Vical in- licenses antifungal from Astellas

Preclinical data indicate faster fungicidal activity than marketed drugs and activity against azole-resistant pathogens

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SAN DIEGO—Vical Inc., which develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases based on its patented DNA-delivery technologies and other therapeutic approaches, has expanded its infectious disease portfolio with the addition of a novel antifungal, ASP2397, in-licensed from Tokyo-based Astellas Pharma Inc.
ASP2397 represents a potential new class of antifungal compounds to address invasive Aspergillus infections, which are major causes of morbidity and mortality in immunocompromised patients, including transplant recipients. It has a new mechanism of action and a low propensity for P450 drug-drug interactions, as well as faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens, according to preclinical studies thus far. As part of the agreement, Astellas, which is also Vical’s partner for the ASP0113 CMV (cytomegalovirus) vaccine program in transplant recipients, will become a shareholder in Vical.
“Vaccine development is a long journey,” notes Vijay B. Samant, Vical’s president and CEO. “The average time to develop a vaccine is 25 years, and there have only been 15 approved in the past 60 years. The advantage is that our technology will cut the time in half and bring public health vaccines to market where conventional technology is not applicable.”
Samant explains that Vical takes DNA that is coated and injects it into a muscle cell, where it makes the copy of the gene sequence. Thus, the Vical technology mimics vaccines and uses the body’s apparatus to make vaccines rapidly. He added that Astellas brings the capabilities of running large clinical trials and commercializing products to the agreement, while Vical offers the ability to manufacture vaccines for clinical trials and after approval, as well as the knowledge of regulatory affairs issues.
According to the license agreement, Astellas is giving Vical an exclusive worldwide license to develop and commercialize ASP2397. Astellas will receive Vical common stock equivalent to approximately 1 percent of outstanding shares and $250,000 in cash. Astellas will also be eligible for up to $100 million in aggregate milestone payments, the vast majority of which are commercial and sales milestones, and single-digit royalties on net sales.
“ASP2397 is an exciting opportunity that has arisen out of the relationship we have built with Astellas,” said Samant. “While advancing our CMV and HSV-2 programs remains the top priority at Vical, this novel candidate adds depth to our pipeline and strengthens Vical’s position as an infectious disease company.”
According to Naoki Okamura, corporate vice president and global head of business development at Astellas, “ASP2397 is a unique antifungal discovered at Astellas, and we are pleased to partner it with Vical, who we believe has the right capabilities to develop this compound and bring it to market.”
ASP2397 is a novel natural product discovered by Astellas from leaf litter fungus collected in a Malaysian national park. Most of the preclinical studies have been completed by Astellas, and Vical is targeting initiation of a Phase 1 trial in the first half of 2016.
Vical intends to develop ASP2397 as a front-line therapy for invasive aspergillosis and as part of a combination regimen for preemptive treatment of fungal infections. This could represent a meaningful commercial opportunity within the $4-billion global market for systemic antifungals.
“We hope to be riding a wave of anti-infective drugs,” Samant said. “Small companies like us can leverage the government-supported incentives and reimbursement while delivering efficacious drugs.”
In other recent news related to Astellas and early-stage pipeline activities, the Japanese Big Pharma announced in late April that it and Cambridge, Mass-based Potenza Therapeutics Inc.—a preclinical-stage biotechnology company focused on using the body’s own immune system to seek out, recognize and destroy tumors—had formed an exclusive research and development collaboration. The goal of the collaboration is to advance a portfolio consisting of programs with novel mechanisms of action targeting immune checkpoint pathways, co-stimulatory signals and regulatory T cells. The agreement includes an option that allows for the future acquisition of Potenza by Astellas on predetermined terms at the end of the collaboration period.
“We are at the beginning of a new era in cancer therapy. First-generation immuno-oncology therapeutics have demonstrated meaningful clinical benefit to patients with certain cancers. The new targets and pathways that Potenza is working on offer promise for continued expansion of immunotherapy treatment options,” said Dr. Daniel Hicklin, co-founder and CEO of Potenza. “We are excited to partner with Astellas to progress our programs in support of their strategy to become a global leader in oncology and next-generation therapeutics.”
Under the terms of the collaboration agreement, Potenza will lead drug discovery activities and deliver development candidates to Astellas. Astellas will be responsible for clinical development activities and commercialization. Specific financial terms will not be disclosed, but include an equity investment, option fee, research funding and potential future acquisition and milestone payments.

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