According to the World Health Organization (WHO), there were approximately 212 million new cases of malaria worldwide as recently as 2015, and the disease remains a major cause of death among children. Of the 429,000 malaria-related deaths that year, an estimated 303,000 were children five years of age or younger. Though it is preventable and curable, the problem is only worsening, as the mosquito-borne infectious disease is becoming more resistant to conventional drugs and treatments. For that reason, combination therapies are increasingly being relied upon to more effectively treat malaria.

The battle is looking brighter with the recent news that Immunovaccine Inc. (IMV:CA)(IMMVF) is expanding its collaboration with Leidos to develop preventative, peptide-based malaria vaccine candidates. Immunovaccine is quickly emerging as a leading name in the immunotherapy and cancer vaccine space of the life sciences sector, partnering with major biotech giants to unlock the potential of its innovative DepoVax™ platform to combat a variety of diseases. Its collaboration with Leidos, a FORTUNE 500 science and technology company, began last year and was supported by the U.S. Agency for International Development (USAID). Immunovaccine’s DepoVax-based platform was selected as one of the preferred formulations for the Leidos Malaria Vaccine Development Program (MVDP) after achieving several preclinical milestones in the initial collaboration.

“We are very encouraged by what Immunovaccine and Leidos have together accomplished through this collaboration thus far,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “The intrinsic mechanism of action that underscores DepoVax has continued to demonstrate the ability to create targeted immune responses across a broad range of difficult diseases. As the program continues to advance, we look forward to the potential for a follow-up clinical study that could leverage our DepoVax technology in the global quest to address malaria.”

The company said that research performed under the collaboration showed that DepoVax-formulated vaccine candidates composed of promising T and B cell targets demonstrated protection against the malaria parasite delivered by mosquito bites. With the expansion of the collaboration, Immunovaccine and Leidos will conduct additional research that focuses on identifying the most promising target-formulation combinations with the intention of advancing the research toward potential clinical stage development.

Immunovaccine’s DepoVax Platform Has Been Gaining Significant Traction

The expansion of the Leidos collaboration to fight malaria is just the latest of a number of significant milestones for Immunovaccine and its DepoVax platform. In early November, the company announced clearance by Health Canada to start recruiting patients for a Phase 2 clinical study of DPX-Survivac, a triple combination immunotherapy for Diffuse Large B-cell Lymphoma (DLBCL) that combines with Merck’s (MRK) pembrolizumab and low-dose cyclophosphamide in this patient population.

DPX-Survivac has also received a Fast-Track designation from the U.S. Food & Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

Immunovaccine currently has a Phase 2 investigator-sponsored Phase 2 trial to assess the safety and anti-tumor activity of DPX-Survivac, which is again in combination with Merck’s pembroluzimab, and low-dose cyclophosphamide as a new ovarian cancer treatment.

It has a separate Phase 1b trial in collaboration with Incyte (INCY) to evaluate DPX-Survivac as a triple combination therapy with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat, and low-dose oral cyclophosphamide in recurrent ovarian cancer patients.

Considering that Eli Lilly (LLY) recently announced an up to $1.8 billion investment with CureVac AG to collaborate on five mRNA cancer vaccines in development, it’s safe to assess that immunotherapy is poised to become a hot segment of the life sciences market going forward.

Immunovaccine is also collaborating with UConn Health to develop personalized cancer immunotherapies based on its DPX-NEO program. In July, the company announced that it successfully formulated 14 neoepitope cancer peptides into one single DepoVax formulation. In lab studies, Immunovaccine’s new combination cancer vaccine demonstrated the ability to generate specific killer T-cell responses against cancer peptides.

But the company is also working on a number of treatments beyond cancer, including DPX-RSV, which is a vaccine candidate for respiratory syncytial virus (RSV) that recently completed the Phase 1 clinical trial. RSV causes 64 million infections and 160,000 deaths annually, according to the WHO. It also has a long-standing collaboration with animal health giant Zoetis (ZTS) on developing veterinary vaccines for cattle.

Taking DepoVax to the Next Level

For Immunovaccine, 2017 has been a year full of significant milestones and positions the company well for more breakthroughs in 2018. In addition to the advances on multiple fronts for DepoVax-based treatments, Immunovaccine has taken many steps to enhance its abilities to continue to execute. In June, the company raised approximately $10 million, with the proceeds to be used for further R&D and clinical advancements of its vaccine candidates.

“The target of DPX-Survivac, survivin, is associated with more than 20 types of hematological and solid cancers,” Ors said at the time. “With this association, and its other unique properties, we have only just begun to scratch the surface of DPX-Survivac’s potential within our growing pipeline. We are excited to continue our aggressive pursuit of bringing groundbreaking immunotherapies to the many millions of underserved people living with difficult-to-treat cancers.”

That same month, the company also introduced its inaugural scientific and clinical advisory committee (SCAC), which was created to bolster Immunovaccine’s scientific resources by providing a deep pool of knowledge, data and access to draw from as it pursues the advancement of its applications based on the DepoVax™ platform.

Considering that, as Ors said, the company has only scratched the surface of the potential applications for DepoVax to treat serious and life-threatening cancers and infectious diseases, 2018 could be poised to be an even bigger year for Immunovaccine.


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