous rounds, was led by Hiroshi Mikitani, CEO of Rakuten Inc., a leading global innovation company in e-commerce, communications and fintech, and chairman of Rakuten Aspyrian. The Series C brings the company's total fundraising to approximately $238 million in equity.
"Developing treatments for cancer patients is a mission I began to pursue years ago and is the motivation behind my investment in Rakuten Aspyrian," said Mr. Mikitani, chairman of Rakuten Aspyrian. "Rakuten Aspyrian's approach of combining a biologic with laser-activation to target tumors holds the potential to offer an alternative treatment option to help cancer patients fight their disease. Our company has advanced rapidly in developing this technology and is now poised to start Phase 3 studies. My vision is to develop and commercialize a strong pipeline of treatments based on Photoimmunotherapy to create a new platform for cancer treatments."
"With this financing we will advance our lead compound ASP-1929, a treatment that received Fast Track designation by the FDA, into a global, pivotal Phase 3 trial to evaluate the efficacy and safety to treat recurrent head and neck squamous cell carcinomas," said Miguel Garcia-Guzman, Ph.D., president and CEO of Rakuten Aspyrian. "I congratulate the Rakuten Aspyrian team for their excellence and commitment to rapidly advancing ASP-1929 into a Phase 3 study by the end of this year."
The financing will also support manufacturing scale-up for the commercialization of ASP-1929 and corporate growth including the initial buildup of commercial operations to support the launch of ASP-1929 in the United States, Japan and Europe.
In addition, this funding will support the expansion of R&D efforts to evaluate the safety and efficacy of ASP-1929 and other therapies in a range of cancer types, including the initiation of two additional Phase 2 proof of concept studies of ASP-1929 in other cancer types before the end of 2018.
"We are honored to be working with Hiroshi Mikitani, a visionary leader who supports our long-term corporate mission of conquering cancer," said Dr. Garcia-Guzman. "With this influx of capital, we are well positioned to advance our company to the next phase towards developing a fully integrated R&D and commercial biopharmaceutical corporation advancing first-in-class precision tumor-targeted therapies."
ASP-1929, a conjugate of cetuximab and IRDye 700DX®, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, pancreas and other cancers. This first-in-class therapy targets cancer cells, after which it is locally activated with red light using a proprietary investigational laser and fiber optics. The local activation of the tumor-selective conjugate targets the tumor but not surrounding normal tissues and structures.
Interim results of the Phase 1/2 trial in patients with head and neck squamous cell carcinoma showed a clinically meaningful improvement in the overall response rate, and potential improvements in progression free survival and overall survival when compared to historical data for the standard of care treatments currently available to this patient population. Top line results of the Phase 1/2 trial are expected later this year.
ASP-1929 is an investigational compound that is not approved for any use in any country.
About Rakuten Aspyrian, Inc.
Rakuten Aspyrian, Inc. is a privately funded clinical stage biotechnology company developing tumor-targeted precision therapies based on its proprietary platform Photoimmunotherapy. Photoimmunotherapy combines key advantages of antibody mediated targeting of the cancer cells to achieve high tumor specificity, together with laser-activation of a biophysical mechanism that induces rapid cancer cell death with precision. Treatments with the Photoimmunotherapy platform lead to targeted and rapid tumor cell death by necrosis, with minimal effects on normal tissue. Rakuten Aspyrian is studying Photoimmunotherapy for use as a monotherapy and in combination with other drugs.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Rakuten Aspyrian actual results, plans and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These "forward-looking" statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to Rakuten Aspyrian's products such as ASP-1929. Such approvals or success may not be obtained or achieved on a timely basis or at all. Forward-looking statements include statements relating to the potential benefits, safety and efficacy of ASP-1929, and the status of current regulatory filings. These statements may be identified by words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "intends," "potential," "may," "suggest, "plan," "strategy," "should," "will" and all other similar expressions, and are based on our current beliefs. In addition, this press release includes qualifying terms such as "significant," "remarkable," "extraordinary," etc. that describe opinions on clinical data. Ongoing clinical studies involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in regulatory approval or commercialization of ASP-1929 which may be impacted by, among other things, problems with the manufacturing process for ASP-1929, the occurrence of adverse safety events, failure to demonstrate therapeutic benefit, and the other risks and uncertainties, both reasonable and unreasonable. We undertake no obligation to publicly update this or any other forward-looking statement, whether because of new information, future developments or events, changes in assumptions, changes in the factors affecting forward-looking statements or otherwise except to the extent required by applicable laws. If Rakuten Aspyrian updates one or more forward-looking statement(s), no inference should be drawn that we will make additional updates with respect to that, those or other forward-looking statements.